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Court grants injunction to prevent US sales of alirocumab due to patent infringement
The U.S. District Court in Delaware has granted an injunction preventing the manufacture, use, sale or offering the sale of the PCSK9 inhibitor alirocumab in the United States due to patent infringement, according to press releases from Amgen and Sanofi/Regeneron.
The injunction will not take effect for 30 days so that Sanofi and Regeneron, manufacturers of alirocumab (Praluent), can seek expedited review of the decision, according to the releases.
In March, a jury ruled in favor of Amgen, manufacturer of evolocumab (Repatha), that two of its patents describing and claiming monoclonal antibodies to PCSK9 were valid.
“The companies believe Amgen’s asserted claims are invalid and will also appeal a prior jury verdict upholding the validity of those patents,” Sanofi and Regeneron stated in their release.
“We will continue to vigorously defend our case through the appeal process as we believe the facts and controlling law support our position,” Joseph LaRosa, senior vice president, general counsel and secretary for Regeneron, said in the release.
Robert A. Bradway, Amgen’s chairman and CEO, said in Amgen’s release: “We are pleased with [the Jan. 5] decision that recognizes Amgen is entitled to an injunction against further infringement of our patent rights. Sanofi and Regeneron admitted they had infringed our patents, and the jury upheld our patents as valid. Protecting intellectual property is essential to our industry as it reinforces the incentives for the large and risky investments we make in innovation to bring forward new medicines to treat serious diseases.”
Amgen stated in its release that it “has the ability to supply all potential Repatha patients and will work to ensure a smooth transition for patients who wish to switch to Repatha.”
Both agents were approved by the FDA in 2015 for reduction of LDL in high-risk patients with atherosclerotic CVD or familial hypercholesterolemia. Both are undergoing outcomes trials to determine the effect on CV events, which could lead to an expanded indication.
Disclosure: Bradway is an employee of Amgen. LaRosa is an employee of Regeneron.
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PCSK9 inhibitors have enormous therapeutic potential to reduce CVD. The patent issues involved are complex, but this is basically a dispute regarding the legality of the broad number of epitopes for PCSK9 binding that Amgen was able to claim in their patents. Regeneron does not deny that their patent infringes on the epitopes claimed in the Amgen patents, but argues that the patent is too broad and therefore invalid. Legally imposed injunctions are unusual, but Amgen was able to successfully convince a federal judge that there is no compelling reason to have both evolocumab and alirocumab on the market while the appeals process continues.
I agree that both evolocumab and alirocumab have comparable efficacy and safety. As clinicians, we will be able to manage the switching of patients from alirocumab to evolocumab, but I am concerned about the lack of competition that may keep costs under better control. With the recent failure of bococizumab, Pfizer’s anti-PCSK9 monoclonal antibody, there will be less competition in the foreseeable future and with outcome trials due to be reported soon, the demand for anti-PCSK9 therapies may significantly increase. I am hopeful a settlement can be reached so we can move forward with continuing to provide this novel class of therapies to our patients who need more aggressive lipid management despite maximally tolerated statins at a reasonable price.
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This action is critically important concerning the ongoing clinical trials examining at the effects of alirocumab on adverse outcomes. For example, ODYSSEY Outcomes has more than 18,000 patients enrolled and is in late follow-up but will require continued supply of alirocumab in order to answer the question of effects on outcomes. It is imperative that U.S. patients be permitted to continue with drug supply until trial completion.