Courthouse Steps Decision: Amgen Inc. v. Sanofi

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Jack Derwin:  Hello and welcome to this Federal Society virtual event. My name is Jack Derwin and I'm Associate Director of the Practice Groups here at The Federalist Society. Today, we're excited to host a Courthouse Steps discussion on last week's Supreme Court ruling in Amgen v. Sanofi featuring Mr. Robert Rando.

Rob is a partner with Greenspoon Marder LLP's intellectual property department where he focuses his practice on patent and other intellectual property infringement disputes. Rob has more than 30 years of civil litigation experience at the trial and appellate court levels and has served as counsel of record on a number of amicus briefs, including one in the case we're discussing today, filed on behalf of the New York Intellectual Property Law Association, of which Rob is president.

After Robert's presentation, we'll go to audience Q&A. Please enter any questions for him into the Q&A function at the bottom right of your Zoom window. And I'll note that, as always, all expressions of opinion on today's program are those of the guest speaker joining us. With that, Rob, I will pass it over to you.

Robert Rando:  Good afternoon, and thank you very much, Jack. And I would like to thank The Federalist Society for the opportunity to discuss this case with those of you attending the webinar. The Amgen v. Sanofi, case the patent infringement case involving the scientific invention concerning patent genus claims in the monoclonal antibody space, as it relates to drugs that reduce LDL cholesterol. It is an important case for a couple of reasons.

The decision in this case has a huge impact on whether the incentive to invest in and innovate within the U.S. patent system for these types of potentially life-saving drugs will continue. It will also impact patent enablement issues and other [inaudible 01:33] as well. Emerging technologies like AI will likely be impacted.

While the case presented issues regarding the question of statutory interpretation with respect to the plain language of the patent enablement statute—that is, 35 USC Section 112(a)—the Court's decision appears to gloss over it and conflates the claim provision 35 USC Section 112(b), which requires that "the specification shall conclude with one or more claims, particularly pointing out and distinctly claiming the subject matter which the inventor or the joint inventors regards as the invention."

The Court also relied upon its growing precedence, as argued by Respondent, to reach its decision. Moreover, there was not much attention paid to its variance with the lack of support in the plain language of the governing patent enablement statute.

Before we get to the decision, some background on the case. Excuse me. I'm sorry. On November 4, 2022, Supreme Court granted cert in this patent infringement case involving the application and statutory enablement requirement of section 112(a) of the patent law as to what it referred to as genus claims as it applied in the context of pharmaceutical applications.

The two patents in dispute relate to antibody drugs that reduce low-density lipoproteins (LDL) cholesterol, the human body normally relies on LDL receptors in the liver to remove LDL cholesterol from the bloodstream. A naturally occurring protein, PCSK9, binds to and causes the destruction of LDL receptors, leading to higher levels of LDL cholesterol. The patented invention is for technology that relies on antibodies that bind to that protein, inhibiting it from binding to LDL receptors, leaving them free to extract cholesterol from the bloodstream.

Amgen obtained the two patents that broadly claimed the genus of all antibodies that bind to certain amino acid on PCSK9, a first function, and block its binding to LDL receptors, a second function. The common specification for the patents discloses that Amgen used a trial-and-error method to generate and screen antibodies that meet the claim language.

Using this process, Amgen identified numerous antibodies that meet the claim language, but the specification discloses only the amino acid sequences of about two dozen of these antibodies. The specification also provides a three-dimensional structure of only two of those antibodies.

At trial, Respondent introduced evidence that claims had a scope that could cover millions of antibodies and, given the unpredictability of antibody science, a person skilled in the art would have to test every single antibody generated by Amgen's methods to determine whether it had the necessary functional properties and was then encompassed by the claims. At a first trial, the defendants conceded infringement, and the jury found the patents valid.

