Earlier today, the Federal Circuit Court of Appeals published their en banc opinion in Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. Central to the court’s holding is that the first paragraph of 35 U.S.C. § 112 includes distinct written description and enablement requirements. Here is the first paragraph of 35 U.S.C. § 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The court uses this language to support a written description requirement wherein the patent specification itself must demonstrate possession of the invention. The court explains that, “while the description requirement does not demand any particular form of disclosure, or that the specification recite the claimed invention in haec verba, a description that merely renders the invention obvious does not satisfy the requirement.” The court also holds that the enablement requirement separately requires the patent specification enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention.
From a practical perspective the court recognizes “perhaps there is little difference in some fields between describing an invention and enabling one to make and use it, but that is not always true of certain inventions, including chemical and chemical-like inventions.”
As a result of this holding, it is as important as ever to ensure that your patent application includes an enabling disclosure that clearly demonstrates possession of the invention. These requirements apply to all utility patents regardless of whether they start as provisional or non-provisional utility patent applications.
Tags: federal circuit court of appeals, patent examination, patent law
