Life Sciences Commercialisation in Canada: Overview

The Canadian life sciences sector is robust and active. According to recent statistics from the Government of Canada, Canada captures 4% of global clinical trials, fourth in number of clinical trials sites, and is the G7 leader in clinical trial productivity (number of trials/population). In 2021, the manufacturing portion of the sector employed an average of about 32,513 people and over the last five years employment has grown by 8%. The industry includes start-ups as well as established subsidiaries of multinational pharmaceutical companies. Canada has a patented medicines linkage regime dealing with generic access to the market. It also regulates the pricing of patented medicines through the Patented Medicine Prices Review Board.

As the health care system in Canada is largely public, the life sciences industry frequently interacts with all levels of government. The process for the approval and sale of a medicinal product in Canada can be complicated and time consuming for those relying on the public system as it involves both federal authorities (Health Canada for medicinal product approval) and provincial and territorial authorities (for access to medicinal products). Patients can secure private health care for certain conditions, although universal health care remains a core part of the Canadian health care system.

Most Canadian biotechnology companies are privately owned small and mid-size enterprises. The sector has experienced significant growth in recent years in terms of number of venture capital deals and cash invested. Canada's Health/Bio-sciences Economic Strategy Table has made recommendations to increase the pace of commercialisation in Canada to increase global competitiveness. Industry access to federal funding includes the Scientific Research and Experimental Development Tax Incentive Program (SR&ED), the National Research Council's Industrial Research Assistance Program (IRAP), and other granting councils including the Canadian Institutes for Health Research.

The Canadian government also invested in improving access to biotechnology research and production facilities through its Strategic Innovation Fund (SIF), which is providing CAN600 million over two years to support COVID-19 vaccine and therapy clinical trials.

Industry transaction trends see larger pharmaceutical companies partnering with start-ups with promising research and development pipelines.

Jurisdiction over health care is shared between the federal, provincial, and territorial governments. The federal government is responsible for regulating the safety and efficacy of drugs under the Food and Drugs Act (FDA). The provincial and territorial governments are responsible for delivering health care services to Canadians.

Under the Canada Health Act, the federal government provides financial support to the provinces and territories to deliver health care services in the form of Canadian Health Transfer payments. This federal funding is contingent on provincial and territorial compliance with shared principles to ensure that all Canadians have comparable access to a minimum level of insured health care services.

Pharmaceutical businesses primarily engage with the federal government to obtain marketing authorisation (MA) for medicines from Health Canada.

The federal government also has limited jurisdiction to regulate the prices of patented medicines under the Patent Act. It also funds certain prescription drug plans for patients under its jurisdiction, including for First Nations and Inuit, veterans, Canada's armed forces, refugees, and inmates in federal penitentiaries.

Pharmaceutical businesses engage with provincial and territorial governments over the reimbursement and sale of medicines, including in hospitals. Pharmacies are also regulated at the provincial and territorial level.

Provincial and territorial governments negotiate prices of publicly funded medicines. After a medicine is approved by Health Canada, a health technology assessment (HTA) is conducted to evaluate the value or opportunity cost associated with reimbursing a new drug. The two main HTA bodies in Canada are the Canadian Agency for Drugs and Technologies in Health (CADTH) and the Institut national d'excellence en santé et services sociaux (INESSS). CADTH provides the federal, provincial, and territorial health ministries with non-binding recommendations on whether to reimburse a particular drug product. INESSS does the same in the province of Québec.

The pan-Canadian Pharmaceutical Association (pCPA) is a negotiating alliance of federal, provincial, and territorial public drug plans. The pCPA uses HTA assessments and recommendations, among other considerations, to negotiate listing terms with drug manufacturers in consideration for public funding. Listing terms can include rebate payments, research grants, patient support programs, or free goods.

In addition, the Patented Medicine Prices Review Board (PMPRB) monitors the maximum price of patented medicines to ensure that rights holders are not abusing their patent rights by selling patented medicines at an "excessive price". The PMPRB is an independent and quasi-judicial body established under the Patent Act. It has jurisdiction to require rights holders to report certain ex-factory price information and to hold public hearings where it alleges excessive prices are being charged. The PMPRB has jurisdiction to seek price reductions of maximum selling prices and can order the repayment of excess revenues from pharmaceutical manufacturers to the Crown if a patented medicine is found to be excessively priced.

