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An Anticipatory Reference Must Adequately Enable Possession of the Desired Invention

October 02, 2003

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Last Month at the Federal Circuit - November 2003

Judges:  Newman (author), Gajarsa, and Dyk

In Elan Pharmaceuticals, Inc. v. Mayo Foundation for Medical Education and Research, No. 00-1467 (Fed. Cir. Oct. 2, 2003), the Federal Circuit reversed a SJ of patent invalidity and the case for a determination of whether the allegedly anticipating prior art properly enabled the claimed invention. Elan Pharmaceuticals, Inc. (“Elan”) owns the two patents-in-suit, U.S. Patent Nos. 5,612,486 and 5,850,003 (collectively “Elan’s patents”), and sued Mayo Foundation for Medical Education and Research (“Mayo”) for infringement. Mayo moved for SJ of invalidity based on U.S. Patent No. 5,455,169 (“the Mullan reference”), which the district granted.

Elan’s patents are directed to transgenic rodents (“the Elan mouse”) whose genetic makeup has been modified to include the Swedish mutation, which is an abnormal gene thought to be linked to Alzheimer’s disease. The Mullan reference describes the Swedish mutation.

On appeal, the Federal Circuit explained that the disclosure of an allegedly anticipating reference must be adequate to enable possession of the desired invention, and concluded that Elan’s arguments were more properly characterized as enablement arguments than inherency arguments, because Elan’s arguments were more factually based on the Mullan reference not enabling the Elan mouse. Thus, the basic question at issue was whether the Mullan reference adequately enabled possession of the Elan mouse.

The Federal Circuit explained that enablement requires that the reference teach one of ordinary skill in the art to make or carry out the claimed invention without undue experimentation, and further explained that a determination of whether the amount of requisite experimentation is undue may include consideration of “the Wands factors,” which include: “(1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.” In re Wands, 858 F.2d 731 (Fed. Cir. 1988).

Elan argued that, while the Mullan reference foresaw a transgenic mouse and compiled known methods of gene transfer, including expression of the Swedish mutated protein, it did not teach or suggest which method might create the Elan mouse. Conversely, Mayo argued that the disclosure of the Mullan reference was comprehensive and that Elan did eventually succeed with one of Mullan’s disclosed inventions.

The Federal Circuit determined that the Mullan reference does contain an extensive description of the Swedish mutation and states that it provides a transgenic animal whose cells contain the mutated gene. However, the Court remanded the case for examination of whether the Mullan reference required a person of ordinary skill to perform undue experimentation, in view of the Wands factors, to produce the Elan mouse.