House and Senate Bills Would Provide Incentive for Repurposing Old Biologics

By Donald Zuhn --

Last month, Sen. Richard Blumenthal (D-CT) and Rep. Joaquin Castro (D-TX) introduced legislation in the Senate and House, respectively, that would extend the term of certain patents claiming a method of using a biological product.  The companion bills, entitled the "Independent Innovator and Repurposing Act" (S. 2150 and H.R. 4287), profess "[t]o 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, and for other purposes."

The legislation would extend by five years the term of a patent claiming a method of using a biological product provided that the patent has not already been extended under 35 U.S.C. § 156.  To secure an extension, the patentee must apply for the extension before the patent expires and establish, inter alia, that the patent was issued to an "independent innovator," the owner of record is the independent innovator or a qualified small business in which the independent innovator has an ownership interest, and a commercial marketing application under 42 U.S.C. § 262(a) for a method of use claimed in the patent has been filed.

The legislation defines a biological product by reference to 42 U.S.C. § 262(a)(i)(1) as meaning "a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings."  According to the companion bills, an "independent innovator" is any person or entity that obtains a method of use patent for a biological product and is not, at the time of invention or patent filing, affiliated with the holder of an approved commercial marketing application under 42 U.S.C. § 262(a) for the biological product.

Comments

[Heebie-Jeebies]

A small step in the right direction, but if finding additional uses for existing biologic drugs is the goal, it's not enough. In particular, there's no reason to exclude the innovators themselves from such research; they may actually be better poised than others to identify and develop additional uses.

[Creedmoor]

So then a company seeking to commercialize such a method would ask the independent innovator for a license rather than an assignment, so the independent innovator would still be the owner of record and the patent would remain eligible for extension? Why encourage game-playing? If Congress wants to incentivize new uses for products, it should just do it across the board and not create different rights for different categories of patent owners.