Sanofi wins Supreme Court cholesterol drug dispute with Amgen
Amgen had sought to collect millions in damages from Sanofi because the pharmaceutical company makes a rival drug called Praluent, which works by a similar mechanism as Amgen’s Repatha, in a case dating back to 2014.
In a complicated case involving biotech patents for a high cholesterol treatment – and being closely watched by the patent world – the Supreme Court on Thursday affirmed the Federal Circuit and handed a major victory to Sanofi in its intellectual property battle with Amgen over Repatha, a treatment for high cholesterol.
Amgen sought to collect millions of dollars in damages from Sanofi and its partner, Regeneron Pharmaceuticals because Sanofi makes a rival drug called Praluent, which works by a similar mechanism as Repatha. Amgen initially sought a court injunction to force Praluent off the market, which was denied by an appeals court.
In the Supreme Court case, Justice Neil Gorsuch’s opinion, which dated back to 2014, shirked recent precedents in the biotech space and instead focused on some of the Supreme Court’s early patent precedents, involving inventors who have become household names taught in grade school.
“Today’s case may involve a new technology, but the legal principle is the same,” Gorsuch wrote.
The decision involved the technical question over whether Amgen’s patent claims for a certain type of cholesterol treatment were properly “enabled” under the Patent Act. In order for patent claims to be considered as such, they need to be described “in such full, clear, concise, and exact terms as to enable” a skilled professional to make and use the invention.
Gorsuch, writing for a unanimous court, said Amgen had not met that bar. Amgen had claimed a monopoly on “the entire genus” of antibodies that help the body’s process of extracting bad cholesterol, without actually explaining how scientists might create them, he said. Amgen’s descriptions of coming up with the antibodies “amount to little more than two research assignments,” Gorsuch said. “Amgen offers persons skilled in the art little more than advice to engage in ‘trial and error.’”
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The ruling, though perhaps unwelcome news to patent owners, is not necessarily a bombshell for the patent world, said Will Milliken, the co-chair of the appellate practice at the intellectual property boutique Sterne Kessler.
“I don’t think that this decision signals a sea change in the law for patent practitioners because, at least at a high level, it means that the law is basically what the Federal Circuit has been saying the law is,” he said.
Still, Milliken found the sources of authority that Gorsuch relied on in his opinion to be notable.
“Rather than use precedents in antibody cases, or even in biotech cases like maybe from more recent Federal Circuit decisions, the Supreme Court went back and based its reasoning on its own enablement decisions, which are all quite old and deal with very different technology areas,” he said. “It’s also another example of the Supreme Court in patent cases going back to the first principles that it laid down maybe in the 1800s and not caring so much about the way that the doctrine may or may not have developed in the lower courts in the more modern era.”
One of the first decisions that Gorsuch cites in the case comes from the 1854 case O’Reilly v. Morse. Gorsuch sets the scene by introducing famed inventor Samuel Morse as he comes up with a prototype for a telegraph system while speaking to his fellow passengers about electromagnetism on a transatlantic voyage.
Years later, Morse found himself defending the validity of his patent for the telegraph before the Supreme Court, which upheld most of his claims with the exception of one it deemed “too broad, and not warranted by law.”
“The problem was that it covered all means of achieving telegraphic communication, yet Morse had not described how to make and use them all,” Gorsuch explained.
Gorsuch also invoked Thomas Edison in a 1895 case known as The Incandescent Lamp Patent. In that case, the court ruled in Edison’s favor and said that a patent for an “electric lamp” owned by Edison’s competitors, William Sawyer and Albon Man, had claimed too much without the proper justification.
“Instead of confining themselves to carbonized paper, as they might properly have done, and in fact did in their third claim, they made a broad claim for every fibrous or textile material,” the Supreme Court wrote in its decision at the time.
Finally, Gorsuch cited a 1928 decision known as Holland Furniture Co. v. Perkins Glue Co. involving starch glue for wood veneering.
What should modern day patent litigators in the biotech sphere make of Gorsuch’s ruling?
“It’s helpful that we have a definitive pronouncement on what the law is from the Supreme Court, but there’s not a ton of guidance beyond the principles that everyone already seemed to agree on,” said Sterne Kessler’s Milliken, whose firm filed an amicus brief supporting Amgen in the case at the Federal Circuit.