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. 5, No. 2

Summer 2015

Relevant court decisions highlighted in this issue:

  • Teva Pharms USA, Inc. v. Sandoz, Inc.
    Patent claim is indefinite when a patentee gives conflicting definitions of the term during prosecution.
  • Shire Development, LLC v. Watson Pharms., Inc.
    Claim construction relying solely upon the claims, specification, and file history is subject to de novo review despite the district court’s hearing expert testimony.
  • Novartis Pharms. Corp. v. Watson Labs., Inc.
    Appeals court affirms finding of non-obviousness as to one defendant given lack of proof evidencing motivation to combine relevant prior art references; and affirms finding of non-infringement as to second defendant because certain inactive ingredient is not a “antioxidant” as the claim requires.
  • Classen Immunotherapies, Inc. v. Elan Pharms., Inc.
    Activities related to the filing of an sNDA are exempt from infringement under 271(e)(1) safe harbor.

Relevant ANDA updates highlighted in this issue:

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

Oren D. Langer

Partner

Assistant Managing Partner, New York Office
Member of Executive Board

Ryan M. Schultz

Partner

Pronouns: he/him

Denying Otsuka’s request for an injunction because the defendant drug manufacturer’s products did not contain the pharmaceutical combination required by the claims of Otsuka’s patent.
The FDA may approve an ANDA, which carves out an indication protected by orphan drug exclusivity as long as the ANDA with that carved out label remained safe and effective for the remaining non-protected conditions of use.
Claims directed to incorporating gelling agents to combat potential drug abuse found infringed but invalid as obvious.
Claim construction relying solely upon the claims, specification, and file history is subject to de novo review despite the district court’s hearing expert testimony.
FDA’s approval of an ANDA carving out a specific indication was not overturned, even if the generic drug was in practice prescribed for the carved-out indication.
Vague product-labelling language, coupled with speculation about a physician’s medical practice, is not enough to show a likelihood of success in proving induced infringement.
Patent claim is indefinite when a patentee gives conflicting definitions of the term during prosecution.
FDA’s decision to delay final approval of a related application during the three year exclusivity period was not arbitrary or capricious.
FDA’s decision not to award five-year exclusivity was set aside because of inconsistencies in construing the term “active ingredient.
50 percent reasonable royalty was proper; "entire market value" rule was inapplicable in this case; and no damages may be awarded on post-expiration sales during period of pediatric exclusivity.
To prove obviousness, only a reasonable expectation of success, not a guarantee, is needed.
Words of degree—i.e., “high,” “low,” “satisfactory” and “reliable”—found within a disputed claim term rendered that term invalid as indefinite.
Finding of infringement resulted from the finding that the proper approach to analyzing clinical trial safety data was to use a means statistical analysis, not a percentage analysis.
Activities related to the filing of an sNDA are exempt from infringement under 271(e)(1) safe harbor.
Claim for induced infringement dismissed when generic label contains proper carve-out language, and claim for contributory infringement remains when accused products—although used in non-infringing ways—are for the most part used in accordance with the patented method.
Specification providing a list of alternative compounds may form the basis for the disclosure-dedication rule to preclude a claim of infringement under the doctrine of equivalents.
Failure to demonstrate that one of skill would have a reasonable expectation of success for a proposed combination dooms an obviousness challenge.
Appeals court affirms finding of non-obviousness as to one defendant given lack of proof evidencing motivation to combine relevant prior art references; and affirms finding of non-infringement as to second defendant because certain inactive ingredient is not a “antioxidant” as the claim requires.

Vol. 5, No. 1

Spring 2015

Vol. 5, No. 3

Fall 2015

Vol. 5, No. 4

Winter 2015