Patents & Trademarks
The low-down on the situation regarding patents and trademarks in Canadian pharma. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for USD 99.
1. What are the basic requirements to obtain patent and trademark protection?
In order to obtain patent or trademark protection, one must submit an application to the Canadian Intellectual Property Office (“CIPO”) and comply with the formalities of the application process set out by the agency. All forms and guidelines are available on the CIPO website. Trademark registration lasts for fifteen years and is renewable indefinitely (presuming continuous use), while a patent is valid for a single term of twenty years.
2. What agencies or bodies regulate patents and trademarks?
In Canada, CIPO is responsible for patent and trademark regulation. The PMPRB regulates the pricing of patented medicines.
3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?
Under Canadian intellectual property (“IP”) law, any word, sound, design, or combination thereof may be registered as a trademark if it is used to distinguish the goods or services of a person or an organization, or to signal certain qualities of the goods or services to the consumer from those of others. Currently, scents and tastes may not be trademarked under Canadian IP law.
Furthermore, the following marks may not be registered as a trademark under Canadian IP law: marks that include the name and surname of a person, marks that are clearly descriptive or deceptively misdescriptive, marks that refer (misleadingly or not) to the place of origin of the product, marks that use the name of the good or service in a different language, marks that are confusingly similar to existing or pending trademarks, and marks that are confusingly similar to prohibited trademarks, namely official marks that are controlled by specific institutions.
In the pharmaceutical industry, patents provide drug innovators a period of market exclusivity, during which generic manufacturers are prohibited from manufacturing or selling the patented product. Typically, commercially successful drugs will have numerous patents disclosing the active ingredient(s), coatings, therapeutic indications, dosing, manufacturing methods, and other aspects of the drug.
There are three main criteria for the patentability of an invention: it must be novel, useful, and inventive (or non-obvious). Novelty is met if the invention (or the improvement thereof) is the first of its kind in the world. Canada operates on a first-to-file system, and as such, a patentable invention must be “new” as of the application filing date. Utility is met if the invention has a useful function and is operable. It is not necessary to show commercial success in the patent application to meet the utility requirement, but commercial success may be an indicator of non-obviousness in the case of an attempt to invalidate a patent. Finally, inventiveness is met if the invention constitutes the development of an entirely new technology or the improvement of an existing one that would not have otherwise been obvious to a person working in the respective field, that is a person skilled in the art in light of the common general knowledge and the state of the art as a whole and without any particular creativity.
A patent may be granted to an invention that is either an art, a product, a composition, a machine, a process, or an improvement of any of these. The invention described and claimed in the patent application must be reduced to a practical form and not be a disembodied idea or concept. As such, higher life forms, scientific principles, mere discoveries of nature, abstract (mathematical) theorems, purely mental operations, and forms of energy are not patentable. The purpose of these preclusions is to distinguish disembodied inventions that attempt to monopolize natural phenomena or laws of nature from the practical applications of such principles. Moreover, while diagnostic methods are generally patentable, methods of medical treatment are not.
4. How can patents and trademarks be revoked?
The owner of a registered trademark can lose that right by having the trademark expunged or removed from the Register of Trademarks. In a non-use expungement proceeding, any party, including the Trademark Registrar, may request that CIPO require the trademark registrant to demonstrate they have used the trademark in accordance with the listed goods and services within the last three-year period. In the event that the registrant cannot show evidence of use, nor any special circumstances justifying the non-use of the trademark, the registration will be expunged. Once the Registrar has rendered a final decision to expunge the trademark or amend or maintain the registration, the registrant or other party may appeal to the Federal Court of Canada.
A registered trademark may also be declared invalid and therefore removed from the Register and deemed unenforceable to third parties. There are four grounds for invalidating a trademark:
- Unregistrability: in the event that the trademark is deemed to have not complied with trademark law requirements at the time of its registration;
- Non-distinctiveness: if it can be shown that a trademark is not distinctive of the registrant’s goods or services;
- Abandonment: if it can be shown that a trademark has been abandoned due to non-use in Canada or the owner’s intention to abandon the mark; and,
- Non-entitlement: if it can be shown that the registrant was not the person entitled to have the trademark registered.
A patent may be invalidated based on the following grounds:
- Anticipation: a patent must not be anticipated by a prior document. To prove anticipation, one must be able to look at a prior, single document and find in it all the information necessary to produce the claimed invention without the use of any inventive skill;
- Obviousness: a patent must be inventive or non-obvious. There is a four-step test to prove obviousness: first, identify the person skilled in the art and the general knowledge of that person; second, identify the inventive concept of the patent claim; third, identify any differences that may exist between that which comprises the state of the art and the inventive concept of the claim; and, fourth, as if without any knowledge of the invention claimed, assess whether these differences would have been obvious to the person skilled in the art or whether they require any degree of invention;
- Double patenting: a patent must not be granted to an invention for which there already exists a patent, where at least one claim of the first and second patents is identical (coterminous double patenting) or where the subject matter of the second patent becomes obvious in light of the first (obviousness double patenting);
- Covetous claiming: patent claims are covetous if they exceed their permissible scope by exceeding the scope of the invention that was actually made or the invention described in the patent specification;
- Ambiguity: a patent claim must define distinctly and in explicit terms the subject matter for which exclusive rights are claimed;
- Lack of sufficient disclosure: a patent must fully describe the invention in the specification and, as such, should enable a person skilled in the art to implement the invention described in the patent and make the same successful use of the invention;
- Lack of utility: a patent must describe an invention that is useful, and the invention must be operable or do what the patent claims it will do. Patent utility must be established as of the claim date, either by demonstration or sound prediction or through a promise (as of 2017, a patentee is no longer held to the promise of the claims);
- Unpatentable subject matter: disembodied ideas or concepts are unpatentable. For example, Canadian case law has determined that methods of medical treatment, higher life forms (including plant and animal forms), architectural plans, methods involving professional skill, and business methods with no practical application are unpatentable; and,
- Fraud on the Patent Office: a patent will be invalidated if any material allegations in the patent petition are untrue or if a willful omission or addition, with the purpose of misleading, is made in the petition.
