Otsuka Pharmaceutical Co., Ltd. v. Orchid Pharma Ltd. et al

MOTION for Summary Judgment of Noninfringement

D.N.J.September 23, 2016

KAREN A. CONFOY FOX ROTHSCHILD LLP Princeton Pike Corporate Center 997 Lenox Drive, Building 3 Lawrenceville, NJ 08648 Telephone: (609) 896-3600 Facsimile: (609) 896-1469 E-mail: kconfoy@foxrothschild.com Attorneys for Defendants Orchid Pharma Ltd., Orchid Healthcare, Orchid Pharma, Inc., and Orgenus Pharma Inc. UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY OTSUKA PHARMACEUTICAL CO., LTD., Plaintiff, v. ORCHID PHARMA LTD., ORCHID HEALTHCARE, ORCHID PHARMA, INC. and ORGENUS PHARMA INC., Defendants. Civil Action No. 1:16-cv-00405-JBS-KMW NOTICE OF MOTION FOR SUMMARY JUDGMENT OF NONINFRINGEMENT Oral Argument Requested Return Date: October 17, 2016 Filed Electronically PLEASE TAKE NOTICE that on October 17, 2016, or on a date to be determin d by the Court, Defendants Orchid Pharma Ltd., Orchid Healthcare, Orchid Pharma, Inc., and Orgenus Pharma Inc. (collectively, “Orchid”), through counsel, Fox Rothschild LLP and Schiff Hardin LLP, shall move before the Honorable Jerome B. Simandle, U.S.D.J., for the entry of an Order Granting Summary Judgment of Noninfringement pursuant to Federal Rule of Civil Procedure 56 and Local Civil Rule 56.1. PLEASE TAKE FURTHER NOTICE that in support of its Motion, Orchid shall rely upon the Memorandum of Law, Statement of Uncontested Facts Pursuant to Local Civil Rule 56.1, and the Declaration of Karen A. Confoy with annexed exhibits submitted herewith, Case 1:16-cv-00405-JBS-KMW Document 105 Filed 09/23/16 Page 1 of 2 PageID: 1377 2 together with the pleadings and papers submitted and on file and such other and further argument that may be presented at the hearing on this Motion. PLEASE TAKE FURTHER NOTICE that a proposed form of order is submitted herewith. PLEASE TAKE FURTHER NOTICE that oral argument is requested. Dated: September 23, 2016 /s/ Karen A. Confoy OF COUNSEL: SAILESH K. PATEL (admitted Pro Hac Vice) JASON G. HARP (admitted Pro Hac Vice) THOMAS RAMMER (admitted Pro Hac Vice) HELEN H. JI (admitted Pro Hac Vice) JAIMIN H. SHAH (admitted Pro Hac Vice) SCHIFF HARDIN LLP 233 South Wacker Drive, Suite 6600 Chicago, IL 60606 (312) 258-5500 spatel@schiffhardin.com jharp@schiffhardin.com trammer@schiffhardin.com hji@schiffhardin.com jshah@schiffhardin.com KAREN A. CONFOY FOX ROTHSCHILD LLP Princeton Pike Corporate Center 997 Lenox Drive Building 3 Lawrenceville, NJ 08648 (609) 844-3033 kconfoy@foxrothschild.com JOHN K. HSU (admitted Pro Hac Vice) SCHIFF HARDIN LLP 901 K Street NW Suite 700 Washington, DC 20001 (202) 778-6400 jhsu@schiffhardin.com Attorneys for Defendants Orchid Pharma Limited, Orchid Pharma USA Inc., and Orgenus Pharma Inc. Case 1:16-cv-00405-JBS-KMW Document 105 Filed 09/23/16 Page 2 of 2 PageID: 1378 UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY OTSUKA PHARMACEUTICAL CO., LTD, Plaintiff, v. ORCHID PHARMA LIMITED, ORCHID HEALTHCARE, ORCHID PHARMA, INC., AND ORGENUS PHARMA INC., Defendants. Civil Action No. 1:16-cv-00405- JBS-KMW FILED UNDER SEAL Oral Argument Requested Return Date: October 17, 2016 Filed Electronically ORCHID’S MEMORANDUM OF LAW IN SUPPORT OF ITS MOTION FOR SUMMARY JUDGMENT OF NONINFRINGEMENT OF COUNSEL: SAILESH K. PATEL (admitted Pro Hac Vice) JASON G. HARP (admitted Pro Hac Vice) THOMAS A. RAMMER (admitted Pro Hac Vice) HELEN H. JI (admitted Pro Hac Vice) JAIMIN H. SHAH (admitted Pro Hac Vice) SCHIFF HARDIN LLP 233 South Wacker Drive, Suite 6600 Chicago, IL 60606 (312) 258-5500 spatel@schiffhardin.com jharp@schiffhardin.com trammer@schiffhardin.com hji@schiffhardin.com jshah@schiffhardin.com JOHN K. HSU (admitted Pro Hac Vice) SCHIFF HARDIN LLP 901 K Street NW Suite 700 Washington, DC 20001 (202) 778-6400 jhsu@schiffhardin.com FOX ROTHSCHILD LLP KAREN A. CONFOY 997 Lenox Drive, Building 3 Lawrenceville, NJ 08648 Telephone: (609) 896-3600 Facsimile: (609) 896-1469 kconfoy@foxrothschild.com Attorneys for Defendants Orchid Pharma Limited, Orchid Pharma USA Inc., and Orgenus Pharma Inc. Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 1 of 46 PageID: 1379 – i – TABLE OF CONTENTS TABLE OF CONTENTS ........................................................................................... i TABLE OF AUTHORITIES .................................................................................... iii INTRODUCTION ..................................................................................................... 1 FACTUAL BACKGROUND .................................................................................... 3 I. NATURE AND STAGE OF THE PROCEEDINGS ...................................... 3 II. THE LOW-HYGROSCOPICITY PATENTS ................................................ 4 A. The ’615 Patent ..................................................................................... 4 B. The ’796 Patent ..................................................................................... 5 C. The ’760 Patent ..................................................................................... 5 D. Every Asserted Claim Of The Low-Hygroscopicity Patents Requires Low-Hygroscopicity Aripiprazole Crystals .......................................... 6 III. THE ’421 PATENT ......................................................................................... 7 IV. ORCHID’S ANDA PRODUCTS .................................................................... 8 A. ............................................................................. 8 B. ..10 V. OTSUKA HAS SHOWN NO EVIDENCE OF INFRINGEMENT .............11 A. The Parties’ Contentions .....................................................................11 B. The Myerson Report Is Devoid Of Any Evidence Of Infringement Of The Low-Hygroscopicity Limitation ..................................................12 C. The Byrn Report Is Devoid Of Any Evidence Of Infringement Of The Calcium Silicate Limitation ................................................................13 ARGUMENT ...........................................................................................................13 I. LEGAL BACKGROUND .............................................................................15 II. OTSUKA HAS FAILED TO MEET ITS BURDEN OF PROVING INFRINGEMENT OF THE LOW-HYGROSCOPICITY CLAIMS............18 A. Otsuka Failed To Allege Infringement ...............................................18 1. Otsuka Has Never Explained Its Theory Of Infringement .......19 Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 2 of 46 PageID: 1380 – ii – 2. Dr. Myerson’s Report Contains No Evidence Showing The Orchid Meets The Low-Hygroscopicity Limitation .................20 B. ............................23 1. ............23 2. .............................................................25 C. Orchid’s IR ANDA Product Does Not Infringe The Asserted Claims Of The Low-Hygroscopicity Patents Under The Doctrine Of Equivalents ..........................................................................................26 III. OTSUKA HAS FAILED TO MEET ITS BURDEN OF PROVING INFRINGEMENT OF THE ASSERTED ’421 CLAIMS ............................30 A. .........30 B. Otsuka Has Failed To Meet Its Burden Of Proving Infringement Under The Doctrine Of Equivalents ...................................................32 1. Otsuka Failed To Properly Allege Infringement By Orchid’s ODT ANDA Product Under The Doctrine Of Equivalents ......33 2. Orchid’s ODT ANDA Product Fails The Function/Way/Result Test, ........................................................................35 3. Otsuka Cannot Use The Doctrine Of Equivalents To Recapture The Prior Art .............................................................................36 4. Otsuka Cannot Use The Doctrine Of Equivalents When It Would Vitiate Its Claims ..........................................................37 IV. ..............................................................................39 CONCLUSION ........................................................................................................40 Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 3 of 46 PageID: 1381 – iii – TABLE OF AUTHORITIES Cases Abbott Labs. v. TorPharm, Inc., 300 F.3d 1367 (Fed. Cir. 2002) .................................................................... passim Acumed LLC v. Advanced Surgical Servs., 561 F.3d 199 (3d Cir. 2009) .................................................................................16 Akzo Nobel Coatings, Inc. v. Dow Chem. Co., 811 F.3d 1334 (Fed. Cir. 2016) .................................................................... passim Anderson v. Liberty Lobby, Inc., 477 U.S. 242 (1986) .............................................................................................16 AquaTex Indus. v. Techniche Sols., 479 F.3d 1320 (Fed. Cir. 2007) ..................................................................... 17, 35 Bai v. L & L Wings, Inc., 160 F.3d 1350 (Fed. Cir. 1998) ..................................................................... 30, 31 Bayer AG v. Etan Phann. Research Corp., 212 F.3d 1241 (Fed. Cir. 2000) .................................................................... passim Bristol–Myers Squibb Co. v. Royce Lab., Inc., 69 F.3d 1130 (Fed. Cir. 1995) ..............................................................................39 Builders Concrete, Inc. v. Bremerton Concrete Prods. Co., 757 F.2d 255 (Fed. Cir. 1985) ..............................................................................16 Cambrian Sci. Corp. v. Cox Commc’ns, Inc., 617 F. App’x 989 (Fed. Cir. 2015) .......................................................... 26, 33, 34 Celotex Corp. v. Catrett, 477 U.S. 317 (1986) .............................................................................................15 CVI/Beta Ventures, Inc. v. Tura LP, 112 F.3d 1146 (Fed. Cir. 1997) ............................................................................16 Depuy Spine, Inc. v. Medtronic Sofamore Danek, Inc., 469 F. 3d 1005 (Fed. Cir. 2006) .................................................................... 37, 38 Exigent Tech., Inc. v. Atrana Solutions, Inc., 442 F.3d 1301 (Fed. Cir. 2006) .................................................................... passim Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 493 F.3d 1368 (Fed. Cir. 2007) ............................................................................33 Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 4 of 46 PageID: 1382 – iv – Freedman Seating Co. v. Am. Seating Co., 420 F.3d 1350 (Fed. Cir. 2005) ............................................................... 29, 37, 38 Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562 (Fed. Cir. 1997) ............................................................................39 Graver Tank & Mfg. Co. v. Linde Air Products Co., 339 U.S. 605 (1950) ...................................................................................... 33, 36 Jackson v. Danberg, 594 F.3d 210 (3d Cir. 2010) .................................................................................16 Johnson & Johnston Assocs. v. R.E. Serv. Co., 285 F.3d 1046 (Fed. Cir. 2002) ..................................................................... 27, 28 Jonsson v. Stanley Works, 903 F.2d 812 (Fed. Cir. 1990) ..............................................................................29 Laitram Corp. v. Morehouse Indus., Inc., 143 F.3d 1456 (Fed. Cir. 1998) ............................................................................29 London v. Carson Pirie Scott & Co., 946 F. 2d 1534 (Fed. Cir. 1991) ...........................................................................17 Moore USA, Inc. v. Standard Register Co., 229 F.3d 1091 (Fed. Cir. 2000) ..................................................................... 17, 32 Novartis Corp. v. Ben Venue Labs., Inc., 271 F.3d 1043 (Fed. Cir. 2001) ..................................................................... 