Meena Alnajar is an IPilogue Senior Editor and a 3L JD Candidate at Osgoode Hall Law School .

A protects your intangible property from others’ use, but what happens when patent protection operates in a way that ensures no other innovators can build upon a patented invention? When IP and competition clashes, authorities will step in to regulate as demonstrated in a recent dawn raid.

On September 13, 2022 the Swiss Competition Commission (“COMCO”) the pharmaceutical company Novartis’ headquarters in Switzerland at . A rather unusual visit, COMCO proceeded to raid the company’s headquarters for all information related to an unidentified . According to the regulator, the drug’s patent could be a blocking patent used to prevent competing products’ entry into the market. Novartis is allegedly protecting its dermatology drug by using one patent to launch proceedings against possible competitors in the market. Here we see IP and competition law colliding with blocking patents wielded as an anti-competitive tool.

A blocking patent can prevent another inventor from using the patent’s technology or improving it. A blocking patent is often cited by during the patent application examination phase to block a patent application or a patent’s challenger (such as those claiming an existing patent should be invalid). On July 22, 2021, held in Chemours v. Daikin that “[a] blocking patent is one that is in place before the claimed invention because such a blocking patent may deter non-owners and non-licensees from investing the resources needed to make, develop, and market such a later, ‘blocked’ invention.” A blocking patent is therefore broad in scope to deter people from innovating in any way related to the blocking patent. Overall, these patents are a helpful business tool, blocking a competitor to conserve the patent’s commercial success while also observing where competitors are attempting to . But when too successful, the blocking patent has a on competition. Innovators’ fear of overtakes their willingness to build on the invention and the blocking patent becomes an anti-competitive red flag to regulators.

In the Novartis , authorities are questioning whether Novartis is acting appropriately with its drug patent. The investigation is still in its and in the company have slightly fallen after the raid was announced. Regulators unexpectedly taking a business’ commercially sensitive information is not ideal. The investigation thus raises a further question, when does a business’ patent portfolio become anti-competitive and subject to a raid?

Patent rights and anti-competitive practices can overlap. Patent holders should take action to ensure that their IP use does not violate their jurisdiction’s competition law. Balance must be maintained in the patent system through the : setting strict patent content boundaries, preventing exclusive licensing that stops other competitors from market entry, and preventing restrictive selling practices where patent rights are used to price fix. While blocking patents can close the doors to competitors, these patents can open the doors for someone else, like regulators, to come in and conduct their information raids.

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Meena Alnajar is an IPilogue Senior Editor, an IP Innovation Clinic Senior Fellow, and a 3L JD Candidate at Osgoode Hall Law School. This article was written as a requirement for Prof. Pina D'Agostino's IP Intensive Program.

This term, I had the amazing opportunity to work at AstraZeneca Canada through Osgoode’s Intellectual Property Law and Technology Intensive Program placement. I worked within the legal team, under the supervision of Denise Lacombe, Head of Legal and collaborated with Lynne Sweeney, Legal Counsel and Cristina Aguirre, Privacy Officer as well. I know the skills and support I gained will be everlasting in my legal career.

As we slowly returned to in-person work at the company, I had the opportunity to attend some incredible in-person events. The largest event was the All-Employee Event held at the Mississauga Convention Centre. The event started with the CEO’s opening address reflecting on AstraZeneca’s growth over the last few years. AstraZeneca has expanding clinical trial and research teams which is a hopeful development for research in rare diseases. I was seated with a digital marketing employee, employees in the clinical research and development team, and an employee in the respiratory team. We discussed how we can continue to strengthen our teamwork skills and how everyone’s projects were going. I appreciated the company’s efforts to encourage employees to acknowledge not only the strengths, but areas for growth.

The legal team at AstraZeneca is highly adaptable, working with Denise and AstraZeneca’s different teams, I observed her skillfully respond to urgent issues and achieve compromise amongst team members. Some work highlights for me personally were: drafting a procurement contract, investigating the Patented Medicines Prices Review Board (“PMPRB”) Draft Guidelines, and drafting a response to an Access to Information request.

AstraZeneca is a global company, some contracts can require engaging in services in other countries. The contract must be adjusted to meet a jurisdiction’s requirements through a side letter. I worked with Lynne to draft a side letter and she taught me the necessary terms and considerations to comply with Canadian laws, in particular taxation law, privacy requirements in consultation with the Privacy Officer, Cristina, and currency. Drafting this letter helped me practice and execute my contract drafting skills which is essential in corporate law.

