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On Nov. 29, 2004, the U.S. Supreme Court declined to consider an appeal by the University of Rochester in a closely watched patent infringement case, University of Rochester v. Searle, 125 S. Ct. 629 (2004). The university had sought to persuade the court to review a decision by the nation’s highest patent court, the U.S. Court of Appeals for the Federal Circuit, which had invalidated Rochester’s patent. Rochester’s unsuccessful appeal was the final skirmish in a four-year battle in which the university reportedly invested $10 million. The dispute in Rochester involved an evolving area in patent law-how extensively must a patent describe an invention in order for the patent to be valid? Historically, courts have required a patent to describe an invention in a manner sufficient to fulfill two important functions. First, a patent must describe an invention sufficiently to enable one of ordinary skill in the relevant field to make and use the claimed invention. Second, if the inventor has conceived of a “best mode” of practicing the invention, the patent must disclose it. Prelude to ‘Rochester’: the ‘Eli Lilly’ case Until 1997, the “enablement” and “best mode” requirements generally were the only tests used by courts to determine whether a patent had provided sufficient disclosure of the invention it claimed. During that year, however, a three-judge panel of the Federal Circuit decided a case, Regents of the University of California v. Eli Lilly, 119 F.3d 1559 (Fed. Cir. 1997), which suggested, for the first time, that a patent could satisfy the enablement and best-mode requirements, yet nonetheless fail to describe the invention “adequately,” and that such patent must be invalidated. In Lilly, patent claims directed to a micro-organism containing a human insulin “cDNA” were deemed invalid-even though the patent did recite a general method of preparing human insulin cDNA that might have satisfied the traditional enablement requirement-because the patent did not provide a structural or physical description of the claimed cDNA. The Lilly court articulated a new ground for invalidity-”inadequate written description” of a claimed invention-that clearly differed from, and seemed more demanding than, the traditional enablement requirement. Because Lilly distinguished between the newly articulated “written description” requirement and the traditional enablement requirement, and held that both are required for patentability, some viewed the case as creating a “superenablement” requirement that elevated the bar for patentability, at least for biotechnology. Lilly also suggested that patent applicants in certain areas of biotechnology might be required to conduct substantially greater experimentation to “adequately” describe their inventions. As Judge Randall R. Rader later would comment, “a ‘precise definition’ of [a] new protein, as required by Lilly, apparently requires tedious disclosure of thousands of potential permutations of the amino acid sequence that all fall within a proper description of the protein’s functions, properties, and DNA source.” Moba B.V. v. Diamond Automation Inc., 325 F.3d 1306, 1325 (Fed. Cir. 2003) (Rader, J., concurring). Over the next few years, cases arose that questioned Lilly‘s rationale and scope. In 2004, the Rochester case provided an opportunity for the Federal Circuit to clarify its written-description jurisprudence. Rochester involved a patent, held by the university, directed to methods of using compounds referred to as COX-2 inhibitors (anti-inflammatories) to treat patients. The patent did not identify or describe any COX-2 inhibitors; rather, it described a method for testing compounds to determine if a given compound inhibited COX-2 activity within the body. When the patent issued in April 2000, Rochester filed suit against G.D. Searle & Co., Pfizer Inc. and others, alleging that Pfizer’s sale of COX-2 inhibitors Celebrex and Bextra infringed the university’s patent. At summary judgment, the district court held the patent invalid as lacking an adequate written description of the claimed invention, due to its failure to describe any COX-2 inhibitors. 249 F. Supp. 2d 216 (2003). The district court also found that the patent failed the conventional enablement test. On appeal, a panel of the Federal Circuit affirmed, upholding the trial court’s determination that the patent lacked an adequate written description of the claimed invention. 358 F.3d 916 (2004). The panel declined even to consider the enablement question, holding it to be moot. Accordingly, the patent was invalidated solely for failure to satisfy the written-description requirement. A subsequent petition by the university, asking the full Federal Circuit to rehear the case en banc, was denied, 7-5, and provided a glimpse into how deeply the court is fractured on the fundamental question of whether written description may serve as grounds for invalidating a patent. 