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.

The post TRIPS COVID-19 Intellectual Property Waiver: Response to Reported Compromise 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.

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Photos from and , created on .

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

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In anticipation of Canada’s federal election on September 20, 2021, it is relevant to research the federal parties’ platforms as they relate to intellectual property (IP), innovation, and technology. In this post, I will look at the of the Liberal Party of Canada (“Liberal Party”) and the Green Party of Canada (“Green Party”). Make sure to check out my colleague ’s post investigating .

��The Liberal Party of Canada’s 2021 Federal Election Platform

Three main points involving technology and intellectual property stick out in the Liberal Party’s platform for the upcoming election:

1.Prime Minister Justin Trudeau has yet to confirm if he supports the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Waiver.

As push to support and request that wealthier countries relax their IP protection laws to ensure the COVID-19 vaccine is shared globally, Prime Minister Justin Trudeau has yet to comment. In May 2021, Trudeau said that he supports sharing vaccines globally and that he . However, this was the last time Trudeau spoke publicly about the matter, and he has yet to acknowledge it while campaigning. Three days after his comment, published a to the Prime Minister, urging him to support the waiver and help countries like India and South Africa combat their COVID-19 outbreaks.

2. The Liberal Party plans to create , an initiative “to help innovators access expert intellectual property services, with $90 million over two years, and another $75 million over three years for a similar Industrial Research Assistance Program for high-growth firms.”

The Liberal Party sees this investment as supporting small businesses, innovators, tech start-ups, and more. The Liberal Party acknowledges the value of IP and states that they would love to see the economy use the IP community for growth opportunities. As such, they plan to support ElevateIP with a Strategic Intellectual Property Program Review, which will assess this initiative and help programming from the start of research to near-commercial projects. This initiative is said to ensure Canadians reap the benefits from the IP and tech industry. ��������������������

3. The Liberal Party plans to renew the .

In 2017, the Canadian government for the world’s first nationwide Artificial Intelligence (AI) strategy. The strategy aims to foster a more collaborative AI environment by attracting AI researchers to the country. Additionally, the Liberal Party hopes to advance national initiatives in the AI community to help society better understand the implications of AI. Renewing this strategy would bring Canada to the forefront of the global AI community.

The Liberal Party’s platform includes a few more noteworthy points. The Liberal Party hopes to provide to support small business technology needs and connect those small businesses with younger people looking for tech careers over four years. The platform also speaks to helping large-scale energy technology projects by providing them with $1 billion over five years. Lastly, the Liberal Party plans to create the Centre for Innovation and Clean Energy in British Columbia during their next term, with an estimated cost of $35 million.

The Green Party of Canada’s 2021 Federal Election Platform

The Green Party has yet to release a full election platform. Leader Annamie Paul says that circumstances are different this election and anyone who wants to see the Green Party’s platform can “.” For the party known to be environment-focused, Paul states that not much has changed since the 2019 election. Paul reiterated this when British Columbia’s heatwave claimed multiple lives earlier this summer.��

With this, three noteworthy points emerge from the Green Party’s platform as they relate to IP, innovation, and energy:

1.The Green Party plans to in First Nations communities, aligned with the .

This point intersects with several issues, including economy and affordability, Indigenous affairs, and energy. The Green Party hopes to partner with Indigenous communities to revamp the east-west electricity grid to transmit renewable energy from one region to another. This will create renewable energy for First Nations communities at a lower cost than building a new grid in areas without access to these energy sources.

2. The Green Party plans to invest in comprehensive training programs to repurpose the skills of industrial trades workers for jobs in the renewable energy sector.

The Green Party hopes that this plan will provide skilled workers in Canada with secure employment opportunities.

3. The Green Party hopes to implement an energy efficiency retrofit program for all buildings.

“Energy efficiency retrofitting” upgrades a building’s energy-consuming system. Retrofitting could involve improving light fixtures, windows, doors, ventilation, or insulation to make ��buildings more energy and economically efficient. The Green Party hopes to create a program to make sure buildings around Canada can help fight the climate crisis.

The Green Party still has time to release a new, expanded platform within the coming weeks.

The post The Parties’ Plans for IP: Liberal Party & Green Party appeared first on IPOsgoode.

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.

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.

The post TRIPS: A Barrier to Covid-19 Vaccine Access? appeared first on IPOsgoode.

