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Tag Archives: ANDA

Federal Circuit Upholds One Claim Covering Combigan

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

Federal Circuit Upholds Fentora Patents, But Affirms Non-Infringement

Posted in Enablement; Federal Circuit Decisions

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 underscores the importance of aligning evidence of infringement with the governing claim construction.Continue reading this entry

Supreme Court To Hear AndroGel Reverse Payment Case

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 Finds Treximet Patents Non-Obvious And Infringed

Posted in 103; Doctrine of Equivalents; Federal Circuit Decisions

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 Federal Circuit’s decisions. While the court reached opposite determinations as to obviousness, in each case it affirmed the decision on appeal. Continue reading this entry

Federal Circuit Uses Dependent Claims To Construe “Therapeutically Effective Amount”

Posted in 103; Claim Construction; Federal Circuit Decisions

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 agent that overlapped with the concentration recited in several dependent claims. Two claims that recited a specific concentration outside the range disclosed in the prior art and used in Alcon’s commercial product were upheld, due in part to the evidence of commercial success.

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Federal Circuit Has Final Say In Caraco Prandin Case

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 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

Federal Circuit Clears Way For Generic Yasmin

Posted in Federal Circuit Decisions

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.)

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

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

Federal Circuit Draws Two Lines In Crestor ANDA Litigation

Posted in Federal Circuit Decisions; Infringement

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 at issue. Continue reading this entry

Supreme Court To Hear Orange Book Listing Case

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.

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When Words Matter: Drug Labels vs. Kit Labels

Posted in Federal Circuit Decisions

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 claims are not given patentable weight when assessing validity.

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The Federal Circuit Solidifies The Future For Subsequent ANDA Litigation

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.

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