Emily Xiang is an IPilogue Writer and a 3L JD Candidate at Osgoode Hall Law School.

Huge changes have come to the Canadian Copyright Act. In late November of 2022, an was signed to fix December 30, 2022 as the date on which Division 16 of Part 5 of the Copyright Act came into force. The amendments come by way of legislation passed back in June 2022 Ěýto increase the term of copyright protection from 50 years to 70 years following the end of the calendar year of the author’s death.

The new changes are in line with Canada’s treaty obligations under the , which came into force on July 1st, 2020. Under CUSMA, the country made a commitment to extend its general term of copyright protection from 50 years to 70 years following the life of the author, with a transition period lasting until the end of 2022 to implement the changes. The extension brings Canada , including with many of its major trading partners, such as the United States, the United Kingdom, and the European Union. This extension will hopefully generate new opportunities for investment and commerce for Canada’s creative industries.

Following CUSMA, the Government of Canada commenced in early 2021 on the implications of the proposed copyright term extension. The consultations were met with mixed reactions. Many believed that the extended term of protection would provide rights holders with , thereby incentivizing creative production. On the other hand, the proposed amendments also garnered significant pushback, particularly from user-oriented groups, as the extended term would mean further restriction on public access. An overview of the differing views from the perspective of the educational publishing industry in particular can be found in .Ěý

Following the public consultations, Prime Minister Justin Trudeau also addressed mandate letters to the Ministers of and of , requesting that the departments work together to amend the Copyright Act in order to further protect artists, creators, and copyright holders. A commitment to making the legislative changes was also included in the .

With the changes to the Copyright Act coming into effect, there is more clarity as to what works might be encompassed by the new amendments. According to , the extended term of protection will not apply to works that already entered the public domain before the amendments come into force. Works with copyright set to expire on or before December 30, 2022 will not be privy to the extended protection term. In other words, the extension will not operate retroactively. On the other hand, copyright in a work that is set to expire on or after December 31, 2022 should benefit from an additional 20 years of protection.Ěý

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Jasmine Yu is anĚýIPilogueĚýWriter and aĚý1L JD Candidate at the University of Toronto.

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After numerous delays over two years, amendments to the Patented Medicines Regulations, which governs Canada’s Patented Medicine Prices Review Board (), is finally set to come into force this year, on — at least for now.

Who is the Patented Medicine Prices Review Board?

The PMPRB is a Canadian that regulates the prices of patented pharmaceuticals to avoid excessive pharmaceutical prices. The board’s objective is to balance encouraging pharmaceutical research and development (R&D) investment with the public health interest of reducing pharmaceutical prices for consumers.

The PMPRB derives its legal authority partly from the , which specifies the information and documents patentees must provide to the Board, price requirements for drugs sold in Canada, and more.

Why Amend?

The PMPRB saw it fit to introduce changes to its legal framework because it was under the current scheme — Canadian patented drug prices were the third highest globally, while pharmaceutical R&D investment has declined.

The Amendments

The PMPRB first published the amendments on . The first substantive revision to the Regulations since the Board’s establishment in 1987, it will bring major changes to the PMPRB’s current legal framework.

There are :

First, the amendments added three new price regulatory factors to consider whether a patented drug’s price is excessive.

Second, the amendments updated the list of comparator countries, whose drug prices serve as a “benchmark” to establish the range of prices that the pharmaceutical companies find acceptable for their patented medicines. According to the PMPRB, the updated countries have similar consumer protection policies, economic wealth, and marketed medications as Canada. The United States, for example, was removed for having vastly different consumer protection priorities — its drug prices are 247% higher than Canada’s.

Third, there were changes in patentees’ pricing and sales reporting requirements. For instance, the reporting requirement was reduced for medicines at a low risk of excessive pricing, such as veterinary drugs and generics.Ěý

The amendments, once in effect, will apply to all drugs issued a drug identification number (DIN) on or after the amendments’ publication — August 21, 2019. Those that received a DIN before this date must still comply with certain other provisions.

