January 07, 2021

IAM Quotes Chris Loh on a Surprise Change to the FDA Purple Book That Creates Risk and Opportunity for Biosimilar Producers

2 min

On January 7, 2021, Chris Loh was quoted in IAM on a potentially significant amendment to the U.S. biosimilar patent litigation framework. Requiring the Food and Drug Administration (FDA) to publish information on patents relevant to such disputes, the change seeks to boost transparency and help biosimilar producers bring products to market.

According to the article, the FDA’s Purple Book, which lists approved biologic products, has not hitherto included information on the patents that could be asserted in biosimilar IP disputes under the Biologics Price Competition and Innovation Act (BPCIA). Under this framework, biosimilar applicants have had to depend on their own patent search and analysis efforts to discern the nature of the often large and complex patent estates protecting biologics. Once the biosimilar producer submits its Abbreviated Biologics License Application, a multistep information-sharing process known as the patent dance takes place, helping to determine which rights will be asserted in litigation and in how many phases.

The new section, "Biological Patent Transparency," requires the FDA to publish in its Purple Book a list of biologics exclusivities and patents which originators have included in the 3A lists they send to imitators at the beginning of a patent dance. A 3A list states every patent that a rights holder reasonably believes might be infringed by a biosimilar product, based on the initial product and manufacturing information provided by the applicant.

But the amendment creates potential risks for biosimilar producers. While agreeing that imitators may gain access to some useful information, Loh warns that 3A lists may also reveal sensitive information about biosimilar products. “If 3A listings are more targeted, there could be issues around the confidentiality of the processes used in the production of biosimilar products,” he explains. “Rival biosimilar companies may be able to glean the contours of what the applicant is doing.”