On appeal, the Federal Circuit affirmed in part, reversed in part, vacated, and remanded. On remand, the jury found two of five asserted claims invalid for lack of adequate written description, but found three remaining claims valid. The district court granted Respondents motion for JMO Ellis to enablement, concluding that, under the Federal Circuit's long-established multi-factor test for evaluating enablement in the case of In re Wands. Amgen is patent required on new experimentation and was, thus, not enabled.

On a second appeal, the Federal Circuit unanimously affirmed the district court, and considering the Wands factor, the Court determined that undue experimentation was necessary to enable the full scope of Amgen's double-function claims. Further, the evidence established that the relevant field of science was unpredictable and there was the conspicuous absence of non-conclusory evidence that the full scope of the broad claims can predictably be generated by the described methods.

Under these facts, the Court explained no reasonable jury could conclude that anything but substantial time and effort would be required to reach the full scope of claimed embodiments. Weighing the Wands factor, the Court concluded that undue experimentation would be required to practice the full scope of these claims.

In its petition for cert, Amgen argued that, in this case, the Federal Circuit applied a recent court-made hurdle to enablement to genus claims like Amgen's and ruled that it is not enough that the patent meet the statutory requirement, that it teach skilled artisans to make and use the invention as per the plain language of the statute. Instead, the Federal Circuit required the specification allow skilled artisans to reach the full scope of claimed embodiments to cumulatively identify and make all or nearly all possible variations of invention without substantial time and effort.

Amgen argued that there was no dispute that patents enable skilled artisans to make and use those antibodies. They could make the 26 antibodies identified in the patent by amino acid sequence and could make other antibodies within the claims by following the patent's step-by-step roadmap, which employs method routine and the antibody parts.

As Amgen pointed out in their petition, no one—neither Respondents nor there experts nor the Court—identified even one actual embodiment that could not be made following the patent's disclosure. So the question before the Court was whether enablement is governed by the statutory requirement that specification teach those skilled in the art to make and use the claimed invention or whether it must instead enable those skilled in the art to reach the full scope of claimed embodiments without undue experimentation; that is, to cumulatively identify and make all or nearly all embodiments of the invention without substantial time and effort.

Now the decision. Justice Gorsuch, writing the opinion in the unanimous decision, opens up with an excellent distillation of the science involved with the monoclonal antibody treatment for reducing LDL cholesterol at a level for non-scientists to understand. For our purposes, the unanimous decision does not lend itself to a sexy nor lengthy discussion; however, I'll use my best efforts to create the former and not the latter.

I will start at the outset pointing out that my praise of the Court's treatment of the underlying science is somewhat in contrast to my assessment of some of the rest of the opinion, which I will reveal after discussing the decision. However, I will also point out that I have the utmost respect and admiration for this Court.

So, after fairly lengthy discussion of the science and the facts of the proceedings, the Court begins where all good patent decision should begin, and that is with Article I, Section 8, Clause 8, followed by the description of the patent bargain, and finishing with Federalist 43. The Court goes on to characterize the disclosure part of the patent bargain as the "enablement obligation" that has remained intact over time, including when Congress revised the patent laws and cites various cases to that effect.

The Court then points out its enablement requirement precedent in Wood (1846), Morse (1854), Incandescent Lamp (1895), Minerals Separation (1916), and Holland Furniture (1928). The Court also acknowledges that the technologies seem a world away from the antibody treatments of today but concludes that the decisions are no less instructive for it.

The Court then proceeds to provide a wonderful stroll down memory lane with this precedent. First, Justice Gorsuch discussed the Morse case in a manner reminiscent of Justice Cardozo's style: painting the setting and the scene. He then closed for Morse 14 Lawyer Edition 601 (1854) that "the Court held the claim too broad and not warranted by law."

He then states that the problem was that it covered all means of achieving telegraphic communication, yet Morse had not described how to make and use them all. Further quoting from Morse, "If the eighth claim can be maintained," the Morse Court concluded, "there was no necessity for any specification further than to say that he had discovered that, by using the motive power of electromagnetism, he could print intelligible characters at any distance."

