Tagged: ANDA

The United States Patent Trial and Appeal Board (“PTAB”) recently interpreted what constitutes a “trigger” under 35 U.S.C. § 315(b). The PTAB concluded that under the statute, a “complaint alleging infringement of the patent” does not include arbitration proceedings. Amkor Tech., Inc. (“Amkor”) and Tessera, Inc. (“Tessera”) executed a license agreement in 1996 (“Agreement”) under which Amkor had rights to use Tessera technology covered by U.S. Patent No. 6,046,076 (“the ‘076 patent”) in exchange for the payment of royalties. In 2009, a dispute arose regarding the payment of royalties under the Agreement. Amkor availed itself to the arbitration provision in the Agreement and initiated an arbitration proceeding seeking declaratory relief that it was fully compliant with the terms of the Agreement. In its answer to Amkor’s arbitration request, Tessera included counterclaims for patent infringement. In July 2012, the arbitration tribunal found that Amkor did fail to pay royalties on certain products covered by claims of the ‘076 patent.

Ranbaxy Laboratories, Ltd. (“Ranbaxy”) and Vertex Pharmaceutical, Inc. (“Vertex”) recently settled an inter partes review (“IPR”) proceeding regarding Vertex’s U.S. Patent No. 6,436,989 (“the ‘989 Patent”). Vertex had listed the ‘989 Patent in the FDA’s published Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the Orange Book, as covering its HIV drug, Lexiva®. The significance of this event is the rarity of the use of IPR on patents typically challenged under the Hatch-Waxman framework. Recent statistics show that the majority of IPR have involved electrical/computer patents. Less than 6% of IPRs have been directed to biotechnology/pharmaceutical patents. The likely reason for the limited use of IPR on pharmaceutical patents, particularly those listed in the Orange Book, is the estoppel provisions of the IPR proceedings. See 35 U.S.C. §§ 315(e).

Last week, the Federal Circuit, in Sunovion Pharm. v. Teva Pharm. USA, et al., addressed the appropriate infringement analysis in the context of Hatch-Waxman (aka “ANDA”) litigation. It held: Although no traditional patent infringement [occurs] until a patented product is made, used, or sold, under the Hatch-Waxman framework, the filing of an ANDA itself constitutes a technical infringement for jurisdictional purposes. But the ultimate infringement question is determined by traditional patent law principles and, if a product that an ANDA applicant is asking the FDA to approve for sale falls within the scope of an issued patent, a judgment of infringement must necessarily ensue.