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Federal Circuit Rules Patent Applications Must Have Separate Written Description
Friday, April 16, 2010
Analysis of Ariad Decision by Wolf, Greenfield & Sacks, P.C.
In the recent case of Ariad Pharmaceuticals, Inc. v. Eli Lilly and Company, the en banc (full court) Court of Appeals for the Federal Circuit (Federal Circuit) reaffirmed that patent applications must contain: (1) a written description of the invention (the "written description requirement") and (2) a written description of the manner and process of making and using the invention (the "enablement requirement"), according to Roque El-Hayek, an associate with Wolf, Greenfield & Sacks, P.C., a Boston intellectual property law firm.
Although the decision did not change existing law, it addresses a long-standing question about the written description requirement. Starting with Regents of the University of California v. Eli Lilly & Co. in 1997, the Federal Circuit has relied upon the existence of a written description requirement separate from the enablement requirement to invalidate numerous patents in the biotech field. Several Federal Circuit judges have disagreed with this interpretation of the underlying Federal statute (35 U.S.C.§112, first paragraph).
Now that the en banc Federal Circuit has reaffirmed the existence of a separate written description requirement, it may be more difficult to patent basic research that has not yet been fully reduced to practical implementation, El-Hayek points out.
The Federal Circuit's holding in Ariad emphasizes the importance of drafting patent applications with as much detail as possible.
Ariad Pharmaceuticals, Inc. (along with other research institutions, collectively, "Ariad") sued Eli Lilly and Company ("Lilly") before the United States District Court for the District of Massachusetts for infringing U.S. Patent 6,410,516, which relates to the regulation of gene expression by NF-kappa B protein. The asserted claims are directed to methods that encompass using a genus of compounds that reduce NF-kappa B binding to NF-kappa B recognition sites in response to external influences.
Lilly argued that the asserted claims are invalid because they are not supported by an adequate written description. In April 2006, a jury found that two of Lilly's products infringed Ariad's claims and that the asserted claims were not invalid. Lilly appealed and in April 2009, a three-judge panel of the Federal Circuit reversed the jury's verdict, holding that the Ariad claims were invalid for lack of written description.
Ariad petitioned for rehearing by the full Federal Circuit, contending that the written description requirement is satisfied if the specification enables one of ordinary skill in the art to make and use the claimed invention. The en banc court agreed to rehear the case.
Federal Circuit's Decision
The en banc court reaffirmed the panel's earlier decision and adopted its application of the law to this case. The Federal Circuit construed U.S. patent law to require that a specification include (1) a written description of the invention and (2) a written description of the manner and process of making and using the invention sufficient to enable one of skill to make and use the invention. In reaching its decision, the court noted that Congress would have written the statute differently, if it had intended enablement to be the sole description requirement and also concluded that "if the law of written description is to be changed . . . such a decision would require good reason and would rest with Congress."
The Federal Circuit also noted that it has consistently held that 35 U.S.C.§112, first paragraph, contains a written description requirement separate from enablement and that the Supreme Court also recognized the existence of a written description requirement separate from the enablement requirement, El-Hayek points out.
The Federal Circuit affirmed that a separate written description requirement applies not only to claims added or amended after the patent's filing date, but also to claims as originally filed. The court further stated that, "a generic claim may define a vast genus of chemical compounds, and yet the question may still remain whether the specification demonstrates that the applicant has invented species sufficient to support a claim to a genus."
It also noted a particular problem with genus claims that use functional language to define the boundary of the genus because, "in such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result."
The court recognized that determining whether a patent complies with the written description requirement will necessarily vary depending on the context, but it did list a few broad principles for all cases:
"the written description requirement does not demand either examples or an actual reduction to practice";
The specification itself must demonstrate actual "possession"; and
A description that merely renders the invention obvious does not satisfy the written description requirement.
The court recognized that "the written description requirement also ensures that when a patent claims a genus by its function or result, the specification recites sufficient materials to accomplish that function." It also noted that this is "a problem that is particularly acute in the biological arts." Although the court noted that universities might not have the resources to work out the practical implications of all scientific research, its view is that patenting research theories imposes costs downstream and discourages later invention.
The Federal Circuit decision ended, at least for now, several years of controversy and uncertainty surrounding the written description requirement. The decision emphasized that the hallmark of written description is sufficiency of the disclosure in an application as filed. However, the Federal Circuit provided only general guidelines - and no clear guidance - as to what constitutes compliance with the written description requirement. The court acknowledged that there are no "bright-line" rules and that compliance with the requirement depends on the context.
In view of the decision, patent applicants are advised to include as much detail as possible in their applications, whether provisional or non-provisional, and avoid drafting applications with only broad disclosures. Important details to consider including are those relating to features, such as structure, formula, chemical name, and physical properties, of the species encompassed by a claimed genus or that accomplish the claimed function.
In claims in which functional language is used, it is important to provide details relating to the structural features critical for the claimed function. Sufficient examples should be provided to represent the entire scope of the claims. Drafting patent applications with such detailed disclosures will lessen the risk of a written description challenge during prosecution or litigation.
Wolf Greenfield, the largest law firm in New England devoted exclusively to intellectual property law, serves companies that make everything from pharmaceuticals to software to electronics to snowboards, as well as representing academic research centers. The firm counsels clients in the areas of patents, trademarks, copyrights, designs, trade secrets, and related licensing and litigation. Web: www.wolfgreenfield.com.
Henry Stimpson, Stimpson Communications, 508-647-0705, HStimpson@StimpsonCommunications.com
Sara Crocker, Wolf Greenfield, 617-646-8231, email@example.com
Cristina Brennan. Wolf Greenfield, 617-646-8259, Cristina.Brennan@wolfgreenfield.com
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