Court concerned about scope of patent covering millions of antibodies
on Mar 29, 2023 at 3:09 pm
During oral argument in Amgen Inc. v. Sanofi on Monday, the justices explored how to write an opinion on patent enablement when the parties agree on almost everything about the legal standard.
“Enablement” is the requirement that a patent must enable others to make and use the invention without undue experimentation. Amgen obtained a patent covering potentially millions of cholesterol-lowering antibodies. The patent is based on how the antibodies work but lists details for only 26 example antibodies. Sanofi made an infringing antibody and contends that Amgen’s patent is invalid because it fails the enablement requirement.
No clear consensus emerged on Monday about exactly how to resolve the case, but the argument offered three notable themes, all circling around whether a scientist would have to engage in “undue experimentation” to use Amgen’s patented invention.
Skepticism about the breadth of Amgen’s patent
Amgen’s patent addresses monoclonal antibodies that lower LDL, or “bad,” cholesterol. The patent covers every monoclonal antibody that binds to particular sweet spots on a particular protein and blocks that protein from binding to LDL receptors.
The justices seemed concerned about just how much the patent covered. The first out of the gate, Justice Clarence Thomas, asked Jeffrey Lamken, arguing for Amgen, “Would you take a minute and tell us exactly what the invention is?”
At times, Lamken tried to focus the inquiry on a few hundred “meaningfully distinct” antibodies covered by the patent. But everyone else, including many of the justices, framed the patent as applying much more broadly. Arguing for Sanofi, Paul Clement told the justices that the patent covers “millions and millions of antibodies.” This concept of “millions” of potential antibodies became a major focus of the argument, with “millions” appearing in the transcript two dozen times.
Almost no dispute about the legal standard for enablement
Throughout the argument, the justices searched for disagreement between the parties on the legal test. As my case preview suggested, the parties’ written briefs focused on what legal standard the court should adopt, but in reality the parties agree on almost everything, at least when it comes to the proper test. Both sides agree that a patent fails the “enablement” requirement if it requires undue experimentation. And both agree that patents must “enable the entire scope of the claim,” and that the enablement must be “commensurate with the scope of the claims.” They also agree in principle with most of the caselaw from the U.S. Court of Appeals for the Federal Circuit, which hears the nation’s appeals in patent cases.
This general agreement left the justices wondering what exactly the parties wanted them to do. Justice Elena Kagan asked, if both sides “agree on the appropriate legal test,  are we simply arguing now about how that test applies in this case?”
Justice Neil Gorsuch followed up, “So, if we agree on the law, what’s left for this Court?”
In one of the funnier moments of the morning, Clement responded to Gorsuch by inviting the court to dismiss the petition as improvidently granted — which would let Sanofi’s victory in the lower court stand and suggest there was not much for the court to do.
Arguing for the federal government, Colleen Sinzdak echoed Clement’s invitation and added, “We do not think that the Federal Circuit said anything wrong here.”
In light of the broad agreement on the core legal principles, much of the discussion focused on how to apply the “undue experimentation” standard to genus patents — a broad category of invention that is defined by how the thing works. Here, for example, should a court consider the extent of experimentation required to reach any antibody covered by the patent, without knowing which one in advance? Or a specific, particular antibody? Most of the covered antibodies? Or all of the covered antibodies?
The way Amgen’s patent explains things, a scientist essentially creates random antibodies and checks whether they work. Using this technique, it appears to be relatively easy to create an antibody covered by the patent, although the scientist will not know ahead of time which antibody it will be. Lamken claimed that narrowing things from 3,000 antibody candidates to 384 working antibodies costs only $30.
But it appears to be extremely difficult to use the technique to create a specific antibody. Clement said, “I mean, get a big cup of coffee because it is going to take forever.” Sinzdak argued that Amgen has “not given the information that a person skilled in the art would need to make and use all of the antibodies within the genus.”
Ultimately, this case has implications far beyond the particular LDL-lowering drugs at issue. The real question is what it takes to have a valid patent that covers an entire genus.
Stanford law professor Mark Lemley, who wrote a friend-of-the-court brief with a group of other intellectual property professors and multiple academic articles about the importance of allowing genus claims, received considerable airtime. Kagan asked Clement to address Lemley’s view.
Clement did not mince words. “[T]he truth has a way of leaking out,” he admitted, “because I think functional genus claims are terrible. I think they retard the science.” Sinzdak agreed. She told the justices that broad genus claims “stifle innovation.”
Lamken countered that genus claims are “entirely legitimate,” and gave several examples, such as James Watts’ steam engine. “You don’t say which variant, which embodiment of the steam engine you have claimed,” Lamken noted. “It’s the steam engine, that principle, the invention which encompasses myriad types of inventions.”
Today genus patents are particularly common in pharmaceutical, chemical, and biotech development. The court’s decision in this case could have a major impact on innovation and production in these fields.