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. 1

Spring 2013

The Spring 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:

  • Cephalon, Inc. v. Watson Pharma., Inc.(Fed.Cir.)
  • In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation
  • Allergan, Inc. v. Barr Lab., 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

In a bench trial, the Court, acting as the finder of fact, is free to ignore the testimony of an expert it has determined lack credibility.
Composition claim is invalid when the patented molecule was an obvious modification of a lead compound that existed in the prior art.
4.71/1 does not fall “between 5/1 and 15/1,” particularly when the range was limited during prosecution to avoid prior art.
Court rejects claims of obviousness, lack of written description, and derivation, and finds patent valid.
Counterclaims are subject to the heightened pleading standards established in Iqbal and Twombly; affirmative defenses are not.
Summary judgment of non-infringement granted when generic manufacturer presents evidence of FDA submissions showing that its generic product is “essentially free” of the claimed isomer.
Patents-in-suit relating to the “unpredictable and mysterious” art of hair growth were infringed and enforceable.
When prior art preparation does not necessarily result in claimed composition, asserted claims are not inherently anticipated; because polymorphs are unpredictable a skilled artisan would not have had a reasonable expectation of success in formulating most stable form of claimed composition.
Judgment of non-infringement affirmed when claim required accused products to be “saliva activated” and patent holder tested them in water; judgment of non-enablement reversed because the fact that some experimentation is necessary does not render a patent not enabled.
Reference Listed Drug, NDA Holder, Generic Drug Name, ANDA Applicant(s), Indication and Launch Date
Affirming entry of preliminary injunction and construing a settlement agreement.
Filing a paragraph IV certification is not required for a District Court to have subject matter jurisdiction over a claim of patent infringement; all that is required is the allegation of patent infringement.
Plaintiff’s summary judgment motion that its patent was not invalid for lack of written description and lack of enablement, and defendant’s motion for summary judgment of non-infringement, were denied.

Vol. 3, No. 2

Summer 2013

Vol. 3, No. 3

Fall 2013

Vol. 3, No. 4

Winter 2013