Ryan Erdman is an IP Innovation Clinic Fellow and a 2L JD Candidate at Osgoode Hall Law School. This article was written as a requirement for Prof. Pina D’Agostino’s Directed Reading: IP Innovation Program course.

In October of 2020, India and South Africa submitted a proposal to the WTO for a waiver of provisions of the Trade-Related Aspects of the Intellectual Property Rights (“TRIPS”) Agreement in a response to global inequities in access to COVID-19 interventions. Namely, they intended to ensure that essential vaccines, medicines, and equipment would be made available “promptly, in sufficient quantities, and at affordable prices” on a global scale by eliminating both established and anticipated barriers created by intellectual property rights. In May 2021, after a long period of steady opposition from high income countries, the Biden Administration changed course and signaled support for a waiver of certain intellectual property protections. At the time, I on these developments, noting how the scope of a waiver that countries like the United States (and the others that would now come to the table) would agree to remained a key and complex issue. Critically, the Biden Administration’s announcement did not directly support the waiver initially proposed 7 months prior, which was purposefully broad, and many took this as a sign any waiver eventually agreed upon would be much narrower.

Almost 18 months later, the first real development in terms of an agreement has been reported with the US, EU, India and South Africa close to agreeing on a significant “compromise.” Where the original waiver proposal also looked to eliminate barriers created by IP protections related to accessibility to necessary technology in the areas of diagnostics, P.P.E., and other therapeutic drugs, the leaked text shows that the potential agreement will only immediately cover COVID-19 vaccine patents. While the text is said to have a provision where WTO members will vote on the inclusion of these additional interventions within 6 months, given how the negotiations have proceeded thus far, there are many reasons to doubt that the additional aspects to the agreement will come to fruition. While they note that no official agreement has been reached, the US that the leaked text offers “the most promising path toward achieving a concrete and meaningful outcome."

Immediate reaction from both sides of the “waiver debate” have been somewhat negative, and continue to represent the complex balancing act between exclusive protection for IP and the need for appropriate and timely public access to health technology during a pandemic. Those in favour of a complete waiver have continued to express that these technologies, which include rapid and affordable testing and novel anti-viral treatments are becoming equally important in the short and long-term global effort against COVID-19 and emerging strains. Further, some have how the leaked text creates novel barriers in relation to the use of compulsory licenses, as point 3(a) of the compromised text notes that while eligible WTO members may issue a single authorization for individual products, countries are required to “list all patents necessary” for production and supply. As this would include patents for all underlying fragments and processes related to the vaccine, it would be far more burdensome than what is currently required under the TRIPS agreement. ��

Those in opposition of the waiver remain with the view that the waiver does little practically (in addition to current flexibilities under the TRIPS agreement) to support greater accessibility to vaccines. Where there are also questions about whether supply is even a key issue at this time, a waiver of patent protections still does little to close key information gaps in technical processes and restrictions on use of trial data. The fear remains that the waiver would only serve to negatively impact the foundational incentive structure for research and development into vaccines, especially those targeting emerging pathogens.

While positive sentiment has been given by those like WTO Director-General Ngozi Okonjo-Iweala, who has the leaked text a “breakthrough,” the true impact of any waiver remains uncertain. Certainly, the true effects on future use and liability of significant technological innovation created during the “COVID period” remains immeasurable.

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

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In 2015, Inside Out captivated audiences with its creative insight into the emotional landscape of a pre-teen girl named Riley. The film’s main characters are manifestations of young girl’s internal emotions that attempt to help her navigate various experiences and challenges in her life. The brilliance of the film’s storytelling was realized through its depth and the way it resonates with individuals of all ages. Winning the that year, it has grown to be regarded as one of the best animated films of all time.

While the general and critical response was overwhelmingly positive, one individual who did not experience the same initial “joy” was , a graduate of Sheridan College in Oakville, Ontario. In July 2018, Pourshian commenced an action against Walt Disney Pictures Inc., Pixar Animation Studios, and four other subsidiaries claiming that they infringed on his copyright to a film he initially conceived as a high school student. The claim was brought under��sections 3��and��27��of Canada’s��

In 2000, Pourshian, then a film student at Sheridan College, wrote the screenplay and produced a short movie similarly titled Inside Out, where the protagonist was guided by their personified internal organs. According to Pourshian, the film was “widely shown” at the school, and the defendants, having a “close relationship” with Sheridan College, would have had access to his film on numerous occasions. Further, he claims former students at the college now working with Disney and Pixar were tied to the production.

The recent did not surround the substance or efficacy of the infringement claims, but revised a preliminary jurisdictional order. The U.S.-based defendants initially brought a motion to stay the action on the basis that Ontario lacked jurisdiction. In October 2019, a Master granted the order against all defendants, except for Pixar, Walt Disney Pictures Inc., and Disney Shopping Inc.

