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 Spring 2020

The Spring 2020 issue of GENERICally Speaking 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:

  • Galderma Labs., L.P. v. Amneal Pharms. LLC
  • Boehringer Ingelheim Pharms. Inc. v. Mylan Pharms. Inc.
  • Galderma Labs., L.P. v. Teva Pharms. USA, Inc.

Relevant ANDA Updates highlighted in this issue:

  • ANDA Approvals
  • ANDA Litigation Settlements
  • Generic Launches
  • New ANDA Cases
Defendant did not infringe the patent-in-suit under the doctrine of equivalents, and proffered clear and convincing evidence that the patent-in-suit was invalid as obvious because it named an improper inventor, and unenforceable due to the inequitable conduct of defendant’s chief scientific officer.
Although defendants were found to induce infringement of the asserted method claims in the patents-in-suit, those claims were invalid as obvious.
The Federal Circuit affirmed an infringement finding on one set of patents-in-suit and reversed an infringement finding on another.
Because a method of treating a specific disease for specific patients using a specific compound at specific doses to achieve a specific outcome qualifies as patentable subject matter, the district court’s judgment finding otherwise was reversed.
Once the first-filer ANDA applicant launched its product, it could no longer forfeit its 180-day exclusivity, thereby rendering the subsequent ANDA filer Plaintiff’s declaratory-judgment claim moot.
Because a skilled artisan would not have had a reasonable expectation of success in modifying the prior art to come up with the claimed invention, neither of defendants’ affirmative defenses could overcome their burden to prove invalidity.
The appellate court reversed and remanded the district court’s finding that the asserted claims are invalid as anticipated.
Because Takeda could not show a likelihood of success on the merits or that it would suffer irreparable harm, the court denied its motion for a preliminary injunction.
The appellate court found no clear error in the lower court’s factual findings related to obviousness, and affirmed.
Because plaintiff’s patent rights were limited to the “active ingredient” in its FDA-approved product at the time of administration, before the product is consumed by a human patient, PTE did not apply and the court granted defendant’s motion to dismiss.
Following a bench trial finding that two defendants did not infringe and one defendant infringed the patent-in-suit, the Federal Circuit modified the judgment so that one defendant did not infringe and two defendants infringed the patent-in-suit.

GENERICally Speaking Winter 2020

Winter 2020