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. 6, No. 3

Fall 2016

Relevant court decisions highlighted in this issue:

  • The Medicines Co. v. Hospira, Inc.
    On-sale bar is not triggered by production of drug by third party, even if that drug is stockpiled and later sold.
  • Allergan Sales, LLC v. Sandoz, Inc.
    Issue and claim preclusion do not apply when (i) the court issues a new claim construction; and (ii) the defendant has engaged in a section viii carve out in its proposed ANDA label.
  • Classen Immunotherapies, Inc. v. Elan Pharms., Inc.
    Reanalyzing clinical data to identify patentable information and filing patent applications as well as making and selling a drug with a revised label reflecting the information derived from that clinical study falls into the § 271(e)(1) safe harbor provision and does not infringe as a matter of law.

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

Issue and claim preclusion do not apply when (i) the court issues a new claim construction; and (ii) the defendant has engaged in a section viii carve out in its proposed ANDA label.
Subsequent patent teaching a formulation of specific dosage amounts was not invalid for general or double-patenting obviousness when the specific dosages produced unexpected results contrary to the knowledge of one of ordinary skill at the time of patenting.
The FDA’s interpretation of the statutory language determining when an NDA is “initially submitted” is due deference, is reasonable, is consistent, and is not arbitrary or capricious.
Reanalyzing clinical data to identify patentable information and filing patent applications as well as making and selling a drug with a revised label reflecting the information derived from that clinical study falls into the § 271(e)(1) safe harbor provision and does not infringe as a matter of law.
Two of plaintiff’s patents relating to the formulation and application of axillary transdermal testosterone were invalid while a third patent was valid and infringed by one of the joint defendants.
FDA’s prior practice of refusing to grant five-year exclusivity to fixed-combination drug products containing a novel active drug substance was arbitrary and capricious.
A label that states that patients may use a dosing schedule that differs from the label’s proposed schedule does not create a defense to induced infringement.
Relying on the Federal Circuit’s likelihood-of-success standard for awarding preliminary injunctions, the district court preliminary enjoined defendants from infringing the patent-in-suit.
GSK adequately pled a claim of induced infringement alleging facts concerning ways in which Teva actively promoted its generic product and the content of Teva’s skinny label.
All of the proposed terms for construction are indefinite.
A patent is obvious in view of the knowledge of one of skill in the art to disclose the gaps not inherently disclosed in the primary reference.
A patent-term extension of a continuation does not violate 35 U.S.C. § 156 because a patentee can extend the term for one chosen patent.
Based on Defendants’ proposed ANDA labels, the court found Defendants liable for induced infringement; the claims were not invalid as obvious.
On-sale bar is not triggered by production of drug by third party, even if that drug is stockpiled and later sold.
Given the recent Supreme Court decisions concerning jurisdiction, general jurisdiction over branded drug company does not exist because branded company defends itself in prior litigation, and specific jurisdiction is not present when the branded drug company has limited contacts with the forum.
An exceptional case finding is not supported when there was a genuine issue regarding how to test to determine if a claim element is present.
After stipulating to infringement, the court addressed and rejected various arguments that the asserted claims were invalid.
The court rejected defendant’s obviousness defense, finding fault with its lead-compound analysis and probative evidence of secondary considerations of non-obviousness; the court also found the asserted claims infringed directly and by inducement, but found no contributory infringement.

Vol. 6, No. 1

Spring 2016

Vol. 6, No. 2

Summer 2016

Vol. 6, No. 4

Winter 2016