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Jasmine Yu is anÌęIPilogueÌęWriter and aÌę1L JD Candidate at the University of Toronto.

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

Who is the Patented Medicine Prices Review Board?

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

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

Why Amend?

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

The Amendments

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

There are :

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

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

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

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

A double-edged sword?

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

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

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

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

Conclusion

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

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

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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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Meena Alnajar is an IPilogue Writer, IP Innovation Clinic Fellow, and a 2L JD Candidate at Osgoode Hall Law School.

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Leaves may be falling in time for autumn, but Canada just got a whole lot greener. ESG Clean Energy, LLC ("ESG"), a corporation responsible for clean energy solutions for distributed power generation, announced that they signed with Viking Energy Group, Inc. ("Viking") for use of ESG’s carbon dioxide-free power generation technology in all of Canada. This licence will foster green energy developments by using ESG’s cutting-edge patented technology to generate net-zero carbon emissions from services such as .

The agreement gives Viking the exclusive patent rights to ESG’s technology and knowledge regarding clean energy. The licence is exclusive for all of Canada, which means an of clean energy systems can be built throughout the country. Why did ESG choose to licence its patent rights in such a way? What does each party gain? According to ESG’s President, , the agreement “allows us to provide more effective energy solutions outside the United States by leveraging the experience, expertise, and relationships within the entire Viking and Camber organization." ESG is, in a sense, trying to garner input to enrich green technology for wider audiences. Further, ESG is recognizing that producing green technology should be a global effort to help combat climate change, a global crisis.

An means no person other than the named licensee can use the intellectual property during the patent’s life span. ESG’s granting of a exclusive patent right is broad, which may appear to risk their IP protection. However, wide-scale issues like climate change may need a push to accessible IP and innovative technology. Global issues often alter the patent landscape, encouraging the side-stepping of many patent laws in favour of the public good. More recently, COVID-19 has Ìę waiving the patent rights for COVID-19 vaccines to hasten vaccine production and manufacturing around the world. However, critics pushed back to the idea of a waiver, arguing that IP rights are a in research and production. Mutual agreements for exclusive and broad patent licenses, such as the green technology agreement between ESG and Viking, may be the compromise to promote faster solutions to the world’s growing climate crisis.

ESG and Viking may arguably be driven to increase green technologies by increased profits via more IP licenses and contracting parties. This does not negate the potential positive benefits that may flow from this exclusive licensing for green technology. The International Renewable Energy Agency (“IRENA”) has stressed that decarbonisation in the form of low-carbon technologies needs to happen . Not only are decarbonisation technologies needed to limit global warming, but to protect the global economy as well. IRENA’s research estimates that delaying decarbonisation could due to the devaluation of electrical infrastructure. IRENA suggests is a critical strategy to implement these technologies. ESG’s exclusive patent licensing, with the goal of knowledge sharing and technological development, may thus hold the key to improving our environment.

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

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Brief History of Insulin

In 1921, Dr. Frederick Banting, Charles Best, and James Collip successfully isolated the hormone , discovering a new life-saving treatment for managing diabetes in humans. By 1923, insulin was widely-produced and available to the general public.

Dr. Banting and research facilitator Dr. Macleod, refused to put their names on the patent for the drug, with Banting stating Thus, the first patent application for an insulin patent was filed under Best and Collip’s names. However, as all the co-inventors believed that the medicine should be widely available and not restricted by costs, they sold their intellectual property rights to the University of Toronto for Today, contrary to the co-inventors’ intentions, insulin is highly unaffordable for individuals around the world who rely on the lifesaving treatment, including in the United States.

Insulin Price Rise

Over 30 million people in the U.S. live with diabetes and around a third of them require insulin to survive. From 1960 – 2019, the price of a vial increased from , over forty times the rate of U.S. inflation. Soaring prices have left many with few options besides rationing or skipping doses altogether, a practice that has harmful and To put it in perspective, a carton of insulin costs . Many researchers and doctors attribute these price hikes to lax regulatory measures on drug-pricing in the U.S. How do patents play into this? Only a handful of companies control the market and those companies are increasingly modifying their insulin products, improving them, and typically protecting them with additional patents. It’s a practice that some call the “cost of innovation”. However s for the consumer. Most patients are prescribed the newer, modified formulations, instead of the older ones. Unfortunately, no true affordable generic is currently available. Enter : a group of individuals who hope to make insulin more accessible for everyone. Ìę

Insulin Bio-hackers

is essentially a do-it-yourself (DIY) approach to biology. works to create insulin that is , easily replicable, and most importantly, affordable. The group is comprised of volunteer scientists and community advocates. The . Di Franco himself lives with Type-1 diabetes and was motivated to create the project after witnessing the rising prices of insulin in the U.S.

The project is not limited to the U.S. and, if successful, seeks to provide insulin to other parts of the world where patients similarly struggle to access insulin. To date, the project has made some strides in their discoveries. They announced their first major milestone at the end of 2018, . Open Insulin estimates that they may be able to develop a version of insulin that - a stark difference in price from what is currently available. While optimistic, the project faces various regulatory obstacles. The group will not be able to produce market insulin without the approval. They may, however, publish their findings to help support other biohackers around the globe.

Even if they are unable to release generic insulin to market, their innovative research and goals are making waves, increasing awareness, and inspiring others to push for solutions to the insulin cost problem. Check them out at !