17, 18 Novartis Pharms. Corp. v. Abbott Labs., 294 F. Supp. 2d 557 (D. Del. 2003), aff’d, 375 F.3d 1328 (Fed. Cir. 2004) ........................................................... 17, 32 Omega Eng’g, Inc. v. Raytek Corp., 334 F.3d 1314 (Fed. Cir. 2003) ............................................................................28 Orsatti v. New Jersey State Police, 71 F.3d 480 (3d Cir. 1995) ................................................................ 15, 19, 22, 34 Purdue Phanna L.P. v. Boehringer Ingelheim GMBH, 237 F.3d 1359 (Fed. Cir. 2001) ............................................................................16 Reckitt Benckiser Inc. v. Tris Pharma, Inc., No. CIV.A. 09-3125 FLW, 2011 WL 6723400 (D.N.J. Dec. 21, 2011) ....................................... 18, 21, 23, 34 Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 5 of 46 PageID: 1383 – v – Spectrum Pharms., Inc. v. Sandoz Inc., 802 F.3d 1326 (Fed. Cir. 2015) ..................................................................... 28, 29 Texas Instruments Inc. v. Cypress Semiconductor Corp., 90 F.3d 1558 (Fed. Cir. 1996) ..............................................................................17 Trading Techs. Int’l, Inc. v. Open E Cry, LLC, 728 F.3d 1309 (Fed. Cir. 2013) ............................................................................28 Warner Lambert Co. v. Purepac Pharm. Co., No. CIV.A. 98-2749 (JCL), 2003 WL 21698310 (D.N.J. May 22, 2003) ...........15 Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17 (1997) ...............................................................................................32 Wilson Sporting Goods v. David Geoffrey & Assoc., 904 F. 2d 677 (Fed. Cir. 1990) .............................................................................29 Statutes § 271(a) ....................................................................................................................11 35 U.S.C. § 271(e)(1) ........................................................................................ 11, 39 Fed. R. Civ. P. 56(c).................................................................................................15 Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 6 of 46 PageID: 1384 – 1 – INTRODUCTION Defendants Orchid Pharma Limited, Orchid Healthcare, Orchid Pharma, Inc., and Orgenus Pharma Inc. (collectively “Orchid”) hereby move for summary judgment of non-infringement of asserted claims 3, 4, 15, and 16 of U.S. Patent No. 8,017,615 (“the ’615 patent); asserted claims 1 and 2 of U.S. Patent No. 8,580,796 (“the ’796 patent); and asserted claims 1 and 2 of U.S. Patent No. 8,642,760 (“the ’760 patent) (collectively the “low-hygroscopicity patents”); and asserted claims 1– 17 of U.S. Patent No. 8,518,421 (“the ’421 patent”). In this Hatch-Waxman Act litigation, Plaintiff Otsuka Pharmaceutical Company, Ltd. (“Otsuka” or “Plaintiff”) alleges that Orchid infringes the asserted claims of the low-hygroscopicity patents by the filing of an Abbreviated New Drug Applications (ANDAs) seeking FDA approval to market Orchid’s Aripiprazole tablets 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg (“Orchid’s IR ANDA Product”) and Aripiprazole orally disintegrating tablets 10 mg and 15 mg (“Orchid’s ODT ANDA Product”) as generic versions of Otuska’s Abilify® and Abilify Discmelt®, respectively. Otsuka further alleges that Orchid infringes the asserted claims of the ’421 patent by the filing of its ODT ANDA. Despite having the burden of proof, Otsuka has failed—both during fact and expert discovery—to offer evidence sufficient to raise a genuine issue of fact regarding non-infringement. Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 7 of 46 PageID: 1385 – 2 – First, Orchid’s ANDA products do not contain the low-hygroscopicity API required by each and every asserted claim of the low-hygroscopicity patents. The prior art disclosed aripiprazole Type-I crystals, which the common specification of the low-hygroscopicity patents admits were known in the industry before their priority date. Indeed, the low-hygroscopicity patents distinguish Crystals B from the prior art Type-I crystals based solely on hygroscopicity, as determined by a certain hygroscopicity test. . . . Second, each of the asserted claims of the ’421 patent requires the use of calcium silicate as a dispersing agent. . Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 8 of 46 PageID: 1386 – 3 – Otsuka has failed to show how these two limitations are met by Orchid’s ANDA products. Its infringement contentions are conclusory, simply citing to pages of Orchid’s ANDAs that actually demonstrate that Orchid’s ANDA products do not infringe. Otsuka’s infringement experts admit that they have no evidence that Orchid’s ANDA products will meet these two limitations, and provide no cogent argument to support Otsuka’s allegations. Otsuka has failed to meet it burden to show by a preponderance of the evidence that Otsuka’s ANDAs products infringe any of its asserted claims, and therefore Orchid is entitled to summary judgment of non-infringement. FACTUAL BACKGROUND I. NATURE AND STAGE OF THE PROCEEDINGS By letter dated , Orchid notified Plaintiff that Orchid had filed ANDA No. 20-2683 and ANDA No. 20-2547 with the FDA seeking approval to market Orchid’s IR ANDA Product and ODT ANDA Product as generic versions of Otuska’s Abilify® and Abilify Discmelt®, respectively. See Defendant Orchid’s Statement of Uncontested Facts Pursuant to L. Civ. R. 56.1 (“SOF”) 79. On January 22, 2016, Otsuka filed a complaint against Orchid alleging infringement of the ’615 patent; the ’796 patent; the ’760 patent; and the ’421 patent. Dkt. No. 1. Fact discovery has been completed, and Otsuka has served its opening expert reports concerning its infringement case against Orchid, which must contain any and Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 9 of 46 PageID: 1387 – 4 – all evidence and theories to support Otsuka’s allegations. Orchid has served its rebuttal non-infringement reports, and Otsuka has filed its reply reports. No trial date has yet been scheduled. Orchid has been able to depose one of Otsuka’s infringement experts, Dr. Myerson, but Otsuka refused to produce Dr. Byrn for a deposition before this Court’s dispositive motions deadline. Orchid reserves its right to inform the Court of any additional information from Dr. Byrn’s deposition. II. THE LOW-HYGROSCOPICITY PATENTS A. The ’615 Patent The ’615 patent has ten independent claims and eight dependent claims. Claims 1, 2, 5, 8, 11–14, 17, and 18 are directed to a process for preparing the pharmaceutical solid oral preparation. Claims 3, 4, 6, 7, 9, 10, 15, and 16 are directed to a pharmaceutical solid oral preparation of anhydrous Aripiprazole crystals having low hygroscopicity. Plaintiff has asserted that the products described in both Orchid’s IR ANDA and Orchid’s ODT ANDA will infringe claims 3, 4, 15, and 16 of the ’615 patent. SOF 1. The independent claims of the ’615 patent are directed to a pharmaceutical solid oral preparation of “Anhydrous Aripiprazole Crystals B,” having low hygroscopicity, and defined by an X-ray powder diffraction pattern, an IR spectrum, certain thermogravimetric and differential scanning calorimetry features, and Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 10 of 46 PageID: 1388 – 5 – particle size. SOF 19–20. Specifically, the claims define “low hygroscopicity” as not having moisture content higher than 0.40% (with respect to claims 3 and 15), and 0.10% (with respect to claims 4 and 16) after 24 hours in a desiccator maintained at a temperature of 60°C and a humidity level of 100%. SOF 19–22. B. The ’796 Patent The ’796 patent has two independent claims and no dependent claims. SOF 24–25. Both claims are directed to a polymorphic form of Aripiprazole, namely “Anhydrous Aripiprazole Crystals B,” which is characterized as having low hygroscopicity as compared to prior known anhydrous forms of Aripiprazole. Id. Each claim expressly defines its “low hygroscopicity” limitation as “0.40% or less” moisture content in Claim 1 and as “0.10% or less” moisture content in Claim 2, when placed in a desiccator at defined parameters. Id. Plaintiff has asserted Claims 1 and 2 of the ’796 patent against both Orchid ANDA products. SOF 1. C. The ’760 Patent The ’760 patent has two independent claims and no dependent claims. SOF 27–28. Both claims are directed to the stable anhydrous Aripiprazole drug substance, characterized as having lower hygroscopicity in comparison to prior known anhydrous forms of Aripiprazole. Id. Each claim expressly defines the requirement for “low hygroscopicity” as requiring a moisture content of less than 0.40% (regarding Claim 1) or 0.10% (regarding Claim 2) when the claimed crystals Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 11 of 46 PageID: 1389 – 6 – are placed for 24 hours in a desiccator at 60°C and 100% humidity. Id. Plaintiff has asserted claims 1and 2 of the ’760 patent against both Orchid products. SOF 1. D. Every Asserted Claim Of The Low-Hygroscopicity Patents Requires Low-Hygroscopicity Aripiprazole Crystals Each and every asserted claim of the low-hygroscopicity patents requires low- hygroscopicity aripiprazole crystals. SOF 31–33. The three asserted low- hygroscopicity patents all share a substantially identical specification, which identifies the “present invention” as a form of aripiprazole crystal that has “reduced hygroscopicity” compared to the prior-art crystal forms, and defines the allegedly new reduced-hygroscopic form of aripiprazole as “Anhydrous Aripiprazole Crystals B.” SOF 21, 34. The specifications unequivocally distinguish Crystals B from the prior art Type-I crystals based solely on hygroscopicity at certain harsh conditions. SOF 36; see also SOF 3–13. The specifications provide a certain “Hygroscopicity-Test Method” to determine whether a given aripiprazole sample is the Anhydrous Aripiprazole Crystals B or not: One g of the sample was accurately weighed in a weighing bottle (diameter 5 cm), covered with kimwipes and left to rest in a 60° C./100% RH environment (water/dessicator). 24 hours later, the weighing bottle was removed, transferred to an environment of a room temperature and about 30% RH (magnesium chloride hexahydrate saturated water solution/ dessicator) and left to rest for 24 hours and the water content of the sample was measured by the Karl Fischer method. Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 12 of 46 PageID: 1390 – 7 – SOF 11. After so conditioning, the specification states that Anhydrous Aripiprazole Crystals B will have water content less than 0.40%. SOF 13; see also SOF 10. The specification makes clear that aripiprazole crystals that have higher than 0.40% water content under the hygroscopicity test are not the claimed Anhydrous Aripiprazole Crystals B. Id. This fact was adopted in the Court’s Markman Order. See Markman Order at 4–5. During the prosecution of the ’615 patent, the patent examiner rejected the claim term “low hygroscopicity” as indefinite. SOF 38. In response, the patentee explained that the term “is not indefinite when understood in the context of the claim limitation ‘wherein low hygroscopicity is a moisture content of 0.40% or less by placing said Crystals for 24 hours in a dessicator maintained at a temperature of 60 °C and a humidity level of 100 %.’” Id. Applying the Court claim construction, the asserted claims only claim aripiprazole crystals, drug substances, and pharmaceutical products where the aripiprazole active pharmaceutical ingredient (“API”) has a moisture content of less than either 0.40% or 0.10%, depending on the claim, after being subjected to the “Hygroscopicity-Test Method” provided in the asserted patents. SOF 35. III. THE ’421 PATENT Each asserted claim of the ’421 patent is directed to a so-called “flash-melt” pharmaceutical dosage form comprising at least a medicament, two Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 13 of 46 PageID: 1391 – 8 – superdisintegrants, a dispersing agent, and a binder. SOF 39. Each claim expressly specifies that the medicament is aripiprazole, the dispersing agent is calcium silicate, and the superdisintegrants are crospovidone and croscarmellose sodium. SOF 41– 42. Plaintiff originally asserted Claims 1–17 of the ’421 patent with respect to Orchid’s ODT ANDA, but its Opening Expert Report Of Stephen R. Byrn, Ph.D concerning the alleged infringement of the ’421 patent was limited to claims 1, 6–8, and 13. SOF 40. All of the claims of the e’421 patent include the limitation of “a dispersing agent … wherein the dispersing agent is calcium silicate.” SOF 41. In overcoming an obviousness rejection during the prosecution of the ’421 patent, the patentee argued that calcium silicate is not a substitute for superdisintegrants. SOF 45. The patentee additionally distinguished the alleged invention from the prior art by noting that greater amounts of calcium silicate (the dispersing agent) are used, whereas the prior art only disclosed minor amounts of calcium silicate. Id. IV. ORCHID’S ANDA PRODUCTS A. Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 14 of 46 PageID: 1392 – 9 – Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 15 of 46 PageID: 1393 Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 16 of 46 PageID: 1394 – 11 – V. OTSUKA HAS SHOWN NO EVIDENCE OF INFRINGEMENT A. The Parties’ Contentions Otsuka’s May 6, 2016 Infringement Contentions provided no substantive explanation of Otsuka’s infringement positions. In the body of its contentions, Otsuka conclusorily alleged that Orchid has committed an act of infringement under 35 U.S.C. § 271(e)(2) of the asserted patent claims by submitting its ANDAs and that Orchid will infringe under § 271(a) the asserted claims if Orchid commercializes the products after FDA approval. SOF 82. In the claim charts, Otsuka provided no reasoning or explanation of why, how, or where in its view the Orchid products meet the low-hygroscopicity or calcium silicate claim elements either literally or under the doctrine of equivalents. SOF 83. The Bates citations to large portions of Orchid’s ANDA and DMF referred to Orchid’s ANDA documents that generally recite various characteristics and components of the accused products, but did not explain specifically how Orchid’s ANDA products met the low-hygroscopicity or calcium silicate limitations of the asserted claims. Id. By contrast, Orchid’s Noninfringement Contentions expressly detailed how its ANDA products do not infringe in part because a) Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 17 of 46 PageID: 1395 – 12 – and b) . SOF 84–85. B. The Myerson Report Is Devoid Of Any Evidence Of Infringement Of The Low-Hygroscopicity Limitation Otsuka’s last opportunity to provide infringement evidence concerning the low-hygroscopicity patents was the Expert Report of Dr. Meyerson. SOF 88. Dr. Myerson does not have a “fully formed” opinion as to whether the Orchid ANDA products meet all of the limitations of the asserted claims. SOF 90, 125. The Myerson Report does not discuss . . SOF 93. The rest of the Myerson report addresses other characterizations of the crystals as expressed in some of the claims and the Court’s claim construction. These characterizations do not distinguish the claimed Crystals B from the prior art polymorphs, and therefore are irrelevant to determining whether Orchid’s crystals infringe. SOF 101–115. These deficiencies are not corrected in Dr. Myerson’s Reply reports. See SOF 123–131. Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 18 of 46 PageID: 1396 – 13 – C. The Byrn Report Is Devoid Of Any Evidence Of Infringement Of The Calcium Silicate Limitation Similarly, Otsuka’s last opportunity to provide infringement evidence concerning the ’421 patent was the Expert Report of Dr. Byrn. SOF 116. . These deficiencies are not corrected in Dr. Byrn’s Reply report. See SOF 132. ARGUMENT Orchid’s ANDA products do not literally infringe the asserted claims because they do not meet the low-hygroscopicity aripiprazole crystals limitation required by each and every asserted claim of the low-hygroscopicity patents, nor the calcium silicate dispersing agent requirements of the ’421 patent. Controlling precedent Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 19 of 46 PageID: 1397 – 14 – legally forecloses any argument that Orchid’s ANDA products infringe under the doctrine of equivalents. As a matter of fact and law, Otsuka has not and cannot meet its burden of proving infringement of any of the asserted claims, and therefore Orchid is entitled to summary judgment of noninfringement. Unlike a typical patent case, the infringement analysis here turns on what is written in Orchid’s ANDA. As the Federal Circuit has explained, “drug manufacturers are bound by strict statutory provisions to sell only those products that comport with the ANDA’s description of the drug,” and thus, “an ANDA specification defining a proposed generic drug in a manner that directly addresses the issue of infringement will control the infringement inquiry.” Abbott Labs. v. TorPharm, Inc., 300 F.3d 1367, 1373 (Fed. Cir. 2002). Focusing exclusively on what is written in the ANDA makes sense, the Federal Circuit reasoned, because any departure from that written description is strictly forbidden and subject to many possible sanctions, including potential “criminal sanctions.” Bayer AG v. Etan Phann. Research Corp., 212 F.3d 1241, 1250 (Fed. Cir. 2000). Moreover, in an ANDA case like this one, the infringement inquiry is often determined before any commercial launch of the ANDA product. To satisfy its burden of showing infringement, therefore, Otsuka must prove that the written description of Orchid’s proposed product in its ANDA includes every element of the properly construed asserted patent claims. Otsuka cannot carry Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 20 of 46 PageID: 1398 – 15 – that burden. Otsuka failed to show anything in Orchid’s ANDAs supporting its infringement arguments. Thus, there is no dispute that Orchid’s products do not literally infringe any of the asserted claims. . Furthermore, Otsuka has failed to provide any explanation of how the doctrine of equivalents applies here. On the record, there are no more material facts in dispute. I. LEGAL BACKGROUND Summary judgment is a procedural tool that obviates the need for trial by identifying and disposing of groundless claims and defenses. See Celotex Corp. v. Catrett, 477 U.S. 317, 323–24 (1986). Relief is warranted where “the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law.” Warner Lambert Co. v. Purepac Pharm. Co., No. CIV.A. 98-2749 (JCL), 2003 WL 21698310, at *2 (D.N.J. May 22, 2003) (citing Fed. R. Civ. P. 56(c)). The existence of some alleged factual dispute between the parties will not defeat an otherwise properly supported motion for summary judgment. Id. The nonmovant’s burden is significant: it “must point to concrete evidence in the record.” Orsatti v. New Jersey State Police, 71 F.3d 480, 484 (3d Cir. 1995). “Speculation and conjecture may not defeat a motion Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 21 of 46 PageID: 1399 – 16 – for summary judgment.” Jackson v. Danberg, 594 F.3d 210, 227 (3d Cir. 2010) (quoting Acumed LLC v. Advanced Surgical Servs., 561 F.3d 199, 228 (3d Cir. 2009)). A mere “scintilla of evidence” in support of the nonmoving party is insufficient for a court to deny summary judgment. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 252 (1986). Otsuka, as the patentee, bears the burden of proving infringement by a preponderance of the evidence. See Bayer, 212 F.3d at 1247; CVI/Beta Ventures, Inc. v. Tura LP, 112 F.3d 1146, 1161 (Fed. Cir. 1997). There are two steps to the infringement inquiry. First, the scope of the relevant claim language must be construed. Purdue Phanna L.P. v. Boehringer Ingelheim GMBH, 237 F.3d 1359, 1363 (Fed. Cir. 2001). Second, the Court must compare the properly construed claims to the accused product. Id. Proving “[l]iteral infringement requires that the accused [product] embody every element of the claim.” Builders Concrete, Inc. v. Bremerton Concrete Prods. Co., 757 F.2d 255, 257 (Fed. Cir. 1985). “If any claim limitation is absent from the accused [product], there is no literal infringement as a matter of law.” Bayer, 212 F.3d at 1247. “A finding of infringement under the doctrine of equivalents requires a showing that the difference between the claimed invention and the accused product or method was insubstantial or that the accused product or method performs the substantially same function in substantially the same way with substantially the same Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 22 of 46 PageID: 1400 – 17 – result as each claim limitation of the patented product or method.” AquaTex Indus. v. Techniche Sols., 479 F.3d 1320, 1326 (Fed. Cir. 2007). “A patentee must establish ‘equivalency on a limitation-by-limitation basis’ by ‘particularized testimony and linking argument’ as to the insubstantiality of the differences between the claimed invention and the accused device or process. Akzo Nobel Coatings, Inc. v. Dow Chem. Co., 811 F.3d 1334, 1342 (Fed. Cir. 2016) (quoting Texas Instruments Inc. v. Cypress Semiconductor Corp., 90 F.3d 1558, 1566 (Fed. Cir. 1996)). “‘[A]ll claim limitations are not entitled to an equal scope of equivalents [and] [u]ltimately, ‘many limitations warrant little, if any, range of equivalents.’” Id. (quoting Moore USA, Inc. v. Standard Register Co., 229 F.3d 1091, 1106 (Fed. Cir. 2000)). Indeed, courts caution that applying this doctrine should be the exception and not the rule in patent infringement actions. Novartis Pharms. Corp. v. Abbott Labs., 294 F. Supp. 2d 557, 563 (D. Del. 2003), aff’d, 375 F.3d 1328 (Fed. Cir. 2004) (quoting London v. Carson Pirie Scott & Co., 946 F. 2d 1534, 1538 (Fed. Cir. 1991)). Since the burden of proving infringement rests with Otsuka, Orchid can meet its burden to justify summary judgment “either by providing evidence that would preclude a finding of infringement, or by showing that the evidence on file fails to establish a material issue of fact essential to the patentee’s case.” Novartis Corp. v. Ben Venue Labs., Inc., 271 F.3d 1043, 1046 (Fed. Cir. 2001); see also Exigent Tech., Inc. v. Atrana Solutions, Inc., 442 F.3d 1301, 1308–09 (Fed. Cir. 2006) (“In light of Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 23 of 46 PageID: 1401 – 18 – Celotex . . . nothing more is required than the filing of a summary judgment motion stating that the patentee had no evidence of infringement and pointing to the specific ways in which accused systems did not meet the claim limitations.”). The Federal Circuit has explained, “[u]nder modern summary judgment law, a patentee who fails to provide probative evidence of infringement runs the risk of being peremptorily nonsuited ... Evidence from which a reasonable fact-finder could find infringement will forestall this possibility. However, a party does not meet this evidentiary threshold merely by submitting the affidavit of an expert who opines that the accused device meets the claim limitations.” Id. at 1050–51 (citations omitted). Precedent requires “that the factual predicate of an expert’s opinion must find some support in the record, and has emphasized that mere ‘theoretical speculations’ lacking a basis in the record will not create a genuine issue of fact ... Moreover, where an expert’s opinion is predicated on factual assumptions, those assumptions must also find some support in the record.” Id. at 1051; see also Reckitt Benckiser Inc. v. Tris Pharma, Inc., No. CIV.A. 09-3125 FLW, 2011 WL 6723400, at *5 (D.N.J. Dec. 21, 2011). II. OTSUKA HAS FAILED TO MEET ITS BURDEN OF PROVING INFRINGEMENT OF THE LOW-HYGROSCOPICITY CLAIMS A. Otsuka Failed To Allege Infringement Otsuka has failed to present a supportable theory of how Orchid’s ANDA products meet the low-hygroscopicity limitation of the asserted claims. Nowhere in its complaint, contentions, or expert reports does Otsuka identify any evidence that Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 24 of 46 PageID: 1402 – 19 – Orchid’s API did, does, or will meet the stringent hygroscopicity limitations of the asserted claims. To the contrary, , . On this basis alone, Orchid is entitled to summary judgment of noninfringement. Orsatti, 71 F.3d at 484; BenVenue, 271 F.3d at 1046; Exigent Tech., 442 F.3d at 1308–09. 