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Today, what fuels the growth of biotech companies is new inventions, and what protects those inventions is the patent system. The grant of a patent is premised on a fundamental bargained-for exchange: The inventor must provide a full, complete and enabling description of the invention and, in exchange, the government provides the inventor with the right to exclude others from practicing the invention. Sounds simple enough, yet in recent years, the U.S. Court of Appeals for the Federal Circuit has struck down many biotech patents because the inventor failed to live up to his end of the bargain by failing to provide a full, complete and enabling description of the invention. Most recently, on April 10, the Federal Circuit found that a patent application assigned to Mycogen Plant Science Inc. failed to provide an enabling description of an invention directed to transgenic tomato plants. Adang v. Fischhoff, 286 F.3d 1346 (Fed. Cir. 2002). From this and other cases, a trend may be appearing from the Federal Circuit of imposing stricter conformity by the biotech industry to the written description and enablement requirements imposed by the patent statute. Before discussing Adangand the trend that this case may portend, it is necessary to understand the requirements that the patent system imposes on the inventor in exchange for the grant of a patent. The requirement that the inventor must provide a full, complete and enabling description of the invention is statutorily mandated by 35 U.S.C. 112, first paragraph. This statute provides, in relevant part, that: “The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same.” 35 U.S.C. 112, � 1 (1994). This portion of 35 U.S.C. 112, � 1 is recognized as setting forth two distinct requirements: the “written description” and “enablement” requirements. These “ensure that the scope of the patentee’s right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.” See Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345 (Fed. Cir. 2000). The inventor must comply with both of these requirements in order to be entitled to a patent. Because the written-description requirement is a separate one, it will not be addressed here. Suffice it to say, the written-description requirement “ensures that, as of the filing date [of the patent application], the inventor conveyed with reasonable clarity to those of skill in the art that he was in possession of the subject matter of the claims.” Union Oil Co. of California v. Atlantic Richfield Co., 208 F.3d 989, 997 (Fed. Cir. 2000). The enablement requirement of � 112 “ensures that the public knowledge is enriched by the patent specification to a degree at least commensurate with the scope of the claims.” National Recovery Techs. Inc. v. Magnetic Separation Sys. Inc., 166 F.3d 1190, 1196 (Fed. Cir. 1999). To be enabling, a patent specification must teach those skilled in the art “how to make and use the full scope of the claimed invention without ‘undue experimentation.’” Genentech Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997). Adang was found to have run afoul of this requirement of the patent statute. The issue in Adang v. Fischhoffwas whether Michael J. Adang or David A. Fischhoff was the first to invent an invention directed to tomato plants that have been genetically modified to incorporate a bacterial gene that confers insect resistance. Both had patent applications pending before the U.S. Patent and Trademark Office (PTO) directed to essentially the same invention. Since the U.S. patent system is premised on who was the first to invent as opposed to who was the first to file, a special proceeding called an interference was declared by the PTO to sort out the issue of who was the first to invent the claimed invention. Adang’s ability to prevail hinged on whether he was entitled to the filing date of his 1986 patent application. Adang’s 1986 patent application contained a working example showing the successful transformation of the bacterial gene, Bt, that confers insect resistance into a tobacco plant. Adang’s 1986 patent application also described at least 94 kinds of plants, including tomatoes, which may be protected from insects by transformation with the Bt gene. The application did not contain any working examples showing that he had actually conferred insect resistance to a tomato plant through transformation with the Bt gene. Rather, Adang’s patent application contained the following prophetic statement: “The present invention contemplates that the hybrid plasmid transformation vectors may be used to develop plant cells … exhibiting insect resistance properties. It is contemplated that plants, particularly dicotyledonous plants, other than those described below in the examples can be transformed such as cotton, sugarbeet, soybean, rape.” THE PTO’S DECISION The PTO looked at two principal sources of evidence in finding that Adang had failed to provide an enabling disclosure. First, the PTO noted that Adang admitted to the PTO that transformation of plant cells in the 1986 time frame was an area of unpredictable success. Adang distinguished a prior art reference on the basis that “the experiments were invalid because [the experimenter] used a completely different strain of tobacco from the strain Adang used in Adang’s example.” 286 F.3d at 1350. From this the PTO inferred that if it was difficult to infer success from one strain of tobacco into an expectation of success into a second strain of tobacco, a person of skill in the art would not have expected success in transforming other plants, including tomatoes. Second, the PTO looked at publications contemporaneous with the filing date of Adang’s application, including a publication by Adang. These publications evidenced the difficulties the field was facing in obtaining transformation of plant cells with the Bt gene. The PTO found that the combination of Adang’s admission coupled with the contemporaneous references raised “substantial doubts” that Adang’s 1986 application would have enabled those of skill in the art to practice the claimed invention. The Federal Circuit found that there was substantial evidence supporting the PTO’s determination that Adang’s 1986 patent application did not enable a person of skill in the art to practice the claimed invention. Like the PTO, the Federal Circuit used Adang’s admissions and contemporaneous references as evidence that undue experimentation would have been required to practice the claimed invention based upon the disclosure in Adang’s 1986 patent application. The Federal Circuit, however, also took note that Adang’s 1986 patent application contained nothing other than a prophetic statement that the methodology that had been shown to work in tobacco could be extended to 94 other species of plants, including the tomato. THE IMPACT OF ‘ADANG’ Although the impact of Adangmay not be immediately appreciated, it appears that the Federal Circuit has begun to scrutinize biotech patents more closely from the perspective of whether the inventor has complied with the written-description and enablement requirements. Here, Adang had complied with the written-description requirement because he prophetically disclosed that transformed tomatoes could be made. For many years now, it has been customary in drafting patent applications to include one or more working examples directed to one embodiment of an invention (in Adang, a tobacco plant) and prophetic statements that the invention could be used for things other than what had been shown in the examples (in Adang, the 94 other plant species, including the tomato). By doing so, one provided the necessary written description for obtaining later patent claims to the embodiments described in the prophetic statements. This was precisely the strategy that Adang employed. He invented the concept of making transformed plants containing a bacterial gene conferring insect resistance. He proved that this technology worked in tobacco plants. From this success, Adang filed a patent application seeking to protect his invention and the logical extension of his invention, 94 other commercially valuable plants. The only thing Adang had not done was prove that his invention would work in the other recited plant species. The Federal Circuit’s decision taken to its logical extension seems to indicate that the strategy of expanding upon the working examples of a patent application through the inclusion of prophetic statements of what else the invention may be used for may no longer be accepted. If that is so, biotech companies may see that many patents they have obtained over the past decade will not survive an enablement scrutiny from the perspective that Adangprovides. Kevin McCabe is an associate at Washington, D.C.’s Finnegan, Henderson, Farabow, Garrett & Dunner, www.finnegan.com . His practice focuses on patent litigation, principally in the field of biotechnology.

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