Canadian Researchers and Patenting of Higher Life

INTRODUCTION A biotechnology issue that can be of importance to some academics or researchers is the patentability of their new and useful inventions. This is particularly relevant to the questions whether (1) in the sphere of biotechnology a new use of an old compound can be patented because it is covered by the definition of utility; and, more importantly; (2) higher life is included in the definition of life? The Supreme Court of Canada in two decisions has answered these questions. It is useful to reproduce some of the provisions of the Canadian Patent Act. An means new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter. The commissioner grant a patent for an invention to the inventor or the inventor's legal representative if an application for the patent in Canada is filed in accordance with this Act and all other requirements for the issuance of a patent under this Act are met. Whenever the Commissioner is satisfied that an applicant is not by law entitled to be granted a patent, he shall refuse the application and, by registered letter addressed to the applicant or his registered agent, notify the applicant of the refusal and of the ground or reason therefor. NEW USE FOR OLD COMPOUND The respondents, in Apotex Inc v Welcome Foundation Ltd,1 identified a new use (treatment of HIV) for an old compound, and after independent research, obtained a patent for it. The appellants, generic drug manufacturers, challenged the validity of the patent on the ground that the necessary utility had not been established, in that at the date of the application for the patent the respondents did not have sufficient information to make a The trial judge and the Federal Court of Appeal rejected the challenge. The Supreme Court of Canada dismissed the appeal. The court confirmed that the doctrine of balances the public interest in early disclosure of new and useful inventions, even before their utility has been fully verified by tests. It also protects the public interests in avoiding cluttering the public domain with useless patents and granting monopoly rights in exchange for speculation or misinformation. The disclosures made in the patent, for a medical prescription that is of real use and benefit, fulfilled its side of the bargain with the public, and thus was entitled to legal protection for what was disclosed in the application. The Court stated that the doctrine of sound prediction has three components: * There must be a factual basis for the prediction. * The inventor must have at the date of the patent application an articulable and sound line of reasoning from which the desired result can be inferred from the factual basis. * There must be proper disclosure. The Court added: The soundness (or otherwise) of the prediction is a question of fact. The doctrine of sound prediction, in its nature, presupposes that further work remains to be done. Care must be taken, however, that the doctrine is not abused, and that sound prediction is not diluted to include a lucky guess or mere speculation. The court also confirmed that utility is an essential part of the statutory definition of an invention. The statutory requirement is that the inventor must be in a position to establish utility as of the date the patent is applied for, on the basis of either demonstration or sound application based on the information and expertise available. The Court added, Where the subject matter of the patent is a new use for an old compound, it is not enough that the invention is reduced to a definite and practical shape by the formulation of a written or oral description. Nor is it enough for a patent owner to be able to buttress speculation with post-patent proof. If a patent sought to be supported on the basis of sound prediction is subsequently challenged, the challenge will succeed if the prediction at the date of the application was not sound, or, irrespective of the prediction, there is evidence of lack of utility in respect of some of the area covered. …

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