Exploring the CAFC’s Ridiculous Written Description Standard for Life Sciences Patents

“One would think that a topic as fundamental, well-established, and frankly simplistic as the written description requirement would not present any difficulty for supposed learned judges of the Federal Circuit. Unfortunately, that assumption would be incorrect.”

https://depositphotos.com/63773275/stock-photo-sanity-or-insanity-arrows-concept.htmlThe written description requirement is really the backbone of the quid pro quo between the public and the patent applicant. In exchange for information about an invention, society is willing to grant the applicant a patent, which conveys exclusive rights for a limited period of time to what is claimed, not described. But the description provided in the specification must demonstration that the applicant really has an invention in the first place and what the boundaries of that invention are—this is the written description requirement in lay terms.

In legalese, the written description requirement, dating back to The Telephone Cases, 126 U.S. 1 (1888), has required enough description so that the invention is described with “sufficient clearness and precision to enable those skilled in the matter to understand [the invention].” And more recently, the Supreme Court reiterated that “Section 112 requires only a written description of the invention… in such full, clear, concise, and exact terms as to enable any person skilled in the art… to make and use the same.” Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012).

The critical aspect of the written description requirement, as with virtually every other analytical aspect of patent law, is that the invention is considered through the eyes of one of skill in the relevant subject matter. This obviously makes sense; if the invention relates to a sophisticated area of computational neurobiology, do we really care whether an aeronautical engineer who specializes in aerodynamics and propulsion understands the nuances of the invention? No. The law only cares whether one of skill in the subject area of the invention understands the description.

A New and Impossible Standard

One would think that a topic as fundamental, well-established, and frankly simplistic as the written description requirement would not present any difficulty for supposed learned judges of the Federal Circuit. Unfortunately, that assumption would be incorrect. Recent cases in the life sciences area, however, suggest a higher level of disclosure is being required by some judges of the Federal Circuit. Indeed, such a high level of disclosure that the standard cannot possibly be met if what the court has stated is applied literally as a test moving forward.

As difficult as it is to believe, the Federal Circuit has actually said that inventors must convey both “known and unknown” aspects of the invention in order to satisfy the written description requirement. Indeed, according to the Federal Circuit in Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330 (Fed. Circ. 2021), to demonstrate possession and satisfy the written description requirement found in 35 U.S.C. 112(a), the inventors needed to convey that they possessed both “known and unknown” aspects of the claimed invention. But how can an inventor describe something that is unknown? And where does “possession” come into play when that term and concept is not even mentioned in the statute? Juno Therapeutics has petitioned the Supreme Court to take up this case.

Of course, this “known and unknown” standard of disclosure to satisfy the written description requirement is idiotic and cannot be what the law requires. Not only is it illogical to require an inventor to disclose that which they don’t know in order to obtain a patent, which is obviously impossible, but this standard—if it is in fact a standard—fundamentally violates the underpinning of the law of obviousness. The Federal Circuit correctly explained that which is unknown cannot be obvious in Honeywell Int’l Inc. v. Mexichem Amanco Holding S.A. DE C.V., 865 F.3d 1348 (Fed. Cir. 2017). This issue arises in the area of obviousness due to the fact that examiners will from time to time reject claims as being inherently obvious, so there is a well-established understanding that “[o]bviousness cannot be predicated on what is unknown.” In re Rijckaert, 9 F.3d 1531 1531, 1534 (Fed. Cir., 1993) (citing In re Spormann, 363 F.2d 444, 448 (CCPA 1996)). And if what is unknown cannot make a claimed invention obvious, unknown aspects of an invention have no rightful bearing on written description.

Will SCOTUS Restore Sanity?

Meanwhile, the U.S. Supreme Court has also been petitioned by Biogen, asking the Court to consider whether the written description must disclose data that demonstrates the claimed invention is “effective” and emphasize the claimed invention by singling it out. This petition follows a contentious decision of the Federal Circuit in March, and the denial of a petition for panel rehearing and rehearing en banc. Dissenting from the Federal Circuit’s rehearing denial were Chief Judge Kimberly Moore and Circuit Judges Alan Lourie and Pauline Newman, who argued that Biogen’s written description disclosed every claim limitation in the patent. The dissent contended that the rest of the Federal Circuit introduced extraneous considerations into the Section 112 written description analysis, which they of course did.

Hopefully the Supreme Court will bring some sanity to this important area of law.

Join Us Live

If you are interested in this issue, please join us October 25-26 for Life Sciences 2022, which is a part of the IPWatchdog Masters™ series of live and in-person events. A panel of experts will discuss written description requirement, the tension between the statute and Supreme Court interpretation, how the Federal Circuit case law is evolving, what this means for the future of innovation, and what applications can and should do to respond. See also the full Agenda.