This follows the unwillingness or inability of the United States to modify its legislation that effectively banned Americans from gambling on foreign websites after under the . Antigua and Barbuda must now decide whether they will use the authority granted by the WTO and suspend some of the protection of intellectual property belonging to US rights holders.

It is not the first time that a WTO dispute-settlement panel has authorized what is known as the “cross-retaliation” involving intellectual property. Typically, when one WTO Member fails to implement the findings of a dispute-settlement panel, the other party to the dispute can be authorized to “retaliate” by imposing trade sanctions in the same area (as the dispute). However, in certain cases it is difficult, if not impossible, for certain WTO Members to retaliate in that same area. For example, when WTO panels found that its banana import quotas violated Ecuador’s rights under WTO Agreements, . This authority was never used, in part because Ecuador realized that if it did so, it would likely destroy the market for Ecuadorian music unable to compete with “free” European music.

Whether or not Antigua and Barbuda decide to retaliate as now authorized, the WTO decision is interesting on several different levels. First, it shows that, from the perspective of trade law, a dollar is a dollar. Copyright can be valued on the same common denominator as a banana or an online gambling site. For those of us who work in the area of intellectual property, this equipollency between very different types of activities and industries seems a bit contrived.

Second, the case shows that the WTO dispute-settlement system does not always work well when the “winning” party is a small country such as Ecuador or Antigua and Barbuda. A system of compensation, in which the “losing” party would actually pay the government of the “winning” party for losses incurred, exists in the WTO but it is mostly theoretical because it can only be used when the losing party agrees. This case shows that it may be time to reexamine the role of compensation in WTO dispute-settlement cases to avoid similar cases of hardly justifiable retaliation between unrelated industries.

Third, this is another case in which the United States is unwilling or unable to implement the findings of a WTO dispute-settlement panel that found it in violation of its WTO obligations. and has yet to implement the findings of that panel report, dealing with an exception preventing the licensing of music performed in most US bars, hotels, restaurants and supermarkets. This policy direction may eventually lead certain other WTO’s members to doubt the efficacy of the WTO dispute-settlement system.

In the particular case hard questions have surfaced as to the way in which the authorization given Antigua and Barbuda may be used. First, the authorization to retaliate is limited to the territory of Antigua and Barbuda. As a result, any use of that authority in the online environment will undoubtedly raise jurisdictional issues. In fact, if the authority to retaliate is used in the territory of Antigua and Barbuda in a way that affects copyright protection in other countries, including the United States, would that not constitute a violation by Antigua and Barbuda of its obligations under the TRIPS Agreement?

Second, how is Antigua and Barbuda supposed to evaluate how to leave $21 million of copyright value unprotected, given that this is the cap of the WTO authorization, ��and what gain will Antigua and Barbuda make by selling copyrighted US goods? Will it affect Antiguan sellers of similar goods from non-US origins? Should one calculate the�� “copyright value” (typically licensing) that is normally included in the price of such goods but will not be? What rate(s) should be used?

Third, as a matter of international law, some may question the WTO’s ability to suspend not just obligations under the TRIPS Agreement, but also under copyright treaties administered elsewhere, including the World Intellectual Property Organization (WIPO).�� By somehow allowing Antigua and Barbuda not to comply with its obligations under, for example, the Berne Convention, to which both Antigua and Barbuda and the United States are party to, has the WTO Dispute-Settlement Body created a precedent that might be used in very different contexts?

Bottom line, this case demonstrates that while there are gains to be made by incorporating international legal rules in the WTO (in particular in the area of dispute-settlement), there are also potential risks in boiling all subject matter to a mere matter of dollars and cents. More importantly, a clear need has emerged for more work to be done on the interface between trade rules and rules that have their own history and normative underpinnings, such as copyright law.

Daniel Gervais is Professor of Law and Director of the Intellectual Property Program at Vanderbilt University. Before joining Vanderbilt Law School in 2008, he was Acting Dean of the Common Law Section at the University of Ottawa. His focus is on international intellectual property law. He is also Editor-in-Chief of the Journal of World Intellectual Property and editor of . In 2012, he became the first North American Law Professor elected to the Academy of Europe.

The post When Trade and Intellectual Property Collide appeared first on IPOsgoode.

