Merck Sharp & Dohme Corp. v. Fresenius Kabi USA, LlcBRIEF in OppositionD.N.J.October 3, 2016WINSTON & STRAWN LLP The Legal Center One Riverfront Plaza, Suite 730 Newark, New Jersey 07102 (973) 848-7676 James S. Richter Attorneys for Defendant Fresenius Kabi USA, LLC. UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY MERCK SHARP & DOHME CORP., Plaintiff, v. FRESENIUS KABI USA, LLC, Defendant. ) ) ) ) ) C.A. No. 14-4989 (SRC)(CLW) ) ) ) ) ) DEFENDANT’S BRIEF IN OPPOSITION TO PLAINTIFF’S MOTION FOR SUMMARY JUDGMENT THAT IT HOLDS TITLE TO THE ’300 PATENT Case 2:14-cv-04989-SRC-CLW Document 228 Filed 10/03/16 Page 1 of 12 PageID: 3005 i TABLE OF CONTENTS TABLE OF CONTENTS ........................................................................................................................ i TABLE OF AUTHORITIES ................................................................................................................... ii INTRODUCTION .......................................................................................................................... 1 BACKGROUND ............................................................................................................................ 1 LEGAL STANDARDS FOR SUMMARY JUDGMENT AND STANDING .............................. 3 ARGUMENT .................................................................................................................................. 5 CONCLUSION ............................................................................................................................... 7 Case 2:14-cv-04989-SRC-CLW Document 228 Filed 10/03/16 Page 2 of 12 PageID: 3006 ii TABLE OF AUTHORITIES Cases Abbott Labs. v. Diamedix Corp., 47 F.3d 1128 (Fed. Cir. 1995) .................................................................................................... 6 Abraxis Bioscience, Inc. v. Navinta LLC, 625 F.3d 1359 (Fed. Cir. 2010) .............................................................................................. 4, 5 Anderson v. Liberty Lobby, Inc., 477 U.S. 242 (1986) .................................................................................................................... 4 Bd. of Trustees of Leland Stanford Junior Univ. v. Roche Molecular Sys., Inc., 583 F.3d 832 (Fed. Cir. 2009), aff’d, 563 U.S. 776 (2011) .......................................................................................................... 4 Blunt v. Lower Merion Sch. Dist., 767 F.3d 247, (3d Cir. 2014), cert. denied sub nom. Allston v. Lower Merion Sch. Dist., 135 S. Ct. 1738 (2015) ................... 4 Chabal v. Reagan, 822 F.2d 349 (3d Cir.1987) ........................................................................................................ 6 FW/PBS Inc. v. City of Dallas, 493 U.S. 215 (1990) .................................................................................................................... 6 Keene Corp. v. U.S., 508 U.S. 200 (1993) .................................................................................................................... 4 Lujan v. Defenders of Wildlife, 504 U.S. 555 (1992) .................................................................................................................... 4 Pandrol USA, LP v. Airboss Ry. Prods., 320 F.3d 1354 (Fed. Cir. 2003) .................................................................................................. 4 Paradise Creations, Inc. v. UV Sales, Inc., 315 F.3d 1304 (Fed. Cir. 2003) .................................................................................................. 4 Pub. Interest Research Grp. of N.J., Inc. v. Magnesium Elektron, Inc., 123 F.3d 111 (3d Cir. 1997) ....................................................................................................... 6 Sicom Sys., Ltd. v. Agilent Techs., Inc., 427 F.3d 971 (Fed. Cir. 2005) .................................................................................................... 4 Speedplay, Inc. v. Bebop, Inc., 211 F.3d 1245 (Fed. Cir. 2000) .................................................................................................. 5 Tolan v. Cotton, 134 S. Ct. 1861 (2014) ............................................................................................................ 3, 4 Vaupel Textilmaschinen KG v. Meccanica Euro Italia S.P.A., 944 F.2d 870 (Fed. Cir. 1991) ................................................................................................ 5, 6 Case 2:14-cv-04989-SRC-CLW Document 228 Filed 10/03/16 Page 3 of 12 PageID: 3007 iii WiAV Sols. LLC v. Motorola, Inc., 631 F.3d 1257 (Fed. Cir. 2010) .................................................................................................. 4 Statutes Fed. R. Civ. P. 56(a) ....................................................................................................................... 3 Case 2:14-cv-04989-SRC-CLW Document 228 Filed 10/03/16 Page 4 of 12 PageID: 3008 1 INTRODUCTION Merck had every chance to resolve the standing issue by simply producing one document: its license of the ’300 patent to Teva. Merck chose not to do so, and has still steadfastly refused to produce the document, despite the facts that (a) the agreement with Teva was a “license;” (b) without knowing what rights Teva has, Merck cannot show standing; and (c) there is a stringent Discovery Confidentiality Order in this case protecting any confidentiality concerns. Merck has instead taken the most wasteful path of seeking summary judgment, even though there have been and remain serious questions of fact precluding an early judgment on standing without the Teva License in hand. Merck tries to avoid the real issue by stating that it has shown the chain of title to various “assignments” for the ’300 patent, but that is not the issue. The issue is whether Merck gave a license to Teva that transferred enough rights such that Merck by itself does not have standing, without adding Teva as a party. It would have taken minutes for counsel to review the Teva License and confirm Merck has standing or not, but Merck has repeatedly refused to produce the agreement even though it is a part of Merck’s affirmative case on which Merck alone has the burden of proof. Instead of producing the agreement, Merck instead submits conclusory argument and declarations that can never show what rights Teva has to see whether Teva needs to be added as a party. BACKGROUND Even in discovery, Merck had the burden to produce documents to show standing, or upon which it intended to rely at trial, which are fairly simple propositions. Instead of acknowledging the obligation for these purposes, Merck tries to point the finger elsewhere, and for Fresenius Kabi’s discovery for other issues. Case 2:14-cv-04989-SRC-CLW Document 228 Filed 10/03/16 Page 5 of 12 PageID: 3009 2 Fresenius Kabi asked Merck about its proof of standing, and Merck only submitted a response during discovery that it will produce documents. Ex. A1, MERCK’S RESPONSES TO FRESENIUS KABI’S FIRST SET OF INTERROGATORIES (NOS. 1-8) TO MERCK, at 1. Yet to this day, Merck has yet to provide an actual response to this interrogatory nor has it produced all pertinent documents, and in particular the Teva License. Instead, Merck moves for summary judgment after sitting on its hands for nearly a year during the scope of this litigation Fresenius Kabi did seek discovery to probe Merck’s evidentiary basis for possible claims of secondary considerations of non-obviousness, which at the time could have included the secondary consideration “licensing to others.” For that reason, on October 21, 2014, Fresenius Kabi served it first set of requests for production on Merck, including requests asking for license agreements as to the ’300 patent. Ex. B, MERCK’S RESPONSES TO FRESENIUS KABI’S FIRST SET OF REQUESTS FOR PRODUCTION, at 20, 24, Req. Nos. 18 (“Licenses or offers to license each of the patents-in-suit and all documents relating to negotiations about such a license.”) and 23 (“Documents relating to any licensing, royalty sharing, manufacturing, or supply agreements concerning Cancidas.”). Merck responded on November 24, 2014 stating that it would produce documents responsive to both of these requests at least as to the ’300 patent. Id. But Merck never produced the Teva license. Because Merck was not relying on the secondary consideration of “license to others,” Fresenius Kabi had no need for the license for reasons related to Fresenius Kabi’s own case. 1 Exhibits cited herein refer to exhibits attached to the DECLARATION OF THOMAS A. RAMMER IN SUPPORT OF DEFENDANT’S BRIEF IN OPPOSITION TO PLAINTIFF’S MOTION FOR SUMMARY JUDGMENT THAT IT HOLDS TITLE TO THE ’300 PATENT, filed concurrently with this brief. Case 2:14-cv-04989-SRC-CLW Document 228 Filed 10/03/16 Page 6 of 12 PageID: 3010 Case 2:14-cv-04989-SRC-CLW Document 228 Filed 10/03/16 Page 7 of 12 PageID: 3011 4 inferences are to be drawn in [the nonmovant’s] favor.” Id. at 1863 (quoting Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986)). Merck must prove that it has standing to bring this case because a court may exercise jurisdiction only if a plaintiff has standing to sue on the date it files suit. Abraxis Bioscience, Inc. v. Navinta LLC, 625 F.3d 1359, 1364 (Fed. Cir. 2010) (quoting Keene Corp. v. U.S., 508 U.S. 200, 207 (1993) (There is a “longstanding principle that the ‘jurisdiction of the Court depends upon the state of things at the time of the action brought.’”); Sicom Sys., Ltd. v. Agilent Techs., Inc., 427 F.3d 971, 976 (Fed. Cir. 2005) (“The party bringing the action bears the burden of establishing that it has standing.”); see also Lujan v. Defenders of Wildlife, 504 U.S. 555, 560 (1992). It is not Fresenius Kabi’s burden to challenge Merck’s standing as Merck suggests, but “in a patent infringement action, ‘the plaintiff must demonstrate that it held enforceable title to the patent at the inception of the lawsuit’ to assert standing.” Id. (quoting Paradise Creations, Inc. v. UV Sales, Inc., 315 F.3d 1304, 1309–310 (Fed. Cir. 2003)). Moreover, even though Fresenius Kabi raised the issue as early as when it filed affirmative defenses, standing is an issue that can be raised at any time. Bd. of Trustees of Leland Stanford Junior Univ. v. Roche Molecular Sys., Inc., 583 F.3d 832, 841 (Fed. Cir. 2009), aff’d, 563 U.S. 776 (2011); see also Blunt v. Lower Merion Sch. Dist., 767 F.3d 247, 280 (3d Cir. 2014), cert. denied sub nom. Allston v. Lower Merion Sch. Dist., 135 S. Ct. 1738 (2015); Pandrol USA, LP v. Airboss Ry. Prods., 320 F.3d 1354, 1367 (Fed. Cir. 2003). “[T]he touchstone of constitutional standing in a patent infringement suit is whether a party can establish that it has an exclusionary right in a patent that, if violated by another, would cause the party holding the exclusionary right to suffer legal injury.” WiAV Sols. LLC v. Motorola, Inc., 631 F.3d 1257, 1265 (Fed. Cir. 2010). Case 2:14-cv-04989-SRC-CLW Document 228 Filed 10/03/16 Page 8 of 12 PageID: 3012 5 ARGUMENT By not producing the Teva license, Merck cannot show that it has standing. There is a genuine material question of fact concerning Merck’s ownership rights in the ’300 patent, and in turn its standing in this case, because Merck has not produced the Teva License. While Merck may unilaterally assert that there were “no rights granted to” Teva, that is a disputed fact. And without the Teva License, it is a fact that cannot be confirmed because there are often cases where a party argues or believes that it did not transfer any substantial rights, but in fact legally there are enough transferred rights or benefits so as to create a standing issue. Speedplay, Inc. v. Bebop, Inc., 211 F.3d 1245, 1250 (Fed. Cir. 2000) (“A party that has been granted all substantial rights under the patent is considered the owner regardless of how the parties characterize the transaction that conveyed those rights.”) (emphasis added).At this point, Merck has simply stated that the Teva License does not affect its ownership rights, but this will only be determined by examining the actual rights conveyed in the Teva License. See Vaupel Textilmaschinen KG v. Meccanica Euro Italia S.P.A., 944 F.2d 870, 873 (Fed. Cir. 1991) (“[W]hether a transfer of a particular right or interest under a patent is an assignment or a license does not depend upon the name by which it calls itself, but upon the legal effect of its provisions.”); Abraxis, 625 F.3d at 1364 (“Whether an assignment of patent rights in an agreement is automatic or merely a promise to assign depends on the contractual language itself.”). Merck’s mere allegation that it owns all right, title and interest in and to the ’300 patent is not sufficient to establish ownership and to meet its burden to show standing. There are several examples where license agreements are found to convey substantial rights despite what the parties called a document or labeled the agreement. See, e.g., Speedplay, 211 F.3d at 1250–52 (agreement transferring certain patent rights constituted assignment of all substantial rights in patents at issue, Case 2:14-cv-04989-SRC-CLW Document 228 Filed 10/03/16 Page 9 of 12 PageID: 3013 6 even though assignor retained right to bring infringement suit if assignee chose not to and assignee was required to ask for consent for further assignments); Vaupel, 944 F.2d at 875 (agreement transferring patent rights constituted assignment of all substantial rights in patent where assignor retained only (1) veto right on sublicensing; (2) right to obtain patents on invention in other countries; (3) reversionary right to patent in event of bankruptcy; and (4) right to receive infringement damages); see also Abbott Labs. v. Diamedix Corp., 47 F.3d 1128, 1131–32 (Fed. Cir. 1995) (holding that the license agreement did not transfer enough rights to convey standing to the purportedly exclusive licensee). Merck has a vital reason to produce the Teva License and any other agreements it has yet to disclose. After all, “standing is ‘perhaps the most important’ of jurisdictional doctrines.” Pub. Interest Research Grp. of N.J., Inc. v. Magnesium Elektron, Inc., 123 F.3d 111, 117 (3d Cir. 1997) (citing FW/PBS Inc. v. City of Dallas, 493 U.S. 215, 230–31 (1990); Chabal v. Reagan, 822 F.2d 349, 355 (3d Cir.1987)). The evidence of record shows that, despite public statements allegedly to the contrary, the Teva License includes a patent license which calls into question whether Merck has properly retained all of the ownership rights to the ’300 patent. This substantial question of Merck’s standing means that Merck is not entitled to summary judgment on this issue. It is therefore incumbent upon Merck to prove that it has retained ownership rights to confer standing to sue in this case, especially in light of the unexamined Teva License. Merck has repeatedly shirked this responsibility. Yet at the same time Merck wants Fresenius Kabi to stipulate to its ownership without proving that it has sufficient rights to the ’300 patent and has led to unnecessary letter briefs to this Court, and now even a summary judgment motion, over an issue that Merck could have solved by allowing Fresenius Kabi counsel to inspect the Teva license agreement. Case 2:14-cv-04989-SRC-CLW Document 228 Filed 10/03/16 Page 10 of 12 PageID: 3014 7 Even if Merck makes the same arguments it makes now at trial, the evidence it presents still is not enough to show standing in the absence of the license agreement with Teva. Until that document is produced and examined, standing cannot be shown