“That [the Justices] believe this decision changes nothing is entirely irrelevant. This decision, because of the evidence, clearly ushers in a cataclysmic shift in the law of enablement.”
Earlier today, the United States Supreme Court issued its decision in Amgen, Inc. v. Sanofi et al. The Court held, as many feared they would, that the 26 antibody examples and detailed instructions for generating additional antibodies within the genus—which covered some 400 pages and included a CD Rom of the x-ray crystallography coordinates of Amgen’s “anchor” (or lead) antibodies 21B12 (Repatha) and 31H4—was insufficient to satisfy the enablement requirement. Unfortunately, the Supreme Court did not explain what level of detail would have been sufficient, nor did the Court provide direction to the industry on what more is expected to satisfy the enablement requirement. So, we simply learned today that the extraordinary disclosure and detail provided by Amgen was not enough.
Although the Supreme Court, in an opinion authored by Justice Gorsuch, said they are not ruling that “a specification always must describe with particularity how to make and use every single embodiment”, that is exactly the effect the ruling will have on patent practice. Indeed, there is no other reasonable interpretation of the Court’s holding, given that there was expert testimony that the specification consisted of a “rich handbook,” providing “a wealth of information” about the claimed antibodies. Appx. 3910(763:1-12). Amgen’s expert also testified that skilled artisans following the patents’ roadmap “would be certain to make all” the antibodies across the claims. Appx. 3909 (762:10-20), 3908 (757:12-14). So, Sanofi’s argument—bought by the Supreme Court—that the information and detail provided by Amgen provided “little more than a trial-and-error process of discovery,” was simply incorrect based on the evidence. The Supreme Court can say whatever they like, and proclaim this is not a change to the law of enablement, but that they believe this decision changes nothing is entirely irrelevant. This decision, because of the evidence, clearly ushers in a cataclysmic shift in the law of enablement.
While today’s decision does not categorically eliminate broad genus claims, there can be no doubt that innovators within the life sciences community and beyond will be questioning the continued viability of broad genus claims. The importance of that is obvious to anyone familiar with patent practice, research and development, or capital markets. Often, but not as often as we would like, innovators will achieve fundamental breakthroughs. These leaps are precisely what the patent system is intended to encourage. We, of course, celebrate incremental innovation as a meaningful achievement, but what society wants are the types of innovations that shift the paradigm, and those types of inventions are by necessity going to cover far more scope because they are foundational.
What They Said
After the Supreme Court’s ruling today, to have broad claims that survive an enablement challenge you might not need to have an example for every embodiment, but you are going to need a lot of examples. How many? Well, in true Supreme Court fashion, they did not answer that critical question, but instead provided a meaningless and scientifically unhelpful characterization without boundaries or meaning:
[I]t may suffice to give an example (or a few examples) if the specification also discloses ‘some general quality . . . running through’ the class that gives it ‘a peculiar fitness for the particular purpose’”, wrote Gorsuch. “In some cases, disclosing that general quality may reliably enable a person skilled in the art to make and use all of what is claimed, not merely a subset.
I’m sure Justice Gorsuch and the rest of the Supreme Court find this to be helpful and meaningful guidance. The problem is with the facts and evidence of this case. The evidence established that a skilled artisan could make and use all of what Amgen claimed, not merely a subset. The evidence established that the innovation being so important and fundamental covered a lot of embodiments—perhaps millions of embodiments. Based on this decision, the fact that one of skill in the art could, based on the 400-plus pages of disclosure, make the claimed invention was insufficient. It would take a long time to follow the instructions provided and make what Amgen invented, and regardless of what the Supreme Court or Federal Circuit say, a roadmap to a broad invention is simply insufficient.
Indeed, Justice Gorsuch in a rather patronizing way discounted the argument made by Amgen relating to the conflation of basic enablement law with undue experimentation. Gorsuch wrote:
[I]t suggests that the Federal Circuit erred by applying an enablement test unmoored from the statutory text. As Amgen sees it, that court conflated the question whether an invention is enabled with the question how long may it take a person skilled in the art to make every embodiment within a broad claim. We do not see it that way. While we agree with Amgen that enablement is not measured against the cumulative time and effort it takes to make every embodiment within a claim, we are not so sure the Federal Circuit thought otherwise.
Gorsuch would go on to say that the Federal Circuit specifically noted in its decision that the effort required to exhaust a genus is not dispositive. But again, what both the Federal Circuit and Supreme Court held is inconsistent with the actual evidence of the case. That they want this to be the case does not make it factually fit into the overall puzzle. It also ignores generations of enablement law.
