Biologic Patent Transparency Act - New Bill Aimed at Biologics

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 any biosimilar and interchangeable biological products, the bill would require substantial additional information, including the official and proprietary name of each biologic product, each patent submitted in accordance with the act, the date of licensure and application number for each product, the marketing status, dosage form, route of administration, reference product if applicable, and any period of exclusivity associated with the product.

The bill is ostensibly designed to help reduce patent thickets associated with biologics and help promote competition in the marketplace. The senators behind the bill specifically noted that the legislation is an attempt to stop patent gaming that blocks consumers from accessing lower-cost biologics.

Commentators have noted the bill is contradictory to the so-called patent dance of the BPCIA. But, when the bill goes to committee, changes may be proposed to both bills to bring them into accord before the bill is enacted (if ever).