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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As part of the Osgoode Intellectual Property Law & Technology Intensive Program, I had the wonderful opportunity of completing a 10-week internship at AstraZeneca Canada (“AstraZeneca”). I can confidently say my internship experience, under the supervision of Denise Lacombe, Head of Legal at AstraZeneca, has been the highlight of my law school career. I also had the pleasure of working with Cristina Aguirre, Privacy Officer at AstraZeneca, and learned about the day-to-day operations of a major pharmaceutical company from her perspective.

One of the most enjoyable aspects of my internship was attending townhalls and meetings with different teams at the company. In addition to learning more about the company from legal, business, marketing, and human resources perspectives, I had the opportunity to witness the passion that each team member brought to their work and the company’s mission. As an innovative pharmaceutical company, AstraZeneca is truly on the cutting edge of science and the team’s innovative spirit was evident in every meeting.

At the beginning of my internship, I expressed that my main goal was to gain a realistic perspective on the responsibilities of an in-house counsel working in the pharmaceutical industry. I was pleased to gain exposure to a variety of topics including patent litigation, pharmaceutical regulations, and privacy law over the course of my internship.

As a multinational pharmaceutical company, AstraZeneca is often involved in complex patent litigation. During my internship, I was given the opportunity to review and provide input on court submissions for ongoing patent disputes. I was excited to participate in meetings with Denise and a group of experienced patent litigators and try to absorb as much knowledge about the field as I could. As a student with deep interest in patent law, I felt fortunate to be able to gain insight about high-stakes patent disputes outside of the traditional classroom environment and apply my theoretical knowledge of the topic to real-world problems.

As the pharmaceutical industry is heavily regulated in Canada, a significant portion of the work I did during my placement pertained to compliance with industry regulations. Reviewing advertising materials and ensuring compliance with the Pharmaceutical Advertising Advisory Board Code was a great exercise in legal research and sound judgement for me. Additionally, I was tasked with reviewing the Patented Medicines Prices Review Board Guidelines and answering questions pertaining to pricing issues for existing patented drugs as well as medicines with “patent pending” status in Canada. I found assignments pertaining to the regulatory regime around the pharmaceutical industry to be helpful in sharpening my analytical skills as well as improving my attention to details. Aside from learning about the existing regulations, one of the aspects that I enjoyed about the assignments was Denise’s willingness to provide her practical perspective on the issues that the company faced and help me navigate the regulatory framework through the lens of a business-savvy in-house counsel.

I began my internship at a very exciting time for privacy law in Canada. On September 22, 2021, Quebec’s Bill 64, received Royal Assent. Bill 64 is projected to transform Quebec’s private-sector privacy law regime as it comes into effect over the next three years. As one of my assignments, I conducted extensive research into the topic and prepared a memorandum providing commentary on the effects of the legislation on a company that relies on patient data for medical research. Given my interest in privacy law and my involvement in several projects pertaining to the field in law school, I was naturally excited to delve deep into the topic. The opportunity to expand my knowledge of the evolving privacy law regime in Canada was one of the most rewarding aspects of my internship.

My placement not only provided me with insight about the complex legal landscape of the industry, but it also made me appreciate the business aspect of the operations of a multinational pharmaceutical company. I am deeply grateful to Professors Vaver and D’Agostino as well as Denise Lacombe and Cristina Aguirre for providing this unique learning opportunity to Osgoode students. I am positive the skills I cultivated over the course of my internship will aid me in my future legal career.

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There is clearly some significant tension between the right to protect or commercialize intellectual property and ensuring that we’re manufacturing the vaccines as quickly as possible. This issue , where a proposal has been set forth which, if approved, would allow members to choose not to grant or enforce IP related COVID-19 medical tools until global herd immunity is achieved. Just yesterday, Ambassador Katherine Tai, United States Trade Representative, announced .

Currently, there are four approved COVID-19 vaccines in Canada, and each developer has different viewpoints when it comes to the intellectual property rights for their vaccine.

