Supernus Pharm. v. Torrent Pharm.

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SUPERNUS PHARMACEUTICALS, INC., Plaintiff, v. TORRENT PHARMACEUTICALS LTD., et al., Defendants.

Civil Action No. 21-06964 (GC) (DEA)

United States District Court, D. New Jersey

January 30, 2024

Charles M. Lizza William C. Baton Sarah A. Sullivan SAUL EWING LLP Edgar H. Haug Nicholas F. Giove Richard F. Kurz Andrew S. Wasson Jason A. Kanter Anna N. Lukacher Jessica M. Stookey Chinmay P. Bagwe HAUG PARTNERS LLP Counsel for Plaintiff Supernus Pharmaceuticals, Inc

Rebekah R. Conroy STONE CONROY LLC Neal Seth (pro hac vice) Wesley Weeks (pro hac vice) Lawrence Sung (pro hac vice) Corey Weinstein (pro hac vice) WILEY REIN, LLP Counsel for Defendants Torrent Pharmaceuticals Ltd. and Torrent Pharma Inc.

OPINION FILED UNDER TEMPORARY SEAL

CASTNER, District Judge

This matter comes before the Court upon a Hatch-Waxman patent-infringement action brought by Plaintiff Supernus Pharmaceuticals, Inc. (Supernus) against Defendants Torrent Pharmaceuticals Ltd. and Torrent Pharma Inc. (Torrent), stemming from Torrent's Abbreviated New Drug Application seeking approval to market a generic version of Supernus's drug product. Supernus alleges that Torrent's ANDA Products infringe claims of three patents in suit: claim 14 of U.S. Patent No. 8,992,989 ('989 patent); claim 14 of U.S. Patent No. 9,549,940 ('940 patent); and claims 13 and 23 of U.S. Patent No. 9,622,983 ('983 patent).^[1]

The Court held a bench trial on Supernus's infringement claims and Torrent's invalidity defenses. In this Opinion, the Court resolves disputes over infringement and validity of the Patents-in-Suit, including reserved decisions on motions in limine and trial objections and motions. The Court discusses the procedural history and trial record, and then makes findings of fact and conclusions of law in accordance with Federal Rule of Civil Procedure (“Rule”) 52(a). The findings of fact are based on the Court's observations at trial, credibility judgments, and review of all admissible record evidence.

For the reasons set forth below, and other good cause shown, the Court finds that Torrent's ANDA Products INFRINGE on the Patents-in-Suit and that the asserted patents are VALID.^[2]

I. FACTS ESTABLISHED

The following facts are stipulated, not disputed, or established by undisputed record evidence in the Final Pretrial Order, the Joint Proposed Findings of Fact, or both^[3]:

A. The Parties

1. Plaintiff Supernus is a corporation organized and existing under the laws of Delaware, having its principal place of business at 9715 Key West Avenue, Rockville, Maryland 20850. (PFF ¶ 1 (citing ECF No. 133 ¶ 29).)

2. Defendant Torrent Pharmaceuticals Ltd. is a corporation operating and existing under the laws of India, with its principal place of business at Torrent House, Off. Ashram Road, Ahmedabad, Gujarat, 380009, India. (PFF ¶ 2 (citing ECF No. 133 ¶ 30).)

3. Defendant Torrent Pharma Inc. is a Delaware limited liability company having its principal place of business at 150 Allen Road, Suite 102, Basking Ridge, N.J. 07920. (PFF ¶ 3 (citing ECF No. 133 ¶ 31).)

4. Defendant Torrent Pharmaceuticals Inc. is a subsidiary of Torrent Pharmaceuticals Ltd. (PFF ¶ 4 (citing ECF No. 133 ¶ 32).)

B. Background

5. This is a civil action for patent infringement that is brought by Supernus against Torrent arising under the patent laws of the United States, Title 35, United States Code.^[4](PFF ¶ 5 (citing ECF No. 133 ¶ 21).)

6. Supernus asserts that Torrent infringes claims of three patents - United States Patent Nos. 8,992,989 ('989 patent); 9,549,940 ('940 patent); and 9,622,983 ('983 patent) (collectively, the “Patents-in-Suit”). (PFF ¶ 6 (citing ECF No. 133 ¶ 23).)

7. This case involves the drug product Trokendi XR^®, which is sold by Supernus and is indicated for treatment of epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older; adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older; and preventive treatment of migraine in patients 12 years of age and older. (PFF ¶ 7 (citing ECF No. 133 ¶ 22).)

8. Supernus owns the FDA approved New Drug Application (NDA) No. 201635 for Trokendi XR^®, topiramate extended-release capsules, 25 mg, 50 mg, 100 mg, and 200 mg. (PFF ¶ 8 (citing ECF No. 133 ¶¶ 28, 33).)

9. Pursuant to 21 U.S.C. §§ 355(b)(1) and 355(c)(2), FDA's publication titled “Approved Drug Products with Therapeutic Equivalence Evaluations” (commonly known as the “Orange Book”) lists ten (10) patents as covering Supernus's Trokendi XR^®. The Orange Book lists the Patents-in-Suit and also the following patents, which are no longer asserted against Torrent: United States Patent Nos. 8,298,576 ('576 patent), 8,298,580 ('580 patent), 8,663,683 ('683 patent), 8,877,248 ('248 patent), 8,889,191 ('191 patent), 9,555,004 ('004 patent), and 10,314,790 ('790 patent). (PFF ¶ 9 (citing ECF No. 133 ¶ 34).)

