- A U.S. District Court jury ruled in favor of Amgen in its PCSK9 patent fight against Regeneron and Sanofi, the defending companies said on Wednesday. The jury upheld the validity of two Amgen patents on antibodies targeting the PCSK9 enzyme, which binds to LDL cholesterol receptors.
- Amgen had sued Sanofi and Regeneron in 2014, claiming their high-cholesterol drug Praluent infringed on Amgen's patents for Repatha. Both Praluent and Repatha were approved by the FDA only one month apart, in July and August of last year.
- The jury, however, did not award damages or set royalties. A hearing on a permanent injunction will be held in the "near future." Regeneron indicated it would appeal the case in the Federal Circuit Court of Appeals.
The verdict will likely hurt Sanofi and Regeneron as they work to compete against Amgen in the PCSK9 space. Both are priced similarly high, at $14,000 a year, and have faced slower uptake than expected post-launch.
The two have split payer coverage, with UnitedHealth's OptumRx making Praluent its preferred drug, while CVS Health exclusively covering Repatha. The other major pharmacy benefits manager, Express Scripts, has covered both drugs but recently indicated both drugs would need to be "appropriately managed" in an annual drug price report.
In a joint statement reacting to the verdict, Regeneron and Sanofi indicated they "strong disagree" with the decision. "Sanofi and Regeneron believe these Amgen patent claims are invalid in the ongoing U.S.patent infringement lawsuit and plan to appeal the judgment," the companies said. The appeal would go the Federal Circuit Court of Appeals.
For its part, Amgen indicated it expected damages proceedings to follow, while thanking the jury for ruling in its favor. "We are thankful that the jury weighed the evidence carefully and recognized the validity of Amgen's patents on Repatha," said Amgen CEO Robert A. Bradway.
Sanofi and Regeneron characterized the jury's decision as a first step in an ongoing process and emphasized it would not impact the companies' ability to deliver the drug to patients.
Praluent pulled in only 9 million euros in sales since July, but Sanofi and Regeneron hope its expanded coverage in the U.S. market will boost that figure. Although Amgen did not break out Repatha sales in its fourth quarter report, it has likely not earned much more than Praluent's figure.
The case was heard in Federal Court in Delaware and a hearing on a permanent injunction is set for March 23-24, according to The Street. Damages or potential royalties owed to Amgen will also have to be determined.
This post has been updated to include a statement from Amgen.