Gov’t Brief on Full Scope Enablement: Specification Must Enable the Entire Genus

by Dennis Crouch

The Solicitor General’s new brief in Amgen v. Sanofi shrugs off the case–identifying petitioner’s arguments as meritless:

Petitioners contend that the court of appeals erred by treating enablement as a question of law and by examining the full scope of the claims in assessing whether they are fully enabled. Those arguments lack merit and further review is not warranted.

Gov’t CVSG Brief in Amgen Inc. v. Sanofi, 21-757 (Supreme Court 2022).

The petition argued that genus claims–especially those functionally claimed–are being asked to comply with a heightened enablement standard.  The Gov’t agreed that at times it may be difficult to enable an entire genus, but not because of any heightened standard.  Rather, “broad claims naturally require more extensive enablement” since the patent’s disclosure “must be commensurate with the scope of its claims. . . . When, as here, a patent claims an entire genus based on its function, the patent must enable that entire genus.” The brief cites to Consolidated Electric Light Co. v. McKeesport Light Co., 159 U.S. 465 (1895) and Holland Furniture Co. v. Perkins Glue Co., 277 U.S. 245 (1928) as representative.  In those cases, the Supreme Court used to enforce patents whose scope encompassed, but far exceeded, the examples given in the specification.  Of course, the Brief’s bold statements fail to contend with the reality that enabling the “entire genus” will effectively curtail genus claims, and the resulting policy shifts.  I expect that a Supreme Court decision in the the case would not go as far as suggested by the Gov’t Brief, but the middle ground might not be enough to flip the result here.

The Gov’t Brief also explains enablement as a mixed question of fact and law.  Although the jury sided with the patentee, the district court judge rejected the verdict on JMOL  — holding that the claims lacked enablement.  That JMOL determination was affirmed on appeal.  The Government brief does not delve deeply into the issues raised but simply states:

Petitioners complain about the formulation the court of appeals used in articulating the standard of review, but they do not identify any practical implications flowing from that disagreement.

Id.

Usually, the SG brief is the most important amicus brief at predicting certiorari.  However, that might no longer be true for today’s 6-3 conservative majority hearing remarks from a liberal administration.

13 thoughts on “Gov’t Brief on Full Scope Enablement: Specification Must Enable the Entire Genus

  1. 4

    Dennis, I subscribe to your blog so I read them in my email. This is super convenient, but the font size in your emails is really small and hard to read. Could you update your emails to use a larger font size?

  2. 3

    Similarly in Holland Furniture Co. v. Perkins Glue Co., 277 U.S. 245 (1928), the Court held that the disclosure of “a particular starch glue” with a certain function did not enable a claim for “all starch glues” with that function, given that “[o]ne attempting to use or avoid the use of [the] discovery as so claimed and described functionally could do so only after elaborate experimentation,” id. at 256-257. The Court explained that “[a] claim so broad” would improperly “extend[ ]” the “patent monopoly” “beyond the discovery” by permitting “the inventor who has discovered that a defined type of starch answers the required purpose to exclude others from all other types of starch.” Id. at 257.

    /golfclap

    I’m glad someone knows what they’re doing. Nothing so succinctly encompasses the two principle concerns as those lines: unjust enrichment due to an overbroad scope and a lack of notice as to what actual embodiments are cleaved from the public sphere.

    In this case, by contrast, the district court determined that a “person of ordinary skill in the art” using the random-generation method and “attempting to obtain a claimed antibody that is not disclosed” “ ‘would have to do essentially the same amount of work as the inventors of the patents-in-suit.’ ” Pet. App. 40a (citation omitted).

    Functional claimers better hope that this logic does not catch on. I have yet to see a functional claim where applicants have gotten even halfway there on their scopes.

    1. 3.1

      Random, can you write a bit more. Here in Europe, on enablement, we have a line of case law that can be summarised as “one example is enough”. I think that is often the case, even with functional claims. Suppose the invention is a foldable tennis racquet (and that this subject matter is new and not obvious). How many embodiments do I need? Or suppose I just invented PTCA (percutaneous trans-luminal coronary angioplasty). If I enable just one stent and just one delivery catheter, isn’t that enough to enable the full scope of my claim?

