Must Whole Patent Be Nixed To Forfeit 180-Day Exclusivity?

By Jaimin Shah and Steve Auten (July 25, 2018, 1:09 PM EDT) -- What happens to a first applicant's 180-day exclusivity when the Federal Circuit issues a final decision rendering only the asserted claims (i.e., less than all claims) of a patent invalid or not infringed? Is such a finding sufficient to trigger forfeiture of the exclusivity under the statute? Our research has not found a court or U.S. Food and Drug Administration decision that has yet considered this question.[1],[2]...

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