There is no universal prescription drug coverage in Canada. Prescription drugs are reimbursed through a combination of public and private funding. The provincial and territorial governments are responsible for most public drug funding. Provincial and territorial reimbursement of prescription drugs is limited to eligible patients, including children, seniors, and recipients of social assistance benefits. Although governments negotiate reimbursement terms collectively through the pCPA, each government is responsible for entering into its own reimbursement agreement with the drug manufacturer to fund a particular product, known as Product Listing Agreements (PLA). The non-binding reimbursement recommendations made by HTA bodies play a significant role in determining whether the pCPA will negotiate terms for reimbursement.

Private insurance drug coverage is also available in Canada through group plans organised by employers. Private insurers also maintain lists of drug products eligible for reimbursement and may also negotiate listing terms with drug manufacturers.

The prices of reimbursed generic medicines are also regulated. The pCPA maintains a pan-Canadian Tiered Pricing Framework that benchmarks the price of generic medicines at anywhere from 25% to 85% of the brand medicine price, depending on the number of generic products on the market.

Pharmacist reimbursement models are province-specific and vary based on whether a patient has public or private insurance coverage for drugs.

Generally, pharmacists charge dispensing fees and mark-ups in connection with the sale of prescription drugs. Most provinces restrict the dispensing fees and mark-ups that can be charged under the public insurance plan. Otherwise, there are typically no restrictions on how much a pharmacist can charge as a dispensing fee or mark-up. In some provinces, pharmacists are prohibited from receiving rebates or other incentives from manufacturers in connection with the sale of drugs.

Pharmacists may automatically make generic substitutions for drug products, and typically must offer patients the lowest cost alternative at the time of dispensing. Some provinces may also reimburse for professional services, such as medication reviews, minor ailment assessments, or injections.

Requirements for sale (such as a prescription) are set both federally and provincially. Generally, drugs fall into one of the following categories under the National Drug Schedules programme of the National Association of Pharmacy Regulatory Authorities:

Some provinces have additional schedules. The federal Prescription Drug List established by Health Canada sets out drugs that must be sold by prescription in all provinces.

Online pharmacies are permitted but the pharmacy must be licensed by the provincial or territorial pharmacy regulatory authority in the jurisdiction where the business is established.

Wholesale distribution involves the general import, export, sale, and distribution of medicines to retailers, including other distributors, pharmacies, and clinics.

Wholesalers and distributors of medicines must obtain a drug establishment licence (DEL) from Health Canada and follow good manufacturing and distribution practices. Guidance on DEL applications is on the Health Canada website.

The types of activities authorised under the licence depend on the types of products the wholesaler deals (for example, prescription versus over-the-counter). Wholesalers must maintain their DEL in good standing.

Provincial registration may also be required when distributing to pharmacies.

Health Canada is responsible for compliance monitoring and enforcement activities related to health products. Health Canada's approach is guided by the principles of its Compliance and enforcement policy framework.

The Regulatory Operations and Enforcement Branch in Health Canada is responsible for health product compliance monitoring activities, such as industry inspections and product investigations.

Health Canada can take a number of enforcement actions to address non-compliance, including:

Health Canada can also apply for a court injunction to prevent certain conduct, or refer the results of any investigation to the Public Prosecution Service of Canada, recommending prosecution of offences under the FDA and the Criminal Code of Canada, where applicable. Those found guilty can face a fine, a term of imprisonment, or both.

Importers must ensure that health products imported for sale comply with the FDA and the Food and Drug Regulations (FDR) at the time of import.

Imported health products must be authorised for sale in Canada and must be imported by appropriately licensed persons. Supporting documents and product information can include the following:

In addition, the products must be manufactured, packaged, labelled, and tested at compliant foreign sites, and have Canadian authorised labelling.

Canada is a participant to mutual recognition agreements covering medicinal product good manufacturing practices (GMP) compliance programmes with other parties, including the EU, Australia, and the UK. The evidence required to support a foreign building's compliance with GMP requirements is set out in Health Canada's guidance GUI-0080.

Parallel imports of medicinal products are not allowed in Canada.