10. The inventors assigned ownership of all Orange Book Patents to Supernus. (PFF ¶ 10 (citing ECF No. 133 ¶ 36).)

11. Torrent filed Abbreviated New Drug Application No. 215918 (Torrent's ANDA) with the FDA seeking approval to engage in commercial marketing of a generic version of Trokendi XR^® (Torrent's ANDA Products). (PFF ¶ 11 (citing 133 ¶ 55).)

12. On or about June 15, 2021, Torrent sent a letter pursuant to 21 U.S.C. § 355(j)(2)(B) and 21 C.F.R. § 314.95 regarding the Torrent ANDA Products and the '576, '580, '683, '248, '191, '989, '940, '004, '983, and '790 patents (the “June 15 Notice Letter”) to Supernus. (PFF ¶ 12 (citing ECF No. 133 ¶ 56).)

13. Torrent's ANDA references Trokendi XR^® (topiramate extended-release capsules) as the reference listed drug, or “RLD.” (PFF ¶ 13 (citing ECF No. 133 ¶ 57).)

14. The Torrent ANDA Products are extended release formulations of topiramate. (PFF ¶ 14 (citing ECF No. 133 ¶ 59).)

15. The Torrent ANDA Products are topiramate extended-release capsules, 25 mg, 50 mg, 100 mg, and 200 mg. (PFF ¶ 15 (citing ECF No. 133 ¶ 58).)

16. Torrent has asserted affirmative defenses stating that the Patents-in-Suit are invalid and not infringed, directly or indirectly. (PFF ¶ 17 (citing ECF No. 133 ¶ 24).)

17. Torrent Pharmaceuticals Ltd. also brought counterclaims for a declaratory judgment of non-infringement with respect to the Patents-in-Suit. (PFF ¶ 18 (citing ECF No. 133 ¶ 25).)

18. Supernus asserted affirmative defenses stating that, among other things, the Patents-in-Suit are valid and enforceable, and infringed by Torrent's ANDA Products. (PFF ¶ 19 (citing ECF No. 133 ¶ 26).)

C. The Accused Product

19. The composition of Torrent's ANDA Products is disclosed in the Quality Overall Summary (QOS) that Torrent submitted to the FDA. (PFF ¶ 20 (citing PTX106.3-5; Patel Tr. 65:12-66:2, 75:11-17, 75:20-22; Tr. 240:22-242:24, 232:2-237:24.).)^[5]

20. Torrent's ANDA Products comprise gelatin capsules that are filled with beads where each bead comprises (i) sugar sphere coated with a seal coating, (ii) a topiramate drug coating layer coated on top of each sugar sphere, and (iii) a release controlling polymer coating layer coated on top of the topiramate-coated beads. (PFF ¶ 21 (citing Patel Tr. 21:18-24, 22:5-15; Tr. 240:22-242:24, 232:2-237:24; PTX106.3-5).)

21. At the core of the Torrent ANDA Products beads is an inert sugar sphere. (PFF ¶ 22 (Pl.) (citing PTX106.3; Patel Tr. 66:3-12; Tr. 240:22-241:8).)

22. A seal coating suspension is coated on top of the sugar sphere. (PFF ¶ 23 (Pl.) (citing PTX106.3; Patel Tr. 66:13-16; Tr. 240:22-241:18).)

23. A drug coating suspension is coated on top of the seal coating suspension layer. The drug coating suspension layer contains the active pharmaceutical ingredient (API), topiramate, along with various excipients. The beads coated with the drug coating suspension are also referred to as “drug coated pellets.” (PFF ¶ 24 (Pl.) (citing PTX106.3; Patel Tr. 67:2-5, 67:19-22; Tr. 240:17-242:2).)

24. Torrent's ANDA Products comprise polyvinyl acetate dispersion as a release controlling polymer. (PFF ¶ 25; PTX106.3-4.)

25. The common polymer coated beads are filled into capsules, and each capsule may contain hundreds of beads. (PFF ¶ 26 (Pl.) (citing PTX106.4-5; Patel Tr. 21:18-24; Tr. 240:17-241:5; Tr. 61:19-62:2).)

26. Torrent developed a formulation “to mimic the physiochemical characteristics of RLD [i.e., Supernus's Trokendi XR^® product]. No other formulations were explored.” (PFF ¶ 27 (Pl.) (citing Patel. Tr. 302:8-17; PTX106.29).)

27. Torrent represented to the FDA that its ANDA Product is bioequivalent to Supernus's Trokendi XR^®. (PFF ¶ 28 (citing Patel Tr. 55:3-7, 251:1-11).)

D. The Patents-in-Suit and the Asserted Claims

28. Supernus is asserting claim 14 of the '989 patent, claim 14 of the '940 patent, and claims 13 and 23 of the '983 patent (the “Asserted Claims”) against Torrent in this action. (PFF ¶ 29 (citing ECF No. 133 ¶ 49).)

29. The '989 patent is titled “Sustained-Release Formulations of Topiramate.” (PFF ¶ 30 (citing ECF No. 133 ¶ 37).)

30. The '989 patent issued on March 31, 2015. (PFF ¶ 31 (citing ECF No. 133 ¶ 38).)

31. The '989 patent claims priority to U.S. Provisional Patent Application No. 60/859,502, which has a priority date of November 17, 2006. (PFF ¶ 32 (citing ECF No. 133 ¶ 39).)

32. The '989 patent issued from U.S. Patent Application No. 14/499,462. (PFF ¶ 33 (citing ECF No. 133 ¶ 40).)

33. Claim 14 of the '989 patent reads:

14. A sustained release formulation of topiramate comprising topiramate as an active ingredient, which is released immediately and continuously upon administration from the formulation, the

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