Proposed new bill would create new patent term extension for certain biologics patents in USA

Earlier this week in the USA, legislation was introduced allowing new sponsors to gain intellectual property protection for already-approved biologic drugs that gain approval for new indications by Senator Richard Blumenthal (Democrat, Connecticut) and Representatives Joaquin Castro Joaquin Castro (Dem, Texas) and Randy Forbes (Republican, Virginia).

The Independent Innovator and Repurposing Act was presented by the lawmakers in their respective houses of Congress ( S 2150; HR 4287), writes Kurt Karst of law firm Hyman, Phelps & McNamara on its FDA Law Blog.

Styled as a bill to advance the public health by encouraging independent innovators to pursue drug repurposing research and develop new treatments and cures by providing appropriate intellectual property protections for those innovations, the Independent Innovator and Repurposing Act, if enacted, would allow the sponsor of a Biological License Application (BLA) for a biological product approved pursuant to Section 351(a) of the Public Health Service Act to obtain a Patent Term Extension (PTE) of five years (or an interim extension for successive one-year periods as appropriate) for a patent claiming a method of using that approved biological product because of “regulatory delay,” Mr Karst explains.