In this article, Paul A. Calvo, Ph.D. discusses the growth of biosimilars that is leading many biopharmaceutical firms to seek second-generation patents, particularly for antibody production. “With respect to biosimilars, the reason for increased interest in keeping information secret is the sense that many originator companies will bypass filing for patent protection,” said Dr. Calvo. The article discusses patent hurdles, prior user defense, trade secrets, business flexibility, and inter partes reviews.

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