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In early 1997, the U.S. Patent and Trademark Office uncovered a hornet’s nest when it announced the likelihood that patent claims would be granted to genomic fragments called expressed sequence tags (ESTs) and single nucleotide polymorphisms (SNPs). In the heady times of the Human Genome Project, thousands of these ESTs and SNPs were being obtained with only a nominal understanding of their biological value. Undaunted, companies filed hundreds of patent applications seeking IP rights to these genomic fragments with bare indications of what they were and even fainter disclosures of what they did. Moreover, these patent claims were of broad enough scope to capture as an infringer any user of a product derived from genomic material that included a patented sequence. Such fears rekindled the public outcry over gene patenting generally and its potential chilling effect on biotechnology and pharmaceutical research and development. But the Patent Gold Rush was on. Still, like most gold rushes, the dreams of riches from the ownership of genomic data alone began to fade almost as quickly as they arose. Despite its announcement, the PTO initially took no action on EST and SNP claims. Perhaps no other class of inventions has ever so significantly challenged patent law dogma. To qualify for patent protection, an invention must be useful, new and nonobvious to one skilled in the pertinent technical field. Also, the invention must be described in a manner compliant with the standards of written description, enablement, best mode and definiteness. These requirements help ensure that the public receives a valuable benefit from the disclosure of an innovative technology in return for a grant of temporary exclusivity to the patentee. In particular, a patent applicant must be able to teach the public about the invention by providing a reasonably clear answer to two fundamental questions: “What is it?” and “What does it do?” With regard to ESTs and SNPs, the response to “What is it?” was problematic enough, and the response to “What does it do?” was simply unknown. The PTO struggled with attempts to reconcile the applicability of traditional, generic principles of patent law to this emerging technology. The PTO initially issued the 1999 Revised Interim Utility Examination Guidelines, only to withdraw them in the face of critical public comment. The reissue of the PTO prescriptions in this regard ultimately came in the form of the 2001 Utility Examination Guidelines. The operative framework for meeting the requirements of 35 U.S.C. 101 now includes the mandate for a patent applicant to articulate a specific, substantial and credible utility. One inherent problem with making sense of the patent law is the temporal distortion that occurs between the time patent claims are filed and the time the PTO and/or federal courts pass on the patentability or invalidity of those claims. Of course, much, if not everything, can change in that time. What seemed impossible back then can be child’s play today. When ESTs and SNPs were discovered, their elucidation through the automated isolation and purification of vast numbers of genomic fragments to facilitate chemical formula descriptions occurred without anything being learnt about their origin, fit or function. Such an abstract process of invention hardly came with a complete answer as to what the invention was, much less yielded any insight as to what the invention did. The question therefore sat like the Riddle of the Sphinx: Can you patent ESTs and SNPs? The U.S. Court of Appeals for the Federal Circuit will have an opportunity shortly in In re Fisher, No. 04-1465 (appeal filed July 14, 2004), to write the last chapter in a long-awaited ending to this suspenseful story. The Fisher case arrived this past summer for the Federal Circuit’s review from a decision by the PTO Board of Patent Appeals and Interferences that affirmed in part and reversed in part the patent examiner’s rejection of the patent claims in a Monsanto Co. patent application to ESTs derived from a maize leaf tissue cDNA library. Ex parte Fisher, No. 2002-2046 (Bd. Pat. Apps. & Interferences March 16, 2004) (concerning U.S. patent application Serial No. 09/619, 643). The board agreed with the patent examiner that the claimed invention failed to satisfy the utility and enablement requirements, but disagreed with the written-description rejection. Monsanto had asserted that the claimed ESTs were useful for producing a plant containing reduced levels of a protein; determining an association between a polymorphism and a plant trait; isolating a genetic region or nucleic acid; determining a level or pattern in a plant cell of a protein in a plant; determining a mutation in a plant whose presence is predictive of a mutation affecting a level or pattern of a protein; acting as molecular tags to isolate genetic regions, isolate genes, map genes and determine gene function; and identifying tissues. However, the board reasoned that virtually any nucleic acid could manifest these generic uses. Among other things, Monsanto argued to the board that ESTs have real-world value as seen from the growth of a multimillion-dollar industry in the United States premised on the usefulness of ESTs. The board noted that the claims were drawn to ESTs alone, rather than to practical applications of ESTs. In any event, the patent examiner and the board found that, absent teaching about particular plant proteins or traits, these asserted uses were not specific or substantial enough to satisfy the utility requirement of 35 U.S.C. 101. Based on the same scarcity of information, both also concluded that the patent applicant did not satisfy the enablement requirement. As for the written-description requirement, uncertainty has plagued the patent jurisprudence. The itinerant standard currently requires, at least for genomic inventions, that the patent applicant has taught the complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. In Fisher, the board concluded with little, if any, explanation that Monsanto’s patent claims were supported by adequate written description. In addressing the patentability of the EST claims in Fisher, the Federal Circuit has the chance to reinforce the quid pro quo of a suitable primer on the claimed invention in exchange for the patent grant. Furthermore, because the true scope of a patent claim can be difficult to assess, especially when the patent is granted, the potential consequences of conferring the power to block off whole areas of scientific development may warrant a healthy skepticism at the start. In this regard, it would seem ill advised to undermine the ability of the PTO to engage in a deliberate scrutiny of patent claims to prevent any reach beyond what is deserved by the knowledge otherwise imparted by the patent. The Federal Circuit, therefore, may well decide to authorize the PTO to place a stricter demand on patent applicants to clarify what the invention does. In turn, a reinvigoration of the utility requirement will have the collateral effect of enhancing the public’s appreciation of what the invention is. This might help offset criticism that the public has received little, if any, educational benefit in trade for the grant of exclusivity to the patent holder. Lawrence M. Sung is a professor and intellectual property program director at the University of Maryland School of Law. He is also in private law practice in Washington, specializing in biotechnology patent counseling, and can be reached at click here[email protected] If you are interested in submitting an article to law.com, please click here for our submission guidelines.

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