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Ryan Erdman is anÌęIPilogueÌęWriter and a 2L JD Candidate atÌęOsgoodeÌęHall Law School.Ìę

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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%Ìęof 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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Per the Federal Court’s decision in ,Ìęthe Promise Doctrine holds that if a patent application promised a particular utility, it was necessary to prove that function in order to acquire the patent. Furthermore, in the absence of any promised utility, proving even a miniscule amount of utility is enough to be found patentable. Since patents are deemed invalid if there is an insufficiency of utility under s. 2 of the patent act's definition of 'invention' and per paragraph 46 of , the effect of the Promise Doctrine was to substantially raise the bar for applicants that alleged benefits to their inventions by denying patent protections for those who failed to meet the stated promises.

In court, the series of decisions and appeals in the AstraZeneca Canada Inc v Apotex Inc suit focused on whether the Promise Doctrine should be used to find AstraZeneca’s ‘653 patent – pertaining to optically pure salts of the (-) enantiomer of omeprazole, esomeprazole – invalid because the patent promised more utility than it could deliver.

At the , Justice Rennie found two alleged utilities: using esomeprazole as a proton-pump inhibitor (effectively reducing stomach acidity) and having superior pharmokinetic and metabolic characteristics so that its therapeutic profile in clients would be more stable. By applying the Promise Doctrine, the ‘653 patent was found invalid for not meeting the utility requirement of of the Patent Act for the alleged superior therapeutic profile, despite the utility of esomeprazole being proven as a proton pump inhibitor. At the , the judgment of the lower court and the applicability of the Promise Doctrine were affirmed.

However, the decision from the SCC demonstrated that the Promise Doctrine and the analyses of the lower courts run contrary to the form of the Patent Act by conflating the requirements set out in s. 2 and s. 27.3. demands there be some useful aspect of a creation for it to be regarded as an invention at law. If some usefulness is present, the invention must be disclosed as specified in of the Act in its patent application. In , Dickson J clarified that the usefulness standard set out in s. 2 of the Patent Act acts as a “condition precedent to an invention” whereas s. 27.3 merely sets out disclosure requirements that are to be interpreted independently of s. 2. So, the Promise Doctrine goes against the independent interpretation of these two sections of the Act by demanding that the utility requirement set out in s. 2 be fulfilled or predicted at the time of filing, or otherwise find the invention pre-condition for patentability vitiated.

The SCC noted that the Promise Doctrine is also at odds with the Act where multiple utility promises are made. Under the Doctrine, all utility promises would have to be satisfied for the usefulness threshold in s. 2 to be met. However, the opinion of the SCC is that any single use “that is demonstrated or soundly predicted by the filing date” would be adequate to satisfy the demands of s. 2. Requiring all utility promises to be met, would be “unfair” and can lead to “otherwise useful invention[s] to be deprived of patent protection” simply because some promises were not demonstrated or predicted.

Given the highly experimental and sometimes tangential nature of innovation, a lack of protection for inventions that have managed to achieve some, but not all, of the promised utilities highlights the the Promise Doctrine appears to have on research and development. Citing the work of , and , , the SCC found that “inventions are like a many-faceted prism: multiple claims
 covering all facets are allowed in the same patent if a single general inventive concept links them.”

Considering a multiplicity of promises is especially important in pharmaceutical development and organic syntheses where broad, overarching concepts like an improved therapeutic profile may be anticipated, but not proven in full. The possibility of off-target therapeutic effects or side-effects can make an exacting prediction of utility difficult and, under the Promise Doctrine, may bar legal protection. After all, as the SCC established in ., “the patent regime has a dual purpose – to incentivise [creation] and to encourage inventors to publicly disclose [their knowledge] for society’s benefit.” If the bar for acquiring a patent is set too high, some inventors may get cold feet.

Dominic Cerilli is the IPilogue content editor and social media coordinator as well as a JD candidate at Osgoode Hall Law School.

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What is CRISPR?

Some scientists believe the design and development of new biomolecules is as much an art as it is science. The Ìędiscussed, and used, by Dr. Pearlman capitalizes on an adaptive immunity system found naturally in bacteria and archaea that uses clustered, regularly interspaced short palindromic repeat (CRISPER) DNA segments to fend off invading viruses. In naturally adapting to a virus invading the cell, CRISPR associated proteins (Cas proteins) will create a spacer unit of genetic code that is unique to the invading virus and incorporate this spacer into the CRISPR region of the cell’s genome. This unique spacer unit will then be transcribed (that is, converted from double stranded DNA to RNA), associate with Cas proteins to form a functional complex, and then target and inactivate the very same type of virus that led to the creation of the spacer unit.

In the laboratory, genome editing uses the functional complex found in this adaptive immunity mechanism to insert or remove genetic code from the genome of a cell. By attaching a synthetic, guiding portion of RNA (sgRNA) to Cas proteins they can be directed to a portion of the genome, through complimentary base pairing with the sgRNA, where Cas will recognize a portion of the genome and cut it to either insert a new region or to remove a portion and disrupt the expression of a gene. By cutting out sections of DNA a gene can be disrupted and lose its functional expression in the cell. In other words, it will no longer be able to produce the molecular products responsible for its former physical trait. By inserting new regions of DNA, the genome can be expanded to confer resistance to invading pathogens, such as viruses, or to express new protein products that can add or enhance the cell’s function. For example, a new portion of DNA may be inserted that codes for a digestive protein not normally found in the cell and, consequently, grant a new molecular digestive mechanism.

What does Genome Editing have to do with Law?

