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Amgen United States Patent and Trademark Office Intellectual Property Protection

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

McDermott Will & Emery

PTO Continues to Wave Wands in Assessing Enablement

McDermott Will & Emery on

In light of the 2023 Supreme Court of the United States decision in Amgen Inc. v. Sanofi, the US Patent & Trademark Office (PTO) published guidelines for PTO employees to use, regardless of technology, to ascertain compliance...more

Haug Partners LLP

Baxalta’s Antibody Patent Held Invalid under Amgen’s Enablement Standard by the Federal Circuit

Haug Partners LLP on

In Baxalta, Inc. v. Genentech, Inc., the Court of Appeals for the Federal Circuit upheld a summary judgment finding from the District of Delaware (Judge Timothy B. Dyk) that claims 1-4, 19 and 20 of Baxalta’s patent directed...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

Patterson Belknap Webb & Tyler LLP

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

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

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