Tuesday, March 23, 2010

Ariad v. Eli Lilly: Pragmatism Prevails over Coherent Patent Doctrine

Yesterday in Ariad v. Eli Lilly, a majority of the en banc Federal Circuit decided to retain both traditional and Lilly written description as distinct requirements of patentability. I filed an amicus brief in the case arguing against the Lilly written description requirement (LWD), the brief and some of my objections to LWD are available in earlier posts to this blog. Essentially, I have argued that any positive policy aspects of LWD can be better accomplished using the enablement requirement, and that the courts have failed to articulate any coherent standard for compliance with LWD beyond the requirements of enablement. Federal Circuit judges Linn and Rader recognize this problem in their dissents to Ariad.

Still, I was not at all surprised that the majority decided to retain LWD, because it has developed into a useful tool for invalidating clearly objectionable patent claims precisely because it lacks any coherent standard. When faced with a patent such as Ariad's, which I think most people would consider overreaching, instead of having to find by clear and convincing evidence that the claim fails to satisfy one of the more rigorously articulated standards such as nonobviousness or enablement, the court need merely conclude that the application fails to adequately demonstrate the patentee had “possession” of the claimed invention, or, in the alternative, that the application fails to show that the patentee "invented" the invention, and the claim is invalid. No need to go through the more rigorous proofs necessary to show lack of enablement or obviousness.

As noted perceptively by Judge Rader in his dissent, "the courts inadequate description of its written description requirement acts as a wildcard on which the court may rely when it faces a patent that it feels as unworthy of protection.”In other words, the main value of LWD is its lack of any articulated standards for compliance - it provides a pragmatically useful tool for a company like Eli Lilly to dispose of an "unworthy" patent by merely convincing a court of its unworthiness. In the view of many, including myself, Ariad's claim should be found invalid for lack of enablement, but because the criteria for establishing lack of enablement, such as assessment of the Wands factors, are more well defined they can also be more difficult to establish, hence the appeal of an essentially standardless patentability requirement such as LWD.

When the Federal Circuit created LWD in 1997 in Regents of the University of California v. Eli Lilly, it was initially thought of as a serious blow to biotechnology. Typical of the tone of the time, one commentator lambasted Lilly as "an unmitigated disaster that if followed, has the potential for causing untold havoc in the biotechnology field." An article was published in Science predicting that Lilly would have a broad impact on biotechnology, and many feared that LWD would prevent biotechnology inventors from obtaining adequate protection for their inventions. For more discussion of the Lilly decision and response to it, see my 2007 article "Is Lilly Written Description a Paper Tiger?"

In view of the widely held perception that LWD was bad for biotechnology, it might come as surprise to find that major biotechnology companies Amgen, Glaxo Smith Kline, and Abbott all filed amicus briefs in Araid supporting Lilly and retention of LWD. Note that the support comes from major biopharmaceutical companies selling blockbuster drugs, who like Eli Lilly see the pragmatic usefulness of LWD as a tool for invalidating unwarranted and irksome patents such as Ariad’s. Other biotechnology companies, presumably more concerned about the negative impact of LWD on their ability to obtain adequate patent protection for their biotechnology inventions than the threat of being sued for infringing and "unworthy" patent, joined me in arguing against LWD. Universities also filed an amicus brief arguing for elimination of LWD. The Biotechnology Industry Organization (BIO) did not weigh in with an amicus brief, I would guess because their membership, which includes universities, small biotechnology companies, as well as large biopharmaceutical companies like Eli Lilly, was too divided on the issue to take a unified stand.

As a practical matter, I don't think that retaining LWD will have a major impact on biotechnology or patent law in general. As shown in empirical studies conducted independently by me and Dennis Crouch of Patently-O fame, it appears to be very rare for a patent claim to be rejected or invalidated solely based on failure to comply with LWD (both studies are cited in Judge Rader's dissent). In most cases, enablement would be sufficient to handle the job. As shown in my Paper Tiger article, contrary to earlier predictions, LWD has for the most part not prevented biotechnology inventors from obtaining relatively broad scope of protection for their inventions. Its main function is to police claim scope, and in practice patent applicants are routinely granted broad scope of coverage for biomolecule inventions based on a relatively modest disclosure of some relationship between structure and function, or by describing a few representative molecular species falling within the claimed genus. LWD is being used to limit claim scope for some biomolecule inventions, but I would assert that the patent office could achieve the same policy objective using the enablement requirement if it did not have LWD, and in fact my experience looking at many Board of Patent Appeal and Interference decisions involving LWD usually enablement and LWD rejections are raised in tandem.

I also think that “unworthy” claims, such as Ariad's claims asserted against Eli Lilly (and Amgen in a separate case), or the University of Rochester's COX-2 claims asserted against drug companies selling COX-2 inhibitor drugs (and invalidated under LWD in University of Rochester v. G.D. Searle & Co.), could have been invalidated more properly using the enablement requirement. In Rochester, in fact, the district court did find a claims invalid for lack of enablement, but the Federal Circuit did not address the issue as moot. The main problem, as I see it, is that by using LWD instead of enablement to invalidate questionable claims such as Ariad's, the Federal Circuit fails to develop case law articulating the contours of the enablement requirement, which is the appropriate doctrine for addressing these sorts of overly broad claims. In his dissent to the panel decision in Ariad v. Eli Lilly, Judge Linn raised this exact concern.

