01Jul 2020
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In a recent case, Actavis Laboratories v. Nalproprion Pharmaceuticals, the Supreme Court denied certiorari to a case which would have clarified the statute 35 U.S.C. § 112(a) lack of written description.

The case arose from a District Court decision that one claim (claim 11) of U.S. Patent 8,916,195 was not invalid for failure to satisfy the written description requirement.

Claim 11 was directed, inter alia, to a method of treating overweight or obesity… wherein said sustained release formulation of naltrexone has an in vitro dissolution… test of USP Apparatus 2 Paddle Method.

The crux of the matter was while the claim recited test USP 2, the specification only disclosed test USP 1.

The District Court based its decision on the equivalence of the two tested. According to the Court, one skilled in the art would have had no doubt that the inventors were in possession of the claimed invention because the two tests were allegedly substantially equivalent.

In conclusion, the District Court holding was that a substantially equivalent method is sufficient to satisfy the written description requirement.

It should be noted that the written description requirement has several policy objectives:

  • It ensures that an applicant has invented the subject matter which is claimed; 
  • It conveys to the public what the applicant claims as the invention; and
  • The written description requirement promotes the progress of the useful arts by ensuring that patentees adequately describe their inventions in their patent specifications in exchange for the right to exclude others from practicing the invention for the duration of the patent’s term.

The Supreme Court showed its reticence to respond to requests for clarifications on Section 112(a).

Please contact me at silvia@salvadorilaw.com with questions or comments.

Silvia Salvadori, PhD

Silvia Salvadori, PhD