Written Description - A Must Or Not?

Originally published December 17, 2004

INTRODUCTION

Recently, the United States Court of Appeals for the Federal Circuit strongly reaffirmed a patentee's obligation to provide a written description in a patent to comply with the written description requirement of 35 U.S.C. §112 ¶1. The Federal Circuit rendered this decision in University of Rochester v. G.D. Searle & Co.[i] Specifically, the Federal Circuit upheld the Federal District Court for the Western District of New York's decision[ii] to invalidate the University of Rochester's patent[iii] based on the patentee's failure to comply with the written description requirement of §112. This decision, as well as the opinions rejecting the appeal to rehear the case en banc, confirms the continuing vitality of a written description requirement in the law, independent of enablement, new matter and priority issues.

While the Federal Court has clearly rejected the proposition that there is no independent requirement for written description in 35 U.S.C. §112, the Court leaves open the question on how fundamental research is to be protected where the inventors have a clear path to the final goal, but lack the resources to achieve the goal before their competitors. Many have suggested the decision in Rochester leads to the undesirable result that a product cannot be claimed until it is "in hand and reduced to practice" even if the product and the means of obtaining the product can be clearly described (enabled). Moreover, the effect of this decision will have repercussions not only with respect to patent claim drafting practice, but also with respect to commercialization of inventions.[iv]

THE WRITTEN DESCRIPTION REQUIREMENT - A BRIEF HISTORY

Generally speaking, a patent disclosure must contain the following three elements: (a) written description, (b) enablement and (c) best mode.[v] The basis for the written description requirement stems from 35. U.S.C. §112 ¶1, which states: 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.[vi]

Although §112 references a "written description," many believe it is unclear whether this reference is meant to be independent from or in addition to the enablement requirement.[vii] However, historically, the CCPA made absolutely clear the independent existence of the written description requirement. In In re Barker[viii], the CCPA reaffirmed the principle that an application could satisfy the written description requirement and not the enablement requirement, or vice versa, citing to the 1967 decision In re Ruschig.[ix] Oddly, this particular citation may be inapt, as the CCPA in Ruschig[x] specifically observed that the rejection being affirmed did not spring from 35 U.S.C. §112. Nonetheless, the CCPA in Ruschig did specify that "'[t]he specification shall contain a written description of the invention."'[xi]

Later, in Vas-Cath Inc. v. Mahurkar[xii], and numerous subsequent cases, the Federal Circuit applied the written description requirement particularly to questions involving priority claims.[xiii] Specifically, the Vas-Cath Court used the written description as the baseline to determine whether a patent applicant had "described" his invention with sufficient clarity in a case he had filed prior to the case in which the claims in dispute were first presented.[xiv] The court continues to police priority claims under the written description rubric today as seen in Chiron Corp. v. Genentech, Inc.[xv]

The Vas-Cath decision, and its progeny, led some to believe that the Federal Circuit had decided to confine application of the written description requirement to priority contests that is until the Federal Circuit's decision in Regents of the University of California v. Eli Lilly & Co.[xvi] In Lilly, the Federal Circuit began a series of decisions more broadly applying the written description requirement independent of priority concerns. Specifically, the Federal Circuit applied the written description requirement to reject attempts to claim subject matter, such as genetically recombinant technology and related biotechnology, through use of functional language, where the actual structure or character of the subject matter claimed was not envisioned at the time of filing.[xvii]

The Federal Circuit received intense criticism for the Lilly decision. Nonetheless, the court has routinely applied the written description requirement, even where claims for benefit of priority cases were not involved. For example, in Enzo Biochem, Inc. v...