Mallinckrodt IP et al v. B. Braun Medical Inc.

ANSWERING BRIEF in Opposition re MOTION to Dismiss for Lack of Jurisdiction Over the Subject Matter

D. Del.November 13, 2017

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE MALLINCKRODT IP UNLIMITED COMPANY, MALLINCKRODT HOSPITAL PRODUCTS INC., and SCR PHARMATOP, Plaintiffs, v. B. BRAUN MEDICAL INC., Defendant. ) ) ) ) ) ) ) ) ) ) ) C.A. No. 17-365 (LPS) NEW PHARMATOP L.P.’S AND SCR PHARMATOP’S BRIEF IN OPPOSITION TO B. BRAUN MEDICAL INC.’S MOTION TO DISMISS SCR PHARMATOP UNDER RULE 12(b)(1) OF COUNSEL: Charles A. Weiss Merri C. Moken HOLLAND & KNIGHT LLP 31 West 52nd Street New York, NY 10019 (212) 513-3200 Attorneys for SCR Pharmatop Brian T. Moriarty Lawrence P. Cogswell, III, Ph.D. HAMILTON, BROOK, SMITH & REYNOLDS, P.C. Seaport West 155 Seaport Boulevard Boston, MA 02210 (617) 607-5900 Attorneys for New Pharmatop MORRIS, NICHOLS, ARSHT & TUNNELL LLP Thomas C. Grimm (#1098) Jeremy A. Tigan (#5239) Stephen J. Kraftschik (#5623) 1201 N. Market Street P.O. Box 1347 Wilmington, DE 19899-1347 (302) 658-9200 tgrimm@mnat.com jtigan@mnat.com skraftschik@mnat.com Attorneys for SCR Pharmatop and New Pharmatop November 13, 2017 Case 1:17-cv-00365-LPS Document 54 Filed 11/13/17 Page 1 of 17 PageID #: 1495 - i - TABLE OF CONTENTS Page TABLE OF AUTHORITIES .......................................................................................................... ii I. INTRODUCTION .................................................................................................................. 1 II. STATEMENT OF FACTS ..................................................................................................... 2 A. Braun’s Serial Notice Letters Triggered Multiple Complaints and 30- Months Stays ............................................................................................................2 B. SCR Pharmatop Is Pharmatop, Registration Number 407552702 ...........................3 C. The ’218 Patent ........................................................................................................5 D. The Transfer of the ’218 Patent from Pharmatop to New Pharmatop .....................6 E. Discovery Provided to Braun. ..................................................................................7 III. ARGUMENT .......................................................................................................................... 8 A. Pharmatop Had Standing When the Initial Complaint Was Filed .........................10 B. Pharmatop Had Standing when the Amended Complaint Was Filed ....................11 C. Only Pharmatop Assigned its Interests to New Pharmatop in 2017 ......................12 IV. CONCLUSION ..................................................................................................................... 13 Case 1:17-cv-00365-LPS Document 54 Filed 11/13/17 Page 2 of 17 PageID #: 1496 - ii - TABLE OF AUTHORITIES Cases Page(s) Abraxis Bioscience, Inc. v. Navinta LLC, 625 F.3d 1359 (Fed. Cir. 2010)............................................................................................8, 12 Bd. of Trs. of Leland Stanford Jr. Univ. v. Roche Molecular Sys. Inc., 583 F.3d 832 (Fed. Cir. 2009)..................................................................................................12 Cadence Pharma. Inc. v. Excela Pharma. Scis., LLC, 2013 WL 11083853 (D. Del. Nov. 14, 2013) ............................................................................6 Davis v. Wells Fargo, 824 F.3d 333, 2016 WL 3033938 (3d Cir. 2016) ..................................................................8, 9 Kehr Packages, Inc. v. Fidelcor, Inc., 926 F.2d 1406 (3d Cir.1991)......................................................................................................8 Mortensen v. First Fed. Sav. & Loan Ass’n, 549 F.2d 884 (3d Cir. 1977).......................................................................................................9 Petruska v. Gannon Univ., 462 F.3d 294 (3d Cir. 2006).......................................................................................................9 