Biogen Int'l GMBH v. Amneal Pharm. LLC

487 F.Supp.3d 254

BIOGEN INTERNATIONAL GMBH and Biogen MA Inc., Plaintiffs,

v.AMNEAL PHARMACEUTICALS LLC, et al., Defendants.

C.A. No. 17-823 (MN)

United States District Court, D. Delaware.

Signed September 16, 2020

Steven J. Balick, Andrew C. Mayo, Ashby & Geddes, Wilmington, DE; James B. Monroe, Eric J. Fues, Laura P. Masurovsky, Paul W. Browning, Li Feng, Andrew E. Renison, Jeanette M. Roorda, Aaron G. Clay, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, Washington, DC; William F. Lee, Wilmer Cutler Pickering Hale and Dorr LLP, Boston, MA – attorneys for Plaintiffs.

Stephen B. Brauerman, Bayard, P.A., Wilmington, DE – attorney for Defendants Hetero USA Inc., Hetero Labs Limited Unit-III, and Hetero Labs Limited, and Shilpa Medicare Limited.

John C. Phillips, Jr., David A. Bilson, Phillips, McLaughlin & Hall, P.A., Wilmington, DE – attorneys for Defendants MSN Laboratories Private Ltd. and MSN Pharmaceuticals Inc., Sandoz Inc. and Prinston Pharmaceutical Inc., and Zydus Pharmaceuticals (USA) Inc.

George C. Lombardi, Winston & Strawn LLP, Chicago, IL – attorney for Defendants MSN Laboratories Private Limited, MSN Pharmaceuticals Inc. and Sandoz Inc.

MEMORANDUM OPINION

NOREIKA, U.S. DISTRICT JUDGE:

This is a patent infringement action arising under the Hatch-Waxman Act. Before the Court is the issue of whether the recent judgment in the Northern District of West Virginia that the asserted claims of U.S. Patent No. 8,399,514 ("the ’514 Patent") are invalid should apply here under the principles of collateral estoppel. For the reasons set forth below, the Court finds that collateral estoppel applies.

I. BACKGROUND

Plaintiffs Biogen International GmbH and Biogen MA Inc. (collectively, "Plaintiffs" or "Biogen") hold approved New Drug Application ("NDA") No. 204063 for the use of dimethyl fumarate delayed-release capsules for the treatment of relapsing forms of multiple sclerosis ("MS"). (D.I. 335, Ex. 1 ¶ 24). Plaintiffs market their delayed-release dimethyl fumarate ("DMF") capsules under the trade name Tecfidera®, which is an FDA-approved oral medication indicated for relapsing forms of MS. (Id. ¶¶ 25-26). Plaintiffs own patents involving fumarates and treatment of MS, two of which (the ’514 Patent and another patent) are listed in the Orange Book for NDA No. 204063. (See id. ¶ 21). The ’514 Patent, titled "Treatment for Multiple Sclerosis," issued on March 19, 2013 and expires on February 7, 2028. (See ’514 Patent ; see also D.I. 335, Ex. 1 ¶¶ 18 & 20). The ’514 Patent contains twenty claims, all of which are directed to methods of treating MS with about 480 mg of DMF, monomethyl fumarate ("MMF") or a combination thereof.

Plaintiffs sued a number of defendants in this District for patent infringement based on the filings of Abbreviated New Drug Applications ("ANDAs") seeking to market generic versions of Tecfidera®.¹ This case is a consolidated action that proceeded to trial with following defendants: Hetero USA Inc., Hetero Labs limited Unit-III, Hetero Labs Ltd., Hetero USA Inc. (together, "Hetero"), MSN Laboratories Private Ltd., MSN Pharmaceuticals Inc. (together, "MSN"), Prinston Pharmaceutical Inc. ("Prinston"), Sandoz Inc. ("Sandoz"), Shilpa Medicare Ltd. ("Shilpa") and Zydus Pharmaceuticals (USA) Inc. ("Zydus") (collectively, "Defendants"). The other parties sued by Plaintiffs were either dismissed or stipulated to infringement and the actions were stayed pending resolution of this consolidated action (with the parties agreeing to be bound by the outcome here). In December 2019, the Court presided over a five-day bench trial limited to the issue of the validity of the ’514 Patent.² (See D.I. 393, 394, 395, 396 & 397). At trial, Defendants contended that claims 1-4, 6, 8-13, 15 and 16 ("the Asserted Claims") of the ’514 Patent were invalid for lack of written description, lack of enablement, improper inventorship and derivation, obviousness and anticipation. (See D.I. 335, Ex. 3 ¶ 110). After trial, the parties submitted proposed findings of fact and post-trial briefs. (See D.I. 350, 351, 352, 353, 357, 358, 359, 360; see also D.I. 362, 363, 364, 365, 366, 367, 368, 369, 372, 373, 374). Post-trial briefing concluded on March 16, 2020 and this Court has not yet issued its post-trial opinion.

