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Short Circuit 3.24.2010: The Federal Circuit issued much anticipated opinion on written description in Ariad v. Eli Lilly

Ariad Pharmaceuticals, Inc., Massachusetts Institute of Technology, The Whitehead Institute for Biomedical Research, and The President and Fellows of Harvard College v. Eli Lilly and Company, slip op. 3/22/2010 (Fed. Cir. 2010)

The Federal Circuit issued its much anticipated en banc opinion on written description in Ariad v. Eli Lilly this week and essentially confirmed that the current written description doctrine first created in Regents of the University of California v. Eli Lilly and Co., 119 F.3d 1559 (Fed. Cir. 1997) is the law of the land. Given the patent-unfriendly nature of the currently constituted Supreme Court, this decision is unlikely to be reviewed and even more unlikely to be reversed.

In short, the Federal Circuit held that 35 U.S.C. § 112, first paragraph, contains a written description requirement separate from the enablement requirement and that this requirement applies even to originally filed claims. It enunciated that the written description "test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art. Based on that inquiry, the specification must describe an invention understandable to the skilled artisan and show that the inventor actually invented the invention claimed."

The court purported to base its decision on the statutory language of § 112, Supreme Court precedent, and stare decisis. Reading the decision, the concurring opinion and the two dissenting opinion we believe that the statutory language itself is too ambiguous to settle the issue. Similarly, the Supreme Court cases cited in the majority opinion do not appear to compel at least the court's second holding that the requirement applies even to originally filed claims. One of the cases, Schriber-Schroth Co. v. Cleveland Trust Co., 305 U.S. 47 (1938), dealt with an amended claim. Another, Gill v. Wells, 89 U.S. 1 (1874), dealt with a reissue claim. Thus, neither of these cases struck down an originally filed claim under the written description requirement. The only cited Supreme Court decision dated after Regents v. Eli Lilly is Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722 (2002). Festo had nothing to do with the written description requirement and dealt exclusively with the extent of prosecution history estoppel within the doctrine of equivalents. As ably illustrated in the dissents, however, the court's reliance on stare decisis was misplaced. The majority opinion states that its current jurisprudence has been the law for over forty years, and that "If the law of written description is to be changed … such a decision would require good reason and would rest with Congress." In reality, prior to Regents v. Eli Lilly, nether the Supreme Court, the Federal Circuit, nor its predecessor court, the C.C.P.A., had never invalidated an originally filed claim under the written description requirement, other than in the context of priority.

So what are the consequences of Ariad v. Eli Lilly for the patentee and patent practitioner? The court was not clear, but did leave some tea leaves to be read. As a starting point, the court stated "we do not try here to predict and adjudicate all the factual scenarios to which the written description requirement could be applied. Nor do we set out any bright-line rules governing, for example, the number of species that must be disclosed to describe a genus claim, as this number necessarily changes with each invention, and it changes with progress in a field." The court then repeated "a few broad principles that hold true across all cases". These were no more than the well settled law that the written description requirement does not demand either examples or an actual reduction to practice as long as a constructive reduction to practice identifies the invention in a definite way, that the written description must be found within the specification itself, that a description that merely renders the invention obvious is not enough, and that the disclosure of structural features common to the members of the genus can be sufficient.

However, these generalities are not helpful to the patentee or practitioner. Rather, the way the court applied the written description requirement to the Ariad patent at issue may inform the practitioner. The court stated that "Ariad claims methods comprising the single step of reducing NF-?B activity." It noted that "The specification of the ‘516 patent hypothesizes three classes of molecules potentially capable of reducing NF-?B activity: specific inhibitors, dominant interfering molecules, and decoy molecules." It then went on to analyze what the ‘516 patent described about each of these three classes of molecules. Its findings are in relevant part, as follows.