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12 comments so far. Add my comment.

  • [Avatar for sarah mcpherson]
    sarah mcpherson
    September 24, 2022 07:59 am

    RICO COUNSEL WILL GET THE 5,560,312 AND 5,832,857 INFO BEFORE YOU SPLIT IT.

  • [Avatar for Greg DeLassus]
    Greg DeLassus
    September 23, 2022 01:34 pm

    How can something be “useful” without being “effective”?

  • [Avatar for C.Whewell]
    C.Whewell
    September 23, 2022 01:22 pm

    The word “effective” is a joke, there is no requirement for effectiveness, only “new and useful”, which is modified by the “any” in front of it. We don’t need no steenkin new definitions or phony requirements.

  • [Avatar for Greg DeLassus]
    Greg DeLassus
    September 23, 2022 12:01 pm

    +1 to everything that TFCFM wrote at 11:29 am.

  • [Avatar for TFCFM]
    TFCFM
    September 23, 2022 11:29 am

    A small, but critical, clarification: Gene states,

    >>GQ>>… the description provided in the specification must demonstrat[e] that the applicant really has an invention in the first place and what the boundaries of that invention are—this is the written description requirement in lay terms.<<GQ<<

    This is accurate, insofar as it goes, but hedges on a critical bit: The described invention and the claimed invention have to be the SAME invention.

    Exaggerating to make a point, one cannot invent-and-adequately-describe a modestly-improved mousetrap and be thereby be entitled to claim the wildest rocket-ships, cancer-cures, wireless communications devices, futuristic non-disclosed mousetraps, and (oh yeah, the mousetrap that I actually invented, too) for which the one's imagination can describe a boundary.

    Similarly (and more realistically in the biotech space), if one invents a useful new molecule (or a new use for an old one) within a certain broad class of molecules, and if the one adequately describes the new-molecule/new-use, the one is surely permitted to claim that molecule/use.

    Furthermore, in a fact- and field-specific manner, description of the actually-invented molecule/use may (actually; i.e., in the real world) be adequate to allow skilled artisans in the field to reliably predict that barely-different molecules will certainly or almost-certainly have the same utility.

    However, given the inherent (and situation-specific) unpredictability of chemistry, biochemistry, and medicine there will usually, if not always, be a "boundary" (sharp or not) beyond which not-explicitly-disclosed molecules will cease to reliably exhibit the same or similar utility as the disclosed molecule(s). Beyond that boundary, of course, the invention will be inoperable in some, many, or all embodiments — depending, unpredictably, on which molecule one selects. In my view, much of modern refinement of the WDR relates to specifying this boundary.

    Once upon a time (or, in the Bad Old Days, if one prefers), one could disclose a single molecule, assert that other molecules in one or more classes which include that molecule "can be expected" to exhibit the-same-or-similar, assert also that routine screening could be used separate wheat-molecules from chaff-molecules, and expect to obtain a claim to, effectively, "my molecule and any molecule in the disclosed class(es) that exhibits at least ____ much [disclosed function]." Such a claim rightly includes the molecule/use the inventor actually invented, but also includes molecules/uses neither invented nor recognized by the patentee, those molecules/uses merely representing future-inventions-that-might-compete-with-the-patentee's-if-someone-were-to-make-them.

    In these less-Bad, less-Old days, the courts appear to be seeking to refashion biotech patents from the hunting licenses of the Bad Old Days to grants of legal rights which reward only the successful conclusion of the hunt.

    It is both commonsensical and legally true that a patent description must describe a claimed invention THROUGHOUT ITS SCOPE. (See Kennecott v. Kyocera, Fed. Cir. 1987; "The purpose of the [written] description requirement … is to state what is needed to fulfil the enablement criteria"). Disclosing one (or two or twenty) molecule(s) that adequately enable performance of the claimed invention surely suffices as a written description of the invention as it relates to that/those molecule(s). Moreover, when substitution of a not-explicitly-disclosed molecule in place of a disclosed one would reliably be expected to have the same utility, claims drawn to such substitute molecules ought also be considered to have been adequately described. However, beyond the boundary of "reliably-operable-if-substituted" molecules (a.k.a. "anything and everything that works, whether I've invented it or not") , one is attempting to pre-empt future inventions rather than protect what one has already invented.

    THIS, I think, is what modern WDR law seeks to limit. Furthermore, such limitation seems to me entirely justifiable, in that inventors ought to be able to protect what-they've-invented, and not whatever-might-compete-with-their-invention-even-though-they-didn't-invent-it.

  • [Avatar for Anon]
    Anon
    September 23, 2022 11:11 am

    MaxDrei,

    Your view is the opposite of a mind willing to understand, and here exhibits that very illogical propensity of conformation bias.

