Publications

Update December 5, 2002

SUPREME COURT OF CANADA FINDS THAT HIGHER LIFE FORMS ARE NOT PATENTABLE IN CANADA

Harvard College v. Canada (Commissioner of Patents)

(Supreme Court of Canada, December 5, 2002)

This was an appeal by the Commissioner of Patents of a Federal Court of Appeal decision that held that claims to higher life forms were patentable.

The Supreme Court of Canada in a 5:4 majority decision held that higher life forms, including the Harvard transgenic oncomouse were not patentable subject matter. In a decision drawing on principles of statutory interpretation, the Supreme Court held that higher life forms are not included within the definition of "invention" in s. 2 of the Patent Act, because they are not a "manufacture" or "composition of matter" as defined in the Act. The Court agreed with the original Patent Commissioner's and Federal Court Trial Division's decision to reject the patent claims to the oncomouse per se and suggested that it is for Parliament to decide significant policy issues that appeared to require a dramatic expansion of the traditional patent regime.

However, the Supreme Court confirmed that the process claims for creating the onco mouse and the claims to lower life forms, such as DNA and cellular constructs were patentable. As such, the actual impact of this decision on biotechnology patents may be limited.

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SUPREME COURT CONFIRMS THAT "USE" CLAIMS ARE PATENTABLE AND THAT THE DOCTRINE OF SOUND PREDICTION PERMITS PROTECTION OF EARLY STAGE INVENTIONS

Novopharm Ltd. and Apotex Inc. v. The Wellcome Foundation Limited, Glaxo Wellcome Inc. et al.

(Supreme Court of Canada, December 5, 2002)

Glaxo sued Novopharm and Apotex alleging infringement of a patent for a new use of AZT for prevention and treatment of the Human Immunodeficiency Virus (HIV) that causes Acquired Immune Deficiency Syndrome (AIDS). In its defence, Novopharm and Apotex argued that the patent was invalid on the basis of i) incorrect inventorship, ii) lack of novelty and inventiveness and iii) improper pharmaceutical "use" claims.

The Supreme Court, in a unanimous ruling, upheld the Federal Court of Appeal's decision, which found some use claims valid and infringed and other use claims overly broad and invalid. Key points of the decision include:

i) Methods of medical treatment are not permitted in Canada, however, use claims are permissible. Use claims do not fence in a method of medical treatment.

ii) Use claims will be invalid if there is a lack of utility in part of the claim or lack of a sound prediction. The doctrine of "sound prediction" allows a patentee to claim a new use of a known compound even before its utility has been fully verified by tests. Glaxo had sufficient information about AZT and its activity against HIV in human cells to make a sound prediction that AZT would be useful in the treatment and prophylaxis of HIV/AIDS in humans. To the extent that certain claims went beyond the limits of a sound prediction, they were invalid.

iii) Highly skilled scientists who merely verify an inventive concept (as opposed to participating in creating the inventive concept) are not inventors. In any event, omitting inventors would only void a patent if it was a "material" misstatement that was "willfully made for the purpose of misleading" which was not present in this case.

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In other news…

On November 22, 2002 the Federal Court Trial Division released its decision in Westaim Corporation v. Royal Canadian Mint. The primary issues in the case were whether the Royal Canadian Mint infringed Westaim's patent for a process to make electroplated coin blanks, and whether Westaim's patent was valid. The trial judge dismissed Westaim's action and held that its patent was invalid as being obvious. Bereskin & Parr's Robert MacFarlane and Andrew McIntosh represented the successful Royal Canadian Mint.

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