Michelle Mao is an IPilogue Writer and an incoming 2L JD candidate at Osgoode Hall Law School.

Soon, manufacturers will be able to use NIH-licenced technologies to develop COVID-19 technologies for sale and distribution to low and middle-income countries. This is because the has finalized its its NIH-owned COVID-19 technology patents to the and the ’s (WHO) ). There will be a total of shared, including technologies supporting vaccine development, drug and diagnostic development, and prospective vaccine candidates. These technologies will be brought under a global and non-exclusive licence. Additionally, under the agreement, the NIH for products licensed in the United Nations’ .

While it may feel like the pandemic is ending in higher socioeconomic countries like the United States and Canada, vaccination levels in low-income countries are still , at around 15.9% first-dose vaccination rate. This continues the trend of COVID-19 pandemic leaving low-income countries in the face of expensive, patented COVID-19 vaccines and drugs. Allowing manufacturers to access previously patented technologies to develop their own products can dramatically decrease the cost of accessing COVID-19 technologies. A wider pool of manufacturers creating their own products to supply to lower and middle-income countries means they must compete with other manufacturers to keep the cost of products low.

During the early stages of the COVID-19 pandemic, scientists across the globe raced to develop life-saving medicines that could end the global crisis. Those efforts are by intellectual property laws, allowing scientists to securely make scientific advances without the worry of another competing lab “stealing” their discoveries. Now, due to a combination of a well-developed COVID-19 scientific field and the global obligations of the United States, the NIH feels ready to agree to a global non-exclusive licence for several of its patented COVID-19 technologies.

This agreement finally comes after from scholars in public health, intellectual property, and scientists about potential global inequalities that could arise in vaccine and drug development in a global pandemic. Due to the lack of economic resources for lower-income and middle-income countries for vaccine doses and a to manufacture their own COVID-19 medicines, it was predicted that lower-income countries would be hardest hit. Additionally, from the beginning of the pandemic, health-advocacy organizations have for pharmaceutical companies to share their patent knowledge so that lower-income countries can produce their own generic versions of COVID-19 drugs.

While the sharing of NIH-licensed COVID-19 technologies comes as good news for lower and middle-income countries still grappling with the pandemic, this licensing agreement may have come too little, too late. The pandemic has already swept through a majority of nations where many lives may have been saved if there was quicker and wider access to the life-saving COVID-19 vaccines that the higher income countries had first access to.

In future global crises, the problem of balancing intellectual property protections with global cooperation and socioeconomic inequality will continue. Hopefully, the COVID-19 pandemic can shed some light on how future policy considerations can be made to protect scientific innovation while minimising the sacrifice.

The post More Accessible COVID-19 Technology on the Horizon: The National Institute of Health Licenses its COVID-19 Tech Patents to the WHO and the Medicines Patent Pool appeared first on IPOsgoode.

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Shannon Flynn is a Guest Writer and the Managing Editor of ReHack Magazine.

Over two years have passed since the SARS-CoV-2 virus, better known today as COVID-19, made its first appearance in the city of Wuhan, China. In those two years, the virus has circled the globe, killing more than five million people —a number that has climbed with the spread of the new, highly transmissible Omicron variant. Treatments and vaccines have emerged, but the challenge now lies in ensuring everyone has equal access to these measures.

The biggest challenge is getting supplies to low-income countries that need them the most— places where are vaccinated but have high population densities that can contribute to community spread. In response, some countries are asking the World Trade Organization (WTO) to waive the intellectual property (IP) laws that cover the COVID-19 vaccines and treatments.

Is this a good idea or an enormous mistake? How can IP waivers help manage the Omicron strain?

The Risk of Omicron

We’ve made our way through most of the Greek alphabet as new COVID-19 variants emerge and either spread or vanish. Why did Omicron become a variant of concern so quickly?

Early evidence suggests Omicron may be more transmissible than previous incarnations of the virus, making it spread faster than Delta and other variants. In mid-December 2021, researchers in Hong Kong found that the Omicron variant 70 times more quickly than the Delta variant. They believed those characteristics might contribute to its comparatively more efficient spread.

Studies show Omicron is more infectious, even among vaccinated and boosted individuals. It was also thought that this variant caused milder infections. However, this may be due to the low vaccination rate in South Africa, where it was first observed. , most South Africans have already been exposed to the COVID-19 virus and developed some level of immunity.

Both and released statements claiming their vaccines are effective against Omicron after a third booster dose, but most boosters are available only in high-income countries. While over is fully vaccinated, there isn’t much information on how many individuals received a third booster shot and from where.

Furthermore, in April 2021, the World Health Organization (WHO) stated that went to individuals in high-income countries. The challenge is getting the vaccine to low-income countries with very low vaccination rates.

IP Protection or Waivers

What do COVID-19 and the Omicron variant have to do with intellectual property rights and waivers? In October 2020, representatives from India and South Africa the WTO.

The 2020 Proposal

The 2020 proposal to the WTO waives parts of the TRIPS Agreement, intellectual property rights.

A part of the proposal read: “Many countries, especially developing countries, may face institutional and legal difficulties when using flexibilities available in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement).”

People have TRIPS Agreement could cause cumbersome barriers to vaccine access. The 2020 proposal requested “a waiver from the implementation, application and enforcement of Sections 1, 4, 5 and 7 of Part II of the TRIPS Agreement in relation to prevention, containment or treatment of COVID-19.”

The parties behind the proposal wished for the waivers to remain active until global widespread access to the vaccine was possible.

