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or not, and in all imaginable forms. If we should in this act exclude all trades in which quackery exists, the statute would be quite uselass. There exist then no reasons for distinguishing the pharmaceutical preparations from the other inventions which can be protected by patent.
It is true that there are some who think that because foods and drugs are so much bound up with public health there should be no patents on inventions in that field. They would put inventions that are beneficial to health in the same class with those that are injurious, and deny patents on the former just as on the latter. They contend, in effect, that although society properly should pay for other inventions, of less value to society, it should confiscate food and drug inventions without paying for them because they are of such great value to society. They say that the inventor in the field of foods and drugs should be unselfishly motivated by the good of the public, with no thought of profit for himself. Perhaps he should. Undoubtedly he often is so motivated. But is he wise, from the very standpoint of the good of the public? Disregarding any question of honesty, would society be wise in fostering that idea? Does his unselfishness, and would any notion by society that he must be unselfish, accomplish its purpose? Does that unselfishness, and would that notion, do as much for society as a patent would do? No! That unselfishness on the part of the inventor defeats its own purpose. The new food or drug will in most cases become more readily and more quickly available to the public with the help of a patent than with no patent. The very giving of it to the public may deprive the public of it. The manufacturer may feel unable to take up the matter, with its possibilities if not probabilities of loss, unless he has the protection of a patent; for the cost to the reputable manufacturer of making a new drug available to the public is often enormous, on account of the extensive chemical, pharmacological, and clinical tests which must be made before the effectiveness and safety and limitations of the new drug can
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be established with sufficient certainty to warrant offering it to the public, and on account of the inability of more than one proposed drug in ten to survive those tests, I n addition, society is more likely to get a high-grade product at the outset, and the invention is thus more likely to be favorably accepted by the public so that it may really serve society, if at most only a few carefully selected manufacturers are licensed. Furthermore, even if the high-minded attempt to give an invention to the public without reward were always a real benefit to the public as to that particular invention, any notion by society that there must be such unselfishness on the part of the inventor of a new food or drug would hold back development. Although many research workers in the field of foods and drugs seek no personal reward, why should that high-mindedness on their ’ part lead society to deprive itself in that field of the motivating profit motive which gives it the benefit of so many inventions, in that field as well as in others? The interest of the public demands that inventions be made in the field of foods and drugs, and that those inventions be made available to the public. Probably this is true in this field even more than in other fields, because the maintenance of the public health is perhaps as important a function of government as can be conceived. With this in view, it would be directly contrary to the public interest to remove from the field of foods and drugs the incentive of exclusiveness which has proved so effective in the field of inventions generally. For the very purpose of serving society, therefore, it is essential that the incentive of exclusive rights be kept open for the inventor in the field of foods and drugs, not for his benefit but for the benefit of society, so that he will labor more diligently and society may ultimately have the fruits of that labor. RECEIVEDSeptember 13, 1937.
re Patents on Foods and Medicinals in the Public Interest? H. L. RUSSELL The great majority of patents F T H E R E is a n y one do not even pay their own Wisconsin Alumni Research Foundation, Madison, Wis. thing that e x p e r i e n c e cost, much less make money teaches in the handline: for the patentee or the owner of patent matters, it is tha; of the patent. Not infrequently this may be due to the fact each patent problem must be studied individually; that it that the inventor is so handicapped financialIy that he has would not be the part of wisdom to attempt to classify them insufficient resources with which to develop the patented idea. by groups and say, for instance, that all medical discoveries Seldom will he find anyone willing to risk money on developor inventions should or should not be patented. ing the idea unless this backer is to get the lion’s share of any The primary idea of the Government in granting amonopoly prospective returns. in the form of a patent is that the discovery will be developed, in the long run, in the public interest. But the mere invenCommercially Profitable Patents tion of a useful process or product and securing a patent The public has a grossly exaggerated idea of the returns thereon stops far short of accomplishing anything permanent derived from the commercial exploitation of patents. The in the public interest. To be of real value to the public, the successful cases that find their way into the press are few and idea must not only be perfected so as to be commercially far between. One hears nothing of the thousands of patents practicable, but it must actually be put to work. For this that are never developed a t all. reason the Government extends the period of monopoly to The director of research of a well-known industrial laborasevente6i years. tory furnished the following figures on the experience of his The ordinary course of development of a patentable idea own organization: I n the course of twenty-odd years, his involves years of effort before it can be commercially applied; company had concerned itself with the development of about until it is successfully reduced to business practice, it cannot three hundred and thirty patents. With only ten of these be expected to yield any income of substantial importance.
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patents had his organization received any income; the remaining three hundred and twenty were worse than useless, since substantial sums had been spent to secure the patents and no returns had come. While ten were yielding some income, only three were producing sufficient revenue to pay the cost of maintaining the organization and pay dividends to the stockholders. This is a low average, but the record of this laboratory is probably representative.
