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845 Off. Gaz. Pat. Office 1 (1967)

handle is hein.intprop/uspagaz0582 and id is 1 raw text is: U.S. DEPARTMENT OF COMMERCE OFFICIAL GAZETTE of the UNITED STATES PATENT OFFICE December 5, 1967 Volume 845 Number 1 PATENTS NOTICES Board of Appeals Decisions Rendered in the Month of October 1967 Examiner affirmed ---------------------------------201 Examiner affirmed in part -------------------------- 31 Examiner reversed -------------------------------- 74 Total -------------------------------------- 306 Guidelines for Disclosures of Utility in Patent Applications for Drugs The following are guidelines which the Patent Office pro- poses to adopt in the examination of applications for patents for drugs. Comments as to these guidelines will be considered if received on or before January 16, 1968, on which date a public hearing on the matter will be held at 10 :00 a.m. In Building 34 (3rd floor) at Crystal Plaza. All persons wishing to be heard orally at that time are requested to notify the Commissioner of their intended appearance. Oct. 24, 1967. EDWARD J. BRENNER, Commissioner of Patents. GUIDELINES FOR DISCLOSURES OF UTILITY IN DRUG CASES Introduction It is felt that special consideration be accorded utility disclosures in drug cases in view of the public interest, par- ticularly as expressed in Public Law 87-781. SEc. 702(a) * * * (d) The Secretary is authorized and directed, upon request from the Commissioner of Patents, to furnish full and complete information with respect to such ques- tions relating to drugs as the Commissioner may submit concerning any patent applications. The Secretary is further authorized, upon receipt of any such request, to conduct or cause to be conducted, such research as may be required. The Food, Drug and Cosmetic Act defines a drug- The term drug means (A) articles recognized in the official United States Pharmacopeia, Official Homeo- pathic Pharmacopeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any articles specified in clause (A), (B), or (C) ; but does not include devices or their components, parts, or accessories. SEc. 201(g) (1) Federal Food, Drug, and Cosmetic Act as amended. In addition, compositions adapted to be applied to or used by human beings e.g., cosmetics, dentifrices, mouthwashes, etc. may be treated in the same manner as drugs if there is a question that their use may affect the health or well being of the person. 35 U.S.O. 101 Since predictability in this field is limited, a question should be raised as to the adequacy of the disclosure that a claimed genus possesses the asserted utility or operativeness under Section 101. That it does is reasonably inferable from a dis- closure or showing of a sufficient number of representative examples together with a statement applicable to the genus as a whole. Utility must be definite and in currently available form; not merely for further investigation or research. Thus gen- eralized and vague assertions such as therapeutic agents, for pharmaceutical purposes, biological activity, Inter- mediates, and for making further unspecified preparations are regarded as too nebulous and insufficient. If the asserted utility is believable on its face and not un- reasonable the burden is on the examiner to give adequate reasons for disbelief. On the other hand, incredible statements such as the cure or remission of malignant tumors, cure of tuberculosis or diabetes or of any disease condition or symp- tom known to be intractable to treatment will require ade- quate proof on the part of applicants for patents. It is pre- sumed that applicants for patents are in the best position to supply evidence to support the assertions. A spectrum of credibility exists between the noted limits. Criteria for testing the compliance of the assertion of the utility with Section 101 and the credibility of these assertions depends, inter alia, upon the nature of the disease, the seri- ousness of the use contemplated, the scope of the results claimed, the similarity to known successful drugs, the speci- ficity with which the use is identified, the pattern of the bio- logical response and the art knowledge concerning such re- sponse, and the safety of the drug, where necessary. In instances where a question of proof to satisfy Section 101 is involved, the evidence offered is to be tested by the same criteria. If the specified or implied utility involves humans, clinical evidence is necessary; however, there is authority that animal tests are acceptable if the tests are of a kind that the results are known to be closely correlated with human utility. In accordance with the present case law, if there is no assertion of human utility, operativeness for use on standard test animals is adequate for patent purposes. Further, if the evidence shows that the drug is not safe in the dosage or mode of use for which it is effective, the disclosure will not satisfy the utility requirement of Section 101. Abso- lute safety is not necessarily required. 35 U.S.O. 112 The standards of disclosure for compliance with Section 112 In respect to the statutory language of written descrip- tion of * * * using the invention as to enable any person skilled in the art to which it pertains * * * to use the same are to be strictly construed in view of the special public New Applications Received During October 1967 Patents --------------------------------------- 7650 Designs --------------------------------------- 428 Plant Patents --------------------------------- 13 Reissues -------------------------------------- 14 Total ----------------------------------- 8105 Issue-December 5, 1967 Patents - - 1282-No. 3,355,744 to No. 3,357,025, incl. Designs ------- 54-No. 209,444 to No. 209,497, incl. Plant Patents-- 2-No. 2,781 to No. 2,782, incl. Reissues ------- 7-No. 26,315,to No. 26,321, incl. Total - 1345 1

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