It is a tumultuous time for patented medicine pricing in Canada. On October 6, 2022, the PMPRB released Draft Guidelines and is open to consultation until December 5, 2022. PMPRB’s proposed changes have been the subject of judicial proceedings. The new Guidelines could affect how improvement medicines are priced and change the ‘excessive price’ definition. I researched the case law to find areas that may be concerning for the industry and suggested how AstraZeneca could approach the consultation. I remain intrigued to see how the Guidelines, set for implementation in January 2024, may be changed upon receiving consultations.��

As someone with an avid interest in IP, I wanted to be involved in patent-related work. AstraZeneca focuses on clinical research but also marketing and sales of its IP. An ongoing challenge in the pharmaceutical industry is a patented product’s loss of exclusivity. Once the patent expires, the product’s position in the marketplace is compromised as generics can enter without risking infringement litigation. I was fortunate to sit in and learn about creative ways the marketing team was proposing to continue to compete in the market after losing exclusivity.

I also drafted an Access to Information request response letter. An anonymous requester sought information about a contract AstraZeneca recently entered. To balance Canada’s principles regarding freedom of information and the right to maintain confidential business information, a company can respond to the relevant Access to Information office within the government with proposed redactions to the information requested before releasing it to the requesting party. While people have a right to information, companies also have the right to protect confidential, commercially sensitive information that would compromise its competitive position or reveal its business practices. I exercised analytical and legal research skills to support the proposed redactions grounded in the statute, Access to Information Act, and competition law principles. This exercise prepared me for requests that all lawyers typically receive and must respond to for their client.

This placement at AstraZeneca was an invaluable experience as to an in-house counsel’s work experience and a global company’s operations. My insights were encouraged and developed through Denise’s guidance, Cristina’s privacy expertise, and Lynne’s feedback sessions. I contributed towards projects that will help launch lifesaving medicines. Learning about the breadth of stakeholders involved in pharmaceutical development was an unforgettable experience that has deepened my appreciation for this innovative industry. I am grateful to Professor Pina D’Agostino, Ashley Moniz, Denise Lacombe, Lynne Sweeney, and Cristina Aguirre for fostering this opportunity.

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Serena Nath is an IPilogue Writer and a 2L JD candidate at Osgoode Hall Law School.

Controversy and uncertainty in the field of patent eligibility have resulted in decade-long fights over what can be patented and what cannot be, especially regarding diagnostic tests. There is currently a congressional push to let drug companies patent diagnostic tests in the United States. This push comes from Senator Thom Tills. On August 2, 2022, Senator Tills introduced Bill , titled the Patent Eligibility Restoration Act of 2022, which, in part, aims to change currently existing US federal patent law regarding patent eligibility for different classes of inventions. ��

History of Patenting Diagnostic Methods

The bill was largely motivated by several Supreme Court rulings over the past decade, which have created exceptions to patent eligibility in biotechnology and pharmaceuticals. Traditionally, an inventor can gain patent protection for their invention if it is novel, non-obvious, and has utility. However, in 2012, the court in ruled that diagnostic tests that reflect naturally occurring biological phenomena cannot be patented because one cannot have a monopoly on a relationship based on natural principles. This ruling was then reaffirmed later in . This exception in the eligibility of diagnostic tests led to widespread confusion regarding patent eligibility. In particular, the chief judge of the US’s top patent court, Kimberly A. Moore, saying that Federal Circuit judges are now unsure of how to apply the patent eligibility provision. Additionally, these exceptions have led to patents being rejected in the United States but approved in other jurisdictions with similar patent laws, such as Europe, thus discouraging biotech companies from investing in diagnostic methods. In response, Bill S.4734 is being presented to address this confusion and increase innovation in the United States via more specific patent eligibility standards that are likely to expand the ability to patent modified genes and pharmaceutical processes, including diagnostic methods.

The Debate over S. 4734

This proposed bill has drawn much debate. On the one hand, , such as the American Civil Liberties Union, have expressed concern that this bill will allow pharmaceutical companies to take advantage of this expanded patent eligibility by creating monopolies over essential diagnostic methods resulting in decreased access to these methods and overall harm to the health of Americans. However, , such as the Council of Innovation Promotion, argue that the bill will increase investment into diagnostic research, which decreased significantly after the Mayo decision. These groups point to the pharmaceutical industry’s response to COVID-19, arguing that patents were the basis for creating the vaccines.