Dr. Pearlman noted that there has been an explosion of scientific literature covering the CRISPR system of genome editing since 2010 and it appears that the momentum will only grow in the coming years. The ability to edit genomes can allow for the expression of new protein products that can be of great commercial value as well as pave the way for new medical treatments that circumvent traditional pharmaceuticals. Additionally, Dr. Pearlman noted that the CRISPR system can be used to produce heritable traits – that is, changes that can be transferred from a parent to their offspring. With this sort of molecular modification becoming more pragmatic, it becomes paramount to have a thorough understanding of the biochemical expression pathways that govern genomic expression to keep an eye on the ethical implications of modification. If human genome editing were to become available, should those with advantageous genomic modifications be treated differently by public health systems? To whom should these technologies be made available, if ever? These questions are beyond the scope of current genomic technology but, with the growing pace of CRISPR methodologies, designs may soon start to reach more readily into the macroscopic domain.

What Makes Scientific Designs Different?

With the cost of biochemical research and development increasing and a billion-dollar entry fee for the drug and biomolecular development market it follows that when an industrially relevant molecule is finally created the developer should be able to recuperate their investment and benefit from their work. Normally, the boundaries of property rights require contextual understanding: what is the nature of comparable products, if the new product’s design is generic or obvious, and if the new product can have a place in its intended market. The differentiating criteria of the sciences become pronounced when considering the esoteric nature of the discipline. How can one reasonably expect a thorough consideration of the distinguishing criteria for obscure scientific concepts, like base pair fidelity, when the requisite knowledge is held only by a few people, like Dr. Pearlman, who have committed years, if not decades, to the study? The nuanced nature of genetics can make innovations in genome editing or CRISPR technology appear to be near imitation; however, the modification of a single nucleotide in the genetic code can have a profound impact on the success and possible application of a biotechnology.

Synthesis, Structure, and Industry

What amount of scientific knowledge is sufficient in legal practice? that a special breed of IP lawyer will arise to confront the high demands of contemporary science and technology patents. Considering the high financial stakes and the significant likelihood that a new molecule or molecular technique will fail the requisite safety tests at any of a multitude of stages, a lot of designs are left in the laboratory. A re-engineering of the approach or scrapping the project in its entirety may follow, meaning product patents should not be initiated until after the molecule has been proven safe for its regular use instead of when it is first designed or synthesized in the lab. Additionally, research and development can indirectly prioritize self-benefit over scientific collaboration since scientists rely on design details to learn about their ever-developing field and most details are kept secret until after a patent has been granted.

This is where innovation becomes conservative and structure becomes especially important. Does a single elemental substitution in the genetic code constitute a new product if the application remains the same? What about changing a single gene to modify a physical characteristic that relies on multiple genes? While certain business practices, such as non-competition deals, are commonly found outside of the sciences, unique can arise from small chemical modifications which effectively extend a patent beyond its expiry date through the issuing of a new patent for a highly similar molecule. Furthermore, patents may be sought for generic parts of biotechnology procedures that are nonessential to its action, prohibiting competitors from including strategies in their approach and significantly , or even demolishing, a competing synthesis. Lastly, meeting the testing and safety demands of different communities poses an for introduction into a global market due to different national regulatory standards.

So, What Makes It My Molecule?

The same fundamental concepts that apply to patents outside of genome engineering also apply to those inside the discipline but with a stringent demand to understand the nuances of molecular design. An integration of mechanistic knowledge may prove to be key when evaluating possible distinguishing criteria among patents filed for similar compounds but it is ultimately up to practicing lawyers to integrate sufficient scientific knowledge to accurately capture the scope of their client’s designs.

Dominic Cerilli is the Content Editor for the IPilogue and a JD Candidate at Osgoode Hall Law School.

[1] Dr. Pearlman's talk was organized by The 91ŃÇÉ« Collegium for Practical Ethics and The 91ŃÇÉ« Centre for Public Policy and Law under the leadership of Ian Stedman.Ìę Support for the event was provided by IP Osgoode, McLaughlin College, 91ŃÇÉ« - Faculty of Health, 91ŃÇÉ« - Faculty of Science, and 91ŃÇÉ«'s Office of the VPRI.

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The Medicines Patent Pool

The (MPP) is a United Nations-backed organization that aims to improve access to HIV medicines for people living in LDCs. In 2014 they launched the (PHTI) to focus on a pressing concern in the African continent: overcoming barriers to develop paediatric formulations of HIV medications. In , they obtained a licence from Merck to develop paediatric formulations of raltegravir, adding this key drug to their pool that already includes lopinavir and ritonavir with AbbVie Inc.

In the , generic manufacturers in the specified LDCs are allowed to research and develop alternate or improved formulations of raltegravir for children. Considering those living in LDCs cannot afford these medications, Merck will not be cannibalizing its own sales. This agreement is significant because Merck retains the right of first refusal of licensure or purchase if the manufacturer develops an improved formulation and intends to market the product outside of the specified countries they serve.

A Unique Opportunity

Improved or altered formulations are methods for drug manufacturers to retain a portion of market share when the patent of the original drug expires (see for exampleÌęÌęandÌę). By expanding the range of licensing agreements beyond HIV medications, drug manufacturers can outsource R&D of new formulations of their patented drugs at no upfront cost, while improving access to life-saving medicines in LDCs. Empowering LDCs to develop its own drug manufacturing industries has many advantages overÌęthe traditional method of directly donating medications.

Win-Win?

