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. 5, No. 4

Winter 2015

The Winter 2015 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:

  • Cubist Pharms., Inc. v. Hospira, Inc.
  • Prometheus Labs., Inc. v. Roxane Labs., Inc. 
  • Spectrum Pharms., Inc. v. Sandoz, 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

Certificate of correction correcting structural diagram of a claimed compound did not broaden the patent’s claims nor did it render the patent invalid on written-description grounds.
FDA correspondence in connection with a pending NDA did not render the patent-in-suit invalid on the basis of derivation; also, the FDA approval letter and approved package insert did not render that patent invalid on the bases of anticipation and obviousness.
All of the patents-in-suit were valid and enforceable, and all but one—because of a different dosage strength associated with the proposed ANDA product—were infringed.
To properly bring a claim for induced infringement, plaintiff must make allegations—supported by fact so as to make those allegations plausible—regarding Defendants’ specific intent or any specific acts taken to encourage direct infringement.
Species patent is obvious in view of genus patent where all of the claim limitations in the species patent were present in the prior art and the differences between the prior art and the instant claims are insubstantial.
The substantially pure claimed compound was obvious when both the 50/50 mixture and the pure compound were known in the art; the ANDA product also does not infringe the patent when the dosage strength is well below the claimed amount.
Reference Listed Drug, NDA Holder, Generic Drug Name, ANDA Applicant(s), Indication and Launch Date

Vol. 5, No. 1

Spring 2015

Vol. 5, No. 2

Summer 2015

Vol. 5, No. 3

Fall 2015