Sicom Sys., Ltd. v. Agilent Techs., Inc., 427 F.3d 971 (Fed. Cir. 2005)....................................................................................................8 SiRF Tech. v. Int’l Trade Comm., 601 F.3d 1319 (Fed. Cir. 2010)..................................................................................................9 W.L. Gore & Assoc., Inc. v C.R. Bard, Inc., 198 F. Supp. 3d 366 (D. Del. 2016) ...........................................................................8, 9, 10, 11 WiAV Solutions LLC v. Motorola, Inc., 631 F.3d 1257 (Fed. Cir. 2010)............................................................................................9, 10 Rules and Statutes 35 U.S.C. § 261 ................................................................................................................................9 35 USC § 100(d) ............................................................................................................................12 Fed. R. Civ. P. 12(b)(1)....................................................................................................................8 Fed. R. Civ. P. 25(c) ......................................................................................................................12 Case 1:17-cv-00365-LPS Document 54 Filed 11/13/17 Page 3 of 17 PageID #: 1497 - 1 - I. INTRODUCTION New Pharmatop, L.P. (“New Pharmatop”) and SCR Pharmatop (“Pharmatop”) respectfully submit this brief in opposition to B. Braun Medical Inc.’s (“Braun”) cross-motion to dismiss Pharmatop from this action filed by Pharmatop along with co-Plaintiffs Mallinckrodt IP Unlimited, and Mallinckrodt Hospital Products Inc. (collectively “Mallinckrodt”) for lack of standing (D.I. 50). Braun does not seek to dismiss this action in its entirety, and its arguments seeking to dismiss Pharmatop are misguided. Braun’s standing arguments are all based on its observation that the named plaintiff in this case is “SCR Pharmatop” whereas the September 15, 2017, assignment of the ’218 Patent (the “‘2017 Assignment”) to New Pharmatop was from “SC Pharmatop” (D.I. 50 at 1–2). Braun speculates that the one-letter difference in Pharmatop’s prefatory initials—“SC” versus “SCR”— reflects two different underlying corporate entities, rather than two standard variants referring to the exact same company. Based on that pure—and plainly incorrect—conjecture, Braun further theorizes that if “SC Pharmatop” was the actual owner of ’218 Patent, then “SCR Pharmatop” never was, rendering “SCR Pharmatop” an improper plaintiff in this case. These arguments are non-substantive word play and wholly ignore the pertinent substance. As explained in the accompanying declaration of Mme. Laurence Lessertois, the French court-appointed legal representative of Pharmatop, “SCR Pharmatop” and “SC Pharmatop” are (and have always been) the same company. Lessertois Decl. ¶ 9. That company was the sole owner of the ’218 Patent until it sold it to New Pharmatop in September 2017 (id. ¶ 14). Pharmatop is a French company that was formed in Versailles, by the inventors of the ’218 Patent Danielle Fredj and Francois Dietlin in France in 1996 and assigned registration number 407 552 702 (id. Ex. B). The French registration document states its official name as being simply “Pharmatop” (id.). Pharmatop is a type of French partnership known as a “Société Case 1:17-cv-00365-LPS Document 54 Filed 11/13/17 Page 4 of 17 PageID #: 1498 - 2 - Civile” (S.C.), and it was formed to engage in pharmaceutical research (recherché, in French) (id. ¶ 10). As a research company, Pharmatop referred to itself at times as a “Société Civile de recherché” and then began calling itself, at times, “Pharmatop SCR” (id. ¶ 9). At other times, it referred to itself as “Pharmatop SC” or simply “Pharmatop” (id.). The use of these different versions of the name Pharmatop does not change the fact that there is and was only one company: Pharmatop (id.). Whether the company is called “SC Pharmatop,” “SCR Pharmatop,” or simply “Pharmatop,” it is beyond