In the years to come the effects of the patent cliff will continue to eliminate important sources of revenue for Big Pharma. These companies also face the need to increase R&D budgets to avoid grinding drug development to a halt. Undoubtedly, cost-effective ways to extract value from current patents will be crucial. Thus, Big Pharma should pursue an expansion of licensing opportunities with organizations such as MPP with great interest since it serves the dual purpose of improving drug access in developing nations while potentially extending the life cycle of their patented drugs.

Jason Ho is an IPilogue Editor and a JD Candidate at Osgoode Hall Law School.

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In the intellectual property arena, Congress enacted the Leahy-Smith America Invents Act[4] in September 2011, providing a complete overhaul of the U.S. patent system. The next year, high-stakes patent trials resulted in three eye-popping verdicts, each exceeding $1 billion.[5]Ìę By the end of the 2012 Term, the United States Supreme Court has reviewed an unusually large number of patent cases.[6]Ìę As Timothy Holbrook reminded us:

Starting in around 2000, the Supreme Court became active, if not even hyperactive, in patent law. . . . Additionally, the Supreme Court’s intervention is no longer on the periphery of patent law. The cases they have decided go right to the substance of patent law: the doctrine of equivalents and prosecution history estoppel, subject matter eligibility, induced infringement, the statutory experimental use defense, to name but a few.[7]

Of great interest in the 2012 Term was Association for Molecular Pathology v. Myriad Genetics, Inc.[8]Ìę Lying at the intersection of intellectual property and public health, this case concerned the patentability of composition and method claims covering two isolated human genes associated with breast and ovarian cancers as well as their alterations and mutations. In a surprisingly short decision, Justice Clarence Thomas held that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that [synthetically created DNA segment known as complementary DNA] is patent eligible because it is not naturally occurring.”[9]Ìę He further noted that the case did not involve patent claims in “an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes,” “patents on new applications of knowledge about the BRCA1 and BRCA2 genes,” and “the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.”[10]Ìę Although it is too early to assess the full implications of this narrowly written decision, it is not hard to appreciate the decision’s potential impact on U.S. biotechnology and life science industries. Myriad Genetics will also raise important questions about the appropriate level of patent protection in relation to the development of biologics[11] and diagnostic kits.[12]

At the international level, there has been a decade-long, but still vibrant, debate about the major impediments the Agreement on Trade-Related Aspects of Intellectual Property Rights[13] (“TRIPS Agreement”) has generated to access to essential medicines in less developed countries—a term used collectively to cover both developed and least developed countries as identified within the World Trade Organization (“WTO”).[14]Ìę Since the TRIPS Agreement entered into force in January 1995, it not only has taken away the wide policy space less developed countries once enjoyed at the international level,[15] but it has also resulted in needless deaths and suffering to patients that have acquired either the human immunodeficiency virus (“HIV”) or the Acquired Immune Deficiency Syndrome (“AIDS”).[16]Ìę The pandemic caused by HIV/AIDS, malaria, and tuberculosis has also greatly reduced the productivity of many countries in sub-Saharan Africa.[17]

In December 2013, WTO member states met in the Ninth Ministerial Conference in Bali, with the hope of reviving the Doha Development Round of Trade Negotiations (“Doha Round”).[18]Ìę This ministerial conference was held a few months after WTO members agreed at the Council for Trade-Related Aspects of Intellectual Property Rights (“TRIPS Council”) to extend the transition period for least developed countries.[19]Ìę Article 66 of the TRIPS Agreement initially set the period at ten years.[20]Ìę In November 2005, shortly before the Sixth Ministerial Conference in Hong Kong, WTO members agreed to extend the period for seven-and-a-half years until July 1, 2013, as long as the extension-seeking country has not yet met the TRIPS requirements or has not already offered protection in excess of those requirements.[21]Ìę Building on Haiti’s formal request for another extension on behalf of the Least Developed Countries Group,[22] the June 2013 TRIPS Council decision further extended the transition period for eight years until July 1, 2021 without the earlier “non-rollback” commitment.[23]

Notwithstanding this recent extension for least developed countries, there remains another deadline that is highly important to the global access to medicines debate. This deadline concerns the ratification of the protocol to amend the TRIPS Agreement, which WTO member states adopted also shortly before the Hong Kong Ministerial.[24]Ìę If ratified by two-thirds of the WTO membership, the new Article 31bis would allow countries with insufficient or no manufacturing capacity to import generic versions of patented pharmaceuticals. Although the initial deadline for ratification was December 1, 2007, that deadline has since been extended four times to December 31, 2015. As of this writing, slightly less than a third of the 159 WTO member states have ratified the proposed amendment.[25]Ìę If the amendment fails to attain the requisite ratifications by the new deadline, this deadline will have to be extended again.[26]

Sadly, with all the interrelated developments in the intellectual property and public health arenas both within and outside the United States, the domestic debate remains surprisingly disconnected from the international debate. Because of this disconnect, the laws and policies Congress and the administration adopt often do not synchronize with developments abroad. To help bridge this disconnect, this Article discusses the interrelationship between intellectual property and public health in the context of communicable diseases. This type of disease is intentionally picked to highlight how developments abroad could easily affect what happens at home, and vice versa.

Parts I to III of this Article recount three distinct “virostories”—stories about viruses responsible for AIDS, the Severe Acute Respiratory Syndrome (“SARS”),[27] and the avian influenza.[28]Ìę Part I discusses the ongoing developments within the WTO concerning efforts to address the access-to-medicines problems in relation to HIV/AIDS and other pandemics. Part II documents the unusual race among research and health institutions in Canada, Hong Kong, and the United States to patent technologies involving the isolated gene sequences of the SARS coronavirus. This Part also explores the use of patenting as a defensive measure and the development of patent pools as a solution to prevent the creation of a patent thicket. Part III examines the recent efforts by Indonesia, India, and other members of the Non-Aligned Movement to claim sovereignty over viruses found within their jurisdictions. This Part focuses on the H5N1 strain of the avian influenza virus in Indonesia.