Pfizer/BioNTech

BioNTech, which partnered with Pfizer in April 2020, has that it relies on a combination of trade secrets and patents to protect various aspects of their mRNA manufacturing technologies. A Pfizer executive, in opposition to the World Trade Organization proposal, that “[intellectual property], which is the blood of the private sector, is what brought a solution to this pandemic and it is not a barrier right now.” Some experts have that even if they were to share their vaccine patent, no facility not already being used would have the suitable technology to manufacture the mRNA vaccine.��

Moderna

Moderna, which has related to its mRNA-based COVID-19 vaccine, has taken a slightly different approach when it comes to its intellectual property. While recognizing the importance of intellectual property rights in encouraging research, the company has to not enforce their COVID-19 related patents against those making vaccines to combat the pandemic. Additionally, the pledge states that they are willing to license their intellectual property to others after the pandemic to eliminate any barriers to vaccine development. ����

��AstraZeneca and Johnson & Johnson

The two developers of the non-mRNA-based vaccines are arguably taking the most relaxed approach when it comes to protecting their intellectual property rights and commercialization strategy. Both and have publicly pledged that their vaccines will be developed and distributed on a not-for-profit basis. The companies are licensing and collaborating with a number of facilities to ensure there are enough vaccines to vaccinate the global population in a timely manner.

It is difficult to support the idea that relaxing intellectual property rights for COVID-19 vaccines would have any effect on the ability to manufacture them faster. As explained above, there are two developers manufacturing vaccines without regard for profit, and two developers who use relatively novel, complex technologies and may have already maximized the manufacturing potential. Our main focus should be on ensuring that enough vaccines are distributed on a global scale so developing countries are not disadvantaged.

Written by Tyler McLaughlin, JD Candidate 2022, enrolled in Professor D'Agostino's Directed Reading: IP Innovation Clinic course at Osgoode Hall Law School. As part of the course requirements, students were asked to write a blog on a topic of their choice.��

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No beats skipped here

As one could imagine, the pharmaceutical industry is in full swing in the midst of a global pandemic. Despite the virtual/remote nature of this year’s IP Intensive and placement, my supervisor ensured that I was sufficiently immersed in AZC’s operations, through regular Zoom “touch-base” meetings and by connecting me with employees from various departments of the organization. From meeting individuals from the compliance, marketing, and digital transformation departments (to name a few), I was given a holistic understanding of the “big picture” operations of a pharmaceutical company.

In fact, interning at AZC during a global pandemic represented a unique opportunity. I learned about, and contributed to the resolution of, issues related to vaccine development and marketing— including vaccine contract review and constitutional analyses on the division of powers as relates to vaccine dissemination strategies. I also had the opportunity to review and comment on official submissions to Parliament regarding the passage of their COVID-19-related interim orders, in particular the order creating alternate routes for expeditious drug authorization to combat shortages.

A newfound interest in privacy law

Prior to my involvement with the IP Intensive, I considered myself someone solely interested in traditional IP law (i.e., copyrights, trademarks, and patents). I am grateful for the “Technology” aspect of the IP Intensive, for it thrust us into discussions on timely issues such as privacy and data rights. In fact, I would say that the legal field engaged with most during my placement was privacy law (even more so than IP). While clear to see with hindsight, I had no idea the extent to which privacy considerations impacted pharma’s operations. I worked on tasks such as: appraising cookie notices for PIPEDA compliance; reviewing corporate privacy training modules; and providing feedback on federal and provincial privacy legislation amendment proposals (this last one is timely, given Parliament’s recent introduction of the Digital Charter Implementation Act, 2020, which will likely lead Canada to a more GDPR-esque privacy regime).

Patented medicine pricing issues

One constant cause for concern during my placement at AZC relates to the Patented Medicine Prices Review Board’s (“PMPRB”) 2020 Guidelines. The price regulation of patented drugs affects virtually the entirety of AZC’s product line, and therefore represents a source of uncertainty with respect to AZC’s—and other patented drug manufacturers’—operations. I assisted my supervisor in researching PMPRB court cases as well as commenting on submissions from Innovative Medicines Canada (“IMC”) asking for clarity on the Guidelines’ proposed amendments.

