GENERICally Speaking - Vol. 3, No. 1

The Hatch-Waxman Litigation practice group at Robins Kaplan LLP is pleased to offer the latest edition of its quarterly publication regarding ANDA patent litigation issues and the generics business, GENERICally Speaking: A Hatch-Waxman Litigation Bulletin.

Taking on an ANDA patent litigation requires significant corporate resources, time, and money. Staying on top of industry news and outcomes, following trends in the judiciary and the steps others are taking, and keeping informed of recently-enacted rules and legislation are critical.

This bulletin provides you and your company with some of the knowledge beneficial to remaining attentive to the complexity of ANDA patent litigation. We hope you find it helpful.

Relevant Court Decisions

  • Cephalon, Inc. v. Watson Pharma., Inc.(Fed.Cir.)
    Judgment of non-infringement affirmed when claim required accused products to be “saliva activated” and patent holder tested them in water; judgment of non-enablement reversed because the fact that some experimentation is necessary does not render a patent not enabled.
  • In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation
    Affirming entry of preliminary injunction and construing a settlement agreement.
  • Allergan, Inc. v. Barr Lab., Inc.
    In a bench trial, the Court, acting as the finder of fact, is free to ignore the testimony of an expert it has determined lack credibility.
  • Cephalon, Inc. v. Watson Pharma., Inc. (D.Del.)
    When prior art preparation does not necessarily result in claimed composition, asserted claims are not inherently anticipated; because polymorphs are unpredictable a skilled artisan would not have had a reasonable expectation of success in formulating most stable form of claimed composition.
  • Shire Development LLC. v. Watson Pharma., Inc.
    Plaintiff’s summary judgment motion that its patent was not invalid for lack of written description and lack of enablement, and defendant’s motion for summary judgment of non-infringement, were denied.
  • Merck Sharp & Dohme Corp. v. Sandoz Inc.
    Filing a paragraph IV certification is not required for a District Court to have subject matter jurisdiction over a claim of patent infringement; all that is required is the allegation of patent infringement.
  • Bristol-Myers Squibb Co. v. Teva Pharma. USA, Inc.
    Composition claim is invalid when the patented molecule was an obvious modification of a lead compound that existed in the prior art.
  • Senju Pharma. Co. Ltd. v. Apotex, Inc.
    Counterclaims are subject to the heightened pleading standards established in Iqbal and Twombly; affirmative defenses are not.
  • Pfizer Inc. v. Watson Pharma., Inc.
    Court rejects claims of obviousness, lack of written description, and derivation, and finds patent valid.
  • Allergan, Inc. v. Apotex, Inc.
    Patents-in-suit relating to the “unpredictable and mysterious” art of hair growth were infringed and enforceable.
  • Braintree Labs., Inc. v. Novel Labs., Inc.
    Finding that the administration of half a dose was not off-label use, and fell within the claimed limitations, court granted summary judgment of infringement; finding that genuine issues of material fact existed concerning obviousness, the court denied summary judgment of invalidity; finding that unfair competition and false marking are “beyond” the Hatch-Waxman Act, the court granted summary judgment dismissing those counterclaims.
  • Sunovion Pharma. Inc. v. Teva Pharma. USA, Inc.
    Summary judgment of non-infringement granted when generic manufacturer presents evidence of FDA submissions showing that its generic product is “essentially free” of the claimed isomer.
  • In re Fenofibrate Patent Litig.
    4.71/1 does not fall “between 5/1 and 15/1,” particularly when the range was limited during prosecution to avoid prior art.

The articles on our Website include some of the publications and papers authored by our attorneys, both before and after they joined our firm. The content of these articles should not be taken as legal advice.