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 Summer 2020

Summer 2020

The Summer 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:

  • Eagle Pharms. Inc. v. Slayback Pharma LLC
  • Biogen Int’l Gmbh v. Banner Life Sciences LLC
  • Valeant Pharms. Int’l, Inc. v. Mylan Pharms. Inc.

Relevant ANDA Updates highlighted in this issue:

505(b)(2) Applications and New Drug Applications
Reported settlements in federal district court cases
Drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications
Federal district court cases that are filed pursuant to the Hatch-Waxman Act
Converting from a PIV certification to a PIII certification does not rid the district court of subject matter jurisdiction, but it does warrant granting defendant’s motion for judgment on the pleadings.
Because a skilled artisan would have recognized the limitations of one prior-art reference and would have been motivated to select the teachings of another reference to overcome them, the patents-in-suit were obvious.
Because the proposed label of the ANDA product did not contemplate the claimed timeframe in the asserted patent for administering the drug, the court granted defendant’s motion for judgment of non-infringement on the pleadings.
Amending claims and adding inventor to claim new aspect of invention, without amending specification, results in judgment of invalidity for lack of written description.
Judgment of non-infringement on the pleadings affirmed when disclosure-dedication doctrine barred patent owner’s claims for infringement under the doctrine of equivalents.
Because a POSA would not have selected the prior-art compound as a “lead compound,” and there was evidence that the invention met an unmet need and overcame industry skepticism, defendant failed to prove that the patents-in-suit were obvious.
The court found that defendants had not met their clear-and-convincing burden of proving that formulation and method-of-treatments patents-in-suit were obvious.
Because defendant’s NDA product does not include any salt or ester of the active ingredient in Plaintiff’s reference drug, patent term extension did not apply and judgment of non-infringement was affirmed.
The court granted defendant’s motion to enforce its settlement agreement, finding that the agreement was not anticompetitive and in violation of antitrust law.
Because the prior art taught overlapping pH ranges and structurally similar compounds as those claimed in the patent-in-suit, the Federal Circuit reversed summary judgment of non-obviousness.
Subject-matter jurisdiction under the Hatch-Waxman Act does not require (i) a Paragraph IV certification by the ANDA holder; or (ii) the patents-in-suit to be listed in the Orange Book.

GENERICally Speaking Winter 2020

Winter 2020

GENERICally Speaking Spring 2020

Spring 2020