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In a widely followed appeal with extensive amici briefing, the U.S. Court of Appeals for the Federal Circuit recently issued In re Fisher, 2005 WL 2139421 (Fed. Cir. Sept. 7, 2005), a decision of importance to patent law and biotechnology. A panel majority of the Federal Circuit concluded that the “utility” standard, which requires a patented invention to be useful, presents a higher hurdle than many had supposed, and that certain expressed sequence tags (ESTs) — genetic fragments commonly used as probes — do not meet that standard. The case arises from a patent application for ESTs filed by Dane K. Fisher and others and owned by Monsanto Co. The U.S. Patent and Trademark Office (PTO) rejected the patent claims for lack of utility, and Fisher appealed. The Federal Circuit affirmed on Sept. 7, holding that the rejection was supported by substantial evidence. In doing so, the panel majority resolved issues that have been percolating for years. The utility requirement is embodied in 35 U.S.C. 101, which provides: “Whoever invents … any new and useful … composition of matter … may obtain a patent therefor.” In 1817, Justice Joseph Story suggested that the requirement was met so long as the claimed subject matter was not “frivolous, or injurious to the well-being, good policy, or good morals of society.” Lowell v. Lewis, 15 F. Cas. 1018 (C.C. Mass. 1817). But in 1966, the U.S. Supreme Court in Brenner v. Manson suggested another, higher standard, requiring a “substantial utility … where specific benefit exists in currently available form.” 383 U.S. 519, 534-35 (1966). Following Brenner, the Federal Circuit required a substantial or practical utility to be disclosed if not readily apparent. In re Ziegler, 992 F.2d 1197 (Fed. Cir. 1993). But the court still did not characterize utility as a significant hurdle, suggesting it would be overcome unless the claimed matter were “totally incapable of achieving a useful result.” Brooktree Corp. v. Advanced Micro Devices Inc., 977 F.2d 1555, 1571 (Fed. Cir. 1992). Various entities relied on a minimalist view to support attempts to patent genetic data, particularly when genetic sequencing became practical in the 1990s. For example, the National Institutes of Health (NIH) and others filed applications for uncharacterized ESTs. NIH later abandoned its EST applications and ultimately argued against EST patentability, but other entities continued to seek patents. The relevant technology involves the study of genes and related cellular processes. Genes are segments of chromosomal deoxyribonucleic acid (DNA) which are typically “expressed” by “transcription” of DNA into messenger ribonucleic acid (mRNA), and “translation” of mRNA into proteins. The diverse mRNAs in cells can be purified and reverse-transcribed into complementary DNA (cDNA) molecules that correspond to genes expressed at the time of sampling. The cDNAs in turn can be partially sequenced to provide ESTs. Accordingly, each EST represents a cDNA fragment sequence. Scientists can synthesize DNA molecules that have the EST sequence and thus bind to corresponding mRNAs. When labeled, these molecules serve as tools for detecting the mRNAs and the expression of corresponding genes. An EST itself often provides insight into the nature and function of the corresponding gene and/or protein. Sometimes, however, the EST is uninformative beyond indicating that some gene is expressed. Fisher raised the question of whether a patent application claiming an EST satisfies the utility requirement in the absence of any information about the nature or function of the corresponding gene or protein. Partially in response to public debate about such applications, the PTO issued guidelines to assess the utility and “written description” patentability requirements. 66 Fed. Reg. 1092 (Jan. 5, 2001) (utility); 66 Fed. Reg. 1099 (Jan. 5, 2001) (written description). The PTO also issued training materials with biotechnology-specific examples. According to the guidelines, an examiner should not reject an invention if it has a well-established utility or if the application discloses a specific and substantial utility. The PTO suggested in Example 9 of its training materials that cDNA fragments in isolation do not meet this standard. ADOPTION OF PTO GUIDELINES The following year, the Federal Circuit adopted the PTO’s written-description guidelines after having initially rejected them. Enzo Biochem v. Gen-Probe, 296 F.3d 1316 (Fed. Cir. 2002). The court’s deference to these guidelines was considered significant. See Lawrence T. Kass and Michael N. Nitabach, “Federal Circuit reconsiders ruling in ‘Enzo Biochem,’” NLJ, Oct. 14, 2002, at C13. But it was not until Fisher that the court had occasion to assess the utility guidelines. In his patent application, Fisher claimed five ESTs derived from corn leaf cells during anthesis, i.e., pollen shedding. He disclosed nothing about the structure or function of the corresponding genes, what proteins they encoded or even whether they served some function specific to anthesis. He disclosed only six generic uses for the ESTs, e.g., as markers for gene expression or to measure mRNA levels in a sample. The examiner found that the disclosed uses were not specific to the claimed ESTs, but rather were generally applicable to any EST. The examiner also considered the uses insubstantial, reasoning that if a scientist found one of the claimed sequences in a sample, he would not know how to use the information. The examiner therefore rejected the claimed ESTs for lack of utility under � 101. Fisher appealed to the PTO Board of Patent Appeals and Interferences, which affirmed the examiner’s rejections. Fisher then appealed the board’s decision to the Federal Circuit. Represented by former Solicitor General Seth Waxman and others, Fisher emphasized Story’s minimalist view of the utility requirement. Fisher contended that, even after Brenner, the utility threshold is not