Spero (Chief MJ, San Francisco)

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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Defendant Shine Bathrooms had already been hit with an order for default judgment and double damages in a patent case brought by Robern, Inc.  And the hits keep coming for Shine, as it was recently ordered to pay over $250,000 in attorneys’ fees under the “exceptional case” standard of 35 U.S.C. § 285.

Notably, Judge Seeborg awarded attorneys’ fees even though there had been no explicit finding of willfulness.  The opinion explains the relationship between willfulness and exceptional case fees: a finding of willfulness is “a sufficient basis” for awarding exceptional case attorneys’ fees, and “when a trial court denies attorney fees in spite of a finding of willful infringement, the court must explain why the case is not ‘exceptional.’”[1]  An express finding of willfulness is not an absolute prerequisite, however.  In Shine’s case, even though there had not been an explicit finding of willfulness in the order for default judgement, “most of the factors relevant to awarding enhanced damages—including those related to willfulness—weighed heavily against defendant.”[2]


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