Double Patenting and Selection Patents
Double Patenting
Canada has strict double patenting laws. The claims of two (or more) patents must be "patentably distinct" (i.e. novel and inventive) in view of one another. Canadian Examiners may not be aware of related applications during prosecution. It is therefore important to deal with related cases proactively, preferably before any patent issues. Terminal disclaimer is not available as a remedy and claims cannot be amended after issuance to deal with double patenting issues. Double patenting is a common ground of invalidity during litigation.
Divisional Applications
Applicant-directed ("voluntary") divisional applications are not advised in Canada due to our laws on double patenting. It is important to ensure that the claims of a single application cover all aspects/scopes of the invention to be protected. There are no excess claim fees in Canada and multiple-claim dependencies are permitted. A divisional application filed in response to a Canadian unity of invention objection is protected from a future double patenting challenge.
Selection Patents
Selection patents are permitted in Canada if the selection possesses an unexpected advantage (or lack of disadvantage) and that advantage is disclosed in the patent specification. Comparative data can be helpful. Extrinsic evidence cannot be relied upon to demonstrate a proper selection.
Expedited Examination
Patent Prosecution Highway
The Patent Prosecution Highway (PPH) provides a means to accelerate prosecution by conforming the Canadian claims to those allowed or granted in a foreign jurisdiction with which Canada has a PPH agreement. Claims of multiple cases from one Jurisdiction may be combined. Currently, there is no government fee for making a request under PPH.
Due to Canada's laws on double patenting, it is important to ensure that the claims pursued under PPH cover all aspects/scopes of the invention to be protected since voluntary divisionals are not advised. It is common for Applicants to base the PPH request on a limited claim set granted in another jurisdiction. In such cases, Applicant may be surrendering scope of protection that could have otherwise been pursued in Canada.
Special Order
An alternate mechanism for expedited examination, that is more flexible than the PPH, is Special Order examination. Special Order is requested by stating that failure to advance the application is likely to prejudice the Applicant's rights; the official government fee is $500.00. Under Special Order, the claims in Canada are not necessarily limited by conforming to allowed claims in a foreign jurisdiction.
Green Technology Applications
A further mechanism for expedited examination relates to Green Technology Applications. If the application relates to "technology the commercialization of which would help to resolve or mitigate environmental impacts or to conserve the natural environment and resources", the government fee is waived.
Regulatory Considerations
Notice of Compliance (NOC)
If the application relates to a medicinal product for which regulatory approval in Canada has been (or may be) sought, the resulting patent may be eligible for listing on the Patent Register, which has significant benefit to innovators. To be eligible for listing, the patent must have a claim explicitly directed to the medicinal ingredient, use, dosage form or formulation for which approval is ultimately granted.
Patented Medicines Price Review Board (PMPRB)
The Patented Medicines Price Review Board (PMPRB) regulates the prices of patented medicines in Canada. If a patent relates in any way (i.e. "by the merest slender thread") to a commercial drug product in Canada, then the resulting patent must be reported to the Patented Medicines Price Review Board (PMPRB). This is the case even if the claims recite an unapproved medical indication, a process or polymorph not currently in use, or the patent cannot otherwise be listed on the Patent Register. Should the PMPRB determine that the issued patent relates to a commercial product, the PMPRB will have jurisdiction to determine the maximum price of such commercial product until the patent expires or permanently lapses, even if other patents covering such products per se have expired. Moreover, such jurisdiction will be retroactive to the date of publication of the application and could thus potentially effect sales from previous years. These issues should be considered before paying the final fee.
Inoperable Embodiments
In Canada, if a claim is found to encompass an inoperable embodiment, the entire claim is invalid. Claims of intermediate and narrow scope are therefore valuable from an enforcement perspective.
Claims may be amended any time during prosecution. There are no claim fees in Canada, and multiple-claim dependencies are permitted.
Patent Eligible Subject Matter
Methods of medical treatment (e.g., Method of treating condition X by administering Y) are not patentable in Canada. However, such claims may be rewritten in to corresponding "Use-Type", "Swiss Style" and "compound/composition for use", type formats, which are not directed to methods of medical treatment and are permissible in the Canadian Patent Office.
Method of diagnosis claims should be permitted if no "treatment" steps are claimed. However, these cases appear to have been set aside in the Patent Office pending the issuance of a practice notice.
Higher life forms are not patentable. Claims to genes, cells, methods of making or using the higher life forms are currently patentable.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
