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

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Courtney

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

Kevin

In a decision dated March 19, 1993, the Board affirmed the examiner's final rejection. The three-page opinion, which lacked any additional analysis, relied entirely on the examiner's reasoning. Although noting that it also would have been proper for the examiner to reject the claims under 35 U.S.C. Sec. 101, the Board affirmed solely on the basis of the Examiner's Sec. 112 p 1 rejection. This appeal followed.

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 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. See Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384, 231 USPQ 81, 94 (Fed.Cir.1986), cert. denied, 480 U.S. 947, 107 S.Ct. 1606, 94 L.Ed.2d 792 (1987). In support, the Commissioner argues that the disclosed uses in the '944 application, namely the "treatment of diseases" and "antitumor substances," are similar to the nebulous disclosure found insufficient in In re Kirk, 376 F.2d 936, 153 USPQ 48 (CCPA 1967). This argument is not without merit. 17

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. Citing various references,15 the Board found, and the Commissioner now argues, that the tests offered by the applicants to prove utility were inadequate to convince one of ordinary skill in the art that the claimed compounds are useful as antitumor agents.16 This court's predecessor has stated: 23 [A] specification disclosure which contains a teaching of the manner and process of making and using the invention in terms which correspond in scope to those used in describing and defining the subject matter sought to be patented must be taken as in compliance with the enabling requirement of the first paragraph of Sec. 112 unless there is reason to doubt the objective truth of the statements contained therein which must be relied on for enabling support. 24 In re Marzocchi, 439 F.2d 220, 223, 169 USPQ 367, 369 (CCPA 1971). From this it follows that the PTO has the initial burden of challenging a presumptively correct assertion of utility in the disclosure. Id. at 224, 169 USPQ at 370. Only after the PTO provides evidence showing that one of ordinary skill in the art would reasonably doubt the asserted utility does the burden shift to the applicant to provide rebuttal evidence sufficient to convince such a person of the invention's asserted utility. See In re Bundy, 642 F.2d 430, 433, 209 USPQ 48, 51 (CCPA 1981).17 25 The PTO has not met this initial burden. The references cited by the Board, Pazdur and Martin,18 do not question the usefulness of any compound as an antitumor agent or provide any other evidence to cause one of skill in the art to question the asserted utility of applicants' compounds. Rather, these references merely discuss the therapeutic predictive value of in vivo murine tests--relevant only if applicants must prove the ultimate value in humans of their asserted utility. Likewise, we do not find that the nature of applicants' invention alone would cause one of skill in the art to reasonably doubt the asserted usefulness. 26

We do not rest our decision there, however. Even if one skilled in the art would have reasonably questioned the asserted utility, i.e., even if the PTO met its initial burden thereby shifting the burden to the applicants to offer rebuttal evidence, applicants proffered sufficient evidence to convince one of skill in the art of the asserted utility. In particular, applicants provided through Dr. Kluge's declaration19 test results showing that several compounds within the scope of the claims exhibited significant antitumor activity against the L1210 standard tumor model in vivo. Such evidence alone should have been sufficient to satisfy applicants' burden. 29 The prior art further supports the conclusion that one skilled in the art would be convinced of the applicants' asserted utility.

FDA approval, however, is not a prerequisite for finding a compound useful within the meaning of the patent laws. Scott, 34 F.3d 1058, 1063, 32 USPQ2d 1115, 1120. Usefulness in patent law, and in particular in the context of pharmaceutical inventions, necessarily includes the expectation of further research and development. The stage at which an invention in this field becomes useful is well before it is ready to be administered to humans. Were we to require Phase II testing in order to prove utility, the associated costs would prevent many companies from obtaining patent protection on promising new inventions, thereby eliminating an incentive to pursue, through research and development, potential cures in many crucial areas such as the treatment of cancer. 37

The Commissioner takes this opportunity to raise the question of this court's standard of review when deciding cases on appeal from the PTO. Traditionally we have recited our standard of review to be, with regard to questions of law, that review is without deference to the views of the Agency, In re Donaldson, 16 F.3d 1189, 1192, 29 USPQ2d 1845, 1848 (Fed.Cir.1994) (in banc), In re Caveney, 761 F.2d 671, 674, 226 USPQ 1, 3 (Fed.Cir.1985), and with regard to questions of fact, we defer to the Agency unless its findings are "clearly erroneous." See, e.g., In re Baxter Travenol Labs, 952 F.2d 388, 21 USPQ2d 1281 (Fed.Cir.1991); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed.Cir.1990); In re De Blauwe, 736 F.2d 699, 222 USPQ 191 (Fed.Cir.1984). 39

