Patents, Progress & Patient Access
April 10, 2018
Could a recent memorandum from the U.S. Patent and Trademark Office impact treatment options for patients? Washington, DC’s nonprofit Bipartisan Policy Center says: Yes.
As the group explains in a new issue brief, confusion has surrounded the issue of patents for the proteins that power biologic medicines to treat diseases such as rheumatoid arthritis, cancer and migraine. These proteins are known as “therapeutic antibodies.”
By addressing that confusion, the issue brief explains, the U.S. Patent and Trademark Office can encourage innovation, allowing patients to enjoy a range of biologic treatment options.
Bipartisan Policy Center Report
The Bipartisan Policy Center explores the issue in “Advancing Innovation, Competition, and Access to Therapeutic Antibodies through Patent Policy.”
As the paper explains, inventors are required to provide a written description of their invention when they apply for a patent. In granting patents for therapeutic antibodies, however, the U.S. Patent and Trademark Office allowed for an exception. On several occasions, inventors were allowed to provide a description of the antibody’s target, known as an antigen, rather than a description of the antibody itself.
Known as the “antibody exception,” the approach prompted questions about how broad claims based on antigen descriptions could be. For instance, could competitors with different antibodies that targeted the same antigen obtain a patent and create an alternate drug?
The issue landed in the U.S. court system, while decisions from the U.S. Patent and Trademark Office suggested ongoing confusion.
New Guidance from the U.S. Patent and Trademark Office
Now, a memorandum from the U.S. Patent and Trademark confronts inconsistencies head on.
“The purpose of this memorandum is to clarify the applicability of [U.S. Patent and Trademark Office] guidance,” explains Robert Bahr, deputy commissioner for patent examination policy. Bahr acknowledges recent decisions by the U.S. Court of Appeals for the Federal Circuit, which determined that inventors must describe a therapeutic antibody itself, not just the antigen it affects.
Bahr goes on to explain that the agency is updating training materials for its patent examiners that will reflect the court’s decision.
Updated guidance will “accelerate innovation, promote competition, and most importantly, improve patient access,” explained the Bipartisan Policy Center’s Janet Marchibroda in a statement. The group’s paper argues that laws must “protect both innovation and innovative competition.”Biologics, Innovation, Regulatory Issues
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