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. 7, No. 4

Winter 2017

Relevant court decisions highlighted in this issue:

  • Allergan Sales, LLC v. Sandoz. Inc.
    The district court’s validity analysis was affirmed, but its infringement finding was reversed because the district court relied on equivalency when plaintiff alleged only literal infringement.
  • Genzyme Corp. v. Dr. Reddy’s Labs., Ltd.
    Because a POSA would not have had a reasonable expectation of success that a reference disclosing increasing white blood cells also disclosed increased stem-cell mobilization, the asserted claim was not obvious.
  • Forest Labs., Inc. v. Teva Pharms. USA, Inc.
    When the asserted claim required that the concentration profiles of the extended-release formulation and the immediate-release formulation be measured in human pharmacokinetic studies, and the patent failed to identify a particular comparison study to be performed, its claims were indefinite.

Relevant ANDA updates highlighted in this issue:

  • ANDA Approvals
  • ANDA Litigation Settlements
  • Generic Launches
  • New ANDA Cases
The district court’s validity analysis was affirmed, but its infringement finding was reversed because the district court relied on equivalency when plaintiff alleged only literal infringement.
Defendant’s motion for judgment on the pleadings and for sanctions were premature and denied because there existed material disputes of fact between the parties concerning the prosecution history of the ’405 patent.
Because a POSA would not have had a reasonable expectation of success that a reference disclosing increasing white blood cells also disclosed increased stem-cell mobilization, the asserted claim was not obvious.
Eli Lilly’s narrowing amendment to overcome the Examiner’s rejection during prosecution could not serve as a basis for defendant’s motion for summary-judgment of non-infringement.
Due to the experimental nature of anti-cancer therapeutics at the time of invention, defendant did not establish by clear and convincing evidence that one of ordinary skill would be motivated nor have a reasonable expectation of success to select the drug formulation in the patents.
When the asserted claim required that the concentration profiles of the extended-release formulation and the immediate-release formulation be measured in human pharmacokinetic studies, and the patent failed to identify a particular comparison study to be performed, its claims were indefinite.
Upholding the district court’s trial determinations because there was no evidence that the district court failed to consider secondary considerations of nonobviousness and the district court was under no obligation to consider theories not raised at trial.
Jury verdict of non-obviousness upheld; willful-infringement verdict overturned.
Venue for the Teva USA claims was not proper in the Northern District of Texas as Teva USA did not commit any act of infringement in the district nor did it have a regular and established place of business there.
The Federal Circuit affirmed the trial court’s finding of infringement and validity.
Because Mylan’s sample productions were not representative of its ANDA product, its summary-judgment motion was dismissed until Otsuka was able to test a proper sample and thereby adequately respond to the motion.
The district court clearly erred when it failed to consider the relevant prior art before it, relying instead on expert-witness testimony.
Obviousness finding was affirmed because the claimed subject matter was known in the art and the secondary considerations did not overcome the strong obviousness case.
Upholding recommendation for summary judgment because water was not a “gelling agent” in the context of the patent-in-suit.
The “clinical trials” section of defendants’ proposed label evidenced induced infringement of the asserted claims, which were also found to be non-obvious.
Because a person of ordinary skill would not have found it obvious to modify the prior art of record to arrive at the claimed invention, trial court ruling of invalidity was reversed.
Dissolution profile and testing limitations in asserted claims were valid and infringed.

Vol. 7, No. 1

Spring 2017

Vol. 7, No. 2

Summer 2017

Vol. 7, No. 3

Fall 2017