Next, once again providing a nice setting for Incandescent Lamp 159 U.S. 465 (1895) in the same manner as Morse and then quoting from the case. "Sawyer and Man supposed they had discovered in carbonized paper the best material for an incandescent conductor, but instead of confining themselves to carbonized paper, as they might probably have done—and in fact did in their third claim—they made a broad claim for every fibrous and textile material."

Even that broad claim might have been permissible, the Court allowed, if Sawyer and Man had disclosed a quality common to fibrous and textiles substances that made them peculiarly adapted to incandescent lighting. Had they done so, others would have known how to select among such materials to make an operable lamp, but the records show that most fibrous and textile materials failed to work, and so only through painstaking experimentation did Edison discover that bamboo answered the required purpose. The Court summed up things this way: "The fact that paper happens to belong to the fibrous kingdom did not invest Sawyer and Man with sovereignty over this entire kingdom."

Similarly, with the Holland Furniture case, 277 U.S. 245 (1916), quoting from the case, "One attempting to use or avoid the use of pertinent discovery, as so claimed and described functionally, to do so only after elaborate experimentation with different starches" To be sure, the Holland Furniture Court held Perkins was entitled to his patent on the specific starch glue it had invented. The specification described that glue's characteristic ingredient with particularity. Perkins could not claim all starch glues made from whatever starch happened to perform as well as animal glue."

"To hold otherwise," the Holland Furniture Court said, "would extend the monopoly beyond the invention." The Amgen Court concluded that Morse, Incandescent Lamp, and Holland Furniture reinforces the simple statutory command and if a patent claims an entire class of processes, machines, manufacturers, or composition of matter, the patent specification must enable a person skilled in the art to make and use the entire class.

And, in other words, the specification must enable the full scope of the invention as defined by claim. The more one claims, the more one must enable, according to this Court. The Court then turns to its precedent that upheld claims that would challenge its not enabling in Wood v. Underhill, 12 Lawyer Edition 23 (1846), and Minerals Separation v. Hyde, 242 U.S. 261 (1916).

The Court cited the case that stated, "Nor is a specification necessarily inadequate just because it leaves the skilled artist to engage in some measure of adaptation or testing." In Wood, a patent claimed the process for making bricks by mixing coal dust into clay. The patent included a general rule about the proportion of dust and clay to use and offered two alternative proportions where the clay has some peculiarity.

The Wood Court can upheld the claim, recognizing that some small difference in the proportions must occasionally be required, given the varieties of clay. Similarly, in Minerals Separation, the Court dismissed the challenge to a claim process for separating metal from mineral ores. The record shows that preliminary tests were required to adapt the process to any particular ore.

The Minerals Separation Court explained that the certainty which the law required in patents is not greater than is reasonable. And because the composition of ores there is infinite, it was impossible to specify the patent the precise treatment which would be most successful and economical in each case.

So I'll pause here and merely observe that these distinctions are not crystal clear to make. The Court identifies two additional cases rejecting non-enablement challenges: Ives v. Hamilton, 92 U.S. 426 (1876), upholding a claim for an improvement in sawmills based on curved guides at the upper end of the saw. Even though the specification did not state the nature of the curve, because a good mechanic acquainted with the construction of sawmills and having the patent and diagram before him would have no difficulty in adopting the improvement and making suitable curves."

In Tilghman v. Proctor, 102 U.S. 707 (1881), upholding claim for process of separating fats and oils, even though the specification suggests a trial with different degrees of heat so as to ascertain that which is best for each particular kind of fat. And in a rather unhelpful statement for practitioners, the Amgen Court goes on, "Decisions such as wood and mineral separation established that a specification may call for a reasonable amount of experimentation to make and use a patented invention."

What is reasonable, in any case, will depend on the nature of the invention and the underlying art. And the real throwaway line that follows, "Judges may no more subtract from the requirements for obtaining a patent that Congress has prescribed than they may add to them," citing Bilski.

