Comments of the Washington Legal Foundation to the Food and Drug Administration Concerning Citizen Petition by Abbott Laboratories Regarding Biosimilar Applications That Cite Biological Products for Which the BLA Was Submitted to FDA Before March 23,2010

摘要

The Washington Legal Foundation (WLF) submits these comments in support of Citizen Petition No. FDA-2012-P-0317, filed by Abbott Laboratories on April 2, 2012. In particular, WLF wishes to respond to comments filed in recent months with respect to thePetition by the Generic Pharmaceutical Association (GPhA), Therapeutic Proteins International, LLC (TPI), and the law firm of Zuckerman Spaeder LLP (Zuckerman).The Biologies Price Competition and Innovation Act of 2009 (BPCIA), adopted by Congress and signed into law by President Obama on March 23, 2010, creates a pathway whereby firms may seek FDA marketing approval for "biosimilars," biological products thatare highly similar to previously licensed biological products. WLF agrees with Abbott that, in approving biosimilars, FDA will of necessity "use" information supplied to it by the sponsor of the earlier licensed product (often referred to as the "reference product"). As FDA fully recognizes, much of that information—including analytical, preclinical, and clinical data, as well as detailed manufacturing information—qualifies as a trade secret and was provided to FDA with the explicit understanding thatsecrecy would be maintained. Under well-established trade secret law, use of trade secrets that results in diminution in the value of the secrets violates the property rights of the trade secret owner.