Tag Archives: ANDA

Federal Circuit Upholds One Claim Covering Combigan

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 … Continue reading this entry

Federal Circuit Upholds Fentora Patents, But Affirms Non-Infringement

In Cephalon, Inc. v. Watson Pharmaceuticals, Inc., the Federal Circuit reversed the district court’s finding that two Orange Book-listed patents for Cephalon’s FENTORA® product were invalid, but affirmed the district court’s finding that Watson’s ANDA product would not infringe the patents. The Federal Circuit decision reviews the “undue experimentation” standard for lack of enablement, and … Continue reading this entry

Supreme Court To Hear AndroGel Reverse Payment Case

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 … Continue reading this entry

Federal Circuit Finds Treximet Patents Non-Obvious And Infringed

In Pozen, Inc. v. Par Pharmaceutical Inc., the Federal Circuit upheld the district court’s determination that the patents at issue were not invalid as obvious and were infringed by the subject Abbreviated New Drug Applications (ANDAs). Comparing this case to In re Droge, I cannot help but wonder how much the procedural posture impacted the … Continue reading this entry

Federal Circuit Uses Dependent Claims To Construe "Therapeutically Effective Amount"

In Alcon Research, Ltd. v. Apotex Inc., the Federal Circuit held that most claims of Alcon’s patent were obvious in view of prior art that suggested the use of the recited active agent to treat the recited condition, but not by the recited mechanism of action, because the prior art used a concentration of active … Continue reading this entry

Federal Circuit Has Final Say In Caraco Prandin Case

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 … Continue reading this entry

Federal Circuit Upholds Declaratory Judgment Jurisdiction Over Subsequent ANDA Litigation

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 … Continue reading this entry

Federal Circuit Clears Way For Generic Yasmin

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, … Continue reading this entry

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

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 … Continue reading this entry

Federal Circuit Draws Two Lines In Crestor ANDA Litigation

In AstraZeneca Pharmaceuticals LP v. Apotex Corp., the Federal Circuit held that the district court had jurisdiction over AstraZeneca’s ANDA complaint, but also held that the complaint should be dismissed for failing to state a viable claim for relief because the ANDAs included Section viii statements that carved out the methods claimed in the patents … Continue reading this entry

Supreme Court To Hear Orange Book Listing Case

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 … Continue reading this entry

When Words Matter: Drug Labels vs. Kit Labels

The Federal Circuit decision in AstraZeneca LP v. Apotex, Inc. reveals an interesting dichotomy in the role of printed material in pharmaceutical patent disputes. On the one hand, the court found that proposed labeling for Apotex’s drug product supported a claim of induced infringement, while on the other it confirmed that the labeling included in AstraZeneca’s kit … Continue reading this entry

The Federal Circuit Solidifies The Future For Subsequent ANDA Litigation

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 … Continue reading this entry