The recent Federal Court ruling on the validity of the PMPRB’s recent amendments (i.e., that they fall within the broad regulation-making authority of the Governor-in-Council under the Patent Act as part of the valid legislative goal of “abusing patent monopolies”) are bound to be challenged by IMC, and I am glad to know that I may have played a small part in the process of clarifying this important area of law.

Miscellaneous adventures

In addition to the privacy- and IP-related legal issues I mentioned, I was also involved in a wide spectrum of legal and policy issues touching on a variety of AZC’s operations. For example, I took part in the following miscellaneous, yet significant, operational tasks: providing insights into the Food and Drug Regulations’ amendment to include nurse practitioners in the list of “practitioners” to whom drug samples may be distributed; reviewing consent notices for compliance with Canada’s Anti-Spam Legislation; and clarifying health and safety committee requirements under the Occupational Health and Safety Act.

Conclusion

My placement at AZC was undoubtedly the highlight of my law school career, providing me with an invaluable adjunct to the traditional course-based law school curriculum. I am grateful for the work done by the Legal Affairs department to make my virtual placement as immersive and rewarding as if it were done in person. I look forward to applying the knowledge and skills gained in my future career endeavours, as well as to keeping in touch with the awesome individuals I had the pleasure of connecting with during my placement.

Written by Daniel Joseph, JD Candidate 2021, enrolled in Professors D’Agostino’s and Vaver’s 2020/2021 IP Law & Technology Intensive Program at Osgoode Hall Law School. As part of the program requirements, students were asked to write a reflective blog on their internship experience.

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My internship at AZC surpassed my expectations. I not only built on my understanding of patent law, but also obtained experience in other legal fields. My AZC supervisor assigned tasks in a wide range of areas, including privacy, competition, and corporate law. This presented a unique opportunity for me to apply the knowledge I gained from my law school courses and build on my understanding of less familiar topics.

In addition to learning about law, my internship took me beyond the legal landscape to the business aspects of the pharmaceutical industry. I was invited to attend meetings where AZC employees discussed business strategies for company projects. My supervisor also organized one-on-one meetings between AZC employees and myself to familiarize me with the company’s operations. For example, I met with a member of the marketing department to discuss how a drug successfully reaches its patient population. In the meeting, they described the complexities of the process and challenges they face in their position. They also explained how their department contributes alongside other AZC departments to achieve the company’s goals.

During my time at AZC, I had the opportunity to investigate the current issues affecting Canada’s pharmaceutical industry. These included the legislative changes surrounding the Patented Medicine Prices Review Board and the United States of America’s proposal to import drugs from the Canadian market. Through completing tasks on these topics, I became better acquainted with the relevant parties and critical milestones for each matter. I was also privileged to be amongst AZC employees, who are directly affected by these issues. By speaking with these individuals, I gained their unique perspective on the topics, which furthered my understanding of these issues and how they impact the pharmaceutical industry.

Although the above experiences were insightful, my favorite aspect of the internship was the chance to interact with AZC’s science landscape. As a law student with a background in medical science research, I have always had a passion to see how law and science may be combined in the workplace. AZC is a great example of this combination, for science is always present in the work environment. While at my internship completing legal tasks, I was invited by in-house counsel to attend seminars that described recent medical innovations in the company’s different therapeutic fields. Furthermore, much of my work allowed me to utilize my scientific background. My prior experience enabled me to better understand legal matters that involved pharmaceutical concepts and determine the implications that stem from these situations.

I enjoyed my internship at AZC. It provided me with valuable opportunities to learn about a diverse range of topics, while facilitating this learning through a friendly environment with a positive legal department that is genuinely interested in its students’ growth. I am confident that Osgoode Hall’s Intellectual Property Law and Technology Intensive Program has had a memorable impact on my law school journey.

Written by Imtiaz Karamat, JD Candidate 2020, enrolled in Professors D’Agostino and Vaver 2019/2020 IP & Technology Law Intensive Program at Osgoode Hall Law School. As part of the course requirements, students were asked to write a reflective blog on their internship experience.