To help illustrate the need to take a global, holistic, multidisciplinary socio-legal approach, which will be the focus of the second half of this Article, Parts I to III embrace the narrative technique. Such a technique enables the stories to be told in a way that would be meaningful to those participating in both the intellectual property and public health debates. The thick descriptions the article provides also highlight related issues on cross- border trade, global governance, human development, North-South relations, international sovereignty, human rights protection, and medical and biological ethics. With a wide range of characters, openings, plot twists, and endings, these virostories provide insight into the different facets of the international patent debate. By bringing together HIV/AIDS, SARS, and H5N1, this Article will further remind policymakers that the discussion on the TRIPS Agreement should not focus so much on the HIV/AIDS crisis in the less developed world to the point that they ignore other similar problems created by an out-of-balance intellectual property system.[29]

Part IV draws seven important lessons from the three earlier narratives to advance a new, integrated approach to setting international intellectual property norms. This new approach takes account of both the existing problems concerning the TRIPS Agreement and the new problems precipitated by the negotiation of the Anti-Counterfeiting Trade Agreement (“ACTA”),[30] the Trans-Pacific Partnership (“TPP”) Agreement,[31] and other nonmultilateral trade and investment agreements.[32]Ìę Tying domestic laws and policies to the international debate, this Part focuses on three sets of issues that often come up in the international intellectual property norm- setting process: negotiation gains, the negotiation process, and negotiated outcomes.

By bringing together both the descriptive and the prescriptive, this Article seeks to drive home the message that the international intellectual property and public health debates could easily spill over into the domestic debates, and vice versa. Just as viruses do not recognize national boundaries[33]—as health professionals have repeatedly warned us— policymakers and commentators should also think more holistically and globally about the connections between the domestic and international debates and between developments in the intellectual property and public health arenas. After all, there are non-altruistic reasons for developed countries to promote access to essential medicines in the less developed world.

Featured here is the Introduction of a paper by , IP Osgoode Research Affiliate, Kern Family Chair in Intellectual Property Law and Founding Director of the Intellectual Property Law Center at Drake University Law School. Born and raised in Hong Kong, Professor Yu is a leading expert in international intellectual property and communications law. He also writes and lectures extensively on international trade, international and comparative law, and the transition of the legal systems in China and Hong Kong. The full article was published in 45 Ariz.St. L. J. 1564 (2013) and can also be found .

[1] Pub. L. No. 111-148, 124 Stat. 119 (2010).

[2] Pub. L. No. 111-152, 124 Stat. 1029 (2010).

[3] Nat’l Fed’n of Indep. Bus. v. Sebelius, 132 S. Ct. 2566, 2608 (2012).

[4] Pub. L. No. 112-29, 125 Stat. 284 (2011).

[5] See Amanda Bronstad, IP Awards Dominate, NAT’L L.J., Mar. 4, 2013, http://www.law.com/jsp/nlj/PubArticleNLJ.jsp?id=1202590587509&slreturn=20131006195123 (reporting the verdicts from the lawsuit Carnegie Mellon University filed against Marvell Technology, the lawsuit Apple filed against Samsung Electronics, and the lawsuit Monsanto filed against DuPont).

[6] For a discussion of the Court’s growing interest, see generally Timothy R. Holbrook, Explaining the Supreme Court’s Interest in Patent Law, 3 IP THEORY 62 (2013).

[7] Id. at 63–64 (footnotes omitted). 8. 133 S. Ct. 2107 (2013).

[8] 133 S. Ct. 2107 (2013).

[9] Id. at 2111.

[10] Id. at 2119–20.

[11] For discussions of intellectual property issues in relation to biologics, see generally Donna M. Gitter, Innovators and Imitators: An Analysis of Proposed Legislation Implementing an Abbreviated Approval Pathway for Follow-on Biologics in the United States, 35 FLA. ST. U. L. REV. 555 (2008); Christopher M. Holman, Maintaining Incentives for Healthcare Innovation: A Response to the FTC’s Report on Follow-on Biologics, 11 MINN. J.L. SCI. & TECH. 755 (2010); Gregory N. Mandel, The Generic Biologics Debate: Industry’s Unintended Admission that Biotech Patents Fail Enablement, 11 VA. J.L. & TECH. 8 (2006); Symposium, Follow-on Biologics: Implementation Challenges and Opportunities, 41 SETON HALL L. REV. 501 (2011).

[12] See, e.g., EDSON BEAS RODRIGUES JR., THE GENERAL EXCEPTION CLAUSES OF THE TRIPS AGREEMENT: PROMOTING SUSTAINABLE DEVELOPMENT 168–69 (2012) (discussing the impact of gene patents on the development of diagnostic kits); Rochelle C. Dreyfuss & James P. Evans, From Bilski Back to Benson: Preemption, Inventing Around, and the Case of Genetic Diagnostics, 63 STAN. L. REV. 1349, 1361–70 (2011) (providing a case study of patent-related issues arising in genetic diagnostics).

[13] Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh AgreementEstablishing the World Trade Organization, Annex 1C, 108 Stat. 4809, 869 U.N.T.S. 299 [hereinafter TRIPS Agreement].

