Canada has seen a number of legislative changes in 2014 and 2015 to its Industrial Design Act, the Plant Breeder's Right's Act and the Patent Act. In addition, a Practice Notice related to the Examination of medical diagnostic applications was released by the Canadian Intellectual Property Office (CIPO) in summer 2015, greatly altering the examination procedure and scope of claims that will be allowed by the patent office for diagnostic innovations. A brief synopsis of some of the key changes follows.
Amendments to Canada's Industrial Design Act passed December 2014 have yet to come into force. The amendments introduce changes to registration criteria to bring the Act in line with the Hague Agreement, which allows an applicant to obtain industrial design protection in member states on the basis of a single application. The amendments remove the requirement for originality, introduce a novelty requirement, allow for multiple designs in a single application, and introduce provisions for pre-issue publication. The twelve month grace period is now tied to the priority date and the amendments allow for claiming domestic priority. In addition, the term of protection which is now 10 years from registration, will be the later of 10 years from the registration date or 15 years from the filing date, ensuring that holders receive a minimum of 10 years of protection.
Canada's Plant Breeders' Rights Act (PBRA) was amended to bring the PBRA in line with UPOV, the international plant breeders' regime and came into force on February 27, 2015. The amendments provide for a new grace period allowing a plant variety to be sold in Canada for up to one year prior to the date of application. This grace period exists in addition to the current grace period for sales outside Canada. The term of exclusivity has also been extended from 18 to 25 years for trees, vines, or categories that will be specified by the regulations, or 20 years for all other varieties.
Canada's Patent Act has also seen significant changes introduced which are also not yet in force. Amendments to the Patent Act bring it in line with the Patent Law Treaty. Key changes include the ability to add material contained in a previously filed patent application after the filing date, an opportunity to restore a lost priority right, and unlike the current situation, allow anyone to pay maintenance fees on behalf of an Applicant. Canada's reinstatement provisions were also amended. At present an application that is abandoned can be reinstated as of right if the reinstatement fee and the required action that resulted in abandonment is taken within 12 months of the deadline. The amendments introduce a "due care" standard, although it is unclear at present how the "due care" standard will be applied. Regulations under the amended Patent Act will also introduce a "safe harbour" period and no right of action will exist against a third party acting in good faith that infringes in respect of an abandoned patent.
Although not having the force of law, the Patent Notice to Examiners regarding examination of medical diagnostic methods is having an immediate effect on the scope of patent protection that is being allowed by the Patent Office for diagnostic innovations.
CIPO released a Practice Notice related to the patentability of medical diagnostic applications on June 29, 2015, Examination Practice Respecting Medical Diagnostic Methods – PN 2015-02. The Practice Notice directs Examiners to identify the problem to be solved, guided by the description as well as their understanding of the common general knowledge ("CGK") in the art. The Practice Notice identifies that the problems to be solved in diagnostic methods can be considered as: 1) "data acquisition problems" and 2) "data analysis problems". Methods improving or identifying non-CGK methods (e.g. using a new antibody or non-CGK method for that analyte) for quantitating an analyte may be considered a data acquisition problem, whereas a discovery of an allegedly new correlation between a condition and a known analyte is likely a data analysis problem. If the problem is a data acquisition problem, the solution is provided by the elements that provide a means to acquire data about the analyte. If the problem is a data analysis problem, the solution is provided by the elements relating to the analysis of the acquired data for the purpose of providing diagnostic meaning.
It is clear that data acquisition problem solutions are more likely to be patentable: "[w]here a physical step of data acquisition is identified as an essential element of the construed claim, the claimed subject-matter will likely be statutory". In contrast, "a diagnostic method claim construed as consisting solely of essential elements that are disembodied (e.g. mental processes lacking physicality, no practical application, etc.) will be identified as defective" and not patentable subject matter.
There are several issues with the examination proposed in the Practice Notice. A problem solution approach is not clearly grounded in Canadian law and may be contrary to case-law asserting that claim language should have primacy and components of a claim are presumed to be essential unless the contrary is indicated in the patent. Nonetheless, until judicial pronoucement, it will be advisable to identify any improvements and differences in the method from non-CGK methods and/or to consider any additional steps, combinations of markers or particular reagents that would support arguments that a problem to be solved is a data acquisition problem.
Additional legislative changes are also expected on the horizon to address requirements mandated by other agreements such as the Canada Europe Trans-Atlantic Agreement (CETA) and the Trans Pacific Partnership (TPP). Status updates are available upon request.