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GENERICally Speaking - Vol. 7, No. 3

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

  • Millennium Pharms., Inc. v. Sandoz Inc.
    In reversing the district court’s finding of obviousness, the Federal Circuit found flaws in the district court’s lead-compound analysis and its dismissal of objective indicia of non-obviousness.
  • Merck Sharp & Dohme Corp. v. Actavis Labs. Fl, Inc.
    Because plaintiff was able to swear behind a 102(a) and 102(e) reference, defendants’ anticipation and obviousness arguments were rejected.
  • Kowa Co. Ltd. v. Amneal Pharms. LLC
    Because the prior art did not explicitly or inherently disclose the claimed polymorphs, the court found the patent-in-suit valid and infringed.
  • Bristol-Myers Squibb Co. v. Mylan Pharms., Inc.
    Because defendant is part of a corporate family that includes approximately forty Delaware entities, has regularly litigated in the District, targeted at least some Delaware physicians, consistent with its having an integrated distribution network for all its generic products, the court cannot say that defendant does not have a regular and established place of business in Delaware.
  • Mallinckrodt Hosp. Prods. IP Ltd. v. Praxair Distrib., Inc.
    Asserted claims were not patentable because they claimed natural phenomena without containing any inventive concept sufficient to transform the claimed phenomena of nature into a patent-eligible application.
  • Tris Pharma, Inc. v. Actavis Labs. FL, Inc.
    Because the prior-art disclosure would lead one of skill to the purported invention, the asserted claims were found invalid as obvious.
  • Reckitt Benckiser Pharms., Inc. v. Dr. Reddy’s Labs. S.A.
    The court applied the dedicated disclosure rule to find no infringement.
  • Allergan Sales, LLC v. Teva Pharms. USA, Inc.
    Generic company’s original ANDA, though amended, provided subject-matter jurisdiction for patent litigation, and its recertification under PIV did nothing to change that, particularly when the reformulated product was not significantly different from the original product.
  • Allergan, Inc. v. Teva Pharms. USA, Inc.
    Failing to find a likelihood of success, urgency, or irreparable harm, the court denied plaintiff’s request that defendants provide notice of a potential at-risk launch.
  • Reckitt Benckiser LLC v. Amneal Pharms. LLC
    In view of its claim construction and expert credibility findings, the Court found generic manufacturers’ proposed products did not infringe the patents-in-suit.
  • Supernus Pharms., Inc. v. TWi Pharms., Inc.
    In view of court’s claim construction, patents relating to formulation and administration of oxcarbazepine were valid and infringed.
  • Pfizer Inc. v. Mylan Pharms. Inc.
    Defendants’ lead-compound analysis failed to persuade the court that the patents-in-suit were invalid, and even had that argument been successful, the court found that Defendant did not establish that modifying the lead compound to the claimed prodrug would have been obvious.
  • Ferring Pharms. Inc. v. Par Pharm., Inc.
    The court found Plaintiff’s expert’s qualifications were more closely aligned with the technology at issue in the case, and credited his testimony in finding that Defendant’s ANDA product infringed the asserted claims.
  • Horizon Pharma, Inc. v. Dr. Reddy’s Labs., Inc.
    Given two critical differences between the invention and the prior art, the claims of the patents-in-suit were not obvious; they were adequately described, and were infringed.
  • In re Sebela Patent Litigation
    One of the patents-in-suit was not infringed because the IR spectrum of the generic product did not include each claimed peak, and the remaining patents-in-suit were invalid as obvious.

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.