Canada is an attractive market for pharmaceutical manufacturers. While universal healthcare does not currently extend to drugs in an outpatient setting, most Canadian consumers have some form of drug coverage through government programs and/or private insurance. Further, Health Canada, the regulatory body for drug approvals, is well-respected globally, and approval in Canada may be recognized favourably in other jurisdictions. Below are ten patent and regulatory topics that in-house counsel need to know before bringing an innovative product to Canada.
1. Regulatory pathways: generics, biosimilars, submissions based on literature and market experience, drugs for rare diseases
Canada's Food and Drug Regulations1 define four broad types of submissions leading to marketing approval (notice of compliance or NOC) of a new drug: (1) a new drug submission (typically for innovative drugs); (2) an extraordinary new drug submission; (3) an abbreviated new drug submission (for generic drugs); and (4) supplements.
Biosimilars are approved by way of a new drug submission, with information and submission requirements set out in a Guidance document2. If the biosimilar demonstrates similarity with a reference drug, Health Canada will accept a reduced non-clinical and clinical data package for the biosimilar. Innovators should be aware that if you decide not to seek regulatory approval in Canada, while not common, Health Canada may still approve another company's new drug submission relying on third-party literature and market experience (see Guidance)3. Drugs for rare diseases are approved under the standard pathways (see Health Canada's description4 of its regulatory approach to drugs for rare diseases). Orphan drug exclusivity is not available in Canada.
2. Eight year data exclusivity for new biologic and pharmaceutical drugs
The only form of regulatory exclusivity available in Canada is data protection. If your drug is an innovative drug, it will be granted eight years of market exclusivity from first Notice of Compliance (NOC) (8.5 years with the pediatric extension) pursuant to C.08.004.1 of the Food and Drug Regulations5. Further, a submission for a biosimilar or generic drug cannot be filed until six years from first NOC of the innovative drug. An innovative drug, which can be a biologic, is defined as "a drug that contains a medicinal ingredient not previously approved in a drug by the Minister and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph". No application is required to obtain data protection (see Guidance)6. Once granted, the drug is listed on the Register of Innovative Drugs7.
3. Certificates of supplementary protection
A certificate of supplementary protection (CSP) is similar to a European supplementary protection certificate (SPC) (see comparison8; Patent Act Sections 104-1349, CSP Regulations10). It grants an additional patent-like term calculated by subtracting the patent filing date from the NOC date, minus five years, to a maximum of two years. You will need to take careful note of the application requirements (see Guidance11), including two deadlines. First, your Canadian new drug submission must be filed within twelve months of the filing of the first application for marketing approval of the medicinal ingredient or combination of medicinal ingredients in the United States, Europe or any member country thereof, Japan, Switzerland and Australia. Second, the CSP application must be filed with Health Canada within 120 days of the later of the date of grant of the NOC and patent grant date. A CSP application may be filed by the drug manufacturer or any patentee of an eligible patent (e.g., a patent claiming the medicinal ingredient or combination of medicinal ingredients, or a use thereof). Applicants may wish to have the patent grant before the NOC issues as this may govern entitlement in the event of a conflict with a competing CSP application. Pending CSP applications and granted and rejected CSP applications are listed on the CSP Register12. If a CSP is granted, it will be automatically reviewed for Patent Register eligibility (see #5 below). If the corresponding patent is listed on the Patent Register, the CSP will also be listed.
Patents are granted a 20-year term from the Canadian (Patent Cooperation Treaty) filing date. Other than the sui generis protection granted by a CSP, there are no other term extensions in Canada at this time. Canada has agreed to a Patent Term Adjustment (PTA) for Patent Office delays under the Canada-United States-Mexico Agreement (CUSMA), but with a long transition window giving Canada 4.5 years from the July 1, 2020 date of CUSMA to introduce Patent Term Adjustment (PTA).
The standards for patentability are very similar in Canada to many other jurisdictions, and typically an invention patentable in the US is also patentable in Canada. One exception relates to the scope of patent- eligible subject matter, as methods of medical treatment cannot be patented at this time. It is generally possible, however, to protect this subject matter by alternative claim formats.
5. Listing patents on Patent Register
The linkage Regulations (Patented Medicines (Notice of Compliance) Regulations13) are similar to the US Hatch-Waxman regime, see comparison14. The litigation aspects are described in: 10 Things You Need to Know about Life Sciences Patent Litigation in Canada15. This regime, you will need to ensure that patent lists are submitted (1) together with the regulatory submission (e.g., NDS or supplemental NDS) or (2) for any later-granting patents, within 30 days of issuance, provided the patent application was filed before the regulatory submission is filed (see Regulations16 and Guidance17). Because a generic or biosimilar filer need only address patents listed on the Patent Register18 by the date they file their regulatory submission, you should try to ensure all patents that you wish to be listed issue and are listed by expiry of the six-year no-filing period provided by data protection (see # 2 above). However, if a patent is not listed before a generic or biosimilar filing or at all, if the generic or biosimilar manufacturer addresses any other patents listed on the Patent Register and serves a notice of allegation, you will have the opportunity to bring an action regarding such other patent. In general, patents cannot be listed unless they claim the medicinal ingredient, formulation, dosage form, or use approved by the regulatory submission.
