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.

GENERICally Speaking Winter 2020

Winter 2020

The Winter 2020 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.

A few of the relevant court decisions highlighted in this issue:

  • Persion Pharms. LLC v. Alvogen Malta Operations Ltd.
  • HZNP Medicines LLC v. Actavis Labs. UT, Inc.
  • Horizon Meds. LLC v. Dr. Reddy’s Labs., Inc.

Relevant ANDA Updates highlighted in this issue:

  • ANDA Approvals
  • ANDA Litigation Settlements
  • Generic Launches
  • New ANDA Cases

Oren D. Langer


Managing Partner, New York Office
Member of Executive Board

The Federal Circuit affirmed the district court’s obviousness determination, holding that the district court correctly applied the law of inherency and did not clearly err in its factual findings relating to obviousness and objective indicia.
After a five-day jury trial finding non-infringement, Plaintiff’s Rule 59(e) motion for a new trial was denied.
Summary judgment of no contributory infringement granted but denied with respect to induced infringement.
While its decision was a “close call,” the court was not prepared to find that plaintiff’s tactics entirely baseless or its litigation conduct so egregious as to warrant fees.
Relying on a Federal Circuit decision that invalidated for lacking an adequate written description a patent from which the patents-in-suit descend, the court denied plaintiff’s motion for a preliminary injunction for failing to show a likelihood of success on the merits.
Because Delaware was an improper venue for defendant Mylan, and defendant 3M demonstrated that various factors weighed in favor of a transfer, the case was transferred to the Northern District of West Virginia.
The district court’s findings regarding indefiniteness, non-infringement, and non-obviousness were affirmed by the appellate court.

GENERICally Speaking Spring 2020

Spring 2020

GENERICally Speaking Summer 2020

Summer 2020

GENERICally Speaking Fall 2020

Fall 2020