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. 3

Fall 2015

The Fall 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:

  • Shire LLC v. Amneal Pharms. LLC
  • Allergan, Inc., v. Sandoz Inc.
  • The Medicines Co. v. Hospira, 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

Personal jurisdiction over defendants existed in Indiana when PIV Certification notice letter was sent to a corporation incorporated in that state.
Trial court did not err when it found that there was no motivation to pursue modified concentration of existing drug and no reasonable expectation of success in doing so, and asserted claims met the Section 112 requirements for enablement and adequate written description.
Patentee disavowed any meaning to claim term at issue other than that which was described in the specification, and in view of that construction, cross motions for summary judgment were denied.
Indirect infringement is present when the patient and prescribing information describe all claimed steps.
The fact that the “bioavailability of oxymorphone is increased in people with impaired kidney function” is a natural law that is not subject to patent protection.
Controlled-release oxymorphone patents held infringed and valid while abuse-proof oxymorphone patent held infringed but invalid as obvious.
The asserted claims were invalid as obvious when two of three elements were plainly in the prior art while the third element was an inherent result of the combination of the first two elements.
Asserted claim was invalid and infringed after the court considered and rejected arguments related to on-sale bar, anticipation, obviousness, and lack of written description.
Motion to transfer denied when related litigation concerning the same patent was not co-pending and involved different accused products.
The asserted claims were invalid as obvious when two of three elements were plainly in the prior art while the third element was an inherent result of the combination of the first two elements.
Determining if compounds are similar for obviousness requires analysis of the entire structure.
Personal jurisdiction does not exist when the only contact in the jurisdiction is plaintiff incorporation in the forum.
On remand, asserted claims were obvious on the basis of inherency and the full scope of the claimed particle size range was not enabled; thus, the patent-in-suit was invalid.
Failure to raise a claim-construction issue precludes a party from arguing claim differentiation.
There is no personal jurisdiction over defendant when PIV Certification notice letter was mailed to one state and defendants were headquartered in another state.
Claims held invalid based on application of on-sale bar when sale of manufacturing services was deemed a commercial offer for sale.
Proposed ANDA formulation infringed the patent-in-suit under the doctrine of equivalents; defendants’ obviousness defense was also rejected.
Lead compound analysis established that the asserted claims were not invalid as obvious.
Affirming finding of validity and infringement of patents-in-suit, but finding a supplier of components reasonably related to the submission of an ANDA falls within the safe harbor provision of 35 USC § 271(1) and is not liable for infringement
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. 4

Winter 2015