Richard de Almeida is a 3L JD Candidate at Osgoode Hall Law School. This article was written as a requirement for Prof. Pina D’Agostino’s IP Intensive Program.

This semester, as part of Osgoode’s Intellectual Property Law & Technology Intensive Program, I had the pleasure of participating in a 10-week internship at Teva Canada (“Teva”), a (mainly) generics pharmaceutical company, and it was the highlight of my tenure thus far at Osgoode.

Heading into the program, I had one main goal: to know what it’s like to truly practice law. Frankly, after two years in law school, I feel like I know the general schema of academically learning any new type of law. You start with the legislation, fill in the gaps with the caselaw, and get some secondary commentary to critique and make unique arguments around the current framework. Working at Teva has given me this experience of feeling like a real practicing lawyer and so much more.

Within minutes of working there, I was already growing in my legal development from being academically into practically trained as I learned about my supervisor’s door policy, to protect Teva’s confidentiality in all dealings. As obvious as it sounds in hindsight, his door policy really opened my eyes. In law school’s academic setting, we always learned the importance of confidentiality and the implications of failing that duty. But it was always presented as a mistake we’d make intentionally, or at least explicitly. I never realized how something as simple as a door policy can give life to these principles. It was the perfect microcosm to exemplify the difference between learning and practicing the law, which was exactly what I was looking for.

Throughout the term, I continued to have these realizations. In the patent law textbook, we learned about filing and expiry dates of patents in one chapter, and grounds for invalidity in another. In practice, these two are connected. Teva can never rely on a patent expiry date as another generic may be in litigation to invalidate that patent tomorrow, in which case Teva would be too behind to launch their own version of the medicine if they weren’t paying attention to the litigation within the industry. This integration of patent law concepts also demonstrated the interplay between business and the law as the legal department’s vigilance on these matters was crucial to business success.

This is where the learning experience truly took off. Not only did I learn what it meant to be a practising lawyer, but also what it meant to be an in-house counsel. If you’re someone who likes to juggle multiple tasks at a time, in-house counsel is the way to go as I saw my supervisor, Ben Gray, who is Vice-President and General Counsel of Teva, manage a multitude of tasks. From meetings with the Canadian Generics Pharmaceutical Association (CGPA), Teva’s industry association to discuss policy goals to ensure Teva and the generic industry’s future, to dealing with Health Canada policy changes implicating the importation of drug products, to understanding the litigation landscape, to managing internal conflicts such as human resource or product liability suits; the list and tasks to do are both endlessly engaging and vital to the entire business.

I also had the privilege of making contract amendments and drafting an entirely new contract through “Canadianizing” an American reference contract. I participated in a settlement negotiation. I attended a patent law Colloquium that Teva sponsors at University of Toronto. I also had the pleasure of speaking to and working with Teva’s External Counsel at firms like Osler and Aitken Klee whose expertise on PM(NOC) litigation was enriching.

Lastly what I most appreciated from the Intensive experience was the kindness and support from everyone at Teva. Sometimes playing catch-up can make you feel like you’re burdening the team, but everyone was willing to teach me with genuine excitement which was so precious to my experience. I am so grateful to everyone I worked with at Teva as well as Professor Pina D’Agostino and Ashley Moniz for providing and administrating this valuable and essential program. The skills I have developed over my internship will assuredly help me in my legal career and I will always be proud to say I was an Intensive alumnus.

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I was largely oblivious to the processes of prescription and generic substitution before my internship at Teva Pharmaceuticals. Little did I know that pharmacists had the discretion of substituting generics for brand name medicines, unless the prescriber had indicated ‘no substitution’ on the prescription, which might occur if a patient had experienced an adverse reaction to an alternative brand. Little did I know that the price of patented medicines is capped on a case-by-case basis by the federal Patented Medicine Prices Review Board. And little did I know that every provincial/territorial jurisdiction in Canada is party to a Tiered Pricing Framework that also places ceilings on generic drug prices relative to the reference brand price. I was fortunate to have a patient and knowledgeable supervisor in Ben Gray with whom to discuss a number of patent issues involving litigation strategy, biologics, skinny labeling, and means by which pharmaceutical companies seek to extend their commercial monopolies.

My internship at Teva afforded me the opportunity to connect with members of the inhouse legal team, including counsel and a law clerk, as well as external counsel to gain a clearer picture of the division of labour on legal matters. In-house counsel oversaw matters on the macro level, sometimes handling matters independently, but also procuring and providing instruction to external counsel and allocating resources across files. External counsel were assigned to individual files, but in-house counsel kept abreast of developments through regular updates to their litigation reports, which provide an overview of ongoing litigation from claims to timelines. The management of intellectual property, having its own dedicated counsel and litigation report separate from all other legal matters, is unsurprisingly a priority for Teva.