[14] See Peter K. Yu, The International Enclosure Movement, 82 IND. L.J. 827, 858–62 (2007) (discussing these deleterious impacts). For book-length discussions of access-to- medicines problems in relation to the TRIPS Agreement, see generally SUDIP CHAUDHURI, THE WTO AND INDIA’S PHARMACEUTICALS INDUSTRY: PATENT PROTECTION, TRIPS, AND DEVELOPING COUNTRIES (2005); HOLGER HESTERMEYER, HUMAN RIGHTS AND THE WTO: THE CASE OF PATENTS AND ACCESS TO MEDICINES (2008); CYNTHIA M. HO, ACCESS TO MEDICINE IN THE GLOBAL ECONOMY: INTERNATIONAL AGREEMENTS ON PATENTS AND RELATED RIGHTS (2011); INTELLECTUAL PROPERTY, PHARMACEUTICALS, AND PUBLIC HEALTH: ACCESS TO DRUGS IN DEVELOPING COUNTRIES (Kenneth C. Shadlen et al. eds., 2012); VALBONA MUZAKA, THE POLITICS OF INTELLECTUAL PROPERTY RIGHTS AND ACCESS TO MEDICINES (2011); NEGOTIATING HEALTH: INTELLECTUAL PROPERTY AND ACCESS TO MEDICINES (Pedro Roffe et al. eds., 2006) [hereinafter NEGOTIATING HEALTH].

[15] See generally Yu, The International Enclosure Movement, supra note 14, at 855–72 (discussing the growing enclosure of the policy space of less developed countries at the international level).

[16] For discussions of access-to-medicines problems in relation to HIV/AIDS, see generally THE GLOBAL GOVERNANCE OF HIV/AIDS: INTELLECTUAL PROPERTY AND ACCESS TO ESSENTIAL MEDICINES (Obijiofor Aginam, John Harrington & Peter K. Yu eds., 2013) [hereinafter GLOBAL GOVERNANCE OF HIV/AIDS]; THE POLITICAL ECONOMY OF HIV/AIDS IN DEVELOPING COUNTRIES: TRIPS, PUBLIC HEALTH SYSTEMS AND FREE ACCESS (Benjamin Coriat ed., 2008) [hereinafter POLITICAL ECONOMY OF HIV/AIDS].

[17] See FRANKLYN LISK, GLOBAL INSTITUTIONS AND THE HIV/AIDS EPIDEMIC: RESPONDING TO AN INTERNATIONAL CRISIS 82–92 (2009) (discussing the impact of HIV/AIDS on human resource capacity); Wolfgang Hein et al., Introduction: Globalization, HIV/AIDS and the Rise of Global Health Governance, in GLOBAL HEALTH GOVERNANCE AND THE FIGHT AGAINST HIV/AIDS 1, 7 (Wolfgang Hein et al., eds., 2007) [hereinafter FIGHT AGAINST HIV/AIDS] (“HIV/AIDS and infectious diseases strike hardest at the productive parts of the population, at the pool of experienced individuals that would qualify for leading positions in society, leading to economic decline.”); Colin McInnes, National Security and Global Health Governance, in GLOBAL HEALTH GOVERNANCE: CRISIS, INSTITUTIONS AND POLITICAL ECONOMY 42, 48 (Adrian Kay & Owain David Williams eds., 2009) [hereinafter GLOBAL HEALTH GOVERNANCE] (noting the “disproportionate impact [of HIV/AIDS] upon workers in what should be the most productive period of their lives”); Geoff Tansey, Introduction: Legal Fictions and Public Health, in NEGOTIATING HEALTH, supra note 14, at 1, 2 (noting that, in rural Africa, “HIV/AIDS is devastating farming families and undermining their ability to farm”); Srividhya Ragavan, The Jekyll and Hyde Story of International Trade: The Supreme Court in PhRMA v. Walsh and the TRIPS Agreement, 38 U. RICH. L. REV. 777, 821 (2004) [hereinafter Ragavan, Jekyll and Hyde] (“An epidemic increase of AIDS reduced life expectancy and affected labor and economic output, as the younger casualties increase. Consequently, national productivity declined in several developing nations since the loss of labor from the loss of each life affected a proportionate value of output.” (footnotes omitted)); Yu, The International Enclosure Movement, supra note 14, at 855 (“At the macro level, health problems could also lower the productivity of a country—to the point that it will fall behind its trading partners in terms of economic development, technological innovation, industrial progress, and national competitiveness.”).

[18] Press Release, World Trade Org. [WTO], Bali Ministerial to Be Held 3–6 December 2013 (Dec. 11, 2012), http://www.wto.org/english/news_e/news12_e/gc_11dec12_e.htm.

[19] Press Release, WTO, The Least Developed Get Eight Years More Leeway on Protecting Intellectual Property (June 11, 2013), http://www.wto.org/english/news_e/ news13_e/trip_11jun13_e.htm.

[20] TRIPS Agreement art. 66.

[21] Press Release, WTO, Poorest Countries Given More Time to Apply Intellectual Property Rules (Nov. 29, 2005), http://www.wto.org/english/news_e/pres05_e/pr424_e.htm.

