Guest Post: Ariad v. Lily: Choosing to Not Disrupt the Settled Expectations of the Patent Community

I asked Howard Skaist for his views on the recent decision in Ariad v. Eli Lilly. He wrote the following:

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By Howard Skaist of Berkeley Law, LLC.

In an en banc case closely watched by the patent bar, the Federal Circuit made little change to the law regarding written description and provided little additional guidance, despite a majority opinion nearly 40 pages long, two concurrences, two dissents and having received 25 amicus briefs. At a high level, the case can probably be best understood as having been resolved on policy grounds in the face of an unclear statute and Supreme Court precedent that does not directly address the question at hand; however, policy is only a portion of the justification that the majority of the full court uses for the outcome. 

The fundamental question is whether or not a separate and independent written description requirement exists under 35 USC section 112, first paragraph.  The majority answers the question in the affirmative, relying on the language of the statute, Supreme Court precedent and policy considerations.  However, the concurrence and dissenting opinions demonstrate that this language of the statute is far from clear and that the Supreme Court precedent does not really address the question directly.  Therefore, the main division among the judges appears to rest on policy considerations.  In addition to the policy considerations regarding the advisability of a written description requirement, the majority apparently does not want to “disrupt the settled expectations of the inventing community….”  Majority Opinion at 16. 

The facts of this case suggest that it may have been a good one to test policy rationales since it was brought by a variety of academic and research institutions, including MIT and Harvard, against Eli Lilly.  The inventors had made a fundamental research discovery in biotechnology and hypothesized several possible ways to take advantage of it, but it took those working in the field several more years to successfully develop a product exploiting the discovery.  Therefore, at the core of this case, a legitimate question exists regarding the role or purpose of a patent system and how research or academic institutions should fare under existing legal standards.  Also telling is the citation by Gajarsa in his concurrence of work by Dennis Crouch and Chris Holman showing that few cases have invalidated claims based on written description.  Linn, in his dissent, also cites to Crouch’s work. 

Ariad and a variety of institutions sued Eli Lilly on US Patent 6,410,516 the day the patent issued.  The inventors were the first to identify NF-xB and uncover the mechanism by which it activates gene expression underlying the body’s immune response to infection.  Thus, the inventors recognized and suggested that artificially interfering with NF-xB activity could reduce harmful symptoms of certain diseases.  At the District Court level, a jury determined that Lily infringed the four claims asserted and determined the patent to not be invalid for anticipation, lack of enablement or lack of written description.  However, on appeal, the Federal Circuit reversed and held the patent invalid under 35 USC 112, first paragraph, for failing to provide an adequate written description.  Ariad petitioned for en banc review and the Federal Circuit granted the petition. 

In the en banc opinion, the majority does a good job clarifying the heart of the dispute by stating: “[A]lthough the parties take diametrically opposed positions on the existence of a written description requirement separate from enablement, both agree that the specification must contain a written description of the invention to establish what the invention is.  The dispute, therefore, centers on the standard to be applied and whether it applies to original claim language.”  The point of departure therefore appears to center more upon whether or not original claims can be held invalid for lack of written description or not.  The conventional view had been that a claim supports itself.  However, Federal Circuit decisions in the last few years have challenged that thinking, such as Fiers v. Revel, Enzo v. Gen-Probe and LizardTech v. Earth Res. Mapping.  Here, the Federal Circuit establishes that those decisions were correct. 

As alluded to above, the majority does not agree with Ariad’s arguments about the wording of the statute or its characterization of the relevant Supreme Court precedent.  However, Gajarsa, while concurring, states: “[T]he text of section 112, paragraph 1 is a model of legislative ambiguity.”  Likewise, even the majority, in discussing the Supreme Court precedent concedes: “Although the Court did not expressly state that it was applying a description of the invention requirement separate from enablement, that is exactly what the Court did.” Majority Opinion at 14. Therefore, Ariad’s points may have more substance than the majority concedes. Nonetheless, the Federal Circuit states that “[a]s a subsidiary federal court,” majority opinion at 15, it is obligated to follow such precedent.  The Federal Circuit, however, does directly address Ariad’s contention that original claims should be treated differently than amended claims saying that the distinction does not exist in the language of section 112 and that Ariad has not provided a principled basis for making the distinction being asserted.  Majority Opinion at 19. 

The court challenges directly the thinking that an original claim necessarily supports itself under written description: 

“Although many original claims will satisfy the written description requirement, certain claims may not. For example, a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus. The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.”  Majority Opinion at 20. 