While I did encounter a trademark issue pertaining to licensing the use of Teva’s brand materials, the IP matters I was exposed to mostly concerned patents. Though I have completed a handful of undergraduate courses in chemistry, that information has since laid dormant in my brain—so it was to my relief when Ben assured me that a PhD in chemistry is not a prerequisite to the in-house work that he does. I don’t know that the same can be said for the work of external counsel having now reviewed a couple lengthy Notices of Application pursuant to the PM(NOC) Regulations. Admittedly, I took numerous detours while reading to refresh my memory on the meaning of various terms describing chemical groups and molecular structure.

As Teva markets both brand name and generic products, it also both defends and challenges the validity of patents. I found it valuable to be placed with an entity whose interests lie on both sides of the social bargain in patent law. Updating litigation reports on intellectual property and non-intellectual property matters with law clerk Lynn Chacra allowed me to survey a range of legal issues that can arise for a pharmaceutical company. The matters I engaged with in more depth, though, were IP-related. In the
course of my work, I became more familiar with the Patent Act, the Patented Medicines (Notice of Compliance) Regulations, and the Rules of Civil Procedure. But my takeaways were not limited to hard skills.

Future dealings with most corporate adversaries, co-plaintiffs and co-defendants is to be expected in an oligopolistic industry like pharmaceuticals. As I allude to in the title of this blog—it’s a small world in big pharma. Aside from a firm grasp of the relevant substantive law and procedural frameworks, the importance of soft skills cannot be overstated in building respectful working relationships with adversaries and colleagues alike. For instance, favourable procedural arrangements and even settlements can sometimes be reached on consent of the parties. Co-plaintiffs or co-defendants may also pursue joint litigation to pool resources. It was my pleasure to be placed with an office that exemplifies professionalism from the technical to the relational. Owing to my positive experience with the Teva team, I have arranged to virtually observe an appeal hearing after the formal conclusion of my internship, so I can say with complete sincerity that I would choose this internship again.

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For one long-term project, I was able to engage with the Patented Medicines (Notice of Compliance) Regulations, which provide generic companies with a way to market their products before a patent relating to the drug, which is owned by brand-name manufacturers, expires. Initiating the process requires drafting a Notice of Allegation (NOA), which must include a description of various aspects of the drug such as its medicinal ingredient, dosage form, and strength. In the NOA, one can assert that the generic product does not infringe upon the relevant patent. Arguments can also be made in the alternative (i.e. in the case a product does infringe upon a patent). My project involved an analysis of the latter; specifically, I was tasked with drafting arguments contesting the validity of certain patents. I reviewed the applicable Canadian patents for a specific product, found prior art anticipating aspects of the patents, and developed potential arguments that could be used in an NOA to question the validity of the patents. It became clear to me that coming up with compelling arguments regarding the validity of a pharmaceutical patent requires understanding the complexities of the specific molecules and their chemical interactions. Generally, having a deep-seated understanding of the scientific terms and related phenomena is an asset. Thankfully, I had the help of my supervisors at Teva, who were able to guide me through any questions I had. In working through this project, I recognized the importance of teamwork and mentorship, and I appreciated the intricate process of ensuring that affordable versions of brand-name medications are made available to the public. I also saw how the pharmaceutical ecosystem is dynamic and symbiotic—brand-name and generic manufacturers must work together with the ultimate goal of providing safe, effective drugs to the people who need it the most.

Along with this challenging and rewarding project, I assisted the team with legal drafting, as well as updating the market research group on the state of ongoing litigation involving Teva and other generic pharmaceutical companies. Through such tasks, I observed how working with an in-house legal team is highly collaborative as it functions within a large company interdependent on multiple other departments.

As a law student, the ability to get any hands-on legal experience is highly beneficial. While classes certainly provide students with the discipline and background to become an effective lawyer, placements such as those provided by the Intensive allow students to gain the practical skills necessary to become a working professional.

I would like to thank my supervisors and teachers, including Ben Gray, David Solomon, and Kane Denike for taking the time to educate me about the industry and guide me through my tasks. I am also thankful to Professor D’Agostino and Professor Vaver for ensuring that the program ran smoothly and for making my placement possible. Above all, I am grateful for the time and care taken to support and enrich my law school experience during such an unprecedented time. Despite all the uncertainty surrounding the school year, it was great to be a part of a program that kept things operating as “normal” as possible.

