Tuesday, April 7, 2009

Ariad v. Eli Lilly and In Re Kubin: One Federal Circuit Panel Perpetuates the Lilly Written Description Doctrine, While Another Avoids Addressing It

I am one of those that believes the written description requirement should be used only to police against the introduction of new matter into claims, and not as a separate requirement of patentability. In previous posts , I have explained some of the reasoning behind my objection to what I refer to as the “Lilly written description requirement,” named after the 1997 Regents of UC v . Eli Lilly decision, wherein the Federal Circuit relied on written description to invalidate originally filed claims directed towards the insulin gene. Some judges on the Federal Circuit, in particular Judge Rader and Judge Linn, share this distaste for the Lilly written doctrine. Nonetheless, the trend in recent years, both in the courts and Patent and Trademark Office (PTO) has been towards the perpetuation and expansion of Lilly written description as a distinct doctrine of patentability, and this trend continued last week in Ariad v. Eli Lilly.

In Ariad v. Eli Lilly, the Federal Circuit reversed a Massachusetts District Court and invalidated Ariad's claims broadly reciting methods of repressing the activity of NF-kB, an important regulator on gene transcription. The facts of the case are discussed in earlier posts to this blog. Although my interest in the case has primarily been focused on Lilly's argument that the claims are patent ineligible for wholly encompassing a natural phenomenon, the Federal Circuit panel deciding the case avoided the issue of patent eligibility by ruling that all of the asserted claims failed to comply with the written description requirement.

Ariad’s invalidated claims are reminiscent of the University of Rochester's claims, directed towards methods of inhibiting prostaglandin H synthase-2 (PGHS-2, a also referred to as COX-2), which were held invalid for violating the Lilly written description requirement in University of Rochester v. G.D. Searle, 358 F.3d 916 (Fed. Cir. 2004). The University of Rochester's claims broadly recited "a method for selectively inhibiting PGHS-2 activity in a human host, comprising administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product.” The Federal Circuit found that the claims failed written description requirement because the specification did not specifically describe any non-steroidal compound that would perform the claimed function. Rochester is one of the seminal Lilly written description cases, and marked a significant expansion in the reach of the doctrine. This was the first instance in which the Federal Circuit applied the doctrine to invalidate method claims; prior to Rochester, Lilly written description had only been applied to biomolecules claims, i.e. nucleic acids and antibodies.

Similarly, Ariad’s claims purport to broadly cover methods of inhibiting NF-kB activity, while providing little if any disclosure of molecules capable of accomplishing this inhibition. Ariad attempted unsuccessfully to distinguish its claims from those of the University of Rochester’s, pointing out that the University's claims specifically recited the use of a non-steroidal compound, while Ariad's do not explicitly mention any compound. This strikes me as a ridiculous argument. Essentially, Ariad was arguing that because its claims were drafted more broadly than the University’s, implicitly encompassing any compound that would achieve the desired function, its specification was not required to describe any compound. The Federal Circuit saw through this specious argument, and held that “[R]egardless of whether the asserted claims recite a compound, Ariad still must describe some way of performing the claimed methods."

Turning to Ariad’s specification, the Federal Circuit noted that it identified three classes of molecules potentially capable of reducing NF-kB activity: specific inhibitors, dominantly interfering molecules, and decoy molecules. Regarding the first two classes, the Federal Circuit found that, as of the effective filing date in 1989, the specification failed to provide any more than vague functional descriptions of the molecules.

With respect to decoy molecules, the Federal Circuit acknowledged that the specification provides specific examples of decoy molecules, including structures, leaving "little doubt that the specification adequately described the actual molecules to one of ordinary skill in the art." Nonetheless, the court went on to conclude that the specification failed to adequately describe “using those molecules to reduce NF-kB activity.” It noted that the specification taught a method of reducing NF-kB activity using decoy molecules that would bind NF-kB and thereby effect negative regulation of NF-kB activity, and acknowledged that prophetic examples are routinely used to satisfy the written description requirement in the chemical arts, but nevertheless concluded that the “disclosure is not so much an ‘example’ as it is a mere mention of the desired outcome.” The court failed to articulate why Ariad’s disclosure of using specifically described decoy molecules to negatively regulate NF-kB is insufficient to satisfy written description, except for the conclusory statement that "there is no descriptive link between the table of decoy molecules and reducing NF-kB activity” (emphasis added).

Later, the court provides a more convincing justification its decision to invalidate Ariad's claims, holding that regardless of whether the use of decoy molecules was adequately described, the disclosure was insufficient to "bear the weight of the vast scope of these generic claims.” In other words, the court invoked the Lilly written description requirement to invalidate the claims for being overly broad, claiming more subject matter than was justified by the scant disclosure. In closing, the court pointed out that it was the extreme breadth of the claims that had been their undoing, and that "for its own reasons, Ariad maintained the breadth of these claims to claim construction and into trial. . . . The motto, ‘beware of what one asks for,’ might be applicable here."

