Perspectives in Biology and Medicine

THE DEVELOPMENT AND DISSEMINATION OF NON-PATENTABLE THERAPIES (NPTs) ROBERT S. ROOT-BERNSTEIN* Harvard researchers recently raised a firestorm of protest when they patented the use of light therapy to treat common chronobiological complaints , such as disturbed sleep patterns resulting from working night shifts or travelling overseas. The controversy stems from two aspects of their claim. First, researchers in the chronobiology field contend that all of the information used in the Harvard patent was in the public domain, and as such, is not patentable. They are petitioning to have the patents overturned. Second, and crucial to the point of this essay, the Harvard researchers claim that it was necessary to obtain patent rights in order to develop the therapeutic aspects of light treatment, since no commercial company would assume the necessary financial risks of product development without the protection afforded by a patent. The implication is that without patents, patients will not be able to benefit from chronobiological research results because they are publically available [I]. The light therapy case has many facets, most of which I shall sidestep in this essay. I will not, for example, address the issue of whether light therapy should or should not be patentable. That issue, for the present, must remain the prerogative of the Patent Office. The essential points for this essay are (1) why light therapy, or any other therapy, should need or be perceived to need patent protection in order to be competitive in the market place, and (2) whether it is possible to imagine a system complementary to the patent system that would foster non-patentable therapies. Given the proven utility of light therapy, it would be a shame for it to become economically or commercially non-viable, should the Harvard patents be rescinded. The problem is that there appears to be no alternative mechanism for effectively bringing such therapies to The author expresses appreciation to actuary Robert Maver, F.A.S., for discussions concerning the medical insurance industry possibilities. *Department of Physiology, Michigan State University, East Lansing, Michigan 48824.© 1995 by The University of Chicago. All rights reserved. 0031-5982/95/3901-0938$01.00 110 Robert S. Root-Bernstein ¦ Non-Patentable Therapies market. And, as I shall demonstrate below, this problem is not unique to the light therapy case. Begin by considering the issue of whether patentability is the crux of the matter or only a manifestation of a broader problem. The test of the matter is to be found in counterexamples. The fact is that neither baking soda, which can be used as a dentrifice, nor vitamins, which are essential to health, are patented substances, and yet both have very large markets. The critical operational element is clearly not patentability per se, but rather marketability. In a very general sense, the marketability of any therapy or substance meant for medical use is determined by whether or not it is regulated by the Food and Drug Administration. Baking soda and vitamins are not. Their manufacturers do not need to demonstrate safety or efficacy, since no claims of improving health or treating illness are made for these products by their manufacturers. They are not competing with other therapies against which they must prove themselves to be better. Light therapy, and other therapies to be discussed below, do make claims of therapeutic efficacy, and therefore fall under FDA regulation. For purposes of this essay, whenever I refer to non-patentable therapies (NPTs), I will therefore mean this FDA-regulated group of therapies. Now, the crucial question is why patent protection is necessary, or perceived to be necessary, to the marketability of regulated therapies. The answer is purely economic and is to be found in the costs required to satisfy FDA regulations. A 1990 study of 12 pharmaceutical companies that brought 93 drugs into clinical trials between 1983 and 1990 to satisfy FDA requirements, found that the average out-of-pocket expenses for the clinical development period were $11 million (in 1987 dollars) per drug [2]. This figure ignores pre-clinical development costs necessary to get the drugs to the clinic. The study also found that only one of four drugs that began clinical trials eventually received FDA approval. Thus, the...