US Congress confirms new drug patent listing law
A $2.3 trillion spending bill passed by the US Congress yesterday, December 21 includes a proposed change to the laws concerning biologic drugs.
The coronavirus relief bill, which provides for $900 million in economic relief from the COVID-19 pandemic and $1.4 trillion in federal spending, includes changes to the law that will compel biosimilar companies to share patent data with the Food and Drug Administration (FDA) so that it becomes publicly available.
According to the Biologics Price Competition and Innovation Act (BPCIA), biologics licence holders and companies seeking to market a generic product must exchange information about patents that could feature in subsequent litigation. Until now, that exchange—except as revealed in court filings—has been private.
In February 2020, the US Food and Drug Administration confirmed plans to improve the transparency of its database of all FDA-licensed biological products. Officially known as the “ Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations,” the database is commonly referred to as the “Purple Book".
On December 10, the US Senate passed two bills, H.R. 1520 (Purple Book Continuity Act of 2019) and H.R. 1503 (Orange Book Transparency Act of 2019) to ensure greater transparency in drug patent listings; increase competition in the generics market; and reduce the cost of prescription drugs.
The bill passed on Monday enacts the first of these laws, which holds that the FDA's Purple Book must include more information about the patents that cover the products featured in the book, and will require pharmaceutical companies to submit more information about their products to the FDA.
Proponents of the mandate say that it will prevent patent listing errors that could delay biosimilars from coming to the market sooner. However, critics of the proposed measure have suggested the changes to the Purple Book do not go far enough.
Writing in the National Law Review, Christopher Bruno, senior associate at McDermott Will & Emery, stated: “While the bill puts a new burden on brand manufacturers to list their patent information for public availability, the disclosure only includes patents that have already been identified and exchanged between parties in a BPCIA pre-litigation exchange.”
While the Senate’s second bill provided for similar changes to requirements for the FDA's Orange Book for small-molecule drugs, this provision was omitted from Monday's bill.
