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. 2

Summer 2016

Relevant court decisions highlighted in this issue:

  • Spectrum Pharms., Inc. v. Burwell
    DC Circuit affirms district court’s summary judgment that the FDA’s ANDA approval for one indication was proper even though branded company enjoyed exclusivity on same product for treatment of another indication.
  • Intendis GMBH et al. v. Glenmark Pharms. Inc., USA
    Affirming district court’s application of the doctrine of equivalents, in part, on the basis of Defendants’ representations to the FDA in their ANDA.
  • Merck & Cie v. Watson Labs., Inc.
    Because a fax containing essential price, delivery, and payment terms to sell the covered product was a premature commercial exploitation of the claimed invention, the asserted claim was invalid under the on-sale bar.

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

Specific jurisdiction is present in any state where the generic manufacture may sell its ANDA product after FDA approval.
A proposed combination will not render a patent obvious wherein the proposed combination improperly relies on hindsight.
A proposed combination will not render a patent obvious wherein the proposed combination includes changing the core structure of the lead compound.
Plaintiff is awarded injunctive relief following analysis of the eBay factors, but said relief cannot be awarded under § 271(e)(4)(A) because the patents-in-suit issued after Defendants’ ANDAs were filed.
Dismissal of “artificial” § 271(e)(2)(A) claim is warranted when patent holder can bring actual infringement claims against Defendants under § 271(a).
Validity of patent-in-suit upheld in light of art determined to be non-analogous by patent examiner.
Applying the Federal Circuit’s recent decision in Acorda Therapeutics, the court denied defendants’ motion to dismiss on grounds of lack of personal jurisdiction, and also denied defendants’ Rule 12(b)(6) motion because § 271(e)(2) does not explicitly require an entity to sign the ANDA in order for it to be a properly-named defendant.
The asserted claims of the patents-in-suit were not obvious because a POSA would not have been motivated to improve the prior art in line with the inventions claimed.
Affirming district court’s application of the doctrine of equivalents, in part, on the basis of Defendants’ representations to the FDA in their ANDA.
Because a fax containing essential price, delivery, and payment terms to sell the covered product was a premature commercial exploitation of the claimed invention, the asserted claim was invalid under the on-sale bar.
Allowing certification for appeal of patent with severable invention from remaining patents in suit.
Post-hoc expert conclusions were not sufficient to contradict prior-art publications relating to obviousness.
One of Plaintiffs’ patents was valid and infringed while the remaining patents-in-suit were either invalid or not infringed.
DC Circuit affirms district court’s summary judgment that the FDA’s ANDA approval for one indication was proper even though branded company enjoyed exclusivity on same product for treatment of another indication.
A product label that does not encourage direct infringement cannot be the basis for an induced infringement claim.

Vol. 6, No. 1

Spring 2016

Vol. 6, No. 3

Fall 2016

Vol. 6, No. 4

Winter 2016