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Regulatory Focus™ > News Articles > Bill Would Create Incentives to Seek New Approvals for Old Biologics

Bill Would Create Incentives to Seek New Approvals for Old Biologics

Posted 25 March 2014 | By Alexander Gaffney, RAC

A new bill introduced in the US House of Representatives on 24 March 2014 would grant companies additional patent protections for repurposed biological products.

Bill Basics

The bill, the Independent Innovator and Repurposing Act (IIRA), is cosponsored by Reps. Joaquin Castro (D-TX) and Randy Forbes (R-VA) and is intended to provide "appropriate intellectual property protections" for some products.

Those products, the bill explains, are any biologicals regulated under Section 351(i)(1) of the Public Health Service Act:

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.

Bill Details

At its core, the bill would allow sponsors of biological products to apply for an extension of the term of their original patent for an additional five years if the product was approved for a new use, and the sponsor is not affiliated with (or the same as) the original sponsor of the product.

The intent, the legislation says, is to incentivize research and development for new treatments and cures by repurposing already-approved drugs.

This approach is already being advanced within industry and government, as companies share their compound libraries with one another and work with the National Center for Advancing Translational Science (NCATS) to screen potentially useful compounds.

But where Castro and Forbes' bill would differ is in its focus on already-approved products-not discarded ones.

While the bill would apply to all future products, it would also be retroactive to all products approved in the last 10 years that meet its terms.


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