The Biologic Patent Transparency Act (S. 659) was introduced by Senators Susan M. Collins ((R) Maine) and Tim Kaine ((D) Virginia) to address an unintended burden when new biological products are presented to the FDA for approval. According to the sponsors, the Act “seeks to help increase patent transparency, promote biosimilar competition, bring needed biosimilar treatments to patients faster, and ultimately, lower drug prices for consumers.” Currently, there is no “official” listing of patents that relate to biological products comparable to what is available for small molecule drug products that are subject to patent and market exclusivity. Small molecule drug products patent listings are located in the commonly known “Orange Book.” Despite a lot of attention focused on biosimilar products and numerous litigations around the country, there is no official book for biologics that provides the transparency found with small molecule drugs. Instead, an “unofficial” book known as the “Purple Book” purports to identify the patents that cover a biological product.
The Biologic Patent Transparency Act remedies this deficiency and requires manufacturers of approved biological products to list the patents covering their products with the FDA. In particular, the Act provides for the following:
- Codification and publication of the Purple Book to ensure that the public is aware of patents covering a biological product;
- Listing composition patents, method of use patents, and manufacturing patents;
- Identifying information related to the biosimilarity and/or interchangeability of the product;
- Identifying regulatory/marketing exclusivities;
- Listing the approved indications for the biological product; and
- Limiting the ability of a patent filer to enforce late-filed patents by the manufacturer of a biological product if a biosimilar application has already been filed with the goal of removing barriers as part of the product development process.
The fate of the Biologic Patent Transparency Act is uncertain. Nevertheless, with the competition in the biologics space increasing, attention by Congress to critical patent related aspects is welcomed. Gibbons will update this post as more information on the proposed legislation is identified.