The FDR allow the importation of non-compliant drugs provided that both the:

Pharmaceutical advertising is regulated under the FDA and the FDR.

The regulatory regime is overseen by the Marketed Health Products Division at Health Canada.

Two self-regulatory industry bodies, known as advertising pre-clearance agencies (APAs), provide pre-clearance and complaint adjudication services. Each manages their own industry codes on fair and truthful advertising. Ad Standards Canada (ASC) mainly reviews direct-to-consumer advertising, while the Pharmaceutical Advertising Advisory Board (PAAB) oversees advertising directed at HCPs. Health Canada works closely with the APAs but use of APA services is voluntary.

Pharmaceutical advertising is also regulated under the general advertising rules of the Competition Act, administered by the Competition Bureau.

Under the FDA, "advertisement" is broadly defined as any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any drug.

There are no exemptions as to what constitutes an advertisement under the law and regulations. Health Canada publishes an interpretation document on The Distinction Between Advertising and Other Activities to distinguish what constitutes an advertisement and what constitutes non-promotional communications.

There are no laws or regulations requiring companies to set up internal procedures for managing and approving their pharmaceutical advertising materials. Where a company chooses to use the pre-clearance services of an APA, the APA may require the advertising to be signed off by internal medical personnel.

In general, pharmaceutical advertising is not required to be approved by a regulator. Use of pre-clearance services by APAs is largely voluntary. In some cases, Health Canada may require pre-clearance of advertising before its use in the market as part of the terms of a pharmaceutical MA. In addition, a medical journal or broadcast media may request advertising to be pre-cleared before publication. Timelines and procedures can vary widely for the APAs and may take up to six months in some cases. There is also no requirement to disclose pharmaceutical advertising to regulators after it has been published.

There are no laws or regulations on comparative pharmaceutical advertising. Health Canada has published an interpretation guidance on Therapeutic Comparative Advertising: Directive and Guidance Document. This is to help advertisers and APAs understand the data requirements for advertisers to make comparative therapeutic claims related to efficacy, onset or duration of action, and comparisons of side effect profiles and other safety parameters.

Under C.08.002 of the FDR, advertising of unlicensed products is prohibited. Health Canada also considers that sharing information about new indications before approval is false and misleading advertising contrary to section 9 of the FDA. Therefore, promotion of new products or indications before approval is prohibited.

Health Canada's guidance on The Distinction Between Advertising and Other Activities sets out certain activities not considered promotional, including sharing information in conferences and scientific meetings, formulary packages and price lists, press releases and investor communications, and unsolicited requests for information. However, even these activities may be considered promotional, depending on the circumstances.

There are no specific rules on social media advertising for pharmaceuticals. The definition of "advertisement" in the FDA is broad and covers advertising in any media (see Question 10).

Communications from a corporate social media account must comply with all rules on pharmaceutical advertising. Posts that link to websites or non-Canadian information may be considered contrary to advertising rules. Companies also often have internal policies and procedures on employees' use of social media accounts. In addition, pharmaceutical companies should be aware of their obligations to investigate and report adverse events they may learn about through social media.

The APAs have specific guidance on the use of social media and advertising. In general, companies are responsible for their social media accounts and must comply with all industry codes for advertising. PAAB's Guidance Document for Online Activities contains some general practices for overseeing online information, including monitoring for adverse effects and removing user-generated content that contains off-label information.

Health Canada is responsible for enforcing the rules on pharmaceutical advertising under the FDA and the FDR. Health Canada may also co-operate with the Competition Bureau to enforce improper pharmaceutical advertising under the Competition Act.

Enforcement by these federal bodies may include fines or imprisonment. Health Canada takes a stepwise and risk-based approach to compliance and enforcement. In most cases, compliance is achieved using a co-operative approach. Stronger action may be taken for activities deemed high risk, including seizure of non-compliant advertising materials, site visits, public communications, or other enforcement actions.

Advertising complaints can be filed with Health Canada by a competitor, HCP, or the general public. Health Canada publishes a list of advertising complaints that it has addressed or is assessing for next steps. In some cases, Health Canada may refer less severe complaints to the APAs to be adjudicated under their advertising codes. Each APA has its own processes and procedures for handling advertising complaints. The APAs have no authority to penalise advertisers but can publish their findings online and request broadcasters and publishers to reject non-compliant advertising. Advertisers who fail to co-operate with an APA ruling can also be referred to Health Canada or the Competition Bureau for further investigation and enforcement.