either by summary judgment or at trial. A witness testifying along the lines of Merck’s argument still could not show as a matter of law that Merck had standing, because the fact remains that there is a Teva License that no one except Merck has seen, and which does provide some unknown rights to Teva. The question remains what rights those are, and if they are enough to affect standing, which is a determination that can be made after reviewing the Teva document. All Merck has to do, if it really does have standing, is to produce the Teva license (and indeed any other licenses to the ’300 patent, if they exist). This is a problem created solely by Merck, and one that only Merck can address. CONCLUSION Fresenius Kabi respectfully requests that the Court deny Merck’s request for Summary Judgment on the ownership of the ’300 patent. WINSTON & STRAWN LLP Attorneys for Defendant Fresenius Kabi USA, LLC By: s/ James S. Richter James S. Richter jrichter@winston.com Dated: October 3, 2016 OF COUNSEL: Imron T. Aly Thomas A. Rammer Emily Peña Schiff Hardin LLP 233 S. Wacker Drive Chicago, IL 60606 (312) 258-5500 John K. Hsu 901 K Street NW, Suite 700 Washington, DC 20001 (202) 778-6400 George C. Yu Schiff Hardin LLP One Market Street, Spear Street Tower Thirty-Second Floor San Francisco, CA 94105 (415) 901-8700 Case 2:14-cv-04989-SRC-CLW Document 228 Filed 10/03/16 Page 11 of 12 PageID: 3015 CERTIFICATION OF SERVICE I hereby certify that on October 3, 2016, copies of the foregoing DEFENDANT’S BRIEF IN OPPOSITION TO PLAINTIFF’S MOTION FOR SUMMARY JUDGMENT THAT IT HOLDS TITLE TO THE ’300 PATENT were served by electronic filing and electronic mail upon all counsel of record. I certify that the foregoing statements made by me are true. I am aware that if any of the foregoing statements are willfully false, I am subject to punishment. s/ James S. Richter James S. Richter jrichter@winston.com Dated: October 3, 2016 Case 2:14-cv-04989-SRC-CLW Document 228 Filed 10/03/16 Page 12 of 12 PageID: 3016 WINSTON & STRAWN LLP The Legal Center One Riverfront Plaza, Suite 730 Newark, New Jersey 07102 (973) 848-7676 James S. Richter Attorneys for Defendant Fresenius Kabi USA, LLC. UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY MERCK SHARP & DOHME CORP., Plaintiff, v. FRESENIUS KABI USA, LLC, Defendant. ) ) ) ) ) C.A. No. 14-4989 (SRC)(CLW) ) ) ) ) ) DECLARATION OF THOMAS A. RAMMER IN SUPPORT OF DEFENDANT’S BRIEF IN OPPOSITION TO PLAINTIFF’S MOTION FOR SUMMARY JUDGMENT THAT IT HOLDS TITLE TO THE ’300 PATENT Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 1 of 70 PageID: 3017 I, Thomas A. Rammer, do hereby declare as follows: 1. I am an attorney at law of the State of Illinois and an attorney with the firm of Schiff Hardin LLP, counsel for Defendant Fresenius Kabi USA, LLC (“Fresenius Kabi”) in the above action. I make this Declaration in support of Defendant’s Brief In Opposition To Plaintiff’s Motion For Summary Judgment That It Holds Title To The ’300 Patent. 2. Attached as Exhibit A is a true and correct copy of MERCK’S RESPONSES TO FRESENIUS KABI’S FIRST SET OF INTERROGATORIES (NOS. 1-8) TO MERCK. 3. Attached as Exhibit B is a true and correct copy of MERCK’S RESPONSES TO FRESENIUS KABI’S FIRST SET OF REQUESTS FOR PRODUCTION. 4. Attached as Exhibit C and filed under seal is a true and correct copy of is a true and correct copy of the email entitled “RE: Merck Sharp & Dohme Corp. v. Fresenius Kabi USA, LLC, 14-4989-SRC-CLW (D.N.J.),” sent to Fresenius’s counsel of record from Matthew Traupman, Merck’s counsel of record, dated August 18, 2016. I declare under penalty of perjury under the laws of the United States of America that the foregoing is true and correct. Executed on October 3, 2016, in Chicago, IL. /s/ Thomas A. Rammer Thomas A. Rammer Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 2 of 70 PageID: 3018 EXHIBIT A Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 3 of 70 PageID: 3019 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY David E. De Lorenzi, Esq. GIBBONS P.C. One Gateway Center Newark, New Jersey 07102-5310 (973) 596-4500 OF COUNSEL: Brian V. Slater Gregory B. Sephton Jason A. Leonard FITZPATRICK, CELLA, HARPER & SCINTO 1290 Avenue of the Americas New York, NY 10104-3800 (212) 218-2100 Attorneys for Plaintiff Merck Sharp & Dohme Corp. MERCK SHARP & DOHME CORP., Plaintiff, v. FRESENIUS KABI USA, LLC, Defendant. ) ) ) ) ) ) ) ) ) ) C.A. No. 14-4989 (SRC)(CLW) MERCK’S RESPONSES TO FRESENIUS KABI’S FIRST SET OF INTERROGATORIES (NOS. 1-8) TO MERCK Pursuant to Rule 33 of the Federal Rules of Civil Procedure, Plaintiff Merck Sharp & Dohme Corp. (“Merck”) hereby objects and responds to the First Set of Interrogatories (Nos. 1- 8) (“Interrogatories”) of Defendant Fresenius Kabi USA, LLC (“Fresenius”), served on October 21, 2014, as follows: Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 4 of 70 PageID: 3020 2 GENERAL OBJECTIONS Merck makes the following general objections to the Interrogatories, which apply to each individual interrogatory, and shall have the same force and effect as if fully set forth in response to each individual interrogatory: 1. Merck objects to the Interrogatories, including the “Definitions and Instructions, to the extent they purport to impose obligations on Merck that exceed or are inconsistent with its obligations under, or are premature in light of, the Federal Rules of Civil Procedure and the Local Civil Rules of the United States Court for the District of New Jersey (“Local Rules”), including but not limited to Local Rule 33.1. 2. Merck objects to the Interrogatories to the extent they seek information protected by the attorney-client privilege, attorney work product immunity, joint defense privilege or any other applicable privilege or immunity. Nothing contained in Merck’s responses is intended to be, or in any way shall be deemed to be, a waiver of any such applicable privilege or immunity. An objection based on attorney-client privilege, work product immunity and/or any other applicable privilege or immunity should not be construed as a representation that such information exists or existed. Such an objection indicates only that the Interrogatories are of such a scope as to embrace subject matter protected by attorney-client privilege, work product immunity and/or any other applicable privilege or immunity. 3. Merck objects to Fresenius’ definition of “Fresenius Kabi’s NDA Product” as vague and ambiguous to the extent that it does not specifically identify the drug product referenced in Fresenius’ New Drug Application (“NDA”) No. 206110. Merck further objects to Fresenius’ definition of “Fresenius Kabi’s NDA Product” as indefinite, overly broad, Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 5 of 70 PageID: 3021 3 unduly burdensome, and neither relevant nor reasonably calculated to lead to the discovery of admissible evidence. 4. Merck objects to Fresenius’ instruction in Paragraph 4 as being vague, ambiguous, indefinite, overly broad, unduly burdensome, and neither relevant nor reasonably calculated to lead to the discovery of admissible evidence. Merck further objects to this instruction insofar as it imposes any requirement or obligation on Merck which is inconsistent with, is not found in, or exceeds the requirements of the Federal Rules of Civil Procedure and the Local Rules. 5. Merck objects to Fresenius’ instruction in Paragraph 5 insofar as it imposes any requirement or obligation on Merck which is inconsistent with, is not found in, or exceeds the requirements of the Federal Rules of Civil Procedure and the Local Rules. 6. Merck objects to the Interrogatories to the extent that they are overly broad and unduly burdensome, and seek information or the production of documents or things not relevant to any claim or defense raised in this lawsuit, or reasonably calculated to lead to the discovery of admissible evidence. Fed. R. Civ. P. 26(b)(1). 7. Merck objects to the Interrogatories to the extent that they are unreasonably cumulative or duplicative of other Interrogatories, or seek information or the production of documents and things that are obtainable from another source that is more convenient, less burdensome, or less expensive. Fed. R. Civ. P. 26(b)(2)(C)(i). 8. Merck objects to the Interrogatories to the extent that they call for information or the production of documents or things for which the burden or expense of production outweighs its likely benefit in resolving the issues of this action. Fed. R. Civ. P. 26(b)(2)(C)(iii). Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 6 of 70 PageID: 3022 4 9. Merck objects to the Interrogatories to the extent that they call for information or the production of documents or things available to Fresenius from its own files, from files within its custody or control, or from public sources. 10. Merck objects to the Interrogatories to the extent they seek information that is not reasonably available to or within the possession, custody or control of Merck. 11. Merck objects to providing any information or the production of documents and things that is protected by disclosure under any court order or third party confidentiality agreement or stipulation. 12. Merck objects to the Interrogatories to the extent they call for a legal conclusion. 13. Where Merck agrees to produce documents, it will do so by making a reasonable search of logical repositories in the United States where Plaintiff resides. Merck will not search libraries or the files of patent agents or attorneys who are not employed by Merck. 14. Merck reserves the right to redact from the documents it produces irrelevant, non-responsive, privileged and/or work product information. 15. Merck objects to the Interrogatories to the extent they call for information or the production of documents or things concerning Merck’s research and development occurring after the March 28, 1997 U.S. filing date of U.S. Patent No. 5,952,300 (“the ’300 patent”) as overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeking information that is irrelevant to any claim or defense in this action. 16. Merck objects to the Interrogatories to the extent they seek information related to U.S. Pat. No. 5,514,650 (“the ’650 patent). At the Fed. R. Civ. P. conference on Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 7 of 70 PageID: 3023 5 November 6, 2014, Fresenius agreed to withdraw its challenge to the ’650 patent by converting to a Paragraph III certification. As such, any information related to the ’650 patent is irrelevant to the remaining claims and defenses in this case. Accordingly, Merck need not, and will not, address discovery requests relating to the ’650 patent. 17. Merck objects to these requests as overly broad, unduly burdensome and irrelevant to the extent they call for the production of documents or things created after June 23, 2014, the date of the Paragraph IV notice letter received by Merck from Fresenius in the pending litigation. 18. Merck specifically reserves all objections as to the competency, relevancy, materiality, and admissibility of its documents or the subject matter thereof, all objections as to burden, vagueness, overbreadth, and ambiguity, and all rights to object on any ground to the use of any document, or the subject matter thereof, in any subsequent proceeding, including, without limitation, the trial of this or any other action. 19. Merck’s provision of information or documents notwithstanding the objectionable nature of any of the Instructions or Definitions, or the Interrogatories or Document Requests themselves, should not be construed as: (i) a stipulation that the material is relevant, (ii) a waiver of the General Objections or objections asserted in response to specific Interrogatories or Document Requests, or (iii) an agreement that the requests for similar information will be treated in a similar manner. 20. Merck objects to the Interrogatories as overly broad, unduly burdensome and irrelevant to the extent they call for information or documents and things concerning sales, marketing, accounting, finances, manufacture, and regulatory applications outside the United States regarding Cancidas®. Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 8 of 70 PageID: 3024 6 21. No objection, limitation, or response, or lack thereof, made herein, shall be an admission by Merck as to (a) the truth of any of the statements made in the Interrogatory, or (b) the existence or non-existence of documents responsive to the Interrogatory. 22. Merck objects to the Interrogatories as premature to the extent they seek information regarding contentions at a time inconsistent with the Scheduling Order in this case, the Federal Rules of Civil Procedure and/or the Local Rules. 23. Merck objects to the Interrogatories to the extent the subject matter of the Interrogatories is more properly addressed by other forms of discovery, including expert discovery. 24. Discovery is not yet complete in this case, and Merck’s objections and responses are based on Merck’s best knowledge, information and belief at this time. Merck’s objections and responses are made without prejudice to Merck’s right to revise or supplement them based on the discovery taken in this case or on facts or circumstances that may become known to Merck during the remainder of discovery. Further, Merck’s objections and responses are based on Merck’s good-faith interpretation of the individual interrogatories and are subject to correction for errors or omission, if any. 25. Merck objects to the Interrogatories to the extent they contain multiple, unrelated subparts resulting in a total number of Interrogatories in excess of the limits agreed to by the parties and set forth in the Scheduling Order. Merck does not waive this objection by providing the below responses, and reserves the right to object to these Interrogatories, including in response to any request for supplemental or amended responses. 