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Tris Pharma, Inc. v. Actavis Laboratories FL, Inc.

United States District Court, D. Delaware

September 5, 2017

TRIS PHARMA, INC., Plaintiff,
v.
ACTAVIS LABORATORIES FL, INC., Defendant.

          MEMORANDUM

         I. INTRODUCTION

         In this Hatch-Waxman patent infringement action, plaintiff Tris Pharma, Inc. ("Tris") alleges patent infringement by defendant Actavis Laboratories FL, Inc. ("Actavis"). Plaintiff alleges that, by filing Abbreviated New Drug Applications ("ANDAs") seeking approval to market generic versions of Quillivant XR®, Defendant infringed U.S. Patent Nos. 8, 46, 765 ("the '765 patent"), 8, 563, 033 ("the '033 patent"), 8, 778, 390 ("the '390 patent"), 8, 956, 649 ("the '649 patent"), 9, 040, 083 ("the '083 patent"). The court held a five-day bench trial in this matter beginning on February 6, 2017. Presently before the court are the parties' post-trial proposed findings of fact and conclusions of law concerning infringement of and the validity of the patents-in-suit, specifically whether the asserted claims are invalid as obvious under 35 U.S.C. § 103. (D.I. 151; D.I. 152.)

         Pursuant to Federal Rule of Civil Procedure 52(a), having considered the entire record in this case and the applicable law, the court concludes that all asserted claims of the patents-in-suit are invalid due to obviousness. These findings of fact and conclusions of law are set forth in further detail below.

         II. FINDINGS OF FACT[1]

         A. The Parties

         1. Plaintiff Tris Pharma, Inc. is a company organized and existing under the laws of New Jersey, having its principal place of business at 2033 Route 130, Suite D, Monmouth Junction, N.J. 08852.

         2. Defendant Actavis Laboratories FL, Inc. is a corporation organized and existing under the laws of Florida, having an address at 2945 W. Corporate Lakes Blvd., Weston, FL.

         3. The court has subject matter jurisdiction and personal jurisdiction over all parties.

         B. Background

         4. Tris holds an approved New Drug Application ("NDA") No. 202100 under Section 505(a) of the Federal Food, Drug and Cosmetic Act ("FFDCA"), 21 U.S.C. § 355(a), for an extended release methylphenidate suspension, which Tris sells under the trade name Quillivant XR®.

         5. On September 27, 2012, the United States Food and Drug Administration ("FDA") approved Quillivant XR® for treatment of Attention Deficit Hyperactivity Disorder (ADHD).

         6. Pursuant to 21 U.S.C. § 355(b)(1), and attendant FDA regulations, the '667 Patent, the '903 patent, the '765 patent, the '033 patent, the '390 patent, the '649 patent, and the '083 patent (collectively, "the patents-in-suit") are listed in the FDA publication, "Approved Drug Products with Therapeutic Equivalence Evaluations" (the "Orange Book"), with respect to Quillivant XR®.

         C. The Patents-in-Suit

         7. The '765 patent issued on June 18, 2013 and is entitled "Orally Effective Methylphenidate Extended Release Powder And Aqueous Suspension Product." The '765 patent names Ketan Mehta, Yu-Hsing Tu, and Ashok Perumal as inventors. Tris Pharma, Inc. is the assignee of the '765 patent.

         8. The '033 patent issued on October 22, 2013 and is entitled "Orally Effective Methylphenidate Extended Release Powder And Aqueous Suspension Product." The '033 patent names Ketan, Mehta, Yu-Hsing Tu, and Ashok Perumal as inventors. Tris Pharma, Inc. is the assignee of the '033 patent.

         9. The '390 patent issued on July 15, 2014 and is entitled "Orally Effective Methylphenidate Extended Release Powder And Aqueous Suspension Product." The '390 Patent names Ketan Mehta, Yu-Hsing Tu, and Ashok Perumal as inventors. Tris Pharma, Inc. is the assignee of the '390 patent.

         10. The '649 patent issued on February 17, 2015 and is entitled "Orally Effective Methylphenidate Extended Release Powder And Aqueous Suspension Product." The '649 patent names Ketan Mehta, Yu-Hsing Tu, and Ashok Perumal as inventors. Tris Pharma, Inc. is the assignee of the '649 patent.

         11. The '083 patent issued on May 26, 2015 and is entitled "Orally Effective Methylphenidate Extended Release Powder And Aqueous Suspension Product." The '083 patent names Ketan Mehta, Yu-Hsing Tu, and Ashok Perumal as inventors. Tris Pharma, Inc. is the assignee of the '083 patent.

         (1) The Asserted Claims

         12. Tris has asserted infringement of claims 6, 13, 16, 18, 20, 25, and 30 of the '765 patent against Actavis.

         13. Tris has asserted infringement of claims 4 and 10 of the '033 patent against Actavis.

         14. Tris has asserted infringement of claims 15, 16, and 20 of the '390 patent against Actavis.

         15. Tris has asserted infringement of claims 12, 22, 23, 25, 26, 27, and 33 of the '649 patent against Actavis.

         16. Tris has asserted infringement of claims 5, 6, 7, 8, 12, 15, 16, and 17 of the '083 patent against Actavis.

         i. '765 Patent, Claim 6

         17. Claim 6 of the '765 patent reads:

The suspensions according to claim 1, wherein the suspension has a pharmacokinetic profile in which the single mean plasma concentration peak for d-methylphenidate has an area under the curve (AUC)0-∞ of about 114 ng-hr/mL to about 180 ng-hr/mL, Cmax of . about 11 ng/mL to about 17 ng/mL, Tmax of about 4 hours to about 5.25 hours and Tl/2 of about 5 hours to about 7 hours following a single oral administration of an aqueous suspension at a dose equivalent to 60 mg racemic methylphenidate HCL in adults.