In the future, I think it will be interesting to watch how the Federal Circuit applies to LWD to antibodies claims. As pointed out in my brief, the Federal Circuit and patent office apply to LWD to antibodies in a manner entirely consistent with how it is applied to other biomolecules. The current practice is to allow extremely broad patent scope covering any antibody recognizing any epitope on an antigen, based on a mere disclosure of the antigen. This is an important issue, because so many of the new biologic drugs, and biologic drugs in the pipeline, are based on antibodies. Recently, Abbott Laboratories was found liable for infringing a broad antibody claim based on its marketing of the biologic drug Humira, with the jury awarding the plaintiff $1.67 billion, reportedly the largest patent verdict in history. Abbott has appealed the decision, and absent a settlement will undoubtedly attempt to convince the Federal Circuit that broad antibody claims of this sort are invalid under LWD, more in line with the way LWD is applied outside the context of antibodies. In fact, Abbott made this very point in the amicus brief it filed in Ariad, available here courtesy of Patent Docs.


Kyle Jensen said...

great analysis, as always Chris@

Anonymous said...

Yes, great analysis--thanks very much. I had not read any of the briefs, but was mystified by the use of written description rather than enablement to knock out these claims; now I get it.

Anonymous said...

I've practiced patent law for several decades, involving complex chemical and sometimes biochemical issues. In my opinion this case undermines clearly established precedent and will generate significant confusion in the Patent Office and in the Courts.

All issues of chemistry and biotechnology aside, the problem here is the holding that an originally filed claim is invalid for failure to meet the description requirement of 35 USC § 112, and the implications of that holding.

The crux of the holding and the inherent confusion as to the meaning and implications of the holding are found in the Court's statement:

Furthermore, while it is true that original claims are part of the original specification, In re Gardner, 480 F.2d 879, 879 (CCPA 1973), that truism fails to address the question whether original claim language necessarily discloses the subject matter that it claims."

As acknowledged by the Court, original patent claims are uniformly recognized as a portion of the original specification. Although not expressly stated by the Court, it necessarily follows, and has long been recognized by the courts, that original patent claims also constitute a portion of the original disclosure of the invention.

Hence, the "question" raised in the above cited quotation can be rephrased as ... the question whether the disclosure of subject matter via an original claim necessarily discloses the subject matter of the claim.

But that "question" is not a question at all. By any application of logic the disclosure of the patent claim must be seen as disclosing the subject matter of the claim.

I do agree with the Court that there are separate description and enablement requirements in 35 USC § 112. I've addressed the issue numerous (probably hundreds) times over the years. Basically, one can see the description requirement as a prohibition against filing a patent specification disclosing one or more new principles of science and later adding patent claims directed to new applications of the scientific principle(s) to specific problems, not originally disclosed in the patent application.

This issue has a converse side often seen in rejections in the PTO, and invalidity positions urged in the courts; namely, that mere disclosure of a principle of science by the prior art renders obvious all practical applications of the scientific principle, on the basis that any such application of the scientific principle is "within the skill of the art". In general, this is not a proper basis for for a determination of unpatentability or a holding of invalidity.

But by the same token, mere disclosures of new principles of science do not properly constitute sufficient disclosure to support new patent claims directed to undisclosed applications of the scientific principles to specific problems.

The problem is the current case is that the Court does not distinguish between disclosure and enablement as a basis for unpatentability. The scope of a patent claim can be fully supported by the disclosure of the patent application, yet not be patentable on the basis that the original specification (which includes the original claims by the way) does not reasonably enable practice of the full scope of the claimed subject matter.

One might reconcile this case on the basis that the Court was dealing with claims directed to ambiguous generic subject matter. However the proper basis for determining invalidity in that case would be indefiniteness as per the second paragraph of Section 112...


Anonymous said...

I've been a biotech practitioner since there were steam-powered PCRs, but I have to admit that I don't understand this case... if the Ariad patent was valid and infringed, then it would have been infringed by the prior ingestion of compounds which pre-dated it-- the Lilly compounds acted by the same pathway then as they do today. Yes, the Court had to invalidate the Ariad patents, but why by this route? I was hoping this fact pattern would give us some new insights on inherency.

Chris Holman said...

This last comment brings up a very good point, i.e., since Ariad's claims would arguably cover the use of prior art drugs which acts through the NF-kB pathway, and even drinking red wine and moving from the sun into the shade will affect NF-kB, why wasn't the Ariad claim invalidated for inherent anticipation? Eli Lilly raised this argument, but as I recall the District Court excluded much of the evidence based on a theory that it was hearsay. This is a fascinating aspect of the case which I haven't seen discussed elsewhere. I have not looked at the district court decision for a while, but it struck me that the District Court ruling seem to imply that scientific articles would not be available to invalidate a patent because they are hearsay. In any event, I think part of the expiration for why the claims were not invalidated for in anticipation is because Eli Lilly was prevented from entering much of the evidence at the district court level.

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