BREAKING NEWS: Federal Circuit vacates injunction against sale of Praluent®

Biologics Litigation  •  U.S. Federal Circuit Decisions

As we reported earlier this year, on January 5, 2017, Judge Robinson of the District of Delaware entered a permanent injunction prohibiting the sale of Sanofi and Regeneron’s Praluent® (alirocumab) product after the defendants stipulated to infringement of the asserted claims of the patents and a jury found the claims to be valid.  On February 8, however, the Federal Circuit issued a stay of the injunction, pending appeal.

This morning, the Federal Circuit issued an opinion that vacated the permanent injunction and remanded the appeal to the district court for a new trial on the defendants’ lack of written description and lack of enablement defenses. The Federal Circuit ruled that the district court had erred by categorically excluding evidence regarding those defenses and improperly instructed the jury regarding written description.

The Court explained that it was vacating the permanent injunction on multiple grounds. As an initial matter, vacatur of the injunction was necessary because the Court was vacating the district court’s judgment as to written description and enablement and remanding for a new trial.  The Court also found that the district court’s permanent injunction analysis was improper for two reasons:  First, the Court noted that an injunction was improper here because “the district court had concluded that issuing a permanent injunction would disserve the public interest.”   Citing the Supreme Court’s eBay decision, the Court explained:  “If a plaintiff fails to show ‘that the public interest would not be disserved by a permanent injunction,’ then the district court may not issue an injunction.”

Second, the Court found that the district court had erred in its analysis of the “public interest” factor by relying solely on the defendants’ argument that the public would be disserved by an injunction because it would eliminate the public’s choice of available drugs. The Court explained that “[j]ust as a patent owner does not automatically receive an injunction merely by proving infringement, see eBay, 547 U.S. at 394, an accused infringer cannot escape an injunction merely by producing infringing drugs.”  “Accordingly,” the Court held, “a reduction in choice of drugs cannot be the sole reason for a district court to deny an injunction.”

The Federal Circuit’s decision, however, is only a reversal and vacatur in-part: The Court affirmed the district court’s grant of judgment as a matter of law of non-obviousness, finding that the district court correctly excluded the defendants’ proffered references as improper prior art.

Stay tuned to Big Molecule Watch for further coverage of this case.

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