The 2021 Revised Proposal

to the WTO in May 2021. It includes representation from several countries beyond India and South Africa. The newer document discusses growing concerns associated with emerging variants and how they make the need for global vaccine distribution and production even more urgent. The proposal’s authors also note that the original text’s scope was too broad. The revised proposal focuses exclusively on “health products and technologies.”

The revised proposal asks for a “practical and flexible duration” regarding the waiver length. The authors request an initial term of at least three years from the decision date. After that, the General Council—the WTO’s highest decision-making body—could review whether the exceptional circumstances that originally justified the waiver were still present and if it was appropriate to set an ending date.

What Would the TRIPS Waiver Do?

TRIPS has been the . However, it’s important to clarify that a waiver would not be an instant and all-encompassing solution for improving vaccine access. It will theoretically pave the way for increased production of vaccines and related health technologies in more countries.

However, it takes time and in countries with few or none. The waived intellectual property rights would let parties utilize the vaccine technology without penalties but affected nations and the people living there would not benefit immediately.

Some people also argue that waiving the IP rights for everyone who needs them. That’s because there would be a larger number of parties trying to buy raw materials, driving up the associated prices.

Additionally, it takes vaccine production capacity. That’s on top of the up to $1 billion required to build the factory. Even once manufacturers get up and running, additional complications, such as new variants and the uncertainties surrounding vaccine durability, could make things more difficult for those making COVID-19 vaccines for the first time.

A potential alternative is for the international community for research and development (R&D) and manufacturing on each continent. The WHO is working on one for South Africa associated with COVID-19 vaccines.

Managing Omicron

As we move into 2022, it’s becoming increasingly apparent that , similar to the influenza virus. This means that there will probably be a continuous demand for new and updated vaccines and booster shots moving forward. Getting your annual COVID-19 shot may become as common as getting your yearly flu shot.

Moderna has it won’t be enforcing its patent rights to its COVID-19 vaccine during the pandemic. However, that may change in a couple of years if and when the WHO declares the pandemic is over and the virus has become endemic.

As discussed earlier, waiving IP rights won’t remove all the barriers that currently prohibit worldwide vaccine production. When the virus reaches the endemic stage, it could lessen the incentive to set up the necessary facilities. Right now, Moderna and Pfizer are vaccines to combat Omicron, even though they both claim that their vaccines—with three doses—are effective against the new variant.

The post How IP Waivers Can Help Manage the Omicron Strain appeared first on IPOsgoode.

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Prof. Pina D’Agostino is the Founder and Director of IP Osgoode, the IP Intensive Program, and the IP Innovation Clinic, the Founder and Editor-in-Chief of the IPilogue, the Deputy Editor of the Intellectual Property Journal, and an Associate Professor at Osgoode Hall Law School. This article features contributions from Ryan Wong (IP Osgoode & IP Innovation Clinic Alumnus), Sabrina Macklai (IPilogue Senior Editor), Tianchu Gao (IPilogue Writer), and Ashley Moniz (IPilogue Managing Editor).

2021 was an exciting year for the IPilogue. Our hard-working students and community members published more than twice as many articles than in 2020 and the most articles in a calendar year since 2011. This sharp increase helped us stay up to date with some of the biggest topics shaking up intellectual property: from , to ; and from growing investments in and , to IP registrars around the world grappling with whether to acknowledge ��as an inventor or artist. This article summarizes the top developments reported on our blog and in patents, trademarks, and copyright law in 2021. For a review of Privacy legislation in Canada, check out .

Top 10 Most Read IPilogue Articles Published in 2021

1. by Sabrina Macklai & Emily Chow
2. by Prof. David Vaver
3. by Claire Wortsman
4. By Claire Wortsman
5. by Natalie Bravo
6. by Prof. Giuseppina D’Agostino
7. by Bonnie Hassanzadeh
8. By Meena Alnajar
9. by Prof. David Vaver
10. by Bonnie Hassanzadeh

Introducing the College of Patent Agents & Trademark Agents

On , the came into force. The Act established the (‘’), an independent public interest regulator of patent and trademark agents in Canada. The purpose of the College is “to enhance the public’s ability to secure the rights provided under the and the .” The College’s responsibilities include maintaining professional competencies and ethics, issuing licences, collecting fees, and administering certification exams. This development marks a key milestone for the profession and for Canada’s . Though still in its infancy, the College has been criticized for and its , which may impose an additional fee on lawyer agents. It remains to be seen how influential the College is on the profession as it is expected to be fully operational within the next two years.

Patents

Overbreadth as an Independent Ground of Invalidity

On July 28, 2021, the Federal Court of Appeal confirmed overbreadth as a standalone attack on patent validity: . In this case, the appellants argued that there is no statutory basis for overbreadth as a ground for invalidity. The Federal Court of Appeal disagreed and found that overbreadth can be supported by a combination of sections 27(3) and 27(4) of the Patent Act. Case law has often overlapped overbreadth with other grounds of invalidity such as obviousness, anticipation, and inutility.��

First Time Interpreting Patent Agent Privilege

Similar to solicitor-client privilege, patent agent privilege was introduced by section 16.1 of the Patent Act on June 24, 2016. The first case on patent agent privilege was decided this year: In this decision, the Federal Court provided some helpful commentary and analysis on the application and limitations of patent agent privilege.��

Patent Prosecution History Now Admissible as Evidence

In 2018, section 53.1 of the Patent Act was added to make patent prosecution history admissible as evidence in patent proceedings. This was a significant development as the Supreme Court of Canada had expressly rejected the idea and stated that admitting patent prosecution history “would undermine the public notice function of the claims, and increase uncertainty as well as fuelling the already overheated engines of patent litigation” (Free World Trust v Électro Santé Inc., 2000 SCC 66 at para. 66). Three subsequent Federal Court of Appeal decisions developed this provision further: ; ; and .��

Continued Debates over AI as an Inventor

Around the world, patent registrars grappled with patent applications that credit artificial intelligence software as the inventor. Dr. Stephen Thaler’s “DABUS” (Device for Autonomous Bootstrapping of Unified Sentience) applied for patents around the world for its interlocking food containers. DABUS was granted patents in Australia and South Africa, with . In line with the and the , the disagreed, stating that absent express intention from Congress, the term “individual” in their statutory definition of “inventor” . The Supreme Court of Canada last considered the definition of "inventor" in 2002, but has yet to consider whether it would include non-human entities.

Trademark Law

Parody in Trademarks is No Joke

In , the Federal Court reaffirmed that parody is not a defence against trademark violation. Unlike the 2020 decision ), where the Federal Court failed to find the marks confusing, Justice McHaffie held there was a likelihood of confusion and passing off. This was based partly on the similarity of the trademarks and the overlap of the goods (both offering baked goods). However, even if the nature of the parties’ trades differ, trademark owners may still find recourse against spoofed versions of their marks through claiming depreciation of goodwill under section 22 of the . Here, the Court found goodwill in Subway’s trademarks, which was damaged by the nature of Budway’s products, as contrary to Subway’s “healthy and active” lifestyle promotion. With damages amounting to $40,000, it is clear the courts are unamused by parody in trademarks.

The Road Less Travelled Cannot be Trademarked

Like most countries, Canada bars the registration of “clearly descriptive” trademarks to prevent applicants from monopolizing words that merely describe the goods or services at hand. For this reason, marks consisting of are typically unregistrable. In , the Federal Court clarified when such marks might be protected. Hidden Bench and Locust Lane are two wineries operating on the same little road, “Locust Lane”. Although the Federal Court agreed that Hidden Bench met the threshold for a valid common law trademark over “Locust Lane”, they ultimately held that the mark, as clearly describing the goods and services’ place of origin, lacked both inherent and acquired distinctiveness. Therefore, Hidden Bench could not establish the necessary goodwill for a passing off claim. Only descriptive marks that have acquired a “secondary meaning” through use may warrant protection.

CIPO Addresses the Application Backlog

While filing trademarks is important for brand protection, the examination stage can take . In May, the Canadian Intellectual Property Office (CIPO) new measures to address the application backlog. Trademark owners may now file requests to expedite their examination where the registration of their mark is necessary for special circumstances such as if a Canadian court action involving the mark is expected or underway or if the goods or services are aimed at preventing, diagnosing, treating, or curing COVID-19. If accepted, the examination will take place within two weeks. The examination is also automatically expedited by approximately 6-10 months when the goods and services in the application are listed in CIPO’s . Though it is too early to assess the effect of these changes on mitigating the “”, the backlog of CIPO’s unexamined trademark applications appears to have as of December 13, 2021.

Push to Register Non-French Trademarks for Use in Quebec

Among the controversies associated with Quebec’s proposed Bill 96, , the bill stipulates new requirements for trademark owners operating in Quebec. Currently, under Quebec’s French-language laws, both registered and unregistered (i.e., common law) trademarks recognized under the may appear on public signs, posters, and commercial advertising in Quebec, in languages exclusively other than French. If enacted, Bill 96 would permit only registered non-French trademarks to appear on public signage, provided there is no corresponding registered French version of the mark. The Coalition Avenir Quebec government tabled Bill 96 on May 13, 2021, and Quebec’s National Assembly last examined it on December 10. Some iteration of the bill will likely become law by the end of this year. But even if it fails to pass, businesses relying on common law trademarks would be wise to try to register them, given the many that registration provides.��

Copyright Law

In 2021, the Federal Court and Federal Court of Appeal heard 57 copyright infringement proceedings, approximately of all IP-related litigations at these levels.

Developments in Fair Dealing

The Copyright Act’s section 29 fair dealing provision, which allows for certain uses of copyright-protected materials, remained a central issue. affirmed that fair dealing for the purpose of news reporting (section 29.2 of the Act) must provide attribution, mentioning both the source and the name of the author. An indirect reference to the author accessible through “minimum research” is insufficient. As such, the Federal Court of Appeal rejected Trend Hunter’s argument that hyperlinking to the source article where Stross was credited was sufficient to meet the second requirement. The Court also declined to find fair dealing under s. 29 more broadly, considering that Trend Hunter’s dealing was commercial in nature, reproduced Stross’ work in its entirety, and that alternatives were available.

Fair dealing was once again at issue in , where the Federal Court held that the Conservative Party’s use of the CBC’s news footage of Liberal Party Leader and Prime Minister Justin Trudeau during their 2019 election campaign did not infringe CBC’s copyright. The court undertook a large and liberal interpretation of fair dealing, finding that the Conservative Party’s use of CBC footage was for the purpose of criticism under s. 29.1.

91��ɫ achieved a in the copyright tariff dispute with the Canadian Copyright Licensing Agency (“Access Copyright”) in In a unanimous decision, the Supreme Court ruled that the interim tariff approved by the Copyright Board is not mandatory. Users can choose whether to accept licences or pursue alternative methods to lawfully copy works. Notably, this marked Justice Rosalie Abella’s final decision before her retirement from the Supreme Court of Canada. Throughout her tenure, and her judgement here provided helpful obiter regarding fair dealing as integral to users’ rights.