The justification for patent incentives reaches a high point when it solves a ravaging health problem, such as proving a cure for malaria, AIDS, or Lyme disease. It dips to its nadir when it interferes with research or interferes with professional judgment or practice. However, patent owners want profit from patents. If they can, they would like to control competitors. of Santa Clara University summarizes the situation:

While each patent dispute is unique, most fit the profile of one of a limited number of patent litigation stories. When an independent inventor sues a large company, for instance, a David v. Goliath match-up results. In contrast, if the parties are more evenly matched, comprising two large private or publicly traded corporations, the result can be patent warfare, potentially of global dimensions.…the strategic use of patent litigation by well-established large companies against their smaller, less-established rivals has been called predatory. , 87 N.C. L. Rev. 1571, 1577 (2009).

Congress has power to enlarge patent law to “include anything under the sun that is made by man.” However, it is extremely unlikely to contradict the Supreme Court's "bright-line prohibition against patenting laws of nature, mathematical formulas and the like.” Applying this principle, the Court rejected the United States government's amicus argument that the case ought these claims ought to be judged on the basis of novelty (), obviousness (), or specificity (), rather than on the fundamental uestion of patentability per se. Congress�� has always acquiesced in the Supreme Court interpretation of permissible scope. See also, .

The world patent picture

United States patent laws and practices cast a long shadow in world intellectual property. Entities that seek to promote high capital value for patent rights have been able to draw on United States patent policy as an example of strong proprietary rights. The Bilski and Mayo cases provide a basis to push the other direction, in favor of access rights.

The great mass of humanity needs access to medical advances now more than even. However, in the international patent regime created by the current and the (“Trade Related aspects of Intellectual Property”) loads the dice against such access. states that this treaty structure does little, however, "to explicitly safeguard the interests of those who seek to use protected works. In some ways, this structure is not surprising. Because the free traders who negotiated the GATT worked in an environment in which the core concern, reducing market barriers, was viewed as producing (at least in the long term) unmitigated welfare gains." Rochelle Cooper Dreyfuss, .

Scope for medical advance

The Court patent laws must not interfere with research and practice. It stated:

The patent claims at issue implicate this concern. In telling a doctor to measure metabolite levels and to consider the resulting measurements in light of the correlations they describe, they tie up his subsequent treatment decision regardless of whether he changes his dosage in the light of the inference he draws using the correlations. And they threaten to inhibit the development of more refined treatment recommendations that combine Prometheus' correlations with later discoveries.

Doctors and small companies now have a better chance to move ahead with constructive practices and innovations.

All in all, March 20 was a good day for the public.

is a United States attorney, law professor, and writer. He has previously written for the IPilogue and .

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While health activists, generic manufacturers and several academics lauded the decision, the multinational pharmaceutical industry was up in arms.

The facts of the case are thus:

In August 2011, Natco, an Indian generic manufactured applied for a compulsory licence in respect of Bayer’s patent covering an anticancer drug, Sorefanib Tosylate, meant for patients with advanced kidney and liver cancer.

Underlying the Indian Patents Act is the philosophy that if an intellectual property owner abuses her statutorily granted monopoly by engaging in prohibitive pricing (where a patented drug is priced out of the reach of the average consumer) or by failing to supply adequate quantities of the IP good to the public, a compulsory licence will issue (after three years from the date of grant of the patent).

Constituting what many regard as a for compulsory licensing, the Controller General of Patents, PH Kurian found that all the grounds prescribed in section 84 of the Indian Patents Act for the issuance of a compulsory licence had been met, namely:

1. Bayer supplied the drug to hardly 2% of the total patient population of approximately 8000 patients that required the drug. Therefore, the reasonable requirements of the public with respect to the patented drug (Nexavar) were clearly not met.

2. Bayer’s pricing of the drug was excessive and did not constitute a "reasonably affordable" price. It charged Rs 2.8 lakhs for a months' supply of the drug, whereas Natco was willing to supply the same quantity at Rs 8800 per month.

3. Since Bayer did not manufacture reasonable quantities of the drug in India, but merely imported it, it could not be said to have complied with the “working” requirement under the Indian Patents Act. The Controller held in pertinent part that “'worked in the territory of India" under section 84 meant manufactured to a reasonable extent in India."

The Controller then proceeded to issue the licence, stating that Natco ought to pay 6% of its net sales to Bayer as royalty.

Local Working:

The Controllers decision on “local working” is likely to prove controversial, since almost 90% of MNC drugs are not manufactured in India, and therefore susceptible to compulsory licences. However, a close reading of the decision suggests that it is backed by cogent reasons and tenable under the law.

