As part of Osgoode’s Intellectual Property Law & Technology Intensive Program, I had the distinct pleasure of working with the Legal Affairs team at AstraZeneca Canada. With a technical background in the life sciences and a keen interest in pursuing a legal career engaged in this field, having the opportunity to gain first hand experience in the operational side of the pharmaceutical industry was very exciting and, ultimately, very rewarding. In fact, I will remember it as among the most enriching learning experiences of my time at Osgoode Hall Law School.
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.