1. Otsuka Has Never Explained Its Theory Of Infringement Otsuka’s infringement contentions cited to portions of Orchid’s ANDAs . SOF 81–84. Indeed, Otsuka cited pages expressly showing:  SOF 84. Otsuka does not have sufficient evidence to allege infringement in this case, much less carry its burden of proving infringement by a preponderance of the evidence. Bayer, 212 F.3d at 1247. Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 25 of 46 PageID: 1403 – 20 – 2. Dr. Myerson’s Report Contains No Evidence Showing The Orchid Meets The Low-Hygroscopicity Limitation . Dr. Myerson’s deficiencies are not corrected in his Reply reports. See SOF 123–131. Otsuka therefore has no support for its allegations of infringement of the low-hygroscopicity patents, and Orchid is entitled to summary judgment of noninfringement. Akzo, 811 F.3d at 1341 (affirming summary judgment of noninfringement because a bare declaration by patentee’s expert did not raise genuine issue of material fact as to whether accused product literally infringed). As explained Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 26 of 46 PageID: 1404 – 21 – below, his conclusions are scientifically unsound and do not raise a genuine issue of fact. See Reckitt, 2011 WL 6723400, at *5. . Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 27 of 46 PageID: 1405 – 22 – Dr. Myerson has nothing else to support the conclusion Otsuka asked him to hold. Without an explanation of its theory, much less any actual evidence showing or even suggesting infringement, Otsuka has failed to meet its burden and summary judgment of noninfringement is warranted. Orsatti, 71 F.3d at 484; BenVenue, 271 F.3d at 1046; Exigent Tech., 442 F.3d at 1308–09. Like the court in Reckitt, which dismissed the plaintiff’s argument that rested on an expert opinion that “appears to be based, entirely, on information he was told by counsel Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 28 of 46 PageID: 1406 – 23 – and not based on first hand review or knowledge,” (Reckitt, 2011 WL 6723400, at *7), this Court should grant summary judgment of noninfringement to Orchid. B. Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 29 of 46 PageID: 1407 – 24 – There is, therefore, no genuine dispute that Orchid’s aripiprazole API exceeds the hygroscopicity limitations of the asserted claims, and therefore will not infringe the asserted low-hygroscopicity claims. See TorPharm, 300 F.3d at 1373; Bayer, 212 F.3d at 1250. Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 30 of 46 PageID: 1408 – 25 – 2. Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 31 of 46 PageID: 1409 – 26 – C. Orchid’s IR ANDA Product Does Not Infringe The Asserted Claims Of The Low-Hygroscopicity Patents Under The Doctrine Of Equivalents Otsuka made no substantiated argument that Orchid’s ANDA products infringe the low-hygroscopicity patents under the doctrine of equivalents. SOF 83. Its contentions contained only boilerplate place-holder language, and its last opportunity in the Myerson report contained no argument or evidence save a bare, unsubstantiated statement that “any differences between Defendant’s API and generic aripiprazole products and the subject matter of the asserted claims are insubstantial.” SOF 83, 100, 129. Otsuka has waived this argument. See Cambrian Sci. Corp. v. Cox Commc’ns, Inc., 617 F. App’x 989, 994 (Fed. Cir. 2015) (holding that “paragraphs simply conclude[ing] that if literal infringement is not met, then it is the expert’s opinion that the … limitation is met under the doctrine of equivalents because any differences between the structure and the claim limitations are Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 32 of 46 PageID: 1410 – 27 – insubstantial … are devoid of any particularized testimony or linking arguments [and] lack any factual statements,” and therefore affirming summary judgment of non-infringement). Even if Otsuka had not waived this argument, The doctrine of equivalents cannot be used to encompass subject matter that was disclosed in the specification but left unclaimed. Johnson & Johnston Assocs. v. R.E. Serv. Co., 285 F.3d 1046, 1054–55 (Fed. Cir. 2002). Such unclaimed subject matter is dedicated to the public. Id. In the shared specification of the low-hygroscopicity patents, the patent applicant disclosed an aripiprazole drug substance having a hygroscopicity moisture content of 0.5 % or less in the low-hygroscopicity patents’ specification, but did not claim such a drug substance or preparation containing such a substance. SOF 37. Further, the patent applicant expressly limited the meaning of the term “low hygroscopicity” to “moisture content of 0.40% or less after placing said Crystals for 24 hours in a desiccator maintained at a temperature of 60°C and a humidity level of 100%” during prosecution. SOF 38. Thus, the patentee dedicated the unclaimed subject matter to the public and is barred by prosecution disclaimer from expanding the scope of the claims to include the Orchid products under the doctrine Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 33 of 46 PageID: 1411 – 28 – of equivalents. Johnson & Johnston, 285 F.3d at 1054–55; Omega Eng’g, Inc. v. Raytek Corp., 334 F.3d 1314, 1324 (Fed. Cir. 2003). Also, “where the patentee has unequivocally disavowed a certain meaning to obtain his patent, the doctrine of prosecution disclaimer attaches and narrows the ordinary meaning of the claim congruent with the scope of the surrender.” Omega Eng’g, 334 F.3d at 1324. Prosecution history estoppel applies “when an applicant during prosecution either makes an argument evincing a “‘clear and unmistakable surrender’ of subject matter, or narrows a claim ‘to avoid the prior art, or otherwise to address a specific concern . . . that arguably would have rendered the claimed subject matter unpatentable.’” Spectrum Pharms., Inc. v. Sandoz Inc., 802 F.3d 1326, 1337 (Fed. Cir. 2015) (emphasis added) (internal citations omitted). “The applicant is then estopped from later invoking the doctrine of equivalents to recapture the surrendered subject matter.” Id. “[A] single action during prosecution can engender both a prosecution disclaimer and prosecution history estoppel.” Trading Techs. Int’l, Inc. v. Open E Cry, LLC, 728 F.3d 1309, 1322 (Fed. Cir. 2013). In responding to an indefiniteness rejection by the examiner during prosecution of the ’615 patent, the patent applicant asserted that the term “low hygroscopicity” is not indefinite when read in the context of the claim limitation “wherein said low hygroscopicity is a moisture content of 0.40% or less after placing said Crystals for 24 hours in a desiccators maintained at a temperature of 60°C and a humidity level Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 34 of 46 PageID: 1412 – 29 – of 100%.”1 SOF 38. Thus, under the doctrine of prosecution history estoppel, the patentee surrendered any subject matter outside the scope of the claim term and cannot recapture it now under the doctrine of equivalents. Spectrum Pharms., 802 F.3d at 1337. A patentee cannot assert the doctrine of equivalents where finding infringement by the alleged equivalent would entirely vitiate a particular claimed element. See Freedman Seating Co. v. Am. Seating Co., 420 F.3d 1350, 1358 (Fed. Cir. 2005). The doctrine of equivalents also cannot be used to assert a range of equivalents that would encompass the prior art. See, e.g., Wilson Sporting Goods v. David Geoffrey & Assoc., 904 F. 2d 677, 684 (Fed. Cir. 1990) (“[S]ince prior art always limits what an inventor could have claimed, it limits the range of permissible equivalents of a claim.”). 1 All three of the low-hygroscopicity patents are related family members, and therefore the estoppel allies to all of them equally. See Laitram Corp. v. Morehouse Indus., Inc., 143 F.3d 1456, 1460 n.2 (Fed. Cir. 1998) (citing Jonsson v. Stanley Works, 903 F.2d 812, 818 (Fed. Cir. 1990)). Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 35 of 46 PageID: 1413 – 30 – Thus, for at least these reasons, the Orchid products are substantially different from the subject matter of the low-hygroscopicity patents such that the manufacture, use, sale, offer for sale, and/or importation thereof would not infringe the asserted claims either literally or under the doctrine of equivalents. Summary judgment of noninfringement is therefore warranted. See Bai v. L & L Wings, Inc., 160 F.3d 1350, 1353 (Fed. Cir. 1998). III. OTSUKA HAS FAILED TO MEET ITS BURDEN OF PROVING INFRINGEMENT OF THE ASSERTED ’421 CLAIMS A. Orchid does not literally infringe asserted claims 1–17 of the ’421 patent as a matter of law. In order to establish literal infringement, the patentee must show that all elements of the asserted claims are met by the accused product.2 Bayer, 212 F.3d 2 Otsuka has only accused Orchid’s ODT ANDA product of infringing the ’421 patent, not Orchid’s IR ANDA product. SOF 1. Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 36 of 46 PageID: 1414 – 31 – at 1247; Bai, 160 F.3d at 1353. As with the low-hygroscopicity patents, Otsuka has not met this burden. Otsuka’s barebones infringement contentions provide no explanation as to its theories. Otsuka has not provided any theory for Orchid’s alleged infringement of claims 2–5, 9–12, and 14–17 at all, as Otsuka’s expert Dr. Byrn has declined to provide any opinion regarding infringement of these claims. SOF 40, 117. Thus, Otsuka has not met its burden and a finding of summary judgment of non- infringement is appropriate for at least claims 2–5, 9–12, and 14–17. Bayer, 212 F.3d at 1247; TorPharm, 300 F.3d at 1373; Akzo, 811 F.3d at 1341. Further, as explained above, remaining claims 1, 6–8, and 13 Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 37 of 46 PageID: 1415 – 32 – Plainly, there is no literal infringement and an order of summary judgment of no literal infringement of claims 1–17 should be entered. Bayer, 212 F.3d at 1247; TorPharm, 300 F.3d at 1373. B. Otsuka Has Failed To Meet Its Burden Of Proving Infringement Under The Doctrine Of Equivalents It now appears that Otsuka is no longer asserting that Orchid’s ODT ANDA product will literally infringe the ’421 patent, but is relying solely on the doctrine of equivalents to allege infringement. Again, Otsuka fails to meet its burden. Although infringement under the doctrine of equivalents is a question of fact, summary judgment is proper “[w]here the evidence is such that no reasonable jury could determine two elements to be equivalent.” Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 39 n.8 (1997). The Federal Circuit has cautioned that application of the doctrine of equivalents is the exception, not the rule. See Novartis, 294 F. Supp. 2d at 557 (citation omitted). Further, “many limitations warrant little, if any, range of equivalents.” Akzo, 811 F.3d at 1342 (quoting Moore USA, 229 F.3d at 1106). Courts alternately apply one of two tests to determine if a product infringes patent claims under the doctrine of equivalents: either the accused equivalent (1) represents an “insubstantial” change from the claim language or (2) “performs substantially the same function in substantially the same way to obtain Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 38 of 46 PageID: 1416 – 33 – the same result.” Graver Tank & Mfg. Co. v. Linde Air Products Co., 339 U.S. 605, 608 (1950); Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 493 F.3d 1368, 1377 (Fed. Cir. 2007).3 As explained more fully below, Otsuka has failed to meet its burden under both of these tests. 