GENERICally Speaking Hatch Waxman Bulletin

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.

Vol. 7, No. 3

Fall 2017

Relevant court decisions highlighted in this issue:

  • 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.
  • ANDA Approvals
  • ANDA Litigation Settlements
  • Generic Launches
  • New ANDA Cases

Oren D. Langer

Partner

Managing Partner, New York Office
Member of Executive Board

Ryan M. Schultz

Partner

Pronouns: he/him

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.
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.
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.
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.
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.
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.
Because the prior art did not explicitly or inherently disclose the claimed polymorphs, the court found the patent-in-suit valid and infringed.
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.
Because plaintiff was able to swear behind a 102(a) and 102(e) reference, defendants’ anticipation and obviousness arguments were rejected.
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.
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.
In view of its claim construction and expert credibility findings, the Court found generic manufacturers’ proposed products did not infringe the patents-in-suit.
The court applied the dedicated disclosure rule to find no infringement.
Because the prior-art disclosure would lead one of skill to the purported invention, the asserted claims were found invalid as obvious.

Vol. 7, No. 1

Spring 2017

Vol. 7, No. 2

Summer 2017

Vol. 7, No. 4

Winter 2017