An Enabling Written Description

by Dennis Crouch

As Jason Rantanen posted, the Supreme Court has granted certiorari in Amgen v. Sanofi, agreeing to hear its first patent case in two terms.  The case has the potential of shaking up disclosure doctrine in a big way.  In particular, Amgen argues that the Federal Circuit incorrectly created two separate requirements from overlapping textual portions of Section 112(a): Written Description and Enablement.  Truthfully, having two separate and distinct requirements reflects an incoherent textual analysis of the statute. Over the past several years, both of these doctrines have increasingly focused on a “full scope” disclosure that makes it virtually impossible to include broad claims, especially genus claims with functional limitations as Amgen did in this case.   More to come. . .

 

29 thoughts on “An Enabling Written Description

  1. 10

    WD and enablement are different and should be.

    Basically, the problem comes in with added knowledge of a person of ordinary skill in the art. As I can claim things that aren’t in the specification that are enabled but it would be different to have notice of them without a WD. Consider added claims.

    Full scope is just wrong the way the CAFC is analyzing it. Scope should be based on enablement. And you can’t tell if something is a full scope if there aren’t other inventions that are within the claims scope. If there were other inventions within the claim scope, then the claims would have been rejected under 103 or 102.

    So, how can one tell if it is possible to invent something within the claim scope when it has not been invented? A judge is supposed to decide this?

    Also, the solution is the reverse doctrine of equivalents. If something is within the claim scope after the claims are granted, then the question is whether this new invention is inventive in view of the patented claims.

  2. 9

    Interesting paragraph on the PatentDocs blog report:
    “As always, it is impossible to discern the Court’s reasoning for granting certiorari, particularly when it is against the recommendations of the SG. (The last patent case where these circumstances arose was in LabCorp v. Metabolite; in that case the Court ultimately decided certiorari had been improvidently granted and after oral argument dismissed the writ.)”

    1. 9.1

      I think Amgen will line up pretty well for the Court to decide something. I think it’s interesting that the claims in Wands and the claims in Amgen are generally similar. The Wands court decided that the PTO rejection was erroneous but the Amgen court decided the issued patent was invalid. I also find it interesting that the Wands opinion explained that the state of the art was quite advanced and the Amgen opinion didn’t mention it.

  3. 8

    Its an artificial distinction, and needless dissection to try to separate WD and enablement. Academically it might be intriguing but they’re two peas in a pod, and ya can’t have one without also having the other, when both are present, as they must be, in a proper spec.

    oohh, ooo, lets separate out a third…. lets create…. the “Teaching Requirement”. “If it pleases the court, plaintiff failed to teach….____ and ___. In fact, the word “teach” doesn’t even appear once in their entire spec.”
    Lack of support for 112 para. 6 is clearly a violation of the Teaching Requirement, for failing to teach any equivalents”

  4. 7

    I believe the Federal Circuit approach in Wands and in Amgen is backwards. The approach looks at a patented claim, presumed valid unless proven otherwise by clear and convincing evidence, and says, “That claim is broader in scope than what is described in the specification, so it is invalid.” The better approach, in my opinion, is to presume the claim valid, but only for the scope supported by the specification. If a claim can cover certain scope, from a Markman standpoint, that should be the scope of the valid claim. A patented claim should only be invalidated under 112 if there is no scope supported by any written description or enablement. In Amgen, in my opinion, the Federal Circuit should have reviewed the construed scope in comparison to the scope of description and enablement and, finding a mismatch, should have instructed the district court to construe the claims in light of the specification. The statutory presumption of validity should not tolerate finding a claim invalid because it is too broad for the specification. Just construe the claim properly. My $0.02.

    1. 7.1

      In other words, you agree with Burk & Lemley (2009)‘s suggestion to revive central claiming and apply 112(f) much more aggressively than is presently done. Not a bad idea, necessarily, but you will get a ton of pushback on this.

      1. 7.1.1

        I don’t think I necessarily agree with that.