[22] Communication from Haiti on Behalf of the LDC Group, Request for an Extension of the Transitional Period Under Article 66.1 of the TRIPS Agreement, IP/C/W/583 (Nov. 5, 2012). Haiti initially proposed to extend the transition period “for as long as the WTO Member remains a least developed country.” That proposal, though eventually failed, earned the support of the Joint United Nations Programme on HIV/AIDS (UNAIDS), the United Nations Development Programme (UNDP), and more than 300 civil society organizations. See UNAIDS & UNDP, TRIPS Transition Period Extensions for Least-developed Countries 6 (UNAIDS, Issue Brief, 2013), http://www.unaids.org/en/media/unaids/contentassets/documents/ unaidspublication/2013/JC2474_TRIPS-transition-period-extensions_en.pdf [hereinafter UNAIDS/UNDP Issue Brief] (calling on the WTO members to give “close and immediate attention” to the extension request from least developed countries); Catherine Saez, WTO: LDCs to Press for Extension for TRIPS, Plain Packaging Back, INTELL. PROP. WATCH (Feb. 26, 2013, 2:15 PM), http://www.ip-watch.org/2013/02/26/wto-ldcs-to-press-for-extension-for-trips-plain- packaging-back (reporting the support least developed countries received from UNAIDS, UNDP, and civil society organizations).

[23] Council for Trade-Related Aspects of Intellectual Property [TRIPS Council], Extension of the Transition Period Under Article 66.1 for Least Developed Country Members: Decision of the Council for TRIPS of 11 June 2013, IP/C/64 (June 11, 2013). For discussions of this extension, see generally Frederick M. Abbott, Technical Note: The LDC TRIPS Transition Extension and the Question of Rollback (ICTSD Programme on Innovation, Technology and Intellectual Property, Policy Brief No. 15, 2013), available at http://ictsd.org/ downloads/2013/05/the-ldc-trips-transition-extension-and-the-question-of-rollback.pdf; Arno Hold & Bryan Christopher Mercurio, After the Second Extension of the Transition Period for LDCs: How Can the WTO Gradually Integrate the Poorest Countries into TRIPS? (NCCR Trade Regulation, World Trade Institute, University of Bern, Working Paper No. 2013/42, 2013), available at http://ssrn.com/abstract=2302335.

[24] General Council, Amendment of the TRIPS Agreement, WT/L/641 (Dec. 8, 2005) [hereinafter TRIPS Amendment], available at http://www.wto.org/english/ tratop_e/trips_e/wtl641_e.htm; see also Yu, The International Enclosure Movement, supra note 14, at 872–86 (tracing the development of Article 31bis of the TRIPS Agreement).

[25] Members Accepting Amendment of the TRIPS Agreement, WTO, http://www.wto.org/english/tratop_e/trips_e/amendment_e.htm (last updated Oct. 21, 2013) [hereinafter Members Accepting Amendment].

[26] See General Council, Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, ¶ 11, WT/L/540 (Sept. 1, 2003), 43 I.L.M. 509 (2004) [hereinafter August 30 Decision] (stating that the waivers granted in this decision “shall terminate for each Member on the date on which an amendment to the TRIPS Agreement replacing its provisions takes effect for that Member”).

[27] For discussions of SARS, see generally THOMAS ABRAHAM, TWENTY-FIRST CENTURY PLAGUE: THE STORY OF SARS (2007); TIM BROOKES, BEHIND THE MASK: HOW THE WORLD SURVIVED SARS, THE FIRST EPIDEMIC OF THE 21ST CENTURY (2004); DAVID P. FIDLER, SARS, GOVERNANCE AND THE GLOBALIZATION OF DISEASE (2004); KARL TARO GREENFELD, CHINA SYNDROME: THE TRUE STORY OF THE 21ST CENTURY’S FIRST GREAT EPIDEMIC (2006); WORLD HEALTH ORG. [WHO], SARS: HOW A GLOBAL EPIDEMIC WAS STOPPED (2006) [hereinafter HOW A GLOBAL EPIDEMIC WAS STOPPED].

[28] See generally AVIAN INFLUENZA: SCIENCE, POLICY AND POLITICS (Ian Scoones ed., 2010) [hereinafter AVIAN INFLUENZA] (discussing avian influenza).

[29] As the U.K. Commission on Intellectual Property Rights reminded us:

It is particularly important not to allow the debate in [the intellectual property] area to be influenced unduly by the HIV/AIDS experience, dramatic though it is. Apart from HIV/AIDS, which is the biggest single cause of mortality in developing countries, TB and malaria claim almost as many lives. Together all three diseases claimed nearly six million lives [in 2001], and led to debilitating illness for millions more. In addition, there are a number of less common diseases which are collectively important. These include, for instance, measles, sleeping sickness, leishmaniasis and Chagas disease.

COMM’N ON INTELLECTUAL PROP. RIGHTS, INTEGRATING INTELLECTUAL PROPERTY RIGHTS AND
DEVELOPMENT POLICY: REPORT OF THE COMMISSION ON INTELLECTUAL PROPERTY RIGHTS 30
(2002) [hereinafter IPR COMMISSION REPORT] (footnote omitted).

[30] Anti-Counterfeiting Trade Agreement, opened for signature May 1, 2011, 50 I.L.M. 243 (2011) [hereinafter ACTA].

[31] See Trans-Pacific Partnership, OFFICE OF THE U.S. TRADE REP., http://www.ustr.gov/tpp (last visited Nov. 7, 2013) (providing up-to-date information about the TPP).