Relevant here, Plaintiffs also sued Mylan Pharmaceuticals, Inc. ("Mylan") in the Northern District of West Virginia for infringement based on Mylan's submission of an ANDA seeking to market a generic version of Tecfidera®. See Complaint, Biogen Int'l GmbH v. Mylan Pharm., Inc. , No. 1:17-116 (N.D. W. Va. June 30, 2017). In that case, Plaintiffs asserted the ’514 Patent against Mylan (the same claims asserted here), as well as a number of other patents that expired prior to or shortly after trial (and were therefore dismissed). The West Virginia court held a bench trial in February 2020 limited to the issue of the validity of the ’514 Patent and, on June 18, 2020, issued its post-trial opinion. See generally Biogen Int'l GmbH v. Mylan Pharm. Inc. , No. 1:17-116, 2020 WL 3317105 (N.D.W. Va. June 18, 2020) ("the Mylan decision"). The court ultimately found that Mylan had proven by clear and convincing evidence that the Asserted Claims of the ’514 Patent are invalid for lack of written description. Id.

On June 19, 2020, this Court directed the parties to submit limited supplemental briefing on the impact of the Mylan decision on the issues pending here. (See D.I. 377). The Court received a submission from Plaintiffs (D.I. 387) and a "Supplemental Post-Trial Brief on the Invalidity of the ’514 Patent" from Defendants who proceeded to trial in this action (D.I. 388). The defendants who stipulated to stay their respective actions were allowed to participate in Defendants’ supplemental briefing. (See D.I. 379, 381, 383 & 385). On August 11, 2020, the Court heard oral argument on the effect of the Mylan decision on this and the related actions. (D.I. 398). The issue now before the Court is whether the judgment of invalidity rendered in the Mylan case should apply here under the principles of collateral estoppel.

II. LEGAL STANDARD

Collateral estoppel (also known as issue preclusion) is a doctrine that operates to preclude a party from relitigating an issue that has previously been decided. See Anderson v. Gen. Motors LLC , No. 18-621-LPS, 2019 WL 4393177, at *4 (D. Del. Sept. 13, 2019). Under Third Circuit law, collateral estoppel applies when: (1) the identical issue was previously adjudicated, (2) that issue was actually litigated, (3) the previous determination was necessary to the decision and (4) the party being precluded from relitigating the issue was fully represented in the prior action. See Jean Alexander Cosmetics, Inc. v. L'Oreal USA, Inc. , 458 F.3d 244, 249 (3d Cir. 2006) ; see also Allergan, Inc. v. Sandoz, Inc. , 681 F. App'x 955, 959 (Fed. Cir. 2017) (regional circuit law governs issues of collateral estoppel). The Third Circuit has also described the inquiry as looking to whether the party being precluded had a "full and fair opportunity" to litigate the contested issue in the previous action and whether that issue was decided by a "final and valid judgment." Jean Alexander , 458 F.3d at 249 (citations omitted). Similarly, in the patent context, the Federal Circuit has explained that "a judgment of invalidity will have no collateral estoppel effect if the patentee can show that it did not have a full and fair opportunity to litigate." Pharmacia & Upjohn Co. v. Mylan Pharm., Inc. , 170 F.3d 1373, 1379 (Fed. Cir. 1999). "The party seeking to effectuate an estoppel has the burden of demonstrating the propriety of its application." Suppan v. Dadonna , 203 F.3d 228, 233 (3d Cir. 2000).

III. DISCUSSION

The Court begins with a discussion of the ’514 Patent, followed by a discussion of the Mylan decision before ultimately turning to the factors in the collateral-estoppel analysis.

A. The ’514 Patent

The ’514 Patent is a continuation of U.S. Patent Application No. 12/529,296 ("the ’296 Application"), which was filed on August 7, 2009 and eventually abandoned. Originally titled "Nrf2 Screening Assays and Related Methods and Compositions," the ’296 Application contained seventeen claims, all of which were directed to methods of evaluating neuroprotective properties of test compounds or treating mammals with neurological diseases with those test compounds. ( ’296 Application at Claims 1-17). On June 20, 2011, Plaintiffs amended the ’296 Application by changing the title to "Treatment for Multiple Sclerosis," deleting all previously presented claims and adding sixteen new claims to methods of treating MS with about 480 mg per day of DMF, MMF or a combination thereof. ( ’296 Application, June 20, 2011 Preliminary Amendment). On October 28, 2011, Plaintiffs amended the ’296 Application again to add Gilmore O'Neill as a named inventor and to add three new claims directed to elevated gene expression levels. ( ’296 Application, October 28, 2011 Supplemental Amendment & October 28, 2011 Request to Add Inventor). The ’296 Application was abandoned in favor of U.S. Patent Application No. 13/326,426, which was filed on February 12, 2012 and is a continuation of the ’296 Application. After Plaintiffs successfully overcame obviousness rejections, that continuation application issued as the ’514 Patent on March 29, 2013. The ’514 Patent ultimately claims a priority date of February 8, 2007.³

The claims of the ’514 Patent are all directed to methods of treating MS with "about 480 mg per day" of DMF, MMF or a combination thereof. There is, however, little mention in the specification⁴ of using these fumarates to treat MS specifically, and the only reference to 480 mg appears in the following paragraph:

For DMF or MMF, an effective amount can range from 1 mg/kg to 50 mg/kg (e.g., from 2.5 mg/kg to 20 mg/kg or from 2.5 mg/kg to 15 mg/kg). Effective doses will also vary, as recognized by those skilled in the art, dependent on route of

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