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BPC Issue Brief Supports New Guidance by U.S. Patent and Trademark Office on Therapeutic Antibodies

Headshot of Joann Donnellan
Joann Donnellan

Washington, D.C.– Today, the Bipartisan Policy Center released a new issue brief that examines the patent policies governing therapeutic antibodies that can target a particular disease state. The brief, Advancing Innovation, Competition, and Access to Therapeutic Antibodies through Patent Policy, outlines a set of findings and recommendations developed following a months-long process involving research, interviews, and meetings with experts and stakeholders, including the U.S. Patent and Trademark Office (USPTO). It was released during an event at BPC where the USPTO shared details of its recent updates to guidance for patent claims drawn to antibodies that will have a positive impact on patients.

Since 2000, the USPTO has allowed antibody developers to avoid having to provide a full written description of their invention, a requirement that is applicable to all other inventions. This has resulted in claims broader than the disclosed invention. In February, the USPTO released a memo to patent examiners stating that it now intends to align its guidance and related training materials with recent Federal Circuit Court decisions regarding this matter, thereby improving clarity and reducing uncertainty in therapeutic antibody development.

“This is a win-win for both patients and manufacturers,” said Janet Marchibroda, BPC’s director of health innovation. “Manufacturers will have the confidence to invest in the research and development of new therapeutic antibodies with clear, balanced, and consistently applied policies in place, and patients will have access to more options for managing, or even curing, their conditions.”

As the brief explains, therapeutic antibodies effectively treat a wide range of diseases such as rheumatoid arthritis, multiple sclerosis, and several types of cancer. However, delivering on the promise of these therapies requires policies that not only encourage investment in research and development, but also promote competition, and ensure that—once approved—these therapies will be accessible to patients.

“USPTO’s updated guidance, and the implementation activities that follow, are expected to accelerate innovation, promote competition, and most importantly, improve patient access to these important therapies which help treat complex, chronic, and sometimes life-threatening conditions,” added Marchibroda.

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