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I worked closely with AstraZeneca Canada’s legal team, Denise Lacombe, the legal director, and Cristina Aguirre, a soon-to-be paralegal, and I saw the company through their eyes. The legal duo is consulted on any number of questions and dilemmas, including those specific to the pharmaceutical industry, and the more general inhouse concerns. Thankfully, I was able to help out with both. I was particularly interested in learning about the regulatory structures that govern pharmaceutical operations in Canada. I met with government and regulatory affairs coordinators who deal with both federal and provincial governments, and quickly appreciated how the pharmaceutical industry is truly one of the most heavily-regulated around the world, and understandably so. This is especially true in Canada in comparison with other countries. For example, one of my assignments required me to review a Canadian application for a . A CSP affords novel drugs with an extra few years of patent protection; due to the tremendous costs of pharmaceutical R&D, the additional few years of protection could help the business a lot. Canada only recently added CSPs to its patent system as a result of signing the Comprehensive Economic and Trade Agreement in 2017, whereas other countries had been providing then for decades. Not only was Canada slow to adopt CSPs, I learned through my research that its review of CSP applications is quite restrictive when compared to international counterparts, making it significantly more difficult to get the added protection here.

Similar restrictive practices are evidenced in Canada’s which recently proposed updates to its price-cap calculations. While it is always easy to shrug away the opposition against these regulations by profit-driven pharmaceutical companies, I spoke with many people at AstraZeneca who shared serious concerns for how these new changes may impact their business. For such a regulated industry, I was shocked to find out how little interaction and influence pharmaceutical players actually have with Health Canada.

One of the most meaningful parts of my time at AstraZeneca was learning about its many partnerships. Since day one, I was tasked with reviewing and drafting partnership agreements between AstraZeneca and any number of parties, including patient support groups, researchers, healthcare providers, and other pharmaceutical companies. This also involved ensuring the utmost standards in IP protection, confidentiality, and privacy clauses. (This experience was easily the best class of contract drafting I could have hoped for). While law school teaches us about the legal side of business agreements, my experience in the IP intensive highlighted the human side of transactions, especially in this industry: while every party to a deal came with their own objectives and agendas, the ultimate goal of scientific exchange and public health formed the foundation of all the agreements and negotiations I was privy to. It has been wonderful getting to know each stakeholder in this capacity.

I already know that my 10-week experience at AstraZeneca will help shape my career and future decision-making. I learned from really fantastic practitioners in a dynamic industry that we all benefit from. I’d like to thank Professor D’Agostino, Professor Vaver, Michelle Li, and everyone who made the IP Intensive possible, I am forever grateful for the learning environment you created for me and my fellow students.�� Thank you!

Written by Shira Sasson.�� Shira is a JD Candidate at Osgoode Hall Law School and was enrolled in Osgoode’s Intellectual Property Law and Technology Intensive Program. As part of the program requirements, students were asked to write a reflective blog on their internship experience.

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The most exciting part of my internship was learning the business of a pharmaceutical company. Like all heavily regulated industries, there are many complexities involved in bringing a product to market. In the pharmaceutical context, the product must be approved by Health Canada, the style of marketing is closely monitored and the organizations that pay for the product are not usually the patient. All of these complexities create a fascinating industry to explore. Through meeting with individuals in different roles and learning about their contributions to AstraZeneca, I learned about all of these considerations.

In addition to learning about the business, my time at AstraZeneca allowed me to explore the many different aspects of IP protection for pharmaceuticals. Patents are not the only avenue of IP protection for a pharmaceutical company. I had the experience to research the law on the requirements to obtain a 6-month pediatric extension for data protection. I completed various research projects involving the PM(NOC) Regulations. Additionally, I wrote a memo for people without legal training explaining the requirements and application process for obtaining a Certificate of Supplementary Protection.

Some my most rewarding work was contributing to policy position documents prepared by (IMC), an organization that represents innovative pharmaceutical companies in Canada, including AstraZeneca. During my internship, IMC wrote a consultation submission in response to Health Canada’s proposed expansion of the definition of “identical medicinal ingredient”. This change would make it easier for generic manufacturers to file Abbreviated New Drug Submissions (ANDS), which allows the generic manufacturer to refer to the safety and efficacy data of the innovator manufacturer. I had the opportunity to research the Food and Drug Regulations, propose new arguments and provide feedback on IMC’s submissions. I also provided a similar contribution to IMC’s submission regarding changes to the Patented Medicines Prices Review Board.