26. These responses and the objections and limitations contained herein are subject to and without waiver of (a) the right to make additional or supplemental objections to Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 9 of 70 PageID: 3025 7 these or other interrogatories, and (b) the right to revise, correct, amend, or modify these responses upon, among other things, the discovery of additional facts and materials, further investigation and other developments in this proceeding. SPECIFIC OBJECTIONS AND RESPONSES TO FRESENIUS’ INTERROGATORIES (NOS. 1-8) INTERROGATORY 1: Explain MSD’s contention that it has standing to bring suit in the above-captioned matter, including identification and description of the chain of title for each accused patent from its filing to the present day. RESPONSE TO INTERROGATORY 1: Merck objects to this interrogatory as premature because Merck’s obligation to produce documents regarding ownership of the patents-in-suit is not due until January 21, 2015. Merck also objects to this interrogatory on the grounds that it is not relevant to any claim or defense currently in this action and not reasonably calculated to lead to the discovery of admissible evidence. Merck also objects to this interrogatory as overbroad and unduly burdensome. Merck also objects to this interrogatory to the extent it calls for a legal conclusion. Merck further objects to this interrogatory to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Subject to its general and specific objections, Merck responds as follows: Merck is the assignee of the U.S. Pat. No. 5,952,300 (“the ’300 patent”). Pursuant to Fed. R. Civ. P. 33(d) and Local Rule 3.2(d), Merck has produced or will produce non-privileged documents from which additional information requested by this interrogatory may be derived or ascertained. Merck will supplement this answer if appropriate as discovery progresses. INTERROGATORY 2: If MSD intends to rely upon secondary considerations of non-obviousness to rebut Fresenius Kabi’s contention that the asserted claims are obvious, identify upon which Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 10 of 70 PageID: 3026 8 considerations MSD intends to rely and, for each asserted consideration, identify documents and factual support for each asserted consideration and the nexus therefore. RESPONSE TO INTERROGATORY 2: Merck objects to this interrogatory as premature on the grounds that fact discovery has only just commenced and is not scheduled to be completed until September 30, 2015. Merck further objects to this interrogatory to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck also objects to this interrogatory as premature on the ground that Fresenius has not yet specified through invalidity contentions any grounds alleging invalidity due to obviousness, despite bearing the burden of proving invalidity. The ’300 patent is presumed valid under 35 U.S.C. § 282, and Fresenius bears the burden of establishing invalidity by clear and convincing evidence. Merck further objects to this interrogatory to the extent it prematurely seeks expert discovery. Under the Scheduling Order, Merck’s response to Fresenius’ invalidity contentions is not due until January 21, 2015, rebuttal expert reports are not due until December 16, 2015, and expert discovery will not be completed until February 4, 2016. To the extent there are any documents supporting Merck’s contention on any secondary considerations of non-obviousness to rebut Fresenius Kabi’s contention that the asserted claims are obvious, they will be produced subject to Merck’s objections. Merck will supplement this answer if appropriate as discovery progresses. INTERROGATORY 3: Explain the basis for Plaintiffs’ denial in their Answer to Fresenius Kabi’s Counterclaims (D.I. # 15) paragraph 24 and identify documents and facts that support Plaintiffs’ basis for their denial. RESPONSE TO INTERROGATORY 3: Merck objects to this interrogatory to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 11 of 70 PageID: 3027 9 INTERROGATORY 4: Explain the basis for Plaintiffs’ denial in their Answer to Fresenius Kabi’s Counterclaims (D.I. # 15) paragraph 29 and identify documents and facts that support Plaintiffs’ basis for their denial. RESPONSE TO INTERROGATORY 4: Merck objects to this interrogatory as premature on the grounds that fact discovery has only just commenced and is not scheduled to be completed until September 30, 2015. Merck also objects to this interrogatory as premature on the ground that Fresenius has not yet specified through invalidity contentions any grounds alleging invalidity, despite bearing the burden of proving invalidity. The patents-in-suit are presumed valid under 35 U.S.C. § 282, and Fresenius bears the burden of establishing invalidity by clear and convincing evidence. Merck further objects to this interrogatory to the extent it prematurely seeks expert discovery. Fresenius has not yet provided permission for Merck to provide a copy of Fresenius’ NDA to experts. Moreover, under the Scheduling Order, opening expert reports with respect to all issues on which such party bears the burden of proof are not due until November 16, 2015, and expert discovery will not be completed until February 4, 2016. To the extent there are any documents concerning Merck’s denial in its Answer to Fresenius Kabi’s Counterclaims (D.I. # 15) paragraph 29, they will be produced subject to Merck’s objections. Subject to its general and specific objections, Merck responds as follows: The ’300 patent is not invalid for failure to comply with the statutory prerequisites of Title 35 of the United States Code, 35. U.S.C. § 101 et seq., including one or more of §§ 101, 102, 103, 112 and/or 116, or other judicially-created bases for invalidation and unenforceability. Merck will supplement this answer if appropriate as discovery progresses. INTERROGATORY 5: Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 12 of 70 PageID: 3028 10 State the date that MSD contends each asserted claim of the patents-in-suit may claim priority, and state in full and informative detail the basis for each assertion as to each claim. RESPONSE TO INTERROGATORY 5: Merck objects to this interrogatory as premature on the grounds that fact discovery has only just commenced and is not scheduled to be completed until September 30, 2015. Merck further objects to this interrogatory to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck also objects to this interrogatory as premature on the ground that Fresenius has not yet specified through invalidity contentions any grounds alleging invalidity due to obviousness, despite bearing the burden of proving invalidity. The ’300 patent is presumed valid under 35 U.S.C. § 282, and Fresenius bears the burden of establishing invalidity by clear and convincing evidence. Merck further objects to this interrogatory to the extent it prematurely seeks expert discovery. Under the Scheduling Order, opening expert reports with respect to all issues on which such party bears the burden of proof are not due until November 16, 2015, and expert discovery will not be completed until February 4, 2016. Subject to its general and specific objections, Merck responds as follows: The ’300 patent is entitled to a priority date that is not later than April 19, 1996, which is the date of the filing of the U.S. provisional application that ultimately led to issuance of the ‘300 patent. Merck will supplement this answer if appropriate as discovery progresses. INTERROGATORY 6: State the level of skill in the art MSD contends a person of ordinary skill in the art would possess for each of the patents-in-suit and identify the bases for those contentions. Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 13 of 70 PageID: 3029 11 RESPONSE TO INTERROGATORY 6: Merck objects to this interrogatory as premature on the grounds that fact discovery has only just commenced and is not scheduled to be completed until September 30, 2015. Merck further objects to this interrogatory to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck also objects to this interrogatory as premature on the ground that Fresenius has not yet specified through invalidity contentions any grounds alleging invalidity due to obviousness, despite bearing the burden of proving invalidity. The ’300 patent is presumed valid under 35 U.S.C. § 282, and Fresenius bears the burden of establishing invalidity by clear and convincing evidence. Merck further objects to this interrogatory to the extent it prematurely seeks expert discovery. Under the Scheduling Order, opening expert reports with respect to all issues on which such party bears the burden of proof are not due until November 16, 2015, and expert discovery will not be completed until February 4, 2016. Merck will supplement this answer if appropriate as discovery progresses. INTERROGATORY 7: Identify the persons involved with or responsible for the preparation, submission, amendment, and/or seeking approval of NDA No. 21-227, and provide a brief description of each person’s involvement or responsibility. RESPONSE TO INTERROGATORY 7: Merck objects to this interrogatory as premature on the grounds that fact discovery has only just commenced and is not scheduled to be completed until September 30, 2015. Merck further objects to this interrogatory to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck also objects to this interrogatory as overly broad and unduly burdensome in requesting a narrative description including virtually every detail of an entire FDA regulatory filing and in requesting the identity and involvement of every single person involved in such filing. Merck further objects to this interrogatory as Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 14 of 70 PageID: 3030 12 seeking information that is neither relevant nor reasonably calculated to lead to the discovery of admissible evidence. Subject to its general and specific objections, Merck has produced or will produce non-privileged documents, pursuant to Fed. R. Civ. P. 33(d), from which information requested by this interrogatory may be derived or ascertained. Merck will supplement this answer if appropriate as discovery progresses. INTERROGATORY 8: Identify the persons involved with or responsible for the consideration, testing or selection of any caspofungin-containing formulation or any other aza cyclohexapeptide compound, including the final selection of the formulation used in NDA No. 21-227, and provide a brief description of each person’s involvement or responsibility. RESPONSE TO INTERROGATORY 8: Merck objects to this interrogatory as premature on the grounds that fact discovery has only just commenced and is not scheduled to be completed until September 30, 2015. Merck further objects to this interrogatory to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck also objects to this interrogatory as overly broad and unduly burdensome in requesting a narrative description including virtually every detail of an entire research project. Merck further objects to this interrogatory as seeking information that is neither relevant nor reasonably calculated to lead to the discovery of admissible evidence. Subject to its general and specific objections, Merck has produced or will produce non-privileged documents, pursuant to Fed. R. Civ. P. 33(d), from which information requested by this interrogatory may be derived or ascertained. Merck will supplement this answer if appropriate as discovery progresses. Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 15 of 70 PageID: 3031 13 OF COUNSEL: Brian V. Slater Gregory B. Sephton Jason A. Leonard FITZPATRICK, CELLA, HARPER & SCINTO 1290 Avenue of the Americas New York, NY 10104-3800 (212) 218-2100 November 24, 2014 s/ David E. De Lorenzi David E. De Lorenzi, Esq. GIBBONS P.C. One Gateway Center Newark, NJ 07102-5310 (973) 596-4500 Attorneys for Plaintiff Merck Sharp & Dohme Corp. Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 16 of 70 PageID: 3032 CERTIFICATE OF SERVICE I, hereby certify that on November 24, 2014, true and correct copies of MERCK’S RESPONSES TO FRESENIUS KABI’S FIRST SET OF INTERROGATORIES (NOS. 1-8) were caused to be served upon the following in the manner indicated: Michael E. Patunas, Esq. Mayra V. Tarantino, Esq. LITE DEPALMA GREENBERG, LLC Two Gateway Center, Suite 1201 Newark, New Jersey 07102 Tel.: (973) 623-3000 Fax: (973) 623-0858 Email: mpatunas@litedepalma.com mtarantino@litedepalma.com VIA ELECTRONIC MAIL Imron Aly, Esq. Nimita Parekh, Esq. Joel Wallace, Esq. Gina Bassi, Esq. SCHIFF HARDIN LLP 233 S. Wacker Drive Chicago, IL 60606 Tel.: (312) 258-5500 Fax: (312) 258-5600 Email: ialy@schiffhardin.com nparekh@schiffhardin.com jwallace@schiffhardin.com gbassi@schiffhardin.com VIA ELECTRONIC MAIL Alison Maddeford, Esq. SCHIFF HARDIN LLP One Market, Spear Street Tower Thirty-Second Floor San Francisco, DA 94105 Tel.: (415) 901-8700 Fax: (415) 901-8701 Email: amaddeford@schiffhardin.com Attorneys for Defendant Fresenius Kabi USA, LLC VIA ELECTRONIC MAIL Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 17 of 70 PageID: 3033 2 s/ David E. De Lorenzi, Esq David E. De Lorenzi, Esq. Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 18 of 70 PageID: 3034 EXHIBIT B Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 19 of 70 PageID: 3035 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY David E. De Lorenzi, Esq. GIBBONS P.C. One Gateway Center Newark, New Jersey 07102-5310 (973) 596-4500 OF COUNSEL: Brian V. Slater Gregory B. Sephton Jason A. Leonard FITZPATRICK, CELLA, HARPER & SCINTO 1290 Avenue of the Americas New York, NY 10104-3800 (212) 218-2100 Attorneys for Plaintiff Merck Sharp & Dohme Corp. MERCK SHARP & DOHME CORP., Plaintiff, v. FRESENIUS KABI USA, LLC, Defendant. ) ) ) ) ) ) ) ) ) ) C.A. No. 14-4989 (SRC)(CLW) MERCK’S RESPONSES TO FRESENIUS KABI’S FIRST SET OF REQUESTS FOR THE PRODUCTION OF DOCUMENTS AND THINGS (NOS. 1-46) Pursuant to Rules 26 and 34 of the Federal Rules of Civil Procedure and the applicable Local Rules of the United States District Court for the District of New Jersey, Plaintiff Merck Sharp & Dohme Corp. (“Merck”) hereby objects and responds to Defendant Fresenius Kabi USA, LLC’s (“Fresenius”) First Set of Requests for Production of Documents and Things (Nos. 1-46), served on October 21, 2014, as follows: Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 20 of 70 PageID: 3036 2 GENERAL OBJECTIONS Merck objects generally to these requests, including the definitions and instructions applicable thereto, to the extent set forth below. The following general objections and statements shall apply to and be included in Merck’s response to each of Fresenius’ requests, whether or not mentioned expressly in any particular response. Merck does not waive any of its general objections by also stating specific objections to any particular document request. 1. Merck objects to these requests, including the Definitions and Instructions, to the extent they purport to impose obligations on Merck that exceed or are inconsistent with its obligations under, or are premature in light of, the Federal Rules of Civil Procedure and the Local Civil Rules of the United States Court for the District of New Jersey (“Local Rules”), including but not limited to Local Rule 34.1. 2. Merck objects to these requests to the extent they seek information protected by the attorney-client privilege, attorney work product immunity, joint defense privilege or any other applicable privilege or immunity. Nothing contained in Merck’s responses is intended to be, or in any way shall be deemed to be, a waiver of any such applicable privilege or immunity. An objection based on attorney-client privilege, work product immunity and/or any other applicable privilege or immunity should not be construed as a representation that such information exists or existed. Such an objection indicates only that these requests are of such a scope as to embrace subject matter protected by attorney-client privilege, work product immunity and/or any other applicable privilege or immunity. 3. Merck objects to these requests to the extent that they are overly broad and unduly burdensome, and seek information or the production of documents or things not relevant Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 21 of 70 PageID: 3037 3 to any claim or defense raised in this lawsuit, or reasonably calculated to lead to the discovery of admissible evidence. Fed. R. Civ. P. 26(b)(1). 4. Merck objects to these requests to the extent that they are unreasonably cumulative or duplicative of other requests, or seek information or the production of documents and things that are obtainable from another source that is more convenient, less burdensome, or less expensive. Fed. R. Civ. P. 26(b)(2)(C)(i). 5. Merck objects to these requests to the extent that they call for information or the production of documents or things for which the burden or expense of production outweighs its likely benefit in resolving the issues of this action. Fed. R. Civ. P. 26(b)(2)(C)(iii). 