This term, I had the pleasure of being placed at Sandoz Canada as part of Osgoode’s Intellectual Property (IP) Law and Technology Intensive Program. Although the placement was a brief ten weeks, it would be impossible to convey the myriad of lessons I learned during this time. Two of the main takeaways I would like to highlight are first, that pharmaceutical law is so much more than the Patent Act, and secondly, that my perceptions of in-house counsel have radically changed as a result of my experiences at Sandoz.
While at Sandoz, I primarily worked with the IP team on patent litigation, although I also participated in some trademark prosecution. Having previously conducted research in molecular biology and worked in science journalism, I had a keen interest in the pharmaceutical industry, and I was eager to engage in technical writing about drugs and patent law. I was given a wide range of tasks including drafting legal memoranda on various legal questions, reviewing licensing agreements and settlement terms, and summarizing litigation strategies for internal review.
What surprised me most about the pharmaceutical industry is how heavily it is shaped by regulatory schemes rather than the Patent Act, which I had previously studied at Osgoode. While my work at Sandoz often involved issues of validity and non-infringement, I generally felt that I was more occupied by the timelines and outcomes dictated by the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) and the Rules of Civil Procedure. Validity and infringement are just a few of the factors that counsel consider when choosing a litigation strategy. Information that is sometimes more important is the predicted launch dates for Sandoz and its competitors, which depend largely on the duration of PM(NOC) litigation.
My experience at Sandoz has led me to understand that the role of in-house counsel is largely unsung. The large, downtown law firms are heavily represented in law schools through networking events and career panels, and professors frequently compare course materials to future work that they expect we will be doing in a law firm. When I first arrived at Sandoz, I had a limited understanding of the work done by corporate legal departments, but I have come to realize that law firms are workhorses while the in-house lawyers run the game. In-house counsel choose the litigation strategy, they choose whether or not to accept advice from external counsel, and they demand quality work from law firms.
While law firms can provide valuable expertise in litigation, they do not generally understand the business needs of their clients (in-house counsel). While Sandoz has a few preferred firms that understand their needs, the legal team also spoke about frustrating experiences with law firms. External counsel tend to advise aggressive litigation strategies that do not align with a client’s business goals, or they will produce a lengthy memo for a legal question that could have been answered with a short email. Although an increasing number of law firms are offering alternative fee arrangements (AFAs), which are preferred by clients over billable hours, companies tend to be dissatisfied with the value provided by law firms.
Being mindful of business operations is something with which in-house counsel struggle as well. A legal department is the client of a law firm, but the department also has clients themselves: the executives at their company. At an off-campus training day in October, I had attended a session about the modern role of in-house counsel presented by Nadia Petrolito, Vice President, General Counsel and Chief Communications Officer at L’Oréal Canada Inc. In the commercial world, lawyers have the reputation of slowing down projects and creating barriers, so Nadia strives to prioritize business considerations and communicate legal issues. Her department publishes an internal monthly newsletter about legal issues that is not only easy to read, it is actually highly anticipated by the other departments. Nadia’s approach to competitors is also modern and financially efficient. She emphasizes the use of “courtesy” letters or phone calls rather than “cease and desist” letters because an amicable approach is likely to achieve positive results without incurring costly litigation fees or damaging the company’s reputation.
I am grateful to IP Osgoode and Sandoz Canada for giving me this rare opportunity to experience pharmaceutical litigation from the frontlines. For those readers who are 2L students considering the IP Intensive, I cannot recommend this program enough. If you are passionate about IP or technology law, be sure to submit an application by the January 25th deadline.
Written by Gillian Burrell. Gillian 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.