Par Pharm., Inc. v. Luitpold Pharms., Inc.

A claim for patent infringement under Hatch-Waxman must be based on the formulation in the ANDA, not on what the FDA may require of the ANDA holder in the future.

April 26, 2017

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

Case Name:  Par Pharm., Inc. v. Luitpold Pharms., Inc., No. 16-2290 (WHW)(CLW), 2017 U.S. Dist. LEXIS 15050 (D.N.J. Feb. 1, 2017) (Walls, J.) 

Drug Product and Patent(s)-in-Suit: Adrenalin® (epinephrine); U.S. Patents Nos. 9,119,876 (“the ’876 patent”) and 9,295,657 (“the ’657 patent”)

Nature of the Case and Issue(s) Presented:  Par is the assignee of several patents for Adrenalin, a product containing 1 mg of the active ingredient epinephrine (adrenaline), which is used primarily to treat allergic reactions. In early 2016, Luitpold filed and ANDA seeking to market epinephrine. Par sued. Though Par admitted that Luitpold’s ANDA formulation of generic epinephrine does contain the same or equivalent ingredients as the formulation specified in the patents-in-suit, the amended complaint alleged that the product proposed in Luitpold’s ANDA “is not the product Luitpold will market.” But in response to Luitpold’s counterclaims, Par alleged that the FDA will require, and Luipold will likely market, a generic product with a formulation that infringes the patents-in-suit.

The ’876 patent claims certain pharmaceutical compositions comprising epinephrine, a medication that has been used for decades. The ’657 patent, which is a continuation of the ’876 patent, claims methods of treating various conditions, such as anaphylaxis and the induction maintenance of mydriasis during intraocular surgery, by administering pharmaceutical compositions comprising epinephrine. Before obtaining the patents-in-suit, Par’s predecessor, JHP Pharmaceuticals (“JHP”), applied for FDA approval of an epinephrine formulation it had marketed for over 100 years. During the FDA approval process, the FDA required JHP to meet strict impurity level requirements for Adrenalin to ensure that patients suffering from emergency anaphylaxis received a medication potent enough to save their lives. Initial FDA approval was therefore conditioned on JHP’s conducting post-marketing studies and committing to further reduce the impurity levels of Adrenalin. Par undertook the post-marketing commitment and successfully developed a new formulation of Adrenalin with significantly fewer impurities, and obtained the patents-in-suit. Par then submitted to the FDA supplemental NDAs reflecting its new formulation, which the FDA ultimately approved.

Luitpold filed a motion for judgment of non-infringement on the pleadings, arguing that Par’s amended complaint relied impermissibly on speculation that at some future time the FDA will require Luitpold to modify its ANDA formulation of generic epinephrine in such a way that it will infringe Par’s patents. Par responded that an ANDA case focuses solely on the product Luitpold intends to market and that Luitpold will have to amend its ANDA in order to obtain FDA approval. The court granted Luitpold’s motion.

Why Luitpold Prevailed:  Par’s argument that the court must look beyond the drug formulation specified in Luitpold’s ANDA is based primarily on the Federal Circuit’s language in Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562 (Fed. Cir. 1997), that the relevant inquiry in a patent infringement case under 35 U.S.C. § 271(e)(2) is the product “likely to be sold following FDA approval.” But the court found that Par took this quotation out of context. The ANDA itself dominates the infringement analysis. The Glaxo court stated, “Under § 271(e)(2)(A), a court must determine whether, if the drug were approved based upon the ANDA, the manufacture, use or sale of that drug would infringe the patent in the conventional sense.” (emphasis in original).

The court found that Luitpold’s ANDA formulation directly addressed the question of infringement and the parties even agreed that the current formulation of Luitpold’s generic epinephrine product, as described in the relevant ANDA, did not infringe the patents-in-suit. The court further found that Par’s argument against the entry of judgment for Luitpold at this stage was based entirely on speculation that the FDA would require Luitpold to adjust its product formulation in a way that would infringe the patents-in-suit. But this argument was premised on the mistaken belief that the Court could and should determine patent infringement by looking to drug formulations and ANDAs not yet in existence.

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