    You attribute to Mr. DeLassus a beneficial trait, NOT because of his exhibiting that trait, but merely because YOU agree with his position.

    I have asked you to compare and contrast the first (majority) with the second (original dissent) decisions, and understand the rather under-handed manner in which the change occurred. A change, mind you, that provided NO new understanding from the original dissent.

    There simply is NO new (legal, judicial reasoning) teaching in that second decision, and ALL that you have here is an assertion of an Ends that was rejected in the original panel.

    Nothing in the second decision survives a mind actually willing to understand in reviewing the sum total of the case.

  • [Avatar for MaxDrei]
    MaxDrei
    September 23, 2022 05:32 am

    Full marks, Gene, for your use of the word “ridiculous” to sum up CAFC jurisprudence. In the dialogue between you and Greg, I am reminded of Anon’s unremitting scolding of me for not having a “mind willing to understand”. It seems to me that those who call out what Chief Judge Moore wrote are falling into the same trap.

    The phrase “mind willing to understand” is part of the Principle of Synthetical Propensity, which demands:

    “building up rather than tearing down, to arrive at an interpretation of the claim which is technically sensible and takes into account the whole disclosure of the patent. The patent must be construed by a mind willing to understand, not a mind desirous of misunderstanding”

    Greg’s is a “mind willing to understand”. Is yours though?

  • [Avatar for Anon]
    Anon
    September 22, 2022 07:05 pm

    An aspect here of claim scope is that a pernicious requirement to “describe all” opens up (yet another) “No patents for you” roadblock that will surely be abused.

    To wit: improvement patents.

    A vast majority of patents are improvement patents.

    Does the fact that an improvement is only later recognized mean that an initial patent, WITHOUT being drafted to explicitly exclude such later advance, would fail for this augmented test?

    In truth, the only claims NOT susceptible would be extreme picture claims – to which, perhaps ONLY Big Pharma would find value in.

    I would add as well, that THIS case has proceeded in an extremely questionable manner, with a dissent turning into a majority with NO change to the matters of the case, and but for the views of that majority simply accorded NO weight in the decision process to rehear the case.

    (my druthers would have been to have some type of Senior Status caveat for O’Malley in regards to the decision to withdraw an otherwise majority panel decision.)

  • [Avatar for Greg DeLassus]
    Greg DeLassus
    September 22, 2022 07:00 pm

    Hopefully the Supreme Court will bring some sanity to this important area of law.

    Hoping that the Supreme Court will bring sanity to some aspect of patent law is like hoping that a hurricane will improve your landscaping. It is theoretically possible, but vanishingly unlikely.

    I never hope to see the Court take cert. on a patent case, because it is so rare a thing that they leave the law better than they found it. If they do take cert. here, however, then I will be praying rosaries that this is the one case in a million where they leave the law in a better state than it was before cert.

  • [Avatar for Greg DeLassus]
    Greg DeLassus
    September 22, 2022 06:25 pm

    Judge Moore’s exact words–in context–were (Id. at 1338) that “[t]o satisfy written description, however, the inventors needed to convey that they possessed the claimed invention, which encompasses all scFvs, known and unknown, as part of the claimed CAR that bind to a selected target,” (emphasis added). It is perfectly clear in context that the reason why unknown material needed to be described here is that the claims read on unknown material. If the patentee had been content to confine the claims to material that the patentee knew and could describe, there would have been no problem.

  • [Avatar for Gene Quinn]
    Gene Quinn
    September 22, 2022 06:12 pm

    @ Greg… The problem with what the Federal Circuit says is that the rest of us have to live with it. Chief Judge Moore did write that it is necessary to disclose both “known and unknown”, which is impossible. If that is not what she meant she shouldn’t have said. If she meant something else specifically in relation to the this set of claims, she should have said that. But she didn’t. So, I think we can all agree that what she did say is wrong, period. Who knows what she meant.

  • [Avatar for Greg DeLassus]
    Greg DeLassus
    September 22, 2022 05:31 pm

    [A]ccording to the Federal Circuit in Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330 (Fed. Circ. 2021), to demonstrate possession and satisfy the written description requirement found in 35 U.S.C. 112(a), the inventors needed to convey that they possessed both “known and unknown” aspects of the claimed invention.

    I do not think that this is a fair summary of Juno v. Kite. The CAFC is not requiring that all biotech claims must be supported by a description of both the known and the unknown. It is still perfectly possible for biotech claims to be supported by a description of only known material.

    Rather, what the CAFC was saying in Juno v. Kite was that those claims had such a capacious scope that the necessary supporting description for that scope would require a description of both known and unknown material. Because it is plainly impossible to describe the unknown, that is how we can tell that Juno’s claims were not adequately supported, and were thus invalid. It might all have been different if Juno had been litigating a narrower set of claims.

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