      Or is it only in the case of covetous and excessively greedy claims within the unpredictable arts that the mantra “one is enough” does not hold?

      1. 3.1.1

        For what little my opinion is worth, I think that the one-is-enough cases are all fine as far as they go. The one-is-enough cases are all careful to make clear that a single example may suffice, depending on the nature of the technology. As the EPO’s Examination Guidelines say (F-III.1) “the application is not usually regarded as satisfying the requirements of Art. 83 unless the description gives a number of examples or describes alternative embodiments or variations extending over the area protected by the claims. However, regard must be had to the facts and evidence of the particular case. There are some instances where even a very broad field is sufficiently exemplified by a limited number of examples or even one example… .”

        So far as this goes, this is just common sense. This way of looking at written description tracks the distinction that one frequently sees in the inventive step context between the so-called “predictable arts” and “unpredictable arts.” Some technologies require more explanation than others in order to be fully enabled. There is nothing wrong with acknowledging that reality when assessing enablement, just as one does when assessing inventive step.

        1. 3.1.1.1

          I am reminded of an old anti-software patent person (who knew precious little about patent law, or about innovation for that matter), whose ‘claim to fame’ rested on Maths (the philosophy leg) and the equivalency thereof.

          The notion being explored here of, “One is enough” is a delightful reminder of how (unintentionally) self-defeating that Anti was.

          As I recall, his nom de plume was PoiR. But it has been ages since the TechDirt and Slashdots have provided anything but the most feeble of anti-patent screed.

      2. 3.1.2

        MaxDrei,

        What exactly do you mean by, “within the unpredictable arts”…?

        Are those per chance the very same arts that Malcolm crows about as being the “grown up” arts?

  3. 2

    Good reasons for cert denial include the fact intensive and peculiarly patent law nature of claim “enablement” issues, plus the Markman requirement for judicial, not jury, interpretation of claim language.

  4. 1

    “the Brief’s bold statements fail to contend with the reality that enabling the “entire genus” will effectively curtail genus claims”

    Perhaps in some arts. Software will no doubt press on with broad functional claims and any mention of requiring enablment for the full scope of how those functions are achieved will result in hysteria.

    1. 1.2

      I mean, enabling the entire genus IS the law, and nobody is really disputing that. The question is by what standard do some particular embodiment disclosures enable the entire genus. The mechanism cited in the brief is to quote the incandescent lamp case (“But the patent specification did not identify ‘some general quality, running through the whole fibrous and textile kingdom, which distinguished it from every other, and gave it a peculiar fitness for the particular purpose.'”) for a generic quality.

      I don’t know if generic quality is the best requirement, but I certainly agree with the logic that a lack of generic quality coupled with noticably different functional results are a good standard for denial of the scope.

      It’s pretty clear where this is going right? Applicants are either going to have to do all the work themselves or they’re going to have to limit themselves to particular embodiments they have discovered work and accept an equivalent means standard. The worst part of the brief for functional claimers is the statement that

      In any event, the court of appeals’ enablement determination was reasonable on the record before it. The court explained that “the claims are far broader in functional diversity than the disclosed examples,” noting that “there are three claimed residues to which not one disclosed example binds” and that, “although the claims include antibodies that bind up to sixteen residues, none of [the] examples binds more than nine.” Pet. App. 13a & n.1; see C.A. App. 4283 (listing “competitor antibodies” that bind more and different residues)

      There is a zero percent chance that the courts are going to allow functional language to disincentivize additional disclosures. There is no mechanism that would allow a claim to, e.g., binding to sixteen residues when the best disclosure binds to nine. Whatever standard pro-functional people want to come up with, it cannot allow someone who discovers the 9 bind to reach the 16 bind embodiment.

    2. 1.3

      Ben (or somebody else) I had supposed that a “genus” is something in biology or chemistry but not in engineering cases. Is it also to be found in functional claiming in engineering inventions? If so, can you give an example?

      1. 1.3.1

        As even MaxDrei can grasp, the “Genus/Species” position is bandied about without care.

        Very much a result of the unthinking “copy/paste” US patent examiner mode.

        I am also reminded of the staggering height of Mount S for those in that mode.

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