July 28 2014 Still safe - the experimental use exception to anticipation Smart & Biggar | Intellectual Property - Canada Intellectual Property FactsDecisionCommentCanada's laws provide a one-year grace period for public disclosures by the applicant (or by a person that obtained knowledge of an invention from the applicant), calculated from the Canadian filing date (for further details please see "Public disclosures of inventions: the grace period"). In Bayer Inc v Apotex Inc, 2014 FC 436, the Federal Court recently confirmed that a further exception exists under Canadian law for disclosures outside the grace period that are made for the purpose of bona fide experimentation.FactsBayer is the owner of Canadian Patent 2,382,426 relating to pharmaceutical compositions comprising drospirenone and ethinylestradiol sold in Canada under the brand name Yaz. Bayer brought an application to the Federal Court to prohibit the minister of health from issuing a notice of compliance to Apotex Inc under the Notice of Compliance Regulations in respect of Apotex's proposed distribution of birth control tablets including drospirenone and ethinylestradiol as active ingredients.Apotex raised several issues regarding the validity of Bayer's patent, including an allegation that certain claims were anticipated because more than one year before the filing date of the application for the patent, Bayer conducted certain clinical studies in Europe and the United States in which what was claimed in the patent was both disclosed and enabled.DecisionThe Federal Court confirmed that public use of an invention does not constitute an anticipatory disclosure under Canadian law if the disclosure is carried out for the purpose of bona fide experimentation, particularly where the experimental use must, of necessity, be conducted in public.Such experimentation must be reasonable and necessary, but may be carried out with a view to either perfecting the invention or testing its merits or practical utility.(1) If a profit or gain is realised or a benefit is derived by the inventor or another person in the course of such experimentation, the use may still be considered experimental if the main purpose remains experimentation throughout. From the moment the use in public ceases to be principally and fundamentally for experimental purposes or the experimentation ceases to be reasonable and necessary, the use becomes a public use as contemplated under the Patent Act.(2)Once a party alleging anticipation has established that the invention has been disclosed to the public more than one year before the Canadian filing date of the application for the patent, to avoid invalidity the patentee must then establish that the use was for bona fide experimentation purposes. This analysis is considered on a case-by-case basis. Evidence to support experimental use can include, for example, restrictions on the recipient's use of the invention or requirements that the recipient is to keep the invention confidential.In Yaz, the court found that although none of the participants in the trials were told what the precise ingredients of the tablets were, and none of the participants actually tested any of the tablets in order to determine their ingredients or passed the tablets on to any other third party for testing, there remained a "theoretical possibility" that such an analysis could have been conducted. Thus, this disclosure more than one year before the Canadian filing date met the requirements for a finding of anticipation.However, the court also found that such disclosure fell within the ambit of the experimental use exemption. Bayer had taken reasonable precautions so as to keep relevant information confidential and to require participants to return any unused tablets. No one connected with the clinical studies received sufficient information so as to know exactly what the ingredients were in the tablets. The clinical studies were necessary to prove that the drug was safe and effective in order to obtain government approval for sale. Without these studies, no commercial sale of the drug could be made. The theoretical possibility that some tablets could have been retained and analysed could not preclude the fact that the clinical trials were experimental and, of necessity, conducted by the provision of tablets to the participants. As a result, the clinical trials satisfied the requirements of an exemption to a finding of anticipation, as the disclosure of the drug was for experimental use.CommentThe Federal Court decision in Yaz is consistent with the corresponding decision in the United States, where it was also held that Bayer's studies were experimental and were not public within the meaning of the relevant statutory provision. However, the Canadian and US decisions contrast starkly with the decision of the Technical Board of Appeal of the European Patent Office, which found that under its relevant law, the information is public if only a single member of the public, not under any obligation of secrecy, had the theoretical possibility of access to particular information. Accordingly, the safest procedure may be to bind participants under written obligations of confidentiality in situations where some experimentation with the invention is unavoidable.For further information on this topic please contact Lisa Thorne at Smart & Biggar/Fetherstonhaugh by telephone (+1 604 682 7780), fax (+1 604 682 0274) or email ([email protected]). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.Endnotes(1) Conway v Ottawa Electric Railway Co (1904), 8 ExCR 432 at 442.(2) Canadian Patent Scaffolding Co Ltd v Delzotto Enterprises Ltd (1978), 42 CPR (2d) 7 at 24).