dispute that all of these names refer to the same corporate entity—namely Pharmatop, bearing French corporate registration number 407 552 702 (id. ¶ 9). As demonstrated by the recorded assignment documents, declarations of Pharmatop, and other supporting documents, the ’218 Patent was owned solely by Pharmatop when this litigation was filed in April 2017 and when the complaint was amended in July 2017. The ’218 Patent continued to be owned exclusively by Pharmatop until it was transferred to New Pharmatop in September 2017 by the 2017 Assignment (D.I. 47 Ex. A). Thus, there is no standing issue and Braun’s motion should be denied. II. STATEMENT OF FACTS A. Braun’s Serial Notice Letters Triggered Multiple Complaints and 30-Months Stays By a letter dated February 21, 2017, Braun sent notice to Pharmatop and Mallinckrodt that it had submitted a New Drug Application pursuant to section 505(b)(2) of the Hatch- Waxman amendment to the Federal Food Drug and Cosmetics Act (the “505(b)(2) Application”) directed to a version of Mallinckrodt’s injectable acetaminophen product Ofirmev ® . Braun’s notice letter also advised that Braun’s 505(b)(2) application included a so-called Paragraph IV certification as to the ’218 Patent. As Braun concedes, within forty-five days of the receipt of the first notice letter, Pharmatop and Mallinckrodt brought this action against Braun (D.I. 50 at 3). Case 1:17-cv-00365-LPS Document 54 Filed 11/13/17 Page 5 of 17 PageID #: 1499 - 3 - That lawsuit triggered a the 30-month stay of FDA approval that blocks the FDA from approving Braun’s 505(b)(2) Application until approximately August 2019.1 The April 3, 2017, complaint in this action identifies Plaintiff Pharmatop as “SCR Pharmatop”: “Plaintiff SCR Pharmatop (‘Pharmatop’) is a business entity organized and existing under the laws of France, having its headquarters at 10, Square St. Florentin, 78150 Le Chesnay, France, As set forth herein, Pharmatop is the assignee of the ’218 patent” (D.I. 1 at ¶ 3). Paragraph 14 recites, in part, “the ’218 patent . . . was duly and legally issued by the United States Patent and Trademark Office (‘PTO’) on January 31, 2006. The named inventors assigned the application which issued as the ’218 patent to Pharmatop” (id. at ¶ 14). On July 21, 2017, Mallinckrodt and Pharmatop filed an amended complaint against Braun that repeated the allegations about SCR Pharmatop set forth above (see D.I. 25 at ¶¶ 3, 22). Braun’s first notice letter did not, for whatever reason, certify to Mallinckrodt’s U.S. Patent No. 9,399,012 (the “’012 Patent”), which was also listed in the Orange Book in February 2017 (D.I. 1 ¶ 27). Braun subsequently amended its 505(b)(2) application and filed a certification to the ’012 Patent. See Braun (5:17-cv-01521) at E.D. Pa, D.I. 14 at 6–7. It gave a new notice to Mallinckrodt in April 2017, which triggered a second thirty-month stay and the filing of a new complaint (id.). B. SCR Pharmatop Is Pharmatop, Registration Number 407552702 Pharmatop was organized in 1996 under French law as a “société civile,” a type of partnership vehicle similar to an LLC (see Lessertois Decl. at 8 and Ex. A) (registration statement)). Such companies are at times abbreviated as “S.C.” But S.C. is not part of the name 1 Braun’s motive in seeking dismissal of the complaint is clear. If the amended complaint is dismissed and then refiled, Braun will seek to argue that the current 30-month stay is no longer applicable and that it can launch its product upon FDA approval, even if the litigation has not concluded. Case 1:17-cv-00365-LPS Document 54 Filed 11/13/17 Page 6 of 17 PageID #: 1500 - 4 - of the company Pharmatop (see id. at ¶ 9). Pharmatop, a very small company, was organized with the specific object of conducting “research, creation and development of pharmaceutical, cosmologic and chemical products” under the official name of “PHARMATOP” (see id. at ¶ 10 and Ex. B). At times, Pharmatop referred to itself as a Société Civile involved in research. For example, in a 1998 corporate document, Pharmatop stated “S.C.R. PHARMATOP, Société