Balancing Patent Rights and Affordability of Prescription Drugs in Addressing Bio-Terrorism: An Analysis of in Re Ciprofloxacin Hydrochloride Antitrust Litigation
12 Pages Posted: 23 Sep 2004
In this article, I review In re Ciprofloxacin Hydrochloride Antitrust Litigation (In re Ciprofloxacin) 166 F. Supp. 2d 740 (E.D.N.Y. 2001)(overruled in 261 F. Supp. 2d 188 (2003) on other grounds). In re Ciprofloxacin was decided a few weeks before the terrorist attacks on the U.S. on September 11, 2001 and the ensuing bio-terrorist threat in which there were at least five anthrax-related fatalities between September 11 and November 22, 2001. In re Ciprofloxacin was brought by consumer from various U.S. states who contended that an agreement by Bayer to pay Barr Laboratories over $100 million was an unlawful restraint of trade in the market for Ciprofloxacin since it effectively eliminated the possibility of generic competition entering the market for Ciprofloxacin and as such foreclosed these consumers from purchasing the drug at competitive or lower prices. The court rejected Bayer's claim that there was a patent exception to antitrust injury. In agreeing with the consumers, the Court held that the validity of a patent did not foreclose the possibility of an antitrust injury. This unnoticed antitrust ruling and the decision by United States government to amass a stockpile of Ciprofloxacin by subsidizing Bayer's production of the drug in response to anthrax bio-terrorist threat shows that the U.S. has adopted two different attitudes in responding to public health emergencies. The first much more favorable in ensuring affordable access to patented drugs in the U.S. at at time when there were very few unfortunate fatalities versus a second and much less favorable approach towards ensuring similar access to life-saving medicines for the HIV/AIDS pandemic in sub-Saharan Africa where fatalities have been in the millions. Thus In re Ciprofloxacin raises important questions relating to where the appropriate balance between protecting inventions, encouraging free competition, and assuring public health lies. Whereas in the domestic context (that is within the United States) the balance between patent protection and free competition has received considerable attention, at the international level, the emerging emergency exception to patent protection is undergoing excruciating growing pains not least because of the U.S.'s commitment to strong protection of pharmaceutical patents.
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