More Turns In Retrovir Patent Dispute

The Supreme Court in the USA has now asked lawyers from the Justice Department to comment on the ongoing appeal by two generic manufacturers which stemmed from a prior ruling which found that Burroughs Wellcome had entitlement to five patents for zidovudine, the active ingredient in the best-selling anti-AIDS product Retrovir (Marketletters passim).

The two companies insist that BW should not receive exclusive patents because some of the testing was performed at the US National Institutes of Health. BW, which received six patents after the NIH found zidovudine to be effective against HIV, sued Barr Laboratories and Novopharm for alleged patent infringement after each company sought permission to sell generic forms of the drug.

At the time, Barr said that two NIH researchers should be added to the patent. The manufacturing of a generic product would then be possible because NIH awarded the company nonexclusive rights to do so. Novopharm claimed that the patents were invalid because the NIH researchers were not named. In a series of appeals, attorneys for the two companies asserted that an invention must demonstrate effectiveness before it can become eligible for a patent.