Tag Archives: Hatch-Waxman

Federal Circuit Upholds One Claim Covering Combigan

Posted by Courtenay Brinckerhoff on 07 May 2013 Posted in 103; Federal Circuit Decisions

In Allergan, Inc. v. Sandoz, Inc., the Federal Circuit reversed the district court in part, finding that Allergan’s composition claims and most of its method claims are invalid as obvious, but upholding one method claim because it recites a non-obvious result. Some of the court’s reasoning in this opinion is troubling, and the non-obvious result may be difficult to extrapolate to other cases, but this case illustrates the value of including a variety of claims that focus on different aspects of the same invention.Continue reading this entry

Supreme Court To Hear AndroGel Reverse Payment Case

Posted by Courtenay Brinckerhoff on 10 January 2013 Posted in Supreme Court Decisions

The Supreme Court granted certiorari in Federal Trade Commission v. Watson Pharmaceuticals, Inc., to address whether and when “reverse payment” agreements made to settle ANDA litigation violate antitrust laws. The Supreme Court may decide whether such reverse payments should be evaluated under the “scope of the patent” test (which upholds most agreements) or the “quick look rule of reason” test (which is more likely to find an antitrust violation). Oral arguments are scheduled for March 25, 2013. Continue reading this entry

Federal Circuit Has Final Say In Caraco Prandin Case

Posted by Courtenay Brinckerhoff on 08 August 2012 Posted in Federal Circuit Decisions

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

Federal Circuit Upholds Declaratory Judgment Jurisdiction Over Subsequent ANDA Litigation

Posted by Courtenay Brinckerhoff on 15 May 2012 Posted in Federal Circuit Decisions; Myriad

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

Supreme Court Reverses Caraco, Finds Right To Challenge Orange Book Use Code

Posted by Courtenay Brinckerhoff on 24 April 2012 Posted in Supreme Court Decisions

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

Supreme Court To Hear Orange Book Listing Case

Posted by Courtenay Brinckerhoff on 26 June 2011 Posted in Supreme Court Decisions

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.

Continue reading this entry

The Federal Circuit Solidifies The Future For Subsequent ANDA Litigation

Posted by Courtenay Brinckerhoff on 12 October 2010 Posted in Federal Circuit Decisions

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.