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. 1

Spring 2015

The Spring 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:

  • Teva Pharms USA, Inc. v. Sandoz, Inc.
  • Apotex Inc. v. Daiichi Sankyo, Inc.
  • Cadence Pharms., Inc. v. Exela PharmSci 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

Defendants’ motion to dismiss for lack of personal jurisdiction is denied because specific jurisdiction exists where Defendant is registered to do business in the forum state and maintains an agent to accept service of process there.
Statutory disclaimer of a patent alone does not eliminate “case or controversy” declaratory-judgment jurisdiction.
Given Federal Circuit’s broader claim construction in preceding appeal, patent-in-suit was found on remand to be invalid as obvious, and objective indicia did not support a contrary finding.
Federal Circuit affirms district court’s findings that the patents-in-suit are valid and infringed.
Specific jurisdiction may exist by sending Notice of ANDA filing letter to the branded drug manufacturer.
Compliance with registered agent statute in Delaware establishes consent to jurisdiction in Delaware for all causes of action.
Reference Listed Drug, NDA Holder, Generic Drug Name, ANDA Applicant(s), Indication and Launch Date
The site of incorporation conferred specific jurisdiction.
Defendants’ motion to dismiss for lack of personal jurisdiction is denied because defendants consented to specific jurisdiction by registering to do business in the forum state and maintaining an agent to accept service of process there.
FDA’s summary-judgment motion that the FDA’s revocation of Ranbaxy’s tentatively approved ANDA was proper is granted; Ranbaxy’s motion for preliminary injunction denied.
The finding of obviousness is affirmed in view of at least seven prior-art references and the panel majority’s acceptance of the district court’s credibility finding concerning defendant’s expert witnesses.
Consent to jurisdiction occurs when complying with registered-agent statute; filing an ANDA is not an initiation of a civil suit precluding the filing of an IPR.
Given the prior art disclosures, coupled with weak evidence of objective indicia of non-obviousness, the court found the patent-in-suit invalid as obvious.
Takeda’s motion to strike TWi’s expert opinions was granted when those opinions were not expressed in TWi’s invalidity contentions.
When claim construction is at issue, the Federal Circuit is to review intrinsic evidence de novo and factual finding associated with extrinsic evidence for clear error.
The claims at issue were a combination of known elements, arranged in a known way, to produce expected results, and the patentee simply patented the resulting blood concentration.

Vol. 5, No. 2

Summer 2015

Vol. 5, No. 3

Fall 2015

Vol. 5, No. 4

Winter 2015