Examiners have been citing Brenner as support for utility rejections in instances where the specification discloses data providing clear evidence of utility for the actual compound in question. Brenner is considered inapplicable under such circumstances. The Courts have repeatedly held that minimal utility is sufficient to meet the requirements of $101. For example, "...it has never been a requirement for patentability that there must be any particular degree of utility.... Absent proof of total incapacity the defense of nonoperativeness or non-utility is not available." In re Nelson, 126 USPO 242, 248, 250 (CCPA 1960), citing Technical Tape Corp. v. Minnesota Mining and Mfg. Co., 110 USPO 260 (S.D.N.Y.). See also In re Langer, 183 USPO 288 (1974), (where the Court stated that any disclosure of utility within the scope of the claims necessarily satisfies the utility requirement unless the objective truth of the statement of utility is questionable to one skilled in the art). Similarly, "...when a properly claimed invention meets one stated objective, utility under §101 is clearly shown". Carl Zeiss Stiftung v. Renishaw, 20 USPO 2d 1094, 1100 (Fed. Cir. 1991); see also Raytheon Corp. v. Roper Co., 220 USPO 592 (Fed. Cir. 1983). Therefore, any stated utility is enough to satisfy the requirements of §101. Thus, drug compositions which have any use, be it therapeutic or not, are useful under §101. If the claims are drawn to therapeutic uses, then therapeutic utility should be shown; however, for compositions, any utility should suffice. Similarly, the standard for utility does not include a requirement of safety, a requirement (solely) of the FDA. In In re Hartop 135 USPQ 419 (CCPA 1962), the court ruled that a drug may be "useful" for patent law purposes even though it has not been shown to be safe for use under the FDA. A third area which is generating a lot of misunderstanding concerns animal testing. The law is clear that testing in "standard experimental animals" is acceptable to prove utility, even if it "may eventually appear that the compound is without value in the treatment of humans". In re Krimmel, 130 USPO 215, 219 (CCPA 1961); see also Ex parte Kreplka, 231 USPO 746 (BP AI 1986). One should clearly distinguish between "utility" in the patent sense, and "effective therapy" in the broader pharmaceutical sense. To satisfy the utility requirement under 35 U.S.C. §101, the applicant need not demonstrate "practical commercial utility", the language sometimes employed by examiners in their utility rejections, but only that utility required in the patent sense, as defined by the case law cited above. NECESSARY CHANGES While we applaud the USPTO's interest in desiring to play an active role in focussing patent law in the biotechnology arena, nevertheless, we are certainly hopeful that the Patent and Trademark Office is sympathetic to the fact that the proposed change in the patent term will significantly increase the burden on the USPTO to conduct its review of biotechnology applications in an expeditious way. Therefore, to minimize the impact of such a change in the patent term, we recommend that the USPTO adopt an action plan that would ensure that biotechnology patent applications would be properly reviewed in a manner similar to that for other industries, a manner that would not effectively reduce the 20 year patent term of patents in the biotechnology industry to one significantly less than that provided by the current standard of 17 years from issue, due to factors outside the applicant's control. Our recommendations for such an action plan follow. First, we encourage USPTO efforts to commit itself to the highest standards in training examiners to know and apply patent law. When the patent term runs only from the date of filing, it is crucial that the applicant's term not be compromised by the applicant having to train the examiner. Second, we encourage USPTO to continue applying its commitment to the highest standards in the quality of the examination of biotechnology applications. When the patent term runs from the date of filing, it is crucial that the applicant's term not be compromised by the applicant having to reargue settled case law. Third, we encourage the USPTO to take measures to ensure that supervisory examiners have sufficient time to work closely with everyone they supervise in every application, and especially early in the review process. Such close supervision by experienced supervisory professionals will minimize unnecessary rejections and rounds of prosecution, and to expedite allowance. Fourth, we encourage the USPTO to take measures to ensure that all examiners are given sufficient time to review an application and that the quality of the review be emphasized, not the quantity. and Fifth, we encourage the USPTO to take measures to ensure caseloads are evenly distributed among the examining groups, that examiners get proper time and credit for "coming up to speed" on any case that is transferred to them. Currently, examiners receive no time credit for