Under C.01.044 of the FDR, advertising of prescription drugs is limited to the name, price, and quantity of the drug. All other claims or messages are prohibited.

Non-prescription vaccines and over-the-counter medications can be advertised to the public but they must not advertise that they are a prevention, treatment, or cure for any disease or condition listed in Schedule A.1 of the FDA. In general, the advertisement should include fair and balanced information.

Prescription drugs cannot be distributed directly to the public. Since the advertising of prescription drugs to the public is limited to the drug's name, price, and quantity, special offers and other types of inducements are not permitted.

Free samples of over-the-counter medication can be distributed to patients by HCPs. The packaging and labelling of all free samples must meet all requirements under the FDR.

In general, patient organisations are considered members of the general public. Advertising or other promotional activities must follow the rules on advertising and promoting medicines to the public (see Question 17).

Innovative Medicines Canada (IMC) is the national trade association of innovative pharmaceutical companies in Canada. IMC member companies abide by IMC's 2022 Code of Ethical Practices (IMC Code) in relation to all stakeholders with an interest in or who are impacted by the activities of member companies.

HCPs are those registered with their provincial regulatory college and authorised to carry out certain restricted activities, including diagnosing, prescribing, and dispensing. Pharmacists are HCPs in all Canadian provinces.

There is no legal definition of a health care organisation in Canada. Health care organisations can include public and private hospitals, long-term care homes, and independent health facilities. In general, there are no additional rules related to advertising to these organisations or the HCPs that work in them.

Advertising to HCPs is permitted. Many companies seek PAAB pre-clearance services for advertising to HCPs. In general, PAAB's Code of Advertising Acceptance requires all advertising to be scientific, supported by robust clinical trials, and contain a fair balance of side effect and safety information.

The IMC Code applies to the activities of all IMC member companies who interact with stakeholders (such as HCPs) for the purpose of commercialising prescription medicines. Non-members are encouraged to adhere to the IMC Code on a voluntary basis. It does not have force of law but generally aligns with the FDA and the FDR.

The IMC Code generally prohibits its members from offering gifts of any kind.

Provincial regulations and rules of professional conduct governing HCPs typically include restrictions on accepting gifts or other benefits that could lead to a conflict of interest.

The FDR allows the distribution of drug samples to registered HCPs, subject to certain limitations:

Under the IMC Code, members can sponsor individual stakeholders or organisations to support bona fide scientific, medical, health care-related, or other activities.

The IMC Code generally provides that hospitality offerings are limited to meals, travel expenses, and accommodation in association with attendance at certain events (such as stand-alone scientific exchange meetings). Any hospitality offerings must be reasonable and not interfere with HCP independence, and cannot extend to spouses/companions or family members accompanying the HCP.

IMC members can retain HCPs for consultant meetings to advise members on aspects of the development of a drug, or aspects of their business, or to provide input on the development of plans, policies, and so on. A written agreement for any such services is required under the IMC Code and the meeting must be held in Canada. An honorarium calculated at fair market value can be provided after the service is rendered and reasonable travel, accommodation, and out-of-pocket expenses can be reimbursed.

There is generally no rule that expressly prohibits giving grants or donations of any form to HCOs such as hospitals.

The IMC Code permits members to loan medical equipment to HCPs for the purpose of improving the prevention, diagnosis, or treatment of diseases in a specific therapeutic area. The intention of a loan cannot be to gain access or influence, or to promote specific prescription medicines, and must comply with certain conditions in the IMC Code.

There is no central regulatory body responsible for the investigation of anti-corruption matters in Canada.

Foreign bribery under Canadian law is governed by the Corruption of Foreign Public Officials Act (CFPOA), which criminalises the bribery of a foreign public official, including directly or indirectly giving, offering, or agreeing to give or offer any form of advantage or benefit to a foreign public official to obtain an advantage in the course of business.