For one, Section 83 of the Act makes clear that patents are not granted only for the purpose of “importation” of the patented product. Secondly, the Indian Patents Act uses the terms "working" and "importation" quite distinctly throughout the Act, making it evident that "working" as used in the Act cannot include "importation".

Some argue that a “local working” provision contravenes the mandate under Article 27 to not “discriminate” between locally produced and imported patented products. Given the fact that in the WTO Canada case, the panel stated that discrimination meant “unjustified differentiation”, one could argue that “local working” is a “justified” differentiation. For one, the Paris Convention clearly stated that “importation” would not amount to working of ��a patent, and that if a patent wasn’t worked, this could be treated as an ��“abuse”. Secondly, TRIPS is premised on the promise of technology transfer to developing countries. And a local working provision is geared towards encouraging such technology transfer. By forcing patentees to “work” their patents in India, the regime encourages local use/transfer of the said technology. A similar provision on “local working” in Brazil’s regime was��challenged by the US—however, the case was later withdrawn and there was no ruling.

This decision of the Indian Patent Office is particularly important since it is not a “government” licence stricto sensu, where the government itself issues and works the licence (sometimes referred to as “government use”), as was the case in Brazil and Thailand. Rather this licence was triggered by the application of a private party (Natco) and the government issued this licence in its capacity as a quasi-judicial authority. In other words, the licence was not issued at the “discretion” of the government, but upon the satisfaction of certain pre-requisites, which when fulfilled, entitled a third party such as Natco to demand a licence.

It bears noting that the licence is very legal in nature and scope and helps temper the excesses of a patent monopoly to achieve public health ends. It is also perfectly compatible with TRIPS, notwithstanding the U.S. Commerce Secretary John Bryson’s that this licence amounted to a “dilution of the international patent regime”

Compulsory Licences and Incentives to�� Innovate

The key question now is: Would such licences decrease incentives to innovate? Thus far, there is no empirical work demonstrating that licences stultify the rate of innovation. The few studies available indicate that licences do not have any significant demonstrable effects on the rate and pace of innovation. Illustratively, empirically tests the rates of patenting and other measures of inventive activity before and after six compulsory licences over drug patents issued in the 1980s and 1990s. She observed no uniform decline in innovation by companies affected by compulsory licences and found very little evidence of a negative impact.

More importantly, one needs to ask whether all countries in the world need to contribute equally to Bayer’s R&D efforts. Or whether countries such as India with significant numbers of poor patients can devise policies to induce lower priced drugs in the market, without worrying excessively about Bayers’ incentives to innovate, given that such incentives are more than adequately provided by western markets such as the US and EU. After all, some of the biggest innovators today benefitted from lax IP regimes in the past. Illustratively, Switzerland, which houses some of the world’s leading refused to introduce product patents till 1977 and it was only after considerable pressure and bullying from Germany that it finally yielded.�� (See Dominique S. Ritter, y, 14 Fordham Intell. Prop. Media & Ent. L.J.��463 (2004).

Lastly, it must be borne in mind that a compulsory licence is not an evisceration of the patent, as is sometimes made out to be in media reports. Rather, it embodies what in their seminal piece describe as a “liability” rule, where the patentee continues to hold the patent and is entitled to a reasonable royalty from every new player entering the market. This advantage (in terms of compensation through royalties) cannot be understated, particularly in a market like India, where the consumer market is highly differentiated in terms of purchasing power. Drug originators typically cater to very high-income consumers, while generics are able to tap into middle and low-income consumer segments as well. Consequently, the possibility of a new generic entrant entering a market segment hitherto untapped by the originator, rather than simply displacing the patentee’s existing customer base is high. To this extent, a compulsory licence may permit an innovator to profit from newer untapped markets.

Shamnad Basheer is the Ministry of HRD Professor of IP Law at the National University of Juridical Sciences (NUJS), Kolkata and founder of Indian IP blog, SpicyIP. He has written on this licensing order at and in an editorial for the . His earlier writings on this theme (including a) were relied on by the Controller General in his order.��

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In late December, industry leader British American Tobacco in Australian courts to pursue damages against a local importer for infringing upon one of its product’s trademarks by covering its packaging with health warnings labels. While the importer conceded that the labels may have partly or entirely obstructed said trademarks, it stressed that it was required by law to do so before the products could be sold in Australia. Indeed, the Australian government has undertaken some strong anti-smoking initiatives.

