In a closely watched patent battle, the U.S. Supreme Court on Thursday unanimously ruled against California-based drugmaker Amgen, affirming a lower court’s decision that Amgen’s French rival Sanofi didn’t infringe on patents on a cholesterol-lowering antibody drug.
The long-running feud involves two rival drugs: Praluent, developed by Sanofi and New York partner Regeneron and greenlit by the FDA in July 2015, and Amgen’s Repatha, which won federal approval just a few weeks later. Both drugs are monoclonal antibodies that help lower “bad” LDL cholesterol by blocking a protein called PCSK9.
Amgen sued Sanofi and Regeneron in 2014 over alleged patent infringement. Amgen won the initial trial in 2016, driving Sanofi to the brink of ending Praluent sales in the United States. However, in 2019, a Delaware judge threw out the jury verdict and invalidated Amgen’s patent claims. Eventually, Amgen was able to convince the U.S. Supreme Court to review the case.
The argument boiled down to a legal standard known as “enablement,” which states that a patent must contain enough detail so that a skilled person in the field may use the claimed invention without “undue” trial and error.
In this case, Amgen insisted that its patent application met the standard because it provides all the information needed for a biochemist to make a PCSK9 blocker. On the other side, Sanofi argued that Amgen’s patent claim, which covers thousands of possible antibodies binding to the PCSK9 protein, goes well beyond what the company has actually invented.
In Thursday’s ruling, the high court unanimously agreed that Repatha fell short of the enablement standard.
To illustrate his point, Gorsuch cited an 1895 case in which inventors of an “electric lamp” with an “incandescing conductor” made of “carbonized paper” claimed that Thomas Edison infringed their patent because a lamp he created used bamboo as a conductor.
“[The U.S. Supreme Court] sided with Edison because the rival inventors, rather than confining their claim to carbonized paper, made a broad claim for every fibrous and textile material,” Gorsuch wrote. “That broad claim might have been permissible if the inventors had disclosed ‘a quality common’ to fibrous and textile substances that made them ‘peculiarly’ adapted to incandescent lighting, but they did not.”
Similarly, the court found that Amgen “has failed to enable all that it has claimed, even allowing for a reasonable degree of experimentation.”
“[Amgen] freely admits that it seeks to claim for itself an entire universe of antibodies,” the opinion read. “Still, it says, its broad claims are enabled because scientists can make and use every undisclosed but functional antibody if they simply follow the company’s ‘roadmap’ or its proposal for ‘conservative substitution.’ We cannot agree.”
Regeneron, which oversees the sale of Praluent in the United States, applauded the decision. The company praised the court for pushing back what it called an attempt to “radically change” the legal standards for patents.
“This Supreme Court decision protects access to this medicine and defends our industry and others against overreaching patent claims that cover an entire therapeutic category and could have a chilling effect on bringing life-saving medicines to people in need,” Leonard Schleifer, the company’s chief executive, said in the statement.
Amgen said in a statement that the company is disappointed in the outcome but will “continue to fight for patent laws and policies that provide meaningful patent protection needed to foster breakthrough innovation.”
As of 2022, Repatha remains the better seller of the two drugs, reaching $688 million in U.S. sales in the financial year of 2022. By contrast, Praluent only generated $130 million domestically for the company during the same period.