Pourshian appealed, and the remaining defendants cross-appealed the decision on the basis that the Master erred in applying the test for determining if the court has jurisdiction over claims against foreign defendants. The test, as established by the Supreme Court of Canada in , looks to determine if there is a “real and substantial connection” between the subject matter of the litigation and the chosen forum. To do so, the court will determine whether there is a presumptive connecting factor (established or novel) between the claim and the jurisdiction. As noted in Van Breda regarding tort claims, connecting factors that��prima facie entitles a court to assume jurisdiction include the defendant residing or carrying out business in the province, the tort being committed in the province, or a contract connected to the dispute being made in the province.

The court found that the Master made at minimum three legal errors, including failing to analyze the meaning of “carrying on” business in Ontario and disregarding evidence filed by the parties. Seeing no utility in sending the case back, the court proceeded to determine jurisdiction in relation to each individual defendant. Pourshian argued that Ontario had jurisdiction because it was the “jurisdiction of reception” for��the movie, the claim was in respect of (intellectual) property in Ontario, and some of the defendants carry on business in Ontario.

Most significantly, the court clarified that copyright infringement is “essentially a statutory tort,” such that the Van Breda analysis is correctly applied, and the analogous connecting factor is whether the alleged copyright infringement occurred in the jurisdiction where the action was brought. Relying on , they note that the infringement can occur both where the communication was transmitted from and where it was received. Subsequently, the court looked to the main issue of whether Pourshian’s claim established a “good arguable case” that each defendant played a role in authorizing the “transmission” or distribution of��the film in Ontario.

Ultimately, the court found sufficient evidence that Ontario had jurisdiction in relation to six of the defendants, largely due to direct connections to the film’s production or its distribution to third-party providers. This reversed the original decision in relation to three defendants. The two remaining defendants, Walt Disney Company (the parent company to the remaining defendants) and American Broadcasting Companies, Inc., successfully rebutted the presumption by proving a lack of involvement in the production and distribution of the film in Ontario.

In what should be an extremely intriguing copyright case moving forward, Pourshian seeks a declaration that he owns the intellectual property to the screenplay, live theatrical production, and the short film Inside Out, and that the defendants infringed his copyright through their production and distribution of��the Disney film. In addition, he is seeking a permanent injunction and damages, which would be significant given that Inside Out more than $850 million worldwide. Interestingly, Pourshian has been in a similar U.S. claim, voluntarily withdrawing a 2018 California lawsuit two months after it was filed.

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Photo Credit: AJ Maestas & Jason Belzer (ADU)

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

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The National College Athletic Association (NCAA), a multi-billion-dollar corporation, serves as the dominant sanctioning organization for college sports in the United States. A defining feature of college sports is the amateurism that underlies all competition, where college athletes can only receive “education-related” compensation (i.e., tuition, school-supplies, room and board). To avoid ineligibility, these elite athletes cannot benefit from or be compensated for the use of their name, image, or likeness (“NIL”). However, the intellectual property rights, including the trademarks routinely protected by celebrities and professional athletes, may no longer be a concern to college athletes. Instead, they can be an exciting new opportunity for college athletes to prosper. ��

The NCAA Division I Council plans to on June 22^nd and 23^rd, 2021. All signs point to the group voting on the proposed NIL rules changes that would fundamentally alter athlete compensation. As noted, , college athletes cannot use their NIL to promote or endorse a product, even without compensation.

The movement for college athlete compensation, a controversial topic in light of the high revenue generated by college sports in the United States, has gained traction since California enacted the Fair Pay to Play Act in September 2019. Since then, 18 states are gearing up to place novel NIL laws into effect, some as soon as July 1, 2021. The legislation places immense pressure on the NCAA to enact its own uniform rule changes, as the integrity of college sports and recruiting could collapse with inequitable practices across state lines. As recently as June 19, 2021, NCAA president Mark Emmert his support for uniform NCAA policies by July 2021. The NCAA president was also to stress the need for federal laws despite any national NIL guidelines from the NCAA.

Of course, some still reject the notion that any changes are necessary, as compensation is seen to detract from the athletic and educational components central to athletic scholarships. Compensation is seen to not significantly impact most college athletes who are unlikely to receive several endorsement offers. Although the majority of athletes do not have national name brand equity, athletes will have local opportunities with smaller platforms. There are also concerns that the fast transition to the upcoming academic year leaves little room for oversight. A lack of education related to the legal process, rights and obligations has already given college athletes difficulties in the . Complications often arise when younger college athletes sign contracts with agents or when they “turn pro.” Major programs have already partnering with companies like Opendorse, which provides athletes with education on building and monetizing their brands.

But in a digital era, social media has undeniably shifted players’ balance of power in the field. Discussing NILs, the ABA has to social media as the “referee that moves the sticks of monetization.” College sports’ biggest stars are polarizing public figures, some with incredibly large followings. Even those who do not have millions of social media followers are set to cash in significantly when acting as influencers or brand ambassadors. For example, the University of Connecticut’s basketball star and AP Women’s Player of the Year, Paige Bueckers, with approximately 830,000 Instagram followers, is set to become one of the most influential college athletes on social media. Athletes with larger followings are to make anywhere from hundreds of thousands to millions of dollars in brand deals before their professional career even begins.