By 2012, all cigarettes sold in Australia must come in plain packaging with no industry or brand imagery save for “.” Debates over similar measures have raged in Canada, where the federal government that it will increase the size of such warning labels to cover 75% of both the front and back of cigarette packages and will include new and more impactful graphic images.

Not surprisingly, tobacco manufacturers and advocates have protested such initiatives. From a practical view, they argue, there is limited evidence that or actually provide the intended deterrence against smoking. From a legal perspective, they have challenged such diminution of their branding by citing regulations like Article 20 of the World Trade Organization’s , which holds that “use of a trademark... shall not be unjustifiably encumbered by special requirements, such as... [mandating] use in [a] manner detrimental to its capability to distinguish goods and services [from one another].” There is further concern that such trademark attenuation will limit consumers’ ability to distinguish legally manufactured from contraband tobacco products, which poses issues related to , if not .

It remains to be seen whether any of the foregoing will stand up to closer scrutiny, or whether tobacco manufacturers are merely blowing smoke. However, Australia, a fellow commonwealth nation, may prove to be a prescient battleground and signal the arguments and outcomes that we might expect in Canada.

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WTO members on 2 March 2010, debated the question of whether a 2003 decision designed to improve access to medicines is working. Although opinions expressed in the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Council varied, members agreed that they should look at real-life experiences in order to assess the system.

that at an earlier 12th February informal meeting, several members - including Brazil, China, Cuba, Ecuador, Egypt, India, Indonesia and Venezuela -��said that the so-called “paragraph 6” amendment is not working effectively. Paragraph 6 refers to the 2001 WTO Doha Declaration on TRIPS and Public Health, which mandated that WTO members solve the problem of medicines access for countries lacking domestic drug production capabilities. Therefore to address the problems faced by countries with insufficient or no manufacturing capacity in the pharmaceutical sector - the 30 August 2003 decision of the general council was adopted which later converted into an amendment of the TRIPS agreement on 6 December 2005.

This amendment has been used only one time, when Canadian drug firm Apotex sent two shipments of AIDS medicines to Rwanda under Canada’s Access to Medicines Regime (CAMR). The effort was led by the Canadian company, which has said it does not plan to repeat the complicated process. Key dates given by Canada, as��reported by��IP watch, included: May 2005, when domestic regulation to allow for export-oriented compulsory licences (passed by the Canadian Parliament a year before) went into effect; December 2005, when Apotex applied to use the system; June 2006 when Apotex's application��was approved; and July 2007 when Rwanda was identified as Apotex’s customer.�� There is a procedural step required by TRIPS in which the patent holders must be contacted to see if they will provide a voluntary licence. After this failed to produce a licence, Apotex applied for a compulsory licence in September 2007, which was then granted in October 2007. The company then had to undergo a review from Rwanda to obtain public tender. After this was granted in May 2008, the drugs were manufactured for a first delivery date in September 2008, nearly 3 years after Apotex applied to use system.

However, compulsory licensing as a policy mechanism can be used to address a number of situations in the context of public health including high prices of medicines, anti competitive practices by pharmaceutical companies, failure by pharmaceutical patent holders to sufficiently supply the market with needed medicines, emergency health situations and the needs for establishing a pharmaceutical base. Compulsory licensing is important for improving access to essential medicines as well as facilitating the development of innovative capacities and Research and Development especially in developing countries. For example, a local working requirement, which is a ground for the issue of such licences, can be important both for improving access to essential medicines as well as facilitating the��technology transfer obligations envisioned in Article 66 of the TRIPS agreement. Further, the countries in need of cheaper versions of patented pharmaceuticals may increasingly face a situation in which they lack the industrial capacity to produce them, while the foreign supplies are unavailable. Due to lack of technical capacity, adequate equipment, human resources, high costs of production, or other obstacles, many developing countries and the LDCs cannot produce the active ingredients needed to manufacture pharmaceutical products. In these circumstances, compulsory licensing is an alternate solution.

The costly prices of medicines should not curtail every human being’s right to good health and for this reason this right is recognized in certain forms as a fundamental right, both under public international law and the domestic law of many civilized nations.�� It is critical that developed countries realize this and therefore create further room for broader interpretation of compulsory licensing. When considering the question of enabling countries lacking manufacturing capacity in pharmaceuticals to make effective use of compulsory licensing, one consideration is enabling the production of generic medicines on larger scale in a simpler fashion.

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