December 2021
By Jhon Carmona, Global Challenges Division and Edward Harris, News and Media Division, WIPO
Some great news broke recently for the worldwide treatment of COVID-19: the Medicines Patent Pool, a UN-backed non-profit organization, of which WIPO is a board member, agreed to work with Pfizer and Merck Sharp & Dohme (MSD), both members of WIPO Re:Search, for the licensing of anti-viral pills − MSD’s molnupiravir and Pfizer’s PF-07321332 − in nearly 100 low- and middle-income countries.
Why this is important
Treating COVID-19 early is key because the cure rate in early infections is higher than in advanced infections. To date, only two oral treatments for early-stage COVID-19 infection have shown promising results: MSD’s molnupiravir and Pfizer’s PF-07321332.
The recently announced licensing agreements will enable mass production and low-cost distribution of these COVID-19 treatments for half of the world population. Under the agreements, MSD and Pfizer will forego royalties for as long as COVID-19 remains a public health emergency of international concern. Sales will continue under normal market conditions elsewhere. This will mean countless human lives will be saved in countries where the need for extra support in moving beyond the pandemic is greatest.
“These deals are very welcome developments and represent a balanced model for promoting the spread of innovative anti-COVID medical technology across the globe,” says WIPO Director General Daren Tang. “I encourage players across the world − those creating these important health technologies, those seeking them and everyone in between − to quickly explore similar arrangements. WIPO stands ready to continue its work to facilitate the sharing of intellectual property (IP), technology and the know-how needed to make it all work.”
Ownership of the IP rights associated with a product or therapy encourages enterprises to commit to the research and development and other outlays needed to develop health technologies.
The role of intellectual property in facilitating these agreements
Ownership of the IP rights associated with a product or therapy encourages enterprises to commit to the research and development and other outlays needed to develop health technologies. In many cases in the health field, development and testing of new products may take years before reaching the market.
The COVID-19 pandemic turbocharged this process, which in some cases included massive public investments alongside those made by the pharmaceutical industry and others. The repurposing of molnupiravir by MSD and Pfizer’s discovery of PF-07321332 were made possible by the incentives provided by the IP system.
Now, with a growing range of COVID-19 vaccines and other products coming online, the international community is targeting universal access. This is where the Medicines Patent Pool and other groups play a role in helping IP-owning enterprises to link up with the local partners who can scale-up production and distribution of medical technologies. The Medicines Patent Pool is an initiative that connects interested parties to promote the voluntary licensing practices of pharmaceutical companies.
Licensing is the most frequently used tool for transferring IP. In a license agreement, the owner of IP rights or the entity that controls their use, allows third parties to develop, manufacture and/or distribute the invention. In other words, the licensor grants authorization to a company that has the manufacturing capacity and distribution channels to bring the invention to potential users. Under the standard licensing model, the licensor receives a royalty fee under agreed financial terms set out in the licensing agreement.
The license agreements for molnupiravir and PF-07321332 are milestones in the fight against the COVID-19 pandemic and a key example of how IP is a critical ingredient in solving pressing problems, serving as the bridge that allows diverse parties to work together with clarity.
In situations, such as public health emergencies, where there is an urgent need to produce an invention at large scale, the standard licensing model often requires additional features to take into account any market failures. These market failures most often relate to limited capacity to manufacture the invention in massive quantities and the risk of concentrating distribution of the invention only in those places where users are able to pay a premium.
Technology transfer agreements offer a solution to this problem. Technology transfer is a collaborative process that allows scientific findings, knowledge and IP to flow from creators, such as research institutions and universities, or business labs, to public and private users. The goal is to transform inventions and scientific outcomes into new innovative products that benefit society. IP ownership allows for this transfer.
Technology transfer also fosters the multiplication of manufacturing plants and, therefore, can dramatically increase production of a much-needed invention, including medicines.
Licensing is the most frequently used tool for transferring IP. In a license agreement, the licensor grants authorization to a company that has the manufacturing capacity and distribution channels to bring the invention to potential users.
WIPO welcomes the agreement of The Medicines Patent Pool and MSD to submit any IP disputes that may arise from their license agreement to mediation under the WIPO Mediation Rules. As one of the elements of WIPO’s COVID-19 response package, WIPO has launched a new mediation service to facilitate contract negotiation and dispute resolution in the life sciences.