If the bill can clarify patent eligibility in the US, it may be worth pursuing further. However, I also question the idea that patent eligibility is the driving force behind biotech innovation.�� The Invention-Induced Theory, argued by proponents for S.4734, posits that patents are an incentive for inventors and that absent patents, there will be no inventions. However, this theory fails to account for inventions induced by the market, scientific curiosity, accident, or ego. Additionally, have shown that patents are not a significant driver of most innovations. Thus, there may be a better way to both reward biotech companies for their creation of diagnostic methods and prevent harmful monopolies over essential lifesaving inventions.

Regardless of which side of this debate you fall on, it is still being determined if S. 4734 will be further explored. When this bill was introduced in August 2022, the Tillis planned to hold hearings focused on this legislation if the Republicans took the senate in the November midterm elections. However, with the , the future of this matter remains uncertain.

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Andrew Masson is an IPilogue Writer and 2L JD candidate��at Osgoode Hall Law School.��

A business’ success is strongly tied to the ability to protect Intellectual Property. However, the USA appears to use patent protections as a sword to attack and acquire large market shares, instead of as a shield to protect from other companies’ encroachment on another’s IP. This position is demonstrated by the , which suggests that the primary use of patents is protection of the market share and not innovation.

The patent office’s enforcement and issuance process greatly impacts the number of competitors that can enter a market. The patent office has therefore become a fundamental part of the economy, as patent protection plays an important part of many businesses’ strategies. Priti Krishtel, Attorney and Co-Founder of the , states that . This naturally leads to questions about the role patents should play in society, especially in the USA, where the enforcement and granting of patents has been seen .

Purpose of Patents

The ‘sword and shield’ metaphor likely oversimplifies the patent process. The data suggests that in practice, patents are not used for innovation. . Thus, many ��incorrectly view the patents primary function as protecting or fostering innovation. Patents ��are instead being used to .

Some believe that using patents as a sword abuses their purpose and others support the protection of businesses it provides. It may be a subjective question if patents should serve this role in business, but this use may have gone too far. Practically speaking, the , and if successful – these issued patents will limit competition and can permit industry monopolies.

How the System Can Be Exploited

It is important to dissect society’s perspectives on the role of patents. For example, one way to “game” or exploit the USA patent system and . “New” medical devices can obtain faster regulatory approval by showing regulators that a product is like an existing product warranting approval. At the same time, the companies will also submit to the patent office that it is novel enough to require a new patent. This process has allowed medical devices to ��is granted through incremental changes.

Conclusions

The problems highlighted are of much greater concern currently in the USA but do not exclusively occur there. The actual rules and laws appear similar to those in Canada but in the USA, the to benefit businesses or large corporations. This perspective initially could have been useful in protecting companies and establishing markets but can result in monopolies and stifle small companies’ innovation. The patent office may need to reform in some way because they have allowed patent “swords” to become common practice. The US ��patent system should ensure patents are not morphed into solely a tool to control market shares. Unfortunately, wielding patents as swords can harm innovation and to solve the problem, the patent office should consider their ability to dull the edge of the patent sword.

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Brandon Pierre is an IPilogue Writer and a 1L JD Candidate at Osgoode Hall Law School.

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In a dizzying exception to an exception of a rule, the case of ’s HIV drug bictegravir underscores the value of a well-planned legal strategy.

(“ViiV”), majority-owned by (“GSK"), claims that Gilead’s (sold under the brand name “Biktarvy”) directly copied its dolutegravir's formulation under (“patent 385”). The with Gilead paying $1.25 billion USD upfront to GSK in early 2022, followed by paying three percent royalties on all future U.S. sales of Biktarvy.

This article delves into the legal doctrines that support the parties’ claims and the overarching strategy to their settlement. The comments pertain specifically to ViiV Healthcare Company v Gilead (case 18-224) in the U.S. District Court for the District of Delaware.

Note that the doctrine of equivalents, dedication-disclosure, and specific exclusion only apply in the United States. Canada uses a purposive approach (see ).

Doctrine of Equivalents

under the doctrine of equivalents, which has two exclusions: dedication-disclosure and specific exclusion.

The prevents parties from circumventing literal infringement by making minor variations to a patented invention. Under the doctrine of equivalents, a patent can be infringed upon if these variations are immaterial. For example, whether a bike has 32 spokes or 36 spokes, it is still a bike.