A preliminary question, then, is whether this is one of those cases in which a difference in the standard of review would make a difference in the outcome. The ultimate issue is whether the Board correctly applied the Sec. 112 p 1 enablement mandate and its implicit requirement of practical utility, or perhaps more accurately the underlying requirement of Sec. 101, to the facts of this case. As we have explained, the issue breaks down into two subsidiary issues: (1) whether a person of ordinary skill in the art would conclude that the applicants had sufficiently described particular diseases addressed by the invention, and (2) whether the Patent Act supports a requirement that makes human testing a prerequisite to patentability under the circumstances of this case. 43 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

If the question concerning the standard of review, raised by the Commissioner, is to be addressed meaningfully, it must arise in a case in which the decision will turn on that question, and, recognizing this, the parties fully brief the issue. This is not that case. We conclude that it is not necessary to the disposition of this case to address the question raised by the Commissioner; accordingly, we decline the invitation to do so. III. CONCLUSION 46 The Board erred in affirming the examiner's rejection under 35 U.S.C. Sec. 112 p 1. The decision is reversed. 47

Maura

The examiner initially rejected applicants' claims in the '690 application as obvious under 35 U.S.C. Sec. 103 in light of U.S. Patent No. 4,614,820, issued to and referred to hereafter as Zee-Cheng et al. Zee-Cheng et al. discloses a benzo[de]isoquinoline compound for use as an antitumor agent with symmetrical substitutions on the 5-position and 8-position of the quinoline ring; in both positions the substitution was either an amino or nitro group.7 Although not identical to the applicants' claimed compounds, the examiner noted the similar substitution pattern (i.e., at the same positions on the isoquinoline ring) and concluded that a mixed substitution of the invention therefore would have been obvious in view of Zee-Cheng et al. 7

In his answer to the applicants' appeal brief, the examiner stated that the final rejection was based on 35 U.S.C. Sec. 112 p 1.9 The examiner first noted that the specification failed to describe any specific disease against which the claimed compounds were active. Furthermore, the examiner concluded that the prior art tests performed in Paull and the tests disclosed in the specification were not sufficient to establish a reasonable expectation that the claimed compounds had a practical utility (i.e. antitumor activity in humans).10 10

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. This is not a new issue; it is one which we would have thought had been settled by case law years ago.11 We note the Commissioner has recently addressed this question in his Examiner Guidelines for Biotech Applications, see 60 Fed.Reg. 97 (1995); 49 Pat.Trademark & Copyright J. (BNA) No. 1210, at 234 (Jan. 5, 1995). 12 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

[A] specification disclosure which contains a teaching of the manner and process of making and using the invention in terms which correspond in scope to those used in describing and defining the subject matter sought to be patented must be taken as in compliance with the enabling requirement of the first paragraph of Sec. 112 unless there is reason to doubt the objective truth of the statements contained therein which must be relied on for enabling support. 24 In re Marzocchi, 439 F.2d 220, 223, 169 USPQ 367, 369 (CCPA 1971). From this it follows that the PTO has the initial burden of challenging a presumptively correct assertion of utility in the disclosure. Id. at 224, 169 USPQ at 370. Only after the PTO provides evidence showing that one of ordinary skill in the art would reasonably doubt the asserted utility does the burden shift to the applicant to provide rebuttal evidence sufficient to convince such a person of the invention's asserted utility. See In re Bundy, 642 F.2d 430, 433, 209 USPQ 48, 51 (CCPA 1981).17 25

The Commissioner, as did the Board, confuses the requirements under the law for obtaining a patent with the requirements for obtaining government approval to market a particular drug for human consumption. See Scott v. Finney, 34 F.3d 1058, 1063, 32 USPQ2d 1115, 1120 (Fed.Cir.1994) ("Testing for the full safety and effectiveness of a prosthetic device is more properly left to the Food and Drug Administration (FDA). Title 35 does not demand that such human testing occur within the confines of Patent and Trademark Office (PTO) proceedings."). 31 Our court's predecessor has determined that proof of an alleged pharmaceutical property for a compound by statistically significant tests with standard experimental animals is sufficient to establish utility. In re Krimmel, 292 F.2d 948, 953, 130 USPQ 215, 219 (CCPA 1961); see also In re Bergel, 292 F.2d 958, 130 USPQ 205 (CCPA 1961). In concluding that similar in vivo tests were adequate proof of utility the court in In re Krimmel stated: 32 We hold as we do because it is our firm conviction that one who has taught the public that a compound exhibits some desirable pharmaceutical property in a standard experimental animal has made a significant and useful contribution to the art, even though it may eventually appear that the compound is without value in the treatment in humans. 33

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