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Advancing Innovation, Competition, and Access for Biologics Through Patent Policy

Bipartisan Policy Center
1225 Eye Street NW
Suite 1000
Washington, DC 20005
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In medicine, intellectual property (IP) protections – such as patents – incentivize the large investments required to produce an array of therapies, creating options for physicians and patients.

U.S. patents generally drive innovation by granting inventors limited rights in exchange for inventors’ publicly disclosing important inventions and advances. This includes a period of exclusivity for inventors to recover their investment and generate capital for developing new therapies. This approach fosters a free flow of information, which allows further innovation.

In some instances, however, IP policies can have unintended consequences. When patent protections are broader than the scope of the invention they protect, they may actually discourage innovation. In such cases, they may also discourage or even block others from pursuing new inventions, thereby reducing competition. This approach ultimately hurts patients by narrowing the range of potential treatments.

In the case of therapeutic antibodies – which have proved to be effective treatments for many serious and life-threaenning diseases, including many cancers, rheumatoid arthritis, and multiple sclerosis – the U.S. Patent and Trade Office (USPTO) has, until recently, allowed antibody inventors to avoid having to provide a “full written description” of their invention – the antibody itself.

The USPTO has already taken important steps to update its guidelines to reflect the law as demonstrated through Federal Circuit court rulings over the years. Within days of confirmation of the new Under Secretary of Commerce for IP and USPTO Director, the USPTO issued a formal memorandum both clarifying and updating its guidance on how written descriptions for antibodies are handled. USPTO’s important updates will have a positive impact on innovation, competition, and access in this vital field of human health.

BPC hosted an event to explore how the USPTO is advancing innovation, competition, and patient access to life-saving therapies through U.S. patent policy, with key insights from legal experts and leaders representing patients and industry.

Keynote remarks by:

Drew Hirshfeld
Commissioner for Patents, U.S. Patent and Trademark Office

Panel discussion with:

Mark Boutin
Chief Executive Officer, National Health Council

Oskar Liivak
Professor of Law, Cornell University Law School

Gil T. Voy 
Vice President, Deputy General Patent Counsel, Eli Lilly and Company 

Moderated by:

Janet Marchibroda
Director of Health Innovation, Bipartisan Policy Center 


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