The law of enablement as always focused on the basic question of whether one of skill in the art can make and use the invention, period. Here, the evidence actually established that one of skill in the art indeed could make all the embodiments covered by the claim—it was just going to take a long time. So, regardless of whether the Supreme Court or Federal Circuit understands the ramifications of their decisions, the industry will understand that functionally the law of enablement has changed. It does not matter whether one of skill in the art can make and use the claimed invention. What matters is whether the specification has enough examples and detail to allow one of skill in the art to make the claimed invention quickly. Because if the claimed invention cannot be made relatively quickly based on the examples provided, not enough examples have been provided regardless of whether one of skill in the art could themselves achieve the invention.
Justice Gorsuch would disagree—and actually said the opposite in his decision. The Supreme Court concluded that “Amgen offers persons skilled in the art little more than advice to engage in ‘trial and error.’” But once again, what Justice Gorsuch wrote is contradicted by the evidence, not to mention scientific reality. Indeed, nothing the Supreme Court may want this decision to mean changes what those who understand the science and evidence will understand the case to hold. The underlying reality based on the facts of the case sadly did not seem to play into the decision at all. And as a result, we are left with a decision that stands for the proposition that 26 examples covering over 400+ pages and supported by a CD Rom of the x-ray crystallography coordinates of Amgen’s “anchor” (or lead) antibodies 21B12 (Repatha) and 31H4 are insufficient. Disclosure allowing one of skill in the art to make and use the invention is not enough, there must be more, and that is a fundamental shift in the law of enablement that will have repercussions for the entire community regardless of industry or technology at issue.
Much Ado About Morse
Despite the Supreme Court not following the evidence actually submitted, and not appreciating the functional effect of this decision, perhaps the most infuriating aspect of the Court’s decision is the thoroughly disingenuous comparison of Amgen’s claimed invention to the claim at issue in the Samuel Morse case—a case the Supreme Court always loves to refer to, regardless of its applicability.
Morse “sought to claim all telegraphic forms of communication”, Gorsuch explained. That characterization severely oversimplifies the Morse case. The Morse patent claimed all uses of electromagnetism, and the specification only described a single use of electromagnetism, and everyone correctly realized that Morse did not invent all uses of electromagnetism. So, the Morse case was easy for everyone—even the Supreme Court—to understand. The broad claim sought by Morse was not enabled. It wasn’t even invented.
In this case, however, there was a roadmap provided and uncontroverted expert testimony that the specification would allow one of skill in the art to make and use the full scope of what was claimed. In fact, the expert testified, and it was not rebutted, that the specification and supporting information provided by Amgen was more detailed than anything he had ever reviewed. And there is also no question that Amgen invented the full scope of what they claimed. So, comparison to Morse is not only inappropriate, but it also insults the intelligence of those who understand the law and science. Like much of the Supreme Court’s decision, what the Court actually says is contradicted by the evidence, testimony and scientific realities. In fact, a first-year law student should be expected to easily distinguish the Morse facts from this Amgen case.
So, what is required of innovators who have made fundamental, broad inventions? How many examples are required? How many pages is enough? How quickly must the specification lead one of skill in the art to all embodiments claimed? None of these questions are answered, but most troubling is, despite evidence that one of skill in the art could make and use the invention, the specification still failed for lack of disclosure.
What we will undoubtedly see moving forward are patent applications that are even longer and more detailed, with far more examples, and efforts to describe a “general quality” that runs through genus, whatever that means.
Join the Discussion
24 comments so far. Add my comment.
Theodore H.May 23, 2023 05:20 pm
Any mention In re Wands is conspicuously absent from the opinion. Surely there there are more relevant sources of law than Morse, Incandescent Lamp, and the Federalist Papers.
AnonMay 22, 2023 10:14 am
Very well stated — and is a prime reason why I have mentioned that the rest of the story vis a vis Morse (and specifically, the claims that were ALLOWED) need be looked at instead of merely the false dicta leaned on by the Court.
Lab JedorMay 21, 2023 06:39 pm
Justice Gorsuch on Morse says: “The problem was that the claim covered all means of achieving telegraphic communication, yet Morse’s specification did not describe how to make or use them all.”
Anyone making such a sweeping statement (“covered all means of achieving telegraphic communication”) should consider the correctness of such an outrageous assertion.
The reason of “rendering claim 8 void” by the Court in Morse was that Morse claims “electro-magnetism” without teaching anything else beyond known “electro-magnets.” The implication is that there may be, could be, would be other “electro-magnetic” devices yet unknown at the time of the Court case that could achieve the same “electro-magnetic” motive force.
