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. 2

Summer 2017

Relevant court decisions highlighted in this issue:

  • Mylan Institutional LLC v. Aurobindo Pharma Ltd.
    District court improperly applied the “function, way, result” test in granting a preliminary injunction concerning process patents, but properly evaluated obviousness and irreparable harm for a purity patent.
  • Braintree Labs., Inc. v. Breckenridge Pharm., Inc.
    Affirming previous claim construction in related case, the district court erred in finding that proposed label would not induce physicians to practice the claimed method.
  • Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc.
    A sale that is conditioned on FDA approval is still a sale for the purposes of the on-sale bar and the AIA’s amendments to the on-sale bar did not change its scope with regards to public disclosure.

Relevant ANDA updates highlighted in this issue:

  • 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

Motion for judgment on the pleadings was denied where claim construction and expert discovery was necessary to decide the issue of non-infringement.
Affirming previous claim construction in related case, the district court erred in finding that proposed label would not induce physicians to practice the claimed method.
Because the word “excitation” in the claim does not include within its scope “mania,” the patent-in-suit, which is not obvious and meets all the requirements of Section 112, is not infringed.
Because plaintiffs may rely on circumstantial evidence to prove intent related to their inducement claim, the court recommended denial of defendants’ motion for summary judgment.
A sale that is conditioned on FDA approval is still a sale for the purposes of the on-sale bar and the AIA’s amendments to the on-sale bar did not change its scope with regards to public disclosure.
The formulation of Pennsaid 2% was not a result of routine optimization of the formulation of Pennsaid 1.5%, therefore the claims were not obvious.
District court improperly applied the “function, way, result” test in granting a preliminary injunction concerning process patents, but properly evaluated obviousness and irreparable harm for a purity patent.
Allegations of infringement about a would-be formulation and seeking discovery about highly confidential, competitive information concerning that would-be formulation necessitated an exceptional case finding and an award of fees and costs.
Finding of non-infringement is warranted where 18 peaks, each identified by wavenumber, are claimed but only 17 peaks are found in the accused product; asserted method claims are held invalid as obvious when all the claimed limitations are within the prior art and secondary considerations mostly weigh in favor of obviousness.
Transfer was appropriate when there was pending litigation in another district involving the same patent and parties.
Because the “efficient mixing” term was a claim limitation in both patents-in-suit, the district court’s finding of infringement with respect to one of those patents was reversed.
The Federal Circuit’s decision on the issue of infringement precludes a trial on remand as to the doctrine of equivalents.

Vol. 7, No. 1

Spring 2017

Vol. 7, No. 3

Fall 2017

Vol. 7, No. 4

Winter 2017