Compulsory Licensure: The Case of Cipro and Beyond

David Resnik and Kenneth De Ville (2002) make the point that U.S. Health and Human Services Secretary Tommy Thompson was morally justified in refusing to override the Cipro patent held by the German company Bayer A.G. and instead come to a satisfactory settlement regarding the amount and the price of Cipro (ciprofloxacin) to be obtained by the U.S. government from Bayer. Compulsory licensure is a legal process that allows a government to ignore the intellectual property rights of an individual or a corporation over any product whose manufacture or use is of great public value in times of national emergency or need. In the United States, 28 U.S.C. sec. 1498 authorizes the U.S. government to override any patent and allow government contractors to mass produce and use the patented product without requiring a license. The patent holder under such circumstances is entitled to obtain appropriate compensation under a court order. Resnik and De Ville argue that the scale of emergency due to the deliberate release of the anthrax spores was not significant enough for the government to declare a medical emergency and trigger 28 U.S.C. sec. 1498. Since the United States is the largest producer of intellectual property rights in the world, any action by the United States government to override a valid patent held by a foreign corporation on a rather shaky medical-need ground would prompt other governments to pursue a similar course of action with regard to patents held by U.S. corporations.

Much of the arguments made by Resnik and De Ville are logical and convincing. While the scale of the emergency during the anthrax scare was certainly low (based on the number of deaths and even infected people), the anxiety level nevertheless was unusually high among the public because of the relatively unknown nature of the pathogen used or its toxin. To complicate matters, it has been repeatedly emphasized that cipro, or for that matter any drug, is of little use if the Bacillus anthracis spores germinate to vegetative cells in the body, particularly in the respiratory tract, and start producing the toxin. Anthrax toxin kills people very quickly, and Cipro is effective only if given early enough for it to prevent the germination of spores. There was thus a great deal of fear in the minds of many people, particularly those working in mail rooms or government buildings, that they might be infected at any time and need Cipro for their protection. Since anthrax spores may survive in the body for a long time, the Cipro treatment needs to be continued for several months. It is in this context that there was a real health emergency that required the government to have ample supplies of Cipro, whether it was obtained by overriding the patent or through negotiations with Bayer.

While Resnik and De Ville focus their arguments only on Cipro, a chemical, they raise some interesting questions with regard to the moral authority of a government, including the United States government, to reject patentability of a product based on public interest and welfare. Can a government take it one step further and reject the patentability of a product, say cultured cells of pluripotent human embryonic stem cells, based on the argument that human embryos are potential human lives and cannot be legally destroyed during the extraction of the stem cells? Cloning of human embryos for therapeutic purposes where the stem cells can be used for tissue regeneration or for potential organ transplantation, is now permitted in the United Kingdom. Purified cultures of human embryonic stem cells are patented in the United States, although no government funding can be used to generate new embryonic stem cell lines from human embryos. Can a foreign government override the U.S. patent on human embryonic stem cell propagation based on the religious belief or public-interest argument that such cells...