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GENERICally Speaking - Vol. 9, No. 2

The Hatch-Waxman Litigation practice group at Robins Kaplan LLP is pleased to offer the latest edition of their 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

  • UCB, Inc. v. Watson Labs. Inc.
    The appellate court affirmed the lower court’s decision that one of the patents-in-suit was valid and infringed under the doctrine of equivalents and that the other patent-in-suit was invalid on the basis of anticipation.
  • Nuvo Pharms. (Ir.) Designated Activity Co. v. Dr. Reddy’s Labs. Inc.
    Judgment of validity was reversed because the patent specification did not demonstrate that the inventor possessed more than a mere wish or hope of his claimed invention.
  • BTG Int’l Ltd. v. Amneal Pharms. LLC
    The Federal Circuit affirmed the PTAB and district court’s finding of obviousness because the prior art showed, both together and individually, that abiraterone and prednisone were considered promising prostate cancer treatments.
  • Novartis Pharma Co. v. West-Ward Pharms. Int’l
    Finding that a POSA would not have had a reasonable expectation of success at coming up with the claimed invention given the disclosure of the prior art, the Federal Circuit affirmed the district court’s finding of non-obviousness.
  • Endo Pharm., Inc. v. Actavis LLC
    The Federal Circuit affirmed the district court’s obviousness finding when defendant was unable to establish a motivation to combine the prior art references and could not establish a POSA’s reasonable expectation of success.
  • Novartis Pharms. Corp. v. Accord Healthcare Inc.
    Motion to dismiss granted when, under the patent venue statute, defendant did not reside in the venue and did not have a regular and established place of business in the venue.
  • Sun Pharm. Indus. v. Saptalis Pharm., LLC
    Relying primarily on the intrinsic record, the the court construed “about” to mean “approximately” and found that a single ingredient could not satisfy two claimed functional limitations.
  • Novartis Pharms. Corp. v. Accord Healthcare Inc.
    After plaintiff was able to persuade the court that it was likely to succeed on the merits, suffer irreparable harm, and that the balance of harms and public interest favored the relief sought, the court preliminarily enjoined defendants from launching at risk their generic products.
  • Eagle Pharms., Inc. v. Slayback Pharma, LLC
    The disclosure-dedication doctrine barred Plaintiff from advancing its infringement claim based on the doctrine of equivalents.
  • Cipla Ltd. v. Amgen Inc.
    Relying solely on its finding that defendant could not show a likelihood of success on the merits, the court denied defendant’s motion for a preliminary injunction enjoining plaintiff from its at-risk launch, even when all other factors favored injunctive relief.
  • Apicore US LLC v. Beloteca, Inc.
    Although the court had personal jurisdiction over defendant, venue was improper in the Eastern District of Texas.
  • Beloteca, Inc. v. Apicore US LLC
    Although the court may exercise personal jurisdiction over defendant, it lacked subject matter jurisdiction over plaintiff’s declaratory judgment action at the time the complaint was filed.

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.