Even Fake Facts are Not Copyrightable

involves the alleged copyright infringement of the famous true-crime story The Black Donnellys. The book had always been presented and accepted as “.” The Federal Court ruled that “an author who publishes what is said to be a nonfiction historical account cannot later claim the account is actually fictional to avoid the principle that there is no copyright in facts.” Given today’s popularity of the phrase “based on a true story”, this ruling is a that there is no copyright in facts, even if they are later found to be untrue.

Copyright in Evolving Content Transmission

In , the Federal Court found the defendant liable for copyright infringement in its provision of pre-loaded set-top boxes and internet protocol television (IPTV) services and awarded the plaintiff nearly $30 million in damages. These services made copyrighted works owned by the plaintiff available to the public without the plaintiff’s permission. This decision marks the first time The court dealt with a similar issue in ). As IPTV is growing increasingly popular across the globe, its poses a challenge in Canada.

Availability of Reverse Class Actions for Copyright Infringement Claims

The first of its kind in Canada, the Federal Court of Appeal in affirmed that reverse class actions may be pursued in connection with copyright infringement claims. Though the matter was sent back to the Federal Court for further consideration, this judgement may encourage and enable mass copyright enforcement in the future, especially in our digital age where copyright infringement is more commonplace.

Public Consultations Ahead of 2022’s Copyright Reform

As part of the (CUSMA), which came into force on July 1, 2020, Canada has until the end of 2022 to implement numerous changes to their domestic copyright laws; most notably, extending the general term of copyright protection from . In light of the upcoming legislative amendments, the Government of Canada hosted three public copyright consultations in 2021:

• ;
• ; and

With the consultations now closed, it will be interesting to see how Canadian copyright laws will change in 2022 to accord not only with international obligations but our ever evolving digital world and public attitudes surrounding copyright laws.

The post 2021 IP Year in Review appeared first on IPOsgoode.

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Sabrina Macklai is an IPilogue Senior Editor and a 2L JD Candidate at the University of Toronto Faculty of Law.

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M. Imtiaz Karamat is an IP Osgoode Alumnus and Licensed Lawyer in Ontario.

The COVID-19 pandemic has drastically changed our day-to-day lives with new public health guidelines and restrictions that impact everything, from how we work to how we move around. In a further attempt to curb the spread of COVID-19, several countries are considering implementing forms of vaccine-based identification as a pre-requisite for accessing certain services or facilitating travel. These so-called “vaccine passports” are a form of proof of vaccination—one which many worry may constitute a serious violation of privacy, introducing more harm than good. As cases of the delta variant of COVID-19 rise, Canada and its provinces must decide whether the potential benefits of these passports warrant their implementation.

The Vaccine Passport Issue

While Canadians can prove their vaccination status in many ways, vaccine passports and offer a consistent, verified means for individuals to prove their vaccination status. At first glance, vaccine passports do not appear drastically different from the immunization record cards most children receive during school. However, unlike traditional immunization records, these passports may have more profound consequences when combined with policies that restrict access to only those who are vaccinated.

Vaccine passports are being considered as a tool to limit the spread of COVID-19 infection by providing an easy method to verify the vaccination status of individuals before allowing them access to certain services and locations. Those in favour of the passports argue that vaccinated individuals have a significantly decreased risk of becoming infected with the COVID-19 virus and transmitting the infection to others. Therefore, they should be allowed to use a vaccine passport to exclusively access services and perform activities that unvaccinated individuals may be barred from.

The implementation of a domestic vaccine passport system has garnered significant debate in Canada. Although vaccine passports may have a serious and legitimate health purpose, officials must carefully consider their intrusion of individuals’ privacy and civil liberties before taking action. A recent by Federal, Provincial, and Territorial Privacy Commissioners (the Commissioners), highlighted that “a vaccine passport presumes that individuals will be required or requested to disclose personal health information – their vaccine/immunity status – in exchange for goods, services and/or access to certain premises or locations.” The disclosure of such sensitive information presents significant privacy risks and governments must develop and implement vaccine passports in compliance with applicable privacy laws and continuously assess the necessity, effectiveness, and proportionality of vaccine passports to justify their use. With such a high threshold, governing bodies are questioning whether enforcing a vaccine passport system is the correct course of action that will yield the most benefit. ��

Even with the Commissioners’ guidance, with mandatory vaccine passports, fearing that they will not only intrude privacy but further perpetuate inequalities. The idea of what may be considered a infringement on individual rights has also garnered significant debate. Such debates have led to , especially against the backdrop of the threat of a potential fourth wave of COVID-19 in Canada.

Federal Response

On July 13, 2021, Prime Minister Justin Trudeau that the federal government will create an “internationally accepted proof of vaccination” to enable international travel, while provinces may create their own domestic vaccine passport regimes pursuant to their jurisdictional authority. , his government plans to work with the international community to ensure that fully vaccinated Canadians are recognized globally as such. He also will look to vaccines certified by the World Health Organization (WHO) to determine which would qualify for a vaccine passport. See the list of WHO-certified vaccines .

To this end, on August 11, the Immigration Minister Marco Mendicino the pan-Canada vaccine passport program for international travel. According to Mendicino, the certificate will be the same across all provinces and will contain information on the individual’s COVID-19 vaccination history, the date they received the vaccine, the type of vaccine administered, and the location of administration. The passport will be available to all citizens, permanent residents, and temporary residents living in Canada who are fully vaccinated. The passport is set to be implemented early this fall.

