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. 3, No. 3

Fall 2013

The Fall 2013 issue of the GENERICally Speaking email campaign provides you and your company with some of the knowledge beneficial to remaining attentive to the complexity of ANDA patent litigation.

Relevant court decisions highlighted in this issue:

  • Sunovion Pharma., Inc. v. Teva Pharms. USA, Inc. (Fed. Cir. Sept. 26, 2013)
  • Pronova Biopharma Norge v. Teva Pharma. USA, Inc. (Fed. Cir. Sept. 12, 2013)
  • Teva Pharma. USA, Inc. v. Sandoz, Inc. (Fed. Cir. July 26, 2013)

Read more about these and other important court decisions, New ANDA Cases, ANDA Litigation Settlements, ANDA Approvals, and Generic Launches.

Oren D. Langer


Managing Partner, New York Office
Member of Executive Board

Ryan M. Schultz


Pronouns: he/him

"Egregious” misconduct on the part of the inventor—someone who is well versed in pharmaceutical formulations and the patent prosecution and enforcement processes—resulted in the Court’s finding of inequitable conduct, laches, and disclaimer.
After construing certain disputed claim terms, the court found the asserted claims infringed and not invalid.
Plaintiffs’ claim construction was adopted because defendants’ proposed construction attempted to read a limitation into the claim and defendants could not prove that a construction in a related case had preclusive effect; as a result, court granted summary judgment of infringement.
Reference Listed Drug, NDA Holder, Generic Drug Name, ANDA Applicant(s), Indication and Launch Date
Defendants failed to meet their burden in showing that the asserted claims were invalid for not meeting the written description requirement and non-enablement.
Because all of defendant’s activity fell under the safe harbor provision, it could not constitute patent infringement.
Based on its claim construction, the court denied defendant’s motion for summary judgment of non-infringement, and because the prior art failed to address the food effect that was the central innovation of the patent-in-suit, summary judgment of invalidity was denied.
Shipping samples that are covered by the patent-in-suit without a confidentiality agreement, without a limitation on usage, and to a skilled artisan that is able to ascertain the claimed elements, is a public use under § 102(b).
An action by the FDA during the pendency of the instant actions rendered claims of infringement and the counterclaims asserting non-infringement moot, and the court declined to exercise jurisdiction over counterclaims asserting invalidity.
Finding that defendants infringe claims 6, 12-16 and that claims 6, 12-16 of the patent-in-suit are invalid for obviousness.
Reversing district court decision of summary judgment of non-infringement and granting infringement as a matter of law.
Granting motion to dismiss because Defendants’ acts were protected by the safe harbor provision of §271(e)(1)
The term “molecular weight” is indefinite because the claims do not indicate which average molecular weight measure is intended, and two different methods were relied on during prosecution to argue against/avoid rejection.)

Vol. 3, No. 1

Spring 2013

Vol. 3, No. 2

Summer 2013

Vol. 3, No. 4

Winter 2013