Apotex, Inc. v. Wellcome Foundation Ltd.

2002 SCC 77 (2002)

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Apotex, Inc. v. Wellcome Foundation Ltd.

Canada Supreme Court
2002 SCC 77 (2002)

  • Written by Jody Stuart, JD

Facts

Wellcome Foundation Ltd. (Wellcome) (defendant) owned the patent for azidothymidine (AZT), a drug used for treating HIV and AIDS. Wellcome did not invent the compound AZT. Rather, Wellcome identified a new use for the drug. The date of Wellcome’s United Kingdom patent application was March 16, 1985, the same as the priority date used to evaluate the invention for Canadian patent purposes. On March 1, 1985, Wellcome received NIH results from the test of AZT against HIV in a human cell line. In addition, Wellcome had its own results from tests on mice. Wellcome’s patent application also described the chain-terminator effect of AZT. Apotex, Inc. (plaintiff), a generic-drug manufacturer, challenged the validity of the AZT patent. The trial judge found that Wellcome’s and the NIH’s AZT test results provided a factual foundation and that Wellcome’s knowledge of the mechanism by which a retrovirus reproduces and the chain-terminator effect of AZT provided a line of reasoning to establish utility. Apotex appealed.

Rule of Law

Issue

Holding and Reasoning (Binnie, J.)

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