On Monday a petition for certiorari was filed to the Supreme Court of the United States by Amgen Inc. and its subsidiaries against Sanofi Aventisub LLC, Regeneron Pharmaceuticals Inc. and Sanofi-Aventis US, LLC. The petition concerns the requirement that a patent provide a written description of the invention and the degree of detail that must be provided.
Section 112 of the Patent Act requires patents to provide “a written description” that “enable[s]” skilled artisans “to make and use” the invention. However, the degree of detail that must be provided in that description is disputed in this petition. The standard from the Supreme Court is the patent’s disclosures must be “sufficiently definite to guide those skilled in the art to * * * successful application” of “the invention.” The plaintiffs indicate that this standard has received an additional clause from the Federal Circuit that the description must also provide this information “without substantial time and effort” on the part of the artisan reading the patent. In other words, in the case of a genus patent, the patent must describe all iterations of the invention, not just those that are currently in use and a pattern for discovering the remaining variations.
The petition also argues regarding who the proper decision making body is regarding the disclosure of information in a patent. The Federal Circuit has held that decisions regarding the disclosure of information in the patent is a question of law, while the petitioner holds that it is a question of fact to be determined by the jury.