Thus, the Court did NOT invalidate claim 8 on “the claim covered all means of achieving telegraphic communication” as asserted in the Amgen opinion. The Court invalidated (“rendered void”) because Morse claimed “all telegraphic communication using electro-magnetism as a motive force.”
The Court in Morse assumed the position of a speculative technology prognosticator, something they were/are not qualified for. The Court should have waited until an invention was made that used “electro-magnetic motive force” without using “electro-magnets.” And they would have waited forever.
In hindsight and after 180 years of technology development we know that such inventions do not exist. The “electro-magnetic” repeater system of Morse, as brilliant as it was, was a technological dead-end. The electro-magnetic printing itself was an invention that still stands.
Radio transmission, modulation technology, amplification, telephony, optical cable, multiplexing, loading coils or other technologies were all invented after the Morse patent expired and in any case would not have been blocked by Claim 8 of Morse, even if invented with the Morse patent in force.
Thus the Court’s Opinion in Amgen: “The problem was that the claim covered all means of achieving telegraphic communication, yet Morse’s specification did not describe how to make or use them all” is wrong. (And the “electro-magnetism” in Morse is NOT Maxwell’s EM field, if one wants to bring that up as a defense.)
BMay 19, 2023 12:29 pm
@ concerned and Pro Say
“Judges may no more subtract from the requirements for obtaining a patent that Congress has prescribed than they may add to them.”
The irony is that the S.Ct. cited Bilski on this
BMay 19, 2023 12:21 pm
I’m not going to disparage the S.Ct. on this. I fully get Morse, and I fully get Moore’s opinion at the CAFC. There’s tension and a grey area as to what is enough for enablement.
The one problem I do see is that the “undue experimentation” requirement fully encompasses some trial and error.
I also note that, in Morse, there was apparently no indicia that enablement was satisfied for all ways of claim 8. Completely open ended claim – but – given the 7 examples provided in Morse – there was no discussion whether those examples were enough.
The irony is that the S.Ct. cites Morse for 101 issues traditionally. Good to see the finally recognize it as a 112a enablement issue.
FWIW – this very aspect of law is asserted in the Killian petition
Pro SeMay 19, 2023 10:24 am
U.S. Design Patents are still strong, I started diversifying to them a few years ago, currently have 16.
Design Patents (at least for me) have deterred my mass infringers thanks to the fears of “willful” Section 289 damages (exclusive to Design).
Where the courts murk up the science and engineering merit:
It’s pretty difficult to murk up ornamental images.
Pro SeMay 19, 2023 10:14 am
For years we’ve read Gene’s analysis and warnings on the long term effects of rulings like this.
I can’t think of one IPW analysis from Gene that has been wrong.
With this, he knows how the street level legalese broadly apply these SCOTUS “new law” standard shifts.
The “Ripple Effect” happens now.
Down to the CAFC and through down to District Court, where “enablement” will be misconstrued, misapplied, and within 5 years, it will be the new Williamson, knocking out Utility Patents for authoring spec and claim language in engineering compliant terms, but not legally careful compliant terms.
It’s a snowball at the size of an avalanche now.
TFCFMMay 19, 2023 10:07 am
>>The Court held, as many feared they would, that the 26 antibody examples and detailed instructions for generating additional antibodies within the genus—which covered some 400 pages and included a CD Rom of the x-ray crystallography coordinates of Amgen’s “anchor” (or lead) antibodies 21B12 (Repatha) and 31H4—was insufficient to satisfy the enablement requirement.<<
More accurately, the Court did not deny that the specification enabled THE SUBJECT MATTER THAT WAS DISCLOSED (26 antibodies). It held that even this detailed disclosure of the 26 antibodies was not sufficient to enable 'any and every antibody which might bind and/or act similarly to the 26 disclosed ones, even though we have no idea what those antibodies are.'
That the patentee was able to specify a research protocol whereby additional antibodies might be expected to be identifiable enables, of course, a method-of-identifying-useful-antibodies type of claim, but not claims to whatever antibodies might someday potentially be identified using the method.
With all due respect, reasonable patent attorneys have been counseling clients about this far-from-unexpected outcome for many years (and fashioning claims and fallback claims accordingly).
Were the technology more textually amenable to the analogy, the decision might well be designated the "Emperor's New Clothes" decision — virtually everyone recognizes that one who wishes to claim an "invention" (the invention being defined by the claims, per patent law 101) must describe and enable the (same) invention. Where one's invention is "a bunch of things," one must describe and enable the whole bunch, not just an example or two (or 26).
