Biologic Patent Transparency Act - New Bill Aimed At Biologics

Author:Ms Lisa M. Mandrusiak
Profession:Oblon, McClelland, Maier & Neustadt, L.L.P

A bipartisan group of senators sponsored a bill this week—the Biologic Patent Transparency Act, S. 659—aimed at making patent information associated with biologics easier to identify and easing the approval process for biosimilar manufacturers encountering patent roadblocks.

The bill tracks some key provisions of the Hatch-Waxman Act. Notably, it requires the holders of an approved biologic product to submit a list of patents associated with the biologic within 30 days of approval. If a new patent is issued, the list must be updated within 30 days. And, the bill would apply retroactively: within 30 days of enactment, the holders of previously-approved biologic products must submit patent lists. The patents required to be disclosed are those for which the holder believes a claim of patent infringement could reasonably be asserted. This is notably broader than the equivalent requirement in the Hatch-Waxman Act, as it includes manufacturing processes as well. If a patent is not timely included in the list, the holder is barred from filing an infringement suit based on that patent.

The bill also specifies actions the FDA must undertake to make this patent information available to the public, namely, to transform the Purple Book into a searchable, useable database similar to the Orange Book within one year of the bill's enactment. While the Purple Book currently lists biological products and...

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