IP Intensive: Sitting at the Crossroads of Law, Medicine, Business, and Government - A Semester at AstraZeneca

I was thrilled when I found out I’d be joining the legal team at AstraZeneca Canada for a semester, as part of Osgoode’s IP Law and Technology Intensive Program. I realized very quickly though that I was joining more than just a legal team – I was joining a culture of interdisciplinary professionals who are committed, beyond all else, to the advancement of medicine. I sat in rooms where doctors, lawyers, government liaisons, marketers, and business developers each had an equal seat at the table; and in these rooms, any variety of topics were covered, from new business ventures, to product launches, to upcoming regulatory challenges, and to R&D investment directions. It was the most energetic and scientifically-fueled environment I have ever been exposed to, and I am incredibly thankful to have been a part of it.

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 Certificate of Supplementary Protection (CSP). 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 Patented Medicine Prices Review Board (PMPRB), 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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