Domestic bribery and corruption is governed under Canada's Criminal Code which prohibits, in part, the bribery of various officials. Whether the CFPOA or the Criminal Code applies depends on whether the offence is deemed to have taken place in Canada.

Both individuals and companies can be held liable under Canada's anti-corruption laws.

There is currently no legislation in Canada mandating companies to disclose information about transfers of value to HCPs or to HCOs.

In 2017, the Ontario government passed the Health Sector Payment Transparency Act, which sets out disclosure obligations akin to the US Physician Payment Sunshine Act. However, the Act has never been brought into force.

Since June 2017, ten Canadian pharmaceutical companies (all IMC members) have voluntarily disclosed payments made to HCPs and HCOs as part of IMC's Voluntary Framework on Disclosure of Payments. The reporting framework is set out on the IMC website.

The general consequences of non-compliance (see Question 16) also apply to marketing to HCPs.

Health Canada is responsible for enforcing the rules on pharmaceutical advertising under the FDA and the FDR. Health Canada may refer less severe complaints to the PAAB, which is responsible for advertising to HCPs, to be adjudicated under their advertising codes.

A patent allows an inventor to claim a limited monopoly over an invention. Canadian patents are issued under the Patent Act. The Patent Act defines an invention as any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement of the same.

To obtain a patent, an invention must be new, non-obvious, have utility, and be directed to patentable subject matter.

Utility patents are available in Canada.

Exclusions from patentable subject-matter include:

The Patent Act does not contain any provisions specific to the patentability of inventions relevant to the life sciences industry.

Most categories of inventions relevant to pharmaceuticals are patentable. These include chemical compounds, compositions, formulations, uses, dosage forms, processes or the results of processes, proteins, and diagnostics.

Lower life forms, genetically modified genes, and cells may also be patentable. Patents may also be available for new combinations, as well as for new uses of known substances.

Canadian patents are examined and issued by the Patent Branch of the Canadian Intellectual Property Office (CIPO). The CIPO website includes procedural and substantive guidance.

The applicant must disclose information including the identity of the inventor(s) and a description of the invention. The description must explain what the invention is and how it works, so that a skilled reader could make the same successful use of the invention as the inventor could at the time of the application.

A Canadian patent application can be filed directly in Canada or through an international application under the Patent Cooperation Treaty (PCT), followed by a national phase entry. Details of the process, including the fees involved, are on the CIPO website for a Canadian application and for a PCT application.

Entitlement to claim an invention is determined on a first-to-file (not a first-to-invent) basis. Canada recognises international claims to priority under the Paris Convention for the Protection of Industrial Property.

The applicant must request a substantive examination, generally within four years of the filing date. The examiner can approve the application or respond with questions and/or objections, to which the applicant must respond. The response can include argument, amendments, or both. This process can take several years. If the application is ultimately refused, it can be reviewed by the Patent Appeal Board, with a possible further appeal to the Federal Court.

Most Canadian patent applications are made available to the public online 18 months after the filing date (or the earliest priority date, if applicable).

There is no process to formally challenge a Canadian patent application during prosecution. However, under section 34.1 of the Patent Act, a third party can file prior art that the person believes has a bearing on patentability. A protest addressing matters other than prior art can also be filed and may be considered by the examiner.

There is also no process for post-grant opposition of a Canadian patent. However, under section 48.1 of the Patent Act, a third party can request a re-examination of any patent claim by filing prior art with the Commissioner of Patents. This is determined by a re-examination board, with a possible appeal by the patentee to the Federal Court.

The term of a Canadian patent is 20 years from the filing date, provided that annual maintenance fees are paid.

A Certificate of Supplementary Protection (CSP) can provide up to two years of patent-like protection for eligible pharmaceutical patents and claimed medicinal ingredient(s) following the expiry of the patent that forms the basis for the CSP (sections 104 to 134, Patent Act and the CSP Regulations, SOR/2017-165). A CSP term is capped at two years and cannot be extended. CSPs are intended to partly compensate for the time required to research and obtain regulatory approval of a new drug.

Under the Canada-United States-Mexico Agreement (CUSMA), Canada has agreed to implement a form of patent-term adjustment for certain delays in patent issuance. Implementing legislation received Royal Assent on 20 June 2023 and is scheduled to come into force by 1 January 2025. The term of patent-term adjustment would be concurrent with any certificate of supplementary protection that may be issued. Additional details on implementation and the term of adjustment are left to regulations, which are likely to be issued before 1 January 2025.

