Ariad v. Lilly Comes Down (On Us) – Judge Lourie Rules!
In a majority opinion authored by Judge Lourie for the Federal Circuit sitting en banc (Appeal No. 2008-1248 (Fed. Cir. March 22, 2010)) (a PDF of which is attached to the end of this post), the court held that there is indeed a written description requirement (WDR) in section 112 that is separate from the enablement requirement and that the claims-in-suit in U.S. Pat. No. 6,410,516, broadly directed to reducing NF-kB activity in cells, are invalid for failure to meet the written description requirement. This decision, though lengthy, amounted to an affirmance of the earlier panel’s decision and, of course, of the “possession” test first articulated (by Judge Lourie) in UC v. Lilly in 1996. Judge Lourie spends about 20 pages writing and re-writing his opinion in UC v. Lilly (which he essentially concedes would be decided differently today). The problem the majority feels they are addressing has not, however, changed in the almost 20 years since UC v. Lilly was decided. It is to reign in overly-broad claims based on discoveries that are not fully realized:
“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”
But what kind of standard is a showing of “a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that [the POSA] can ‘visualize or recognize’ the members of the genus” [quoting Lilly]? Language affirming that there is no requirement for working examples aside, this is a requirement to provide species defined by “structure, formula, chemical name, physical properties … [or] functional claim language … when the art has established a correlation between structure and function…. Merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.”
Judge Lourie concedes that the term ‘possession’ has never been very enlightening, but labors on: “‘Possession as shown in the disclosure’ is a more complete formulation. … For generic claims we have set forth a number of factors for evaluating the adequacy of the disclosure [citing Capon v. Eschar, in which the panel reversed a finding of failure to meet the WDR].” The problem is that the four factors approved of by Judge Lourie mirror four of the Wands factors for testing enablement (state of the prior art art, relative skill of those in the art, the nature of the invention, and the predictability of the art –here I am summarizing the Wands factors).
Judge Lourie’s own pen demonstrates how difficult it is to create standards for evaluation of the WDR that do not also measure enablement. At page 35 of the slip opinion, he analyzes and criticizes the disclosure of “decoy molecules” in the ‘516 specification, which contains some “example structures.” But in the next sentence, Judge Lourie argues: “Yet [the specific description] does not answer the question whether the specification adequately describes using those molecules to reduce NF-kB activity.” Wait a minute, Judge Lourie! You have slid over into a “how to use” test and that is a test for enablement, which you just divorced from written description by rigorous statutory interpretation.
Most damaging in my view, is that patent prosecutors have no way of telling whether or not the species that they include in the specification, in an attempt to meet the written description requirement, will suffice. In other words, given that these NF-kB claims fail the written description requirement test, WOULD ANY NUMBER OF WORKING EXAMPLES SUFFICE TO ALLOW IT TO PASS THE WDR TEST? I think the answer is NO, but the majority lacks the legal nerve to tell us this.
The reason I feel this is the (underlying) fact of the matter is well-articulated at pages 28-29 of the slip opinion, where Judge Lourie quotes the tired language from Brenner v Manson that “a patent is not a hunting license. It is not a reward for the search but compensation for its successful conclusion.” Judge Lourie goes on to conclude that “[r]equiring a written description of the invention limits patent protection to those who actually perform the difficult work of ‘invention’ – that is, conceive of the complete and final invention with all its claimed limitations – and disclose the fruits of that effort to the public.” Where is there support for a requirement that only inventions that are “complete and final” can be patented? No authority is cited.
If this is the standard of invention we must all live with post-Ariad, functional generic claiming is DEAD in chem/pharma practice, and we might as well say so. In the past, many Examiners would allow a functional generic claim along the lines of: “A method comprising treating condition x by administering an effective amount of an inhibitor of enzyme z” so long as the specification disclosed a number of working examples of inhibitors of enzyme z. The inhibitors (y) often were set forth structurally in a dependant claim. But now, to use a quote from Fiers v. Revel cited in the opinion, we cannot expect to be able to “preempt the future before it has arrived. … [The description requirement] is part of the quid pro quo of the patent grant and ensures that the public received a meaningful disclosure in exchange for being excluded from practicing an invention for a period of time.” I can see the PTO “guidelines” being prepared as I type:
“Claims using functional language to describe the use of agents in medicine as affecting biological pathways or ‘mechanisms of action’ are to be rejected under s.112 para.1 on the basis that the specification fails to meet the WDR no matter how many working examples of such agents are present in the specification. Such claims are no more than a ‘hunting license’ that would permit applicants to dominate inventions yet to be made.”
Judge Newman wrote a brief concurring opinion supporting the majority on policy grounds: “Basic scientific principles are not the subject matter of patents, while their application in the focus of this law of commercial invention.” Judge Garjarsa’s concurring opinion argued that such overly broad claims can be invalidated as non-enabled, without the need to locate a separate written description within s.112: “Section 112’s enablement requirement is a more than adequate vehicle for invalidating patent claims that are broader than their disclosure.”
The two dissents-in-part by Judge Rader and Judge Linn were less kind. Judge Linn simply feels that the enablement requirement is a sufficient policer and that “[a]ny claim that uses purely functional language, or covers a broad genus without sufficient supporting examples, will not be enabled.”
Judge Rader refers to the majority’s “undefined ‘written description’ doctrine,” and accuses them of ignoring the problems of “standardless decision making.” He points out that the majority decision sets up conflicts with other areas of patent law, including the maxim that the claims cannot be construed so that they exceed the scope of the rest of the specification. Judge Rader also fears interference with the productive tension between dominant or “blocking patents” and later inventors who make improvements or inventions of selection. Now improvement patents can invalidate earlier generic claims, if the earlier specification did not possess the improvement.
He believes that both the requirement for a written description and a description of how to make and use in the specification should be judged by whether or not they “enable a [POSA] to make and use the claimed invention. Nowhere does the paragraph require that the inventor satisfy some quixotic possession requirement.” In other words, Judge Rader feels that the court, in splitting the WDR from enablement, legally left it hanging:
“The practical effect of the court’s interpretation is that the written description of the invention need not be full. It need not be clear. It need not be concise. It need not be exact. … And, of course, it need not enable. Instead it must satisfy a vague possession notion.”
The “possession notion” arose from UC v. Lilly, gained strength in the Rochester v. Searle and Chiron v. Genentech decisions and today “the rough [legal] beast, its hour come round at last, slouches toward [the PTO] to be born.”
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