Intern works to protect IP for COVID-19 vaccine development

Combo of law and science equips Université de Montréal intern for success while advancing COVID-19 vaccine development

According to the Public Health Agency of Canada, the total number of COVID-19 cases reached a high of 71,486 as of May 13, 2020 — with Ontario and Quebec collectively accounting for 83% of all cases and 92% of the Canadian death toll. With a mortality rate of 3.4%, COVID-19 has created an unprecedented — and growing — demand for a vaccine.

One company that’s addressing the need for a vaccine is Medicago, a biopharmaceutical company that’s using a new manufacturing technology based on Plants and Virus-like Particles (VLP). Medicago is creating a vaccine that has the potential to promote antibody production, and unlike cell culture systems, plant systems do not require complicated growth or storage conditions.

As companies like Medicago begin to develop a working vaccine, components surrounding the product’s distribution also start to gain attention. That’s why Mitacs Accelerate intern Henri Lajeunesse and his academic supervisors Grégoire Leclair, PhD and François-Xavier Lacasse, PhD of the Université de Montréal, have teamed up with Medicago to assess the risks — such as patent protection, trademarks and licencing — inherent to intellectual property (IP) of vaccine development.

From laboratory to pharmacy

As vaccine creation becomes more complex, IP evolves as well, going from simple name protection to dissecting the different stages of research and development (R&D). Analyzing the risks around IP means analyzing the freedom-to-operate (FTO), also referred to as clearance searches, focusing on patent documents that could present an infringement risk. The main reason to consider performing an FTO study is to try to avoid the legal consequences of committing patent infringement.

“Patent FTO studies can be tremendously beneficial in a number of ways. They can help guide business decisions by providing competitive intelligence and assess the risks associated with R&D and capital investments. They can also provide a basis for a defense to allegation of willful patent infringement,” says Lajeunesse.

Before any major subsequent investments are made, it is important to analyze these processes to avoid incurring liability from third-party shareholders, which can make it harder to market and distribute a life-saving vaccine. Since the development of biopharmaceutical products requires considerable investments, recovering the high costs of production and manufacturing depends on maintaining market exclusivity and creating price competition.

“An infringement suit is catastrophic for biological products. If a company invalidates one patent critical for defending a drug, they may not be able to commercialize and offer the product to the public. With vaccines, many companies use similar antigens to prevent a specific infection by immunizing the population. What differentiates those companies are the technology and methods,” he says.

Lajeunesse’s research examines the ways that biopharmaceutical companies can mitigate the risks of counterfeiting once placed on the market by analyzing the laws that protect biological products, like vaccines, and how different biopharmaceutical drugs raise specific IP issues compared to the traditional small molecule drug development.

“The methodology used to conduct this type of analysis requires considerable intellectual rigour since it requires the ability to manipulate complex concepts, both scientific and legal. This dynamic emphasizes the importance of teamwork, since several perspectives can arise for the same risk.”

An interdisciplinary experience

From this internship, Lajeunesse gained invaluable professional skills from the multidisciplinary nature of the project. By combining the knowledge of science and law, he acquired a deep knowledge of the local and global biopharmaceutical industry while advancing public health.

“This research project is personally important to me because it has allowed me to participate in a concrete way in protecting and enhancing the work of high-level scientists and researchers with an innovative vision to offer better solutions and respond effectively to public health issues.”

As a pharmaceutical law student at the Université de Montréal, Lajeunesse’s research complements his academic studies by creating a professional outlet for two distinct fields of study: law and science. With a Bachelor of Law and Bachelor of Science with a focus on Biology Recognition from Laval University, Lajeunesse’s range of academic study coupled with this Accelerate internship, provides him the unique experience and opportunity to hone his expertise on a specific area of focus.

“I fundamentally believe that science and the recognition of the innovation it conveys can be vectors for social transformation of our societies. It is this conviction that has led me to pursue this research at Medicago, a company that pushes scientific frontiers while responding appropriately and effectively to public health issues, particularly in this time of the pandemic.”

In more ways than one, the combined efforts of scientists, researchers, and legal professionals is what makes tackling pandemics, such as COVID-19, possible. By analyzing the process of IP for current and future biological products, Lajeunesse and his team play an essential role in advancing modern society towards a safer and healthier community.

“There is certainly a personal connection between this vision and the current COVID-19 pandemic which, despite the consequences on our populations and economies, exposes the importance given to the world of science and its innovations. The support from Mitacs goes beyond mere funding and, in my opinion, helps build bridges of relationships that are of crucial value to the careers of trainees,” says Lajeunesse

Mitacs’s programs receive funding from multiple partners across Canada. We thank the Government of Canada, the Government of Alberta, the Government of British Columbia, Research Manitoba, the Government of New Brunswick, the Government of Newfoundland and Labrador, the Government of Nova Scotia, the Government of Ontario, Innovation PEI, the Government of Quebec, Fonds de recherche du Québec – Nature et technologies, and the Government of Saskatchewan for supporting us to foster innovation and economic growth throughout the country.

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