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

Patent controversies and court cases

“…Such a legal procedure is called compulsory licensure, which enables a government to ignore the patent rights involving a product or a process during or in the name of a national emergency or needs encompassing national security or medical emergency. 12 Such laws, allowing compulsory licensing, are in the books of the United States and many European countries such as France, Belgium or Switzerland. The US Government's legal authority under 28 USC 1498 allows the government to use a patented device such as camouflage screens for military use (as in Brunswick Corp. v. US, 152 F. 3d 946, 1998) or devices that allow space satellites to remain in orbit in proper orientation (Hughes Aircraft Co. v. US, 86 F. 3d 1566, Fed.…”

“…It is interesting to note in this context that a Bayer antibiotic drug, Ciprofloxacin, known as Cipro, became a subject of discussion for the use of the provisions of 28 USC 1498 during the anthrax bioterrorism scare in the United States in 2001. 12 However, to the credit of the United States Government, the government used the compulsory licensure threat to negotiate with Bayer to reduce the price of Cipro by more than 70% so as to stockpile Cipro in case of a wider anthrax threat that of course never materialized. 12 Thus the compulsory licensure provisions in the patent laws of many countries, particularly developing countries, have kept the drug prices low for many life-saving drugs, including anticancer drugs.…”

Bioterrorism and the Responsible Conduct of Biomedical Research

“…The anthrax attacks caused a great deal of fear and anxiety, and thousands of people began taking antibiotics as a prophylactic measure [Resnik and De Ville, 2002]. Since the person who committed these acts of terror has not been captured or identified, law enforcement and intelligence authorities continue to work on this case.…”

“…First, the public and the press may misunderstand, misinterpret, or misapply information that scientists share on bioterrorism. For example, during the anthrax attacks in the Fall of 2001, many people with no exposure to anthrax spores began taking antibiotics to prevent an anthrax infection [Resnik and De Ville, 2002]. People made the decision to take these drugs based on reports that some people who had been exposed to anthrax were taking antibiotics as a prophylactic measure.…”

Terrorism and Intellectual Property Rights

“…At the time, thousands of people in the United States and Canada began taking Cipro in response to a potential exposure to anthrax or as a prophylactic measure. The US government, which had legal authority to override the patent, ultimately reached a deal with Bayer for the production and distribution of the medication [10]. In an article about this episode, Kenneth DeVille and I argued that the government made a wise decision, and we defended 5 conditions that should be met before the government can legitimately override a patent to respond to terrorism [10]:…”