The Biologic Patent Transparency Act: Proposed Revisions to Purple Book

Earlier this month, a bipartisan group of six senators introduced the Biologic Patent Transparency Act (“BPTA”), which the senators say will “help increase patent transparency, promote biosimilar competition, bring needed biosimilar treatments to patients faster, and ultimately, lower drug prices for consumers.” The sponsors further state that the bill will impose “transparency requirements that are similar to what are required for small molecule drugs under the Hatch-Waxman framework, which has proven successful in promoting the development and use of generic drugs.”

The BPTA will require holders of approved products (including biosimilars approved under 351(k)) to disclose for publication in the Purple Book the patents they “believe[] a claim of patent infringement could reasonably be asserted by the holder,” among other requirements. The Purple Book would include patents provided in the l(3)(A) list of the patent dance. Additionally, the BPTA would require the Purple Book to be codified as a single searchable list that also includes information on biosimilarity and interchangeability, as well as approved indications and information on exclusivities.

The BPTA announcement further described biologic product “patent thickets” as obstacles to competition, and that the BPTA will “encourage manufacturers to apply for patents sooner, allowing prospective biosimilar manufacturers to challenge weak or invalid patents earlier in the product development process.” Allegations of “patent thickets” were recently raised in a putative class action regarding adalimumab, and in litigation by AbbVie regarding Boehringer Ingelheim’s adalimumab product. According to its sponsors, the BPTA would also “[limit] the enforceability of late-filed patents by the biologic manufacturer when a biosimilar application has already been filed with the FDA, by barring certain claims of infringement for patent owners that do not “timely” disclose their patents.

The BPTA announcement echoes comments by the FTC in July 2018 on increasing biosimilar competition. The FTC requested the FDA “improve the Purple Book” by adding among other things patent information.