GENERICally Speaking - Vol. 5, No. 1

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, GENERICally Speaking: A Hatch-Waxman Litigation Bulletin.

Taking on an ANDA patent litigation requires significant corporate resources, time, and money. Staying on top of industry news and outcomes, following trends in the judiciary and the steps others are taking, and keeping informed of recently-enacted rules and legislation are critical.

This bulletin provides you and your company with some of the knowledge beneficial to remaining attentive to the complexity of ANDA patent litigation. We hope you find it helpful.

Relevant Court Decisions

  • Teva Pharms USA, Inc. v. Sandoz, Inc.
    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.
  • Apotex Inc. v. Daiichi Sankyo, Inc.
    Statutory disclaimer of a patent alone does not eliminate “case or controversy” declaratory-judgment jurisdiction.
  • Cadence Pharms., Inc. v. Exela PharmSci Inc.
    Federal Circuit affirms district court’s findings that the patents-in-suit are valid and infringed.
  • Senju Pharm. Co., Ltd. v. Lupin Ltd.
    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.
  • Senju Pharm. Co., Ltd. v. Metrics, Inc.
    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.
  • Otsuka Pharm. Co., Ltd. v. Mylan Inc.
    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.
  • Takeda Pharm. Co., Ltd. v. TWi Pharms., Inc.
    Takeda’s motion to strike TWi’s expert opinions was granted when those opinions were not expressed in TWi’s invalidity contentions.
  • Novartis Pharms. Corp. v. Mylan Inc.
    The site of incorporation conferred specific jurisdiction.
  • Eli Lilly & Co. v. Mylan Pharms., Inc.
    Specific jurisdiction may exist by sending Notice of ANDA filing letter to the branded drug manufacturer.
  • Ranbaxy Labs., Ltd. v. Burwell
    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.
  • Warner Chilcott Co., LLC v. Teva Pharms. USA, Inc.
    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.
  • Forest Labs., Inc. v. Amneal Pharms. LLC
    Compliance with registered agent statute in Delaware establishes consent to jurisdiction in Delaware for all causes of action.
  • Spectrum Pharms., Inc. v. Sandoz Inc.
    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.
  • AstraZeneca LP v. Breath Ltd.
    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.
  • Acorda Therapeutics, Inc. v. Mylan Pharms. Inc.
    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.

New ANDA Cases

ANDA Litigation Settlements

ANDA Approvals

Generic Launches

The articles on our Website include some of the publications and papers authored by our attorneys, both before and after they joined our firm. The content of these articles should not be taken as legal advice.