The Court then addressed the specific Amgen claims at issue. Court found that's Amgen specification enabled the 26 exemplary antibodies and identified by their amino acid sequences. However, the Court stated that the claims before us sweep much broader than those 26 antibodies. And we agree with the lower courts that Amgen has failed to enable all that is has claimed, even allowing for a reasonable degree of experimentation.

The Court noted that, while the technology at the heart of this case is thoroughly modern, from the law's perspective, Amgen's claims bear more than a passing resemblance to this court case long ago in Morse, Incandescent Lamp, and Holland Furniture, and that Amgen seeks to monopolize—that word again—an entire class as being defined by their function, every antibody that both binds particular areas of the sweet spot of the PCSK9 receptors.

The Court stated that the record reflects that this class of antibodies does not include just the 26 that Amgen described by their amino acid sequences, but a vast number of additional antibodies that it has not. Harkening back to its precedent, the Court pointed out that much as Morse sought to claim all telegraphic form of communication, Sawyer and Man sought to claim all fibrous and textile materials for incandescence, and Perkins sought to claim all starch glues that work as well as animal glue for wood veneering, Amgen seeks to claim sovereignty over an entire kingdom of antibodies.

The Court then found that Amgen's argument that 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 amounted to little more than two research assignments.

Going on, the Court stated, "Whether methods like a roadmap or conservative substitution might suffice to enable other claims in other patents," perhaps because this Court suggested in Incandescent Lamp, "the inventor identifies a quality common to every functional embodiment they do not hear.

"They leave a scientist about where Sawyer and Man left Edison: forced to engage in painstaking experimentation to see what works, and that is not enablement. More nearly, it is as a hunting license," citing Brenner v. Manson, 383 U.S. 519. The Court then goes on to shoot down two other arguments raised by Amgen, namely, first, that the CAFC erred by applying an enablement test unmoored from the statutory text; and second, that the CAFC raised the bar for enablement of claims that encompass an entire genus of embodiments defined by their function.

The Court also noted that Amgen argues that an affirmance will risk destroying incentives for breakthrough inventions. And the Court went on to say that striking the proper balance between incentivizing inventors and ensuring the public receives the full benefit of their innovation is a policy judgment that belongs to Congress and that, since 1790, progress has included an enablement mandate as one feature among many designed to achieve the balance it wishes, and that the Court's only duty in this case lies in applying that mandate faithfully.

Justice Gorsuch closed with the following "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." And then, adding a bit of humor, he goes on, "If the Court had not done so in Incandescent Lamp, it might have been writing decisions like Holland Furniture in the dark. And today's case may involve a new technology, but the legal principle is the same."

So some thoughts on my behalf, some thoughts and comments about the decision. First, I would like to raise a few points about the Court's usage of the word "monopoly" to describe the patent right, which is a pet peeve of mine. First, as we know, a patent is not a monopoly for at least the following reasons: Article I, Section 8, Clause 8 of the U.S. Constitution grants inventors the exclusive rights to their discoveries for limited times in exchange for the eventual surrender to society via patented intellectual property.

A monopoly prevents a person from doing or freely accessing something that is part of the public domain. However, patent rights are granted for inventions or discoveries that are new and not obvious and thus not part of the public domain. So patent rights do not take from the people anything that was already in possession of the people, as monopolies do.

Patent rights are traded for the full enabled disclosure of the patented invention that is for the people to freely practice upon termination of the limited exclusive right. Monopolies are not subjected to such a quid pro quo. The monopolist controls and rules the market. However, the patentee has only a limited right to exclude others from practicing the patented invention, and market forces determine, to a large extent, the market value of the patented invention or discovery. In fact, the vast majority of issued patents have negligible or no market value at all.

A monopoly gives the monopolists rights to make, sell, buy, work, or use that may not be had by others. Patent rights are not rights to do any such activities; they are confined to temporarily excluding others from pursuing certain activities concerning the patented invention or discovery.

