Generic company can challenge patent information a brand manufacturer has submitted to FDA: US SC

In a unanimous decision, the US Supreme Court ruled that Congress has authorized a generic company (under 21 U. S. C. §355(j)(5)(C)(ii)(I)) to challenge the patent information a brand manufacturer has submitted to the FDA by bringing a counterclaim against the brand manufacturer in a patent infringement suit.

The Court said “We hold that a generic manufacturer may employ this provision to force correction of a use code that inaccurately describes the brand’s patent as covering a particular method of using the drug in question.”

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