My 10 week internship at Actavis’ Canadian arm (formerly known as Cobalt), through Osgoode’s IP Intensive Program coincided with a very exciting time for the company. The company recently expanded through a number of acquisitions to make it the third-largest generic pharmaceutical company globally, with commercial operations in more than 60 countries worldwide.
As a part of Actavis’ in-house legal team, I gained a deeper understanding of intellectual property (IP) law and its intersection with the pharmaceutical industry. I developed the skills necessary to construe claims of pharmaceutical patents in order to draft clearance opinions, attended a hearing in the Federal Court involving the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) and learned more about the impact government policy has on the development of generic drugs in Canada. Most importantly, this experience allowed me to combine my prior summer experience at an IP law firm with insight gleaned from a client’s perspective.
My internship began with a brief overview of the global structure of the company and discussing some of the unique challenges being faced by the company as a result of its global structure. For example, in addition to providing clearance opinions for products to be marketed in Canada, Canadian legal counsel must consider IP laws in other jurisdictions where drugs intended for the Canadian market may be manufactured. I drafted clearance opinions by reviewing foreign jurisdictions’ patent databases for products that are being manufactured there before being exported to Canada. I also drafted clearance opinions for products Actavis intends to market in emerging markets such as Brazil. These exercises required me to combine my scientific and legal background to understand the synthetic process, formulation and use of specific products to comment on whether they fall within the claims of relevant patents.
I had an opportunity to attend a hearing in a proceeding under the PM(NOC) Regulations, where a brand company sought to prohibit Health Canada from issuing a Notice of Compliance to Actavis for a drug product. Actavis alleged that the patent at issue was invalid and therefore could not be infringed. While preparing for this hearing, I engaged in discussions about the merit of the case with the in-house counsel as well as the external counsel representing Actavis and observed the strategic progression of the case upon hearing the submission from the brand manufacturer.
An opportunity to observe a PM(NOC) Regulations proceeding helped me realize the risks involved for a generic manufacturer in deciding which drugs to include in their portfolio. Despite being successful in a proceeding under the PM(NOC) Regulations and obtaining an NOC, generic manufacturers may face the risk of damages for infringement in a subsequent infringement action under the Patent Act and may incur additional costs of re-litigating issues concerning the same patent. Hands-on experience through this internship enabled me to reflect on the role of patent linkage regulations in Canada.
Entry of generic competition for a particular product depends upon the willingness of a company to challenge the brand manufacturer’s patents. I also gained more insight on the decision-making process for product pipeline development through discussions with the Business Development team. Through these discussions, I learned about the effects of government policies on the growth of global companies such as Actavis. For example, the Ontario government capped the maximum price of generic drugs permitted under the Ontario Drug Benefit (ODB) program to be no more than 25% of the branded product’s price. As a result, the damages a generic manufacturer may be entitled to under section 8 of the PM(NOC) Regulations for being unfairly held off the market have reduced drastically, while the exposure to damages for infringement (based on lost profits of the brand) has remained the same. As a result, the risk of bringing a product to market has increased due to the increase in the difference in potential damages. Such an increase in risk may impact the resources to be allocated to a Canadian subsidiary of a global generic pharmaceutical company. Moreover, higher risk and lower profit may push numerous manufacturers to leave the market with a limited number of manufacturers dominating each type of drug, running the risk of shortages in drug supply for Canadian consumers.
In sum, my experience at Actavis was highly educational. It fostered the ability in me to critically reflect on complex government policies that regulate the pharmaceutical industry and to assess the adequacy of these regulations from a global perspective. I am grateful to Professor Vaver, Michael Migus (in-house counsel at Actavis) and IP Osgoode for their guidance throughout this journey.