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. 1

Spring 2016

Relevant court decisions highlighted in this issue:

  • Acorda Therapeutics Inc. v. Mylan Pharms. Inc.
    The act of filing an ANDA, coupled with intent to market a generic drug in Delaware, was sufficient basis to establish specific personal jurisdiction in Delaware.
  • Warner Chilcott Co., LLC v. Teva Pharms. USA, Inc.
    One of skill in the art would be motivated to obtain the logical goal of a drug to have bioavailability that is affected by coadministration with food.
  • Purdue Pharma L.P. v. Epic Pharma, LLC
    In affirming judgment of invalidity, the Federal Circuit credited the district court’s findings concerning the disclosure of the prior art and the adequacy and reliability of Defendants’ expert’s testing results and methodology.
  • 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

The act of filing an ANDA, coupled with intent to market a generic drug in Delaware, was sufficient basis to establish specific personal jurisdiction in Delaware.
ANDA must be “received” by FDA for district court litigation to proceed.
All that was required to constitute standing by ANDA filer was to show that a patent’s listing constituted an independent barrier to entry into the drug market and that a judicial decision could remove that barrier.
Because the ANDA product does not satisfy the claimed volume limitation of the patent and the use claimed in the patent is not FDA-approved, the ANDA product does not infringe the patent-in-suit.
The district court applied the law of on-sale bar and the written description requirement to support findings that defendant did not meet its burden to show patent invalidity.
In affirming judgment of invalidity, the Federal Circuit credited the district court’s findings concerning the disclosure of the prior art and the adequacy and reliability of Defendants’ expert’s testing results and methodology.
Applying the Federal Circuit’s claim construction on remand, the district court found that Defendant’s’ ANDA product will infringe the asserted claims of the patent-in-suit.
Based on the court’s claim construction, two of the three patents-in-suit were found infringed, and all three were not invalid.
One of skill in the art would be motivated to obtain the logical goal of a drug to have bioavailability that is affected by coadministration with food.

Vol. 6, No. 2

Summer 2016

Vol. 6, No. 3

Fall 2016

Vol. 6, No. 4

Winter 2016