Bioterrorism and Patent Rights: "Compulsory Licensure" and the Case of Cipro

This paper discusses ethical and policy issues relating to the U.S. government's decision not to override Bayer's patent on Cipro in response to increased demands for the drug in the wake of the anthrax bioterrorism scare. Although the government had the legal authority to override the patent, the decision to not override the patent was morally justified. What is true for Cipro is also true for most other patented pharmaceutical agents. While the federal government clearly possesses the legal power to use and sanction the use of patented intellectual property without the consent of the patentee, this authority should be exercised only sparingly with regard to pharmaceutical products. Instead, government policy makers should maintain a strong presumption against overriding patents, and are morally justified in overriding patents only if the action satisfies five stringent conditions: 1) the medication plays a key role in the government's response to a bona fide national medical emergency; 2) there are no alternative remedies; 3) negotiations made in good faith to obtain the medication or a license to produce the medication have failed; 4) the government compensates the company nonetheless; and 5) the action is limited in time or has a sunset clause. We recognize that this series of threshold tests, if followed, will limit government action against pharmaceutical patents in all but a few cases, but believe that moral considerations and overall social good warrant these narrow and exacting criteria.