Pharmaceutical Hatch-Waxman litigation proceeds under a unique framework.  In this case, Hatch-Waxman declaratory judgment (“DJ”) defendants Gilead Sciences, Inc. (“Gilead”) and Astellas Pharma US, Inc. (“Astellas Pharma”) sought to dismiss Astellas Pharma for lack of personal jurisdiction and improper venue, and to dismiss pursuant to Federal Rule of Civil Procedure 19 non-joined and “necessary party” Astellas US LLC (“Astellas LLC’), the exclusive licensee.[1]  DJ plaintiff Apotex Inc. (“Apotex”) did not contest dismissing Astellas Pharma, nor seriously contest lack of personal jurisdiction or improper venue of Astellas LLC.  Instead, Apotex sought to apply the plain language of the Hatch-Waxman Act and its specific provisions regarding Hatch-Waxman DJ actions to prevent dismissal under Rule 19 for failure to join a required party.[2]  Thus, the dispute centered on whether Rule 19 of the Federal Rules of Civil Procedure (“FRCP”) applied to Hatch-Waxman DJ actions and, if so, whether Astellas LLC was a required party necessitating dismissal.

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