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20 Biotechnology L. Rep. 1 (2001)

handle is hein.journals/bothnl20 and id is 1 raw text is: 20 Biotechnology Law Report 1 Number 1 (February 2001) Mary Ann Liebert, Inc. Can Unpredictable New Technology Satisfy Enablement? Enzo Biochem, Inc. v. Calgene, Inc., 188 F.3d 1362 (Fed. Cir. 1999) TERESA SPEHAR, Ph.D., J.D.* INTRODUCTION The enablement requirement for issuance of a U.S. patent can be a difficult threshold to over- come when you have invented a novel technology that you believe can be broadly applied. This is what Dr. Masayori Inouye discovered when he submitted his patent application for genetic antisense technol- ogy. As will be explained more fully below, anti- sense technology is based on the insertion into a cell of a sequence of DNA that is the reverse of some portion of the DNA of the target gene; the goal is to suppress the target gene and thus its protein. Al- though Dr. Inouye had been working with his in- vention in only one model system, he knew it had great potential. Accordingly, he sought to claim the use of the technology in all systems. Had he enabled others to follow the teachings of his invention, or had he merely submitted an unproven general prin- ciple or theory? The answer hinges on the factfinder's analysis of the predictability of the new art. The less predictable the technology, the narrower the protection that will be afforded to claims encompassing the technology. Moreover, the technology will be judged as of the date of filing of the patent application, and argu- ments of postfiling success of the technology will not impact this inquiry. Enzo Biochem, Inc. (Farmingdale, N.Y.) was es- tablished to find and create new technologies for biomedical and scientific use and was the exclusive licensee of the patents in dispute. Calgene, Inc. (Davis, Cal.) is an agricultural biotechnology com- * Teresa Spehar received her Ph.D. from Johns Hopkins Uni- versity and was awarded a J.D. from California Western School of Law in December 2000. pany whose scientists had independently invented and patented the application of antisense technol- ogy to tomato plants. At issue was whether Calgene had infringed Enzo's broad antisense patents, which issued after Calgene's narrower use patent. Un- avoidably, the fight turned into a much larger bat- tle over whether Enzo's patents were valid at all. The second part of this paper presents the proce- dural and factual history that brought the case to the Court of Appeals for the Federal Circuit (CAFC). The third part presents the legal framework provid- ing the backdrop for an analysis of the enablement requirement for patentability. Finally, this paper looks at how the CAFC applied the law of enable- ment to the case before them. PROCEDURAL AND FACTUAL HISTORY The battle began in 1992, when Calgene was preparing for a public offering of its securities.1 A pivotal product, Calgene's FLAVR SAVR tomato, was the result of 12 years and more than $20 mil- lion in research and development by its own scien- tists.2 The FLAVR SAVR tomato was a product of genetic engineering and had the commercial advan- tage of ripening at a slower pace than an unmodi- fied tomato. The core technology involved decreas- ing levels of an enzyme contributing to the ripening process, an enzyme known as polygalacturonase.3 This decrease was achieved through the use of an- tisense regulation to block the expression of the 1 See Enzo Biochem, Inc. v. Calgene, Inc., 14 F. Supp.2d 536, 548 (Del. 1998). 2 See id. s See id. 1

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