A patent grants the right to exclude others from making, constructing, using, or selling the patented invention. This right can be asserted by the patentee and persons claiming under the patentee, such as licensees.

The primary method of enforcing patent rights is an action for infringement, brought in a federal or a provincial court.

Section 55.2 of the Patent Act and the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 create a "linkage" regime for the early resolution of patent disputes between pharmaceutical innovators and manufacturers of subsequent-entry products, such as generics and biosimilars.

Patent infringement occurs when a direct infringer performs all the essential elements of one or more claims in the patent. If the acts of direct infringement are induced by a third party, this third party can also be liable for infringement if certain criteria are met.

The main defences to a patent infringement action are:

Research exemption. Section 55.3 of the Patent Act provides that an act committed for the purpose of experimentation relating to the subject-matter of a patent does not infringe the patent, subject to certain criteria. An experimental-use defence is also recognised at common law.

IP exhaustion. Cases describing the first-sale doctrine in Canada refer to both "exhaustion" and "implied licence". Common to both is the general rule that a patent owner has no right of action against its own customers for patent infringement. However, Canadian law recognises the right to impose express conditions on the buyer's rights at the time of first sale.

Other exemptions. Sections 21.01 to 21.2 of the Patent Act and the Use of Patented Products for International Humanitarian Purposes Regulations, SOR/2005-143, establish a regime for the manufacture and export of generic versions of patented pharmaceutical products to specified countries in need. The products must meet Health Canada requirements on safety and efficacy and criteria of the Commissioner of Patents, including payment of royalties to patentees.

Under section 55.2 of the Patent Act, it is not an infringement of a patent for a person to make, construct, use or sell the patented invention solely for uses reasonably related to the development and submission of information required under any law of Canada, a province, or a country other than Canada that regulates the manufacture, construction, use or sale of any product. This "early working" exception is relied on by manufacturers of subsequent-entry pharmaceutical products, such as generics and biosimilars.

Canada is a party to the following key international IP treaties, among others.

WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

Patent Law Treaty (PLT).

Comprehensive Economic and Trade Agreement (CETA).

Canada-United States- Mexico Agreement (CUSMA).

WIPO Madrid Agreement Concerning the International Registration of Marks 1891.

A trade mark is a sign, or combination of signs, that is used, or proposed to be used, by a person for the purpose of distinguishing their goods and/or services from those of others in the marketplace.

A trade mark can protect words, letters, designs, tastes, textures, moving images, a mode of packaging goods, holograms, sounds, scents, three-dimensional shapes, colours, and/or positioning of signs.

Trade marks that are generally unregistrable include names and surnames and marks that:

The CIPO is the authority responsible for registering trade marks. CIPO provides a roadmap of the trade mark application process on its website.

The process begins with an applicant filing a trade mark application with CIPO. A complete application must include a list of goods and/or services associated with the trade mark.

Details of trade mark application fees are on the CIPO website.

Canada recognises foreign priority for trade mark applications. A request for priority setting out the date and country of filing of the earlier application can be filed with the Registrar of Trademarks within six months after the date on which the earliest application was filed for registration of the same or substantially the same trade mark for use in association with the same kind of goods or services (section 34(1), Trademarks Act). The later-filed application then takes the benefit of the earlier-filed application's filing date.

A trade mark examiner reviews the application to ensure that the trade mark is registrable. In part, CIPO conducts a search of trade mark records to locate any trade marks which may conflict. No search report is provided.

CIPO's current performance target is that a first office action (identifying any issues in the application) from the examiner is issued to the applicant within 18 months from the application filing date if the application's goods and services description uses terms from CIPO's pre-approved list. If an application uses words outside the pre-approved list, a first office action is issued within 36 months after the filing date.

An office action requires a response within six months.

After any office actions have been addressed, the applicant will receive a formal notice of approval or a report refusing the trade mark.

If an application is refused, the applicant can appeal to the Federal Court of Canada.

If the application is approved, it is published in the Trademarks Journal. Once an application is published, third parties have two months to challenge the mark's registration by initiating an opposition proceeding.

