Judge tosses pharmaceutical patent suit for failure to join required party Astellas US

By Scott Holland | May 6, 2019

SAN FRANCISCO – A federal judge agreed to dismiss a pharmaceutical patent infringement suit over jurisdictional issues.

Plaintiff Apotex Inc. wants to market a generic version of Lexiscan, a single-dose prefilled syringe containing a drug commonly used in heart stress tests. On Oct. 23, the company sought declaratory judgment that its regadenoson product did not violate defendant Gilead Sciences’ patents or infringe on the rights of defendant Astellas Pharma US, which held the new drug application for Lexiscan.

Two days later, Gilead and Astellas Pharma asked to have the claims against Astellas dismissed over the argument the court does not have jurisdiction and the entire suit should be dismissed because Apotex did not include Astellas US LLC, a required party. The defendants argued Astellas US LLC cannot be joined because it also is not subject to personal jurisdiction of the court.

According to an opinion written by Chief Magistrate Judge Joseph Spero and filed Jan. 31, Apotex did not dispute the jurisdiction issue relative to Astellas Pharma or Astellas US, leaving only the issue of if dismissal is appropriate based on failure and inability to join a necessary party.

Spero explained The Hatch-Waxman Act allows a generic drug manufacturer to seek expedited approval to market a generic version of an already-approved drug by submitting an abbreviated new drug application. Such a company must send written notification to the patent holder and new drug application holder, then wait 45 days before moving for a declaratory judgment of noninfringement. In addition to the dispute with Apotex, Gilead and Astellas filed three other objections to companies seeking to market generic versions of Lexiscan; those actions are pending in Delaware.

Neither Hatch-Waxman nor the Declaratory Judgment Act expand federal jurisdiction to allow a company to exclude the holder of a new drug application from the motion seeking declaratory judgment, Spero explained. He also found nothing that “suggests that Congress intended to limit the normal procedural rules governing joinder of required parties with respect to such actions or to modify the jurisdictional requirements under substantive patent law.”

Apotex said Astellas US is not an exclusive licensee, at least insofar as is needed to establish whether it must be included in the motion. Included in Apotex’s reasoning is the notion that as a solution, rather than a crystal, Lexiscan is not covered by the relevant patents.

Spero disagreed, saying the evidence shows Astellas US holds an exclusive license and that regadenoson is the solution that comprises Lexiscan. And in any action challenging a patent, an exclusive licensee must be joined. Since there is no dispute the U.S. District Court for the Northern District of California does not have jurisdiction over either Astellas defendant, it is not feasible to join Astellas US.

Allowing Apotex to sell its generic before the patents expire would likely have a substantial negative impact, and since Astellas US’ interests are not identical to Gilead’s, “the risk posed by a competing generic product will therefore have a disproportionately negative impact” on Astellas US, leading Spero to determine Astellas US would be prejudiced if not allowed to join the action, the ruling states.

Spero reached his finding without oral argument and vacated a hearing set for Feb. 8 as part of granting the motion to dismiss.

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