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Cholesterol drug patent case shot down by Supreme Court

Drugmaker Amgen lost its bid to overturn a lower court ruling that invalidated its patents for the creation of antibodies to treat patients with high cholesterol.

WASHINGTON (CN) — In a unanimous ruling Thursday, the Supreme Court shot down the patent case of a pharmaceutical company behind drugs that purport to lower bad cholesterol.

Amgen initiated the litigation at hand in 2014, claiming that Sanofi, a rival French drugmaker, and its partner Regeneron were marketing a drug called Praluent whose makeup infringed its patents for monoclonal antibodies that are key to the Amgen drug Repatha.

Amgen identified 26 antibodies that bind to the protein PCSK9 — which inhibits the extraction of cholesterol from the bloodstream — in its patents by amino-acid sequence, but the company's attorney noted that thousands if not up to millions of other sequences would produce the same result when binding to the gene and could be produced by following the patent’s “step-by-step roadmap” through a process of trial and error. 

Attorney Jeffrey Lamken said at arguments in March that Amgen’s patents are for all antibodies that would bind to PCSK9, including those used in Repatha.

Although a federal jury in Delaware sided with Amgen, agreeing that its patents would apply to the competitor’s drug, the presiding judge overturned their verdict and ruled in favor of Sanofi, a decision that the Federal Circuit later upheld. 

Earlier this year, Amgen appealed to the high court for reconsideration of whether its two Repatha patents are valid based on a section of the Patent Act relating to the written description of the patent. Sanofi argued that the patents miss the law’s enablement requirement if the public “cannot predictably produce specific undisclosed embodiments of the claimed invention” without significant trial and error.

The National Association of Patent Practitioners, pharmaceutical companies, intellectual property law groups, and multiple other entities involved in scientific research filed amici curiae briefs to the Supreme Court in support of Amgen's claim. They argued that the circuit court's ruling imposes hard to overcome barriers that not only prevent innovators from receiving commensurate protection, but threaten scientific innovation and incentives for companies to invest in new discoveries as well.

Sanofi referred to Amgen's suit in its response brief as a "blatant attempt" to rid the market for the anti-cholesterol drug of competitors at arguments. The company, represented by attorney Paul Clement, a former U.S. solicitor general, was backed by Justice Department attorney Colleen Sindak at arguments.

In Thursday's ruling, the justices also sided with Sanofi's argument that Amgen’s patents failed to meet the enablement requirement in their application, which means that the disclosure must explain enough about the invention so that someone skilled in the art can both make and use the invention.

Amgen’s patents failed to meet this standard because they sought to claim an exclusive use of potentially millions more antibodies than the 26 identified by the amino acid sequences that they had taught scientists to make. According to the justices, the company's "roadmap" and substitution proposals to make and use the "entire universe of antibodies" that they seek to claim, forces scientists to "engage in 'painstaking experimentation' to see what works."

"Section 112 of the Patent Act reflects Congress’s judgment that if an inventor claims a lot, but enables only a little, the public does not receive its benefit of the bargain. For more than 150 years, this Court has enforced the statutory enablement requirement according to its terms," Justice Neil Gorsuch wrote. "Today’s case may involve a new technology, but the legal principle is the same."

A spokesperson for Amgen said they are "disappointed" in the outcome of the case, but "will continue to fight for patent laws and policies that provide meaningful patent protection needed to foster breakthrough innovation."

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Categories / Appeals, Business, Government, Health

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