Glaxo Wellcome\'s AZT Patent Affirmed

On October 26, 2000, the Federal Court of Appeal upheld the validity of Glaxo Wellcome Inc.’s Canadian Patent No. 1,238,277, for the use of zidovudine (AZT) in the treatment or prophylaxis of AIDS, and further held that the patent was infringed by generic drug manufacturers Apotex and Novopharm. However, the Court also declared many of the claims of the patent to be invalid because they claimed more than was invented and were ambiguous.

The dispute began in late 1990, when Canadian generic drug manufacturers Apotex Inc. and Novopharm Limited instituted proceedings in the Federal Court of Canada challenging the validity of the patent. Glaxo Wellcome resisted the challenge and instituted infringement proceedings to enforce its patent rights. On March 25, 1998, Mr. Justice Wetston declared that, although the inventors listed on the patent failed to include two U.S. government scientists who were held to be “co-inventors” by Justice Wetston, the patent was valid and the generic AZT products distributed by Apotex and Novopharm infringed the patent. Apotex and Novopharm appealed the trial judgment.

In its reasons, the Federal Court of Appeal noted that the allegation of Apotex and Novopharm that US Government scientists were co-inventors of the use of AZT for the treatment of AIDS was not sustainable. The Court held that the named Glaxo Wellcome inventors were the proper and only inventors, and further rejected Apotex and Novopharm’s contention that the Patent was invalid because the inventors had not demonstrated the utility of AZT in humans by the claimed invention date. An application for leave to appeal this decision to the Supreme Court of Canada is expected.

Glaxo Wellcome was represented Patrick E. Kierans (Toronto), Peter Stanford and Kenneth Sharpe (Ottawa) and Brian Daley (Montreal) of Ogilvy Renault. Apotex was represented by a team from Goodmans LLP (formerly Goodman Phillips & Vineberg), comprised of Harry Radomski, Richard Naiberg and David Scrimger. Novopharm was represented by Carol Hitchman and Warren Sprigings of Hitchman & Sprigings in Toronto.