Guidance for Therapeutic Antibodies

The Bipartisan Policy Center (BPC) on April 4, 2018, released the issue brief “Advancing Innovation, Competition, and Access to Therapeutic Antibodies through Patent Policy”

The brief examines patent policies governing therapeutic antibodies that target a particular disease state. Therapeutic antibodies effectively treat a wide range of diseases such as rheumatoid arthritis, multiple sclerosis, and several types of cancer.

The brief examines patent policies that govern therapeutic antibodies how they work, how they differ from patient policies for other drugs, and how uncertainties and inconsistencies around their application may impact future innovation.

The issue brief also points out  the necessity for polices to keep pace with medical innovation and how recent improvements to patent policies will help protect next generation therapeutic antibodies for patients.

Today, numerous therapeutic antibodies are in the pipeline and this means that delivering therapeutic antibodies targeting a particular disease state now requires policies that not only encourage investment in research and development but also promote competition to ensure that once the therapies are approved, the therapies will be accessible to patients.

The U.S Patent and Trademark Office has allowed antibody developers to avoid having to provide a full written description of their invention which is a requirement applicable to all other inventions.

In February 2018, the USPTO released a memo to patent examiners stating, “The USPTO now intends to align its guidance and related training materials regarding this matter with recent Federal Circuit Court decisions.”

“This is a win-win for both patients and manufacturers,” said Janet Marchibroda, BPC’s Director of Health Innovation. “This means that manufacturers will now have the confidence to invest in research and development of new therapeutic antibodies since clear, balanced, and consistently applied policies are in place which means patients now have access to more options for managing or even curing their conditions.”






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