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The Separate and Distinct Written Description Requirement

Posted Thursday, March 21, 2013 by Mike Cicero

A question that has come up numerous times over the history of the patent laws is whether the written description requirement of 35 U.S.C. §112 is separate and distinct when compared to the enablement requirement of the same paragraph. Because the prominence of questions regarding the distinctness and proper role of the written description requirement had been increasing, in 2010 the United States Court of Appeals for the Federal Circuit granted a petition centering on these issues and directed the parties to brief two questions. First, does 35 U.S.C. § 112, paragraph 1, contain a written description requirement separate from an enablement requirement? Second, if a second written description requirement is set forth in the statute, what is the scope and purpose of that requirement? Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336 (Fed. Cir. 2010). As testament to the patent community’s interest in these issues, the court received twenty-five amicus briefs, a brief from someone not a party to the suit but who offers information regarding the suit, in addition to the parties’ briefs.

In Ariad, the court ultimately agreed with pharmaceutical giant Eli Lilly on its position that §112, 1st paragraph, provides that the specification shall contain (1) a written description of the invention, i.e. the written description requirement, and (2) a written description … 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, i.e. the enablement requirement. Thus, including the best mode requirement, §112, 1st paragraph, has three distinct and separate requirements. This holding is consistent with the Supreme Court’s recent recitation of three requirements in relation to §112, 1st paragraph. See Festo Corp. v Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722 (2002).

At first glance it may be difficult to discern a practical distinction between the written description requirement and the enablement requirement. After all, how can one adequately enable any person skilled in the art to make or use an invention without apprising that person of what exactly the invention is? Perhaps in some, if not most, fields there is little difference between describing an invention and enabling someone to use it. For example, it would be unlikely that one could adequately describe how to make and use a stereo system without describing what the invention is. However, as the court points out in Ariad, there are some arts such as “chemical and chemical-like inventions” where the separate and distinct written description requirement “plays a vital role in curtailing claims that do not require undue experimentation to make and use, and thus satisfy enablement, but that have not been invented, and thus cannot be described.” 598 F.3d at 1352. This is especially true with regard to genus claims where the inventor may not have invented enough species to support a claim to the entire genus.

The test of whether an applicant has satisfied the written description requirement is whether the disclosure of the application reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date. This is different from the test of whether the enablement requirement has been met, i.e. whether one skilled in the art could make and use the invention without undue experimentation. The difference in tests stems from the unique purposes of each requirement. The written description requirement aims to prove possession of the invention, not simply research that is close to a breakthrough, whereas the enablement requirement is more o directed toward the quid pro quo of the patent system.

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