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U.S. Supreme Court to Decide on Enablement Standard for Biotech Antibody Patents in Amgen v. Sanofi

In 2021, the Federal Circuit determined that Amgen’s biotech antibody patents lack enablement, i.e., the specification did not teach one of ordinary skill in the art how to make and use the invention without undue...more

Federal Circuit Denial of En Banc Rehearing in Amgen v. Sanofi Prompts New Considerations in Genus Claims

Based on the denial of rehearing and the Amgen v. Sanofi decision itself, inventors should: Claim as many separate species as possible. Attempt to fashion genus claims that have a limited number of members supported...more

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

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