The Biologic Patent Transparency Act (BPTA), a Senate bill introduced by Senator Susan Collins (R-ME) in March, is an independent, bipartisan attempt to address patent thickets. It does so largely by clarifying an individual biologic product’s patent situation. In achieving this, it can also create a real reason for the existence of the Purple Book.
Today, the Purple Book is nothing more than a listing of biologic agents, their original FDA filing dates, and whether there are any biosimilars of the originator biologic. It provides very few dates when a biologic’s exclusivity period ends. One day, it may list whether a biosimilar is interchangeable with a reference drug, but there are no designated interchangeable biosimilars today (and that seems to be the case in the near future, at least).
Under the Senate BPTA proposal, the originator manufacturer must disclose all relevant patents to the Secretary of Health and Human Services. It states that “…a ‘patent required to be disclosed’ is any patent for which the holder of a biological product license approved under subsection [351](a) or (k), or a biological product application approved under section 505 of the Federal Food, Drug, and Cosmetic Act and deemed to be a license for a biological product under this section on March 23, 2020, believes a claim of patent infringement could reasonably be asserted by the holder, or by a patent owner that has granted an exclusive license to the holder with respect to the biological product that is the subject of such license…” We assume that the patent lists will be provided via the Purple Book, which is supposed to be a reference for prospective biosimilar manufacturers.
The BPTA strives to make the patents held by a manufacturer as transparent as possible. It would require drug makers to list exclusivity periods or any exclusivity extensions received, information related to interchangeability or biosimilarity of a product, approved indications, and mandates updates every 30 days. Of course, this language does not prohibit, restrict, or redress any existing patents. Any changes in the patent law is not the addressed in this proposal.
The seven bill cosponsors (as of May 2, 2019) include a group as diverse as Tim Kaine (D-VA) to Rand Paul (R-KY).
In other biosimilar news…Sandoz announced a partnership with Taiwan-based EirGenix to commercialize the latter’s investigational trastuzumab biosimilar. This agent is currently in phase III trials. Under terms of the agreement, Sandoz will market the agent globally, except for China and Taiwan.