Failure to Secure Patent Protection The idea is not infrequently advanced that the public interest is best served by not taking out a patent on an invention. It should be kept clearly in mind that a negative attitude of this character may still result in an action that is not only not in the public interest but may actually be detrimental to it. Because an inventor fails to protect his invention through the medium of a patent, the public may be the loser. If the inventor fails to patent his own invention, there is nothing to debar someone else from making an application for a patent if the claim which he puts before the patent office can be shown to be novel and useful and has not heretofore been covered by patent application. If a patent is secured by anyone else, the original inventor through his failure to exercise his rights loses all control over the invention and it is quite possible that the discovery may be handled in such a way as not to be in the public interest. Then, if the discoverer makes no effort to control his discovery, anyone is free to use it in any manner he chooses, provided this is done within two years from the time of the original discovery. In the field of medical invention and discovery the danger of misuse is perhaps greatest. The value of so many medical preparations depends upon the uniformity with which proper standards of manufacture are maintained. If this is under rigid control of the patentee, it is to his interest as well as that of the public to see that the purity, uniformity, and stability of the product is ensured. I n the hands of unscrupulous manufacturers whose objective may be immediate profits while the opportunity exists, the interests of the public are wholly neglected.
Babcock’s Milk Test The Babcock milk fat test was nearly ruined in this way. When i t was first suggested t o Dr. Babcock that he should take out a patent, he refused t o do so. His attitude was that ‘(the state of Wisconsin supported my investigation for years when the test was being perfected, and its people are entitled to receive all the benefits derived from its use.” He said that he did not want to make a dollar out of the discovery and therefore refused t o take out a patent. The apparatus included finely calibrated glass test bottles, and, since there was no sort of control over the details of constructing the apparatus, some manufacturers of dairy equipment threw upon the market machines that had uncalibrated glassware. Naturally such machines gave erroneous results. This situation resulted in discrediting the test in many cases. A number of the leading dairy states were therefore forced to organize state control laboratories where all glassware used in the test was first accurately calibrated before sale was permitted. This expense in the end cost much more than would have been the case if the apparatus had been put out under patent license. Any reputable manufacturer under license would doubtIess have been required to ensure dependable apparatus with accurately calibrated glassware. Babcock’s generous action has often been lauded highly, but more than once in recent years he has stated that, if there had been an organization such as a university foundation to which he could have assigned his rights, he would have voluntarily turned it over to the foundation to manage.
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Another method often heralded as highly favorable to the public interest is to take out a patent and then voluntarily dedicate it to the public. This method is not infrequently resorted to by agencies of the Federal Government. I n some instances where a discovery could be immediately utilized without any further experimental development, it is possible that commercial concerns might be willing to run their chances of utilizing such a discovery just as they would be willing to take a nonexclusive license if they knew that the patentee expected to grant a large number of licenses under any given patent. If, however, additional work was needed to develop and perfect the patent properly, it is highly improbable that any commercial concern would be willing to take a license under such conditions and invest the necessary funds to complete the commercial application, if their competitors were also able to have equal privileges without such expenditures. Wherever this method has been tried, the public has rarely benefited because no development has actually taken place. An example was the Cleveland patent on the sterilization of fruit juices by oxygen under high pressure. This patent was secured by a Johns Hopkins University staff member working under a grant from the National Research Council. When the patent issued, it was assigned to the National Academy of Sciences and was dedicated by it to the public. To put the method on the market and have it actually used commercially would have required an expenditure of tens of thousands of dollars. No commercial concern was willing to undertake this obligation without protection for a period that would permit it to get its money back. The result was that the invention never was used, and in the course of events other processes were developed that accoAplished the desired result; for all practical purposes, the invention was lost by dedication to public use.
Inventions by University Staff Members No one questions the ethics of a staff member of a commercial concern who secures a patent, either for himself or his organization. The amazing progress of mechanical invention has been mainly due to the efforts of research workers of such organizations, who are constantly engaged in the development of new ideas. But when a university professor makes a discovery that has a direct practical application to industry or human welfare, he is often subjected to criticism if he attempts to have his invention put to practical use through the medium of patent procedure. Too often when he does so, he fails in large measure because, unaided, he is unable to meet the necessities of the situation. Lack of financial resources to develop the invention to the point where its practicability is proved generally compels him to part with his interest with little or no personal advantage.
Wisconsin Alumni Research Foundation The business device initiated over a decade ago a t the University of Wisconsin to meet this situation offers an outlet for voluntary transfer of patentable ideas of a meritorious nature. If a Wisconsin University staff member or alumnus wishes to make his invention available to the public and thus divest himself of the responsibility of securing, maintaining, defending, and developing a patent, he can offer his project to the Wisconsin Alumni Research Foundation. If the trustees think the idea has sufficient merit to warrant the necessary expenditures of money for its full development, they will take an assignment of the invention and defray all the expenses connected with its ultimate development. If it can be successfully merchandized, any returns are first applied to recoup the foundation for its out-of-pocket ex-
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penditures. The net income is then applied as follows: The inventor receives 15 per cent of this net amount year by year throughout the life of the patent, and the foundation retains the balance which is invested. The income is used for the support of research at the University of Wisconsin. The university itself can hardly be expected to be equipped or to equip itself to handle effectively problems involving such legal and financial obligations. It is obvious that the individual staff member is rarely able to do this type of work unaided. The administrative device referred to has the merit of utilizing the structure of a business corporation; a t the same time it is an independent corporation, not organized for private profit, and the income, if any, goes back to the public because it is used for endowment and support of research. In these days when the social aspects of all problems are regarded as of first importance and are taking precedence over the rights and obligations of the individual, this experiment in the social development of the intellectual effohs of university life is commanding more and more attention. More than a dozen educational institutions, both endowed and publicly supported, have organized similar devices for the better handling of patentable ideas that may have been developed as the oatcome of the research activities of their staffs.
