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Sanofi (SNY) said it is "pleased" with the United States Supreme Court's ruling in Amgen (AMGN) v. Sanofi et. al. The decision unanimously affirms the United States Federal Circuit Court's opinion that is favorable to Sanofi and Regeneron (REGN). Sanofi said: "This ruling reinforces our longstanding belief that Amgen's asserted patent claims are invalid and represents an unequivocal win for America's innovation economy, its scientists, and researchers. Most importantly, it is a win for patients who rely on the lifesaving discoveries made through years of research and investment by the biopharma community. The justices rejected an attempt to radically change the longstanding legal standard for patent validity under the enablement doctrine - a move that would have blocked progress for entire classes of molecules, deterred innovative competition, and led to potential increases of drug prices."

Regeneron Pharmaceuticals (REGN) said it applauds the United States Supreme Court's unanimous opinion ending a nearly decade-long patent dispute related to the Regeneron-invented PCSK9 inhibitor, Praluent. The decision affirms the United States Court of Appeals for the Federal Circuit's opinion, which held that Amgen's (AMGN) asserted U.S. PCSK9 patent claims were invalid. Regeneron said: "This ruling validates Regeneron's longstanding position on this matter and represents an unequivocal win for America's innovation economy, its scientists, and researchers. Most importantly, it is a win for patients who rely on the lifesaving discoveries made through years of research and investment by the biopharma community. The justices rejected an attempt to radically change the longstanding legal standard for patent validity under the enablement doctrine - a move that would have blocked progress for entire classes of molecules, deterred innovative competition, and led to potential increases of drug prices."

In a decision posted to the Supreme Court website, the court stated: "This case concerns patents covering antibodies engineered by scientists that help reduce levels of low-density lipoprotein cholesterol, sometimes called bad cholesterol because it can lead to cardiovascular disease, heart attacks, and strokes. To treat patients with high LDL cholesterol, scientists explored how antibodies might be used to inhibit PCSK9-a naturally occurring protein that binds to and degrades LDL receptors responsible for extracting LDL cholesterol from the bloodstream. Two pharmaceutical companies-Amgen and Sanofi-each developed a PCSK9-inhibiting drug. In 2011, Amgen obtained a patent for the antibody employed in its drug, and Sanofi received one covering the antibody used in its drug... After Amgen obtained the 2014 patents, it sued Sanofi for infringement. Sanofi replied that it was not liable to Amgen for infringement because Amgen's relevant claims were invalid under the Patent Act's 'enablement' requirement. That provision requires a patent applicant to describe the invention 'in such full, clear, concise, and exact terms as to enable any person skilled in the art . . . to make and use the ' as defined by the relevant claims." Reference Link