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Patent Trial and Appeal Board Amgen Pharmaceutical Industry

Venable LLP

Amgen Challenges Opdivo® / Yervoy® Combination Treatment Patents in Three IPRs

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On February 28, 2025, Amgen filed three IPRs against Bristol-Myers Squibb’s patents covering methods of treatment using a combination of Opdivo® (nivolumab), an anti-PD-1 antibody, and Yervoy® (ipilimumab), an anti-CTLA-4...more

Fish & Richardson

Biosimilars 2020 Year in Review

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Introduction - The biosimilar pathway was designed to increase competition for biologics and reduce healthcare costs. Yet 2020 saw a slowdown in biosimilar activity with the lowest number of annual biosimilar approvals since...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - January 2020

PATENT CASE OF THE WEEK - Amgen Inc. v. Amneal Pharmaceuticals LLC, et al., Appeal Nos. 2018-2414, et al. (Fed. Cir. Jan. 7, 2020) - In this appeal from Markman and summary judgment opinions by the district court in a...more

Herbert Smith Freehills Kramer

Biosimilar Litigation Trends and Lessons Learned in 2019

It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more

Goodwin

PTAB Institutes Fresenius’ IPR On Amgen Pegfilgrastim Patent

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As previously reported, earlier this year Fresenius filed a petition for inter partes review of claims 9-10, 13-21 and 23-30 of Amgen’s pegfilgrastim patent – U.S. Patent No. 9,643,997 (“997 patent”). The challenged claims of...more

Goodwin

Biosimilar Legal Decisions to Keep an Eye out for in 2019

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Here are our picks of some legal developments to keep an eye out for in the new year: 1. Etanercept biosimilar trial decision – This past September, in the Immunex v. Sandoz BPCIA patent litigation concerning Sandoz’s...more

Harris Beach Murtha PLLC

Patent Office Issues New Guidance for Antibody Written Description Requirements

Since 1999, the United States Patent and Trademark Office (“Patent Office”) has permitted the claiming of antibodies by disclosing the targeted antigen. In 2002, the Federal Circuit adopted Patent Office guidelines and...more

Goodwin

Biologics IPR Updates

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Last week, the Patent Trial and Appeal Board (“Board”) denied institution of four IPR petitions on biologics-related patents. First, the Board denied institution of IPR2017-01987 and IPR2017-01988, both filed by Sandoz Inc. ...more

Polsinelli

Biosimilars: Strategic Considerations for 2018

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2017 was an eventful year for biosimilars in the U.S. As the number of biosimilar filings increased, important legal and regulatory decisions changed the strategic landscape of the biosimilars market for both innovators and...more

K&L Gates LLP

Humira® Update: Big Guns Take Aim at Top-Selling Biologic

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AbbVie Inc.’s Humira® (adalimumab) was the top selling drug in 2015. Unsurprisingly, it is the focus of biosimilar applicants and patent challengers aiming to get into the market. We provide this update on three events...more

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