An applicant has two months to file a counterstatement to contest an opposition. Both parties can file evidence and written arguments and make submissions at an oral hearing.

If the opposition is successful, the application can be completely or partially refused. This decision can also be appealed to the Federal Court of Canada.

If there is no opposition to an application, or if an opposition is overcome or withdrawn, the application will move to allowance. CIPO then issues a Certificate of Registration and enters the trade mark into the Register of Trademarks.

The main source of competition law is the Competition Act, RSC 1985, c C-34. The Commissioner of Competition has issued detailed Intellectual Property Enforcement Guidelines (IPEG) that outline how competition law interfaces with IP rights. The IPEG is not binding.

Under the IPEG, the mere exercise of an IP right is unlikely to raise a competition issue and is addressed under the "special remedies" provision in section 32 of the Competition Act.

When "something more" than the mere exercise of an IP right is involved, this may engage criminal offences, for example:

It may also engage "reviewable matters", for example:

The Competition Bureau is an independent agency with power to investigate and enforce the Competition Act. This includes the power to bring cases about an application relating to reviewable matters before the Competition Tribunal for adjudication. Criminal matters are referred to the Director of Public Prosecution.

Most recent competition cases involving pharmaceutical companies have related to restrictive trade practices (such as restricting availability of samples, restricting off-label use in a contract, and abuse of dominance/predatory pricing).

The IPEG also includes specific examples to illustrate how the Competition Bureau may review specific types of conduct involving pharmaceutical companies, such as:

Any type of agreement, existing or proposed, between persons, of whom two or more are competitors, that prevents or lessens, or is likely to prevent or lessen, competition substantially in a market is reviewable under section 90.1 of the Competition Act. This provision can capture all types of agreements, including supply and distribution agreements, joint ventures, collaborative research agreements, and consortium agreements.

The IPEG sets out its framework for approaching anti-competitive conduct associated with the exercise of IP rights. According to the IPEG, licensing is, in many cases, pro-competitive, in that it facilitates use of an IP right by additional parties. However, to assess whether a technology licensing agreement is anti-competitive, the Competition Bureau will examine the licence terms and assess whether they create, enhance, or maintain the market power of either party to the agreement.

Generally, the Competition Bureau will not consider licensing agreements involving IP to be anti-competitive unless they reduce competition substantially relative to what would have likely existed without the licence's potentially anti-competitive terms.

Several cases have dealt with IP licensing agreements. For example, in Canada (Director of Investigation and Research) v Tele-Direct (Publications) Inc, the Competition Tribunal found that an enforcement of trade mark rights, including a refusal to license trade marks, even selectively, was not an anti-competitive act within the meaning of section 79(5) of the Competition Act, because the Trademarks Act grants to trade mark owners the right to exercise these very rights.

As it relates to life-cycle management strategies, the Competition Bureau has noted that the provisions of the Competition Act most likely to apply to product-switching conduct are the abuse of dominance provisions because the conduct "involves anticompetitive acts by a single dominant company designed to exclude competitors and to create, maintain, or enhance its market power". Competitors are not, as such, prohibited from engaging in joint communications or lobbying, but should exercise caution when doing so. The Competition Bureau publishes a pamphlet that includes do's and dont's for trade associations and their members.

There are no general requirements for government or regulatory approval of patent or trade mark licences, nor are there restrictions on licensing or transferring patents to foreign parties.

There are no general restrictions on transferring inventions funded, or partially funded, by public investment. However, such funding may be subject to agreements regarding IP ownership and use.

Sections 19 to 19.4 of the Patent Act provide for the Government of Canada or a provincial government to apply for authorisation to use an invention under certain circumstances, including to respond to a public health emergency. Sections 20 and 21 provide for government ownership of inventions in instruments or munitions of war.

To be distributed, a medicinal product must be approved by Health Canada. The FDA governs the safety and quality of all food and drugs sold in Canada. The FDR prescribe the standards of composition, strength, purity, quality, or other properties of the food or drug. As stipulated by the FDR, no manufacturer can market a new drug product until they have submitted a New Drug Submission (NDS) for review. Section C.08.001 of the FDR defines a "new drug" and the requirements for an NDS. In general, an NDS is a collection of data from all studies completed to-date as well as a list of ongoing studies, summarised to present the efficacy and safety profile of the new drug.