My experience at AstraZeneca shaped my views on the innovative pharmaceutical industry as a whole. It is no secret that many people distrust the pharmaceutical industry that enjoys large profits by selling products that are necessary for survival. However, I found that AstraZeneca is a company filled with hard-working, smart people who are dedicated to providing life-saving medicines to the public. The entire culture of the company is fueled on innovation. Everyone is excited to hear about data from new clinical trials involving an AstraZeneca product that will make a real difference in somebody’s life. I felt honoured to be a small part of the company when during a town hall, the Executive Team showed a video of an interviewed patient who had received an AstraZeneca product for free during his involvement in an . The AstraZeneca product had saved his life.

I am incredibly thankful to the Legal Team at AstraZeneca Canada. They have been unbelievable resources for me and I cannot express everything that I have learned from them. They are amazing practitioners and wonderful people. I look forward to continuing to learn from them in the future.

William Chalmers��is a JD Candidate at Osgoode Hall Law School and was enrolled in Osgoode’s Intellectual Property Law and Technology Intensive Program. As part of the program requirements, students were asked to write a reflective blog on their internship experience.

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While at AstraZeneca, I was involved in a wide variety of interesting projects each with its own unique challenges and learning opportunities, including projects relating to IP licensing, parallel trade, subsequent entry biologics, and product pricing. Indeed, the breadth of issues that in-house counsel face on any given day is quite impressive. Nevertheless, of all these projects one in particular stood out above them all – AstraZeneca’s appeal to the Supreme Court of Canada (SCC) on the promise doctrine. The appeal was between AstraZeneca and Apotex Inc., a generic pharmaceutical company, in relation to the Federal Court of Appeal’s decision to hold the substance patent for esomeprazole (NEXIUM) invalid for lack of utility for failing to meet the “promise of the patent”. The potential implications of this decision on the industry are profound.

By the time of my arrival, AstraZeneca, led by external counsel, were far along in their preparation for the SCC hearing having already filed their factum with the Court. As such, focus at this stage was on the rehearsal and refinement of oral submissions. To my great benefit, I was able to attend these rehearsals and participate in the process of fine-tuning arguments. It was a fantastic experience. Observing seasoned IP litigators, with the assistance of a former Supreme Court justice, carefully craft the delivery and structure of arguments and formulate persuasive responses to anticipated questions from the bench was as fascinating as it was informative.

Contemporaneous with these rehearsals was the filing of written submissions by intervening parties to the appeal. There were six interveners in total, including Innovative Medicines Canada and BIOTECanada, Intellectual Property Owners Association, Intellectual Property Institute of Canada, Centre for Intellectual Property Policy, Canadian Generic Pharmaceutical Association, and Fédération internationale des conseils en propriété intellectuelle. Together, these parties represented a broad range of stakeholders, including those from both the innovator and generic sides of the industry. Eager to learn more about the different perspectives raised by the interveners than I could glean from their respective facta, my supervisor arranged for me to sit in on meetings of the Canadian Patent Utility Coalition in which a subset of interveners elaborated on their positions. This was a great opportunity to gain a better appreciation of their main concerns and objectives, particularly in relation to issues like post-filing evidence, sound prediction and international treaties. In turn, this insight was invaluable when I was invited to review and comment on drafts of AstraZeneca’s reply factum. Having the chance to be involved in this process was a lot of fun and a real privilege.

At long last came the day of the appeal. Fortunately, I was able to make the trip up to Ottawa with my supervisor to observe the hearing in person and it was an experience I will not soon forget. Given my specific interest in IP litigation, it was terrific to watch some of the very best in their craft, employing a range of different styles, engage with what was a surprisingly active bench. I was particularly struck by the knowledge and composure demonstrated by counsel in responding to questions. In the end, it was a very exciting day all around and I, along with everyone in AstraZeneca, anxiously await the Court’s decision that is expected some time early next year.

