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

  • United States Senate Committee on the Judiciary
Date:
[1993]
Catalogue details

Licence: Public Domain Mark

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

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    The inconsistent application of Durden by the PTO has also led to severe delay or denial of issuance of process patent protection to deserving inventors. The Federal Circuit acknowledges that there have been conflicting views on this issue both in the PTO Board of Appeals and in the C.C.P.A.?! Moreover, case law exists in this area which conflicts with the Durden reasoning and which would be more appropriately applica- ble to biotechnology process patents.22 The application of Durden by the PTO to biotechnology cases, which involve microorganisms, conflicts with In re Mancy. In Mancy, the court held that a standard method of culturing microorganisms to produce antibiotics could not be treated as prior art in determining the patentability of a similar method using a patentable microbe to produce an antibiotic therefrom. In other words, novelty and nonobviousness of the microbe imparted patent- © ability to a method using it. To the detriment of biotechnology process patent applicants, the PTO has felt constrained to follow Durden rather Mah Mancy. More troubling is the fact that the reasoning in Mancy is the law for inventions in Europe and Japan, where the patenting of process inventions that use patentable starting materials has long been recognized.24 The Federal Circuit revisited the issue of the patentability of processes in In re Pleuddemann.** In that case the patentee had a patent to a starting material that he used in a process to make a patentable final product. Apart from the use of the patented starting material, the method (process) of making the final product was admittedly already known. The Federal Circuit held that the method of using the patented starting material to produce the pat- entable final product was patentable in this particular case. Although the Federal Circuit attempts to distinguish Pleuddemann from Durden, it is difficult, if not impossible, to rec- oncile these two cases. It is not clear why a method of using a starting material should be treated differently, for purposes of de- termining nonobviousness, from a method of making the end prod- uct. Yet, under Pleuddemann, the former is per se nonobvious, while the latter is not. The PTO and the.courts continue to apply Durden to rejet@® claims involving methods of using novel DNA sequences and other recombinant intermediates to make protein products. The classic Durden rejection maintains that a process of making a protein using a novel DNA sequence is obvious, because others have pre- viously used the same process with other DNA sequences to make other proteins. As a result of Pleuddemann, it might be asserted that recombinant DNA patent applications no longer need fear such a Durden rejection of process-of-using claims which are based upon a novel DNA sequence encoding a desired protein X. Unfortu- nately, biotechnology companies have reported that the PTO has generally rejected this reasoning. 21 Durden, 763 F.2d at 1409. 22See, e.g., In re Mancy, 499 F.2d 1289 (C.C.P.A. 1974). See also In re Kuehl, 475 F.2d 658 (C.C.P.A. 1978). 23 499 F.2d 1289 (C.C.P.A. 1973). 24Termeer, supra note 7. 25910 F.2d 823 (Fed. Cir. 1990).
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