Looking at intellectual property rights during the coronavirus pandemic, on June 9, CNBC published the article, “In race to bring vaccine to market, big pharma struggles to protect its intellectual property rights.” A main focus is that “the pharmaceutical industry is being careful to not set any dangerous precedent that may weaken their future intellectual property rights.” Milena Izmirlieva, director of life science at IHS Markit, says, “With vaccine development for Covid-19, pharmaceutical companies are certainly being very careful.” She outlines how many are calling for COVID-19 vaccines to be treated as a public good and therefore sold without profit. But R&D for vaccines is expensive and risky, and most candidates fail. Per CNBC, “Intellectual property rights and patents, which give exclusivity and price control, are fundamental to the pharmaceutical industry as they enable companies to undertake costly research with the promise of future profits.” Izmirlieva added that the goal should be to allow low-income nations quick access while without weakening property rights.
Another take was offered in a July 6 opinion piece by the progressive-minded economic-development organization devex. The author argues that since we must be able to distribute a vaccine worldwide, the “key will be decoupling the production of the vaccine from its development.” Assigning intellectual property rights for vaccines, “would delay ramping up its production, and may make the vaccine unaffordable for low- and middle-income countries. Alternatively, a buy-out of IP rights would allow multiple investors to build up manufacturing capacity.” 37 countries has pledged to share coronavirus intellectual property, “but key players are missing.”
Most new drugs result in IP rights “that allow sole control over the drug’s manufacturing and retailing.” Despite the commonality of government funding, “the IP rights rest mostly with private developers.” These developers set “the price to recover costs, which in most cases remain unknown to the public, and pricing facilitates profits over the entire portfolio of activities pharmaceuticals undertake.” In the past, courts have had to clarify how public investment should affect pricing. Since federal funding for fighting COVID-19 may top $175 billion, “the suspension of IP rights would not set a precedent for any future developments of pharmaceutical products, but instead paves the way for separating out the manufacturing process from that for development.” Multiple generics would be allowed with the buy-out of IP rights.
Practical Help from WIPO
The World Intellectual Property Organization (WIPO) is a global forum for IP policy, information, and cooperation. It is a self-fended agency of the United Nations and has 193 member states. It’s mission “is to lead the development of a balanced and effective international IP system that enables innovation and creativity for the benefit of all.” WIPO has a “COVID-19 Policy Tracker” that offers invaluable granular data on how the various international regulatory agencies are being impacted by the pandemic. In WIPO’S language, this tool “provides information on measures adopted by IP offices in response to the COVID-19 pandemic, such as the extension of deadlines. In addition, the policy tracker provides information on legislative and regulatory measures for access and voluntary actions.”
COVID-19 IP issues will be with us for some time, and we will continue to cover this important intersection of medicine, business, and law at TrialSite News.