by Dennis Crouch
The COVID vaccines do not genetically modify your DNA, but Juno’s patented CAR T-Cell therapy certainly does. Sloan Kettering owns U.S. patent No. 7,446,190 and Juno (BMS) is the exclusive licensee. The patent claims a nucleic acid polymer (DNA/RNA) that encodes for a particular “chimeric T cell receptor.” The idea here is part of a revolutionary CAR T-Cell therapy that genetically modifies a patient’s own T-Cells so that it will be able to recognize (and thus attack) specific antigens. The inventors have been awarded numerous accolades for showing that this approach works to treat some lymphomas. Kite’s “YESCARTA” therapy was found to infringe.
Juno Therapeutics v. Kite Pharma (Fed. Cir. 2021)
The jury awarded the patentees $1.2 billion for Kite’s infringement. On appeal, the Federal Circuit has reversed — finding the claims invalid for lack of written description.
Functional Binding element: The claims are directed to DNA (or some other nucleic acid) coding for a “binding element that specifically interacts with a selected target” in the form of a single chain antibody. But, the patent does not actually disclose the DNA sequence of such a binding element. That failure led the court to find that the claim lacks written description.
The patent does disclose a couple of single-chain antibody fragments that work (and their binding sites): one derived from the “SJ25C1 antibody” that binds to B-cell lymphoma cells; and another derived from the “J591 antibody” that binds prostate cancer cells. The patent explains how those were obtained used, but does not disclose the amino acid sequence of either of these antibodies or their coding nucleic acid sequence.
The basic written description question is whether the functionally claimed “binding element” genus is sufficiently supported by the two examples provided in the specification.
Written description is a question of fact, and the jury sided with the patentee — finding invalidity had not been proven with clear and convincing evidence. The district court supported that ruling and denied Kite’s renewed JMOL motion. On appeal though, the Federal Circuit flipped the verdict — holding that “no reasonable jury could find the ’190 patent’s written description sufficiently demonstrates that the inventors possessed the full scope of the claimed invention.”
Full Scope Written Description: The Patent Act requires that the specification include “a written description of the invention.” 35 U.S.C. § 112*(a). The specification needs to convey that the inventor had “possession” of the claimed invention as of the patent application’s filing date. Written description regularly arises with regard to genus claims — claims covering multiple embodiments. In that situation, the court is looking for possession of the “full scope” of the invention as claimed. Typically this involves disclosure of “either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad. The test is even tougher for functionally-defined genus since structure cannot be derived from the claim language itself.
Here, the court found that the patent provided “no details” about specific embodiments beyond “an alphanumeric designation, SJ25C1, as the source”, and no “general characteristics that would allow” the binding portion to operate.
Without more guidance, in a vast field of possible CD19-specific scFvs with so few of them known, no reasonable jury could find the inventors satisfied the written description requirement.
Slip Op. During the trial, the patentee’s expert witnesses provided explanations regarding how the approach here has facilitated multiple CD-19 specific antibodies to be used as the way claimed by the inventors. On appeal though, the court reminds us that written description must be shown in the patent document istelf — not based upon post-solution activity. “Dr. Sadelain’s testimony about post-priority date developments, therefore, is irrelevant to the inquiry before us.”
Reversed.
= = = =
The case does not go into this, but the original application here is a copy of the nature biotechnology article published by the inventors in January 2002 along with 1-page of text all filed in May 2002. [Provisional App: 52334_60383872]. The issued claims are almost identical to those in the non-provisional filed in May 2003.
DC, I didn’t realize you were a geneticist. Can you speak to reverse transcription?
Thanks Rob.
Re: “The original application here is a copy of the nature biotechnology article published by the inventors in January 2002 along with 1-page of text all filed in May 2002. [Provisional App: 52334_60383872]. ”
I hope this is not another case of inventors shafting their own employer out of all foreign patent rights and income by rushing to publish for personal benefit before their employers patent attorneys could even file an inadequate provisional application? If so, there should logically be personal consequences, but there seems to rarely be so.
“there should logically be personal consequences”
Sloan Kettering is on pretty good financial footing as far as I know so I don’t see why they would feel the need to punish their employees unless some contractual agreement was egregiously violated.
Note also that both the inventors AND Sloan K can bask in the limelight of these “accolades”, regardless of this case.
I would also guess that the attorneys at Juno were well aware of this problem when they negotiated their exclusive license to the patent in question (and that license suddenly got a lot cheaper).
? Destroying financially lucrative patent rights of a research establishment or university by publishing before filing patent applications can have the same effect on its research funding as stealing the same amount.
More of this judicial activism…
The way to deal with scope of enablement is to look at the accused device/method and determine if it is non-obvious over the invention and done in a different way.
