The Truth Leaks Out: Justices Struggle with the Science, Sanofi Welcomes End to Functional Genus Claims in Amgen Oral Arguments

The U.S. Supreme Court heard three separate arguments today in Amgen v. Sanofi, a case that even Sanofi’s counsel agreed could effectively wipe out patents involving genus claims if the Court sides with Sanofi, or—as counsel for Sanofi and the Solicitor General’s Office suggested the Court could do—if it were to dismiss the case as improvidently granted (DIG).

The Court is considering the following question in the case:

“Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to ‘make and use’ the claimed invention, 35 U.S.C. § 112, or whether it must instead enable those skilled in the art ‘to reach the full scope of claimed embodiments’ without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial ‘time and effort.’”

Lamken: Show Why the Amount of Experimentation Matters

Arguing for Amgen, Jeffrey Alan Lamken of MoloLamken repeatedly emphasized that “those seeking to overturn the PTO’s issuance of a patent and verdicts upholding them have to do two things: 1) at least have evidence of some variant in the invention that requires painstaking experimentation and 2) if they identify that, show why that matters to skilled artisans. Because the statute’s about skilled artisans seeking to make and use the invention and reasonableness, not theoretical far corners never shown to affect the ability to do so.”

But the Justices seemed to struggle with grasping what the invention actually is, and expressed some skepticism about the various numbers mentioned in the patent. Amgen’s U.S. Patents No. 8,829,165 (the “’165 patent”) and No. 8,859,741 (the “’741 patent”) identify “the amino-acid sequences of 26 antibodies that bind PCSK9’s sweet spot and thereby block PCSK9 from binding to LDL receptors,” and the company created “384 antibodies that blocked PCSK9 from binding LDL receptors ‘well,’ and 85 that blocked the interaction by ‘greater than 90%.’” The Justices asked Lamken to address Sanofi’s claim that the scope of what Amgen has claimed is actually “millions and millions of antibodies” but his explanations did not put an end to the line of questioning.

Amgen’s argument is that the Federal Circuit’s requirement that one must “reach the full scope” of the claims creates a heightened standard that asks an irrelevant question—it should be quality of experimentation rather than quantity that matters. But Lamken’s inability to provide specific numbers of antibodies covered by the patent seemed unsettling to some of the Justices. Justice Thomas challenged Lamken on the point more than once, and Justice Kagan asked why Amgen had not actually made all of the about 400 antibodies it said blocked PCSK9 from binding LDL receptors if the process for doing so is as routine and easy as Lamken implied. Lamken responded that “a skilled artisan isn’t looking for every possible antibody; they’re just looking for the ones that bind to the right place.”

Clement: Functional Genus Claims are Terrible

For Sanofi, while Paul Clement of Clement & Murphy seemed to have an easier time with respect to questioning overall, he made a surprising admission to Justice Kagan when she asked him to respond to Professor Mark Lemley’s amicus brief claiming the Federal Circuit’s approach would wipe out valuable patents in this area:

Kagan: Mr. Clement, can I ask you to address Professor Lemley’s brief? He has a — seems to have a very strong view that these antibody genus claims are valuable – patents are valuable, or potentially so, and that the Federal Circuit’s test is going to pretty much wipe them out across the board. So why is it that Professor Lemley is wrong in your view?

Clement: ” I think he’s wrong that the existing federal circuit precedent is going to foreclose all genus claims…. It may be in this particular area of antibody science given the current state of the science that you may not have an ability to functionally claim a genus and that’s at some level nobody’s fault, it’s just the way the science works – and personally I think it’s great because what it does is allows different companies to independently develop different large molecule therapies to deal with the same malady.”

Kagan: “I hear you saying that he might be right about the federal circuit’s test invalidating most of these patents, but that’s okay, because we shouldn’t want these patents around.”

Clement: “The truth has a way of leaking out – I mean, yeah, I am saying that because I think functional genus claims are terrible. I think they retard the science.”

Clement pointed the Justices to Sir Gregory Winter’s amicus brief, which argues that “Amgen’s claimed ‘invention’ is simply a hindsight characterization of that which existed naturally.” Winter is a Nobel Prize-winning English molecular biologist known for his work on the therapeutic use of monoclonal antibodies. In his rebuttal, however, Lamken called Winter’s brief “the functional equivalent of an expert report,” which “so closely parallels Sanofi’s brief in the court of appeals that I would commend the Court to look at our reply brief there and it will have the answers to virtually everything that Mr. Winter has [said].”

