Category Archives: Biosimilars

Amgen, Inc. et al. v. Sandoz Inc. et al.

Posted on May 9, 2019 by Patrick J. Halloran, Ph.D., J.D.

Docket Nos. 2018-1551 and -1552 LOURIE, O’MALLEY, REYNA May 8, 2019 Brief summary: DC claim construction findings and grant of SJ of non-infringement to Sandoz regarding its Neupogen® and Neulasta® biosimilars affirmed. Summary: Amgen appealed two DC decisions finding Sandoz’s … Continue reading →

Posted in Biosimilars, Claim Construction, Collateral estoppel, Doctrine of equivalents, Generics / ANDA, Infringement | Leave a comment

Pfizer, Inc. v. Genentech, Inc.

Posted on April 6, 2018 by Patrick J. Halloran, Ph.D., J.D.

IPR2017-01923 (US Pat. No. 7,976,838 B2) April 4, 2018 Decision to Insitute IPR Brief summary: Pfizer request for institution of IPR of Genentech’s ‘838 patent related to the TNFalpha inhibitor rituximab (Rituxan) on obviousness grounds granted. Summary: Pfizer challenged claims … Continue reading →

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Amgen, Inc. et al. v. Sandoz Inc.

Posted on December 15, 2017 by Patrick J. Halloran, Ph.D., J.D.

Docket Nos. 2015-1499 NEWMAN, LOURIE, CHEN December 14, 2017 Brief summary: DC’s dismissal of Amgen’s state law unfair competition and conversion claims was affirmed due to preemption by federal law (BCPIA). Summary: In its 2017 Sandoz v. Amgen decision relating … Continue reading →

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Amgen Inc. et al. v. Apotex Inc. et al.

Posted on November 16, 2017 by Patrick J. Halloran, Ph.D., J.D.

Docket No. 2017-1010 LOURIE, O’MALLEY, TARANTO November 13, 2017 Non-precedential Brief summary: DC decision of no infringement of Amgen’s process patent by Apotex’s ABLA applications regarding Amgen’s Neulasta® and Neupogen® affirmed. Summary: Amgen appealed DC conclusion that Amgen failed to … Continue reading →

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Amgen, Inc. et al. v. Hospira, Inc.

Posted on August 14, 2017 by Patrick J. Halloran, Ph.D., J.D.

Docket No. 2016-2179 DYK, BRYSON, CHEN August 10, 2017 Brief summary: Amgens’s appeal for lack of jurisdiction and petition for a writ of mandamus dismissed and denied, respectively, since DC denial of Amgen’s motion to compel discovery is “reviewable from … Continue reading →

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Sandoz Inc. v. Amgen Inc. et al.

Posted on June 13, 2017 by Patrick J. Halloran, Ph.D., J.D.

SCOTUS No. 15-1039 (decided with 15-1195, Amgen Inc. et al. v. Sandoz Inc.) June 12, 2017 Brief Summary: FC issuance of “a federal injunction prohibiting Sandoz from marketing Zarxio until 180 days after licensure” reversed since “the applicant may provide … Continue reading →

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Amgen Inc. et al. v. Apotex Inc. et al.

Posted on July 11, 2016 by Patrick J. Halloran, Ph.D., J.D.

Docket No. 2016-1308 WALLACH, BRYSON, TARANTO July 5, 2016 Update: Petition for a writ of certiorari denied (12/12/16) Brief Summary: DC grant of preliminary injunction against Apotex regarding a biosimilar Neulasta® affirmed (“an applicant must provide a reference product sponsor … Continue reading →

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Amgen, Inc. et al. v. Sandoz Inc.

Posted on July 22, 2015 by Patrick J. Halloran, Ph.D., J.D.

Docket No. 2015-1499 NEWMAN (C/D), LOURIE, CHEN (D) July 21, 2015 Update:  See SCOTUS June 12, 2017 decision reversing the FC regarding 8A (“the applicant may provide [180 day] notice either before or after receiving FDA approval”). Brief Summary: Opinion … Continue reading →

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Sandoz Inc. v. Amgen Inc. and Hoffman-La Roche Inc.

Posted on December 11, 2014 by Patrick J. Halloran, Ph.D., J.D.

Docket No. 2014-1693 PROST, REYNA, HUGHES December 5, 2014 Brief Summary: DC decision of no Article III case or controversy affirmed because Sandoz had not yet filed for approval of its biosimilar to Amgen’s Enbrel®. Summary: Sandoz appealed DC dismissal … Continue reading →

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