Civile de recherché au capital del . . . .” The document also referenced Pharmatop’s unique identifier – “407 552 702” (see id., Ex. C at 1, 3). Société Civile de recherché and its abbreviation, SCR, are not official French corporate terms, such as S.C., and are also not part of the name of Pharmatop (see id. at ¶ 9 and Ex. B). U.S. Patent No. 6,028,222, that has been litigated extensively in this Court, is also owned by Pharmatop (see Lessertois Decl. at 15). The assignment for that patent was also from “SCR Pharmatop” but the notarial records included with the assignment references Pharmatop’s unique registration number 407 552 702 (id.). This is an additional record showing that SCR Pharmatop is and always has been a reference to Pharmatop, société civile, with unique identifier 407 552 702. Documents that recite “Pharmatop,” “S.C. Pharmatop,” “Pharmatop SC,” “SCR Pharmatop,” and “Pharmatop SCR” refer to the same French company registered in Versailles, France in May of 1996, under the name of PHARMATOP with registration number 407 552 702 (id.). There is no company in France registered as “SCR Pharmatop” (id at ¶¶ 9–12).2 2 While Pharmatop informally used “SCR” to mean Société Civile for research, there is different, special type of French corporation used in international finance known as Société Capital De Risque,” which is not a “société civile” and sometime is also abbreviated as “SCR” (see Lessertois Decl. at ¶ 12). That type of entity has no application to Pharmatop, a French research company (id.). Case 1:17-cv-00365-LPS Document 54 Filed 11/13/17 Page 7 of 17 PageID #: 1501 - 5 - C. The ’218 Patent The initial application leading to the ’218 Patent was filed as a French patent application 00/07231 (brevet) by the inventors of the ’218 Patent, Danièle Fredj and François Deitlin on June 6, 2000 (see ’218 Patent at 1; Lessertois Decl. at 4 and Ex. E). The Priority document, which was reviewed by the USPTO during prosecution of the ’218 patent and is included in the file history for that patent, references Pharmatop and its unique French corporate identification number 407 552 702. As stated by Mme. Lessertois, “Attached hereto as Exhibit E is a copy of the certified French priority document for the ’218 Patent found in the files of the USPTO for the ’218 Patent. This document is a legal record of Pharmatop. Pharmatop, and only Pharmatop, has been the one and only legal owner of French priority application since it was first filed” (id. at ¶ 14). The June 2000 French application was filed as a PCT application PCT/FR01/01749 on June 6, 2001, and published as WO 01/93830 on 13 Dec 2001 (see D.I. 53 at ¶ 6). On August 4, 2003, consistent with the practices of the USPTO, the 2001 French PCT application PCT/FR01/01749 was filed in the USPTO as application 10/332,060 by the inventors. The inventors assigned application 10/332,060 to Pharmatop through a written assignment (see D.I. 53 at ¶ 6, Ex. D). As stated by Mme. Lessertois, “Attached hereto as Exhibit F is a copy of an assignment of the U.S. patent application 10/332,060 from the inventors to Pharmatop dated August 4, 2003, which was obtained from the USPTO. This document is a legal record of Pharmatop. Application 10/332,060 issued as the ’218 patent. The ’218 patent was exclusively and only owned by Pharmatop from the date it issued on January 31, 2006, until September 15, 2017, when it was transferred to a company called New Pharmatop L.P.” (Lessertois Decl. at 14). Case 1:17-cv-00365-LPS Document 54 Filed 11/13/17 Page 8 of 17 PageID #: 1502 - 6 - The assignment of the 10/332,060 application from the inventors to Pharmatop was recorded at the USPTO on August 4, 2003 (see D.I. 47 Ex. B). No other assignment of the ’218 Patent was recorded at the PTO from August 4, 2003 until October 6, 2017 (id.). Pharmatop’s ownership of the ’218 Patent prior to transfer in 2017 was also recognized by this Court. See Cadence Pharma. Inc. v. Excela Pharma. Scis., LLC, 2013 WL 11083853 (D. Del. Nov. 14, 2013) at ¶ 8 (“Pharmatop owns the ’222 and ’218 Patents”). One of the inventors of the ’218 Patent, Mr. Dietlin, testified at trial that he was a manager of Pharmatop, and that the ’218 Patent was owned by Pharmatop. Tr. at pp. 151, 180 (May 20, 2013). D. The Transfer of the ’218 Patent from Pharmatop to New Pharmatop On May 10, 2017, Pharmatop and New Pharmatop reached an agreement, the Asset Purchase Agreement (“APA”), to sell and transfer assets in the future. The transactions contemplated by the APA concerned not only the ’218 Patent, but also many more assets not relevant to this matter (see D.I. 47 Ex. A; D.I. 53 at ¶ 3). The 2017 Assignment states in pertinent part, as follows: WHEREAS, the Assignors and the Assignee are parties to that certain Asset Purchase Agreement, dated as of May 10, 2017 (the “Purchase Agreement”); WHEREAS, pursuant to the Purchase Agreement, the Assignors agreed to, among other things, sell, convey, deliver, transfer and assign to the Assignee, all of the Assignors’ right, title and interest to the Seller Patents, including the Patents set forth on Exhibit A attached hereto; and WHEREAS, the execution and delivery of this Agreement is required in connection with the consummation of the transaction contemplated by the Purchase Agreement. NOW, THEREFORE, in consideration of the promises and mutual agreements set forth in the Purchase Agreement, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Assignee and Assignors hereby agree as follows: Case 1:17-cv-00365-LPS Document 54 Filed 11/13/17 Page 9 of 17 PageID #: 1503 - 7 - Assignment of Seller Patents. The Assignors hereby perpetually and irrevocably sell, convey, deliver, transfer and assign to Assignee, free and clear of all Liens, other than Permitted Liens, all of the Assignors’ right, title and interest in, to and under the Seller Patents, including the Patents set forth on Exhibit A [including US Patent 6,992,218] The APA did not assign New Pharmatop any rights, only the assignment did (see D.I. 47 Ex. B; D.I. 52 at ¶ 4; Lessertois Decl. at ¶ 14). The 2017 Assignment is the legal instrument that actually transferred ownership from Pharmatop to New Pharmatop (see D.I. 47 Ex. 1 (“The Assignors hereby perpetually and irrevocably sell, convey, deliver, transfer and assign to Assignee . . . .”) (emphasis added)). As noted by the current and prior owners of the ’218 Patent, the transfer of ownership occurred only on September 15, 2017 and not before (D.I. 52 at ¶ 4; Lessertois Decl. at ¶ 14). Braun states that S.C. Pharmatop was not the only assignor listed on that 2017 Assignment. As noted on page 1 of the 2017 Assignment, that document assigned a number of different patents and rights in a variety of different jurisdictions (see D.I. 47 at 4). Not all of the patent rights transferred were solely owned by Pharmatop, so Pharmatop was not the only assignor for certain countries outside of the United States (see id. at ¶ 4; Lessertois Decl. at ¶ 14). However, Pharmatop was the only assignor for the ’218 patent (id.). Indeed, until the ’218 Patent was assigned to New Pharmatop on September 15, 2017, the only owner of the ’218 Patent was Pharmatop, as demonstrated by PTO assignment records and the owner’s declaration (D.I. 47 Ex. B). On October 6, 2017, the PTO recorded that assignment from Pharmatop to New Pharmatop (D.I. 47 Ex. B). E. Discovery Provided to Braun. Prior to filing its cross-motion to dismiss, Braun asked for an explanation of certain information and the production of records concerning ownership. Counsel for New Pharmatop Case 1:17-cv-00365-LPS Document 54 Filed 11/13/17 Page 10 of 17 PageID #: 1504 - 8 - suggested that Braun postpone its brief for a week so that New Pharmatop could collect and produce additional documents (see D.I. 53 at ¶ 8, Ex. F). Braun refused that offer. Following the filing of Braun’s cross-motion, New Pharmatop produced over 1,000 pages of records to Braun and a provided a further explanation (id.). New Pharmatop also asked that Braun enter into a stipulation providing adequate and enforceable protection for any confidential documents produced by New Pharmatop, but Braun refused that request as well (id.) The redacted Assignment produced by New Pharmatop to Braun redacts only irrelevant information concerning rights to patents other than the ’218 Patent, including rights in many other countries (see D.I. 47 at 3). This is self-evident from the assignment document (see id. Ex. A). Braun has no need to know what other countries are part of New Pharmatop’s transaction with Pharmatop in order to satisfy itself that the ’218 Patent, which of course pertains only to the United States, was duly and properly assigned. Likewise, the APA contains highly confidential information that is not relevant to standing and, even if it were relevant, cannot be produced without an enforceable protective order (id. at 4). III. ARGUMENT “Standing is a constitutional requirement pursuant to Article III and it is a threshold jurisdictional issue.” W.L. Gore & Assoc., Inc. v C.R. Bard, Inc., 198 F. Supp. 3d 366, 372 (D. Del. 2016), quoting Abraxis Bioscience, Inc. v. Navinta LLC, 625 F.3d 1359, 1363 (Fed. Cir. 2010). The plaintiff bears the burden of persuasion to show it has standing. See Kehr Packages, Inc. v. Fidelcor, Inc., 926 F.2d 1406, 1409 (3d Cir.1991); Sicom Sys., Ltd. v. Agilent Techs., Inc., 427 F.3d 971, 976 (Fed. Cir. 2005). “A challenge to subject matter jurisdiction under Rule 12(b)(1) may be either a facial or a factual attack.’” W.L. Gore, 198 F. Supp. 3d at 372, quoting Davis v. Wells Fargo, 824 F.3d 333, 346 (3d Cir. 2016). “The former challenges subject matter jurisdiction without disputing the facts Case 1:17-cv-00365-LPS Document 54 Filed 11/13/17 Page 11 of 17 PageID #: 1505 - 9 - alleged in the complaint.”) (id.). “In contrast, when subject matter jurisdiction is challenged based upon the sufficiency of jurisdictional facts, the Court is ‘free to weigh the evidence and satisfy itself as to the existence of its power to hear the case.’” W.L. Gore, 198 F. Supp. 3d at 372, quoting Mortensen v. First Fed. Sav. & Loan Ass’n, 549 F.2d 884, 891 (3d Cir. 1977). When considering a factual challenge to standing, “no presumptive truthfulness attaches to plaintiff’s allegations, and the existence of disputed material facts will not preclude the trial court from evaluating for itself the merits of jurisdictional claims.” Petruska v. Gannon Univ., 462 F.3d 294, 302 n.3 (3d Cir. 2006). However, as here, when ownership is established through an assignment, and that assignment has been recorded at the USPTO, the burden of going forward switches from the plaintiff to the challenger (see 35 U.S.C. § 261). “The recording of an assignment ‘creates a presumption of validity as to the assignment and places the burden to rebut such a showing on one challenging the assignment.’” W.L. Gore, 198 F. Supp. 3d at 373, quoting SiRF Tech. v. Int’l Trade Comm., 601 F.3d 1319, 1327–28 (Fed. Cir. 2010). “[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 Solutions LLC v. Motorola, Inc., 631 F.3d 1257, 1265 (Fed. Cir. 2010). In other words, standing can be established by showing that the sole owner (or owners) of a patent is the plaintiff in a patent litigation charging a defendant with infringing that patent. Based on the use of different versions of the name Pharmatop, Braun argues that Pharmatop lacked standing to assert the counts associated with the ’218 Patent both when the initial complaint was filed on April 3, 2017 and when the Amended Complaint was filed on Case 1:17-cv-00365-LPS Document 54 Filed 11/13/17 Page 12 of 17 PageID #: 1506 - 10 - July 21, 2017. Further, because the 2017 Assignment lists more than one assignor, Braun speculates that there must have been multiple owners of the ’218 Patent who were never properly joined in this action. Each ground lacks merit. A. Pharmatop Had Standing When the Initial Complaint Was Filed It is black-letter law that absent certain type of exclusive licensing arrangements, the owner (or owners) of the patent must be the party to bring a lawsuit alleging patent infringement. W.L. Gore, 198 F. Supp. 3d at 372. Standing is established where the sole owner of a patent files an action for infringement of its patent. See