This full scope nonsense is another 101 Alice analysis where POS judges can just invalidate claims based on their personal biases.
Heinous.
link to patentlyo.com
Amazing that they feel no duty to distinguish this case with LazardTech or even discuss scope of enablement and whether the accused method/device is non-obvious over the disclosed embodiments.
NW, if by LazardTech you meant Lizardtech, Inc. v. Earth Res. Mapping, Inc., 424 F.3d 1336 (Fed. Cir. 2005), why would it need to be distinguished, as you suggest? The court ruled in ERM’s favor, finding some of the claims invalid, and that ER Mapper did not infringe the other claims. The case has been viewed by some as an example of the “written description doctrine” which courts may use when applying 35 U.S.C. § 112[3] to decide the validity of patent claims, but by others, as I recall, as an extreme example?
Paul, I am very busy right now. I think I did get the wrong LazardTech. But the point is that the analysis should be driven by comparing the accused device/method with the embodiments disclosed in the specification.
This opinion, which I am going to read when I get the chance, appears to be judge driven. Another test “full scope” that can be invoked anytime to invalidate any claim.
“ The way to deal with scope of enablement is to look at the accused device/method and determine if it is non-obvious”
Remember, folks: these are the same hypocrites who get super frothy when you identify the improvement over the art during an eligibility analysis of a claim. That’s the worst thing ever, we are told, and it’s ALSO “judicial activism.”
So now we know what Wiper and his BFF really means when he refers to “judicial activism”. [we learned this many years ago, in fact]
This doesn’t even make sense MM.
Ditto everything that RG said below.
As for this :”The test is even tougher for functionally-defined genus since structure cannot be derived from the claim language itself.”
if only the rules in the grown-up arts also applied to the silly sandbox where the kiddie patent attorneys play with their oh so shiny computers that were invented just yesterday.
Like maybe describe one actual working species? But I guess that’s just too much work. After all, those people are sooooo important.
The scope of protection granted should be commensurate with the magnitude of the contribution to the art. Simple enough to enunciate that fundamental principle of every patent system under the sun. Harder though, to enforce it.
I really like the title to this post “Full scope written description”. I shouldn’t express an opinion, but I do wonder, MM, whether courts in chem/bio cases are more competent and confident of their opinion about what scope is “commensurate” than when they have before them a CEI “computer-implemented-invention” case.
Max, the idea that the scope of protection should be commensurate with the magnitude of the contribution is not a bad idea except it has a few significant problems. The magnitude of the contribution is not always easily recognized at the time of invention. There have been many inventions whose significance was only recognized in hindsight. This specific example may or may not be in that category, but it happens quite often. Also, the original inventor may not recognize the full importance of the invention or how to fully exploit its potential. That may require years more research and development or additional people to fully understand it. By then, its well past the time of the original invention and the time frame for patenting.
+1
Interesting comments – and upon a second read, there is a more nuanced view being advanced in that it appears that “market acceptance” should NOT be a driver as to power of the patent.
I tend to agree.
“it appears that “market acceptance” should NOT be a driver as to power of the patent.”
I agree that “commercial success” should be irrelevant to the validity of the patent.
While I recognize that your reply is off-point and more of an obfuscation, you may be interested in this:
link to patentdocs.org
Yes, it’s from the site that you unleashed a bevy of your varying pseudonyms – after whining incessantly on this blog that such a type of posting was “the worst thing ever.”
All that might very well be so, Dvan, but what I had in mind was for the scope of protection to be commensurate with what one can derive as the (enabled and described) contribution to the art from the making of a careful comparison of the specification as filed on the filing date of the patent application with the results of the patentability search carried out by the Patent Office.
Accordingly, it did not occur to me that (as you write):
“The magnitude of the contribution is not always easily recognized at the time of invention.”
In these days of First to File, what matters for the validity of a claim is the date of that claim ie its deemed PTO filing date, and NOT the date of invention and NOT market behaviour years later.
Unless, of course, that validity is to be decided by secondary and after-the-event factors like commercial success. The tail should not wag the dog, I say.
“Grown-up” and “silly” — as being applied by the “it’s Opposite Day” Malcolm Mooney, who is the most silly and least grown-up commentator on this blog.
As has been commented on multiple times dating back years now (and certainly prior to his year plus hiatus).
During the trial, the patentee’s expert witnesses provided explanations regarding how the approach here has facilitated multiple CD-19 specific antibodies to be used as the way claimed by the inventors. On appeal though, the court reminds us that written description must be shown in the patent document istelf — not based upon post-solution activity. “Dr. Sadelain’s testimony about post-priority date developments, therefore, is irrelevant to the inquiry before us.”