Intergovernmental Affairs Minister Dominic LeBlanc added that although the federal passport is intended to enable international travel amongst Canadians, the federal government would be willing to work with provinces who so wish to use the passport as a domestic tool.

Provinces Diverge

The lack of strong federal oversight for implementing a domestic vaccine passport system gives the provinces the flexibility to decide based on their own internal policies. This has resulted in divergent views with the various governing bodies arriving at different conclusions on the matter.

The Government of Manitoba has already begun for residents who have two doses of the vaccine and are considered fully immunized. The province’s current public health orders allow fully immunized individuals to access certain services and enable businesses to ask for proof of immunization to ensure compliance. This proof of immunization may take the form of the Manitoba Digital Immunization Card (or its physical counterpart), which contains the first and last names of the cardholder and a QR code that can be scanned by others using the Manitoba Immunization Card app to display the cardholder’s immunization status. Apart from the above information, the card is stated to not provide any other health information.

Although Quebec was only entertaining the idea of its own vaccine passport system, Premier Legault on August 5^th, 2021 that the provinces’ recent surge in new COVID-19 cases now makes it necessary to implement a province-wide passport system by September. The Government of Quebec has that access to certain non-essential services in places with high capacity and a high rate of contact, such as gyms and restaurants, will be restricted using vaccine passports. To access these areas, clients will need to be vaccinated and have a QR code to prove it. Government officials are currently testing smart phone applications that will display (for clients) and identify (for businesses) the QR codes. Those without a smart phone may print their QR code or request a paper version by mail. To ensure privacy, Quebec Health Minister Christian Dubé has said that the app used to identify clients’ QR codes is solely intended for reading purposes and does not collect any data.

Meanwhile, other provinces have strongly opposed the use of domestic vaccine passports. The government of Saskatchewan has firmly rejected the use of such a system, with Premier Scott Moe and the CEO of the Saskatchewan Health Authority, Scott Livingstone, that requesting proof of immunization may violate the province’s privacy laws, including the provinces’ Health Information Protection Act. The Premier of Alberta agrees with this notion, that a passport program within the province would “…in principle contravene the Health Information Act and also possibly the Freedom of Information and Protection of Privacy Act.” A spokesperson for the premier also on August 5 that Alberta will not “be supporting the use of the government of Canada’s international travel credential for uses within Alberta’s borders.”

The Government of Ontario initially took a strong stance against implementing a vaccine passport program, with Premier Doug Ford and Chief Medical Officer of Health Dr. Kieran Moore both the idea. However,

Businesses seeking to collect proof of vaccination information in provinces that do not have passport programs are left to navigate potential privacy pitfalls while developing their own passport system. Although the Commissioners say in their that proceeding under newly enacted public health laws that are specifically developed for vaccine passports would be easier, they suggest that businesses may implement a passport system under existing privacy legislation. Businesses outside of Quebec may find sufficient legal authority to collect vaccination information if they receive the individual’s consent. However, this consent must meet several conditions that may vary with the context of the business, including:

• Consent must be voluntary, meaningful, and based on clear language that describes the purpose to be achieved;
• The information must be necessary for the purpose;
• The purpose must be appropriate to a reasonable person in view of the circumstances; and
• Consent cannot be required as a condition of service.

Looking Forward

As countries across the globe rush to implement their versions of a vaccine passport system, vaccine passports may soon become the norm. Although Trudeau has remained firm that provinces may decide their domestic use of vaccine passports, Canadians in any province who wish to travel abroad will find it difficult to evade the vaccine passport program. Whether vaccine passports truly meet the threshold of necessity for their infringement on civil liberties remains up for debate. However, given their impending ubiquity, it is important that government agencies look to privacy experts like the Commissioners and heed their warnings when developing their own policies. While the COVID-19 pandemic has significantly disrupted our lives, our responses to the pandemic need not be unnecessarily harmful.

The post Phone, Wallet, Keys…Vaccine Passport? Canada’s Response to the Vaccine Passport Debate appeared first on IPOsgoode.

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Ryan Erdman is an��IPilogue��Writer and a 2L JD Candidate at��Osgoode��Hall Law School.��

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In a truly monumental achievement in scientific innovation, there are now authorized COVID-19 vaccines around the globe. However, present inequities in global distribution plague the achievement and ultimate success of these vaccines in ending the pandemic. show that 87% of the over 1 billon doses administered worldwide have been in high-income countries, compared to only 0.2%��of doses administered in low-income countries. As world case numbers continue to rise, the presence and likelihood of variant strains only prolong the immediate harms and long-term impacts. If current trends persist, COVID-19 will continue to devastate countries with less developed and more permeable borders long after developed countries reach majority levels of immunization. At the current pace, it is some low-income countries will not see significant percentages of the population vaccinated until 2023.

The trends in inequitable global access to new medicines are not novel and have long been tied to the intellectual property (IP) rights granted to drug manufacturers in return for taking on the “risk” of research and development (R&D). In general, by awarding a period of limited exclusive rights during which the developer can set non-competitive prices, IP protections inherently and negatively impact affordability. At the beginning of the pandemic, costs and public sector investment affected the ability of high-and upper-middle-income countries to around 6 billion doses through advanced purchase agreements. In October, South Africa and India submitted a to the World Trade Organization (WTO) calling to temporarily waive the Trade-Related Aspects of the Intellectual Property Rights (TRIPS) Agreement provisions relevant to COVID-19 related technology, citing historical and present barriers in affordable and timely access to new medicines created by IP rights. Specifically, they call for a waiver of sections outlining the rights and obligations in the areas of copyright, industrial designs, patents, and the protection of trade secrets relating to “the preventing and treatment of COVID-19.”