WiAV Solutions, 631 F.3d at 1265. Here, as set forth in the Lessertois Declaration, Pharmatop is a French company organized in the form of a “Société Civile”—a type of French partnership vehicle. While that company at times was referred to as SCR Pharmatop or SC Pharmatop, its legal name is simply Pharmatop. Thus, all references to SCR Pharmatop or SC Pharmatop only refer only to Pharmatop with unique corporate identification of 407 552 702. The French PCT/FR01/01749 which was filed as U.S. Application 10/332,060 (leading to the ’218 Patent), was assigned by the inventors to “SCR Pharmatop” in 2003. Pharmatop, registration number 407 552 702, was the owner and assignee of that application (see Lessertois Decl. at ¶ 4). The assignment was recorded at the USPTO. When the ’218 Patent issued on January 31, 2006, it was owned solely by Pharmatop (see id. at ¶ 14). Pharmatop’s sole ownership of the ’218 Patent existed on the date the complaint was filed on April 3, 2017, and continued until September 15, 2017—a date that Braun agrees is the “undisputed” date Pharmatop transferred its interests in the ’218 Patent. In contrast to the recorded assignments, declarations and supporting documents submitted by plaintiffs Pharmatop and New Pharmatop, Braun has not even submitted a moving declaration. In relies solely upon speculative attorney argument. Given that ownership of a patent Case 1:17-cv-00365-LPS Document 54 Filed 11/13/17 Page 13 of 17 PageID #: 1507 - 11 - may be conclusively established by a written assignment, and here that assignment was recorded at the USPTO, Braun was required to produce some proof other than speculation to carry its burden. As noted, the recording of an assignment “creates a presumption of validity as to the assignment and places the burden to rebut such a showing on one challenging the assignment.” W.L. Gore, 198 F. Supp. 3d at 373. Accordingly, as the sole owner of the ’218 Patent as of April 3, 2017, Pharmatop had standing when this suit was filed and Braun’s arguments to the contrary should be rejected as lacking merit. B. Pharmatop Had Standing when the Amended Complaint Was Filed Braun argues that when Pharmatop along with Mallinckrodt filed the amended complaint on July 20, 2017 (D.I. 14), claiming Braun infringed the ’218 Patent, Pharmatop was not the sole and exclusive owner of the ’218 Patent and therefore lacked standing as to the counts associated with the ’218 Patent (D.I. 50 at ¶¶ 7, 10, 13, 15). Braun argues that because New Pharmatop and Pharmatop entered into the APA on May 10, 2017, Pharmatop was not an exclusive owner after May 10, 2017, but somehow was a co-owner of the ’218 Patent with New Pharmatop and New Pharmatop was required to be named as a co-plaintiff. This argument is also without merit. New Pharmatop did not obtain an interest in the ’218 Patent until it was sold and formally assigned to New Pharmatop on September 15, 2017. As the parties to the transaction both unequivocally state, no interests in the ’218 Patent passed to New Pharmatop via the APA (D.I. 52 at ¶¶ 3–4; Lessertois Decl. at ¶ 14). Nor would one expect that to occur. Every corporate agreement is followed by a closing at which money changes hands and assets are transferred. A party is not going to transfer ownership of a valuable asset until it is paid at closing. Case 1:17-cv-00365-LPS Document 54 Filed 11/13/17 Page 14 of 17 PageID #: 1508 - 12 - Here, the 2017 Assignment states that the APA contains an agreement to assign patent rights in the future. The law is clear that “contracts that obligate the owner to grant rights in the future do not vest legal title to the patents in the assignee.” Abraxis at 1364–65; Bd. of Trs. of Leland Stanford Jr. Univ. v. Roche Molecular Sys. Inc., 583 F.3d 832, 841–42 (Fed. Cir. 2009). Thus, New Pharmatop had no ownership interest in the ’218 Patent on July 21, 2017, and was not required to be named as plaintiff. Pharmatop still retained full ownership of the ’218 Patent and had standing to file the Amended Complaint. Only upon execution and delivery of the 2017 Assignment in