Archive for May, 2009

Ariad: “The Future Ain’t What It Used To Be!” Judge Linn’s Concurrence and the Abuse and Neglect of the Enablement Requirement at the Federal Circuit

Tuesday, May 5th, 2009

In my post of April 13, 2009, I concluded with a brief summary of Judge Linn’s cogent concurrence, and noted that I would revisit it. Judge Linn does not believe that it was ever necessary for the court to graft “a separate written description requirement [WDR] onto section 112, paragraph 1.” He noted his dissents in U. of Rochester v. Searle and in Enzo Biochem.v. Gen-Probe, leading decisions in which the Fed. Cir. used the WDR to invalidate biotech claims (at least initially in Enzo, see W. D. Woessner, “Do-Over! The Federal Circuit Takes a Second Look at Enzo v. Gen-Probe,” JPTOS, 85, 275 (April 2003)). Judge Linn wants a claim to be tested against section 112(1) as follows:

The question is, “Does the written description describe the invention recited in the claims – themselves part of the specification – in terms that are sufficient to enable one of skill in the art to make and use the invention and practice the best mode contemplated by the inventor?” That is the mandate of the statute and is all our precedent required, prior to [UC v. Lilly].”

Judge Linn chastised his colleagues for using the WDR to invalidate the claims-in-suit in Ariad that “broadly claim any method for reducing NF-kB activity in cells, including both known and unknown methods,” and ducking the question of whether or not claims written broadly enough to cover any method for achieving a particular result can ever meet the enablement requirement. Lilly had argued that the specification cannot enable unknown methods, but is that always true (or simply a tautology – e.g., if you enable it, it is no longer unknown)? Judge Rader apparently thinks so. See Chiron v. Genentech, 363 F.3d at 1254. But then what are the consequences for a “pioneering” method of treatment claim?

Before even starting to address this question, it is worthwhile, I think, to take a step back and review when the Federal Circuit seems comfortable when faced with affirming or reversing the invalidation or refusal to allow claims due to their failure to meet the WDR and when they do not. Federal Circuit panels seem to be comfortable invalidating claims as failing the WDR when there is essentially no support for claimed subject matter in the specification. This was the factual situation in the U. of Rochester decision (358 F.3d 916), in which no non-steroidal COX-2 inhibitors were disclosed and, of course, in Ariad, discussed in detail in my post below, in which workable NF-kB inhibitors were not disclosed. Of course, it is clear, at least to me, that the claims in both cases would not have been found to meet the enablement requirement either, so why waste a lot of time going through all those messy Wands factors. See also Chiron, 363 F.3d at 1255.

Interestingly, the Fed. Cir. panel in Capon v. Eschar, 418 F.3d 11349 (Fed. Cir. 2005) reversed the Board and found that the highly functional claims of both parties met the WDR (and did not reach enablement). The claims of both parties in the interference were to chimeric genes made up of at least two segments, e.g., a first gene segment encoding a single-chain Fv domain of a specific antibody and a second gene segment encoding the cytoplasmic and extracellular domain of an endogenous protein. (This is a gloss on claim 1 of Eshchar). Why did these claims survive initial scrutiny for adequate description in the specification of the recited claim elements under the hanging sword of the WDR? Because both parties put in evidence that (a) their specifications taught the art how to make such constructs and, more importantly, that (b) representative pieces of DNA useful to make these chimeric genes were available to the art, e.g., were known as of their respective filing dates.

Even before U.C. v. Lilly, the CCPA, the Board, and the Fed. Cir. had held that that which is known to the art need not be described in detail in the specification. Although the Capon, panel addressed this issue as if they had never seen it before, in fact, they were following precedent from the 80’s and early 90’s, that simply makes common sense. (In fact the PTO Written Description Examination Guidelines state: “Information that is well known in the art need not be described in detail in the specification.” citing Lockwood v. Amer. Airlines, 107 F.3d 1565 (Fed. Cir. 1997). In biotech prosecution, I prefer Hybritech Inc. v. Monoclonal Antibodies, Inc., 231 USPQ 81, 94 (Fed. Cir. 1986), cert. denied, 480 U.S. (947) (1987).

How could it be otherwise? Without such real-world pronouncements, applicants would face WDR rejections for using functional terms like “surfactant” or “insulating layer.” Of course, this type of erroneous WDR rejection remains remarkably common in biotech prosecution, but that is the subject for another post.

To return to Capon, the panel then had to decide “the question of whether the specifications adequately support the breadth of all of the claims that are presented… The inventors…state that biological properties typically vary, and that their specifications provide for evaluation of the effectiveness of their chimeric combinations.” 418 F.3d at 1358. Here is where the panel’s struggle is manifest. What standards should be used in such a case (and to test a method claim such as Judge Linn envisions)? If the court is called upon to test enablement, it has before it the Wands factors, all eight of them, by which to resolve the question of whether or not the claimed invention can be practiced without “undue experimentation.” See Wands, 858 F.2d at 737. These factors overlap and use vague language (“nature of the invention”) but they at least guide the inquiry.

But what happens when a panel tries to evaluate whether or not the written description of the invention justifies the scope of the claims? As the panel states in Capon at 1360: “Although the legal criteria of enablement and written description requirement are related and are often met by the same disclosure, they serve discrete legal requirements.” Oh really? And how are those requirements to be tested when failure to meet the WDR due to “overclaiming” is alleged?

Lacking the “easy button” of specifications with no support for generic claims (read U. of Rochester), or in which only one embodiment of a generic claim is disclosed (UC v Lilly), the panel remanded to the Board to “explore the support for each of the claims of both parties,” noting that there were working examples and general teachings in the specifications as well as “known science” with application of precedent to guide review of the scope of the claims.” I bet this is one case the Federal Circuit never wants to see again!

So the tension between the application of the tests for an enabling disclosure and for an adequate written description is palpable. In Capon, the panel came close to creating a WDR test but punted at the last minute. I was going to end with a statement like “If the facts in Capon do not support a finding of sufficiency of the descriptions of largely functional biotech product claims, I cannot imagine what would be sufficient,” but in fact, I began this post with the idea of testing a broad functional method of treatment claim that has substantial support in the specification against the Wands factors, and for adequacy under the WDR, so that will be the subject of the next post. We will see that Judge Linn is appropriately concerned about the fate of method claims, including ones that enjoy much more support than the “Hail Mary” claims dispatched in Ariad.