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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.

On May 5, 2021, the Biden administration����its position to support a temporary global waiver in intellectual property (IP) protection for COVID-19 vaccines to expand vaccine manufacturing and distribution around the world.

The announcement marks the United States’ current position on a broader conversation in the World Trade Organization (WTO) on waiving IP protection for COVID-19 products, including suspending protections for patent, copyright, and industrial designs during the pandemic. It is believed that the reduction of IP protections would allow countries to increase vaccine production and vaccination without fear of being accused of IP infringement. The proposal was first made by South Africa and India and has now garnered support from more than 100 countries. Proponents also include the WTO Director-General, who said that such waivers are within the WTO’s toolbox and there is no better time to use them than in the extraordinary circumstances of the COVID-19 pandemic.

The Biden administration’s stance was met with mixed public reception. Although it was applauded by groups of supporters like Public Citizen and Doctors Without Borders, it faced backlash from pharmaceutical industry stakeholders, who said that IP rights do not present a barrier for access to vaccines and the proposed actions will undermine global efforts to safely combat the pandemic. These stakeholders included the drug industry’s lobbying group, the Pharmaceutical Research and Manufacturers of America, who said that the “...decision will sow confusion between public and private partners, further weaken already strained supply chains and foster the proliferation of counterfeit vaccines.” Other critics said that the Biden administration’s endorsement would undermine incentives to develop products for future pandemics.

The WTO requires consensus among its 164 members to put the proposal into effect and it is still unclear how many countries, including several European nations with influential pharmaceutical industries, will be in favour of the proposal. The Biden administration has said that they will participate in WTO negotiations to reach agreement on the exact terms of the waiver, but that such negotiations will take time before anything firm is put into place. Canada has not taken any position on the proposal, but says it will participate in the negotiations.

Written by M. Imtiaz Karamat, Osgoode Alumnus and Student-at-Law at Deeth Williams Wall LLP.

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Photo Credit: Jon Tyson on Unsplash

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.

The post Biden Support for Covid-19 Intellectual Property Waiver: A Step Below Progress? appeared first on IPOsgoode.

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.��

The post Are Intellectual Property Rights Hindering the COVID-19 Vaccine Manufacturing Potential? appeared first on IPOsgoode.

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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