That a patentee (or an emperor) can fool a patent examiner into allowing a claim directed to a whole bunch of different things that are neither specifically described nor enabled in one's specification does not make the patentees claim (or an emperor's purported clothing) valid.
(Keep in mind, too, that the doctrine of equivalents may yet provide patentees-who-claim-what-they've-actually-invented some scope of protection beyond the literal scope of their claims, at least for insignificantly-different subject matter.)
DavidMay 19, 2023 09:56 am
While I agree the Supreme Court is likely using this case to unjustifiably limit patent rights, maybe Amgen should have claimed the process of producing the antibodies if they wanted broader protection.
Max DreiMay 19, 2023 05:02 am
I think everybody’s right: this Decision changes nothing but also changes everything. But what do I know? I don’t practise in chem/bio and I am not a US patent attorney. But, I have been practising before the EPO for more than 40 years and I find that this Decision confirms that the law on enablement in the USA and in Europe is more or less in harmony. No change. The issue is whether the Patent Office is minded, and enabled, to police effectively what the established law on enablement actually is.
Ex Parte, it is hard to examine whether the threshold of patentable enablement is attained. Applicants use all the leeway available to them to push through to issue the widest claims they can craft. If they didn’t, they wouldn’t be serving their clients. Up to now, they haven’t met with sustained and trenchant resistance from the USPTO, have they? But what is going to happen now, as a result of this Decision? Will it gird the loins and stiffen the sinews of those at the USPTO charged with the enquiry into patentability? I assume so. And will the judicial instance confirm rather than reverse the USPTO’s position on enablement? I assume so.
I assume this eventuality is what is exercising the minds of people like our host on this blog. But what about those in house in chem/bio, like the opposing Parties in this case? Are they not counselling, nothing much happened here folks. Come along now, move along.
Until somebody explains to me otherwise, I will assume that this Decision is, for the owners of chem/bio patents and their competitors, not quite the earthquake that, here, it is being made out to be.
What do others think?
Night WriterMay 18, 2023 11:29 pm
>>Those who think this case won’t hurt are only fooling themselves. This case will be an anchor that all patentees and patent owners are going to need to deal with.
I agree. Going to be ugly.
concernedMay 18, 2023 10:10 pm
Thank you for the observation.
B is asking in our brief that SCOTUS eliminate all judical exceptions. Perhaps B will quote this statement.
And we heard through the grapevine that the judge who penned this majority opinion has voted for cert each time on the s101 issues, but did not have any other support.
Pro SayMay 18, 2023 09:47 pm
Note also this from the decision:
“Judges may no more subtract from the requirements for obtaining a patent that Congress has prescribed than they may add to them.”
And yet . . . when it comes to the fundamental, foundational question of what is and what is not eligible for patent protection . . . they stomped on Congress by giving us . . . Mayo and Alice.
SCOTUS. Hypocrisy. Reins.
Josh MaloneMay 18, 2023 08:24 pm
I agree with the author. The Federal Circuit will have great fun waxing and waning on the insufficiency of our disclosures now. They will ax any claims that aren’t disclosed in the spec. May as well just get a few design patent, and go to China for the utility patents.
concernedMay 18, 2023 07:43 pm
My claims, even though someone called them the bottom 1%, did not have a 112 rejection. Did not have 102 and 103 rejections either. So apparently the claims in this case/article are below my bottom 1%?
Or are the courts out of control? (my vote)
KyleMay 18, 2023 05:45 pm
I notice you never explained how the spec enabled POSAs to “use” the antibodies. What use is enabled by these patents? Robinson said 130 years ago that the standard for a composition is “capable of immediate useful application” s281, and that “actual employment in the art” of a composition is required to show reduction to practice.
Simply making antibodies at least at the experimental stage has long been within the skill in the art.
AnonMay 18, 2023 05:26 pm
To Lab Jedor’s point, would it be helpful to recall the claims of Morse that WERE maintained?
Too many people want to look at the claim eliminated and make pronouncements — with zero appreciation of the context of the rest of the story.
HPMay 18, 2023 05:11 pm
Claim 1: A spaceship capable of traveling to Mars.
Blah blah blah . . .
Example 1: We built a spaceship having XYZ structural features, and traveled to Mars in this spaceship. . .
The invention is not limited to Example 1 with features XYZ. If you do the following, you will be able to create many other spaceships that can also get to Mars: (1) Build a spaceship; (2) send the spaceship out into space; (3) see if the spaceship makes it to Mars; (4) if the spaceship does not make it to Mars; build another spaceship; (5) repeat until you build a spaceship that makes it to Mars.
I haven’t read the patents or the lower-court decisions here, but how is the current case any different? Can someone please explain that to me?
