Biotechnology Patent Protection Act of 1993 : report (to accompany S. 298).

United States Senate Committee on the Judiciary

Date:: [1993]

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Licence: Public Domain Mark

Credit: Biotechnology Patent Protection Act of 1993 : report (to accompany S. 298). Source: Wellcome Collection.

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a substantially pure form or the product is not well characterized prior to the recombinant synthesis, if its basic properties and some aspects of its structure are known, the Patent and Trademark Of- fice (PTO) may assert that the use of recombinant technology to make a pure form of such a product is obvious. The ability to ob- tain a patent for a purified version of a protein merely to block the use of a process to make commercially viable quantities of a recom- binant version of the protein has been criticized.}” The mere existence of a previously discovered protein should not, by itself, always preclude the issuance of a patent for a recombinantly created version of the same protein. The rationale under which a patent may be granted for a product existing in na- ture is that in its natural form, such a product is not available and useful to the public without further isolation and purification. The law as currently expressed provides that to be considered obvious: the differences between the subject matter sought to be patented and the prior art [must be] such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.1° The U.S. Court of Appeals for the Federal Circuit (Federal Cir- cuit) and its predecessor, the U.S. Court of Customs and Patent Appeals (C.C.P.A.), have reiterated many times that an applicant's disclosure in a patent application cannot be treated as prior art in determining the obviousness of the claimed invention.'+ The court has also emphasized that the invention as a whole must be consid- ered in assessing obviousness.’° Finally, the court has cautioned that a patentability determination must be made as of the time the invention was made, and not as part of a hindsi ight reconstruction of the invention given the applicant’s disclosure. Because questions of novelty and obviousness often preclude product patents, the biotechnology industry has become heavily de- pendent upon process patents. Yet, product patents are generally considered to provide better protection for drugs than process or use patents because the latter two types usually can be cir- cumvented more easily. Additionally, it may be more difficult to de- tect the infringement of a process patent than the product patent because products are available to the public, but the processes used to make them are kept secret within the walls of a manufacturer. The biggest problem facing the U.S. biotech industry is the lack of clarity in the rules for patentability of biotech processes. Sound investment decisions require a degree of economic certainty. The lack of legal certainty for biotechnology process patents affects the 12See Merges & Nelson, “On the Com mp Economics of Patent Scope,” 90 Colum. L. Rev. 839, 903-04 (1990). See also Scripps Clinic & Research Found. v. Genentech, Inc., 666 F.Supp. 1379 (N.D. Cal. 1987), modified on reconsideration, 678 F.Supp. 1429 (N.D. Cal. 1988), summ. judg- ment granted, 707 F. Supp. 1547 (N.D. Cal. 1989), affd in part, rev'd in part, vacated in part, 927 F.2d 1565 (Fed. Cir. 1991), (reserving for further ana ysis by the district court the issue whether a patent on a purified protein should serve to block a patent on a recombinant version of the same protein). 1335 U.S.C. 103 (1988), (emphasis added). 14 See, e.g , Panduit Corp . uv. Dennison Mfg. Co., 810 F.2d 1561, 1567-88 (Fed. Cir. 1987), cert. denied, 481 U.S. 1052 (1987); In re Rote, 654 F.2d 450 (C.C.P.A. 1982). 15 See John Deere Co. v. Graham F.2d 529 (8th Cir. 1964), affd 383 U.S. 1 (1966). 16 In re Kuehl, 475 F.2d 658, 66o-65 ‘c. C.P.A. 1973).