The U.S. Court of Appeals for the Second Circuit upheld a decision by Judge Ronnie Abrams, who found that Takeda could be liable for effectively tricking the FDA into requiring other drugmakers to challenge Takeda’s patents instead of letting them “carve out” non-infringing methods of use.
The gamesmanship led to a regulatory process strewn with bottlenecks, according to the consolidated proposed class actions. ...
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