The breadth of the original proposal is important in light of the Biden Administration’s recent supporting a waiver of IP rights. The announcement, however, does not directly support the waiver initially proposed 7 months ago. The scope of the initial waiver proposal was purposefully broad, looking to eliminate barriers created by IP protections related to accessibility of not just vaccines, but also other necessary technology in the areas of diagnostics, P.P.E., and other therapeutic drugs. The scope and duration of a waiver comprise many key issues that will need to be agreed to and countries have shown a to come to the negotiating table in light of the US announcement. Canada has that it will not block a waiver, and that the government is committed to work towards a “consensus-based” solution.

But where time is at a premium, the complexity and length of negotiations is an obvious cause of concern. Given the likelihood of COVID-19 becoming , including the persistent threat of variants, any waiver may significantly affect future innovation in COVID-19 “booster shots” and other vaccine technology. This is part of why Big Pharma has met the Biden Administration’s announcement with continuous and skepticism for the efficacy of any waiver in meeting the objective of timely increases in global production. The most prominent of these criticisms doubts that a waiver will effectively address the true bottlenecks, which is to be the scarcity of raw materials and ingredients and the lack of technical know-how.

This is particularly important in determining the scope of the waiver, as a vaccine “patent waiver”, as the media consistently calls it, is simply underinclusive of the knowledge transfer necessary. While a vaccine patent waiver could help alleviate obstacles around technology fragmentation, where different parties own multiple patents related to one vaccine, scaling up production in developing countries also requires the transfer of technical processes. This would involve numerous types of IP and requires technical expertise to build and implement. Some this is why, even though Moderna has long not to enforce certain COVID-19 patent rights during the pandemic, there has been “no flourishing of factories pumping out “generic” messenger-RNA vaccines.” New manufacturers would also need to generate a novel and comprehensive “”, as they cannot rely on the safety and efficacy clinical trial data of originators like with small molecule drugs. The original waiver addressed both copyright and trade secrets, but there are clear that any waiver is certainly going to be narrower than that originally proposed. Any “consensus-based solution”, if at all, will take months and not include the time for new producers to build production capacity and meet regulatory hurdles. WTO Director-General Ngozi Okonjo-Iweala recently expressed “hope” that a waiver could be agreed upon by .

Nonetheless, while accepting that a waiver may not be a “silver bullet” solution, the announcement has certainly reflected optimism for a critical shift in the status-quo, with the head of the WHO calling it a “monumental moment in the fight against COVID-19.” We could look back on this as the moment where high-income nations finally move-away from strong notions of “vaccine nationalism.” Timely access requires a unified effort and immediate, continued support from developed nations for global initiatives like the UN-backed , which plans to deliver billions of vaccines to low-income countries. Members on both sides of the waiver debate advocated for vaccine-producing nations increasing production and reducing restrictions on the export of vaccines (and materials). Interestingly, some that the threat of a waiver could also be a tactic to push companies into greater licensing strategies and persuade them to exhaust production capacity and sell extra supplies to poor countries. The perceived threat of compulsory licensing has pushed companies to make broader global pledges in the .

Where a pandemic is truly a “” every second matters, yet there are many reasons to believe that we will not feel the effects of any negotiations for a long time. Waiver discussions are sure to intensify ahead of the WTO’s next formal meeting in early June.

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There is clearly some significant tension between the right to protect or commercialize intellectual property and ensuring that we’re manufacturing the vaccines as quickly as possible. This issue , where a proposal has been set forth which, if approved, would allow members to choose not to grant or enforce IP related COVID-19 medical tools until global herd immunity is achieved. Just yesterday, Ambassador Katherine Tai, United States Trade Representative, announced .

Currently, there are four approved COVID-19 vaccines in Canada, and each developer has different viewpoints when it comes to the intellectual property rights for their vaccine.

Pfizer/BioNTech

BioNTech, which partnered with Pfizer in April 2020, has that it relies on a combination of trade secrets and patents to protect various aspects of their mRNA manufacturing technologies. A Pfizer executive, in opposition to the World Trade Organization proposal, that “[intellectual property], which is the blood of the private sector, is what brought a solution to this pandemic and it is not a barrier right now.” Some experts have that even if they were to share their vaccine patent, no facility not already being used would have the suitable technology to manufacture the mRNA vaccine.��

Moderna

Moderna, which has related to its mRNA-based COVID-19 vaccine, has taken a slightly different approach when it comes to its intellectual property. While recognizing the importance of intellectual property rights in encouraging research, the company has to not enforce their COVID-19 related patents against those making vaccines to combat the pandemic. Additionally, the pledge states that they are willing to license their intellectual property to others after the pandemic to eliminate any barriers to vaccine development. ����

��AstraZeneca and Johnson & Johnson

The two developers of the non-mRNA-based vaccines are arguably taking the most relaxed approach when it comes to protecting their intellectual property rights and commercialization strategy. Both and have publicly pledged that their vaccines will be developed and distributed on a not-for-profit basis. The companies are licensing and collaborating with a number of facilities to ensure there are enough vaccines to vaccinate the global population in a timely manner.