, Gilead argued that ViiV could not rely on the doctrine of equivalents due to the dedication-disclosure rule and the doctrine of specific exclusion (see page 2).

Dedication-Disclosure Rule

In the U.S., the dedication-disclosure rule states that if a patent discloses or describes a novel feature, but that feature isn’t listed in the patent’s claims, then the feature is dedicated to the public and is not patent-protected (). For example, a patent could describe a bike with two wheels (bicycle), three wheels (tricycle), or four wheels (quadracycle) and then only claim the two-wheeled design. Under this doctrine, the inventor could not then sue another for using the three-wheeled or four-wheeled design.

Gilead posited that since patent 385 described, but did not claim, the formulation used in Biktarvy, it is available to the public and cannot be recaptured through the doctrine of equivalents (). In Canada, and dismissed ViiV’s claims on a similar basis.

Doctrine of Specific Exclusion

The doctrine of specific exclusion states that a product cannot be deemed equivalent to a patented invention if it is literally the opposite of the patented invention. A product can be deemed “outside the reach of the doctrine of equivalents because that [product] is clearly excluded from the [patent’s] claims whether the exclusion is express or implied” (). For example, a patent for an “electric” bike cannot be equivalent to a “non-electric” bike.

Issues regarding expert testimony, construction of legal claims, and legal precedent .

Concluding Remarks

In the end, settlement was in the best interests of both parties. Pursuing protracted lawsuits in , and elsewhere could exponentially increase litigation costs if the matter were left to courts. There are also significant profits at stake. Sales forecasts for the drug were $1B USD in 2018 and rising to $5B USD annually by 2024 (see ). These targets were far surpassed in 2019 when the drug delivered .

The includes a worldwide patent license to certain ViiV patents related to dolutegravir. ViiV also agreed not to enforce their patents against Gilead for any future product containing bictegravir in exchange for royalties. Since the science implies that both bictegravir and dolutegravir have , the agreements suggest both pharmaceutical companies can move forward profitably.

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Jasmine Yu is an��IPilogue��Writer and a��1L 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.��

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.��

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 Général du Canada,��Québec Superior Court File No. 500-17-109270-192.

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On January 10, 2022, the Canadian Competition Bureau (the Bureau) and Health Canada’s Health Products and Food Branch (the HPFB) issued a����to stakeholders on their continued collaboration to support Canadians’ access to safe, effective, and affordable pharmaceuticals and biologics.

Although the Bureau and HPFB are independent entities, they have complementary mandates in the pharmaceutical sector. The Bureau is responsible for administering and enforcing the��Competition Act, which includes addressing competition issues for the pharmaceutical industry. While the HPFB regulates, evaluates, and monitors therapeutic products available in Canada under the��Food and Drugs Act. This overlap has led to past collaboration on several issues, including mergers and acquisitions, deceptive and misleading claims, and claims of abuse of dominance.

As part of their goal for continued collaboration, both entities plan to maintain a channel of communication to ensure the mutual success of their policy objectives. This includes having the Bureau report to the HPFB on aspects of the pharmaceutical regulatory framework that may impact competition, and the HPFB providing feedback to the Bureau when competition-related issues may result in problems for access to medicines.

The Bureau and HPFB have also committed to working together on Bureau-led enforcement actions, such as when generic pharmaceutical companies report having difficulty obtaining reference samples from branded drug manufacturers. These samples are necessary for generic companies to perform testing for regulatory approval and any difficulties in obtaining samples would delay market launch, with corresponding impact on drug availability. Both the Bureau and HPFB have released guidance for providing access to reference samples and plan to continue working together to monitor and address issues in this area. Based on the extent of guidance documents made available from both entities, branded drug manufacturers are advised to anticipate that the Bureau will treat any explanation for delay in supplying reference products with a high degree of skepticism.

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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. ��

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

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

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

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

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What is CRISPR?

Some scientists believe the design and development of new biomolecules is as much an art as it is science. The ��discussed, 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 York Collegium for Practical Ethics and The York Centre for Public Policy and Law under the leadership of Ian Stedman.�� Support for the event was provided by IP Osgoode, McLaughlin College, �첥��Ƶ - Faculty of Health, �첥��Ƶ - Faculty of Science, and �첥��Ƶ's Office of the VPRI.

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