There is no way of designing around a monopoly, whereas one of the benefits of the patent system is to encourage and motivate other inventors to design around a patented invention and discovery, thus incentivizing innovation and technological advancement beyond that provided by the patentee.

Inventors and patentees are not monopolies. They and the society rely on the patent system originates with the U.S. Constitution, benefits from the patent incentives for investment in new technologies, and also benefits from the widespread and enabled disclosure of such new technologies for everybody to freely practice when its patent rights end.

Second, reading the usage of monopoly in the first two paragraphs of the opinion makes it clear where the decision was going. And third and most importantly, mislabeling a patent as a monopoly only perpetuates the negative connotation for patents, which in the current environment, contributes to the weakening of the patent system.

Another thought I have: The vintage of the precedent, while not relevant to its worth, should be considered in light of the "world of difference" in the aspects of the technology, as opposed to the world of difference in the technologies themselves, which does or possibly should matter. Furthermore, it is likely that the reliance on those cases, in part of the mislabeling of the patent right as a monopoly.

The statutory language and the conflation of 112(a) 112(b) are issues that were also not adequately addressed. One might argue that identifying the make and use element and then engrafting the 112(b), particularly pointing out and distinctly claiming the subject matter which the inventor and joint inventor regards in the invention prong rendered the resulting decision.

Also, the Court's repetition of the line "The more one claims, the more one must enable" only reinforces the prior point. And it is difficult, from my perspective, to reconcile cases like Wood and Minerals Separation and the others that reject the enablement challenge with this case without it appearing to be a completely subjective analysis.

On the positive side, with several references to amicus briefs, this case illustrates the key necessity for amicus filing in patent and other IP cases. It may be those that disagree with the outcome of this case, including Amgen, who wonder whether, notwithstanding Incandescent Lamp, the decision in Amgen v. Sanofi has figurately been written in the dark.

On a more personal note, I had the great good fortune to share a brief conversation with Justice Gorsuch right after the decisions came out in Oil States and SAS, two cases in which I filed an amicus brief. I told him that, from my perspective, with his dissent in Oil States and his opinion in SAS, he was batting 1000. He replied that, while he appreciated my comment, I could rest assured that, during his tenure on the bench, his batting average will go down. And I must say, I do agree; however, from my perspective, he is still way, way, way ahead of Ted Williams.

Now for the patent law commentariat. There are those that have opined that enablement law has not changed, and that, in the aftermath of this decision, attorneys should be more vigilant when reviewing if a patent's claims are functional; that companies are already invoking in the decision in litigation—what a surprise; that patent portfolios should be reviewed for potential reissue; that the patent office will likely be issuing new guidance; that broad claims are not necessarily, per se, banned—I quibble with that one; and that the Amgen ruling promotes medical innovation. I disagree and think that, no pun intended, the jury is out on that comment. And I will now stop here and answer any questions if I can.

Jack Derwin:  Thanks so much, Rob. As you said, we'll now open it up for audience questions, which our audience can enter using the Q&A button at the bottom of your window. As we wait for those to come in, I'll start with one of mine. As very much a non-expert here, I think I was left a little confused at the fact that we got a unanimous decision here upholding the lower court opinion. I was a little confused why they took the case to begin with. Do you have any thoughts there, or is there an easy explanation, or not so much?

Robert Rando:  I don't know if it's an easy explanation. It's a very astute observation. Typically, when cert is granted, there's usually an aspect that the Court is thinking has to be fixed, although, at times putting in some parameter on a lower court decision is also warranted or helpful.

In this case, it may be that initially, the justices didn't quite comprehend the interaction with the technology and the enablement requirements. Before when the decision came down, the briefing and also that oral argument, I was really taken aback by the diametrically opposed view of the facts and the conclusions from both sides.

Every case had the yes and the no and the yes and the not yes or the no and the not no, what have you, but in this case, it seems so dramatically stark. And that may have been enough—and I'm just speculating here—to have initially given the Court its decision to grant. And if you may recall, during oral argument, there were several questions. Certainly, Justice Gossage asked whether this case is really fact-bound, and there was a suggestion that it might be DIGed, but I get the sense that the Court doesn't like to DIG too many.

