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. 8, No. 3

Fall 2018

Relevant court decisions highlighted in this issue:

  • Acorda Therapeutics, Inc. v. Roxane Labs., Inc.
    Federal Circuit affirms judgment of invalidity on the basis of obviousness after reviewing the relevant prior art and discounting some objective indicia of non-obviousness on the basis of the existence of a blocking patent.
  • Orexo AB v. Actavis Elizabeth LLC
    Having found no suggestion that the claimed limitations in the prior art should be selected and combined, and that defendant did not meet its burden of proof in doing so, the Federal Circuit reversed the district court’s obviousness finding.
  • Supernus Pharms., Inc. v. TWi Pharms., Inc.
    The appellate court affirmed the trial court’s findings of infringement and validity, and that its limited reliance on a prior case concerning the same asserted patents but a different defendant was proper.

Relevant ANDA updates highlighted in this issue:

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

Oren D. Langer

Partner

Managing Partner, New York Office
Member of Executive Board

The court granted summary judgment of non-infringement where the accused formulation included an excipient the solubilizing function of which was not in line with the claimed abuse-deterrent function, and denied summary judgment on the issues of issue preclusion and the doctrine of equivalents, where a more extensive factual predicate was necessary.
Federal Circuit affirms judgment of invalidity on the basis of obviousness after reviewing the relevant prior art and discounting some objective indicia of non-obviousness on the basis of the existence of a blocking patent.
Having found no suggestion that the claimed limitations in the prior art should be selected and combined, and that defendant did not meet its burden of proof in doing so, the Federal Circuit reversed the district court’s obviousness finding.
The appellate court affirmed the trial court’s findings of infringement and validity, and that its limited reliance on a prior case concerning the same asserted patents but a different defendant was proper.
Under the doctrine of equivalents, the accused product was found to infringe one set of patents’s “delayed release” claim element, and also infringe another set of patents’ limitation requiring that the drug not reduce skin microflora.
Although infringed, the asserted claims for methods of treating pain in patients with hepatic impairment were held invalid as obvious and lacking an adequate written description.
Given the asserted Markush claim limitations, the court ruled that those defendants whose ANDAs included unrecited or unlisted excipients did not infringe the patent-in-suit.
Dismissing defendants’ arguments, including a lead-compound analysis, the court found that the asserted claim was not invalid as obvious.
Having found that the district court did not commit reversible error in finding that the asserted claims were not obvious, the Federal Circuit affirmed the district court’s decision.
Finding that all four factors weigh in plaintiff’s favor, the court granted plaintiff’s motion for a preliminary injunction.

Vol. 8, No. 1

Spring 2018

Vol. 8, No. 2

Summer 2018