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. 3, No. 2

Summer 2013

The Summer 2013 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:

  • FTC v. Actavis, Inc.
  • Novo Nordisk A/S v. Caraco Pharma. Labs., Ltd.
  • Dey, L.P. v. Sunovion Pharma., 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
Member of Executive Board

Ryan M. Schultz


Pronouns: he/him

Defendant is able to defeat a summary-judgment motion of no inequitable conduct given the lesser burden than having to prove inequitable conduct at trial, and the court's finding that reasonable trier of fact could conclude that patentees withheld material information from USPTO.
Granting plaintiffs' motions seeking a permanent injunction after finding that the patents were valid and infringed.
Appellate court reversed in part district court's finding of non-obviousness when prior art taught claimed combination drug.
First patent-in-suit found infringed, but invalid as obvious and anticipated; second patent-in-suit not infringed as a result of court's claim construction of "micronized powder composition."
Reversing and remanding the case finding that the district court misconstrued the term "substantially pure."
Appellate court reversed finding of validity after prior art (i) found to disclose not only hormonal replacement therapy, but also contraceptive applications, and (ii) taken as a whole, did not teach away from claimed invention.
As a result of credibility findings pertaining to the parties' respective expert witnesses, court held patent-in-suit not invalid.
Clinical trial was not "public use" under 102(b), therefore summary judgment of invalidity was reversed.
Reverse-payment settlement agreements may sometimes violate antitrust laws and a rule-of-reason approach guided by antitrust principles should apply.
Reference Listed Drug, NDA Holder, Generic Drug Name, ANDA Applicant(s), Indication and Launch Date
Finding of obviousness affirmed because patentee could not "overcome" prima facie obviousness with evidence of unexpected results, and finding of unenforceability reversed because omissions, although "troubling," were not material.
Patent-in-suit not invalid, particularly in view of the same or similar arguments being raised, and rejected, in previous actions.
Finding expert's testing and testimony credible, court finds ANDA product infringes melting point claim limitations and rejects lack of written description and non-enablement invalidity arguments.
There is no requirement under the Hatch-Waxman Act that a patent must be listed in the Orange Book in order for a drug manufacturer to bring an infringement action.
Patent-in-suit infringed as a result of meeting particle size limitation as evidenced by expert testing and favorable claim construction; patent-in-suit not invalid given expert witness credibility finding and knowledge of person of ordinary skill.

Vol. 3, No. 1

Spring 2013

Vol. 3, No. 3

Fall 2013

Vol. 3, No. 4

Winter 2013