Wednesday, October 6, 2010

Ariad v. Eli Lilly—The Federal Circuit Confirms the Written Description Requirement

In Ariad Pharms, Inc., et. al. v. Eli Lilly and Co., the Federal Circuit has reaffirmed, en banc, the "written description" requirement of patent law.
The Ariad decision, rendered March 22, has many important ramifications, most evidently in the chemical and pharmaceutical arts, but more broadly in all technical fields. For patent prosecutors, the Ariad decision confirms the importance of careful planning and thorough communication with patent counsel when drafting a patent application. More generally, Ariad provides guidance for analysis of applications and patents for compliance with the written description requirement of law.
The Litigation Between Ariad And Lilly
In 2002, Ariad Pharmaceuticals sued Eli Lilly for patent infringement, and Lilly defended on various grounds, among them patent invalidity. On initial appeal, the Federal Circuit held that the asserted claims were invalid for lack of written description. Ariad Pharms., Inc. v. Eli Lilly & Co., 560 F.3d 1366, 1371 (Fed. Cir. 2009).
Ariad then petitioned the Federal Circuit for rehearing en banc, arguing that the law contains no written description requirement separate from the enablement requirement. In its en banc decision, the Federal Circuit rejected Ariad's argument, and confirmed that the law does indeed provide a "written description" requirement that is distinct from the other disclosure requirements provided by law, in particular the requirement that a patent enable one of skill in the art to practice the claimed invention. In other words, it is insufficient for a patent to teach only how to practice the invention; rather, the patent also must describe the invention.
The claims of the Ariad patent encompassed various methods for regulating "expression" of certain genes.1 Ariad disclosed in its patent specification that several categories of compounds were suitable for use in regulating the gene expression, but Ariad did not describe the compounds in each category. Rather, Ariad only specified the desirability of regulating gene expression, and suggested that certain types of compounds might be operative.
The Federal Circuit held this description to be insufficient: "Such claims merely recite a description of the problem to be solved while claiming all solutions to it." It is impermissible, the court held, to "cover any compound later actually invented and determined to fall within the claim's functional boundaries—leaving it to the pharmaceutical industry to complete an unfinished invention." The Federal Circuit further explained that claims written in functional terms must find support via specific structures, formulas, chemicals or physical properties that achieve the claimed function:

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.

In summary, "an adequate written description . . . requires more than a generic statement of an invention’s boundaries."
Ariad argued that the specification enabled one of skill in the art to prepare suitable compounds, and that this disclosure was sufficient. The Federal Circuit rejected this argument:

If Congress had intended enablement to be the sole description requirement of § 112, first paragraph, the statute would have been written differently.

The court considered a disclosure of a chemical process involving a one-carbon molecule. These teachings might enable someone to practice the invention with three- or four-carbon molecules, but, explained the court, "such compounds have not been described and are not entitled to a patent." "Consider the case where the specification discusses only compound A and contains no broadening language of any kind. This might very well enable one skilled in the art to make and use compounds B and C; yet the class consisting of A, B and C has not been described."
Ruschig: The Flip Side of the Written Description Doctrine
The immediate holding of Ariad is that claims that cover a broad genus, or category, must find equally broad supporting disclosure in the specification. It often will be insufficient to disclose a single compound and subsequently to attempt to claim a class of compounds.
But Ariad also held that the converse is true. It may be insufficient to disclose a broad genus or category of compounds and later attempt to present a claim to a specific one of those compounds. The Ariad court cited In re Ruschig, 379 F.2d 990 (CCPA 1967), with approval. In Ruschig, the specification disclosed a general chemical formula, but did not disclose a specific compound (chlorpropamide). "[T]he specification provided no guides or 'blaze marks' to single out chlorpropamide from all the other compounds, and thus did not support the later-added claim."
The Patent Office refused to allow Ruschig to present a claim to chlorpropamide, and Ruschig appealed to the C.C.P.A. (a predecessor court to the Federal Circuit). The Ruschig court affirmed, holding the chlorpropamide claim to be unpatentable:

Not having been specifically named or mentioned in any manner, one is left to select from the myriads of possibilities encompassed by the broad disclosure, with no guide indicating or directing that this particular selection should be made rather than any of the many others which could also be made.

379 F.2d at 995.
The Ruschig doctrine is applicable in other contexts. For instance, a patent disclosure of "an effective amount of chemical X" may be insufficient to support a claim that specifies "10-20% of chemical X." A disclosure of "a microprocessor" may be insufficient to support a claim to a particular processor architecture. A disclosure of "a supporting beam" may not support a claim to "a wooden support beam."
Satisfaction of the Written Description Requirement is a Factual Inquiry
The Ariad court reaffirmed many earlier cases that held that satisfaction of the written description requirement is a fact question. "We have recognized that determining whether a patent complies with the written description requirement will necessarily vary depending on the context." The level of skill in the art is one factor in this determination. Other factors include the nature and scope of the claims, the complexity and predictability of the relevant technology, the level of existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, and the predictability of the aspect at issue.
According to the Ariad court, the written description law "must be applied to each invention at the time it enters the patent process, for each patented advance has a novel relationship with the state of the art from which it emerges."
Ariad Provides Guidance to Patent Prosecutors and to Courts and Litigators
Patent applicants should take steps to ensure that their patent applications satisfy the written description requirement. The more examples of the invention and its component parts that are disclosed in the specification, and the more specific those examples are, the more likely that the specification will meet the written description requirement. The patent applicant should include both broad and specific language in describing the invention, and should describe the invention in a manner specific to and appropriate for the application in question, keeping in mind the various factors enumerated by Ariad.
An applicant intending to claim the invention broadly (e.g., a class of compounds A, B, C), should disclose the invention broadly (should not disclose only A). Conversely, an applicant may provide a disclosure of a broad category of materials, but would be wise to supplement the broad disclosure with specific examples.
More broadly, Ariad also provides guidance as to how an applicant (or court litigant) should analyze patents for compliance with the written description requirement. Ariad provides several factors that a court will consider in addressing whether a patent claim finds adequate written description.
Planning and communication with skilled patent counsel will be key to any Ariad analysis. Fitch, Even attorneys are available to answer any questions relating to the Ariad case.
This IP Law Alert was authored by Alison Aubry Richards, who is a member of Fitch Even’s IP litigation Practice Group.

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