Posts Tagged: "Antibody Patents"

The Truth Leaks Out: Justices Struggle with the Science, Sanofi Welcomes End to Functional Genus Claims in Amgen Oral Arguments

The U.S. Supreme Court heard three separate arguments today in Amgen v. Sanofi, a case that even Sanofi’s counsel agreed could effectively wipe out patents involving genus claims if the Court sides with Sanofi, or—as counsel for Sanofi and the Solicitor General’s Office suggested the Court could do—if it were to dismiss the case as improvidently granted.

Case Study: Recently Granted Epitope-Based Antibody Patents in the United States, Europe and Japan

Patents involving antibody medicines (antibody patents) are largely grouped into patents specified by antibody amino acid sequences (antibody sequence-based patents) and those not (non-sequence-based patents). Non-sequence-based patents have a broad scope and are thus very useful for protecting antibody medicines. Here, I investigate a recent trend in antibody patents characterized by an antibody-binding site in an antigen.

The Evolution of Antibody Patents

As the pharmaceutical industry continues to shift toward biologic-based drugs, including monoclonal antibodies, protecting the underlying technology has been and continues to be a priority for companies. As with any drug, patenting therapeutic monoclonal antibodies as early as possible in the drug development process is crucial to protect the underlying invention. In the early days of antibody discovery for therapeutic development, protection could be obtained with minimal disclosure of the actual antibody. But as the art and case law have evolved, companies now need far more data to obtain the broadest scope of protection. For that reason, it has become more of a challenge to determine the best time to file with the U.S. Patent and Trademark Office (USPTO). After the America Invents Act (AIA), it is a race to the USPTO to be the first to claim your invention, but you may lack the requisite data to enable you to obtain patent protection in the end.