The majority does provide a few clarifying points regarding application of written description: 

“[The] hallmark of written description is disclosure. Thus, ‘possession as shown in the disclosure’ is a more complete formulation. Yet whatever the specific articulation, the test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.”  Majority Opinion at 24 

The court also acknowledges the disadvantage that this law creates for basic research institutions: 

“[T]he patent law has always been directed to the ‘useful Arts,’ U.S. Const. art. I, § 8, cl. 8, meaning inventions with a practical use, see Brenner v. Manson, 383 U.S. 519, 532-36 (1966). Much university research relates to basic research, including research into scientific principles and mechanisms of action, see, e.g., Rochester, 358 F.3d 916, and universities may not have the resources or inclination to work out the practical implications of all such research, i.e., finding and identifying compounds able to affect the mechanism discovered. That is no failure of the law’s interpretation, but its intention.” 

Conceding that enablement and written description are similar, the court nonetheless maintains that in some fields they can be quite different, particularly in chemistry and biotech: 

“Perhaps there is little difference in some fields between describing an invention and enabling one to make and use it, but that is not always true of certain inventions, including chemical and chemical-like inventions. Thus, although written description and enablement often rise and fall together, requiring a written description of the invention plays a vital role in curtailing claims that do not require undue experimentation to make and use, and thus satisfy enablement, but that have not been invented, and thus cannot be described.”

14 thoughts on “Guest Post: Ariad v. Lily: Choosing to Not Disrupt the Settled Expectations of the Patent Community

  1. In inventing a Written Description requirement in a way that makes them feel comfortable, the Federal Circuit has, once again, thrown their hat into the ring and chosen a peculiar theory about the way language works which doesn’t make sense. Specifically, the Court has said that meaning is somehow derived from a one to one correlation between word or concept (or, in other words, something in the head) and reality. On page 21 of the opinion, meaning, under the Written Description requirement, according to the Court, comes somehow as a result of a likeness between a) what one of skill in the art would “…visualize or recognize…” and b) structural (ie, physical) features or a representative number of species falling within the scope of the genus. In other words, something in the head is isomorphic with the outside world (the structural limitation and/or species). And, somehow one of skill in the art recognizes that isomorphism and derives ‘meaning’ from it; as if one skilled in the art gets a special feeling when the outside object fits, like a hand in a glove, in the inside mental concept.
    According to the Court, meaning sufficient to satisfy the Written Description requirement can NOT come from a functional limitation. Somehow, functional limitations lack that special recognition that structural limitations have.
    Imposing some sort of strange limitation that physical words on the inside, in the head, have to “…fit like a glove…” around designated physical objects on the outside exalts a peculiar metaphysical theory and has some really weird implications. What would one do with numbers (ie, how can something in the head match something that is ‘5’ or has fiveness in the outside world)? So, what exactly, is fiveness? Certainly, numbers can be recited in claims. And what about colors (how would something have ‘redness’)? And, why does functional language fail the test? Is it because the Court can’t “…visualize or recognize…” functional language? Well, how do they visualize or recognize structural language differently from functional language, is there really a ‘something’ in the Court’s head for structural language that isn’t there for functional language? And, is that how the Court gets meaning, from the ‘something’ in the head matching something in the outside world?
    I do not know how meaning works, but I do know that it doesn’t work in the weird way that the Court has hypothesized in Ariad. Meaning does not come from isomorphism, a sort of pairing of things on the inside (the head) with things on the outside. It’s ridiculous to say that one of skill in the art gets a strange or special feeling, that they can ‘visualize’ or ‘recognize’ when they’ve stumbled across a proper written description, a proper meaning, as the Court suggests. And, even without visualization or recognition functional language also has meaning. That is, one skilled in the art could certainly recognize an invention from so-called functional language alone.
    If the Court really has problems with ambiguity, there is an entirely separate section for that, namely 112, 2. Or, if they don’t feel a claimed genus has the correct number of representative species, there is a section (and test) for that too! Reading some weird theory of meaning into the Written Description requirement evinces the fact that the Court really has no idea as to how language operates and is willing to entirely screw up the law as a result.

  2. “I do not presently propose a general assault upon functional claiming based upon this. Rather, I was waging it already and this just provides a hint that my position will eventually wind its way through the courts and triumph. While I personally find this manner of claiming certain things distastefull, and perhaps even subject to the problems mentioned by Ned, I do agree with the court here that it should be fine if everyone knows the STRUCTURE which is being claimed (i.e. there is an art recogn….”

    And you were doing so well 6 – I had a ever-so-fleeting sense that maybe there was hope for you. A couple of useful posts, an inquisitive perspective and then, … , kablooey, a lengthy manifesto full of egomanaical blather.

    Some things never change.

  3. Since aspirin inhibits NF-kappa B and is used in exactly the context that Ariad was using (in the oral arguments in front of the original panel) to differentiate their claims from what happens when you move into the shade from the sunlight, they had/have an anticipation problem that won’t go away.

  4. I do not presently propose a general assault upon functional claiming based upon this. Rather, I was waging it already and this just provides a hint that my position will eventually wind its way through the courts and triumph. While I personally find this manner of claiming certain things distastefull, and perhaps even subject to the problems mentioned by Ned, I do agree with the court here that it should be fine if everyone knows the STRUCTURE which is being claimed (i.e. there is an art recognized correlation between structures and the claimed function).

