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• Ariad Pharmaceuticals v. Eli Lilly (Court of Appeals for the Federal Circuit, 08-1248)

Ariad Pharmaceuticals, Inc. v. Eli Lilly and Company

Overview

In Ariad Pharmaceuticals v. Eli Lilly (08-1248), the Court of Appeals for the Federal Circuit reversed a jury verdict holding a patent infringed and not proven invalid. The court reversed on grounds that the patent was, indeed, invalid because the specification failed to satisfy the separate written description requirement in support of broad method claims, at least one of which required only a single results-based limitation ("reducing NF-kB activity"). In authoring the opinion, Judge Moore revealed herself to be a separatist - believing that the first paragraph of 35 U.S.C. §112 imposes a written description requirement that is separate and distinct from the enablement requirement. Judge Linn concurred in the opinion because it is supported by the court's precedent, but wrote separately to express his belief, again, that §112 imposes no such separate requirement. He explains that the invention of the separate requirement and its application here resulted in the court's failure to reach an important enablement issue: whether a method claim written so broadly as to cover any method for achieving a particular claimed result can "never be valid, since the specification cannot enable unknown methods."

Keywords

inequitable conduct - A patent applicant is justified in expectation that the patent attorneys will determine the legal significance of errors in a patent application and take appropriate action.

written description - Judge Moore, writing for the court, makes it clear that she believes the first paragraph of 35 U.S.C. §112 includes a written description requirement that is separate from the enablement requirement.

written description - The separate written description requirement of 35 U.S.C. §112 is not satisfied for method claims having only a single step where the specification merely suggested the use of three classes of molecules to achieve the desired result.

written description - To satisfy the separate written description requirement of 35 U.S.C. §112 for a method claim reciting a step of "reducing" activity of a natural biological compound, a specification must demonstrate that the inventor possessed the claimed method by sufficiently disclosing molecules capable of achieving the desired "reducing" of activity.

written description - A specification that hypothesizes classes of molecules that are "potentially capable" of achieving a claimed change in biological activity was insufficient to meet the written description requirement where the disclosure amounted to a "vague functional description and an invitation for further research."

written description - While prophetic examples can be sufficient to satisfy the separate written description requirement of the first paragraph of 35 U.S.C. §112, the "mere mention of a desired outcome" is insufficient in the absence of a "descriptive link" between the example and the outcome.

written description - Even though the patent specification adequately described DNA oligonucleotides to the person having ordinary skill in the art, the written description requirement for a generic method claim requiring "reducing activity" of a natural biological compound was not satisfied because the specification merely mentioned a desired outcome of using the described DNA oligonucleotides (binding to the natural compound, thereby reducing its activity) without a "descriptive link" between the oligonucleotides and the reduction in activity.

written description - Although concurring in the opinion because "it is supported by our precedent," Judge Linn wrote separately to express his belief, again, that "our engrafting of a separate written description requirement onto section 112, paragraph 1, is misguided." Judge Linn believes that paragraph 1 requires no more than an enabling written description.

written description - Writing separately, Judge Linn noted that the application of a separate written description requirement, in this case, resulted in the court failing to reach the "important enablement issue" of whether a method claim written so broadly as to cover any method for achieving a particular claimed result can "never be valid, since the specification cannot enable unknown methods."

Detailed review

No detailed review written.

Patent documents

• 6410516 - Nuclear factors associated with transcriptional regulation [.pdf]

Representative figure(s)

[click to enlarge]

Representative claims(s)

• 80. [A method for modifying effects of external influences on a eukaryotic cell, which external influences induce NF-κB-mediated intracellular signaling, the method comprising altering NF-κB activity in the cells such that NF-κB-mediated effects of external influences are modified, wherein NF-κB activity in the cell is reduced] wherein reducing NF-κB activity comprises reducing binding of NF-κB to NF-κB recognition sites on genes which are transcriptionally regulated by NF-κB.

• 95. [A method for reducing, in eukaryotic cells, the level of expression of genes which are activated by extracellular influences which induce NF-κB-mediated intracellular signaling, the method comprising reducing NF-κB activity in the cells such that expression of said genes is reduced], carried out on human cells.

• 144. [A method for reducing bacterial lipopolysaccharide-induced expression of cytokines in mammalian cells, which method comprises reducing NF-κB activity in the cells so as to reduce bacterial lipopolysaccharide-induced expression of said cytokines in the cells] wherein reducing NF-κB activity comprises reducing binding of NF-κB to NF-κB recognition sites on genes which are transcriptionally regulated by NF-κB.

• 145. [A method for reducing bacterial lipopolysaccharide-induced expression of cytokines in mammalian cells, which method comprises reducing NF-κB activity in the cells so as to reduce bacterial lipopolysaccharide-induced expression of said cytokines in the cells], carried out on human cells.

About Promote the Progress

Started in January, 2004 by J. Matthew Buchanan, Promote the Progress was one of the first blogs dedicated to patent law issues. The site now provides the web's first patent education portal dedicated to helping professionals digest, understand, and use the latest information from the courts, Congress, and the Patent and Trademark Office in their daily practices. The original blog still lives on as part of the exciting new portal format.

A detailed history of the site is available on the About page.

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