Written by Esther Kim, JD Candidate 2021, enrolled in Professors D’Agostino and Vaver 2020/2021 IP & Technology Law Intensive Program at Osgoode Hall Law School. As part of the course requirements, students were asked to write a reflective blog on their internship experience.

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I entered the program hoping for a chance to experience practicing intellectual property law as in-house counsel. I hoped to get an opportunity to see how a large company approaches intellectual property; how it views the patent regime, what aspects it considers helpful and harmful, and especially how a large corporate structure adjusts to changes and opportunities afforded by that regime. I was not disappointed.

Most of my time at Teva was directed towards writing reports on the validity of brand pharmaceutical patents. One of the main tasks of the Patent Strategy Group at Teva is to decide which patents might be successfully challenged in court. Successful challenges of current patents often allow Teva to bring generic products to market significantly earlier than would otherwise be possible. In addition to being allowed on the market earlier than otherwise would be possible, the way in which the operate means that Teva may also be able to enter the market as the sole generic pharmaceutical company. Being the first generic company on the market allows Teva to capture a large portion of the generic market, and to hold onto this market share even after other generic companies begin marketing.

In addition, I worked on several of the practical aspects of bringing together the required documentation in preparation for litigation, particularly litigation around damages claimed under section 8 of the Patented Medicines Regulations. Through the process of finding, bringing together, and summarizing documents I was able to get an idea of the amount of effort and cost involved in preparing for pharmaceutical litigation.

I was also able to spend some time working with the corporate law group. This experience allowed me to see the practical side of how a large company like Teva operates. In particular, this allowed me to see the many contracts, agreements, and corporate interactions that underpin the smooth operations of a large pharmaceutical company as it carries out its business operations and takes advantage of the opportunities afforded to it by intellectual property litigation.

I thoroughly enjoyed my time interning at Teva Canada; both the mentoring and the practical experience provided great insight into the operations of such a significant participant in Canada’s Intellectual Property system.

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The Work I did

As part of the Teva Legal Affairs department, I had a chance to participate in many aspects of pharmaceutical patent litigation that were important to the company. This involved drafting pre-litigation invalidity and non-infringement opinions, assessing molecules for entry into various world markets, and supporting current patent litigation that Teva is party to. The majority of the Canadian patent litigation involved proceedings under the , but the placement frequently required consideration of other jurisdictions due to the fact that my supervisor was responsible for Teva’s global patent litigation strategy.

The opportunity to assess pharmaceutical patent portfolios on a global scale was extremely interesting, as I was able to observe some of the nuances between Canadian patent law and the laws governing patents in the US and European Union (EU). This analysis involved tracking patent prosecution that is often much more extensive than their Canadian counterparts and analyzing EU patent opposition proceedings that do not have Canadian equivalents. This research made me appreciate the vast amount of attention that a global pharmaceutical patent portfolio attracts and allowed me to utilize my scientific background when analyzing the arguments in these proceedings. The research also made me more aware of the deep scientific issues that are at play in bio-pharmaceutical patent litigation and the importance of having a solid foundation of scientific knowledge in these areas.

In addition to my exposure to patent litigation I was able to gain some insight into other legal issues that Teva frequently encounters. I had the opportunity throughout my placement to help out on various corporate matters, allowing me to see how IP is treated when it is an auxiliary consideration in the business context. For example, IP issues are often present in employment contracts and supply agreements, and it was fascinating to learn about these important in-house matters from experienced counsel. Lastly, the opportunity to attend meetings with other departments of the company like government and regulatory affairs allowed me to broaden my understanding of the company as a whole and the role that intellectual property matters play in Teva’s business model.

The Benefit of my Experience

The experience that I gained through my semester at Teva gave me insight into a world of legal practice that most lawyers will not see until many years into their careers (if they see it at all). In addition, I had a chance to utilize my background in science and pharmaceutical chemistry which was not only exciting but also a reminder of why I choose to pursue a law degree. Most of all, the placement allowed me to build on my time at an intellectual property boutique law firm by providing me with insight into the needs of a pharmaceutical company client. I have no doubt that my experience at Teva has afforded me a stronger understanding of both the law and the needs of my future clients.

As I am sure you can tell, I truly enjoyed my time at Teva through Osgoode Hall Law School’s , and I would recommend the program to any student with an interest in intellectual property or technology law. Lastly, I wanted to give a special thank you to IP Osgoode’s Michelle Li and Professors Giuseppina D'Agostino and David Vaver for giving me the opportunity to participate in the program and to Dr. Kane Denike, Teva Canada’s Senior Director of Intellectual Property, who was my supervisor throughout the semester.

Adam Falconi 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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