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. 4

Winter 2016

Relevant court decisions highlighted in this issue:

  • Roxane Labs., Inc. v. Camber Pharms. Inc.
    In view of Plaintiff’s prosecution arguments, including one of the inventor’s declarations, the district court’s claim construction was affirmed as was its final judgment of non-infringement; transfer of venue was proper and the district court did not abuse its discretion in so holding.
  • Endo Pharms. Inc. v. Actavis Labs. UT, Inc.
    Obviousness finding was appropriate where there were unpredictable results with each possible proposed combination.
  • Bayer Pharma AG v. Watson Labs., Inc.
    After a ruling of patent validity and infringement, the court did not impose a permanent injunction where patentee, given its highly speculative arguments of a premature ANDA product launch, failed to show irreparable harm and lack of an adequate remedy at law.

Relevant ANDA updates highlighted in this issue:

  • ANDA Approvals
  • ANDA Litigation Settlements
  • Generic Launches
  • New ANDA Cases
Plaintiffs met their burden of proof in showing that defendants’ drug particles are embedded in sufficient polymer particles for the resulting formulation to be described as drug particles “covered by” or “surrounded” in line with the court’s claim construction.
After a ruling of patent validity and infringement, the court did not impose a permanent injunction where patentee, given its highly speculative arguments of a premature ANDA product launch, failed to show irreparable harm and lack of an adequate remedy at law.
Obviousness finding was appropriate where there were unpredictable results with each possible proposed combination.
The two prior-art references relied on by Defendants to prove obviousness did not give a POSA a reasonable expectation of success at making the claimed invention; and Teva’s implied license defense was rejected by the court.
Because a first patent directed to a stable ertapenem composition and a method of stabilizing ertapenem was found valid and infringed, a second patent directed to the creation of the carbamate adduct of ertapenem using routine techniques was invalid as obvious: it contained no inventive concept that was not disclosed in the other patent.
Testing expired samples and conducting “uncontrolled experiments” on non-expired samples lead to a finding of non-infringement.
After a showing of a likelihood of success on the merits and irreparable harm, plaintiff was granted a preliminary injunction preventing defendants from importing isosulfan blue into the US.
While the product patent-in-suit was found to be invalid as obvious, the process patent improving bioavailability of buprenorphine was held valid and infringed.
In view of Plaintiff’s prosecution arguments, including one of the inventor’s declarations, the district court’s claim construction was affirmed as was its final judgment of non-infringement; transfer of venue was proper and the district court did not abuse its discretion in so holding.
Listing Orange-Book patents is not a tortious act as it is required by law, therefore, no specific jurisdiction exists under Ohio’s long-arm statute.

Vol. 6, No. 1

Spring 2016

Vol. 6, No. 2

Summer 2016

Vol. 6, No. 3

Fall 2016