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Biologics and biosimilars together represent a rapidly growing component of the pharmaceutical marketplace, and the unique legal issues that accompany them demand careful strategic planning to successfully navigate proceedings in the myriad venues where disputes will inevitably arise: from the US Patent and Trademark Office (USPTO) and US courts to patent offices and courts abroad. Here, we outline the regulatory and intellectual property legal regime for biosimilars in the US, including the avenues that legal disputes may take, and highlight considerations that US counsel representing clients in biosimilar disputes must weigh to coordinate a global litigation strategy.

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Alicia Russo has extensive experience litigating and prosecuting biologics, biotechnology, bioinformatics and pharmaceutical patents. She has a B.S. in Biology and Chemistry, and an M.S. in Biomedical Sciences. Alicia has published original papers in Science, Nature, Cell and the Proceedings of the National Academia of Sciences.

Methodology

Information contained in the Venable Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable Fitzpatrick BiologicsHQ database.

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