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Wyeth & Cordis Corp. v. Abbott Laboratories

Court of Appeals for the Federal Circuit
720 F. 3d 1380, 2013 WL 3198008, 107 U.S.P.Q. 2d (BNA) 1273 (2013)
ELI5:

Rule of Law:

A patent claim for a genus of chemical compounds, defined by both structure and function, is invalid for nonenablement if practicing its full scope would require a person of ordinary skill in the art to engage in undue experimentation. Such experimentation is considered undue when the specification provides only one working example and requires the synthesis and screening of tens of thousands of candidate compounds to identify others that meet the claimed functional requirements.


Facts:

  • Wyeth owned patents claiming a method of treating or preventing restenosis (the renarrowing of an artery) by administering an "antirestenosis effective amount of rapamycin."
  • The effective filing date for the patents was January 9, 1992.
  • The patents' specification disclosed only one specific compound, sirolimus, and provided data on its effectiveness in inhibiting smooth muscle cell proliferation in rats.
  • The term "rapamycin" was construed to cover any compound containing the core macrocyclic ring structure of sirolimus and also having immunosuppressive and anti-restenotic effects.
  • The defendants marketed stent products that eluted everolimus and zotarolimus, two compounds with the same core ring structure as sirolimus but with different substituents.
  • At the time of filing, the field of chemistry was unpredictable, meaning that even minor structural changes to the sirolimus molecule could unpredictably affect its functional properties.
  • Experts testified that there could be tens of thousands of potential compounds made by varying the substituent groups of the sirolimus molecule.

Procedural Posture:

  • Wyeth filed two separate patent infringement lawsuits against the defendants in the U.S. District Court for the District of New Jersey.
  • The district court held a hearing and adopted Wyeth's proposed construction for the claim term "rapamycin."
  • The defendants filed joint motions for summary judgment, arguing the asserted patent claims were invalid.
  • The district court granted summary judgment in favor of the defendants, ruling that the claims were invalid for nonenablement.
  • Wyeth, as the appellant, appealed the district court's grant of summary judgment to the U.S. Court of Appeals for the Federal Circuit.

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Issue:

Do patent claims covering a method of using a genus of compounds (rapamycin) for treating restenosis fail the enablement requirement of 35 U.S.C. § 112 when the specification discloses only one specific compound (sirolimus) and requires synthesizing and screening tens of thousands of potential variations to determine if they possess the claimed antirestenotic effects?


Opinions:

Majority - Moore, Circuit Judge

Yes, the patent claims are invalid for nonenablement. The specification does not enable one of ordinary skill in the art to practice the full scope of the asserted claims without undue experimentation. The claims cover a broad genus of compounds defined by a functional requirement (anti-restenotic effects), yet the specification only discloses a single species (sirolimus) and provides no guidance on how to modify it while preserving the desired function. A skilled artisan would be forced to synthesize and screen tens of thousands of candidate compounds in an iterative, trial-and-error process. Even if the screening assays themselves are routine, the sheer quantity of compounds to be tested in an unpredictable field, combined with the lack of guidance, constitutes undue experimentation, rendering the claims invalid under 35 U.S.C. § 112.



Analysis:

This decision significantly clarifies the boundary of the "undue experimentation" standard for enablement, particularly for broad, functionally-defined genus claims in unpredictable arts like pharmaceuticals. It establishes that merely disclosing one working example and a method for screening for a desired property is insufficient to support claims to a large genus of compounds. The ruling pressures patent applicants to either provide more comprehensive guidance on structure-activity relationships or to pursue narrower claims that are more commensurate with their actual disclosure. This case serves as a key precedent limiting the ability of patentees to claim vast, unexplored chemical territory based on a single discovery.

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