Biologic Patent Thickets: New Bill Aims to Publicize Info

Regulatory NewsRegulatory News | 06 March 2019 |  By 

A bipartisan group of senators are sponsoring a bill introduced this week that would make public new information about the various patents that can restrict the market entry of new biosimilars.

Known as the Biologic Patent Transparency Act, the bill would publish and make available to the public a single, easily searchable, list that includes various information about the biologics, in addition to explicit information about the patents associated with each product.

Michael Carrier, distinguished professor at Rutgers Law School, told Focus: "In the small-molecule setting, the generics know the relevant patents since they’re listed in the Orange Book. But biosimilars don’t know which patents are held by biologics manufacturers. So this increases transparency. The bill also could conceivably exert a 'shaming' effect if a company is obtaining lots of patents."

The bill, introduced by Sens. Susan Collins (R-ME), Tim Kaine (D-VA), Rob Portman (R-OH), Jeanne Shaheen (D-NH), Mike Braun (R-IN) and Debbie Stabenow (D-MI), comes as outgoing FDA Commissioner Scott Gottlieb explained last summer that patent thickets are “purely designed to deter the entry of approved biosimilars.”

AbbVie’s Humira (adalimumab) has been criticized as the poster child for patent thickets, as the company has fended off biosimilar competition until 2023 with more than 100 patents, even though the main patent on its blockbuster biologic expired in 2016.

Boehringer Ingelheim, which is still fighting AbbVie in court over its adalimumab biosimilar, explained recently: “AbbVie generated a massive number of overlapping and noninventive patents to prevent competition on adalimumab, which has been on sale as Humira since 2003.”

In addition to the bill, FDA has also made clear it’s interested in enhancing its Purple Book (the Orange Book for biosimilars) to include more information about approved biologics.

“The enhanced Purple Book will include more information about approved biological products and will provide a modernized, interactive user experience. As part of the Purple Book enhancements, the FDA will also continue its commitment under the BsUFA II goals letter to publish information about newly approved or withdrawn BLAs and about reference product exclusivity determinations,” FDA said.

Carrier added: "I think this [bill] is consistent with efforts to update the Purple Book and since the Purple Book reaches more broadly than patent thickets, it still is ripe to be addressed."

Biologic Patent Transparency Act


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