1. Otsuka Failed To Properly Allege Infringement By Orchid’s ODT ANDA Product Under The Doctrine Of Equivalents As with the low-hygroscopicity patents, Otsuka’s infringement contentions contained only boilerplate place-holder language regarding its infringement theories for the ’421 patent under the doctrine of equivalents. SOF 86. Those statements cannot save Otsuka from summary judgment of non-infringement. Cambrian, 617 F. App’x at 994 (holding that conclusory statements are insufficient to support allegation of infringement under the doctrine of equivalents without “particularized testimony or linking arguments”). Dr. Byrn’s opening report is no better. 3 Both tests are applied by courts because “[d]ifferent linguistic frameworks may be more suitable to different cases.” Abbott Laboratories v. Sandoz, Inc., 566 F.3d 1282, 1297 (Fed Cir. 2009). Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 39 of 46 PageID: 1417 – 34 – Dr. Byrn’s conclusory opinions, therefore, cannot save Otsuka summary judgment of non-infringement. See Reckitt, 2011 WL 6723400, at *5. Because Dr. Byrn’s opinion is “devoid of any particularized testimony or linking arguments [and] lack any factual statements,” Otsuka has failed to even allege infringement under the doctrine of equivalents, much less carry its burden of proof by a preponderance of the evidence. Cambrian, 617 F. App’x at 994; Orsatti, 71 F.3d at 484; BenVenue, 271 F.3d at 1046; Exigent Tech., 442 F.3d at 1308–09. The Federal Circuit recently upheld a district court’s grant of summary judgment of no infringement under the doctrine of equivalents under very similar facts. In Akzo, the Plaintiff’s expert stated that an accused process operated “in substantially the same way” but failed to describe the precise function that was allegedly substantially the same. 811 F.3d at 1342. Here, Dr. Byrn similarly alleges that the function-way-result test is satisfied, but with no explanation as to what the function-way-result is or how it is satisfied with respect to Orchid’s ODT ANDA product. See SOF 119. Further like in Akzo, Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 40 of 46 PageID: 1418 – 35 – Dr. Byrn does not attempt to articulate how the differences between the two formulations are insubstantial. As acknowledged by the Federal Circuit, “[s]uch ambiguity and generality cannot create a genuine issue of material fact” and are insufficient to survive summary judgment. Akzo, 811 F.3d at 1342. 2. Orchid’s ODT ANDA Product Fails The Function/Way/Result Test, Dr. Byrn would not have been able to provide the necessary particularized testimony or linking arguments . Therefore, Orchid’s ODT ANDA does not infringe any ’421 patent claim under the doctrine of equivalents. See AquaTex, 479 F.3d 1326. Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 41 of 46 PageID: 1419 – 36 – and therefore Orchid does not infringe. See Graver Tank, 339 U.S. at 608. See Graver Tank, 339 U.S. at 608; Akzo, 811 F.3d at 1342. 3. Otsuka Cannot Use The Doctrine Of Equivalents To Recapture The Prior Art A patent claim cannot purport to encompass equivalents where the alleged equivalent was available in the prior art at the time of invention. Depuy Spine, Inc. Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 42 of 46 PageID: 1420 – 37 – v. Medtronic Sofamore Danek, Inc., 469 F. 3d 1005, 1322 (Fed. Cir. 2006). Application of the doctrine of equivalents to encompass the Orchid ODT ANDA product would unjustly expand the claims of the ’421 patent to ensnare the use well known excipients, and therefore is inappropriate. Id. For at least this reasons, Dr. Byrn’s assertion that one could ignore and the ’421 patent claims would require the asserted claims to encompass well known and understood excipients as of the time of invention. 4. Otsuka Cannot Use The Doctrine Of Equivalents When It Would Vitiate Its Claims Finally, application of the doctrine of equivalents to cover Orchid’s ODT ANDA product would improperly vitiate the claims. See Freedman Seating, 420 F.3d at 1358; Depuy, 469 F. 3d at 1017. Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 43 of 46 PageID: 1421 – 38 – . Expanding the scope of the asserted claims to capture the Orchid ODT ANDA product— would read limitation out of the asserted claims entirely. This is contrary to the disclosure of the ’421 patent, and in violation of the controlling precedent. See Freedman Seating, 420 F.3d at 1358; Depuy, 469 F. 3d at 1017. Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 44 of 46 PageID: 1422 – 39 – IV. Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 45 of 46 PageID: 1423 – 40 – CONCLUSION For the foregoing reasons, Orchid respectfully requests that this Court grant summary judgment of noninfringement on all of the asserted claims, and for such other and further relief as the Court deems just and proper. Respectfully Submitted, September 23, 2016 /s/ Karen A. Confoy OF COUNSEL: SAILESH K. PATEL (admitted Pro Hac Vice) JASON G. HARP (admitted Pro Hac Vice) THOMAS RAMMER (admitted Pro Hac Vice) HELEN H. JI (admitted Pro Hac Vice) JAIMIN H. SHAH (admitted Pro Hac Vice) SCHIFF HARDIN LLP 233 South Wacker Drive, Suite 6600 Chicago, IL 60606 (312) 258-5500 spatel@schiffhardin.com jharp@schiffhardin.com trammer@schiffhardin.com hji@schiffhardin.com jshah@schiffhardin.com Karen A. Confoy FOX ROTHSCHILD LLP Princeton Pike Corporate Center 997 Lenox Drive Building 3 Lawrenceville, NJ 08648 (609) 844-3033 kconfoy@foxrothschild.com JOHN K. HSU (admitted Pro Hac Vice) SCHIFF HARDIN LLP 901 K Street NW Suite 700 Washington, DC 20001 (202) 778-6400 jhsu@schiffhardin.com Attorneys for Defendants Orchid Pharma Limited, Orchid Pharma USA Inc., and Orgenus Pharma Inc. Case 1:16-cv-00405-JBS-KMW Document 105-1 Filed 09/23/16 Page 46 of 46 PageID: 1424 UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY OTSUKA PHARMACEUTICAL CO., LTD, Plaintiff, v. ORCHID PHARMA LIMITED, ORCHID HEALTHCARE, ORCHID PHARMA, INC., AND ORGENUS PHARMA INC., Defendants. Civil Action No. 1:16-cv-00405- JBS-KMW FILED UNDER SEAL Oral Argument Requested Return Date: October 17, 2016 Filed Electronically ORCHID’S STATEMENT OF UNCONTESTED FACTS PURSUANT TO LOCAL CIVIL RULE 56.1 OF COUNSEL: SAILESH K. PATEL (admitted Pro Hac Vice) JASON G. HARP (admitted Pro Hac Vice) THOMAS A. RAMMER (admitted Pro Hac Vice) HELEN H. JI (admitted Pro Hac Vice) JAIMIN H. SHAH (admitted Pro Hac Vice) SCHIFF HARDIN LLP 233 South Wacker Drive, Suite 6600 Chicago, IL 60606 (312) 258-5500 spatel@schiffhardin.com jharp@schiffhardin.com trammer@schiffhardin.com hji@schiffhardin.com jshah@schiffhardin.com JOHN K. HSU (admitted Pro Hac Vice) SCHIFF HARDIN LLP 901 K Street NW Suite 700 Washington, DC 20001 (202) 778-6400 jhsu@schiffhardin.com FOX ROTHSCHILD LLP KAREN A. CONFOY 997 Lenox Drive, Building 3 Lawrenceville, NJ 08648 Telephone: (609) 896-3600 Facsimile: (609) 896-1469 kconfoy@foxrothschild.com Attorneys for Defendants Orchid Pharma Limited, Orchid Pharma USA Inc., and Orgenus Pharma Inc. Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 1 of 52 PageID: 1425 – 2 – Pursuant to Rule 56 of the Federal Rules of Civil Procedure and Local Civil Rule 56.1, Defendants Orchid Pharma Limited, Orchid Healthcare, Orchid Pharma, Inc., and Orgenus Pharma Inc. (collectively “Orchid”) submit the following statement of material facts as to which there does not exist a genuine issue. I. THE PATENTS-IN-SUIT 1. Plaintiff has asserted claims from U.S. Patent No. 8,017,615 (“the ’615 patent”) (Exhibit 1)1; 8,580,796 (“the ’796 patent”) (Exhibit 2); 8,642,760 (“the ’760 patent”) (Exhibit 3) (collectively the “low-hygroscopicity patents”); and 8,518,421 (“the ’421 patent”) (Exhibit 4) (together collectively, the “asserted patents” or the “patents-in-suit”). Dkt. No. 1. Specifically, Plaintiff has asserted Claims 3, 4, 15, and 16 of the ’615 patent, Claims 1 and 2 of the ’796 patent, Claims 1 and 2 of the ’760 patent against the products described in Orchid’s ANDA No. 20-2683 and ANDA No. 20-2547, and Claims 1–17 of the ’421 patent only against the product described in Orchid’s ANDA No. 20-2547. Otsuka’s Infringement Contentions, May 6, 2016 (Exhibit 5). II. THE LOW-HYGROSCOPICITY PATENTS A. The Common Specification Of The Low-Hygroscopicity Patents 2. The three low-hygroscopicity patents all share a substantially identical specification. “Rebuttal Expert Report Of Glenn A. Van Buskirk, Ph.D., 1 All referenced exhibits are attached to the accompanying Declaration of Karen A. Confoy. Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 2 of 52 PageID: 1426 – 3 – Regarding Non-Infringement Of U.S. Patent Nos. 8,017,615; 8,580,796; And 8,642,760,” dated Sept. 9, 2016 (Exhibit 6) (“Van Buskirk”) at ¶ 46; Otsuka Pharma. Co. v. Orchid Pharma Ltd., et al., Case No. 16-cv-00405-JB-KMW, Myerson Dep. Rough Tr. at 15:3–5, Sept. 12, 2016 (Exhibit 7) (“Myerson Dep.”). 3. The Abstract states that the “present invention provides low hygroscopic forms of aripiprazole….” ’615 patent (Exhibit 1) at Abstract; ’796 patent (Exhibit 2) at Abstract; ’760 patent (Exhibit 3) at Abstract. 4. The Detailed Description of the Invention states that the “present invention relates to an improved form of aripiprazole having reduced hygroscopicity.” ’615 patent (Exhibit 1) at 1:20–22; ’796 patent (Exhibit 2) at 1:18–20; ’760 patent (Exhibit 3) at 1:21–23. 5. The specification further identifies two prior-art crystal forms (type-I and type-II aripiprazole crystals) by their respective methods of manufacture: Also, Proceedings of the 4th Japanese-Korean Symposium on Separation Technology (Oct. 6-8, 1996) state that, anhydrous aripiprazole crystals exist as type-I crystals and type-II crystals; the type-I crystals of anhydrous aripiprazole can be prepared by recrystallizing from an ethanol solution of aripiprazole, or by heating aripiprazole hydrate at 80° C.; and the type-II crystals of anhydrous aripiprazole can be prepared by heating the type-I crystals of anhydrous aripiprazole at 130 to 140° C. for 15 hours. ’615 patent (Exhibit 1) at 2:14–22; ’796 patent (Exhibit 2) at 2:10–15; ’760 patent (Exhibit 3) at 2:13–18. Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 3 of 52 PageID: 1427 – 4 – 6. The specification refers to both type-I and type-II aripiprazole crystals as “conventional anhydrous aripiprazole crystals.” ’615 patent (Exhibit 1) at 10:50–51, 10:56–57, 12:56–57, 13:7–8, 13:17–18; ’796 patent (Exhibit 2) at 10:47–48, 12:46–47, 13:53–54, 13:4–5, 14:23; ’760 patent (Exhibit 3) at 10:50–51, 10:56–57, 12:56–57, 13:7–8, 13:17–18. 7. The specification discusses two methods of producing prior-art type-I anhydrous aripiprazole crystals: According to Example 1 of Japanese Unexamined Patent Publication No. 191256/1990, anhydrous aripiprazole crystals are manufactured for example by reacting 7-(4- bromobutoxy)-3,4-dihydrocarbostyril with 1-(2,3- dichlorophenylpiperadine and recrystallizing the resulting raw anhydrous aripiprazole with ethanol. Also, according to the Proceedings of the 4th Japanese-Korean Symposium on Separation Technology (Oct. 6-8, 1996), anhydrous aripiprazole crystals are manufactured by heating aripiprazole hydrate at 80° C. ’615 patent (Exhibit 1) at 1: 41–49; ’796 patent (Exhibit 2) at 1:37–45; ’760 patent (Exhibit 3) at 1:40–48. The specification also calls crystals made by these methods “Crude” and “Conventional Anhydrous Aripiprazole crystals.” ’615 patent (Exhibit 1) at 14:24–29; ’796 patent (Exhibit 2) at 14:22–27; ’760 patent (Exhibit 3) at 14:24–29. 8. The specification characterizes the type-I aripiprazole crystals produced by these methods as “being significantly hygroscopic.” ’615 patent Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 4 of 52 PageID: 1428 – 5 – (Exhibit 1) at 1:51–52; ’796 patent (Exhibit 2) at 1:47–48; ’760 patent (Exhibit 3) at 1:50–51. 