New law to improve USFDA Purple Book transparency

January 22, 20210

FDA has taken a crucial step towards improving patent transparency of licensed biologics in a bid to ease biosimilar markers’ access to patent-associated information with regards to biologics. A new law under the Biological Product Patent Transparency Act (BPCIA), signed on December 22, 2020 now requires companies with a biological reference product to disclose patent lists associated with the product to the US FDA within 30-days of disclosure of information to biosimilar companies that have sought such information under the statutorily prescribed pre-litigation exchange of information.  

Previously biosimilar makers had to conduct their own diligence and engage in a “patent dance” of sorts to gain access to patents associated with a biological reference product under a confidentiality agreement with the innovator company. This was a time-consuming practice and often delayed development or commercial launch of biosimilars as some patent information could be difficult to uncover in a freedom-to-operate analysis and licensed patents from other companies, patents on manufacturing processes or specific cell lines would then pose a roadblock in the development and launch of potential biosimilars if the companies entered into a litigation. 

Under the new law, first biosimilar applicant would still require to go through their own diligence and follow the previous route, but all disclosed patents will be made available to public within 30-days of exchange of such information. The available information can be accessed by any subsequent biosimilar makers and would improve transparency of patent rights and hence, avoid any time-intensive patent diligence by biosimilar makers. Disclosed patents for all biologic drugs will be made available to public from June 2021.  

Additionally, the new law also requires FDA to state the exclusivity period for each biological product. Currently, the FDA does not disclose exclusivity period for biologics and although BPCIA provides 12 years of exclusivity, not all innovator biologics are eligible for a 12 year exclusivity period and the said period is determined by on a case-to-case basis. 

The new law is a commendable step towards improving access to biologic information to biosimilar makers and would ease the process of conducting a diligence for development and commercial launch of the product and increasing access to many life-saving biosimilar drugs.  

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