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Chief Justice Finds Generics’ Entry Into Drug Maker’s Exclusive Market Does Not Pose Threat of Irreparable Harm

It is rarely in doubt that a drug-maker has the right to bar generic entry into an exclusive market when the drug-maker’s patent is found valid and infringed by a generic applicant, or when such a finding is deemed reasonably likely by the court.

For this reason, it is somewhat surprising that Chief Judge Roberts denied drug-maker Teva’s request to reinstate an injunction against generic entry against its Copaxone® drug product to treat multiple-sclerosis. Notably, all of Teva’s patents-at-issue will expire at least by September 2015. While the length of remaining patent term could have been a factor in the denial of the request, it is difficult to know. The ruling itself is less than 200 words.

The Chief Justice acknowledged that Teva has shown “a fair prospect of success on the merits,” the prong of the analysis that often trips a patentee’s application for injunctive relief. Instead, this relief was denied because the alleged availability of money damages for past patent infringement was found adequate. Thus, the Chief Justice explained, “the extraordinary relief that Teva seeks is unwarranted.”

While it is very rare for the Supreme Court to reinstitute (rather than continue) a commercial injunction pre-hearing, this decision may spur a certiorari challenge to the long-standing view that drug-makers are typically entitled to injunctive relief against generic entry through patents found valid and infringed, or likely so.

Teva’s “fair prospect of success on the merits” is perhaps more interesting because it suggests the Supreme Court agrees with the original premise of Teva’s petition for certiorari, and will reverse the Federal Circuit’s de novo review standard for at least some matters of claim construction.

The case is Teva Pharmaceuticals USA Inc. et al. v. Sandoz Inc. et al., case number 13-854, in the U.S. Supreme Court.

Click HERE to see the order denying the injunction.

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