A double-edged sword?

The PMPRB views that these amendments will have a and decrease total spending on patented medicines by 5.8% over the next 10 years. These changes are perhaps much needed, as Canada is the only developed country in the world with universal healthcare that . Meanwhile, Canadians pay the highest price for generic drugs in the world and the second-highest prices per capita for prescription drugs — after the US. en Canadians cannot afford their prescription drugs.Ěý

However, there are also opposing voices. Lobby groups, such as , argue that these amendments will have significant negative impacts R&D investment in Canada and on the number of new drugs available to Canadians and on R&D investment in Canada.

IMC and several Canadian pharmaceutical companies brought a judicial review application to challenge numerous provisions. The Federal Court of Canada, in Innovative Medicines Canada v Canada, , struck down subsection 3(4) of the amendments as it was ultra vires the . In a separate case, the Quebec Superior Court declared section 4(4) invalid and unconstitutional.[1]

A group of physicians also voiced their opposition in an . Their arguments mirror that of IMC: the proposed regulations will make Canada an unattractive market for companies launching new drugs, resulting in medications that could alleviate suffering being denied access to Canadians.

Conclusion

Much like how the original intentions of the PMPRB did not actualize into tangible results, and hindsight revealed flaws in its original policy, the actual consequences of these new amendments may not surface immediately. Canadian Pharmacare policy certainly seems to require an iterative process, as numerous stakeholders and market factors are at play. We perhaps need to examine the faults in Canada’s current patchwork system of private and public insurance plans for potential solutions — to strike a balance between affordable medicine and a vibrant R&D environment.

[1] Merck et al, c Le Procureur GĂ©nĂ©ral du Canada,ĚýQuĂ©bec Superior Court File No. 500-17-109270-192.

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Photo by Markus WinklerĚý

Shawn Dhue is an IPilogue Writer and a 2L JD Candidate at Osgoode Hall Law School.

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Since the summer of 2020, the Canadian federal government has been looking for ways to decrease the needless delays and unwanted wait times present in the patent process under the Patent Rules. This search to streamline the patent prosecution procedure is to help Canada meet its obligations under the Patent Cooperation Treaty and Canada-United States-Mexico Agreement (CUSMA). On July 3, 2021, the government proposed , with excess claim fees sticking out to many legal professionals across the country.

:

(i) at the time of a [request] for each claim in excess of 20 claims; and

(ii) at the time of payment of the final fee, for each claim in excess of the greater of:

(a) 20 claims on the date the notice of allowance is sent, and

(b) the sum of 20 claims plus the number of excess claims for which a fee was paid at the time of the [request]

In the , put out by Canada Gazette, the government states that applicants will be encouraged to limit their files with the new fees. This limitation reduces the burden of the Canadian Intellectual Property Office (CIPO) by limiting the number of claims that must be reviewed and likely reducing the number of errors, edits, and comments that the applicants must amend. With these fees, and the hope that applicants abide by the rules, CIPO can reduce the time it takes for an application to be processed.

The current proposal is a standard fee of $100 to be administered for each excess claim over 20, with a fee of $50 for smaller entities. There is no set time when these amendments will come into effect, but Smart & Biggar’s Partner that it will be no later than July 1, 2022.

Currently, wage the debate of whether to request an examination of an application now or later under the new amendments. It seems that some have already found a way to get around the excess fees. David Schwartz : "… [A]n applicant would have the opportunity to avoid the payment of claim fees by amending the application to reduce the number of claims to 20 before or at the time of requesting examination."

However, some firms are still encouraging applicants to consider avoiding the excess fees by requesting examination before the new amendments come into play: “.”

It will be interesting to see the impact of the new amendments on the queue of applications. Regardless, with the push to avoid the excess claims , it seems that CIPO will have a busy start to the new year.

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