Jack Derwin:  We have a few questions coming in now. One is, is enablement and written description that separable?

Robert Rando:  Well, I was saying, the statute is written in a specific manner and that it should be interpreted that way.

Jack Derwin:  Another one here: Are there any hints in this decision that any of the justices’ view patents positively, a constitutional incentive that promotes the public good?

Robert Rando:  I don't even want to say that the justices view them negatively. We've all read decisions and opinions that have been authored by particular justices that might indicate that they don't view them very favorably, and I'll refrain from identifying any. I will say that, from my perspective, certainly, again, after Oil States and SAS, it was my impression that Justice Gorsuch is a strong proponent of a strong patent system, protecting the rights of the individual in their inventions and innovations. So I don't know that you can really pass a general comment on there are no justices or do all of justices have a negative impression or attitude towards patent.

Jack Derwin:  Well, it looks like you did such a good job with your explanation that there aren't many further questions here. I'll do one final call to our audience. As we wait to see if any more come in, I'm curious: I mentioned at the outset that you filed a brief in this case, actually, on behalf of neither party. Can you talk a little bit about the outcome you advocated for?

Robert Rando:  I would love to do that because I'm sure I may be biased, but I believe that the amicus brief that was submitted by New York Intellectual Property Law Association, by me and some of my colleagues provided the most sound solution. The proposal was a solution that allows patents to cover a genus—here, one of the molecules that reflects the scope of the innovation included is still functional requirements, but limits the scope of the granted patent to only those species that can be obtained without undue experimentation by applying that test only when evaluating infringement as a means for considering the scope of the claims.

So in other words, the proposal employs the scope of the enablement to define the scope of the claims, and that the Federal Circuit's full scope test, establishing no inventor should get a patent to a genius claim unless they tested all the species requires not just construction, but also testing functionality. And the alternative is to grant the patent to the genus claim if, at the time of infringement, you determine that undue experimentation was needed to make the species accused of infringement. That species would be considered outside the scope of the patent claim, not infringing.

On the other hand, if all the infringer did was follow the disclosure of the patent without undue experimentation, in queue, species would be within the scope of the patent and being infringement. And the benefit of this solution is that the determination on new experimentation as the full scope of the claims—that is, the species—is not required at the patenting stage and broad disclosure of invention is discouraged.

Unlike the patent examiner's limited resources and time and infringer's ability to challenge enablement, invalidity, and litigation is much greater using expert witnesses who may have conducted extensive tests, and may be able to explain the level of ordinary skill in the art against which the undue experimentation must be evaluated. How was that?

Jack Derwin:  So we did get one final question here. Is there any hint from the decision about how the claim should have been drafted to survive?

Robert Rando:  That's a very interesting question. I don't have a specific example off the top of my head, but I would say this: If you look at the Court's treatment of the precedent, as a general statement, narrower, right? I don't know if that's helpful, but if you look at how the Court treated the precedent, both pro and con, you may be able to -- you may be able to infer from that what better drafting skills may help.

And again, as I said, sure, to conclude from this decision that you have to draft more narrowly, that's a given. And I still think, as I said earlier, that there is still that question out there whether the decision in this case helps to promote more innovation in the space or less. And not only in this space; I worry in terms of this case and its impact on all different arts as well. And I'll just make one final note. Apparently, the Supreme Court was not impressed with the NYIPLA amicus brief.

Jack Derwin:  Well, thank you very much for joining us, Rob. That was a fantastic breakdown, and I know our audience appreciated it as well.

Robert Rando:  Well, thank you again.

Jack Derwin:  And thank you to our audience for tuning into today's program. You can keep up at our website, fedsoc.org, or on all the major social media platforms @fedsoc. With that, we are adjourned. Thank you.

 

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