      2. 7.1.2

        With academics such as these…

    2. 7.2

      But, where does the knowledge of the person of ordinary skill in the art fit in ?
      Certainly its not a factor which can be overlooked.

      I’d suggest that the person of ordinary skill reading the specification and claims realizes that all the means for clauses in the claims include all of those means for’s which are known or well-known to the phosita at the time the applicant had filed. So just b/c something isn’t in the spec, doesn’t mean its not enabled necessarily.

      Where does the knowledge of the phosita fit in, when considering claim breadth ? I don’t think it can be ignored.

      1. 7.2.1

        Phillips v AWH

        1. 7.2.1.1

          I sense a seismic shift upwards in the skill level of all artisans in all fields during the past 2 decades or so, which hasn’t been accounted for, and that older court opinions were operant or levied when persons working in the arts had far less skill. I might expect a patent spec would need to perhaps contain even “less” nowadays b/c of the increased knowledge and skill of workers in var. art fields, just from increased communication abilities alone.

          Its maybe a good question, has the overall skill level of artisans increased enough (if at all) in a way that can be reflcted by the courts w/resp. to what needs to be in a patent spec ?

          Today’s inventors in my experience, have far more skill on average than those of say the early 90’s.

          1. 7.2.1.1.1

            Interesting – and close — but a bit off (you may want to refresh yourself on the patent profanity in regards to the power attributed by the Supreme Court to “prior inventors” in the obviousness context)

            When the Court super-powers what a PHOSITA may know, they necessarily make it so that LESS must be included in future applications.

    3. 7.3

      I should add that Wands was not about an issued patent, but Amgen is.

  5. 6

    The problem with the claim is that it relies way too heavily on functional language. A valid claim would recite at least some comparison to a reference protein sequence existing in one or more actual antibodies identified and described in the priority document, e.g., “wherein said antibody includes a sequence at least 95% identical to SEQ ID No. 1” or some similar language.

    Note that such a claim is a bona fide genus claim potentially covering many, many species (the “argument” that “genus claims can’t be gotten and enforced” is complete b.s., as should be easily recognized by any attorney in the field).

    Should the Supremes decide (incorrectly) for Amgen, it will be an example of patent law being made much worse for everybody, including consumers who are going to end up footing the bill for the additional (undeserved) patent coverage that all players are going to be forced to navigate around …

    1. 6.1

      DC: “genus claims with functional limitations”

      Just to be clear, the claim at issue (reproduced in the other thread) recites ZERO art-distinguishing structural limitations. It’s all functional. That is a problem.

    2. 6.2

      “Note that such a claim is a bona fide genus claim potentially covering many, many species (the “argument” that “genus claims can’t be gotten and enforced” is complete b.s., as should be easily recognized by any attorney in the field).”

      Exactly. People get them all the time, from me myself. The only people whining about the “full scope” disclosure thing are the people that did in fact only invent whatever it is that they described and did not in fact have a valid claim to the whole genus etc. And they’re pretty rare. Obviously, if they think that they invented a much much larger genus or grouping of things, then they can just write it down and swear to it in their oath at time of filing.

  6. 5

    So, Lemley wins again in making this an issue to limit the patent right.

    1. 5.1

      As I have noted — there is ZERO ethical constraints on Academic Lemley in regards to attempting to influence the law (as well as law students).

      Contrast with those actually practicing the law.

  7. 4

    The two 112 text requirements for both “written description..” and “enablement..” were treated distinctly in interferences and their appeals long before the Fed. Cir. supported that distinction in other cases. The two are quite different in many cases and I do not understand why that issue [of being separate or combined requirements] is not separable from the issue in this case of adequate NUMBERS of enablement examples for broad claim scope. Is the former issue actually being argued by either party in this case?

  8. 3

    “that makes it virtually impossible to include broad claims, especially genus claims with functional limitations as Amgen did in this case. ”

    You have said this in a few posts, and you seem to ignore the fact that 112(f) exists and Amgen could undoubtedly have gotten valid claims using 112(f) claiming. (Probably would have gotten the same “full scope” too since, according to Amgen, all species within the genus were equivalent of one of those disclosed in the app).

