In my March 13, 2009, blog entry, I discussed three of the statutory requirements for obtaining a patent that are described in the first paragraph of 35 U.S.C. § 112. These requirements include the written-description requirement, the enablement requirement and the best-mode requirement. I am following up that post with additional discussion on the written-description requirement and the enablement requirement that is based upon recent case law addressing the relationship between both requirements.
The written-description requirement and the enablement requirement are similar to one another. However, they are separate and distinct requirements that must be met by every patent application. This point was recently reinforced by the Court of Appeals for the Federal Circuit (“CAFC”) in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., Case No. 2008-1248 slip op (Fed. Cir. March 22, 2010). The CAFC is the court that has appellate jurisdiction over most patent cases in the U.S. Its decisions are reviewable only by the United States Supreme Court.
The CAFC determined that the written-description requirement is actually two separate requirements that require an applicant for a patent to provide: (1) a description of the invention; and (2) a description of the manner and process of making and using it. It appears that this second written-description requirement is either closely related to the enablement requirement or is, in fact, the enablement requirement.
Based upon the Ariad Pharmaceuticals decision, a prospective applicant for a patent should review his or her patent specification closely to make sure that the application meets both written-description requirements. A prospective applicant should also make sure that the application includes sufficient information regarding the subject matter of the claims to enable one skilled in the art to make and use the claimed invention.
The Ariad Pharmaceuticals court stated that the “hallmark of written description” is disclosure in setting forth the test to determine whether a patent application meets the first written-description requirement. The court also stated that:
"The test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art. Based on that inquiry, the specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention claimed." (Id. at 24)
As a result, a prospective applicant should use this test in determining whether his or her application meets the first written-description requirement.
Finally, the court addressed another issue that is of particular importance to inventors in the chemical and biotech industries. The court rejected the notion that inventions in such fields are subject to a “super enablement” standard. (Id. at 26) In theory, this means that the specification of an application in the chemical field or the biotech field should not be subject to extra scrutiny in determining whether it meets the enablement requirement.