Health Canada has a variety of enforcement powers, including to conduct inspections, investigations, and regulate establishment licensing and related laboratory analysis functions. If Health Canada believes that a therapeutic product presents a serious or imminent risk to the health of Canadians, and the responsible party does not agree to a voluntary recall, Health Canada can order a recall under section 21.3(1)(a) of the FDA.

Product liability claims in Canada are most commonly based in contract and tort law. Against life science companies, claims typically focus on the tort law claim of negligence, because in Canada there is generally no contractual relationship between a drug manufacturer and the ultimate consumer or patient.

A negligence claim involves an allegation that harm was caused by a party failing to act reasonably which leads to the claimant's injury. To succeed in a negligence claim, a claimant must establish that the:

Canadian courts have not recognised the application of strict liability principles.

The product liability framework in Québec is based on its Civil Code and tends to be more consumer oriented, for example, by providing presumptions in favour of consumers in product defect claims. Under Article 1468 of the Québec Civil Code, if a product contains a "safety defect" and causes injury to a third party, the injured party has a right of action against the manufacturer. This right of action also exists against the distributor and supplier of the product, whether they are wholesalers or retailers, and whether or not they imported the product. Article 1469 of the Québec Civil Code specifies that a product has a "safety defect" when it does not afford the degree of safety that a person is normally entitled to expect.

Frequently, claims are brought through a class action in the provincial courts, and any settlement of a class action is public.

Most claims involving defective medicinal products are brought against the product manufacturer based on a failure to warn or product defect.

In certain cases where the medicinal product was prescribed outside of the approved product monograph, a pharmacist or physician may be named as well, to the extent they provided advice on the use of the product. Usually, others in the supply chain, distributors, retailers, physicians, and pharmacists are not named as defendants, although there are exceptions.

Many entities have insurance that covers such claims and others have indemnity provisions in their agreements whereby those up the supply chain will indemnify claims.

Canada does not have innovator liability, and a generic manufacturer of a medicinal product is liable to an injured claimant who took a generic version of the medicinal product, not the innovator who introduced the medicinal product into the market.

A number of defences are available to product liability claims. From a substantive perspective, these include:

Under Article 1473 of the Civil Code of Québec, manufacturers have two principal lines of defence to liability claims:

In addition, procedurally there may be an argument that the limitation period (see Question 39, Limitation periods) within which to bring a claim has expired.

The most effective way to limit liability is to ensure that the product label includes accurate and timely information on any side effects reasonably known at the time.

Limitation periods vary by province, but generally a claim must be brought within two or three years of the date that it is discovered. When a claim is discovered is based on a number of specific factors.

Product liability claims can be brought as individual actions or by way of class actions. In the past 20 years, class actions have tended to be the vehicle of choice for most large-scale product liability claims and are therefore common and often certified. They are often brought on a national basis, and given that the provincial courts adjudicate such claims there may be overlapping class actions in different provinces. Jury trials are relatively rare in Canada, and most product liability claims are adjudicated by a judge at a trial involving oral evidence and cross-examination. In some circumstances claims may be dealt with on a more summary basis.

Damages suffered as a result of a product liability claim generally track those for other tort claims based on negligence. Personal injury damages can include awards for pecuniary loss, such as future care and loss of income, as well as non-pecuniary damages for pain and suffering.

In 1978, the Supreme Court of Canada capped general damages for personal injury at CAN100,000, which has since been adjusted for inflation. Awards at the upper end of the range are reserved for the most serious types of injuries.

While courts also have discretion to award exemplary or punitive damages, they exercise it very sparingly. Outside of Québec, punitive damages are only appropriate in cases where the defendant's conduct is sufficiently reprehensible so as to offend the court's sense of decency.

Provincial health insurers also have legislation that permits them to seek subrogated claims for medical costs as part of a claimant's claim or directly, to the extent that such costs are incurred in relation to a product liability claim.

Whether damages can be claimed in cases in which there is no physical injury, or no sustained mental injury, and for items such as medical monitoring, remains the subject of debate.