    Nevertheless I’d love to see more of this type of language where it isn’t being used as dicta.

    “Especially since in many art areas, the parallel of “function” with “structural features” is so common to those of skill in the art that a mere labeled box on a flow chart serves the recognition function.”

    That however I doubt very seriously would suffice in many cases where the point is supposedly a “point of novelty” since, by definition, that feature is new and the art would not yet have recognized a correlation between structure and function.

    More importantly I doubt further that, in that mysterious “art”, that even 1% of those of ORDINARY (or even supreme master) skill in that “art” would have even the slightest clue as to the true structure that corresponds to even the most basic of those black box functions that are routinely used. Fact of the matter is, probably nobody really knows the actual STRUCTURE(S) that correspond to those functions. And that is a point that I imagine would not be lost on the USSC that I saw at the oral arguments at Bilski.

    I cannot wait for someone to press an issue such as this in the courts. Imma be roflin’ some mao. I doubt if I’ll ever get to see it though, because when pressed, anyone taking the opposite side would probably back down rather than appeal all the way.

  5. Thanks 6.

    You might consider:

    The bottom of page 20 is dictum addressing a chemical compound example of having enough species support for a broad genus claim that has functional language wherein that functional language is claiming a desired result.

    Continuing on page 21, the court states “We held that a sufficient description of a genus instead requires… 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”.

    The court continues: “We have also held that functional claim language can meet the written description requirement when the art has established a correlation between structure and function. See Enzo, 323 F.3d at 964 (quoting 66 Fed. Reg. 1099 (Jan. 5, 2001)).

    You will be hard pressed to expand this dictum into a general assault on functional claiming. Especially since in many art areas, the parallel of “function” with “structural features” is so common to those of skill in the art that a mere labeled box on a flow chart serves the recognition function.

  6. 6, I agree. Functional language has again and again and again caused problems related to scope of the claim vs. scope of the disclosure. Section 112, p. 6, was offered by congress as a solution, but practitioners seem to want to avoid its construction clause by artfully avoiding the invoking language “mean or step for” performing a function, etc. Since claims reciting functional language at the so-called point of novelty can almost by definition never be fully described or enabled, they are certain to be invalid under either O’Reilly v. Morse or Halliburtion unless saved by Section 112, p. 6.

    So what do they want? Their claims to be narrowly construed or to have them invalidated?

    But either way, the problem of functional language without clearly invoking “means or step” needs soon to be addressed by the Feds.

  7. There was some rather strongly worded language in there about functional language and when it is properly used

    Must have missed that. 6, do you have a cite?

  8. Ok, I am going to try this again as it seems that my posts keep disappearing. The interesting situation arises in any area where there is combined private and government interaction as to the restrictions upon private action by the United States Constitution. Any act of Congress must comport with the Constitution. A patent is no different. A patent is basically a contract between the government and a private party that has the effect of law. As a result, the patent MUST comport with constitutional requirements in order to be enforce. One of the consitutional requirements is that any act which Congress proscribes give adquate notice to the public of that behavior to be avoided. Otherwise the act may be struck as being unconstitutionally vague. It is my opinion that the Written Descritpion requirement is Congress’ way of avoiding vagueness problems. In other words, a person of ordinary skill may be able to make, use and invention, because the written description is enabling; however, that does not mean that the written description is not vague in violation of the constitution. The Written Description, therefore, is required and, at a minimum, must sufficiently describe the invention so as to place the public on notice as to what behavior is proscribed.

  9. Obligatory flame of the software “arts”. I’ll just leave it at that.

    Also, the Ariad decision came and went without too much fanfare so far as I can see. Good decision, nothing changes, it’s all good in the neighborhood. There was some rather strongly worded language in there about functional language and when it is properly used. If anything, that is what I’d like to hear more about from the court or PO.

  10. Perhaps there is little difference in some fields between describing an invention and enabling one to make and use it, but that is not always true of certain inventions

    So, for certain inventions then, is it OK for there to be little (or no) difference between describing an invention and enabling one to make and use it?

    (open invitation for flaming the software arts)

  11. Good question Luke. I want to know too.

    The European Patent Convention might provide relevant experience. In Europe, what is a poor judge supposed to do, when a claim of an issued patent lacks a supporting “written description” but the EPC offers the judge no basis to revoke for want of such “written description”?

    Well, he could invoke the Statute’s “insufficiency” requirement, to strike down the claim. Now, is that a “stretch” for the court? My perception is that experience to date suggests that it is not (despite the cries of the Chicken Littles in England, these past 40 years, that the European sky is falling).

    But then again, I’m not chem/bio. What do they think?

    And does Liebel-Flarsheim tell us anything?

  12. Are there any (bio)chemists out there that disagree with the notion that written description and enablement are/should be two different things?

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