Influence of Patent Possibilities
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The opponents of this idea of enabling university research to provide for a part of its own support have voiced the fear that such a procedure would lead to a radical change in the ultimate aim of &heuniversity to prosecute research for its own sake, without regard as to whether anything practical might come from the work. They argue that, if the goal of personal profit is either directly or indirectly present, it is only human nature to be swerved from the pure science objective. It is easy to conjure up such fears and imagine the dire consequences that may follow where the aims of pure science are prostituted in the marts of commerce. It may be argued, on the other hand, that the high ideals of pure science are not very firmly established if its devotees are so suddenly swerved from their avowed objective. It might be a contribution to a solution of this problem if the facts could be ascertained as to what has actually occurred in institutions that have been subjected to such influences. The University of Wisconsin has now been subjected to such conditions for about ten years. During this period the foundation has made available over a half-million dollars for the support of specific research projects. These are annual grants made to the various professors in the natural science field for the support of definite research projects that are under the immediate supervision of the department and are participated in by some hundreds of graduate students each year working under and generally with the professor in charge of the projects. I n this period these funds have been allotted, not by the foundation, but by the Research Committee of the Graduate School for the prosecution of over five hundred projects. Of this number only two research projects have in any way yielded returns that were directly or indirectly related to the development of a patent application. As a matter of fact, these two patents had been taken out before these particular research problems were started. This experience seems to refute the accusation that providing an outlet for university patentable ideas changes the ideals of an institution.
Glearinghouse for Patentable Ideas During this period various university staff members have come to the foundation for advice as how best to handle
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any suggestions which they thought might have patentable possibilities. I n only a single case was the research idea the outcome, either directly or indirectly, of work which the foundation had supported. In a considerable number of instances the foundation has undertaken for such members the requisite patent search to ascertain whether the idea was already covered by the prior art. It has counseled these individuals as to the probable value of the suggested invention and as to whether it was worth while to follow the matter farther. In only one or two instances has it been thought warrantable to undertake the securing of a patent. In other words, the foundation has become the recognized clearinghouse for such matters and has aided materially in guiding university thought,
Medical Patents The following thoughts have been carefully worked out as to patent protection in the medical field. This policy was adopted by the Wisconsin Alumni Research Foundation a t the request of the American Academy of Pediatrics concerning the method of handling medical patents: Owing to the fact that patents dealing with medical matters vary so widely in nature, it is impossible to formulate a policy that can be universally applied; therefore, each case must be separately considered on its merits, keeping in mind, however, in the administration of patents of this type that the humanitarian and general aspects of a problem of this nature must be more critically considered than in an industrial patent. Many discoveries of a medical nature should probably be made available to the profession without any effort t o patent them. Where a lack of proper control in the use of the patented article might result in undue exploitation of the public, lack of uniformity in standardization, and confusion of the public mind as to the inherent values of the product, we believe that patent consideration is preferable. Two good illustrations of this type are insulin and Viosterol. If these medical preparations had been put on the market without any sort of laboratory control, different manufacturers would probably have made their own standards which would have differed widely, with the result that utter confusion of the medical and lay public would have resulted. I n the case of insulin the control was vested in the hands of the Insulin Committee of the University of Toronto; in the case of Viosterol, in the hands of the Wisconsin Alumni Research Foundation. The foundation is spending over $50,000 a year in its control laboratories for the sole purpose of checking the potency, uniformity, and stability of its vitamin D products. This contribution is made wholly from the standpoint of public welfare as an independent check upon the accuracy of the pharmaceutical manufacturer in following scrupulously the standards that have been adopted with reference to the production of this medicinal preparation. I n the case of certain types of medical discoveries, the foundation believes that its obligation is to administer such discoveries and patents in a way to benefit the public without any financial return other than that required to safeguard and control the proper use of the discovery. For instance, this basic principle would be applied to types of medical discoveries in the hormone field. It is the feeling of the foundation that the opportunity for misuse and exploitation in the case of such discoveries is so great that it is much preferable to protect these inventions through the medium of a patent and the discriminating manner in which such a patent can be commercialized. When a possible conflict between the acquisition of royalties and protection of society appears, the foundation believes that the latter has a superior claim over the former. R ~ C ~ I VSeptember ED 20, 1937.