9. The “SUMMARY OF THE INVENTION” section identifies the “present invention” as a form of aripiprazole crystal that has “reduced hygroscopicity” compared to the prior-art crystal forms, and defines the allegedly new reduced-hygroscopic form of aripiprazole as “Anhydrous Aripiprazole Crystals B.” ’615 patent (Exhibit 1) at 2:29–35; ’796 patent (Exhibit 2) at 2:25– 31; ’760 patent (Exhibit 3) at 2:28–34. 10. The specification distinguishes Crystals B from the prior art type-I crystals based solely on hygroscopicity. See ’615 patent (Exhibit 1) at 2:8–13, 2:25–30, 9:62–66, 10:48–67, 18:50–19:40, 23:48–50, 24:1–3, 26:34–37, 32:36–54; ’796 patent (Exhibit 2) at 2:4–9, 2:29–35, 9:59–63, 10:45–64, 18:50–19:40, 23:51– 53, 24:4–6, 26:34–37, 32:36–54; ’760 patent (Exhibit 3) at 2:7–12, 2:29–30, 9:62– 66, 10:48–67, 18:50–19:40, 23:48–50, 24:1–3, 26:34–37, 32:36–54; see also Myerson Dep. (Exhibit 7) at 68:10–21. 11. The “Hygroscopicity-Test Method” provided in the specification of the asserted patents is described as follows: (7) Hygroscopicity Test Method One g of the sample was accurately weighed in a weighing bottle (diameter 5 cm), covered with kimwipes and left to rest in a 60° C./100% RH environment (water/dessicator). 24 hours later, the weighing bottle Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 5 of 52 PageID: 1429 – 6 – was removed, transferred to an environment of a room temperature and about 30% RH (magnesium chloride hexahydrate saturated water solution/ dessicator) and left to rest for 24 hours and the water content of the sample was measured by the Karl Fischer method. ’615 patent (Exhibit 1) at 22:56–64; ’796 patent (Exhibit 2) at 22:59–67; ’760 patent (Exhibit 3) at 22:56–64. 12. Prior art crystals described in Japanese Unexamined Patent Publication No. 191256/1990 are identified as “Reference Example 1” in the specification. ’615 patent (Exhibit 1) at 23:27–50; ’796 patent (Exhibit 2) at 23:30–53; ’760 patent (Exhibit 3) at 23:27–50. Type-I crystals obtained according to the methods described in the 4th Japanese-Korean Symposium on Separation Technology (Oct. 6-8, 1996) are identified as “Reference Example 2” in the specification. ’615 patent (Exhibit 1) at 23:54–24:3; ’796 patent (Exhibit 2) at 23:57–24:6; ’760 patent (Exhibit 3) at 23:55–24:3. 13. Table 1 of the specification compares the hygroscopicity of prior art crystals (“Reference Example 1” and “Reference Example 2”) and Crystals B (“Example 2”), along with other purportedly different crystal forms, after one 24- hour conditioning step. ’615 patent (Exhibit 1) at 23:48–50, 24:1–3, 26:34–37, 32:36–54; ’796 patent (Exhibit 2) at 23:51–53, 24:4–6, 26:34–37, 32:36–54; ’760 patent (Exhibit 3) at 23:48–50, 24:1–3, 26:34–37, 32:36–54; see also “Opening Expert Report of Allan S. Myerson, Ph.D.,” dated August 12, 2016 (Exhibit 8) Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 6 of 52 PageID: 1430 – 7 – (“Myerson”) at ¶¶ 50–53. When left for 24 hours in a dessicator set at humidity 100%, temperature 60° C, the prior art crystals described in “Reference Example 1” and “Reference Example 2” are reported to have exhibited hygroscopicity of 3.28 % and 1.78 %, while the Anhydrous Aripiprazole Crystals B of “Example 2” exhibited hygroscopicity that did not exceed 0.40%. Id. 14. As noted in the Myerson report, Table 1 shows that the difference in hygroscopicity is the distinguishing feature between type-I crystals and Crystals B. Myerson Report (Exhibit 8) at ¶ 54; Myerson Dep. (Exhibit 7) at 18:19–19:16, 66:10–21. 15. The water content of an API would not be significantly different after the second conditioning step than it is after the first high-temperature high- humidity conditioning step of the Hygroscopicity Test Method of the low- hygroscopicity patents. Otsuka Pharma. Co. v. Huahai US Inc., et al., Case No. 14-cv-5537-JB-KMW, Myerson Dep. at 48:2–7, Aug. 25, 2016 (Exhibit 9) (“Myerson-Prinston Dep.”) (“[Q] Would you expect, if you were to have subjected these samples to the second 24-hour period of the hygroscopicity test method of the patents in suit, would you expect the data to change up or down in any significant fashion? A No, I would not.”); id. at 49:13–18 (“A So, of course, if you have one hundred percent relative humidity for 24 hours and you get results where the moisture content hardly moved, it's not going to change significantly or at all at Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 7 of 52 PageID: 1431 – 8 – 30 percent relative humidity for another 24 hours.”); Van Buskirk (Exhibit 6) at ¶¶ 97–98. Otsuka advocated for a claim construction requiring only the first step, indicating it believes the moisture content would likely remain unchanged during the second step. See Otsuka Pharma. Co. v. Torrent Pharma. Ltd., et al., Case No. 14-cv-1078-JB-KMW, Markman Op., at 43 (D.N.J. Nov. 16, 2015) (ECF No. 166). The importance of the second 24-hour conditioning step, as Otsuka’s expert Dr. Stephen Byrn testified in the related cases, is just to cool down the sample before subjecting it to Karl Fischer titration: See Otsuka Pharma. Co. v. Torrent Pharma. Ltd., et al., Case No. 14-cv-1078-JB-KMW, Byrn Dep. at 61:1–62:12, July 24, 2015 (Exhibit 10) (“Byrn. Dep.”). 16. The asserted patents teach a two-step process for making “Aripiprazole Crystals B of low hygroscopicity.” In the first step, conventional aripiprazole hydrate is milled. ’615 patent (Exhibit 1) at 8:41–46; ’796 patent (Exhibit 2) at 8:38–43; ’760 patent (Exhibit 3) at 8:41–46. The milling step converts conventional aripiprazole hydrate to Hydrate A. ’615 patent (Exhibit 1) at 10:19–43; ’796 patent (Exhibit 2) at 10:16–40; ’760 patent (Exhibit 3) at 10:19–43. In the second step, Hydrate A is subjected to 90–125 °C for about 3–50 hours to get Anhydrous Aripiprazole Crystals B. ’615 patent (Exhibit 1) at 8:54–61; 10:24– 43; ’796 patent (Exhibit 2) at 8:51–59; 10:21–40; ’760 patent (Exhibit 3) at 8:54– 61; 10:24–43. The patent specification further teaches “that it is possible to obtain Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 8 of 52 PageID: 1432 – 9 – anhydrous aripiprazole crystals by heating conventional aripiprazole hydrate or conventional anhydrous aripiprazole crystals to a specific temperature but this process does not yield Anhydrous Aripiprazole Crystal B crystalline substance suitable for commercial use in the formulation of solid oral dose formulations.” ’615 patent (Exhibit 1) at 10:48–54; ’796 patent (Exhibit 2) at 10:45–51; ’760 patent (Exhibit 3) at 10:48–54. 17. The asserted patents teach the wet granulation method can be used to formulate tablets containing the Crystals B of the purported invention. ’615 patent (Exhibit 1) at 20:30–21:42; ’796 patent (Exhibit 2) at 20:30–21:42; ’760 patent (Exhibit 3) at 20:30–21:42. The asserted patents also teach that the drying steps applied during wet granulation convert anhydrous crystals or hydrate crystals of aripiprazole to “B type crystals” of anhydrous aripiprazole. ’615 patent (Exhibit 1) at 21:38–42; ’796 patent (Exhibit 2) at 21:38–42; ’760 patent (Exhibit 3) at 21:38– 42. B. The Asserted Claims Of The ’615 Patent 18. Plaintiff has asserted Claims 3, 4, 15, and 16 of the ’615 patent. See ¶ 1 above. 19. Asserted claim 3 of the ’615 Patent states in full: A pharmaceutical solid oral preparation comprising Anhydrous Aripiprazole Crystals B having low hygroscopicity and one or more pharmaceutically acceptable carriers, wherein said low hygroscopicity is a Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 9 of 52 PageID: 1433 – 10 – moisture content of 0.40% or less after placing said Crystals for 24 hours in a desiccator maintained at a temperature of 60° C. and a humidity level of 100%; wherein said Crystals have a powder x-ray diffraction spectrum having characteristic peaks at 2Θ=11.0°, 16.6°, 19.3°, 20.3°, and 22.1°; have particular infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm-1 on the IR (KBr) spectrum; exhibit an endothermic peak near about 141.5° C. in thermogravimetric/differential thermal analysis (heating rate 5° C./min); exhibit an endothermic peak near about 140.7° C. in differential scanning calorimetry (heating rate 5° C./min); and have a mean particle size of 50 μm or less, wherein said pharmaceutical solid oral preparation has at least one dissolution rate selected from the group consisting 60% or more at pH 4.5 after 30 minutes, 70% or more at pH 4.5 after 60 minutes, and 55% or more at pH 5.0 after 60 minutes. 20. Asserted claim 4 of the ’615 Patent states in full: A pharmaceutical solid oral preparation comprising Anhydrous Aripiprazole Crystals B having low hygroscopicity and one or more pharmaceutically acceptable carriers, wherein said low hygroscopicity is a moisture content of 0.10% or less after placing said Crystals for 24 hours in a desiccator maintained at a temperature of 60° C. and a humidity level of 100%; wherein said Crystals have a powder x-ray diffraction spectrum having characteristic peaks at 2Θ=11.0°, 16.6°, 19.3°, 20.3°, and 22.1°; Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 10 of 52 PageID: 1434 – 11 – have particular infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm-1 on the IR (KBr) spectrum; exhibit an endothermic peak near about 141.5° C. in thermogravimetric/differential thermal analysis (heating rate 5° C./min); exhibit an endothermic peak near about 140.7° C. in differential scanning calorimetry (heating rate 5° C./min); and have a mean particle size of 50 μm or less, wherein said pharmaceutical solid oral preparation has at least one dissolution rate selected from the group consisting 60% or more at pH 4.5 after 30 minutes, 70% or more at pH 4.5 after 60 minutes, and 55% or more at pH 5.0 after 60 minutes. 21. Asserted claim 15 of the ’615 Patent states in full: The pharmaceutical solid oral preparation according to claim 3, wherein the mean particle size is measured using a laser diffraction particle size analyzer. 22. Asserted claim 16 of the ’615 Patent states in full: The pharmaceutical solid oral preparation according to claim 4, wherein the mean particle size is measured using a laser diffraction particle size analyzer. C. The Asserted Claims Of The ’796 Patent 23. Plaintiff has asserted Claims 1 and 2 of the ’796 patent. See ¶ 1 above. 24. Asserted claim 1 of the ’796 Patent states in full: Anhydrous Aripiprazole Crystals B having low hygroscopicity wherein said low hygroscopicity is Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 11 of 52 PageID: 1435 – 12 – defined as a moisture content of 0.40% or less when said Crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°C. and a humidity level of 100%. 25. Asserted claim 2 of the ’796 Patent states in full: Anhydrous Aripiprazole Crystals B having low hygroscopicity wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when said Crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°C. and a humidity level of 100%. D. The Asserted Claims Of The ’760 Patent 26. Plaintiff has asserted Claims 1 and 2 of the ’760 patent. See ¶ 1 above. 27. Asserted claim 1 of the ’760 Patent states in full: Aripiprazole drug substance of low hygroscopicity wherein said low hygroscopicity is defined as a moisture content of 0.40% or less after placing said drug substance for 24 hours in a dessicator maintained at a temperature of 60°C. and a humidity level of 100%. 28. Asserted claim 2 of the ’760 Patent states in full: Aripiprazole drug substance of low hygroscopicity wherein said low hygroscopicity is defined as a moisture content of 0.10% or less after placing said drug substance for 24 hours in a dessicator maintained at a temperature of 60°C. and a humidity level of 100%. E. The Court’s Claim Construction 29. The Court entered a Markman Order on November 16, 2015, defining certain claim terms. Otsuka Pharma. Co. v. Torrent Pharma. Ltd., et al., Case No. Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 12 of 52 PageID: 1436 – 13 – 14-cv-1078-JB-KMW, Markman Op., at 4–5 (D.N.J. Nov. 16, 2015) (ECF No. 166). 30. Specifically, the Court has defined the following claim terms as below: “Anhydrous Aripiprazole Crystals B” means “Anhydrous aripiprazole Crystalline substance, having: 1) a proton nuclear magnetic resonance spectrum (DMSO-d6, TMS) having characteristic peaks at [specified levels]; 2) a powder x-ray diffraction spectrum having characteristic peaks at [specified levels]; 3) clear infrared absorption bands at [specified levels] on the IR (KBr) spectrum; [] 4) an endothermic peak near about 141.5° C. in thermogravimetric/ differential thermal analysis (heating rate 5° C./min); 5) an endothermic peak near about 140.7° C. in differential scanning calorimetry (heating rate 5° C./min); and 6) low hygroscopicity, all as specifically defined in the specification of the ’615 patent at 9:37-63 [or the ʼ796 patent at 9:34-60];” “wherein said low hygroscopicity is defined as a moisture content of [0.40%/0.10%] or less after placing said substance/Crystals for 24 hours in a desiccator maintained at a temperature of 60° C and a humidity level of 100%” means “wherein said low hygroscopicity is defined as a moisture content of 0.40% or less [0.10% or less] after the ‘Hygroscopicity-Test Method’ in the specification of the ’615 patent at 22:56-64 [or the ’796 patent at 22:59-67; or the ’760 patent at 22:56-64];” and “aripiprazole drug substance” means “a drug substance that consists of aripiprazole, either in pure chemical form or as the active chemical ingredient in finalized form.” Otsuka Pharma. Co. v. Torrent Pharma. Ltd., et al., Case No. 14-cv-1078- JB-KMW, Markman Op., at 4–5 (D.N.J. Nov. 16, 2015) (ECF No. 166). Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 13 of 52 PageID: 1437 – 14 – F. Every Asserted Claim Of The Low-Hygroscopicity Patents Requires Low-Hygroscopicity Aripiprazole 31. All of the asserted ’615 Patent Claims are directed to pharmaceutical solid oral preparations comprising Anhydrous Aripiprazole Crystals B having low hygroscopicity. See ¶¶ 19–22 above. 32. Both of the asserted ’796 Patent Claims are directed to Anhydrous Aripiprazole Crystals B having low hygroscopicity. See ¶¶ 24–25 above. 33. Both of the asserted ’760 Patent Claims are directed to Aripiprazole drug substance of low hygroscopicity. See ¶¶ 27–28 above. 34. The three asserted low-hygroscopicity patents all share a substantially identical specification, which identifies the “present invention” as a form of aripiprazole crystal that has “reduced hygroscopicity” compared to the prior-art crystal forms, and defines the allegedly new reduced-hygroscopic form of aripiprazole as “Anhydrous Aripiprazole Crystals B.” ’615 patent (Exhibit 1) at 2:29–35; ’796 patent (Exhibit 2) at 2:25–31; ’760 patent (Exhibit 3) at 2:28–34. 35. Applying the Court’s claim construction, the asserted claims of the low-hygroscopicity patents only claim aripiprazole crystals, drug substances, and pharmaceutical products where the aripiprazole active pharmaceutical ingredient (“API”) has a moisture content of less than either 0.40% or 0.10%, depending on the claim, after being subjected to the “Hygroscopicity-Test Method” provided in Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 14 of 52 PageID: 1438 – 15 – the specification of the asserted patents. Van Buskirk (Exhibit 6) at ¶ 76; Myerson Dep. (Exhibit 7) at 17:17–24. 36. The specifications distinguish Crystals B from the prior art Type-I crystals based solely on hygroscopicity at certain harsh conditions. See ’615 patent (Exhibit 1) at 2:8–13, 2:25–30, 9:62–66, 10:48–67, 18:50–19:40, 23:48–50, 24:1– 3, 26:34–37, 32:36–54; ’796 patent (Exhibit 2) at 2:4–9, 2:29–35, 9:59–63, 10:45– 64, 18:50–19:40, 23:51–53, 24:4–6, 26:34–37, 32:36–54; ’760 patent (Exhibit 3) at 2:7–12, 2:29–30, 9:62–66, 10:48–67, 18:50–19:40, 23:48–50, 24:1–3, 26:34–37, 32:36–54; see also Van Buskirk (Exhibit 6) at ¶¶ 54, 57; Myerson Dep. (Exhibit 7) at 66:10–21. G. Relevant Portion Of The Prosecution History Of The ’615 Patent 37. The patent applicant disclosed an aripiprazole drug substance having a hygroscopicity moisture content of 0.5 % or less in the low-hygroscopicity patents’ specification, but did not claim such a drug substance or preparation containing such a substance. See e.g., ’615 patent (Exhibit 1) 5:59–6:2. 38. During prosecution of the ’615 patent, the patent examiner rejected the claim term “low hygroscopicity” as indefinite. See Nonfinal Rejection dated April 26, 2010 (Exhibit 11) (OTSOT0010870–79 at OTSOT0010874). In response, the patentee explained that the term “is not indefinite when understood in the context of the claim limitation ‘wherein low hygroscopicity is a moisture Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 15 of 52 PageID: 1439 – 16 – content of 0.40% or less by placing said Crystals for 24 hours in a dessicator maintained at a temperature of 60 °C and a humidity level of 100 %.’” See Response to Nonfinal Rejection dated October 25, 2010 (Exhibit 12) (OTSOT0011331–55 at OTSOT0011336). III. THE ’421 PATENT 39. Each asserted claim of the ’421 patent is directed to a so-called “flash- melt” pharmaceutical dosage form comprising at least a medicament, two superdisintegrants, a dispersing agent, and a binder. Each claim expressly specifies that the medicament is aripiprazole, the dispersing agent is calcium silicate, and the superdisintegrants are crospovidone and croscarmellose sodium. 40. Plaintiff originally asserted Claims 1–17 of the ’421 patent with respect to Orchid’s ODT ANDA, (see Otsuka’s Infringement Contentions (Exhibit 5) at 3, 5, 25–49), but its “Opening Expert Report of Stephen R. Byrn, Ph.D,” (Exhibit 13)(“Byrn Opening Report”), served on August 12, 2016, only alleged infringement of claims 1, 6–8, and 13. 41. Independent claim 1 is reproduced in its entirety below: A flash-melt pharmaceutical dosage form comprising a medicament, two superdisintegrants, a dispersing agent and a binder wherein said medicament is aripiprazole and wherein said dispersing agent is calcium silicate and wherein said superdisintegrants are crospovidone and croscarmellose sodium, wherein based on the total weight of said dosage form, said crospovidone comprises from about 6 to about 8 percent by weight and said Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 16 of 52 PageID: 1440 – 17 – croscarmellose sodium comprises from about 2 to about 4 percent by weight. Dependent claims 6–8 and 13 depend from claim 1, and therefore include each of the elements as the formulation of claim 1, importantly including “a dispersing agent … wherein the dispersing agent is calcium silicate.” The unasserted claims (claims 2–5, 9–12, 14, and 15) all also contain the same limitation. 42. Claims 6 and 7 depend from claim 1 and each specify a required amount of aripiprazole: A flash-melt pharmaceutical dosage form according to claim 1 wherein said medicament comprises not more than about 30 percent by weight based on the total weight of said dosage form. A flash-melt pharmaceutical dosage form according to claim 1 wherein said medicament comprises not more than about 15 percent by weight based on the total weight of said dosage form. Claim 8 depends from claim 1 and further specifies a required total amount of crospovidone and croscarmellose sodium: A flash-melt pharmaceutical dosage form according to claim 1 wherein said superdisintegrants comprise from about 9 to about 10 percent by weight based on the total weight of said dosage form. Claim 13 depends from claim 1 and further specifies optional binders: A flash-melt pharmaceutical dosage form according to claim 1 wherein said binder is microcrystalline cellulose, hydroxypropyl cellulose, ethyl cellulose, lactose, mannitol or calcium phosphate. Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 17 of 52 PageID: 1441 – 18 – 43. Every claim of the ’421 patent requires a dispersing agent. “Rebuttal Expert Report of Irwin C. Jacobs, Ph.D. Concerning Noninfringement,” dated September 9, 2016, (Exhibit 14) (“Jacobs”) at ¶¶ 52, 70. 44. Every claim specifically requires calcium silicate as the dispersing agent. Id. at ¶¶ 48, 70. 45. The specification of the ’421 patent expressly states calcium silicate is “the primary constituent of the excipient combination of the subject formulation.” ’421 patent (Exhibit 4) at 8:20–25; see also id. at 7:27–28. The specification additionally alleges that in contrast to conventional tableting formulations, the ability to use calcium silicate as the dispersing agent is allegedly unexpected since it is generally recognized by those of ordinary skill in the art as being poorly compressible. Id. at 8:20–25. 46. In overcoming an obviousness rejection during prosecution of the ’421 patent, the patentee argued that calcium silicate is not a substitute for superdisintegrants. Response to Non-final Office Action dated October 31, 2011, (Exhibit 15). The patentee additionally distinguished the alleged invention from the prior art by noting that greater amounts of calcium silicate (the dispersing agent) are used, whereas the prior art only disclosed minor amounts of calcium silicate. Id. Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 18 of 52 PageID: 1442 – 19 – IV. ORCHID’S ANDA PRODUCTS 47. Orchid filed its ANDA No. 20-2683 (“Orchid’s IR ANDA Product”) and ANDA No. 20-2547 (“Orchid’s ODT ANDA Product”) with the FDA seeking approval to market Orchid’s Aripiprazole tablets 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg (“Orchid’s IR ANDA Product”) and Aripiprazole orally disintegrating tablets 10 mg and 15 mg (“Orchid’s ODT ANDA Product”) as generic versions of Otuska’s Abilify® and Abilify Discmelt®, respectively. See Excerpts from Orchid’s DMF and ANDA (Exhibit 16) at ORCHID00007760; ORCHID00023385. 48. Orchid Chemicals & Pharmaceuticals Ltd. is the holder of DMF number 021937. See, e.g., (Exhibit 16) at ORCHID00000021, ORCHID00022833. DMF number 021937 describes the aripiprazole API used in both of Orchid’s ANDA products. Id. at ORCHID00007747; ORCHID00023373; ORCHID00032168. 49. Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 19 of 52 PageID: 1443 – 20 – 50. . 51. . 52. Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 20 of 52 PageID: 1444 – 21 – 53. A. 54. 55. Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 21 of 52 PageID: 1445 – 22 – 56. 57. The 58. 59. Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 22 of 52 PageID: 1446 – 23 – Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 23 of 52 PageID: 1447 – 24 – 60. 61. 62. Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 24 of 52 PageID: 1448 – 25 – 63. Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 25 of 52 PageID: 1449 – 26 – 64. Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 26 of 52 PageID: 1450 Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 27 of 52 PageID: 1451 – 28 – 68. 69. 2. 70. Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 28 of 52 PageID: 1452 – 29 – 71. . 72. 3. 73. Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 29 of 52 PageID: 1453 – 30 – 74. 75. Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 30 of 52 PageID: 1454 – 31 – 76. C. 77. 78. Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 31 of 52 PageID: 1455 V. THE PRESENT LAWSUIT 79. By letter dated , Orchid notified Plaintiff that Orchid had filed ANDA No. 20-2683 and ANDA No. 20-2547 with the FDA seeking approval to market Orchid’s IR ANDA Product and ODT ANDA Product as generic versions of Otuska’s Abilify® and Abilify Discmelt®, respectively. See Notice Letters (Exhibit 20). Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 32 of 52 PageID: 1456 – 33 – 80. On January 22, 2016, Otsuka filed a complaint against Orchid alleging infringement of four patents, U.S. Patent Nos. 8,580,796 (“the ’796 patent”); 8,017,615 (“the ’615 patent”); 8,642,760 patent (“the ’760 patent”); U.S. Patent Nos. 9,089,567 (the ’567 patent”); and 8,518,421 (“the ’421 patent”). Dkt. No. 1. A. The Parties’ Contentions 81. Otsuka’s May 6, 2016 Infringement Contentions provided no substantive explanation of Otsuka’s infringement position. See generally Otsuka’s Infringement Contentions (Exhibit 5). 82. In the body of its contentions, Otsuka alleged that Orchid has committed an act of infringement under 35 U.S.C. § 271(e)(2) of the asserted patent claims by submitting its ANDAs and that Orchid will infringe under § 271(a) the asserted claims if Orchid commercializes the products after FDA approval. Id. at 2–3. 83. In the claim charts, Otsuka provided no reasoning or explanation of why, how, or where in its view the Orchid products meet a claim element either literally or under the doctrine of equivalents. Id. at 7–49. The Bates citations to large portions of Orchid’s ANDA and DMF referred to Orchid’s ANDA documents that generally recite various characteristics and components of the accused products, but did not explain specifically how Orchid’s ANDA products Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 33 of 52 PageID: 1457 – 34 – met the low-hygroscopicity or calcium silicate limitations of the asserted claims. Id. 84. 85. Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 34 of 52 PageID: 1458 – 35 – 86. Otsuka’s infringement contentions contained only boilerplate place- holder language regarding its infringement theories for all of the asserted claims under the doctrine of equivalents. See, e.g., (Exhibit 5) at 7–49 (“To the extent this claim limitation is not literally met, Otsuka asserts that this claim limitation is met under the Doctrine of Equivalents.”). 87. Orchid’s Noninfringement Contentions detailed how its ANDA products do not infringe . See Orchid’s Noninfringement Contentions dated April 22, 2016, (Exhibit 21). B. The Myerson Report Does Not Contain Evidence Of Showing That Orchid’s ANDA Products Meet The Low-Hygroscopicity Limitations 88. Otsuka served the Expert Report of Dr. Myerson concerning infringement on August 12, 2016. See (Exhibit 8). 89. 90. Dr. Myerson does not have a “fully formed” opinion as to whether the Orchid ANDA products meet all of the limitations of the asserted claims. Myerson Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 35 of 52 PageID: 1459 – 36 – (Exhibit 8) at ¶¶ 19, 74, 84, 85, 93, 100, 101, 109; Myerson Dep. (Exhibit 7) at 25:6–11. 91. 92. . 93. Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 36 of 52 PageID: 1460 – 37 – 94. 95. 96. Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 37 of 52 PageID: 1461 – 38 – 97. 98. 99. Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 38 of 52 PageID: 1462 – 39 – 100. The Myerson report contained no argument or evidence concerning the infringement under the doctrine of equivalents other that a single statement that “any differences between Defendant’s API and generic aripiprazole products and the subject matter of the asserted claims are insubstantial.” Myerson (Exhibit 8) at ¶ 112; see also Myerson Dep. (Exhibit 7) at 54:14–19. C. 101. 102. Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 39 of 52 PageID: 1463 – 40 – 103. 104. Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 40 of 52 PageID: 1464 – 41 – Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 41 of 52 PageID: 1465 – 42 – 105. 106. 107. Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 42 of 52 PageID: 1466 – 43 – 108. . 109. 110. 111. Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 43 of 52 PageID: 1467 – 44 – 112. 113. 114. 115. Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 44 of 52 PageID: 1468 – 45 – D. The Byrn Report Is Devoid Of Any Evidence Of Infringement 116. Otsuka served the Expert Report of Dr. Byrn concerning infringement of the ’421 patent on August 12, 2016. Byrn Opening Report (Exhibit 13). 117. Although Otsuka’s complaint and Infringement Contentions alleged infringement of all 17 claims of the ’421 patent, Dr. Byrn’s report was limited to only claims 1, 6–8, and 13. Compare Otsuka’s Infringement Contentions (Exhibit 5) at 3, 5, 25–49, with Byrn Opening Report (Exhibit 13) at ¶¶ 9, 18, 22, 57. Dr. Byrn’s report does not address claims 2–5, 9–12, and 14–17 at all. Id. Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 45 of 52 PageID: 1469 – 46 – 118. 119. 120. Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 46 of 52 PageID: 1470 – 47 – 121. Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 47 of 52 PageID: 1471 – 48 – 122. E. Otsuka’s Reply Expert Reports Do Not Remedy Otsuka’s Deficiencies 123. Otsuka served three reply expert reports on September 23, 2016: 1) the “Reply Expert Report Of Allan S. Myerson, Ph.D.” (responding to Dr. Van Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 48 of 52 PageID: 1472 – 49 – Buskirk) (Exhibit 31) (“Myerson-Van Buskirk Reply”); 2) the “Reply Expert Report Of Allan S. Myerson, Ph.D.” (responding to Dr. MacGillivray) (Exhibit 32) (“Myerson-MacGillivray Reply”); and 3) the “Reply Expert Report Of Stephen R. Byrn, Ph.D. Responding To The Expert Report Of Irwin C. Jacobs, Ph.D. Concerning Noninfringement” (Exhibit 33) (“Byrn Reply”). 124. The Myerson-Van Buskirk Reply repeats Dr. Myerson’s allegations from his Opening report, but does not rely on any evidence to dispute the assertions in Dr. Van Buskirk’s report. Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 49 of 52 PageID: 1473 – 50 – 125. 126. . 127. 128. . Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 50 of 52 PageID: 1474 – 51 – 129. Dr. Myerson states that he disagrees with Dr. Van Buskirk’s analysis and conclusions concerning the doctrine of equivalents, but does not contain any argument or evidence concerning the infringement under the doctrine of equivalents other than repeating his statement that “any differences between Defendant’s API and generic aripiprazole products and the subject matter of the asserted claims are insubstantial.” Myerson-Van Buskirk Reply (Exhibit 31) at ¶¶ 18–22; see also Myerson-MacGillivray Reply (Exhibit 32) at ¶ 16. 130. . 131. 132. Dr. Byrn’s reply report does not assert a function, way, or result . See Byrn Reply (Exhibit 33) at ¶¶ 25–35. Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 51 of 52 PageID: 1475 – 52 – Dr. Byrn’s broad claims cannot sustain Otsuka’s allegations. Id. Respectfully Submitted, September 23, 2016 /s/ Karen A. Confoy OF COUNSEL: SAILESH K. PATEL (admitted Pro Hac Vice) JASON G. HARP (admitted Pro Hac Vice) THOMAS RAMMER (admitted Pro Hac Vice) HELEN H. JI (admitted Pro Hac Vice) JAIMIN H. SHAH (admitted Pro Hac Vice) SCHIFF HARDIN LLP 233 South Wacker Drive, Suite 6600 Chicago, IL 60606 (312) 258-5500 spatel@schiffhardin.com jharp@schiffhardin.com trammer@schiffhardin.com hji@schiffhardin.com jshah@schiffhardin.com Karen A. Confoy FOX ROTHSCHILD LLP Princeton Pike Corporate Center 997 Lenox Drive Building 3 Lawrenceville, NJ 08648 (609) 844-3033 kconfoy@foxrothschild.com JOHN K. HSU (admitted Pro Hac Vice) SCHIFF HARDIN LLP 901 K Street NW Suite 700 Washington, DC 20001 (202) 778-6400 jhsu@schiffhardin.com Attorneys for Defendants Orchid Pharma Limited, Orchid Pharma USA Inc., and Orgenus Pharma Inc. Case 1:16-cv-00405-JBS-KMW Document 105-2 Filed 09/23/16 Page 52 of 52 PageID: 1476 KAREN A. CONFOY FOX ROTHSCHILD LLP Princeton Pike Corporate Center 997 Lenox Drive, Building 3 Lawrenceville, New Jersey 08648 Telephone: (609) 896-3600 Facsimile: (609) 896-1469 kconfoy@foxrothschild.com Of Counsel: SAILESH K. PATEL (Admitted Pro Hac Vice) JASON G. HARP (Admitted Pro Hac Vice) THOMAS A. RAMMER (Admitted Pro Hac Vice) HELEN H. JI (Admitted Pro Hac Vice) JAIMIN H. SHAH (Admitted Pro Hac Vice) SCHIFF HARDIN LLP 233 South Wacker Drive, Suite 6600 Chicago, IL 60606 (312) 258-5500 JOHN K. HSU (admitted Pro Hac Vice) SCHIFF HARDIN LLP 901 K Street NW Suite 700 Washington, DC 20001 (202) 778-6400 Attorneys for Defendants Orchid Pharma Ltd., Orchid Healthcare, Orchid Pharma, Inc., and Orgenus Pharma Inc. UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY OTSUKA PHARMACEUTICAL CO., LTD., Plaintiff, v. ORCHID PHARMA LTD., ORCHID HEALTHCARE, ORCHID PHARMA, INC. and ORGENUS PHARMA INC., Defendants. Civil Action No. 1:16-cv-00405-JBS-KMW Filed Electronically [PROPOSED] ORDER GRANTING SUMMARY JUDGMENT OF NONINFRINGEMENT Case 1:16-cv-00405-JBS-KMW Document 105-3 Filed 09/23/16 Page 1 of 2 PageID: 1477 2 This matter having been opened to the Court by Fox R thschild LLP and Schiff Hardin LLP, counsel for Defendants Orchid Pharma Ltd., Orchid Healthcare, Orchid Pharma, Inc., and Orgenus Pharma Inc. (collectively, “Orchid”), by way of Orchid’s Motion for Summary Judgment of Noninfringement pursuant to Federal Rule of Civil Procedure 56 and Local Civil Rule 56.1; and Plaintiff, through counsel, having received due notice of this Motion and having had the opportunity to be heard; and the Court having considered the papers submitted and having heard arguments of counsel, and for good cause shown; IT IS on this __________ day of ________________________, 2016, ORDERED that Orchid’s Motion be and the same is hereby GRANTED; and it is further ORDERED that all claims against Orchid are hereby dismissed with prejudice. ________________________________________ HONORABLE JEROME B. SIMANDLE United States District Judge Case 1:16-cv-00405-JBS-KMW Document 105-3 Filed 09/23/16 Page 2 of 2 PageID: 1478 KAREN A. CONFOY FOX ROTHSCHILD LLP Princeton Pike Corporate Center 997 Lenox Drive, Building 3 Lawrenceville, New Jersey 08648 Telephone: (609) 896-3600 Facsimile: (609) 896-1469 E-mail: kconfoy@foxrothschild.com Of Counsel: SAILESH K. PATEL (Admitted Pro Hac Vice) JASON G. HARP (Admitted Pro Hac Vice) THOMAS A. RAMMER (Admitted Pro Hac Vice) HELEN H. JI (Admitted Pro Hac Vice) JAIMIN H. SHAH (Admitted Pro Hac Vice) SCHIFF HARDIN LLP 233 South Wacker Drive, Suite 6600 Chicago, IL 60606 (312) 258-5500 JOHN K. HSU (admitted Pro Hac Vice) SCHIFF HARDIN LLP 901 K Street NW Suite 700 Washington, DC 20001 (202) 778-6400 Attorneys for Defendants Orchid Pharma Ltd., Orchid Healthcare, Orchid Pharma, Inc., and Orgenus Pharma Inc. UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY OTSUKA PHARMACEUTICAL CO., LTD., Plaintiff, v. ORCHID PHARMA LTD., ORCHID HEALTHCARE, ORCHID PHARMA, INC. and ORGENUS PHARMA INC., Defendants. Civil Action No. 1:16-cv-00405-JBS-KMW CERTIFICATE OF SERVICE Filed Electronically I, Karen A. Confoy, hereby certify that on September 23, 2016, I caused a true and correct copy of the foregoing: (1) Notice of Motion for Summary Judgment of Noninfringement; Case 1:16-cv-00405-JBS-KMW Document 105-4 Filed 09/23/16 Page 1 of 2 PageID: 1479 2 (2) Memorandum of Law; (3) Statement of Uncontested Facts Pursuant to Local Civil Rule 56.1; (4) Declaration of Karen A. Confoy with annexed exhibits; (5) Proposed Order Granting Summary Judgment of Noninfringement; and (6) this Certificate of Service to be electronically filed with the Clerk of the Court using the CM/ECF system, which will send electronic notification of such filing to all attorneys of record in accordance with this Court’s electronic case filing policies and procedures. I also certify that on this date, I caused a copy of the foregoing documents to be served via e-mail on the following counsel: Melissa A. Chuderewicz James B. Monroe PEPPER HAMILTON LLP Paul W. Browning Suite 400 Eric J. Fues 301 Carnegie Center Denise Main Princeton, New Jersey 08543 FINNEGAN, HENDERSON, (609) 452-0808 FARABOW, GARRETT & DUNNER, LLP (609) 452-1147 (fax) 901 New York Avenue, N.W. chuderewiczm@pepperlaw.com Washington, DC 20001-4413 (202) 408-4000 (202) 408-4400 (fax) james.monroe@finnegan.com paul.browning@finnegan.com eric.fues@finnegan.com denise.main@finnegan.com Dated: September 23, 2016 s//Karen A. Confoy Karen A. Confoy kconfoy@foxrothschild.com Case 1:16-cv-00405-JBS-KMW Document 105-4 Filed 09/23/16 Page 2 of 2 PageID: 1480