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. 9, No. 2

Summer 2019

The Summer 2019 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:

  • UCB, Inc. v. Watson Labs. Inc.
    The appellate court affirmed the lower court’s decision that one of the patents-in-suit was valid and infringed under the doctrine of equivalents and that the other patent-in-suit was invalid on the basis of anticipation.
  • Nuvo Pharms. (Ir.) Designated Activity Co. v. Dr. Reddy’s Labs. Inc.
    Judgment of validity was reversed because the patent specification did not demonstrate that the inventor possessed more than a mere wish or hope of his claimed invention.
  • BTG Int’l Ltd. v. Amneal Pharms. LLC
    The Federal Circuit affirmed the PTAB and district court’s finding of obviousness because the prior art showed, both together and individually, that abiraterone and prednisone were considered promising prostate cancer treatments.

Relevant ANDA Updates highlighted in this issue:

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

Oren D. Langer

Partner

Assistant Managing Partner, New York Office
Member of Executive Board

After plaintiff was able to persuade the court that it was likely to succeed on the merits, suffer irreparable harm, and that the balance of harms and public interest favored the relief sought, the court preliminarily enjoined defendants from launching at risk their generic products.
The appellate court affirmed the lower court’s decision that one of the patents-in-suit was valid and infringed under the doctrine of equivalents and that the other patent-in-suit was invalid on the basis of anticipation.
Relying primarily on the intrinsic record, the the court construed “about” to mean “approximately” and found that a single ingredient could not satisfy two claimed functional limitations.
Motion to dismiss granted when, under the patent venue statute, defendant did not reside in the venue and did not have a regular and established place of business in the venue.
Judgment of validity was reversed because the patent specification did not demonstrate that the inventor possessed more than a mere wish or hope of his claimed invention.
The Federal Circuit affirmed the PTAB and district court’s finding of obviousness because the prior art showed, both together and individually, that abiraterone and prednisone were considered promising prostate cancer treatments.
Finding that a POSA would not have had a reasonable expectation of success at coming up with the claimed invention given the disclosure of the prior art, the Federal Circuit affirmed the district court’s finding of non-obviousness.
The disclosure-dedication doctrine barred Plaintiff from advancing its infringement claim based on the doctrine of equivalents.
The Federal Circuit affirmed the district court’s obviousness finding when defendant was unable to establish a motivation to combine the prior art references and could not establish a POSA’s reasonable expectation of success.
Relying solely on its finding that defendant could not show a likelihood of success on the merits, the court denied defendant’s motion for a preliminary injunction enjoining plaintiff from its at-risk launch, even when all other factors favored injunctive relief.
Although the court had personal jurisdiction over defendant, venue was improper in the Eastern District of Texas.
Although the court may exercise personal jurisdiction over defendant, it lacked subject matter jurisdiction over plaintiff’s declaratory judgment action at the time the complaint was filed.

Vol. 8, No. 4

Winter 2019

Vol. 9, No. 1

Spring 2019

Vol. 9, No. 3

Fall 2019