Canadian Supreme Court Upholds GlaxoSmithKline’s Canadian AZT Patent
Canada's Supreme Court on Thursday upheld GlaxoSmithKline's Canadian patent on the anti-retroviral drug AZT, disallowing generic competition and forcing two generic companies to reimburse GlaxoSmithKline for the money it lost while they produced generic versions of the drug, Toronto's Globe and Mail reports (Makin, Globe and Mail, 12/6). The court ruled that GlaxoSmithKline's 20-year patent, granted in 1985, on AZT -- known generically as zidovudine -- is valid, even though the company had not conducted clinical trials on effectiveness of zidovudine in fighting HIV/AIDS when it applied for the patent. Two Canadian generic drug companies, Apotex and Novopharm, contended GlaxoSmithKline applied for a patent for AZT because it "only speculated" the drug would be effective against HIV/AIDS and had "improperly" claimed credit for discovering the drug's formulation (Lewis, National Post, 12/6). The generic drug companies said that because the NIH was "instrumental" in getting zidovudine recognized as a "genuine" HIV/AIDS drug, GlaxoSmithKline's patent was invalid, the Globe and Mail reports (Globe and Mail, 12/6). However, the court found that GlaxoSmithKline had "sufficient information about AZT and its activity against HIV in human cells to make a sound prediction that it would be useful in the treatment of HIV/AIDS," according to the National Post. According to the court, the "doctrine of sound prediction balances the public interest in early disclosure of new and useful inventions, even before their utility has been fully verified by tests, and the public interest in avoiding cluttering the public domain with useless patents and granting monopoly rights in exchange for speculation or misinformation," the National Post reports (National Post, 12/6).
Results of the Ruling
As a result of the ruling, the two generic drug makers will be forced to pay GlaxoSmithKline nearly $200 million because the company had to reduce the price of AZT to "remain competitive." The ruling is unlikely to have much effect on the price of AZT in Canada, because other drug combinations have since taken AZT's place as the "medication of choice" for treating HIV/AIDS, the Globe and Mail reports (Globe and Mail, 12/6). According to Apotex officials, the ruling will likely end its exportation of zidovudine to developing nations. "The real losers in all of this are the people with AIDS and the health care system," Apotex spokesperson Elie Betito said. Paul Lapierre, executive director of the Canadian AIDS Society, said that changes in drug patent law should be made to allow the manufacture of generic alternatives while allowing the brand-name drug makers to continue to profit financially (National Post, 12/6).
Other AZT Patent Challenges
GlaxoSmithKline faces several similar lawsuits around the world challenging its patent on AZT, including a suit filed by AIDS Healthcare Foundation, which has received backing from Dr. Hiroaki Mitsuya, one of the members of the NIH team that helped create AZT (World Markets Research Centre Daily Analysis, 12/6). Mitsuya alleges that GlaxoSmithKline's U.S. patent on AZT is invalid because the drug company "did not invent" the drug, adding that he and other NIH researchers instead "discovered its use against HIV." Mitsuya added, "As someone who has a legitimate claim to this drug, I demand it be made available to patients worldwide. With 8,500 deaths a day to this dreaded disease, we have no time to waste" (AIDS Healthcare Foundation release).