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A Patent Is Not a Hunting License Written Description Must Show Possession of Claimed Invention

February 13, 2004

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Last Month at the Federal Circuit - March 2004

Judges: Lourie (author), Bryson, and Dyk

In University of Rochester v. G.D. Searle & Co., No. 03-1304 (Fed. Cir. Feb. 13, 2004), the Federal Circuit affirmed the district court’s grant of SJ that U.S. Patent No. 6,048,850 (“the ‘850 patent”) was invalid for failing to comply with the written description requirement of 35 U.S.C. § 112.

The ‘850 patent, owned by the University of Rochester (“Rochester”), generally relates to compounds that inhibit the activity of cyclooxygenases. Cyclooxygenases catalyze the production of prostaglandins, which perform various functions in the body. The ‘850 patent claims a method for selectively inhibiting prostaglandin H synthase-2 (PGHS-2) activity in a human host by administering a “non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product,” but it does not disclose such a compound.

The district court held that the patent claims were invalid for lack of written description and concluded that the patent does not provide any suggestion as to how a compound, as recited in the method, could be made or otherwise obtained other than by trial and error.

The Federal Circuit agreed and held that a patent specification must set forth enough detail to allow a person of ordinary skill in the art to understand what is claimed and to recognize that the inventor invented what is claimed. According to the Court, the method claimed in the ‘850 patent depended upon finding a compound that selectively inhibits PGHS-2 activity, as it would be impossible to practice the claimed method of treatment without such a compound. The Court found that the ‘850 patent did not contain any language, generalized or detailed, that described compounds that would achieve the claimed effect. The Court also ruled that Rochester did not present any evidence that a person of ordinary skill in the art would be able to identify any compound usable in the present invention based solely on the term “non-steroidal compounds that selectively inhibit activity of the PGHS-2 gene product.” In fact, even Rochester’s own expert admitted that one of skill in the art could not understand what compound or compounds would be suitable to practice the claimed invention without trial and error.

Rochester argued that no written description requirement exists independent of the enablement requirement and that, since it contained an enabling disclosure, the ‘850 patent was not invalid. Rochester contended that cases finding a written description requirement separate from the enablement requirement were either distinguishable or wrong. The Defendants argued that the written description requirement is separate from the enablement requirement, and that a patent fails to satisfy the written description requirement if it claims a method of achieving a biological effect without disclosing a compound that can achieve the result.

The Federal Circuit reviewed both the Supreme Court’s and its own precedents and concluded that the written description requirement is separate and distinct from both the enablement and best mode requirements. The Court recognized that while there may be significant overlap between the three requirements of § 112, the written description requirement is indeed independent and serves as a teaching function in which the public is given “meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time.” Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 970 (Fed. Cir. 2002).

The Federal Circuit stated that generalized language will not satisfy the written description requirement if it does not convey the detailed identity of an invention. Although some courts have held that a description of the exact chemical components within the claimed range is not necessary to comply with § 112, the patentee is still required to provide a sufficient description to show one of skill in the art that the inventor possessed the claimed invention at the time of filing.

The Federal Circuit agreed with the district court’s conclusion that the inventors did not have possession or knowledge of the compage pounds necessary to practice the claimed methods as of the filing date, and concluded that in the chemical arts, simply having the threedimensional structures of enzymes, such as cyclooxygenases, does not necessarily allow one of ordinary skill in the art to predict what compounds might bind to and inhibit them.

Rochester also challenged the district court’s ruling that the patent was invalid on SJ, arguing that a patent cannot be held invalid for lack of written description on its face, given the questions of fact the issue raises. The Federal Circuit disagreed and pointed to cases in which it held a patent was invalid for failing to meet the written description requirement based solely on the language of the specification. The Court concluded that since the specification of the ‘850 patent did not disclose which compounds have the desired characteristic of selectively inhibiting PGHS-2, the claimed method could not be practiced, even when considering the knowledge of one skilled in the art.