[32] See, e.g., Central America–Dominican Republic–United States Free Trade Agreement, May 28, 2004 [hereinafter CAFTA-DR], available at http://www.ustr.gov/trade- agreements/free-trade-agreements/cafta-dr-dominican-republic-central-america-fta/final-text; United States–Australia Free Trade Agreement, U.S.-Austl., May 18, 2004 [hereinafter AUSFTA], available at http://www.ustr.gov/trade-agreements/free-trade-agreements/australian- fta/final-text; United States–Singapore Free Trade Agreement, U.S.-Sing., May 6, 2003 [hereinafter SUSFTA], available at http://www.ustr.gov/sites/default/files/ uploads/agreements/fta/singapore/asset_upload_file708_4036.pdf. For discussions of bilateral, plurilateral, and regional trade agreements, see sources cited in Peter K. Yu, Intellectual Property and Human Rights in the Nonmultilateral Era, 64 FLA. L. REV. 1045, 1046 n.1 (2012). For a discussion of intellectual property provisions in international investment agreements, see generally Bryan Mercurio, Awakening the Sleeping Giant: Intellectual Property Rights in International Investment Agreements, 15 J. INT’L ECON. L. 871 (2012).

[33] As Colin McInnes observed:

Health threats, the provision of health care services and the market for pharmaceuticals are increasingly transborder in nature. In terms of health security, this makes defence ‘at the border’ a near impossibility despite efforts by states to do just that. The state can no longer function as a self- contained vessel for health provision (and indeed health security), rather it has become permeable. This is most obliviously the case with infectious disease where the processes of globalization have enabled disease to spread more quickly.

McInnes, supra note 17, at 44 (citation omitted); accord FIDLER, supra note 27, at 13–16 (discussing the “germs do not recognize borders” mantra of public health); MARK W. ZACHER & TANIA J. KEEFE, THE POLITICS OF GLOBAL HEALTH GOVERNANCE: UNITED BY CONTAGION 1 (2008) (“[T]he world is becoming an ever smaller place, and microbes that cause devastating diseases do not stop for border guards.”).

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In last week, Berners-Lee was responding to recent revelations of state-based surveillance in the United States and elsewhere. The father of the web also contends that a ‘digital Magna Carta’ would need to address the often-conflicting rights of users and producers in online environments.

Calls for the calibration of competing rights are not new. At least since the early 2000s, legal scholars and social scientists such as , , and have articulated about reforming intellectual property (IP) laws for emerging realities. The proliferation of digital and networked technologies continues to facilitate social, economic, and political shifts. New transnational political economic arrangements are premised on the ability to employ information and communication technologies (ICTs) to coordinate global production chains. studying the impacts of the ICTs that decentralized, network technologies are transforming historic relations generated during industrial economic times. Advocates for the rights of creators point out how these changes are disrupting existing business models and threatening entire industries.

IP law regimes—most often in the forms of copyrights, patents, and trademarks—are used to incentivize creative endeavours and to protect the moral rights of creators. In doing so, these legal regimes help to convert knowledge—communicative and cultural resources that circulate within communities and contribute to their maintenance and growth—into marketable forms of rent-seeking information.

However, suggests that these systems have led to two contradictory outcomes: increasing returns for rights-holders and a “digital divide”, whereby there is increasing disparity between the ‘haves’ and ‘have-nots’ of contemporary capitalism. Scholars Tzen Wong, Graham Dutfield, and their contributors that IP law is regarded as playing various roles in the maintenance of this development disparity. From this perspective, the ‘digital divide’ is a symptom of the global political economy, within which growing inequality between and within states is exacerbated due to differing levels of access to and control over digital technologies and content.

Govindan Parayil, while knowledge-based economic activities generate growth and wealth for the owners of proprietary information; this also results in inequity for those with restricted or no access to this information and the ability to use existing knowledge in productive ways. A of transnational corporations conducted by Sean Starrs, a PhD Candidate at 91ŃÇÉ«, highlights how the contemporary political economy is marked by the concentration of wealth in developed states, particularly the United States.

Bridging the digital divide between and within states is becoming a key focus of international and domestic policy initiatives. Civil-society organizations as well as governmental and international organizations and forums have proposed ‘information-communication technologies for development’ (ICT4D) as a means of enabling greater connectivity for disadvantaged persons in post-industrial as well as industrializing states. ICT4D proposes that the proliferation of ICTs will alleviate poverty and inequality by providing new groups with the technological tools necessary to engage in capitalist activities. However, as Jan Nederveen Pieterse , this approach often fails to recognize that the digital divide is not entirely digital; instead, the digital divide entails socioeconomic considerations, including the ability to use ICTs as well as digital content for various purposes.

Human rights-based claims are becoming prominent in struggles to address economic inequality and bridge the digital divide. For example, Access to Knowledge (A2K) movements related to international intellectual property debates challenge the privileging of economic and proprietary rights over the rights of users, citizens, and consumers.

, Professor of Information Studies at Syracuse University, A2K movements focused on a number of areas—including life saving medicine, educational materials, biodiversity and the prevention of famine as well as knowledge circulation in digital contexts—have “become a master frame linking many formerly disparate elements of communication and information politics, business, policy, and law. As an intellectual and political movement, A2K is based on a reappraisal of the nature of property rights over information and networks” (p. 12).

As Internet governance and informational policies are adapted to meet contemporary realities, addressing and balancing these sets of rights will be important for bridging the digital divide and economic inequality.

Note: This post is based upon a paper that the author will present at the in Toronto, Canada and reflects the on-going work of his dissertation.

Joseph F. Turcotte is an IPilogue Editor, a PhD Candidate and SSHRC Doctoral Fellow in the Communication & Culture Program (Politics & Policy) at 91ŃÇÉ«, and a Nathanson Graduate Fellow at the Jack & Mae Nathanson Centre on Transnational Human Rights, Crime and Security at Osgoode Hall Law School.

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