Supreme Court Sides with Sanofi and Regeneron in High-Stakes Patent Dispute with Amgen

The U.S. Supreme Court has delivered a long-anticipated victory to pharmaceutical giants Sanofi and Regeneron, ruling unanimously in their favor in a decade-long battle with Amgen over the groundbreaking PCSK9 cholesterol drug Repatha. The Court’s judgment brings a much-needed end to this arduous intellectual property dispute.

The Supreme Court recently ruled in favor of Sanofi and Regeneron in their long-standing patent dispute with Amgen over the cholesterol-lowering drug Repatha. The Supreme Court affirmed the lower court’s decision that Sanofi and Regeneron had not infringed on Amgen’s patents. This ruling marks the end of their legal battle and brings relief for the pharmaceutical industry.

Amgen’s move to monopolize every antibody within the PCSK9 class – those that bind to the sweet spot and block PCSK9 from binding to LDL receptors – has been criticized as a step too far. Even though they have identified 26 such antibodies by their amino acid sequences, there is an enormous number of others that Amgen apparently seeks to restrain. This view was upheld unanimously by Supreme Court Justice Neil Gorsuch in an important ruling.

The unprecedented legal battle between Amgen, the maker of Repatha, Sanofi, and Regeneron for Praluent captivated the drug industry, as the courts were tasked to decide the validity of Amgen’s patents and grant market access for the competition. Despite the intense tug-of-war between the parties, the court’s ultimate ruling will determine the fate of both drugs in the market.

In a unanimous decision, the Supreme Court confirmed a lower court’s ruling, invalidating Amgen’s patents for a PCSK9 inhibitor due to “lack of enablement.” This ruling represents a devastating blow to Amgen who had been attempting to protect its exclusivity of this product in the face of increasing competition for years.

Justice Gorsuch’s ruling on a patent suit brought by Amgen provided clear proof of what some had suspected: that the company’s offer to skilled individuals was more a matter of trial and error than actual guidance. His finding uncovered Amgen’s vague advice, paving the way for a legal sticking point in patent disputes.

The recent ruling by the federal court, potentially impacting biopharma companies’ intellectual property rights, is welcomed news. It will pave the way for increased market competition, leading to more affordable prices of PCSK9 inhibitors and, as a result, better access to these life-saving drugs for patients and healthcare systems. It’s a victory for everyone who stands to benefit from more competitive markets and lower medicine costs.

Sanofi and Regeneron rejoiced in the ruling as a triumph for creativity and rivalry in the domain of cholesterol-lowering medications. Their assertion that allowing them to increase patient access to Praluent will offer an alternate choice for those suffering from high cholesterol was validated.

Amgen expressed its dismay upon the court’s ruling on its patents, asserting that they do fulfill the legal requirements for enablement. “We strongly disagree with the court’s interpretation of the patents,” the company said in an emailed statement to Endpoints.

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