         ii. '765 Patent, Claim 13

         18. Claim 13 of the '765 patent reads:

         The suspension according to claim 1, wherein said suspension contains at least about 80% of water by weight based on the total weight of the suspension.

         iii. '765 Patent, Claim 16

         19. Claim 16 of the '765 patent reads:

         The suspension according to claim 1, wherein the suspension contains about 10 to about 30 parts by weight of methylphenidate as provided in the immediate release component and to about 70 to about 90 parts by weight of sustained release methylphenidate, based upon the total weight of methylphenidate in suspension.

         iv. '765 Patent, Claim 18

         20. Claim 18 of the '765 patent reads:

         The suspension according to claim 17, wherein the buffering agent is a mixture of sodium citrate and anhydrous citric acid.

         v. '765 Patent, Claim 20

         21. Claim 20 of the '765 patent reads:

         The method according to claim 19, wherein the suspension which has a pH from about 4 to about 4.5.

         vi. '765 Patent, Claim 25

         22. Claim 25 of the '765 patent reads:

         The powder blend according to claim 23, wherein the surfactant in the diluent granules comprises a poloxamer.

         vii. '765 Patent, Claim 30

         23. Claim 30 of the '765 patent reads:

         The methylphenidate aqueous extended release oral suspension according to claim 29, which has less than about 3% loss in potency over a period of at least 4 months of storage at room temperature.

         viii. '033 Patent, Claim 4

         24. Claim 4 of the '033 patent reads:

         The suspension according to claim 1, wherein said suspension contains at least 80% of water by weight based on the total weight of the suspension.

         ix. '033 Patent, Claim 10

         25. Claim 10 of the ' 03 3 patent reads:

         The method according to claim 9, wherein the suspension which has a pH from about 4 to about 4.5.

         x. '390 Patent, Claim 15

         26. Claim 15 of the '390 patent reads:

         The suspension according to claim 14 which comprises about 10 to 30 parts by weight of methylphenidate as provided in the immediate release component and to about 70 to about 90 parts by weight of methylphenidate as provided in the sustained release component, based upon the total weight of methylphenidate in suspension.

         xi. '390 Patent, Claim 16

         27. Claim 16 of the '390 patent reads:

         The suspension according to claim 1, wherein said suspension contains at least 80% of water by weight based on the total weight of the suspension.

         xii. '390 Patent, Claim 20

         28. Claim 20 of the '390 patent reads:

         The suspension according to claim 3, wherein the suspension has less than about 5%o loss in potency over a period of at least about 4 months at room temperature.

         xiii. '649 Patent, Claim 12

         29. Claim 12 of the '649 patent reads:

         The methylphenidate aqueous extended release oral suspension according to claim 11, wherein the hydrophilic polymer is polyvinylpyrrolidone.

         xiv. '649 Patent, Claim 22

         30. Claim 22 of the '649 patent reads:

         The methylphenidate aqueous extended release oral suspension according to claim 19, which has less than about 5% loss in potency over a period of about 4 months of storage at room temperature.

         xv. '649 Patent, Claim 23

         31. Claim 23 of the ' 649 patent reads:

         The methylphenidate aqueous extended release oral suspension according to claim 19, which has less than about 1% of threo-a-phenyl-2-piperidineacetic acid hydrochloride impurity after a period of about 4 months of storage at room temperature.

         xvi. '649 Patent, Claim 25

         32. Claim 25 of the '649 patent reads:

         The methylphenidate aqueous extended release oral suspension according to claim 17, wherein said suspension provides a therapeutically effective plasma profile for methylphenidate for about 12 hours following a single oral administration of an aqueous suspension at a dose equivalent to 60 mg racemic methylphenidate HC1 in adults.

         xvii. '649 Patent, Claim 26

         33. Claim 26 of the '649 patent reads:

         The methylphenidate aqueous extended release oral suspension according to claim 17, wherein said suspension provides a single mean average plasma concentration peak for methylphenidate following a single oral administration of an aqueous suspension at a dose equivalent to 60 mg racemic methylphenidate HC1 in adults.

         xviii. '649 Patent, Claim 27

         34. Claim 27 of the '649 patent reads:

         The methylphenidate aqueous extended release oral suspension according to claim 17, wherein said suspension provides a therapeutically effective amount of methylphenidate within 45 minutes after administration following a single oral administration of an aqueous suspension at a dose equivalent to 60 mg racemic methylphenidate HC1 in adults.

         xix. '649 Patent, Claim 33

         35. Claim 33 of the '649 patent reads:

         The methylphenidate aqueous extended release oral suspension according to claim 17, wherein the barrier coating comprises ethycellulose.

         xx. '083 Patent, Claim 5

         36. Claim 5 of the '083 patent reads:

         The powder according to claim 2, wherein the suspension has less than about 5% loss in potency over a period of about 4 months of storage at room temperature.

         xxi. '083 Patent, Claim 6

         37. Claim 6 of the '083 patent reads:

         The powder according to claim 2, wherein the suspension has less than about 1 % of an impurity which is threo-a-phenyl-2-piperidineacetic acid hydrochloride after a period of about 4 months of storage at room temperature.

         xxii. '083 Patent, Claim 7

         38. Claim 7 of the '083 patent reads:

         The powder according to claim 1, wherein the methylphenidate in the immediate release methylphenidate component of (i) comprises about 20% w/w of the total methylphenidate in said powder.

         xxiii. '083 ...


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