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United States Patent and Trademark Office › Amgen › Pharmaceutical Industry

The U.S. Patent and Trademark Office is an agency of the United States Department of Commerce that serves a fundamental role in the U.S. intellectual property system by issuing patents and registering trademarks.... more +
The U.S. Patent and Trademark Office is an agency of the United States Department of Commerce that serves a fundamental role in the U.S. intellectual property system by issuing patents and registering trademarks.    less -
Venable LLP

PTAB Director Discretionarily Denies Opdivo® IPRs Based on Settled Expectations of Patent Owner

Venable LLP on

On July 24, 2025, the PTO Acting Director Coke Morgan Stewart discretionarily denied Amgen’s IPR2025-00601 and IPR2025-00602 challenging Bristol-Myers Squibb’s (“BMS”) U.S. Patent Nos. 9,856,320 (“the ’320 patent”) and...more

Morgan Lewis

Blockbuster Biologics Review | Issue 26

Morgan Lewis on

Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation Act...more

Lathrop GPM

Broad Biotech Patent Claims-the Saga Continues

Lathrop GPM on

There now is increased interest about the written description and enablement requirements for patent applications claiming antibodies. This may stem from the recent U.S. Supreme Court decision in Amgen v. Sanofi, finding lack...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Amgen Faces “Uphill Battle” in Defending Antibody Genus Patentability

Rothwell, Figg, Ernst & Manbeck, P.C. on

On December 9, 2020, the Federal Circuit heard oral arguments on the validity of Amgen’s patents (U.S. Patent Nos. 8,829,165 and 8,859,741) on cholesterol-lowering drug Repatha. Specifically, the question came down to whether...more

Herbert Smith Freehills Kramer

Biosimilar Litigation Trends and Lessons Learned in 2019

Herbert Smith Freehills Kramer on

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

Harris Beach Murtha PLLC

Patent Office Issues New Guidance for Antibody Written Description Requirements

Harris Beach Murtha PLLC on

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

USPTO Releases New Guidance on Patentability of Antibody Claims

Goodwin on

Last month, Robert Bahr, Deputy Commissioner for Patent Examination Policy at the USPTO issued a memorandum to the Patent Examining Corps addressing written description of antibody claims. Many patents covering biological...more

Patterson Belknap Webb & Tyler LLP

USPTO Adopts Amgen v. Sanofi, Excises “Newly Characterized Antigen” Test from its Written Description Guidance for Antibody Claims

Patterson Belknap Webb & Tyler LLP on

Last month, the USPTO issued a memorandum to its patent examining corps clarifying its guidance concerning the written description requirement for claims drawn to antibodies. In the memorandum, the USPTO adopts the Federal...more

McDonnell Boehnen Hulbert & Berghoff LLP

Amgen Inc. v. Sanofi (Fed. Cir. 2017)

McDonnell Boehnen Hulbert & Berghoff LLP on

Last month, the Federal Circuit rendered a decision in Amgen Inc. v. Sanofi that brought clarity to how the Court (and U.S. Patent and Trademark Office) should apply the written description requirement in 35 U.S.C. § 112(a)...more

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