Ferring B.V. v. Actavis, Inc.

Dismissal of “artificial” § 271(e)(2)(A) claim is warranted when patent holder can bring actual infringement claims against Defendants under § 271(a).

July 21, 2016

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name: Ferring B.V. v. Actavis, Inc., Civil No. 15-4222 (SRC)(CLW), 2016 U.S. Dist. LEXIS 69328 (D.N.J. May 26, 2016) (Chesler, J.) 

Drug Product and Patents-in-Suit: Lysteda® (tranexamic acid); U.S. Patent No. 9,060,939 (“the ’939 patent”)

Nature of the Case and Issue(s) Presented: Ferring is the holder of the ’939 patent, issued June 23, 2015, which claims tranexamic acid formulations. On Nov. 13, 2009, the FDA approved Ferring’s NDA for tranexamic acid tablets, which it sells under the name Lysteda. Defendant Watson filed an ANDA on July 23, 2010, seeking FDA approval to market generic tablets containing 650 mg of tranexamic acid that are, allegedly, the same or substantially the same, as Lysteda. The FDA approved Watson’s ANDA on Dec. 27, 2012, after which time Defendants sold generic tranexamic acid tablets to consumers.

Plaintiffs sued alleging that under 35 U.S.C. § 271(e)(2)(A), Defendants had infringed the ’939 patent through the filing of Watson’s ANDA and, additionally, sought damages under 35 U.S.C. § 271(a) based on Defendants’ alleged infringement of the ’939 patent through Watson’s sale of generic tranexamic acid tablets. Defendants moved to dismiss Plaintiffs patent infringement claim under 35 U.S.C. § 271(e)(2)(A) pursuant to Fed. R. Civ. P. 12(b)(1) or 12(b)(6). The court granted Defendants’ motion pursuant to Rule 12(b)(6).

Why Defendants Prevailed:  Defendants first challenged Plaintiffs’ alleged subject-matter jurisdiction to bring this claim, given that the ’939 patent was issued after Defendants’ ANDA was filed with (and had been approved by) the FDA. Given that the Federal Circuit had held that the requirements for jurisdiction in the district courts are met once a patent owner alleges that another’s filing of an ANDA infringes its patent under § 271(e)(2), and this threshold jurisdictional determination does not depend on the ultimate merits of the claims, and that Plaintiffs had alleged that Defendants’ ANDA infringed the ’939 patent, the Court did not dismiss for lack of subject-matter jurisdiction under Rule 12(b)(1) Plaintiffs’ § 271(e)(2)(A) claim.

Next, the court addressed Defendants’ Rule 12(b)(6) argument. Defendants asserted that Plaintiffs had not alleged facts that could plausibly support an infringement claim under § 271(e)(2)(A), given that the ’939 patent issued after Defendants’ ANDA was filed and approved. Given that 35 U.S.C. § 271(e)(1) creates a “safe harbor” permitting generic companies to use a patented invention for the purpose of obtaining premarketing approval, an important purpose of § 271(e)(2) is to permit a pioneer-drug patent holder to enforce its rights before the generic company’s product has been approved by the FDA and brought to market. As an important purpose of § 271(e)(2)(A) is to provide patentees with a cause of action for infringement during the period of time in which the generic company has not actually infringed the patentee’s patent, it is illogical to conclude that the facts of this case should give rise to a § 271(e)(2)(A) claim. Based on the facts Plaintiffs had pled, they no longer needed an artificial-act-of- infringement claim under § 271(e)(2)(A) to enforce their patent rights: they could bring actual infringement claims against Defendants under § 271(a) based on Defendants’ alleged marketing of their ANDA product. Moreover, the statutory language of § 271(e)(2) supported this same outcome, given that submission of an ANDA for a drug claimed “in a patent” or the use of which is claimed in a patent,” for the purpose of obtaining FDA approval for commercial marketing, was an act of infringement. 35 U.S.C. § 271(e)(2)(A). The phrase “claimed in a patent” in the statute indicates that a § 271(e)(2)(A) claim must be based upon a patent that has already been issued at the time the infringing ANDA is filed.

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