Talk:In re Brana, 51 F.3d 1560 (1995)

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At issue in this case is an important question of the legal constraints on patent office examination practice and policy. The question is, with regard to pharmaceutical inventions, what must the applicant prove regarding the practical utility or usefulness of the invention for which patent protection is sought.

The requirement that an invention have utility is found in 35 U.S.C. Sec. 101: "Whoever invents ... any new and useful ... composition of matter ... may obtain a patent therefor...." (emphasis added). It is also implicit in Sec. 112 p 1, which reads: 13

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, and shall set forth the best mode contemplated by the inventor of carrying out his invention. 14

Obviously, if a claimed invention does not have utility, the specification cannot enable one to use it. 15

The Board gives two reasons for the rejection;13 we will consider these in turn.

The first basis for the Board's decision was that the applicants' specification failed to disclose a specific disease against which the claimed compounds are useful, and therefore, absent undue experimentation, one of ordinary skill in the art was precluded from using the invention.

The second basis for the Board's rejection was that, even if the specification did allege a specific use, applicants failed to prove that the claimed compounds are useful.

The first subsidiary issue, whether the application adequately described particular diseases, calls for a judgment about what the various representations and discussions contained in the patent application's specification would say to a person of ordinary skill in the art. We have considered that question carefully, and, for the reasons we explained above in some detail, we conclude that the Board's judgment on this question was erroneous. Our conclusion rests on our understanding of what a person skilled in the art would gather from the various art cited, and from the statements in the application itself. We consider the Board's error to be sufficiently clear that it is reversible whether viewed as clear error or as resulting in an arbitrary and capricious decision. 44

The second subsidiary issue, whether human testing is a prerequisite to patentability, is a pure question of law: what does the practical utility requirement mean in a case of this kind. Under either our traditional standard or under the APA standard no deference is owed the Agency on a question of law, and none was accorded. 45

The Board erred in affirming the examiner's rejection under 35 U.S.C. Sec. 112 p 1. The decision is reversed. 47