Lab JedorMay 18, 2023 05:10 pm
Is a sieving method, a method that rapidly limits possible embodiments to its useful ones, a valid enablement disclosure? It depends on the universe you are working from. Justice Gorsuch refers to a number of anti-bodies equal to trillions of stars in a Galaxy. That is in the order of 10^12 stars. Just randomly considering any of 10^12 (and perhaps up to 10^15 or more) possible embodiments is an almost impossible task.
Reading the Amgen 165 patent, it is clear that using the “proto-type” roadmap of known “potentially viable” anti-body structures, drastically limits the number of required trials, and in the context of the state of the art provides a rapid roadmap to a desirable antibody.
It is true, there is no deterministic list of all anti-bodies. But it is also true that it may be the best mode of selecting desirable anti-bodies, and one that is probably orders of magnitude better than randomly testing 10^12 anti-bodies.
Somebody claiming a novel anti-body based on the above roadmap method would probably not get a patent as being “obvious” by merely doing yeoman’s application of known methods.
This is what ChatGPT says about “roadmap” in drug development:
It’s important to consider that the purpose of a roadmap is not solely about eliminating candidates but also about providing a structured approach and direction for the drug development process. It can help researchers make informed decisions, prioritize resources, and optimize their efforts. Even a small percentage of elimination can be valuable if it leads to more efficient use of time and resources, accelerates the development process, and increases the likelihood of success.
I completely miss any of the above considerations made by overall a rather limited AI application in Justice Gorsuch’s Opinion.
Gorsuch says about Morse: “The problem was that the claim covered all means of achieving telegraphic communication, yet Morse’s specification did not describe how to make or use them all.”
But that is not what Morse claimed. Morse claimed every improvement where the motive power is the electric or galvanic current, and the result is the marking or printing intelligible characters, signs, or letters at a distance. Motive power is to activate or deactivate some mechanism. Which is markedly different from “all means of telegraphic communication.”
Overall, I have the same reaction as Anon. Congress should remove SCOTUS from Patent Matters. They are not qualified to decide these critical matters. It is getting worse, not better.
Gene QuinnMay 18, 2023 04:54 pm
I agree 100%.
The statements made by the Supreme Court in a vacuum are not bad. What is bad is those statements do not match the evidence. What is worse is how this case will be misused by those who already don’t want to issue or who want to invalidate. Even worse still is the fact that patent owners and applicants will not have any way to distinguish this case on the facts.
Those who think this case won’t hurt are only fooling themselves. This case will be an anchor that all patentees and patent owners are going to need to deal with. A new front on the invalidity battlefield has been opened. Not good for innovators who want and need rights.
Gene QuinnMay 18, 2023 04:51 pm
You can choose to hide your head in the sand if you like, but do so at your own risk. My track record of predictions on matters dealing with patent law is impressive. And when I make a statement like this, that the law has dramatically changed, I don’t recall every being proven wrong.
Now to respond… first, the law of enablement has nothing to do with “some experiment” being fine. The question is whether one of skill in the art can make and use the invention based on the disclosure. In this case the answer is YES. The invention can be made by one of skill in the art, so there should never be a question about whether experimentation is undue. Experimentation is not necessary. Effort is necessary, but the ACTUAL evidence and testimony was that those of skill in the art would be able to make the invention, it would just take time (and not require trial and error). The Federal Circuit and Supreme Court ignored the evidence and conflated time with experimentation (much as you have incorrectly done).
Second, anyone who is at all familiar with patent practice can easily predict how examiners will interpret this case. The many examiners who work for the Patent Denial Authority will have a new tool to justify their recalcitrance. And the judges and jurists across the country who believe patents are a monopoly will themselves have new justification for what they predetermined they wanted to do.
The unpredictable arts just got much harder. Too bad for us that the unpredictable arts is where we find the most valuable innovations.
PubliusMay 18, 2023 02:23 pm
Nonsense – this has been the law on enablement for at least decades. 1) the claimed scope must bear a reasonable correlation to the scope of enablement. 2) some experimentation is fine. Phrases such as “Ushers in New Era” and “cataclysmic shift” are just sensationalism for the sake of attention.
AnonMay 18, 2023 01:48 pm
I can predict that this will be another wake-up call to Congress (that would include Congresses use of their Constitutional power of jurisdiction stripping) that will fall on deaf ears.
Night WriterMay 18, 2023 01:32 pm
My worry is this being used by the anti-patent judicial activists on the CAFC to invalidate method claims of information processing by ignoring that functional terms are interpreted by POSITA to include all known solutions.