QJ 53.2 - AlphaFold 3, AI, Antibody Patents, The Future of Broad Pharmaceutical Patent Claims, and Drug Development

ALPHAFOLD 3, AI, ANTIBODY PATENTS, THE FUTURE OF BROAD PHARMACEUTICAL PATENT CLAIMS, AND DRUG DEVELOPMENT 

Artificial intelligence (AI) will have an enormous impact both on pharmaceutical development and patent protection, particularly for antibody therapeutics. In Amgen Inc. v. Sanofi, the U.S. Supreme Court limited the scope of Amgen’s therapeutic antibody patent to only those antibodies that were specifically described in Amgen’s patent application and that had been shown to bind to a particular region of the target antigen, blocking the activity of the antigen that caused disease. The reason for this limitation was the patent requirement of enablement: that potentially millions of antibodies could be generated to the target antigen but that not all would bind in a way that produced the therapeutic effect. The Court concluded that Amgen’s patent had not enabled other scientists to produce antibodies with the desired activity without “undue” experimentation, concluding a decades-long shift in their caselaw limiting the permissible scope of monoclonal antibody patents. Our primary conclusion is that artificial intelligence has the power to overcome the problem of enablement that currently limits the scope of antibody patents. We also conclude that the rapid pace of improvement in AI is likely to bring about significant changes in pharmaceutical patents generally, with the potential to transform the future of drug development and the pharmaceutical industry.