It is difficult to support the idea that relaxing intellectual property rights for COVID-19 vaccines would have any effect on the ability to manufacture them faster. As explained above, there are two developers manufacturing vaccines without regard for profit, and two developers who use relatively novel, complex technologies and may have already maximized the manufacturing potential. Our main focus should be on ensuring that enough vaccines are distributed on a global scale so developing countries are not disadvantaged.

Written by Tyler McLaughlin, JD Candidate 2022, enrolled in Professor D'Agostino's Directed Reading: IP Innovation Clinic course at Osgoode Hall Law School. As part of the course requirements, students were asked to write a blog on a topic of their choice.��

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Canada has notably faced challenges in its ability to procure vaccines, quickly falling behind other countries in our vaccination campaigns despite contracting to receive more than enough vaccines for the population. While Canada’s vaccine rollout has increased in recent weeks, still of our population has been fully vaccinated as of March 14^th, 2021. This is compared to and a staggering

One proposed mechanism for increasing the availability of vaccines worldwide is to loosen patent protections held by vaccine makers over their products. Some countries, including South Africa and India, have sought a waiver under the Trade-Related Aspects of Intellectual Property, or TRIPS, agreement from the World Trade Organization, which would temporarily suspend global intellectual property protections for COVID-19 vaccines during the pandemic. While attempts to secure a waiver have thus far been unsuccessful, another potentially useful tool available under TRIPS is compulsory licensing.

refers to the circumstance where a government permits a third party to produce a patented product without the patent holder’s consent. While compulsory licensing typically requires the user to make an effort to obtain the patent holder’s consent to produce the product, this during a “national emergency”, of which the pandemic would qualify according to Article 31(b) of TRIPS.

Canada has a history of using compulsory licensing, including to support the availability of more affordable pharmaceuticals. For instance, in June 1969, Parliament amended the to allow companies to produce generic copies of pharmaceutical products that were still under patent protection. Recent amendments to the Patent Act under Canada’s COVID-19 have strengthened the Federal Government’s ability to address vaccine shortages through the use of compulsory licenses. Specifically, the are aimed at allowing the Federal Government to permit the “construct[ion], use, and [sale of] a patented invention to the extent necessary to respond to a public health emergency that is a matter of national concern”. The Government must still provide notice and pay royalties to the patent holder; however, the government has no further obligations to negotiate with patent holders.

While compulsory licensing is an attractive potential tool to increase the availability of vaccines, if Canada pursues these licenses, it must first address domestic vaccine production capacity. Unfortunately, similar to the Federal Government’s , Canada’s vaccine manufacturing capacity is also deficient. If Canada commits to increasing its domestic vaccine production capacity, whether through the construction of new facilities or by fitting existing industrial facilities to be capable of producing vaccines, then the use of compulsory licensing could be a future tool to produce generic COVID-19 vaccines or boosters in Canada. These efforts will be particularly important given recent concern that and in the future to control the spread of COVID-19.

Regardless of the strategy employed, Canada clearly needs to improve its approach to secure vaccines for Canadians, and the domestic production of generic vaccines through compulsory licensing should be considered as a potential strategy moving forward.

Claire La Mantia is a 2023 JD Candidate at Osgoode Hall Law School interested in intellectual property, privacy, and health law.

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Efforts to ameliorate this alarming trend have shifted concerns to the role of patent protection in restricting access to pharmaceuticals. The tension between the global intellectual property regime, regulated by the agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), and human rights is at the forefront of this discussion. requires ratifying countries to adopt a minimum standard of intellectual property rights to protect creators and promote innovation. Considerable lobbying by developing nations, concerned that their socio-economic development would be unduly impaired by patent restrictions, led to the incorporation of protective mechanisms into the agreement. Known as , these include tools such as parallel importing and compulsory licensing of pharmaceuticals. While developing nations view these flexibilities as critical for protecting the right to health, nations with strong pharmaceutical infrastructures the implementation of these flexibilities when they view the mechanisms as an infringement on guaranteed intellectual property protection.

While compulsory licensing allows for patent protection to be circumvented during , the continued protection of undisclosed information often impairs the ability of other manufacturers to begin pharmaceutical production. This delay holds particularly true in vaccine production. Discerning the involved in vaccine development takes considerable time and research. Moreover, unlike with generic medications, where demonstrating therapeutic equivalence is sufficient, vaccine manufacturers must develop a production process and conduct timely clinical vaccine trials to test for efficacy and safety. Unless the undisclosed data describing the “k�ԴǷ�-��Ƿ�” can be obtained directly from , patent waiver is insufficient to bring vaccines to market in a timely manner.

In an effort to bring Covid-19 vaccines to in-need regions sooner, India and South Africa submitted a to the World Trade Organization in October 2020 advocating for the waiver of TRIPS obligations, including undisclosed information beyond the purview of the agreement’s flexibilities, in the interest of public health. Developed countries and pharmaceutical companies currently remain to this proposal, maintaining, in part, that it will create a to innovate in future pandemics, and arguing that existing will permit sufficient Covid-19 vaccine access. Whether these claims hold true remain to be seen. These arguments do highlight the consistent conflicting interests in the international intellectual property regime, in which an inherent tension exists between human rights and innovation rights.

Written by Ally Maddeaux, a second year JD candidate at Osgoode Hall Law School. She is a guest contributor to the IPilogue and a Coordinator with the IP Osgoode Innovation Clinic.