From regulatory issues to contract drafting, I am extremely grateful to everyone in the Legal Affairs team at AstraZeneca for all the knowledge and insight they shared with me. Aside from being an impressive group of legal practitioners, they are also wonderful people. I consider myself very fortunate to have had the opportunity to learn from them and look forward to meeting again in practice.

Stephen Dalby is a JD Candidate at Osgoode Hall Law School and was enrolled in Osgoode’s Intellectual Property Law and Technology Intensive Program. As part of the program requirements, students were asked to write a reflective blog on their internship experience.

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One of the most interesting aspects of working at AstraZeneca Canada was having a front row seat to the development of issues currently facing the pharmaceutical industry. In law school I found students were more accustomed to learning about something that had already happened - waiting for a decision to be released or legislation to be updated. However, at AstraZeneca I was able to work in areas where live debate was still taking place. While at AstraZeneca Canada I had the chance to see the AstraZeneca Legal Affairs team, in conjunction with external counsel, submit an application for to the Supreme Court of Canada in a case concerning the utility requirement in patent law. Additionally, I was able to work with the government affairs department in crafting policy statements concerning issues from the with the European Union such as patent term restoration, an innovator right of appeal in PM(NOC) proceedings and data protection as well as the implementation of a set of proposed for pharmaceutical patent litigation settlements.

As understanding the different facets of AstraZeneca's business was an important part of my internship, my placement supervisor arranged for me to go on several "field trips" and to meet with employees from different departments each week so I could learn about their role at the company. For example, one day we went on a tour of AstraZeneca Canada's distribution facility where all their pharmaceutical products are stored and shipped. The guide taught us about what happens when product is returned, when product expires and when, for whatever reason, the product is shipped or stored outside the ideal conditions. While at first glance this may seem far removed from intellectual property law, the next week we attended an examination for discovery where these types of questions came up. After spending time with employees from government affairs, regulatory, and marketing I began to see how all of the various departments came together to carry out the company's goals and to learn about the legal issues they might face on a day-to-day basis. In particular, one of the projects I worked on was updating and redesigning the internal AstraZeneca Canada Legal Affairs website. This gave me some insight into what issues AstraZeneca employees from other departments might seek out the advice of legal affairs for - including what to do if they received an access to information request or how to make sure they were compliant with Canadian Anti-Spam Legislation.

Overall, my experience at AstraZeneca Canada was a very positive one. While my internship was certainly instructive, I also had a lot of fun! I was able to attend a product launch for DUAKLIR GENUAIR, several turkey dinners and a clinic offering AstraZeneca's FluMist product, an intranasal flu vaccine. (While it might be a stretch classifying the latter as fun, it was certainly more enjoyable than the flu shot alternative!) The Legal Affairs team was very welcoming and I am grateful to them for taking the time to teach me about some of the work they are involved in. Participating in the Intellectual Property Law and Technology Intensive Program was one of the highlights of my law school experience. It was a rare chance to become involved in the practical, as opposed to the academic, aspect of intellectual property law and it provided a perspective that was different from both the classroom and working at a law firm as a summer student.

Corey McClary is a JD Candidate at Osgoode Hall Law School and was enrolled in Osgoode’s Intellectual Property Law and Technology Intensive Program. As part of the program requirements, students were asked to write a reflective blog on their internship experience.

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Although this decision primarily turned on the facts, there are some notable points of interest for infringement, claims construction and expert evidence.

The Invention

Omeprazole decreases gastric acid secretion by inhibiting proton pumps. Thus, omeprezole is useful to treat a variety of conditions associated with low stomach pH such as dyspepsia, peptic ulcer disease and gastroesophageal reflux disease.

The activity of omeprazole was known at the time of patent filing, however, the instability of the compound posed challenges to commercialization. Omeprazole had to be stable under two distinct conditions: (1) when exposed to gastric acid and (2) for storage. Unfortunately, traditional enteric coats, which would provide gastric acid resistance, would also react with the omeprazole core to cause degradation under storage conditions.