5. Are foreign patents and trademarks recognized and under what circumstances?
Foreign trademarks may be recognized in Canada to the extent that they are used or made known in Canada (i.e. are well known by the Canadian public through advertising or the distribution of the goods or services it represents) and are not confusing with a trademark previously registered or used or made known in Canada. Likewise, a foreign trademark, duly registered in its country of origin, may be registered in Canada insofar as it is not confusing with a trademark previously registered or used or made known in Canada. A foreign trademark, which is unregistered in Canada and to the extent that it is used or made known in Canada, may oppose a third party in Canada for trademark infringement inasmuch as the third party operates an unregistered trademark in Canada and cannot claim prior use or having been made known in Canada.
Like the United States and other common law jurisdictions, Canada operates on an as-used basis, as opposed to an as-filed basis, upon which many parts of the world operate, including the European Union. Canadian IP law thus recognizes trademark rights based on the goodwill that has accrued solely from using an unregistered mark. However, Canada is set to modernize its IP framework in 2019 so as to adapt to international standards and implement widely adopted international treaties. The use of a trademark, whether its proposed or prior use in Canada or its actual use elsewhere in the world, will no longer be a prerequisite for registration. A trademark application will therefore be registered even if there is no intent to use or there is no actual use of the mark in Canada or abroad. This modernization will be helpful for foreign trademark owners looking to benefit from trademark registration during the pre-commercialization phase of their good or service.
Furthermore, acceding to the “Protocol for the Madrid Agreement Concerning the International Registration of Marks” will offer the possibility of obtaining trademark protection in all member countries through a single international application filed with the World Intellectual Property Organization (“WIPO”). As well, Canada will use the Nice Classification system, administered by WIPO, used to categorize goods and services for the purposes of registering trademarks.
In Canada, it is currently possible to benefit from the Paris Convention for the Protection of Industrial Property (“Paris Convention”) provision that allows a trademark to be filed in any treaty member jurisdiction within six months from the initial filing date in another member jurisdiction. The subsequently-filed Canadian application will be able to claim the filing date from the initial foreign application, and take precedence over any confusingly similar application filed in the priority period.
Foreign patents do not protect an invention in Canada. One must apply for a foreign patent either within Canada, via CIPO under the Patent Cooperation Treaty (“PCT”) or directly with the patent office of the foreign country concerned. As a member of the Paris Convention, it is possible to invoke “convention priority” in Canada, meaning that a filing date in one member country will be recognized by all the other member countries provided one files in those countries within a year of first filing. As such, CIPO will recognize an earlier foreign filing date as long as a Canadian patent application is filed within one year of the foreign filing date and a priority claim is made within sixteen months of that date. The application will be published eighteen months after the convention priority date, not the Canadian filing date. Likewise, it is possible to claim convention priority based on an earlier filed Canadian application.
One may apply for a foreign patent from within Canada through PCT, administered by WIPO. The PCT provides a standard international filing procedure that is shared by the treaty’s member countries. Eighteen months after filing (or after the priority date), the application is made available to the public.
6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?
Most non-patent/trademark barriers to competition to protect medicines or devices were outlined above, including notably, the Health Canada approval/NOC and inspection process. See Regulatory, Pricing and Reimbursement Overview , Question 3.
In addition, data protection provisions in the Food and Drug Regulations guarantee innovative drugs a minimum period of market exclusivity. A generic drug manufacturer cannot apply for regulatory approval, by establishing its bioequivalence to the brand name drug, until the brand drug has been on the market for six years. The generic manufacturer cannot receive regulatory approval until the brand drug has been on the market for at least eight years.
7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?
There are no restrictions on the types of medicines or devices that can be granted patent or trademark protection insofar as the medicines or devices comply with Canadian IP law and drug regulation.
8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?
Licence agreements in Canada may cover virtually any form of IP, including patents and registered and unregistered trademarks. Generally speaking, any business entity established by a foreign licensor in Canada and any joint venture involving a foreign licensor may conduct business in Canada, with or without a domestic subsidiary or branch office.
No filing or regulatory review process is required in advance of carrying out licencing activities in Canada. Licence agreements are made subject to normal contractual rules and obligations. A foreign licensor that plans to conduct business in Canada, however, must notify Industry Canada as required by the Investment Canada Act.
Regarding trademarks, the Trade-Marks Act provides that a licensee’s use of a trademark is deemed to have the same effect as that of the owner of the trademark, thus preserving the distinctiveness of a licenced mark by attributing any use of the mark to one source only (i.e. the owner of the licenced mark). The protection afforded to the owner of a licensed trademark is provided only to the extent that the owner complies with the requirements of the law, namely, giving public notice of the fact that the use of the trademark is licenced use.
As for patents, the Patent Act provides that for a patent licence to have effect in Canada and be enforceable against third parties, the patent owner must register the licence agreement with CIPO.