high and is met unless the invention is totally incapable of achieving a useful result, as the Federal Circuit observed in Brooktree. Fisher argued that the claimed ESTs have specific benefits because they can be used, for example, as markers for specific, functional genes or to measure the level of specific mRNAs in a sample. These benefits are substantial because gene markers assist scientists to navigate through complex genetic maps and mRNA measurements provide information pertinent to detecting changes in gene expression. Fisher also asserted that commercial success with ESTs further demonstrates their usefulness. The government agreed that the utility threshold is not high, but urged that an applicant must disclose at least one specific and substantial utility pursuant to Brenner, as articulated in the PTO’s guidelines. The government further noted that Fisher’s evidence of commercial success involved only EST databases, clone sets and microarrays, not the five individually claimed ESTs. SPECIFIC, SUBSTANTIAL UTILITY Citing case law, the PTO utility guidelines and Example 9 of the training materials, a panel majority of the Federal Circuit affirmed the board’s decision. The majority observed that Brenner apparently rejected Story’s de minimis view of utility and imposed a more rigorous test, requiring a substantial, specific benefit. The majority explained that courts have since used the term “substantial” interchangeably with “practical” and “real world” to mean a claimed discovery must provide some significant, current benefit to the public, not one that may later prove useful after further research. It further stated that a “specific” utility is not so vague as to be meaningless, but rather is a well-defined and particular benefit to the public. The utility guidelines require a specific utility that is particular to the claimed subject matter, the majority observed, and a substantial utility that defines a real-world use. The guidelines caution against focusing on whether an invention is a research tool, and instead focus on whether the invention has a specifically identified substantial utility that does not require further research to identify or confirm. The majority concluded that the guidelines comport with its own interpretation of the utility requirement. It further noted that Example 9 of the training materials applies to the facts in Fisher. The majority was not persuaded by Fisher’s argument that the ESTs could be used as gene markers or to measure the mRNA level in a sample. Those uses are nonspecific, the majority found, because Fisher disclosed nothing to distinguish the five claimed ESTs from the more than 32,000 disclosed in the application. The majority found the uses insubstantial because they represent mere hypothetical possibilities that any EST might achieve, but which the claimed ESTs have not achieved in the real world. The majority distinguished the claimed ESTs from research tools like microscopes that provide immediate, real-world benefits of revealing structure. The majority also dismissed Fisher’s reliance on the general commercial success of EST databases because there was no evidence of commercial interest in the five claimed ESTs. The majority analogized the facts to those in Brenner, where a process for preparing compounds of unknown use was found to lack utility. The majority considered the facts even more analogous to those of In re Kirk, 376 F.2d 936, 941 (C.C.P.A. 1967), where a nebulous assertion that claimed compounds had “biological activity” and “biological properties” was deemed nonspecific. The majority found that here the claimed ESTs similarly lack utility because they can only be used as research intermediates in probing genes of unknown function. Quoting the Supreme Court’s admonishment in Brenner that a patent is not a “hunting license,” and emphasizing that these standards apply with equal force in any scientific discipline, the majority affirmed the board’s rulings. Judge Randall Rader dissented, asserting that the claimed ESTs have utility, at least as research tools in isolating and studying other molecules. Unlike the compounds in Brenner and Kirk, Rader reasoned, the claimed ESTs benefit society. For example, they help scientists to isolate genes or confirm they are being expressed at a particular time. Rader found ESTs analogous to microscopes, which can help identify cancer even though scientists still do not fully understand why cancer grows. Although further research is required, microscopes still have utility because they take scientists one step closer to answering such questions. Fisher will likely seal the fate of many now-pending EST patent applications and raise questions about the patentability of other discoveries that arguably lack specific, substantial utility. Combined with Rader’s concerns, this may portend some controversy. But while Fisher may have raised the bar on utility and is therefore significant, the decision should not jeopardize the patentability of many research tools. Even a single EST may be found to have utility as a probe if coupled with disclosure of information about the corresponding gene or protein. Similarly, a library of ESTs may be found to have utility for determining the genes expressed in a cell at a particular time. The outcome of any particular case, of course, will be fact-dependent. Fisher has potentially broad implications because the majority emphasized that the standards for utility are not limited to biotechnology. Fisher is also significant for its deference to the PTO utility guidelines, which likely will now carry even greater weight. Practitioners should carefully consider Fisher and the guidelines in proceedings before the PTO and courts. Lawrence T. Kass is an associate and patent attorney at Milbank, Tweed, Hadley & McCloy in New York. Michael N. Nitabach is assistant professor of molecular physiology at Yale University and a patent attorney.

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