6. Merck objects to these requests to the extent that they seek documents and things that are not within the possession, custody or control of Merck. Where Merck agrees to produce documents, it will be or has been based on a reasonable search of logical repositories in the United States where Merck resides. Merck will not search libraries or files or patent agents or attorneys who are not employed by Merck. 7. Merck objects to providing any documents and things protected by disclosure under any court order or third party confidentiality agreement or stipulation. 8. Merck objects to these requests to the extent they call for a legal conclusion. 9. Merck objects to these requests to the extent that they call for information or the production of documents or things available from Fresenius from its own files, from files within its custody or control, or from public sources. 10. Merck objects to these requests as overly broad, unduly burdensome and irrelevant to the extent they call for the production of documents or things created after June 23, Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 22 of 70 PageID: 3038 4 2014, the date of the Paragraph IV notice letter received by Merck from Fresenius in the pending litigation. 11. Merck specifically reserves all objections as to the competency, relevancy, materiality, and admissibility of its documents or the subject matter thereof, all objections as to burden, vagueness, overbreadth, and ambiguity, and all rights to object on any ground to the use of any document, or the subject matter thereof, in any subsequent proceeding, including, without limitation, the trial of this, or any other, action. 12. Merck’s provision of information or documents notwithstanding the objectionable nature of any of the Definitions and Instructions, or the Document Requests themselves, should not be construed as: (i) a stipulation that the material is relevant, (ii) a waiver of the General Objections or the objections asserted in response to specific Document Requests, or (iii) an agreement that the requests for similar information will be treated in a similar manner. 13. Merck objects to Fresenius’ definitions of the terms “Cancidas” and “Caspofungin” to the extent they are redundant, and thereby ambiguous and indefinite. For the purposes of these responses and objections, Merck understands both terms to refer to the final drug product described in NDA No. 021227. Merck also objects to the production of documents relating to the research and development of the active molecule, caspofungin, as overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeking information that is irrelevant to any claim or defense in this action. 14. Merck objects to Fresenius’ definition of “Fresenius Kabi’s NDA Product” as vague and ambiguous to the extent that it does not specifically identify the drug product referenced in Fresenius’ New Drug Application (“NDA”) No. 206110. Merck further objects to Fresenius’ definition of “Fresenius Kabi’s NDA Product” as indefinite, overly broad, Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 23 of 70 PageID: 3039 5 unduly burdensome, and neither relevant nor reasonably calculated to lead to the discovery of admissible evidence. 15. Merck objects to Fresenius’ instruction in Paragraph 17 as being vague, ambiguous, indefinite, overly broad, unduly burdensome, and as imposing obligations inconsistent with and in addition to Merck’s obligations under the Federal Rules of Civil Procedure. 16. Merck objects to these requests to the extent they seek information related to U.S. Pat. No. 5,514,650 (“the ’650 patent). At the Fed. R. Civ. P. 16 conference on November 6, 2014, Fresenius agreed to withdraw its challenge to the ’650 patent by converting to a Paragraph III certification. As such, any information related to the ’650 patent is irrelevant to the remaining claims and defenses in this case. Accordingly, Merck need not, and will not, address discovery requests relating to the ’650 patent. 17. Merck reserves the right to redact from the documents it produces irrelevant, non-responsive, privileged and/or work product information. 18. No objection, limitation, or response, or lack thereof, made herein, shall be an admission by Merck as to (a) the truth of any statements made in the discovery request, or (b) the existence or non-existence of documents responsive to the discovery request. 19. Merck objects to these requests to the extent they are inconsistent with the Court’s November 10, 2014 Scheduling Order. 20. Merck objects to these requests to the extent the subject matter of these requests is more properly addressed by other forms of discovery, including expert discovery. 21. Discovery is not yet complete in this case, and Merck’s objections and responses are based on Merck’s best knowledge, information and belief at this time. Merck’s Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 24 of 70 PageID: 3040 6 objections and responses are made without prejudice to Merck’s right to revise or supplement them based on the discovery taken in this case or on facts or circumstances that may become known to Merck during the remainder of discovery. Further, Merck’s objections and responses are based on Merck’s good-faith interpretation of the individual requests and are subject to correction for errors or omissions, if any. 22. These responses and the objections and limitations contained herein are subject to and without waiver of (a) the right to make additional or supplemental objections to these or other document requests, and (b) the right to revise, correct, amend, or modify these responses upon, among other things, the discovery of additional facts and materials, further investigation and other developments in this proceeding. SPECIFIC OBJECTIONS AND RESPONSES TO FRESENIUS’ REQUESTS FOR PRODUCTION (NOS. 1-46) REQUEST No. 1: The prosecution of the patents-in-suit and their foreign counterparts. RESPONSE TO REQUEST No. 1: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. For example, Merck objects to this request to the extent that it fails to delineate the aspects of “[t]he prosecution”. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck objects to this request to the extent that it calls for the production, or the identification on a privilege log, of documents and things related to foreign prosecution. Merck also objects to this request to the extent that it seeks the production of documents and things that Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 25 of 70 PageID: 3041 7 are protected by the attorney-client privilege, work-product immunity, or any other privilege, immunity, or privacy law. Subject to the foregoing general and specific objections, Merck will produce a copy of the file history of the ’300 patent. REQUEST No. 2: Documents concerning patents or patent applications in the families of each of the patents-in-suit. RESPONSE TO REQUEST No. 2: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. For example, Merck objects to this request to the extent that it fails to delineate the criteria by which a patent or patent application is to be considered “in the families of each of the patents-in-suit”. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck also objects to this request to the extent that it seeks information or the production of documents that are cumulative of request No. 1. Merck further objects to this request to the extent that it calls for the production, or the identification on a privilege log, of documents and things related to foreign patent applications and patents and foreign patent prosecution. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, work-product immunity, or any other privilege, immunity, or privacy law. Subject to the foregoing general and specific objections, Merck will produce a copy of the file history of the ’300 patent. Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 26 of 70 PageID: 3042 8 REQUEST No. 3: Documents concerning communications with the Patent and Trademark Office regarding any of the patents-in-suit, including any interviews and declarations. RESPONSE TO REQUEST No. 3: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. For example, Merck objects to this request to the extent that it fails to delineate the scope of a “communication” or otherwise define it. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck also objects to this request to the extent that it seeks information or the production of documents that are cumulative of request Nos. 1-2. Merck further objects to this request to the extent that it calls for the production, or the identification on a privilege log, of documents and things related to foreign prosecution that are subject to the attorney-client privilege and/or work-product immunity. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney- client privilege, work-product immunity, or any other privilege, immunity, or privacy law. Subject to the foregoing general and specific objections, Merck will produce a copy of the file history of the ’300 patent, and any non-privileged documents regarding any interviews or declarations related to the ’300 patent prosecution. REQUEST No. 4: Documents concerning prior art searches and/or validity investigations related to the inventions described in the patents-in-suit. RESPONSE TO REQUEST No. 4: Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 27 of 70 PageID: 3043 9 Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. For example, Merck objects to this request to the extent that it fails to delineate the scope of what is “related” or otherwise define it. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, work- product immunity, or any other privilege, immunity, or privacy law. Merck further objects to this request to the extent that it seeks the production of documents and things that are available from public or other sources. Merck objects to this request because Fresenius has not defined what it considers to be the pertinent art. Subject to the foregoing general and specific objections, Merck will produce non- privileged, non-immune, responsive documents relating to the ’300 patent that are in Merck’s custody or control and can be located after a reasonable search. REQUEST No. 5: Prior art to any claim in the Patents-in-suit. RESPONSE TO REQUEST No. 5: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck also objects to this request to the extent that it seeks the production of documents and things that are Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 28 of 70 PageID: 3044 10 protected by the attorney-client privilege, work-product immunity, or any other privilege, immunity, or privacy law. Merck further objects to this request to the extent that it seeks the production of documents and things that are available from public or other sources. Merck objects to this request to the extent it requires Merck to perform a legal analysis or make a legal conclusion in order to determine whether a document is responsive. Merck further objects to this request because Fresenius has not defined what it considers to be the pertinent art. Merck objects to this request to the extent that it calls for expert testimony and to the extent that this request is premature. Under the Court’s Scheduling Order, opening expert reports are not due until November 16, 2015, and expert discovery will not be completed until February 4, 2016. Subject to the foregoing general and specific objections, Merck will produce non- privileged, non-immune, responsive documents relating to the ’300 patent that are in Merck’s custody or control and can be located after a reasonable search. REQUEST No. 6: Documents, communications, and agreements concerning the chain of title for each of the patents-in-suit from the date of application of each Patent-in-suit through the present day. RES PONSE TO REQUEST No. 6: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, work-product immunity, or any other privilege, Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 29 of 70 PageID: 3045 11 immunity, or privacy law. Merck further objects to this request to the extent that it seeks the production of documents and things that are available from public or other sources. Subject to the foregoing general and specific objections, Merck will produce non- privileged, non-immune, responsive documents relating to the ’300 patent that are in Merck’s custody or control and can be located after a reasonable search. REQUEST No. 7: Correspondence between or among MSD and any Inventor, or between or among Inventors, related to the patents-in-suit or to the prosecution of the patents-in-suit or any of the inventions allegedly described in the patents-in-suit. RESPONSE TO REQUEST No. 7: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. For example, Merck objects to this request to the extent that it is unlimited as to time. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, work-product immunity, or any other privilege, immunity, or privacy law. Merck further objects to this request to the extent that it seeks the production of documents and things that are available from public or other sources. Subject to the foregoing general and specific objections, Merck will produce non- privileged, non-immune, responsive documents relating to the ’300 patent that are in Merck’s custody or control and can be located after a reasonable search. REQUEST No. 8: Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 30 of 70 PageID: 3046 12 Documents concerning the research and development of any of the alleged invention(s) claimed in the patent-in-suit, including, but not limited to, laboratory notebooks, memoranda, invention disclosure forms, research plans, test reports, summaries, presentations, and meeting minutes. RESPONSE TO REQUEST No. 8: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. For example, Merck objects to this request to the extent that it is unlimited as to time. Merck also objects to producing documents relating to the research and development of the active molecule, caspofungin, as overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeking information that is irrelevant to any claim or defense in this action. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Subject to the foregoing general and specific objections, Merck will produce non- privileged, non-immune, responsive documents relating to the inventions claimed in the ’300 patent, which are dated prior to the filing date of the ’300 patent and that are in Merck’s custody or control and can be located after a reasonable search. REQUEST No. 9: Documents concerning the conception of any alleged invention(s) claimed in each of the patents-in-suit. RESPONSE TO REQUEST No. 9: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 31 of 70 PageID: 3047 13 any claim or defense raised in this action. For example, Merck objects to this request to the extent that it fails to delineate the scope of “any alleged invention(s)” or otherwise define it. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, work-product immunity, or any other privilege, immunity, or privacy law. Merck further objects to this request to the extent it requires Merck to perform a legal analysis or make a legal conclusion in order to determine whether a document is responsive. Subject to the foregoing general and specific objections, Merck will produce non- privileged, non-immune, responsive documents relating to the inventions claimed in the ’300 patent, which are dated prior to the filing date of the ’300 patent and that are in Merck’s custody or control and can be located after a reasonable search. REQUEST No. 10: Documents concerning the first reduction to practice of any alleged invention(s) claimed in each of the patents-in-suit. RESPONSE TO REQUEST No. 10: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. For example, Merck objects to this request to the extent that it fails to delineate the scope of “any alleged invention(s)” or otherwise define it. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 32 of 70 PageID: 3048 14 work-product immunity, or any other privilege, immunity, or privacy law. Merck further objects to this request to the extent it requires Merck to perform a legal analysis or make a legal conclusion in order to determine whether a document is responsive. Subject to the foregoing general and specific objections, Merck will produce non- privileged, non-immune, responsive documents relating to the inventions claimed in the ’300 patent, which are dated prior to the filing date of the ’300 patent and that are in Merck’s custody or control and can be located after a reasonable search. REQUEST No. 11: Documents concerning the conception and reduction to practice of Cancidas. RESPONSE TO REQUEST No. 11: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. For example, Merck objects to this request to the extent that it is unlimited as to time and also to the extent that it is vague and ambiguous in light of Fresenius’ definition of “Cancidas”. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, work-product immunity, or any other privilege, immunity, or privacy law. Merck further objects to this request to the extent it requires Merck to perform a legal analysis or make a legal conclusion in order to determine whether a document is responsive. Subject to the foregoing general and specific objections, Merck will produce non- privileged, non-immune, responsive documents relating to the inventions claimed in the ’300 Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 33 of 70 PageID: 3049 15 patent, which are dated prior to the filing date of the ’300 patent and that are in Merck’s custody or control and can be located after a reasonable search. REQUEST No. 12: Documents concerning the development of caspofungin. RESPONSE TO REQUEST No. 12: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. For example, Merck objects to this request to the extent that it is unlimited as to time and also to the extent that it is vague and ambiguous in light of Fresenius’ definition of “caspofungin”. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck also objects to this request to the extent that it seeks information or the production of documents that are cumulative of request No. 8. Merck also objects to producing documents relating to the research and development of the active molecule, caspofungin, as overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeking information that is irrelevant to any claim or defense in this action. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, work-product immunity, or any other privilege, immunity, or privacy law. REQUEST No. 13: Reports and memoranda documenting the development of the selection of substitutions or modifications at each position of caspofungin. RESPONSE TO REQUEST No. 13: Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 34 of 70 PageID: 3050 16 Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. For example, Merck objects to this request to the extent that it is unlimited as to time and also to the extent that it is vague and ambiguous in light of Fresenius’ definition of “caspofungin”. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck also objects to this request to the extent that it seeks information or the production of documents that are cumulative of request No. 8. Merck also objects to producing documents relating to the research and development of the active molecule, caspofungin, as overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeking information that is irrelevant to any claim or defense in this action. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, work-product immunity, or any other privilege, immunity, or privacy law. REQUEST No. 14: Documents concerning comparisons between caspofungin and any other aza cyclohexapeptide compound, including, but not limited to, comparisons of efficacy, safety, or solubility. RESPONSE TO REQUEST No. 14: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. For example, Merck objects to this request to the extent that it is unlimited as to time and also to the extent that it is vague and ambiguous in light Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 35 of 70 PageID: 3051 17 of Fresenius’ definition of “caspofungin”. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck also objects to this request to the extent that it seeks information or the production of documents that are cumulative of request No. 8. Merck also objects to producing documents relating to the research and development of the active molecule, caspofungin, as overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeking information that is irrelevant to any claim or defense in this action. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, work-product immunity, or any other privilege, immunity, or privacy law. REQUEST No. 15: Documents relating to any caspofungin-containing formulation that was studied, reviewed, considered, referred to, or used. RESPONSE TO REQUEST No. 15: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. For example, Merck objects to this request to the extent that it is unlimited as to time and also to the extent that it is vague and ambiguous in light of Fresenius’ definition of “caspofungin” because it does not match the structure, which includes the acetate salt. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck also objects to this request to the extent that it seeks information or the production of documents that are cumulative of request No. 8. Merck also objects to producing documents relating to the research and development of Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 36 of 70 PageID: 3052 18 the active molecule, caspofungin, as overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeking information that is irrelevant to any claim or defense in this action. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, work- product immunity, or any other privilege, immunity, or privacy law. Subject to the foregoing general and specific objections, Merck will produce non- privileged, non-immune, responsive documents relating to the inventions claimed in the ’300 patent, which are dated prior to the filing date of the ’300 patent and that are in Merck’s custody or control and can be located after a reasonable search. REQUEST No. 16: Documents relating to any U.S. foreign, or international patent or patent application concerning Cancidas. RESPONSE TO REQUEST No. 16: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. For example, Merck objects to this request to the extent that it fails to delineate the criteria by which a patent or patent application is to be considered “concerning Cancidas”. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck also objects to this request to the extent that it is unlimited as to time and also to the extent that it is vague and ambiguous in light of Fresenius’ definition of “Cancidas”. Merck objects to this request to the extent that it seeks information or the production of documents that are cumulative of request Nos. 1-3. Merck further objects to this request to the extent that it calls for the Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 37 of 70 PageID: 3053 19 production, or the identification on a privilege log, of documents and things related to foreign prosecution. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, work-product immunity, or any other privilege, immunity, or privacy law. Subject to the foregoing general and specific objections, Merck will produce a copy of the file history of the ’300 patent. REQUEST No. 17: Documents regarding the underlying testing and results related to the examples of the patents-in-suit. RESPONSE TO REQUEST No. 17: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. For example, Merck objects to this request to the extent that it is unlimited as to time. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck also objects to this request to the extent that it seeks information or the production of documents that are cumulative of request No. 8. Merck also objects to producing documents relating to the research and development of the active molecule, caspofungin, as overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeking information that is irrelevant to any claim or defense in this action. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, work-product immunity, or any other privilege, immunity, or privacy law. Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 38 of 70 PageID: 3054 20 Subject to the foregoing general and specific objections, Merck will produce non- privileged, non-immune, responsive documents relating to the examples of the ’300 patent that are in Merck’s custody or control and can be located after a reasonable search. REQUEST No. 18: Licenses or offers to license each of the patents-in-suit and all documents relating to negotiations about such a license. RESPONSE TO REQUEST No. 18: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. Merck objects to this request to the extent that it seeks production of documents and things that contain confidential information of third parties. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, work- product immunity, or any other privilege, immunity, or privacy law. Subject to the foregoing general and specific objections, Merck will produce non- privileged, non-immune, responsive documents relating to the ’300 patent that are in Merck’s custody or control and can be located after a reasonable search. REQUEST No. 19: Documents tending to support or disprove secondary considerations of non-obviousness. RESPONSE TO REQUEST No. 19: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 39 of 70 PageID: 3055 21 evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck objects to this request to the extent it requires Merck to perform a legal analysis or make a legal conclusion in order to determine whether a document is responsive. Merck objects to this request to the extent that it calls for expert testimony and to the extent that this request is premature. Under the Court’s Scheduling Order, responses to Fresenius’ invalidity contentions are not due until January 21, 2015, rebuttal expert reports are not due until December 16, 2015, and expert discovery will not be completed until February 4, 2016. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, work-product immunity, or any other privilege, immunity, or privacy law. Subject to the foregoing general and specific objections, Merck will produce non- privileged, non-immune, responsive documents relating to the ’300 patent that are in Merck’s custody or control and can be located after a reasonable search. REQUEST No. 20: Documents concerning historical or future financial results or performance of Cancidas, including without limitation actual sales, projected sales, revenues, costs, profits, and losses. RESPONSE TO REQUEST No. 20: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. For example, Merck objects to this request to the extent that it is unlimited as to time and also to the extent that it is vague and ambiguous in light Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 40 of 70 PageID: 3056 22 of Fresenius’ definition of “Cancidas”. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, work-product immunity, or any other privilege, immunity, or privacy law. Subject to the foregoing general and specific objections, Merck will produce non- privileged, non-immune, responsive documents that are in Merck’s custody or control and can be located after a reasonable search sufficient to show U.S. sales of the drug product that Merck markets under the trade name Cancidas®. REQUEST No. 21: Documents concerning product or market research, marketing plans, and/or marketing strategy, for Cancidas. RESPONSE TO REQUEST No. 21: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. For example, Merck objects to this request to the extent that it is unlimited as to time and also to the extent that it is vague and ambiguous in light of Fresenius’ definition of “Cancidas”. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, work-product immunity, or any other privilege, immunity, or privacy law. Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 41 of 70 PageID: 3057 23 Subject to the foregoing general and specific objections, Merck will produce representative, non-privileged, non-immune, responsive documents that are in Merck’s custody or control and can be located after a reasonable search related to the drug product marketed by Merck under the trade name Cancidas®. REQUEST No. 22: Documents regarding the actual or anticipated competition or market share for Cancidas. RESPONSE TO REQUEST No. 22: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. For example, Merck objects to this request to the extent that it is unlimited as to time and also to the extent that it is vague and ambiguous in light of Fresenius’ definition of “Cancidas”. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck also objects to this request to the extent that it seeks production of documents and things that contain confidential information of third parties. Merck objects to this request to the extent that it calls for expert testimony and to the extent that this request is premature. Under the Court’s Scheduling Order, opening expert reports are not due until November 16, 2015, and expert discovery will not be completed until February 4, 2016. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney- client privilege, work-product immunity, or any other privilege, immunity, or privacy law. Subject to the foregoing general and specific objections, Merck will produce representative, non-privileged, non-immune, responsive documents that are in Merck’s custody Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 42 of 70 PageID: 3058 24 or control and can be located after a reasonable search related to the drug product marketed by Merck under the trade name Cancidas®. REQUEST No. 23: Documents relating to any licensing, royalty sharing, manufacturing, or supply agreements concerning Cancidas. RESPONSE TO REQUEST No. 23: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. For example, Merck objects to this request to the extent that it is unlimited as to time and also to the extent that it is vague and ambiguous in light of Fresenius’ definition of “Cancidas”. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck objects to this request to the extent that it seeks production of documents and things that contain confidential information of third parties. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, work-product immunity, or any other privilege, immunity, or privacy law. Subject to the foregoing general and specific objections, Merck will produce non- privileged, non-immune, responsive documents that are in Merck’s custody or control and can be located after a reasonable search. REQUEST No. 24: Documents concerning the actual or potential safety, efficacy, effectiveness, or side effects of Cancidas, including internal or external evaluations, FDA reports, customer complaints, and physician reports. RESPONSE TO REQUEST No. 24: Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 43 of 70 PageID: 3059 25 Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. For example, Merck objects to this request to the extent that it is unlimited as to time and also to the extent that it is vague and ambiguous in light of Fresenius’ definition of “Cancidas”. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck objects to this request to the extent that it seeks production of documents and things that contain confidential information of third parties. Merck objects to this request to the extent that it seeks the production of documents and things that are available from public or other sources. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, work-product immunity, or any other privilege, immunity, or privacy law. Subject to the foregoing general and specific objections, Merck will produce a copy of the NDA for Cancidas®. Merck is willing to consider a proposal for a narrowed request from Fresenius if it can explain the relevance of the requested documents to the remaining issues in the case. REQUEST No. 25: Documents concerning studies or tests performed on Fresenius Kabi’s NDA Product. RESPONSE TO REQUEST No. 25: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. For example, Merck objects to this request to the Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 44 of 70 PageID: 3060 26 extent that it is unlimited as to time and also to the extent that it is vague and ambiguous in light of Fresenius’ definition of “Fresenius Kabi’s NDA Product”. Merck also objects to this request on the grounds that it seeks information and the production of documents outside of Merck’s custody, possession, or control. Merck objects to this request to the extent that it calls for expert testimony and to the extent that this request is premature. Under the Court’s Scheduling Order, opening expert reports are not due until November 16, 2015, and expert discovery will not be completed until February 4, 2016. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, work- product immunity, or any other privilege, immunity, or privacy law. Subject to the foregoing general and specific objections, Merck will produce, in accordance with the expert discovery schedule set by the Court, non-privileged, non-immune, responsive documents that are in Merck’s custody or control and can be located after a reasonable search. REQUEST No. 26: Documents concerning studies or tests performed on any component of Fresenius Kabi’s NDA Product. RESPONSE TO REQUEST No. 26: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. For example, Merck objects to this request to the extent that it is unlimited as to time and also to the extent that it is vague and ambiguous in light of Fresenius’ definition of “Fresenius Kabi’s NDA Product”. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 45 of 70 PageID: 3061 27 this case. Merck also objects to this request on the grounds that it seeks information and the production of documents outside of Merck’s custody, possession, or control. Merck objects to this request to the extent that it calls for expert testimony and to the extent that this request is premature. Under the Court’s Scheduling Order, opening expert reports are not due until November 16, 2015, and expert discovery will not be completed until February 4, 2016. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, work-product immunity, or any other privilege, immunity, or privacy law. Subject to the foregoing general and specific objections, Merck will produce, in accordance with the expert discovery schedule set by the Court, non-privileged, non-immune, responsive documents that are in Merck’s custody or control and can be located after a reasonable search. REQUEST No. 27: A complete copy of NDA No. 21-227 and all amendments and supplements thereto. RESPONSE TO REQUEST No. 27: Merck objects to this request to the extent that it is overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. For example, Merck objects to this request to the extent that it seeks “all amendments and supplements”. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, work-product immunity, or any other privilege, immunity, or privacy law. Subject to the foregoing general and specific objections, Merck will produce a copy of NDA No. 21-227. Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 46 of 70 PageID: 3062 28 REQUEST No. 28: Documents concerning communications between MSD and the FDA concerning NDA No 21-227 and any amendments or supplements thereto. RESPONSE TO REQUEST No. 28: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. For example, For example, Merck objects to this request to the extent that it is unlimited as to time and to the extent that it seeks a “[a]ll correspondence” and “any amendments and supplements”. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney- client privilege, work-product immunity, or any other privilege, immunity, or privacy law. Subject to the foregoing general and specific objections, Merck will produce non- privileged, non-immune, responsive documents that are in Merck’s custody or control and can be located after a reasonable search related to the relevant sections of NDA No. 21-227. REQUEST No. 29: Documents representing or concerning the employee file and annual review for each Inventor. RESPONSE TO REQUEST No. 29: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. For example, Merck objects to this request to the extent it is unlimited in time. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, work- Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 47 of 70 PageID: 3063 29 product immunity, or any other privilege, immunity, or privacy law. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. REQUEST No. 30: Documents showing the contribution(s) that each Inventor made to any of the alleged inventions in the patents-in-suit. RESPONSE TO REQUEST No. 30: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. For example, Merck objects to this request to the extent that it is unlimited as to time and to the extent that it seeks discovery of unclaimed subject matter or related to claims not asserted in this litigation. Further, Merck objects to this request to the extent that it fails to delineate the scope of “contribution(s)” or otherwise define it. Merck objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, work-product immunity, or any other privilege, immunity, or privacy law. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Subject to the foregoing general and specific objections, Merck will produce non- privileged, non-immune, responsive documents relating to the ’300 patent that are in Merck’s custody or control and can be located after a reasonable search. REQUEST No. 31: English-language translations (partial or complete) of any foreign-language documents requested in Fresenius’s document production requests. RESPONSE TO REQUEST No. 31: Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 48 of 70 PageID: 3064 30 Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. For example, Merck objects to this request to the extent that this request seeks to impose requirements upon Merck beyond those set forth in the Federal Rules of Civil Procedure, the Local Rules and/or any other applicable authority. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, work- product immunity, or any other privilege, immunity, or privacy law. Merck further objects to this request to the extent that it seeks the production of documents and things that are available from public or other sources. Subject to the foregoing general and specific objections, Merck will produce non- privileged, non-immune, responsive documents that are in Merck’s custody or control and can be located after a reasonable search to the extent that such translations were created in Merck’s regular course of business. To the extent that such translations are produced, Merck does not make any representations as to the accuracy of any such translations. REQUEST No. 32: Invoices or other time sheets reflecting time entries and tasks completed by any expert or consultant retained by or on behalf of MSD. RESPONSE TO REQUEST No. 32: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 49 of 70 PageID: 3065 31 any claim or defense raised in this action. For example, Merck objects to this request to the extent that it is unlimited as to time, not limited to any particular product or litigation, and to the extent that this request seeks information that is protected from discovery pursuant to the Federal Rules of Civil Procedure, including but not limited to Rules 26(b)(4)(B), (C), and/or (D). Merck objects to the request to the extent it seeks discovery from non-testifying consultants as immune from discovery. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck objects to this request to the extent that it calls for expert testimony and to the extent that this request is premature. Under the Court’s Scheduling Order, opening expert reports are not due until November 16, 2015, and expert discovery will not be completed until February 4, 2016. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, work-product immunity, or any other privilege, immunity, or privacy law. REQUEST No. 33: Documents, samples, protocols, results, or other materials provided to or considered by any expert or consultant retained by MSD in connection with the above-captioned matter. RESPONSE TO REQUEST No. 33: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. For example, Merck objects to this request to the extent that it is unlimited as to time and to the extent that this request seeks information that is protected from discovery pursuant to the Federal Rules of Civil Procedure, including but not limited to Rules 26(b)(4)(B), (C), and/or (D). Merck objects to the request to the extent it seeks Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 50 of 70 PageID: 3066 32 discovery from non-testifying consultants as immune from discovery. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck objects to this request to the extent that it calls for expert testimony and to the extent that this request is premature. Under the Court’s Scheduling Order, opening expert reports are not due until November 16, 2015, and expert discovery will not be completed until February 4, 2016. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, work-product immunity, or any other privilege, immunity, or privacy law. Subject to the foregoing general and specific objections, Merck will produce, in accordance with the expert discovery schedule set by the Court, non-privileged, non-immune, responsive documents relating to testifying experts regarding the ’300 patent that are in Merck’s custody or control and can be located after a reasonable search. REQUEST No. 34: Documents received from third parties, for example, but not limited to, in response to subpoenas, in connection with this litigation. RESPONSE TO REQUEST No. 34: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. For example, Merck objects to this request to the extent that it is unlimited as to time, fails to delineate or define “documents received from third parties” and to the extent that this request seeks to impose requirements upon Merck beyond those set forth in the Federal Rules of Civil Procedure, the Local Rules and/or any other applicable authority. Merck further objects to this request to the extent it seeks information Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 51 of 70 PageID: 3067 33 related to the ’650 patent, which is no longer at issue in this case. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, work-product immunity, or any other privilege, immunity, or privacy law. Subject to the foregoing general and specific objections, Merck will produce non- privileged, non-immune, responsive documents that are in Merck’s custody or control and can be located after a reasonable search. REQUEST No. 35: Visual aids, demonstratives, transcripts, and other materials used in any hearing or appearance before the Court in connection with this litigation or any other litigation involving the Patents-in-suit. RESPONSE TO REQUEST No. 35: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. For example, Merck objects to this request to the extent that it is unlimited as to time and subject matter and to the extent that this request seeks to impose requirements upon Merck beyond those set forth in the Federal Rules of Civil Procedure, the Local Rules and/or any other applicable authority. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck further objects to this request to the extent that it seeks the production of documents and things that are available from public or other sources. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney- client privilege, work-product immunity, or any other privilege, immunity, or privacy law. Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 52 of 70 PageID: 3068 34 Subject to the foregoing general and specific objections, Merck will produce non- privileged, non-immune, responsive documents that are in Merck’s custody or control and can be located after a reasonable search, in accordance with the schedule set forth by the Court or as otherwise agreed to by the parties. REQUEST No. 36: Documents or other materials intended to be relied upon as an exhibit at any deposition, hearing, or trial in connection with this litigation. RESPONSE TO REQUEST No. 36: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. For example, Merck objects to this request to the extent that it seeks to impose requirements upon Merck beyond those set forth in the Federal Rules of Civil Procedure, the Local Rules and/or any other applicable authority. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck objects to this request to the extent that it calls for expert testimony and to the extent that this request is premature. Under the Court’s Scheduling Order, opening expert reports are not due until November 16, 2015, and expert discovery will not be completed until February 4, 2016. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, work- product immunity, or any other privilege, immunity, or privacy law. Subject to the foregoing general and specific objections, Merck will produce non- privileged, non-immune, responsive documents that are in Merck’s custody or control and can be Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 53 of 70 PageID: 3069 35 located after a reasonable search, in accordance with the schedule set forth by the Court or as otherwise agreed to by the parties. REQUEST No. 37: Ten samples of Cancidas and one gram of active pharmaceutical ingredient for caspofungin. RESPONSE TO REQUEST No. 37: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. For example, Merck objects to this request to the extent that it is unlimited as to time and also to the extent that it is vague and ambiguous in light of Fresenius’ definitions of “Cancidas” and “caspofungin”. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney- client privilege, work-product immunity, or any other privilege, immunity, or privacy law. Merck objects to this request to the extent that it seeks the production of documents and things that are available from public or other sources. Subject to the foregoing general and specific objections, Merck will produce the active pharmaceutical ingredient in Cancidas®. REQUEST No. 38: Documents and things relied upon, reviewed, or used in preparing MSD’s Answer to Fresenius Kabi’s Counterclaims. RESPONSE TO REQUEST No. 38: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 54 of 70 PageID: 3070 36 any claim or defense raised in this action. For example, Merck objects to this request to the extent that it is unlimited as to time. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck objects to this request to the extent it requires Merck to make a legal conclusion. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, work-product immunity, or any other privilege, immunity, or privacy law. Subject to the foregoing general and specific objections, Merck will produce non- privileged, non-immune, responsive documents that are in Merck’s custody or control and can be located after a reasonable search. REQUEST No. 39: Documents identified in MSD’s Rule 26 Initial Disclosures. RESPONSE TO REQUEST No. 39: Merck objects to this request as overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Subject to the foregoing general and specific objections, Merck will produce non- privileged, non-immune, responsive documents relating to the ’300 patent that are in Merck’s custody or control and can be located after a reasonable search. REQUEST No. 40: All pleadings filed under seal, expert reports, discovery responses, and all exhibits to any such paper served in the matter styled Merck & Co., Inc. v. Sandoz Inc., No. 10-cv-2308-SRC-PS (D.N.J.). Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 55 of 70 PageID: 3071 37 RESPONSE TO REQUEST No. 40: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck objects to this request to the extent that it seeks the production of documents and things that are available from public or other sources. Merck objects to this request to the extent that it seeks information and the production of documents and things that contain the confidential information of third parties, including Sandoz. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, work- product immunity, or any other privilege, immunity, or privacy law. Subject to the foregoing general and specific objections, Merck will produce non- privileged, non-immune, responsive documents relating to the ’300 patent that are in Merck’s custody or control and can be located after a reasonable search. REQUEST No. 41: All pleadings filed under seal, expert reports, discovery responses, and all exhibits to any such paper served in the matter styled Merck & Co., Inc. v. Sandoz Inc., No. 10-cv-1625-SRC-PS (D.N.J.). RESPONSE TO REQUEST No. 41: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 56 of 70 PageID: 3072 38 objects to this request to the extent that it seeks the production of documents and things that are available from public or other sources. Merck objects to this request to the extent that it seeks information and the production of documents and things that contain the confidential information of third parties, including Sandoz. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, work- product immunity, or any other privilege, immunity, or privacy law. Subject to the foregoing general and specific objections, Merck will produce non- privileged, non-immune, responsive documents relating to the ’300 patent that are in Merck’s custody or control and can be located after a reasonable search. REQUEST No. 42: All pleadings filed under seal, expert reports, discovery responses, and all exhibits to any such paper served in the matter styled Merck & Co., Inc. v. Teva Parenteral Medicines, Inc., No. 09-cv-6026-SRC-PS (D.N.J.). RESPONSE TO REQUEST No. 42: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck objects to this request to the extent that it seeks the production of documents and things that are available from public or other sources. Merck objects to this request to the extent that it seeks information and the production of documents and things that contain the confidential information of third parties, including Teva. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, work- product immunity, or any other privilege, immunity, or privacy law. Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 57 of 70 PageID: 3073 39 Subject to the foregoing general and specific objections, Merck will produce non- privileged, non-immune, responsive documents relating to the ’300 patent that are in Merck’s custody or control and can be located after a reasonable search. REQUEST No. 43: All papers and exhibits filed or received in any inter partes review involving any patent- in-suit. RESPONSE TO REQUEST No. 43: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. For example, Merck objects to this request to the extent that it is unlimited as to time. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, work-product immunity, or any other privilege, immunity, or privacy law. Subject to the foregoing general and specific objections, Merck states that it is currently unaware of any documents responsive to this request. REQUEST No. 44: All documents produced to or received from any party against which any of the Patents- in-suit has been asserted. RESPONSE TO REQUEST No. 44: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 58 of 70 PageID: 3074 40 any claim or defense raised in this action. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck objects to this request to the extent that it seeks information and the production of documents and things that contain the confidential information of third parties, including Teva, Sandoz and/or Xellia. Merck further objects to this request as redundant and duplicative of Fresenius’ other requests. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, work-product immunity, or any other privilege, immunity, or privacy law. Subject to the foregoing general and specific objections, Merck will produce non- privileged, non-immune, responsive documents relating to the ’300 patent that are in Merck’s custody or control and can be located after a reasonable search. REQUEST No. 45: All documents, samples, protocols, results, or other materials provided to or considered by by [sic] any expert in any matter in which any of the Patents-in-suit have been asserted. RESPONSE TO REQUEST No. 45: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck objects to this request to the extent that it seeks information and the production of documents and things that contain the confidential information of third parties, including Teva, Sandoz and/or Xellia. Merck further objects to this request as redundant and duplicative of Fresenius’ other requests. Merck objects to this request to the extent that it calls for expert testimony and to the Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 59 of 70 PageID: 3075 41 extent that this request is premature. Under the Court’s Scheduling Order, opening expert reports are not due until November 16, 2015, and expert discovery will not be completed until February 4, 2016. Merck further objects to this request as redundant and duplicative of Fresenius’ other requests. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, work- product immunity, or any other privilege, immunity, or privacy law. Subject to the foregoing general and specific objections, Merck will produce non- privileged, non-immune, responsive documents relating to the ’300 patent that are in Merck’s custody or control and can be located after a reasonable search. REQUEST No. 46: All documents concerning, supporting or refuting MSD’s claim that Fresenius Kabi’s NDA would infringe the Patents-in-suit. RESPONSE TO REQUEST No. 46: Merck objects to this request to the extent that it is vague, ambiguous, overly broad, unduly burdensome, not reasonably calculated to lead to the discovery of admissible evidence, and seeks information or the production of documents or things that are not relevant to any claim or defense raised in this action. Merck further objects to this request to the extent it seeks information related to the ’650 patent, which is no longer at issue in this case. Merck objects to this request to the extent that it seeks information and the production of documents and things that contain the confidential information of third parties, including Teva, Sandoz and/or Xellia. Merck further objects to this request as redundant and duplicative of Fresenius’ other requests. Merck objects to this request to the extent that it calls for expert testimony and to the extent that this request is premature. Under the Court’s Scheduling Order, opening expert reports are not due until November 16, 2015, and expert discovery will not be completed until Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 60 of 70 PageID: 3076 42 February 4, 2016. Merck objects to this request to the extent it requires Merck to perform a legal analysis or make a legal conclusion in order to determine whether a document is responsive. Merck further objects to this request as redundant and duplicative of Fresenius’ other requests. Merck also objects to this request to the extent that it seeks the production of documents and things that are protected by the attorney-client privilege, work-product immunity, or any other privilege, immunity, or privacy law. Subject to the foregoing general and specific objections, Merck will produce non- privileged, non-immune, responsive documents relating to the ’300 patent that are in Merck’s custody or control and can be located after a reasonable search. Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 61 of 70 PageID: 3077 43 OF COUNSEL: Brian V. Slater Gregory B. Sephton Jason A. Leonard FITZPATRICK, CELLA, HARPER & SCINTO 1290 Avenue of the Americas New York, NY 10104-3800 (212) 218-2100 November 24, 2014 s/ David E. De Lorenzi David E. De Lorenzi, Esq. GIBBONS P.C. One Gateway Center Newark, NJ 07102-5310 (973) 596-4500 Attorneys for Plaintiff Merck Sharp & Dohme Corp. Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 62 of 70 PageID: 3078 CERTIFICATE OF SERVICE I, hereby certify that on November 24, 2014, true and correct copies of MERCK’S RESPONSES TO FRESENIUS KABI’S FIRST SET OF REQUESTS FOR THE PRODUCTION OF DOCUMENTS AND THINGS (NOS. 1-46) were caused to be served upon the following in the manner indicated: Michael E. Patunas, Esq. Mayra V. Tarantino, Esq. LITE DEPALMA GREENBERG, LLC Two Gateway Center, Suite 1201 Newark, New Jersey 07102 Tel.: (973) 623-3000 Fax: (973) 623-0858 Email: mpatunas@litedepalma.com mtarantino@litedepalma.com VIA ELECTRONIC MAIL Imron Aly, Esq. Nimita Parekh, Esq. Joel Wallace, Esq. Gina Bassi, Esq. SCHIFF HARDIN LLP 233 S. Wacker Drive Chicago, IL 60606 Tel.: (312) 258-5500 Fax: (312) 258-5600 Email: ialy@schiffhardin.com nparekh@schiffhardin.com jwallace@schiffhardin.com gbassi@schiffhardin.com VIA ELECTRONIC MAIL Alison Maddeford, Esq. SCHIFF HARDIN LLP One Market, Spear Street Tower Thirty-Second Floor San Francisco, DA 94105 Tel.: (415) 901-8700 Fax: (415) 901-8701 Email: amaddeford@schiffhardin.com Attorneys for Defendant Fresenius Kabi USA, LLC VIA ELECTRONIC MAIL Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 63 of 70 PageID: 3079 2 s/ David E. De Lorenzi David E. De Lorenzi, Esq. Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 64 of 70 PageID: 3080 EXHIBIT C Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 65 of 70 PageID: 3081 Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 66 of 70 PageID: 3082 If the reader of this message is not the intended recipient or agent responsible for delivering it to the intended recipient, you are hereby notified that you have received this document in error and that any review, dissemination, distribution, or copying of this message is strictly prohibited. If you have received this communication in error, please notify us immediately by e-mail, and delete the original message. From: Aly, Imron T. [mailto:IAly@schiffhardin.com] Sent: Wednesday, August 17, 2016 3:30 PM To: Matthew Traupman ; Sonalker, Prajakta A. ; Yu, George Chih-Lun ; Rammer, Thomas A. ; Peña, Emily ; jrichter@winston.com; mbogad@winston.com; Turnelius, Bridget Cc: Conde,Dominick ; Leonard, Jason ; Manas, Gregory ; Ray Nimrod ; Chevalier, Charles H. (CChevalier@gibbonslaw.com) ; Delorenzi, David E. (DDelorenzi@gibbonslaw.com) Subject: RE: Merck Sharp & Dohme Corp. v. Fresenius Kabi USA, LLC, 14-4989-SRC-CLW (D.N.J.) Matt, Now we are even more concerned. Put together, it is clear Merck is playing fast and loose with its argument in this litigation. Imron From: Matthew Traupman [matthewtraupman@quinnemanuel.com] Sent: Wednesday, August 17, 2016 2:18 PM To: Aly, Imron T.; Sonalker, Prajakta A.; Yu, George Chih-Lun; Rammer, Thomas A.; Peña, Emily; jrichter@winston.com; mbogad@winston.com; Turnelius, Bridget Cc: Conde,Dominick; Leonard, Jason; Manas, Gregory; Ray Nimrod; Chevalier, Charles H. (CChevalier@gibbonslaw.com); Delorenzi, David E. (DDelorenzi@gibbonslaw.com) Subject: RE: Merck Sharp & Dohme Corp. v. Fresenius Kabi USA, LLC, 14-4989-SRC-CLW (D.N.J.) Imron: You appear to operating under the erroneous assumption that Merck granted Teva a license. As stated in my earlier email and in Merck’s SEC filings, Merck did not grant Teva a license. Thus, there’s no license for you to review. In any event, we’ll let the Court know we’re still at an impasse. Thanks, Matt Matthew Traupman Partner Quinn Emanuel Urquhart & Sullivan, LLP 51 Madison Avenue, 22nd Floor New York, NY 10010 Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 67 of 70 PageID: 3083 212-849-7322 Direct 212-849-7000 Main Office Number 212-849-7100 FAX matthewtraupman@quinnemanuel.com www.quinnemanuel.com NOTICE: The information contained in this e-mail message is intended only for the personal and confidential use of the recipient(s) named above. This message may be an attorney-client communication and/or work product and as such is privileged and confidential. If the reader of this message is not the intended recipient or agent responsible for delivering it to the intended recipient, you are hereby notified that you have received this document in error and that any review, dissemination, distribution, or copying of this message is strictly prohibited. If you have received this communication in error, please notify us immediately by e-mail, and delete the original message. From: Aly, Imron T. [mailto:IAly@schiffhardin.com] Sent: Wednesday, August 17, 2016 3:09 PM To: Matthew Traupman ; Sonalker, Prajakta A. ; Yu, George Chih-Lun ; Rammer, Thomas A. ; Peña, Emily ; jrichter@winston.com; mbogad@winston.com; Turnelius, Bridget Cc: Conde,Dominick ; Leonard, Jason ; Manas, Gregory ; Ray Nimrod ; Chevalier, Charles H. (CChevalier@gibbonslaw.com) ; Delorenzi, David E. (DDelorenzi@gibbonslaw.com) Subject: RE: Merck Sharp & Dohme Corp. v. Fresenius Kabi USA, LLC, 14-4989-SRC-CLW (D.N.J.) Matt, The issue is one for standing, not merely discovery. We cannot stipulate to standing without having the opportunity to review the license. For the prior art stipulation, we produced all the prior art so that Merck could review and confirm the prior art status, which it finally did on Friday. Reciprocity would therefore dictate that Merck also provide the Teva license to make the same assessment, without which we cannot stipulate to standing, nor can Merck prove standing at trial. Regards, Imron From: Matthew Traupman [matthewtraupman@quinnemanuel.com] Sent: Wednesday, August 17, 2016 1:46 PM To: Aly, Imron T.; Sonalker, Prajakta A.; Yu, George Chih-Lun; Rammer, Thomas A.; Peña, Emily; jrichter@winston.com; mbogad@winston.com; Turnelius, Bridget Cc: Conde,Dominick; Leonard, Jason; Manas, Gregory; Ray Nimrod; Chevalier, Charles H. (CChevalier@gibbonslaw.com); Delorenzi, David E. (DDelorenzi@gibbonslaw.com) Subject: RE: Merck Sharp & Dohme Corp. v. Fresenius Kabi USA, LLC, 14-4989-SRC-CLW (D.N.J.) Imron: We will not be producing the