    1. 3.1

      I do not think that the option of 112(f) necessarily saves anyone here.

      1. 3.1.1

        The only complication I could see to validity is that they would have to write it as a combination claim to be able to invoke 112(f) (no single element 112(f) claims). But I can’t imagine that raises tons of difficulty.

        There may be an issue with whether scope would be affected, but that just comes down to arguing equivalence. Which is almost what they are arguing now — that they disclose the full range of the genus and every undisclosed species is analogous to those disclosed. I’d rather argue that point for scope than validity.

        And of course 112(f) is optional. I don’t know that anyone disputes that. Everyone has the option to claim the embodiments disclosed rather than defining claim elements functionally.

        All I’m saying is any analysis concluding, “its impossible to get broad functional claims” without acknowledging 112(f) and why that wouldn’t work is incomplete at best.

        1. 3.1.1.1

          In theory, 112(f) with equivalents would work. In practice, litigation over an alleged equivalent will be a massively expensive and time-consuming pain, both from the evidentiary side of things (doing the necessary research on the antibodies and how they function) and also the “pushing 112(f) to the limit” side of things.

  9. 2

    But see my YLJ Online essay, A Brief Defense of the Written Description Requirement link to papers.ssrn.com in which I argue both for the WD requirement but also (at the time) that Ariad met it (which the court disagreed)

    My take there, as here, is that much of this is bound up in factual disputes about what exactly is described and enabled. I could write basically the same essay today, with the same result – the problem is not the conceptual rule, but debates about just how much needs to be in the specification to claim a genus given that rule.

    1. 2.1

      “the problem is not the conceptual rule, but debates about just how much needs to be in the specification to claim a genus given that rule.”

      Just don’t know about that irl bro. Usually this thing is popping up in one of two situations. Either a. they’re trying to claim some embodiments that still aren’t even enabled after their filing date (even with their disclosure) or b. they’re trying to go back and get a claim on something in the spec broader after they’re a year+ into prosecution and they whoopsie daisy didn’t expound on that part of the disclosure at time of filing. Bottom line, disclose everything you think you’re going to want to claim as well as you can at time of filing and you’ll 99.99% of the time be entirely fine. Even in the remaining .01% you can still usually get decent coverage, just you might possibly miss out on a payday that maybe you could have had if you were more verbose in your disclosure.

      1. 2.1.1

        But you are begging the question. By saying they still aren’t enabled, you are assuming they aren’t enabled. That’s the factual conundrum.

        I get that in the broad run of cases the inquiry is straightforward, but in those cases where they they have discovered some basic principle and want to claim the genus of things that exercise the principle, you are going to see these kinds of factual disputes.

        1. 2.1.1.1

          “By saying they still aren’t enabled, you are assuming they aren’t enabled. ”

          By making a statement (or in this case a findin o lawl based on underlyin fact findins) I’m assuming something? And this is a “factual conundrum”? Wut?

          I generally make my findin’s o lawl based on fact findings based on substantial evidence, I generally don’t assume anything in that process.

          “but in those cases where they they have discovered some basic principle and want to claim the genus of things that exercise the principle, you are going to see these kinds of factual disputes.”

          To the extent that they want to claim a genus of things that exercise a “basic principle”, that’s fine, so long as all of that genus is enabled. If their discovery of a basic principle did not magically enable all of the genus then their claim is not valid (presuming there are things in the genus which are not enabled as of filing anyway).

          1. 2.1.1.1.1

            You still be going in circles there, 6.

  10. 1

    I have maintained for years that with the switch from FtI to FItF, the WD requirement of the statute will come under scrutiny, and pressure. There has to be one statutory provision to confine scope of protection to that which is enabled on the filing date. There also has to be a different statutory provision (WD, or Art 123(2) EPC) to prevent applicants from improving during prosecution the disclosure position they had established at their PTO filing date.

    Given its reputation for obfuscating rather than clarifying the law, SCOTUS has picked up here a decidedly hot potato, one primed and ready for mashing.

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