In a concurring opinion, Judge Linn agreed that the majority's opinion was supported by Federal Circuit precedent, but reiterated his position that the Federal Circuit has been “misguided” in grafting a separate written description requirement onto section 112, paragraph 1. He criticized the panel majority for relying on the Lilly written description requirement and not addressing the important enablement issues in the case. To quote Judge Linn:

As the majority opinion observes, the claims-in-suit broadly claim any method for reducing NF-kB activity in cells, including both known and unknown methods. We have long held that in order to survive the enablement requirement specification "must describe the manner and process of making and using the invention so as to enable a person of skill in the art to making use the full scope of the invention without undue experimentation.” To my knowledge, however, we have not specifically address this requirement in relation to the type of claim at issue here- that is, claims written broadly enough to cover any method for achieving a particular result. It may be, as Lilly argues, that such a claim can never be valid, since the specification cannot enable unknown methods. This is an important issue that we have left unresolved. It is an issue that we would have been compelled to reach had the case been decided on enablement rounds, a basis found in section 112, instead of on written description grounds, a separate basis not justified under that section or any other provision of the Patent Act.

I agree with Judge Linn in this regard. The fundamental problem with Ariad's claims is that they are simply too broad to be justified by the limited disclosure in the patent specification. The enablement requirement is the appropriate tool for policing claim scope, but as observed by Judge Linn, the courts have failed to articulate a workable standard for policing claim scope. Lilly written description doctrine provides nothing in this regard, but to the contrary simply muddies the doctrinal waters. A good example of this can be seen in the majority's opinion in this case, when it struggles to explain why the disclosure of specific structures for decoy molecules in the specification, coupled with a description of using those molecules to inhibit NF-kB, does not constitute adequate description of how to use the molecules to inhibit NF-kB. The majority’s basis for this conclusion, an alleged lack of a “descriptive link” between the disclosed decoy molecules and reducing NF-kB activity, is bizarre. The specification describes the molecules in explicit structural terms, and describes using them to inhibit NF-kB activity. It seems clear that the Federal Circuit's actual concern was that the specification did not enable the use of these molecules to inhibit NF-kB activity, but because the majority chose to rely on written description rather than enablement it had no established doctrinal basis for invalidating the claims, so it coined and apparently novel “descriptive link” requirement for patentability.

The majority's main objection to the claims was based on their broad scope relative to the limited disclosure of the specification; as noted by Judge Linn, traditionally the enablement doctrine has been used to police claim scope. The test for enablement is easy to state: a claim fails to satisfy the enablement requirement if the disclosure is not commensurate in scope with the claims. The actual application of the test to real claims and disclosures is anything but straight forward, as noted by Judge Linn in his concurrence, but at least there is an established standard. In contrast, the Federal Circuit has failed to articulate any meaningful criteria for applying Lilly written description to police claim scope that is distinguishable from enablement. This point was made, for example, by Judge Rader in his dissent from the decision not to hear Lizardtech en banc, and I have discussed in my article “Is Lilly Written Description a Paper Tiger?: A Comprehensive Assessment of the Impact of Eli Lilly and Its Progeny on the Court and PTO.” The emptiness of the Lilly written description requirement is reflected in the Ariad majority’s conclusion that the claims were invalid because the disclosure was insufficient to "bear the weight of the vast scope of these generic claims.”

In re Kubin, decided the same day as Ariad v. Lilly, and described in an earlier post, also involved a written description issue. However, in that case the panel declined to address written description has moot in view of the fact that the claims were invalid based on obviousness. The author of Kubin, Judge Rader, apparently decided that Kubin was not appropriate case to take on the Lilly written description requirement, but perhaps he and other critics of the doctrine will have their chance in another case. The patent office has become much more aggressive in applying Lilly written description as a requirement of patentability requirements separate and distinct from the enablement requirement, as discussed in a previous post, so there should be further opportunities to address the issue in the future.


Michael Risch said...

I've always thought that written description does a job that enablement doesn't. There may be specifications that say "here's how you do it" but don't actually say that the work has been done. Rochester is exactly that. The method for segregating NSAID's is patentable, but claims for the actual NSAID's are not where the method has not actually been used to discover them.

I think reasonable minds might differ on whether this is good policy, but I think the rules, such as they are, are distinguishable at the conceptual level.

I tend to think it is a good policy precisely for the breadth issue. There may be extremely broad claims that are enabled but not described, and we probably don't want to issue patents on them.

Viewed this way, there is an argument that the Sawyer & Mann light bulb in the incandescent case was really a written description + utility case. There's no doubt that Sawyer & Mann enabled one to make ANY light bulb with carbonized fibers. The real problem was that they didn't describe every type of light bulb that would work.

Nick Robinson said...

Hi Chris,

I found your blog post very interesting.i am Nick Robinson,a community member at Patents DOT Com(a comprehensive free patent
search engine).Will like to talk(through email) to you,is this the right time to talk about or should we talk during weekends ?

Nick Robinson


SAW said...

You dont have to enable later developed technology. In re Hogan. But Chiron v Genentech says that if your claim covers such later developed tech, you might lack written description. Ariad seems similar to Chiron in some ways, patentee in both cases had to put forth a very broad construction to capture infringers. Both fail for written description.

A agree with Michael that written description should be a basis for invalidity. But, if you take the opposite view, where is the written description requirement enforced? Only at the PTO level? So if you get a claim by the PTO, written description is presumed fulfilled, and that presumption is not rebuttable?

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