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. 1

Spring 2017

Relevant court decisions highlighted in this issue:

  • Allergan, Inc. v. Sandoz, Inc.
    Collateral estoppel applied when the eyelash “darkness” limitation in the newly-issued patent was litigated in a prior case during claim construction.
  • Shire Development, LLC v. Watson Pharms., Inc.
    Finding of infringement reversed when ANDA product contained an element—related to the invention—that was not within the claimed Markush group.
  • Cumberland Pharms. Inc. v. Mylan Institutional LLC
    A suggestion by the FDA to consider whether to include a stabilizer does not establish the necessary proof to make a derivation argument and, due to no reasonable expectation of success, the district court’s validity findings were affirmed.
  • ANDA Approvals
  • ANDA Litigation Settlements
  • Generic Launches
  • New ANDA Cases

Oren D. Langer

Partner

Managing Partner, New York Office
Member of Executive Board

Ryan M. Schultz

Partner

Pronouns: he/him

Earlier patent claiming treatment of MS was valid, but subsequent patents relating to specific dosing requirements were invalid in light of intervening prior art, including valid earlier patent.
Collateral estoppel applied when the eyelash “darkness” limitation in the newly-issued patent was litigated in a prior case during claim construction.
The court denied Teva’ motion to amend its answer and counterclaims to raise defenses of inequitable conduct and unclean hands.
Seeking a court to enforce an agreed-upon settlement agreement does not bestow that court with subject matter jurisdiction because there is no Article III case or controversy.
The court upheld the validity of the patent-in-suit, but denied an award of fees because its decision was based on an analysis of the credibility of expert witnesses.
A suggestion by the FDA to consider whether to include a stabilizer does not establish the necessary proof to make a derivation argument and, due to no reasonable expectation of success, the district court’s validity findings were affirmed.
The Federal Circuit affirmed the district court’s finding of divided infringement, of obviousness, and that the claim term “vitamin B12” was not indefinite.
Defendant failed to meet its burden in proving a motivation to combine prior-art references and also failed to establish the claimed compound as inherently present in the prior art.
The court rejected Defendant’s Section 112 arguments and found the asserted claims infringed, in large part, based on its earlier claim construction decision.
Having found standing to sue, the court held that the nasal spray formulation of a known drug warranted patent protection.
Because the subject matter of the asserted claims was found in the prior art, would have been obvious to try, and no objective indicia of non-obviousness suggested otherwise, those claims were invalid as obvious.
When opposing experts’ testing and testimony results in equal but opposite results, the patentee does not meet its burden of proving infringement.
One of the patents-in-suit was invalid for obviousness-type double patenting while the other two patents-in-suit were infringed and not invalid as obvious.
A claim for patent infringement under Hatch-Waxman must be based on the formulation in the ANDA, not on what the FDA may require of the ANDA holder in the future.
Whether it were a question of fact not properly determined on the pleadings if claims of subsequent patent were sufficiently different from the claims of previously litigated patents to overcome collateral estoppel issues.
Establishing bioequivalence is not the same as proving infringement, and when the ANDA speaking directly to the issue of non-infringement, summary judgment is warranted.
Defendant’s proposed ANDA products infringed all of the asserted patent claims under the doctrine of equivalents.
A generic manufacturer’s conversion from a PIV certification to a PIII, by itself, does not deprive the court of jurisdiction.
In a bench trial where only the issue of infringement was heard, court credited the testimony of Plaintiff’s expert and found proposed ANDA product would infringe patent-in-suit.
Finding of infringement reversed when ANDA product contained an element—related to the invention—that was not within the claimed Markush group.

Vol. 7, No. 2

Summer 2017

Vol. 7, No. 3

Fall 2017

Vol. 7, No. 4

Winter 2017