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. 4, No. 4

Winter 2014

The Winter 2014 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:

  • Mylan Pharms., Inc. v. FDA
  • Sandoz Inc. v. Amgen Inc.
  • Par Pharm., Inc. v. TWI Pharms., Inc.

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

The FDA responded to the application by identifying various deficiencies.
The issue here concerns whether the Federal Circuit should conduct an en banc hearing regarding the issue of whether evidence that post-dates the effective filing date of the patent may be used to demonstrate unexpected results to defeat an obviousness challenge.
Cubist alleged that Hospira’s ANDA products infringe the asserted claims of the patents-in-suit. The court held a five-day bench trial.
Glenmark, who was not the first ANDA filer, was attempting to obtain FDA approval to market a generic version of drug claimed by the ’340 patent.
The issue here concerns whether the Hatch-Waxman Act requires ANDA applicants to certify as to both an original and a subsequent reissue patent.
Par sued TWi for infringing its patent related to the use of nanosized megestrol formulations to “increase the body mass in a human patient suffering from anorexia, cachexia, or loss of body mass.”
When a POSA would have to undertake significant guesswork to vary the parameters of prior-art compounds in order to formulate the claimed composition, and prior-art lead compounds taught away from the claimed composition, the court found the patents-in-suit not obvious.
The issue here is whether an alleged infringer can file declaratory judgment action seeking a finding of non-infringement and/or invalidity of patents when the alleged infringer has not filed an application with the FDA.
Because the ANDA product did not meet the claimed dosage strength, summary-judgment of non-infringement was granted; issues concerning invalidity were not amenable to summary judgment as disputes of material fact remained.
Hikma launched the accused product, Mitigare, an oral single-ingredient colchicine product indicated for prophylaxis of gout flares in adults.
Generic drug manufacturer was liable for patent infringement as a matter of law when the level of acceptable impurities described in the manufacturer’s ANDA included the range of acceptable impurities claimed in the patent, and its invalidity defenses—anticipation, obviousness, non-enablement, and inequitable conduct—were rejected by the court.
The issue here concerns whether the district court was correct in granting summary judgment in favor of the defendants, finding that the asserted claims of the patents-in-suit were invalid due to obviousness.
Reference Listed Drug, NDA Holder, Generic Drug Name, ANDA Applicant(s), Indication and Launch Date

Vol. 4, No. 1

Spring 2014

Vol. 4, No. 2

Summer 2014