IP Intensive: The Business of Innovation – A Semester at AstraZeneca

As part of Osgoode’s IP Law and Technology Intensive Program, I had the amazing opportunity to serve a 10-week internship at AstraZeneca Canada under the supervision of AstraZeneca’s Legal Director, Denise Lacombe. My experience has been the most rewarding learning experience that I have had at Osgoode Hall Law School.

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 Innovative Medicines Canada (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 AstraZeneca Patient Assistant Program. 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.