"Specific inhibitors are molecules that are ‘able to block (reduce or eliminate) NF-?B binding' to DNA in the nucleus. … The only example of a specific inhibitor given in the specification is I-?B, a naturally occurring molecule whose function is to hold NF-?B in an inactive state until the cell receives certain external influences." However, the court found that the description of I-?B was not actually in the specification as of the priority date of the application determined by the jury, and thus could not be relied upon for purposes of written description.

"Dominantly interfering molecules are ‘a truncated form of the NF-?B molecule.' … The specification provides no example of molecules of this class."

"Decoy molecules are ‘designed to mimic a region of the gene whose expression would normally be induced by NF-?B.' … unlike the other two classes of molecules, the specification proposes example structures for decoy molecules. "[T]here is little doubt that the specification adequately described the actual molecules to one of ordinary skill in the art. Yet this does not answer the question whether the specification adequately describes using those molecules to reduce NF-?B activity. The full extent of the specification's disclosure is that NF-?B ‘would bind the decoy' and thereby, ‘negative regulation can be effected.'" "Prophetic examples are routinely used in the chemical arts, and they certainly can be sufficient to satisfy the written description requirement. But this disclosure is not so much an ‘example' as it is a mere mention of a desired outcome." "[T]here is no descriptive link between the table of decoy molecules and reducing NF-?B activity."

In invalidating the claims under the written description requirement, the court concluded that "[t]he ‘516 patent discloses no working or even prophetic examples of methods that reduce NF-?B activity and no completed synthesis of any of the molecules prophesized to be capable of reducing NF-?B activity." "Whatever thin thread of support a jury might find in the decoy-molecule hypothetical simply cannot bear the weight of the vast scope of these generic claims." "Here, the specification at best describes decoy molecule structures and hypothesizes with no accompanying description that they could be used to reduce NF-?B activity. Yet the asserted claims are far broader."

These passages from the opinion do provide at least some limited guidance to the patentee and practitioner as to how to satisfy the written description requirement as it now exists.

First, for any claim to the use of a compound to affect a particular biological result, the conditions for an assay that will be used to demonstrate that result should be clearly specified. Even if the assay has not yet been actually performed and is provided as a prophetic example, this is a start to satisfying the written description requirement. Second, it may in some cases be worth waiting to file the application until after some biological affect can be proven. This doesn't necessarily have to be an extensive demonstration of biological effect, nor does it necessarily have to utilize the type of compound ultimately desired, as long as it proves the principle. For example, if a small molecule compound is being sought to inhibit a particular protein, inhibition of the expression of the protein by antisense or RNAi may provide adequate proof of principle. For the types of broad claims as sought by Ariad in this case, it would be especially beneficial to be able to show more than one mechanistic means for achieving the biological affect. Commercially available computer assisted drug design companies utilize protein structure to predict small molecules that may be effective, although this requires an investment of some tens of thousands of dollars. If an applicant has a high-throughput assay for biological activity it is possible to use commercially available small-molecule libraries at a lower cost. Some of these libraries are biased toward particular types of proteins such as protein kinases, which may improve the chances of finding some level of biological activity.

In some cases, once the assay and the general type of compound to be tested are known, it may be worthwhile to file a first provisional application using this information to provide a prophetic example. Then, the applicant would have up to one year in which to file a second provisional or a utility application with actual test results obtained after the initial provisional filing. This, of course, will result in a patent having two different priority dates. As illustrated in Ariad v. Eli Lilly, the patentee, in any subsequent litigation involving the patent would need to obtain specific findings on written description for each priority date.

It is interesting how the Federal Circuit stretched so far in this case to demonstrate that no single example of any actual or even constructive reduction to practice had been described in the ‘516 patent. It took a similar approach in University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916 (Fed. Cir. 2004), where the patentee did not describe any specific compound to achieve its claimed biological effect. These two cases should at least allow the practitioner having a specification with at least one prophetic or actual example to distinguish them as some authority that this is enough to satisfy the written description requirement.