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Legislative Encouragement for Small Entities

The Federal government has recognized the ongoing legal clash between new innovators and smaller generic manufacturers. It has since passed legislation such as the and its corresponding to assist judicial decision-making on patent infringement cases. While applications for patents for COVID-19 vaccinations would undoubtedly have to be in accordance with federal legislation, it seems that the federal government and the (CIPO) is encouraging the submission of applications from small entities.

This summer, the CIPO launched a seeking to accelerate examining Canadian patent applications related to COVID-19 relief from small entities, i.e. a university or business employing 50 or fewer employees. With that said, the accelerated examinations of smaller entities' applications results in the risk of having a more significant number of submissions that infringe upon the patents of monopoly biotech manufacturers.

War or Co-operation?

Given the multitude of COVID-19 vaccine candidates, from both large and small entities, the question of whether leading biotech companies will enforce their patents and intellectual property rights persists. Beyond a vaccine produced by large biotech manufacturers, there may be separate COVID-19 vaccines in development that utilize large companies' patented technologies.

Nonetheless, it seems that at least some companies may be leaning towards a more passive enforcement strategy. For example, in October, one of America's leading messenger RNA vaccine (mRNA) developers named , provided a claiming that it would not enforce its COVID-19 related vaccine patents against other 'competitors' making vaccines intended to combat the pandemic. The company also claimed that they would be willing to license its intellectual property for COVID-19 vaccines to others after the pandemic as well. Although the statement also contains a blunt disclaimer stating that Moderna does not guarantee these promises, it is interesting to see more co-operative efforts being put forward in the realm of IP.��

Criticism and Room for Future Collaboration

Moderna has since been the only biotech company manufacturing a vaccine to pledge to share its COVID-19 patents openly with others, and believe that such a model is one that others should follow. However, a great deal of competition lies in the world of IP. While collaboration may seem the most feasible option to tackle a pandemic, sharing information can impede market share and company profitability and create tension among invested shareholders. As a result, we may not see many collaborative efforts to tackle COVID-19 like that of in April 2020. That collective effort sought to advance multiple COVID-19 vaccine candidates through BioNTech's proprietary mRNA vaccine platforms paired with Pfizer's vaccine research expertise.

Still, one can envision that the rising number of cases paired with the onset of cold temperatures will serve as an incentive for future collaboration with both limits on patent enforcement and patent sharing.

Khristoff Browning is an IPilogue Editor and a JD candidate enrolled in his first year at Osgoode Hall Law School.

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In , the and the , a patent can be valid up to 20 years after its filing, which means that the company which develops a COVID-19 vaccine can have a stranglehold on the production and pricing of the vaccine for two decades. This can have a significant impact on the ability for most populations to receive the vaccine. With over cases globally, any delay on the implementation of the vaccine will lead to disastrous loss of life.

In addition to the grave possibility of pharmaceutical companies placing a stranglehold on vaccine production through patent for profit (which they have been known to do in cases like ). The entire process of developing such a vaccine has been hampered by IP regimes. The for governments and pharmaceutical companies to pool their IP resources to allow for both the development phase to be faster as well as to ensure widespread and low-cost manufacturing. However, two of the largest powers in the pharmaceutical business, the and are leading the campaign against such a resolution. This is likely to mean, barring new legislation, that most countries’ patent regime will govern the dissemination of any new COVID-19 vaccine in their jurisdiction.

Although the first wave of vaccine supply will likely be the largest bottleneck, supply has to be maintained, perhaps for years. This is because the COVID-19 vaccine , inoculating one for life, but closer to the seasonal flu vaccine, needing a new one each year for the new mutated strain. This opens up the chance that pharmaceutical companies will make minor improvements to keep updating the patent and keeping their stranglehold on the market similar to the in the US.

So, what does this mean for various jurisdictions around the world?

UK and US:

The UK and the US are against meddling in their traditional patent regimes, hoping to allow free market competition drive innovation and perhaps come up with a wide array of vaccines. This has been the standard approach of these two pharmaceutical giants for decades, but dangers do lurk in the shadows. With major institutional issues in these jurisdictions in the past such as the insulin and opioid crises, it leaves doubt in the ability for their traditional patent regimes to deliver a new vaccine to their hundreds of millions of citizens.

Canada:

In part 12 of Canada’s , a measure was added to allow the health minister to circumvent patent law and ensure enough would be produced locally. These measures could be used if the demand is too great for the patent holder to supply and adequate renumeration would be given. However, Canada’s main pharmaceutical lobby group, Innovative Medicines Canada, regarding how the government wouldn’t have to check with the manufacturer to determine how much they can actually supply. Since the legislation’s coming into force back in March, Canada has not used the bypass powers to supply some direly in need items such as ventilators, so the likelihood of this bypass being used remains to be seen.

New Zealand:

New Zealand’s patent regime has and measures built into it, paving the path for government intervention in circumstances where manufacturers can’t meet supply. Although, these measures are only after negotiating has failed or three years since the patent was granted. This leaves room for pharmaceutical companies to maneuver in a way which may be detrimental to access of the vaccine. As such, there have been to amend these laws for national emergency clauses which would ensure the government to step in.

Current IP regimes worldwide are steeped in many historical issues and aren’t flexible enough to deal with unprecedented cases such as the COVID-19 crisis. There are very few precedents for western countries to even use the measures made available by legislation and this may cause unaffordable hesitation. The loss of life that this will result in may be the wake-up call that heralds a revolution in how people view patents.

Jin Xu is a JD Candidate 2022 at Osgoode Hall Law School.

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