This article was originally published in BIOTECanada's Insight magazine.
Few of us would have imagined that a vaccine to a new virus could be developed in a year. But, 12 months from the first known cases of COVID-19, two vaccines are already being administered within our communities.
In Canada, Quebec- based Medicago Inc. is leading the country in terms of vaccine development, with a plant-produced vaccine candidate. The Pfizer-BioNTech and Moderna vaccines are based on using messenger RNA (mRNA), which when injected, prompts the body to produce the spike (S) protein that covers the surface of the SARS-CoV-2 virus. The approach being used by Medicago is based on the same S protein, but Medicago generates the protein as a virus-like particle in plants, which can then be injected directly into the body. The Medicago vaccine is currently in phase 2/3 clinical trials.
The COVID-19 story began in December of 2019, in Wuhan, China, with reports of an increasing number of people becoming sick with pneumonia of unknown cause. On January 7, 2020, Chinese authorities identified the causal agent as a novel coronavirus1 later named SARS-CoV-2. Just three days later, the first genome sequence of SARS-CoV-2 was made publicly available2. By spring, when most of us were finding ourselves preoccupied with trying to adjust to the new normal of daily life in a pandemic, COVID-19 vaccine development was already well underway, with Pfizer-BioNTech and Moderna establishing themselves as the frontrunners in the race to develop a vaccine. In December of 2020, Health Canada approved both vaccines for use in Canada3.'
The protection of intellectual property (IP) rights is a crucial factor in the process of COVID-19 vaccine development, allowing companies to recoup the enormous investment they make in innovating new products. However, the process of obtaining a patent can be slow. When there is critical pressure to bring a product to market quickly, reconciling the speed of innovation with the typically slow process of obtaining patents requires consideration of multiple issues, including:
1. Patent landscape and freedom-to-operate
Understanding the patent landscape of a technology (i.e., by searching patents and related literature) is important for: assessing the patentability of your own inventions in view of existing technology, examining the risk of infringing existing patents, and identifying key targets for licensing agreements. In the context of Moderna's COVID-19 vaccine, for example, a number of issued and pending third-party patents exist that may need to be licensed, or that could be asserted against Moderna4.
It is important to remember that patent applications are generally not made publicly available until 18 months after their filing date, unless early publication is requested. Therefore, in fast-moving areas of innovation, a single early search is often inadequate – repeated searches are critical.
2. Data for filing
A common concern for many companies is understanding how much data is required to file a patent application; there is often tension between having enough data to show that the invention works, and filing the application as soon as possible. To complicate matters further, different jurisdictions have varying requirements for the amount and type of data required to support a patent. The application should include sufficient data, first, to show a person who works in the field how to make and use the invention, and second, to demonstrate that the invention has an effect. In the context of COVID-19, for example, simply stating that a particular biologic can be used in treating someone with the virus is not sufficient—the application needs to contain some data showing biological activity or effect of that biologic.
3. Where and when to file
Given that a patent application is generally not published until about 18 months from its initial filing date, we cannot yet see how bio-pharma companies developing COVID-19-related technologies are managing their IP, who is filing patents or where patents are being filed.
A common patent strategy used by many companies is to first file a United States provisional application, then an international (PCT) and/or national application(s) one year later. This strategy is optimal for companies who want more time to develop their technology and to decide in which countries to file.
However, if the priority is to obtain a granted patent faster, an alternative strategy involves filing a regular national application in a key jurisdiction. Although this process offers a quicker way to obtain a granted patent compared to the strategy noted above, many patent offices also have mechanisms to further accelerate the prosecution process. To obtain protection in additional countries, a PCT application or national applications can be filed within 12 months from the filing of the first application.
4. Ongoing work and communication
The patenting process does not end when an application is filed. Data generated in the 12 months after the initial filing should be reviewed to assess whether to amend the existing application, or whether the new data are part of a separate invention. It is important to keep the company's patent professional involved in this ongoing work, to ensure that current priorities for the company are understood and acted upon. For example, a patent professional may assist in reviewing results from ongoing landscape searches to evaluate relevance to the invention, advise of possible infringement risks or licensing needs, or advise on further experiments that would be useful to strengthen a patent application.
The rapid development of COVID-19 vaccines provides a case study in which to examine the process of protecting IP rights in an environment where there is critical pressure to bring a product to market. Careful consideration of the patent landscape, data for filing, the filing strategy, and ongoing work should position companies well.
1 WHO. Novel Coronavirus (2019-nCoV) situation report-1. https://www.who.int/ docs/default-source/coronaviruse/situation-reports/20200121-sitrep-1-2019-ncov. pdf?sfvrsn=20a99c10_4
2 Initial genome release of novel coronavirus. http://virological.org/t/initial-ge-nome-release-of-novel-coronavirus/319?from=groupmessage.
4 mrna-20200630 (sec.gov)