At a time when the NCAA is already under significant pressure, the recent unanimous Supreme Court in the antitrust case Alston v NCAA further pushes the narrative of expanded rights for college athletes. While not directly addressing the topic of NIL, the decision won by former student-athletes is a significant moment for defining amateurism in college sports, as the case dealt with restrictions placed by the NCAA on education-related benefits. As critical meetings approach and the July 1^st deadline continues to loom, the next few days could fundamentally change the model of amateurism adapted by the NCAA.

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

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At the onset of the COVID-19 pandemic, the lack of any existing treatment to mitigate the impacts of the novel virus was perceived as an alarming reality. What became clear was that any hope of an effective and timely solution relied on immediate and considerable investment in biomedical research and innovation. The common narrative at the time was that an effective vaccine likely would not be safely distributed for years. Before COVID-19, the fastest vaccine development, targeting mumps in 1967, took 4 years. Fast-forward to just over a year since the beginning of the pandemic, vaccines manufactured by multiple companies have been authorized globally and numerous other candidates are in late stages of clinical trials.

While the race to produce an effective vaccine was won by those who rushed to the market in record time, the most significant implications of this innovation will almost certainly transcend the current pandemic. Two of the most widely distributed vaccines thus far were produced by Moderna and Pfizer-BioNtech. Moderna and Pfizer successfully implemented mRNA technology into a widespread therapeutic vaccine. Having completed the fastest successful vaccine trial in history, the two companies led the efforts to obtain the ever authorization for an mRNA-based vaccine.

The traditional approach to vaccine technology, implemented by Oxford in collaboration with AstraZeneca, relies on an adenovirus vector. Essentially, the individual receives a harmless modified version of a chimpanzee virus containing the genes for the SARS-CoV-2 spike protein. play a critical role in the way the virus is able to penetrate host cells and initiate infection. Mimicking this process, the vaccine prompts the body to create an immune response, preparing the body to face the actual virus. In contrast, the vaccines produced by Moderna and Pfizer-BioNTech work by delivering messenger ribonucleic acid (“mRNA”), the genetic substance responsible for communicating protein-making instructions within a cell, into the body and instruct the body cells to produce the coronavirus spike protein. The body’s immune system would then respond to the protein and learn to attack the virus if it ever came in contact with it

While the pandemic may appear to be a catalyst for this innovation, the groundwork has been in place for years. mRNA technology was actually adapted from decades of previous research into the topic in order to address SARS-CoV-2. Attributed to work done by researchers Katalin Kariko and Drew Weissman at the University of Pennsylvania, their well-documented over several decades culminated in the discovery effective insertion of synthetic mRNA into human cells without being attacked by an immune response. Moderna utilized this mRNA technology to their vaccine candidate just 48 hours after researchers in China revealed the virus’ genetic sequence.

The pandemic was significant not only for discovery, but for establishing the efficacy of the technology. Establishing the efficacy of mRNA-based vaccines opens the floodgates for significant investments in the field. Excitement about mRNA technology has led to of dollars being poured into the sector to produce mRNA-based medicines targeting diseases that are difficult to treat. The pandemic and vaccine rollout also served to help build the by establishing a vast regulatory and manufacturing network for the brand-new technology in under a year. Moderna is to have indicated it has “over����issued or allowed U.S. and foreign patents protecting mRNA-based technology, with over 600 worldwide pending patent applications.” This is tied to an mRNA product pipeline including 26 drug candidates targeting infectious, rare, autoimmune, and cardiovascular diseases. Similarly, two other leading pharmaceutical companies, BioNTech and Curevac, who have an mRNA-based vaccine candidate in with Bayer, also have significant numbers of related to mRNA therapeutics. mRNA technology is believed to be versatile enough to potentially “on-demand proteins associated with specific tumors to teach the body to fight off advanced cancers”, or even missing proteins in cystic fibrosis patients.

The innovation surrounding this technology is intimately tied to their intellectual property rights. Looking more closely at COVID-19 vaccines, have shown the incredibly complex matrix of patents, licenses, sub-licenses, and agreements between various entities in the research and production stages. Part of the reason companies such as Moderna and BioNTech are emerging as major players in the market for mRNA-based medicines is due to their ownership of and strategic partnerships with other pharmaceutical companies. For example, SEC filings a series of sublicenses for mRNA-based technology patents coming from the University of Pennsylvania to Moderna and BioNTech. What is yet to be seen is how intellectual property rights, namely patents and trade secrets, will impact the long-term prospects of mRNA technology. Certainly, the intricacies of research and development in this area could lead to novel and complex IP issues. As waivers of IP rights associated with COVID-19 therapeutics have become a prominent topic over the past year, it is hard to speculate about the future of IP in pandemic-related technologies. The IP landscape surrounding mRNA technology has only begun to unfold.

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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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