Biosimilar Patent Disputes — An Update On The Last 8 Months

Law360, New York (March 31, 2015, 10:27 AM EDT) -- Last September, our Law360 Expert Analysis piece, "Biosimilar Patent Disputes: What Sandoz Appeal May Clarify," brought readers current on the legal guidance to date on scope and exclusivity of the statutory framework of the Biologics Price Competition and Innovation Act for adjudicating patent disputes between an innovator and an entity seeking approval of an alleged biosimilar.[1] As we discussed, the Biologics Act provides a specific and unique set of procedures for the exchange of patent information between the innovator and biosimilar applicant and the litigation of related patent disputes. At that time, the U.S. Food and Drug Administration had only recently...

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