reviewing the file history of a case that has been transferred to them. This only As encourages the examiner to maintain the previous rejections, no matter what the merits of the applicant's arguments are. having a case transferred to a new examiner is not something under the applicant's control, the applicant should not be penalized by unnecessary rounds of prosecution and the new examiner should receive credit for the time spent in review. Sixth, we encourage the USPTO's effort to further reevaluate the "point" system used to grade examiners. INTERFERENCES AND APPEALS As noted above, there are two other circumstances under which an applicant can lose patent term under the proposed implementing legislation--appeals and interferences. The Administration's pending bill addresses both of these instances by providing for an extension of term to compensate for delay. The implementing bill in essence permits an extension of time for up to 5 years for both appeals and interferences. This is only fair. To limit patent term when there is a delay caused by the Patent Office or by another party due to a rejection or priority contest that has been successfully overcome by the applicant would be unjust. Thus, to permit an extension of time, in such circumstances, is an appropriate response. These proposals meet the "fairness" test articulated by Commissioner Lehman, in testimony on August 1, 1991 (when testifying before he become Commissioner on the circumstances under which patent extensions should be granted). There are two areas in which this language could be technically modified that would make the legislation even more positive. First, in the appeals section it would appear equally equitable to include extensions for appeals within the Patent Office. There is no principled distinction between judicial appeals and administrative appeals when the delay has been caused by the Patent Office and the applicant has prevailed. Second, the effective date of the legislation should make clear that the current rules (a 17 year term from filing) apply to all applications that have a priority date before the implementing bill goes into effect, including all continuations, CIP's, and divisionals. This is especially important because investors have reasonably relied on the current system of incentives in backing expensive and time consuming research. This point is underlined by the need to protect currently pending applications from being forced into the new rules by the Patent Office through continuations and divisional applications. CONCLUSION The pending GATT implementing bill is a substantial advance in international trade. The removal of tariff barriers will improve our economic well being. The TRIPS Agreement offers some real improvements in the intellectual property regimes of our trading partners. We support the 20 year patent term from filing because certain steps are being taken to reasonably assure that the effective patent term is not less than exists today. Specifically, we welcome the Administration's implementing bill and its treatment of appeals and interferences, and the various Statements of Administration Action on assured prompt and fair treatment of biotechnology applications. We hope that certain other technical changes in this language will be made during the course of this process. Finally, we welcome the opportunity to work with the Congress and Administration to review the actual implementation of the proposed legislation over the next several years to make sure that no effective patent term is lost to undue administrative or judicial delays. APPENDIX 8.-TESTIMONY OF JEROME H. LEMELSON, LEMELSON NATIONAL PROGRAM, AUGUST 12, 1994 TESTIMONY OF JEROME H. LEMELSON BEFORE THE SUBCOMMITTEE ON INTELLECTUAL PROPERTY AND JUDICIAL ADMINISTRATION AUGUST 12, 1994 American invention and innovation far exceeds the creative output of any nation on earth, and the nature of the U.S. patent system is largely responsible for this astonishing track record. Fundamental to our patent system is the notion that invention and innovation occur only in an environment that stimulates collegial interaction and rewards true creativity. Our patent system, which grants patents to individuals and companies that originate new ideas, products and processes, and provides protection to patentholders for 17 years following the date of issuance, creates just such an environment. Public Information Office 303 East Wacker Drive Suite 1030 Chicago, Illinois 60601 (312) 946-1900 Telephone (312) 946-1922 Facsimile Invention, Innovation and Creativity Lemelson National American inventors and innovators know that even if it takes them years to perfect their inventions and finance the costly process of filing for a patent; even if it takes many more years for the patent office to issue that patent, they are guaranteed 17 years of protection and 17 years of income from patent royalties following issuance of the patent (assuming they are able to license or commercialize their patents). Thus, American inventors and innovators can |