AstraZeneca solved the stability conundrum in the ‘693 patent through “an inert sublayer … disposed on said core region” (see e.g. ). By separating the omeprazole core from the enteric layer with a subcoat, degradation could be avoided, permitting stable storage.

The Issue

The Apotex omeprazole formulation also contained a subcoat between the omeprazole core and the enteric coat. However, this subcoat was the product of an in situ reaction between the omeprazole core and the enteric coat. This method for creating a subcoat was not contemplated by the patentee at the time of patent application.

Does the scope of the claims capture products that result from an unanticipated method of production?

Justice Barnes held that for novel product claims, the scope of the claims are not limited to the methods identified or contemplated by the patentee [182]. Furthermore, Justice Barnes rejected the notion that a patentee has any obligation to teach its competitors how to avoid infringement [185]. Therefore, infringement does not require either party to be able to anticipate the infringement prior to the act. Such a legal conclusion is well grounded in the strict liability nature of patent infringement.

Claim Construction

Given that the method of infringement need not be anticipated, infringement in this case hinged on the meaning of “inert” and “disposed upon”. Through the assistance of expert witnesses, Justice Barnes preferred the nuanced approach to construe “inert” to mean the absence of “reactions that adversely affect the functionality of the formulation” [194]. Expert witnesses, however, provided no assistance to the construction of “disposed upon”, as this was not a term of art in the world of the formulator [170]. Absent a clear meaning to a formulator, Justice Barnes held that “disposed upon” does not signify a process limitation [189].

Of general interest, Justice Barnes cautioned against “the danger of relying too heavily on the disclosure as an interpretive guide to claim language”. In the disclosure, the patentee contemplated direct application of the subcoat layer to the omeprazole core. However, this statement in the disclosure cannot be read into the claims as process limitation when there is no language in the claims to support such a limitation [179].

The ‘693 Patent was previously and similarly construed by Justice Rothstein for a unanimous Federal Court of Appeal in Apotex Inc v AB Hassle, , in the context of a PM(NOC) proceeding between the same parties. While PM(NOC) decisions are not binding for subsequent infringement actions, Justice Barnes held that the construction taken by FCA to “carry some persuasive weight”, especially where the issue of construction does not require specialized knowledge [175].

Patent Infringement

There was little dispute that the Apotex formulation contained a subcoat. Rather, the issue of infringement turned on whether that sublayer was continuous or inert. These issues were resolved largely through technical evidence produced by the expert witnesses.

Expert witnesses for both parties provided diametrically opposing opinions on whether there was structural continuity in the subcoat. Justice Barnes preferred the evidence offered by the AstraZeneca witness, suggesting that the subcoat was continuous [342]. Furthermore, given the fact that the subcoat swells in the presence of water, any gaps that appear when the capsule is dry may very well be sealed once the capsule gets wet [312]. AstraZeneca’s witness also produced data that ruled out the likelihood of significant quantities of omeprazole degradants or other reactive compounds in the Apotex subcoat [364].

Justice Barnes took particular note of the fact that Apotex’s experts chose to attack the experimental methodology and limitations of AstraZeneca’s expert, rather than conduct their own independent tests [298]. In particular, Justice Barnes noted that “[a]n argument that other tests or controls could have been used loses much of its strength where a party chooses not to employ those same suggested methods in its own responding analysis to see if the results differ” [361].

This approach to resolving conflicting expert opinion is consistent with the law of burdens of proof and general approach to ascribing weight to evidence. AstraZeneca had both the persuasive burden and evidentiary burden on the issue of infringement. By adducing evidence to the satisfaction of Justice Barnes, AstraZeneca had discharged its evidentiary burden to raise the issue of a continuous subcoat. Whether AstraZeneca had met its persuasive burden depended on the reliability of the evidence and the cogency of the interpretation of the data. Apotex’s decision to challenge the data meant that the scope of the dispute for infringement was on the reliability of the evidence. It is therefore logical that Apotex’s argument would lose considerable force because those attacking experimental methodologies and limitations “should not benefit from any uncertainty that could easily have been dispelled” [348].

Lou Chang is a JD Candidate at Osgoode Hall Law School and a fan of JRR Tolkien.

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