6. Price controls over patented medicines
While patents are of course a valuable way to protect your inventions, in Canada, they also attract the jurisdiction of the Patented Medicine Prices Review Board (PMPRB) which sets limits on the prices set by patentees (Patent Act, sections 79-10319). The jurisdiction extends to patents that would not be eligible for Patent Register listing (see #5 above) including, for example, process patents and patents that do not claim the approved drug (e.g., patents claiming a non-approved use or alternative formulation). Once a patent issues, the PMPRB asserts jurisdiction retroactively to the laid-open date of the patent application, provided there was a sale in Canada as of that date. More patents do not increase the PMPRB's jurisdiction, except as regards to the term of jurisdiction. The PMPRB loses jurisdiction over a drug once all related patents expire. Significant changes to the factors used to assess whether a price is excessive and the reporting requirements under the Patented Medicines Regulations20 will come into force on July 1, 2021 (see amendments here21 and here22, and here23, and applicable Guidelines24).
7. Transparency: submission filings and clinical trial data
Once your regulatory submission is accepted into review by Health Canada, certain details will be posted by Health Canada: see submissions currently under review25: New drug submissions and submissions currently under review: Supplemental new drug submissions for new uses and once approved, your approved drug will be listed in the NOC database26 and Drug Product Database27. You will also be able to track generic submissions accepted into review here28 (although sponsors are not identified) and biosimilar / submissions relying on third-party data (see #1 above) here29.
Once your regulatory submission is authorized, a Summary Basis of Decision, including a regularly updated Post-Authorization Activity Table (PAAT), will be available30. The PAAT will include brief summaries of activities such as submissions for new uses of the product and whether Health Canada's decisions31 were negative or positive. Regulatory Decision Summaries will also be posted not just after a positive regulatory decision, but also for certain final negative decisions and cancellations.
There is also the recent Public Release of Clinical Information32 regime that requires sponsors to disclose the clinical information in their submission with the exception of personal information (which the sponsor must anonymize) and information meeting a very strict definition of confidential business information. Not only is this regime very onerous and time-consuming for sponsors to comply with, but sponsors are often very concerned regarding the extent of information released under this regime. The information released may go beyond the release of information in other jurisdictions, and potentially provide a disclosure that may impact on patentability. When considering whether an invention may be new and non-obvious over a prior disclosure, the information released by Health Canada should also be considered.
8. Special Access Program
Pursuant to the Special Access Program (SAP) (see Overview33 and Guidance34), health care professionals can request access to certain drugs not available in Canada. SAP only considers permitting access to such drugs for patients with serious or life-threatening conditions, and only when conventional therapies have failed, are unsuitable or are unavailable. If the SAP request is approved and the drug manufacturer wishes to supply the drug, the drug will be sent by the drug manufacturer directly to a practitioner or pharmacist to receive (e.g., the practitioner who made the request, a hospital or community pharmacy). "Pre- positioning" is also allowed, meaning a manufacturer may submit a request for a letter of authorization allowing the drug's import by a drug establishment licence holder for storage until a letter of authorization is issued permitting sale. When considering providing drugs through SAP, you should also consider PMPRB implications.
9. How to calculate Loss of Exclusivity (LOE) date
Your estimated loss exclusivity date should take into account the expiry of data protection (see #2 above) and the expiry date of any patents / CSPs on the Patent Register (see #5 above), taking into account the likelihood that the patent(s) will be infringed and will withstand validity attacks.
10. Marketing the Drug
Once your drug is approved, numerous other regimes and requirements must also be considered. For example, since Canada restricts advertising of prescription drugs to the general public (Direct-to-Consumer Advertising restriction), drug manufacturers must ensure their activities are not considered "advertising" nor otherwise run afoul of advertising laws. Press releases / press conferences intended to inform shareholders, "formulary kits", as well as medical condition focused (versus product focused) communications are some of the activities that, assuming certain conditions are met, do not run afoul of the Direct-to-Consumer Advertising restriction and can therefore be permitted.
Patient support programs are ubiquitous now for various classes of drugs. There are numerous privacy laws in Canada and one privacy issue that needs to be remembered is that transferring / storing personal information outside of Canada can, depending on the privacy legislation that applies, trigger various requirements and potential challenges, in addition to being objectionable for certain patients and health care professionals.
As a result of certain provincial laws which restrict drug manufacturers from providing rebates or other benefits to pharmacies, it is particularly important to ensure any arrangement in this regard is considered carefully and structured appropriately. Though rebate laws are just one healthcare compliance regime that must be taken into account when structuring commercial arrangements, non-compliance in this respect is particularly important since it can result in a drug being disqualified for reimbursement by the provincial payer.
Though this section highlights only three issues, a myriad number of regimes must be considered when marketing a product.
As you will have noted, Canada mirrors the regulatory/patent regimes in other jurisdictions in many respects but has key differences. Pre-planning by co-ordinating between regulatory and patent groups before bringing any drug to Canada is critical to ensure all necessary decisions are taken well in advance of critical deadlines.
This article was originally published on the website of the Association of Corporate Counsel (ACC), the leading global association for in-house counsel. Republished with ACC's permission. Copyright: Association of Corporate Counsel, 2020. All rights reserved. Visit www.acc.com.