375 F.3d 1303 (2004). Judges Pauline Newman, Alan Lourie and Timothy Dyk wrote opinions asserting that patent law does contain a separate written-description requirement. Judges Rader, Arthur Gajarsa and Richard Linn disagreed, writing opinions that criticized Lilly and Rochester. The university then appealed to the Supreme Court. Though some 11 research institutions filed an amicus brief in support of the university’s petition, the Supreme Court declined to take the case. The court doubtless could point to a number of reasons for declining to hear Rochester’s appeal. It may be, for example, that the court prefers to wait for a case involving a patent that clearly is found to meet the enablement and best-mode requirements, yet nonetheless has been invalidated on written-description grounds. However, in view of the split among the members of the Federal Circuit on the written-description issue, the court’s decision not to resolve this critical issue permanently permits the Lilly and Rochester decisions to remain clouded by no little uncertainty. This uncertainty takes a particular toll on universities and other nonprofit research institutions. It is unsurprising that two of the most significant of the written-description cases- Lilly and Rochester-feature universities as plaintiff-patentees adjudged to have failed to meet the written-description requirement. University inventors, particularly those applying for patents in unpredictable fields (e.g., biotechnology), often work amid circumstances that may impair their ability to describe the parameters of their inventions as fully as Lilly and Rochester require. For one thing, it is a natural tendency among university researchers to publish the results of a new discovery within a relatively short time after achieving it. A goal of many university researchers is to advance the body of knowledge in their chosen field so that others may build upon their new discovery; prompt public disclosure of an invention serves this goal. And, in America, prompt public disclosure does not automatically harm the inventor’s chances to receive a patent, as U.S. law affords an inventor up to one year after the public disclosure of an invention to file a patent application on it. Here’s the rub. Many universities have an interest in filing patent applications overseas, and the patent laws of most foreign countries are far less charitable regarding prior publication of an invention. Most foreign patent laws prohibit granting a patent to inventors who publicly disclose their inventions before they file a patent application (which can be a U.S. application); the logic is that the prior publication of the invention already has placed it in the hands of the public. Accordingly, to avoid prejudicing their overseas patent rights, many universities attempt to file U.S. applications covering an invention during what often is only a brief time between an invention’s discovery and its publication in an academic journal. This period may be sufficient to permit preparation of a patent application that satisfies the traditional enablement requirement, but may not permit the extensive experimentation that may be required to describe sufficient permutations of the invention to satisfy the written-description requirement. Limited funding also plays an increasingly important role. A professor operating with a fixed sum of money from a research grant must budget carefully. A decision to allocate scarce resources toward additional experimentation aimed not so much at further advancing scientific knowledge, but at “bulking up” the written description of an application, is one not easily made. How much money should be spent on this experimentation? How many permutations of an invention must be described for a written description to be “adequate?” In each case, this will be a judgment call between the researcher and the patent attorney. Federal Circuit or Supreme Court must resolve issue Ultimately, what is needed in the written-description area is a permanent resolution, from either an en banc Federal Circuit, or from the Supreme Court, of the lingering question whether patent law truly does require the “superenablement” standard set by Lilly and perpetuated by Rochester. If there is a determination that patent law does require more from a patent than enablement of the claims, then university researchers applying for patents in unpredictable arts may be forced to confront difficult questions about their ability and inclination to conduct the increased experimentation that may be necessary to secure a valid patent. If more is not required, then universities seeking patents in the unpredictable arts no longer will be vulnerable to a requirement they may (at least currently) be less well suited to surmount. The Supreme Court’s decision not to hear the University of Rochester’s appeal means that the uncertainty in this area will linger on, until a case arises having facts sufficient to persuade either the full Federal Circuit or the Supreme Court to permanently resolve the dispute. Rochester, ultimately, was not that case. Thomas Morrow ([email protected]) is an associate in the intellectual property department of Houston’s Baker Botts.

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