Clement also used the example of a process for making paint to illustrate the way enablement should work in his view. If one step in the paint making process was to add pigment for the desired color, Clement said, “[w]ell, then a skilled artisan would be able to use that, an actual roadmap, and they would say, all right, I want robin egg blue and they could produce it every time. And if they wanted chartreuse instead, they could produce it any time.”

And while there may be an infinite number of colors one could produce, that would not invalidate the patent if the patent owner failed to produce every single one, because it provides the necessary information to get what the artisan wants every time, Clement explained. However, he added, “this patent does not work this way. What they give you in their roadmap is trial and error.”

U.S. Government: If Antibodies are Special, That’s Congress’s Call, Not the Courts

Colleen Sinzdak of the U.S. Solicitor General’s Office told the Court that the 26 antibodies specifically disclosed in Amgen’s patents are all that is enabled, because they contain the amino acid sequences necessary for a scientist to go into a lab and make those antibodies. “The reason here, just on the clear facts that this is not an enabled genus, is that they have not given the information that a person skilled in the art would need to make and use all of the antibodies within the genus,” Sinzdak said. “It really is that simple.”

Justice Sotomayor asked Sinzdak what the Court should say if they choose not to “DIG” the case, as Clement had earlier joked they might want to do, in order to help explain the law to everyone interested in this area of science. Sinzdak replied that the Court could DIG the case, since the government does not think the Federal Circuit said anything wrong, but that “some of the arguments that we’re hearing from Petitioners suggest that it might be useful to clarify that you really do need to enable each of the different embodiments that you’re claiming that you can’t say these ones don’t “matter….”

Justice Kavanaugh followed up by asking Sinzdak if it would be important for the Court to say it agrees with the Federal Circuit, if it does, “because there’s been, as Justice Kagan points out, a lot of critiques of the Federal Circuit’s approach, and if billions of dollars were on the line, this Court saying as much…along the lines that you propose would eliminate that uncertainty about the legal standard, and then everyone would know it’s up to Congress.”

Sinzdak agreed with the Court that it would be helpful, and noted that, to the extent the Justices agree that antibody patents may just be different, it’s important to note that it’s Congress that needs to “make a special antibody exception” to the patent law.

On rebuttal, Lamken said the “cumulative effort” analysis the Federal Circuit has articulated is not relevant as long as skilled artisans can “make the one they want.” He warned the Court that this case “has incredible impacts,” adding: “Nobody can invest billions of dollars with this decision out there. Nobody can invest billions of dollars if it’s even relevant.”

Hot Takes

Here are some initial reactions to the arguments.

Judge Paul Michel
Chief Judge (ret.), U.S. Court of Appeals for the Federal Circuit

“What human health innovation policy does not need is a brilliant but scientifically uninformed Supreme Court advocate, Paul Clement, guessing that genus claims “retard the science.” How would he know?

As to other companies ‘independently’ developing ‘large molecule therapies to deal with the same malady’, he is again ill-informed, this time about how patent law works. The other companies can and do ‘design around’ the patent, then patent their new invention themselves. This race to the top spawns many new therapies. Nor does anyone doing design around experiments on a patented molecule get sued for infringement but is protected under experimental exception to infringement.”

Matthew Dowd
Dowd Scheffel

“The apparent concern about genus claims is misguided and unfortunate. The use of genus claims for pioneering innovation allows innovators to make discoveries that open many new lines for future development. Those who first invent can rarely perform every experiment and create every embodiment that will follow from the breakthrough innovation. Imposing a standard that forces innovators to spend time generating rote data—in excess of that needed to teach skilled persons to practice claimed inventions—is not consistent with the quid pro quo of the patent system. In an amicus brief filed on behalf of Nature’s Fynd (an innovative food company turning fungal mycelium into a breakthrough protein product), we explained, for example, how the broad Cohen-Boyer patents in the 1970s on recombinant DNA technology “exemplify a pioneering foundational technology being protected by broad patent claims that spurred society-changing innovations.” In a separate article, Professor Adam Mossoff and I detailed the pro-innovation role of genus claims. In short, genus claims—even those that have in part a functional component, like those in the Amgen case—advance the progress of the useful arts.”

The full transcript of the arguments is here.