Teva settlement agreement. As we explained in Court, the confidentiality provision of that agreement prevents us from producing it without Teva’s consent, which we requested but did not receive. Moreover, the time for Fresenius to raise issues about the Teva agreement have long since passed. In any event, the Teva settlement agreement does not grant Teva a license or any other rights to the ‘300 patent. We refer you to Merck’s 10-Q filing for Q1 2011, which states “[t]hat lawsuit has been dismissed with no rights granted to TPM [Teva Parental Medicines].” Because the Teva agreement Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 68 of 70 PageID: 3084 does not grant any rights to the ‘300 patent, it is not within the scope of any of the document requests you identified in your Aug. 5, 2016 letter to Judge Waldor. Given the discussion with Judge Waldor and the publicly available information in Merck’s SEC filings, we also expect that Fresenius will stipulate that Merck owns the ‘300 patent. Please confirm this by the close of business tomorrow as we intend to promptly inform Judge Waldor if the ownership issue remains outstanding. Regards, Matt Matthew Traupman Partner Quinn Emanuel Urquhart & Sullivan, LLP 51 Madison Avenue, 22nd Floor New York, NY 10010 212-849-7322 Direct 212-849-7000 Main Office Number 212-849-7100 FAX matthewtraupman@quinnemanuel.com www.quinnemanuel.com NOTICE: The information contained in this e-mail message is intended only for the personal and confidential use of the recipient(s) named above. This message may be an attorney-client communication and/or work product and as such is privileged and confidential. If the reader of this message is not the intended recipient or agent responsible for delivering it to the intended recipient, you are hereby notified that you have received this document in error and that any review, dissemination, distribution, or copying of this message is strictly prohibited. If you have received this communication in error, please notify us immediately by e-mail, and delete the original message. From: Aly, Imron T. [mailto:IAly@schiffhardin.com] Sent: Tuesday, August 16, 2016 6:59 PM To: Sonalker, Prajakta A. ; Yu, George Chih-Lun ; Rammer, Thomas A. ; Peña, Emily ; jrichter@winston.com; mbogad@winston.com; Turnelius, Bridget Cc: Conde,Dominick ; Leonard, Jason ; Manas, Gregory ; Ray Nimrod ; Matthew Traupman ; Chevalier, Charles H. (CChevalier@gibbonslaw.com) ; Delorenzi, David E. (DDelorenzi@gibbonslaw.com) Subject: RE: Merck Sharp & Dohme Corp. v. Fresenius Kabi USA, LLC, 14-4989-SRC-CLW (D.N.J.) Thank you, Prajakta. Will Merck be producing the Teva settlement and/or license agreement, whether redacted or unredacted? Regards, Imron From: Sonalker, Prajakta A. [mailto:PSonalker@FCHS.COM] Sent: Tuesday, August 16, 2016 5:34 PM Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 69 of 70 PageID: 3085 To: Aly, Imron T.; Yu, George Chih-Lun; Rammer, Thomas A.; Peña, Emily; jrichter@winston.com; mbogad@winston.com; Turnelius, Bridget Cc: Conde,Dominick; Leonard, Jason; Manas, Gregory; 'Ray Nimrod (raynimrod@quinnemanuel.com)' (raynimrod@quinnemanuel.com); Matthew Traupman (matthewtraupman@quinnemanuel.com); Chevalier, Charles H. (CChevalier@gibbonslaw.com); Delorenzi, David E. (DDelorenzi@gibbonslaw.com) Subject: Merck Sharp & Dohme Corp. v. Fresenius Kabi USA, LLC, 14-4989-SRC-CLW (D.N.J.) Imron, We will be producing the Bates-stamped copy of the redacted Xellia settlement agreement that was provided to Fresenius yesterday via Fitzpatrick’s secure ftp. Regards, Prajakta Prajakta A. Sonalker, Ph.D. FITZPATRICK, CELLA, HARPER & SCINTO 1290 Avenue of the Americas New York, NY 10104-3800 T 212-218-2351 F 212-218-2200 PSonalker@FCHS.COM http://www.fitzpatrickcella.com This email message and any attachments are intended for the use of the addressee(s) indicated above. Information that is privileged or otherwise confidential may be contained therein. If you are not the intended recipient(s), you are hereby notified that any dissemination, review or use of this message, documents or information contained therein is strictly prohibited. If you have received this message in error, please immediately delete it and notify us by telephone at (212) 218-2100. Thank you. ------------------------------------------------------------------- This message and any attachments may contain confidential information protected by the attorney-client or other privilege. If you believe that it has been sent to you in error, please reply to the sender that you received the message in error. Then delete it. Thank you. ------------------------------------------------------------------- Case 2:14-cv-04989-SRC-CLW Document 228-1 Filed 10/03/16 Page 70 of 70 PageID: 3086 WINSTON & STRAWN LLP The Legal Center One Riverfront Plaza, Suite 730 Newark, New Jersey 07102 (973) 848-7676 James S. Richter Attorneys for Defendant Fresenius Kabi USA, LLC. UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY MERCK SHARP & DOHME CORP., Plaintiff, v. FRESENIUS KABI USA, LLC, Defendant. ) ) ) ) ) C.A. No. 14-4989 (SRC)(CLW) ) ) ) ) ) DEFENDANT’S L. CIV. R. 56.1 RESPONSIVE AND SUPPLEMENTAL STATEMENT OF FACTS IN OPPOSITION TO PLAINTIFF’S MOTION FOR SUMMARY JUDGMENT THAT IT HOLDS TITLE TO THE ’300 PATENT Pursuant to Local Rule of Civil Procedure 56.1(a), Defendants Fresenius Kabi USA< LLC (“Fresenius Kabi”) respectfully submit these Responsive and Supplemental Statements of Fact in Opposition to Plaintiff’s (“Merck’s”) Motion for Summary Judgment That It Holds Title To The ’300 Patent. FRESENIUS KABI’S RESPONSIVE STATEMENT OF FACTS MERCK FACT 1. This is a Hatch-Waxman patent litigation in which Merck has alleged that Fresenius’s Proposed Caspofungin Product infringes claim 1 of United States Patent No. 5,952,300 patent (“the ’300 patent”). RESPONSE: Undisputed. MERCK FACT 2. The ’300 patent identifies Maneesh J. Nerurkar, William A. Hunke, Case 2:14-cv-04989-SRC-CLW Document 228-2 Filed 10/03/16 Page 1 of 9 PageID: 3087 2 and Michael J. Kaufman (“the Named Inventors”) as inventors. RESPONSE: Undisputed. MERCK FACT 3. On March 26, 1997, the Named Inventors signed an “Assignment and Agreement” in which they agreed to “sell, assign and transfer to MERCK & CO., Inc. … the entire right title and interest, for all countries, in and to certain inventions relating to ANTIFUNGAL COMPOSITIONS described in an application for Letters Patent of the United States….” RESPONSE: Undisputed. MERCK FACT 4. The Assignment and Agreement was recorded with the United States Patent and Trademark Office at Reel 8638, Frame 0396-98. RESPONSE: Undisputed. MERCK FACT 5. On November 2, 2009, Merck & Co., Inc. filed with the New Jersey State Treasurer a Certificate of Adoption of Restated Certificate of Incorporation and a Restated Certificate of Incorporation. RESPONSE: Undisputed. MERCK FACT 6. The Certificate of Adoption became effective on November 3, 2009. RESPONSE: Undisputed. MERCK FACT 7. Among the amendments made in those documents was to change the name from Merck & Co., Inc. to Merck Sharp & Dohme Corp. RESPONSE: Undisputed. Case 2:14-cv-04989-SRC-CLW Document 228-2 Filed 10/03/16 Page 2 of 9 PageID: 3088 3 MERCK FACT 8. The Certificate of Adoption of Restated Certificate of Incorporation and Restated Certificate of Incorporation were recorded with the United States Patent and Trademark Office at Reel 023546, Frame 0646-54. RESPONSE: Undisputed. MERCK FACT 9. On April 30, 2012, Merck Sharp & Dohme Corp. and Schering Corporation filed a Certificate of Merger/Consolidation with the New Jersey State Treasurer. RESPONSE: Undisputed. MERCK FACT 10. The merger between Merck Sharp & Dohme Corp. and Schering Corporation became effective on May 1, 2012. RESPONSE: Undisputed. MERCK FACT 11. The Certificate of Merger/Consolidation identifies Schering Corporation as the surviving business entity. RESPONSE: Undisputed. MERCK FACT 12. The Certificate of Merger/Consolidation was recorded with the United States Patent and Trademark Office at Reel 028850, Frame 544-46. RESPONSE: Undisputed. MERCK FACT 13. On May 2, 2012, Schering Corporation filed a Business Entity Amendment Filing with the New Jersey State Treasurer. RESPONSE: Undisputed. MERCK FACT 14. The Business Entity Amendment Filing was signed on May 2, 2012 and changed the name of Schering Corporation to Merck Sharp & Dohme Corp. Case 2:14-cv-04989-SRC-CLW Document 228-2 Filed 10/03/16 Page 3 of 9 PageID: 3089 4 RESPONSE: Undisputed. MERCK FACT 15. The Business Entity Amendment Filing was recorded with the United States Patent and Trademark Office at Reel 028866, Frame 540-41. RESPONSE: Undisputed. MERCK FACT 16. The United States Patent and Trademark Office identifies Merck Sharp & Dohme Corp. as the title holder of record of the ’300 patent as of the August 7, 2016 filing date of this lawsuit and continuing through to the present. RESPONSE: Undisputed. MERCK FACT 17. There have been no other assignments or other transfers of title or ownership of the ’300 patent, nor have there been any other transfers of substantial rights to the ’300 patent. RESPONSE: Disputed. Merck has failed to show evidence that it has not transferred a substantial ownership right in the ’300 patent to another party, and there is a genuine question what rights were transferred to a third party in the Teva License that Merck has failed to produce for inspection. MERCK FACT 18. The Assignment and Agreement, Certificate of Adoption of Restated Certificate of Incorporation and Restated Certificate of Incorporation, Certificate of Merger/Consolidation, and Business Entity Amendment Filing were produced to Fresenius on January 21, 2015. RESPONSE: Undisputed. MERCK FACT 19. Also on January 21, 2015, Merck served its Preliminary Disclosure of Infringement Contentions. Pursuant to L. Pat. R. 3.2(d), Merck identified, inter alia, the Case 2:14-cv-04989-SRC-CLW Document 228-2 Filed 10/03/16 Page 4 of 9 PageID: 3090 5 Assignment and Agreement, Certificate of Adoption of Restated Certificate of Incorporation and Restated Certificate of Incorporation, Certificate of Merger/Consolidation, and Business Entity Amendment Filing as being relevant to ownership of the ’300 patent. RESPONSE: Undisputed. MERCK FACT 20. Fresenius’s Rule 30(b)(6) notice to Merck sought corporate testimony from Merck regarding the “assignment and chain of ownership” of the ’300 patent. RESPONSE: Undisputed. MERCK FACT 21. Fresenius did not ask Merck’s corporate designee, Sachin Mittal, any questions relating to ownership or title to the ’300 patent. RESPONSE: Fresenius Kabi objects to this “fact” as argumentative and improper under L. Civ. R. 56.1(a), but otherwise undisputed. MERCK FACT 22. Merck also produced to Fresenius two litigation settlement agreements that resolved earlier Hatch-Waxman litigations with Sandoz, Inc. and Xellia Pharmaceuticals ApS. RESPONSE: Undisputed that Merck produced the Sandoz settlement agreement on August 4, 2015, Also undisputed that Merck surprisingly produced the Xellia settlement agreement for the first time during the August 15, 2016 pre-trial conference, after withholding it for more than a year. MERCK FACT 23. Merck was unable to produce a third litigation settlement agreement between Merck and Teva Parental Medicines, Inc. (“Teva”) because the terms of that agreement require Teva’s consent before production can made. Merck asked for, but was unable Case 2:14-cv-04989-SRC-CLW Document 228-2 Filed 10/03/16 Page 5 of 9 PageID: 3091 6 to obtain, Teva’s consent to produce the Teva settlement agreement to Fresenius. RESPONSE: Disputed. Fresenius Kabi objects to this “fact” as argumentative and improper under L. Civ. R. 56.1(a). Merck has not established the extent that it is “unable” to produce the Teva License. Furthermore, even if Teva has refused to grant its consent, Merck has not sought the assistance of the Court to compel Teva’s consent. MERCK FACT 24. Merck informed Fresenius in August 2015 that it sought but was unable to obtain Teva’s consent to produce the Teva settlement agreement. Fresenius did not take any action to secure production of the Teva settlement agreement. RESPONSE: Undisputed that Merck informed Fresenius Kabi that it failed to obtain Teva’s consent to produce the Teva License in August, 2015. Fresenius Kabi otherwise objects to this “fact” as argumentative and improper under L. Civ. R. 56.1(a). MERCK FACT 25. Merck’s 10-Q filing for the first quarter of 2011 states as follows: “In November 2009, a patent infringement lawsuit was filed in the United States against Teva Parenteral Medicines, Inc. (‘TPM’) in respect of TPM’s application to the FDA seeking pre- patent expiry approval to sell a generic version of Cancidas. That lawsuit has been dismissed with no rights granted to TPM.” RESPONSE: Undisputed concerning the bare statements were published in Merck’s 10-Q filing, however Fresenius Kabi otherwise objects to this “fact” as argumentative and improper under L. Civ. R. 56.1(a). MERCK FACT 26. The statements in Merck’s 10-Q have been confirmed by Sachin Mittal, who has submitted a declaration with this motion that the Teva settlement agreement does not grant Teva any rights to the ’300 patent. Specifically, the Teva settlement agreement does not grant Teva a license to the ’300 patent. Case 2:14-cv-04989-SRC-CLW Document 228-2 Filed 10/03/16 Page 6 of 9 PageID: 3092 7 RESPONSE: Undisputed that Merck’s corporate representative restates the bare statements were published in Merck’s 10-Q filing, Fresenius Kabi otherwise objects to this “fact” as argumentative and improper under L. Civ. R. 56.1(a). Fresenius Kabi disputes the “fact” that “the Teva settlement agreement does not grant Teva a license to the ’300 patent,” because Merck has failed to show evidence that it has not transferred a substantial ownership right in the ’300 patent to another party, and there is a genuine question what rights were transferred to a third party in the Teva License that Merck has failed to produce for inspection. MERCK FACT 27. Since 2011, Merck has continued to make, use, sell, and offer to sell Cancidas® in the United States. RESPONSE: Undisputed. MERCK FACT 28. Teva has never launched a capofungin product in the United States. RESPONSE: Undisputed. WINSTON & STRAWN LLP Attorneys for Defendant Fresenius Kabi USA, LLC By: s/ James S. Richter James S. Richter jrichter@winston.com Dated: October 3, 2016 Case 2:14-cv-04989-SRC-CLW Document 228-2 Filed 10/03/16 Page 7 of 9 PageID: 3093 8 OF COUNSEL: Imron T. Aly Thomas A. Rammer Emily Peña Schiff Hardin LLP 233 S. Wacker Drive Chicago, IL 60606 (312) 258-5500 John K. Hsu 901 K Street NW, Suite 700 Washington, DC 20001 (202) 778-6400 George C. Yu Schiff Hardin LLP One Market Street, Spear Street Tower Thirty-Second Floor San Francisco, CA 94105 (415) 901-8700 Case 2:14-cv-04989-SRC-CLW Document 228-2 Filed 10/03/16 Page 8 of 9 PageID: 3094 CERTIFICATION OF SERVICE I hereby certify that on October 3, 2016, copies of the foregoing DEFENDANT’S L. CIV. R. 56.1 RESPONSIVE AND SUPPLEMENTAL STATEMENT OF FACTS IN OPPOSITION TO PLAINTIFF’S MOTION FOR SUMMARY JUDGMENT THAT IT HOLDS TITLE TO THE ’300 PATENT were served by electronic filing and electronic mail upon all counsel of record. I certify that the foregoing statements made by me are true. I am aware that if any of the foregoing statements are willfully false, I am subject to punishment. s/ James S. Richter James S. Richter jrichter@winston.com Dated: October 3, 2016 Case 2:14-cv-04989-SRC-CLW Document 228-2 Filed 10/03/16 Page 9 of 9 PageID: 3095