September did New Pharmatop become the owner of the ’218 Patent. And promptly following that assignment, New Pharmatop moved to substitute as Plaintiff (D.I. 46). Moreover, while the APA did not assign the ’218 Patent to New Pharmatop, even if it did, New Pharmatop would be deemed a party to the Amended Complaint as a matter of law (see 35 USC § 100(d) (“The word ‘patentee’ includes not only the patentee to whom the patent was issued but also the successors in title to the patentee.”)).3 C. Only Pharmatop Assigned its Interests to New Pharmatop in 2017 Braun next claims that because the 2017 Assignment names S.C. Pharmatop as an assignor as well as three additional assignors (inventors Fredj and Dietlin, and a French company New Pharma), there must have been more than one owner of the ’218 Patent at the time the lawsuit was filed. Because these three parties were not listed as plaintiffs in the complaint or amended complaint, Braun argues that there is no standing. Both the new owner of the ’218 Patent, New Pharmatop, and the old owner, Pharmatop, have submitted declarations stating that only Pharmatop was the exclusive and sole owner of the 3 As explained in Braun’s motion to substitute (D.I. 46), the law is clear that where a party becomes the owner of a patent-in-suit during the pendency of litigation pursuant to Federal Rule of Civil Procedure 25(c) (see D.I. 46). Multiple cases from this district confirm the propriety of substitution and maintenance of standing in such circumstances (see id.). Case 1:17-cv-00365-LPS Document 54 Filed 11/13/17 Page 15 of 17 PageID #: 1509 - 13 - ’218 Patent up to September 15, 2017, and that Pharmatop assigned its interests to New Pharmatop on September 15, 2017 (see D.I. 47 Ex. A). Indeed, Braun concedes that it is “undisputed” that Pharmatop transferred its interests as of September 15, 2017 (D.I. 50 at 10). As demonstrated by the 2003 assignment from the inventors to Pharmatop and the USPTO recordation records, there were no other owners of the ’218 Patent other than Pharmatop from the date the ’218 Patent issued on January 31, 2006, up through September 15, 2017. In other words, when the Complaint was filed in April 2017 and the Amended Complaint filed in July 2017, Pharmatop was the sole and exclusive owner of the ’218 Patent and unquestionably had standing to bring the case. The other parties listed in the 2017 Assignment assigned other rights to New Pharmatop which did not include rights in the ’218 Patent because none of those three parties had any such rights in the ’218 Patent (D.I. 47 at 4; Lessertois Decl. at 5). Pharmatop’s sole ownership from 2003 to 2017 is also demonstrated by the 2003 assignment, which was duly recorded at the USPTO. Because that assignment was recorded at the USPTO, Braun was required to produce some proof other than speculation. This argument should also be rejected as lacking merit. IV. CONCLUSION Pharmatop owned the ’218 Patent from issuance until September 5, 2017, when it, alone, transferred all of its rights to New Pharmatop. Thus, there was standing in the case from the filing of the case, through the July 2017 amendment of the complaint and continuing until today. Braun’s cross motion to dismiss for lack of standing should be denied. Case 1:17-cv-00365-LPS Document 54 Filed 11/13/17 Page 16 of 17 PageID #: 1510 - 14 - OF COUNSEL: Charles A. Weiss Merri C. Moken HOLLAND & KNIGHT LLP 31 West 52nd Street New York, NY 10019 (212) 513-3200 Attorneys for SCR Pharmatop Brian T. Moriarty Lawrence P. Cogswell, III, Ph.D. HAMILTON, BROOK, SMITH & REYNOLDS, P.C. Seaport West 155 Seaport Boulevard Boston, MA 02210 (617) 607-5900 Attorneys for New Pharmatop MORRIS, NICHOLS, ARSHT & TUNNELL LLP /s/ Jeremy A. Tigan Thomas C. Grimm (#1098) Jeremy A. Tigan (#5239) Stephen J. Kraftschik (#5623) 1201 N. Market Street P.O. Box 1347 Wilmington, DE 19899-1347 (302) 658-9200 tgrimm@mnat.com jtigan@mnat.com skraftschik@mnat.com Attorneys for SCR Pharmatop and New Pharmatop November 13, 2017 11438800 Case 1:17-cv-00365-LPS Document 54 Filed 11/13/17 Page 17 of 17 PageID #: 1511