Que the common refrain of the (unknowingly) ANTI-patent people that there should be no problem here. The whole point of the patent system is that this patentee’s partial disclosure should be properly sized so that later inventors can be encouraged to find and disclose the uses of the other CD-19 antibodies.
Nobody suggests these patentees couldn’t have also done this follow-on work, and also gotten a patent for the additional “facilitated” research. In fact, since they could CIP and knew about the underlying work prior to the publication (or non-publication) of the application pgpub, they were in the pole position to do this follow on work.
They chose not to.
The correct solution is not to handwave the failure to complete the full scope of the research. The correct solution is to properly size each contribution – These guys taught part of the scope and then follow on research found more/the rest. To each their own disclosure. Not to the original inventor an oversized portion that discourages the follow on. A roadmap to research is not invention.
Great inventions are great not because one person sees the entire field, but because their disclosure prompts so many to stand upon their shoulders. One person is rarely both the first and last word on a subject, which is what one would have to conclude to award them a functional scope over their novelty.
I read Supreme Court precedent as essentially banning functional language at the point of novelty, but even those who don’t ought to recognize how fraught with peril that choice of claiming is.
Cases like this one make me sad. It is disappointing when innovators who have made the world a better place go away empty-handed. Our patent system can and should be better. A well-known professor once told me that the purpose of the United States patent system is to encourage kids to grow up to be scientists and engineers, by holding out for them the prospect of fame and financial success. In other words, those who provide us with useful inventions, and the risk-taking companies who support them, should become rich and famous, or what are we doing here?
These folks all have made millions, but that might seem like nothing compared to billions.
“those who provide us with useful inventions, and the risk-taking companies who support them, should become rich and famous, or what are we doing here?”
Maybe it’s a good time to step out of the office and get some fresh air. Have you ever noticed how many different kinds of plants are growing in the park?
If your life’s meaning hinges on the possibility of being “rich and famous” it is almost certainly best for you and society to off yourself as soon as possible. Society will be fine without you getting rich and famous, and someone else will do the inventing.
I’m sure you have a huge passion for improving public education, too, right?
In other words, those who provide us with useful inventions, and the risk-taking companies who support them, should become rich and famous, or what are we doing here?
As they say in the movie Class Action “They should have had a better lawyer.”
It’s not like the risk of drawing an invalid scope can’t be mitigated with proper usage of dependent claims or entirely eliminated with means-plus claiming.
“Que the common refrain of the (unknowingly) ANTI-patent people that…”
You are misusing the term “ANTI-patent.”
You are misusing the term “ANTI-patent.”
No, I’m not. Overbroad scopes (which you routinely argue for, especially whenever 101 crops up) lowers all of the number of patents issued, the quality of the disclosures to gain those patents, and the total amount of research done. Those are all opposite the purposes of the patent act, and are all anti-patent.
“ Overbroad scopes (which you routinely argue for,”
LOL – nope, as you are quite wrong here in that it is only in YOUR warped view that what I DO argue for is ‘overbroad.’
As to the rest of the supposed effects – you are quite literally making these things up whole cloth.
it is only in YOUR warped view that what I DO argue for is ‘overbroad.’
Ah, okay. What you argue for is the validity of scopes that courts do not generally uphold as valid because they find them overbroad, better? I leave to you to argue that the system/scoreboard/Supreme Court are incorrect and anon is the true wellspring of valid legal theory.
Lol – falling back to the notion of “scoreboard” when it was a known that scoreboard is broken (especially on the cases you like) is NOT a winning argument and only shows how little you understand the larger issues at play.
“The correct solution is not to handwave the failure to complete the full scope of the research”
That’s a pretty Strawman. Mind pointing out where anyone has ever postulated that as being “a correct solution?”
That’s a pretty Strawman. Mind pointing out where anyone has ever postulated that as being “a correct solution?”
I think Nightwriter constantly suggests that “scope of enablement” should be the only test for scope. If you give him enough time I’m sure he’ll circle around to it on this thread.
He might – but you would still be in error of attempting to portray HIS views as being the same as your strawman here.
He might – but you would still be in error of attempting to portray HIS views as being the same as your strawman here.
It’s his view I particularly had in mind when I wrote that statement, so by definition it’s not a strawman. He excuses the applicant from doing the research (possession under WD) because the disclosure enables without undue experimentation.
First wrong: “when I wrote that statement,”
Presuming that just because you wrote it, it must be correct is itself a plain error.
The point is that your aim was off, so what you think is Night Writer’s position is not Night Writer’s position.
“so by definition it’s not a strawman”
This is merely compounded error – since your aim is off and you mis-attribute a position that no one actually has, by definition, your statement IS a strawman.
“A roadmap to research is not invention.”
Yup. I have said as much — and certainly there is NO definition out there that would label me as anti-patent.
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