On July 30, 2012 the Federal Circuit issued what should be its final decision in the litigation between Caraco Pharmaceutical Labs. and Novo Nordisk A/S surrounding Caraco’s generic version of Novo Nordisk’s Prandin® repaglinide product. Earlier this year the Supreme Court held that 21 USC § 355(j)(5)(C)(ii)(I) provides Caraco with a mechanism for challenging the use code associated with Novo Nordisk’s Orange Book listed patent. In this appeal, Novo Nordisk challenged the district court’s injunction requiring Novo Nordisk to replace the use code with specific language. In this decision, the Federal Circuit modified that injunction to give Novo Nordisk some discretion in drafting the use code language. Continue reading this entry
In Dey Pharma, LP v. Sunovion Pharmaceuticals, Inc., the Federal Circuit affirmed the district court’s determination that it could exercise jurisdiction over a declaratory judgment action brought by a subsequent ANDA filer. This case follows earlier decisions in Teva Pharmaceuticals USA, Inc. v. Eisai Co., Ltd., Caraco Pharmaceutical Laboratories, Ltd. v. Forest Laboratories, Inc. and Janssen Pharmaceutica, N.V. v. Apotex, Inc., which I discussed in this article, and addresses the circumstances under which a subsequent ANDA filer can bring a declaratory judgment action to challenge Orange Book listed patents when the first ANDA filer has not yet entered the market.Continue reading this entry
In Bayer Schering Pharma AG v. Lupin, Ltd., the Federal Circuit upheld the district court’s determination that the Abbreviated New Drug Applications at issue did not infringe the asserted patent related to Yasmin. In particular, the Federal Circuit agreed that the FDA had not approved Yasmin for the method of use claimed in the patent, and so filing the ANDAs could not amount to infringement of the patent.
While this case is similar to Caraco Pharmaceutical Labs., Ltd. v. Novo Nordisk A/S, in that it relates to a method of use patent in the ANDA framework, it raises different issues than those decided by the Supreme Court a day after this Federal Circuit decision was issued. (Please see this article for a discussion of Caraco.)
On April 17, 2012 the Supreme Court issued a unanimous decision in Caraco Pharmaceutical Labs., Ltd. v. Novo Nordisk A/S, reversing the Federal Circuit decision and finding that 21 USC § 355(j)(5)(C)(ii)(I) provides a mechanism for a generic drug manufacturer to challenge the accuracy of a use code associated with an Orange Book listed patent. This decision may permit generic manufacturers to obtain earlier FDA approval for certain generic drugs, but may not solve all of the problems that can arise from an overly broad use code. Continue reading this entry
This week the Supreme Court will hear oral arguments in two cases that are important to the pharmaceutical industry: (i) Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S and (ii) Mayo Collaborative Services v. Prometheus Laboratories, Inc. Continue reading this entry
On June 27, 2011, the Supreme Court granted certiorari in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S. This means that the Court will review the Federal Circuit decision which held that the ANDA litigation counterclaim provision of the Hatch-Waxman Act does not permit a counterclaim to challenge a method patent listing when the listed patent claims at least one approved method of using the drug, and does not permit a challenge of a use code narrative on the basis that it is broader than the relevant patent claims.
In Teva Pharmaceuticals USA, Inc. v. Eisai Co., Ltd., the Federal Circuit addressed complicated subject matter jurisdiction issues in the context of a declaratory judgment (DJ) action that was brought in accordance with the Hatch-Waxman Act by a subsequent ANDA filer. The court determined that the DJ action should proceed, even though the patent owner could not have brought an infringement action to enforce the challenged patents. The court’s decision may encourage DJ actions by other subsequent ANDA filers, with the potential to hasten the market entry of more generic drug products.