By AJ Wenn and Gopal Gannamraj
In response to the recent COVID-19 pandemic, governments and agencies around the world are discussing and implementing measures to allow for the quick and easy spread of scientific knowledge and ideas that may help with the diagnosis, treatment and prevention of COVID-19. For example, Canada, Germany, France and Israel have considered or enacted emergency legislation to allow for the suspension of patent rights, either across the board or directed to specific drugs and devices. 1
Here in the United States, Senator Ben Sasse (R-NE) has introduced a bill that would create the “Facilitating Innovation to Fight Coronavirus Act” that would delay and then extend patent protection for new and existing medical devices and drugs intended to treat COVID-19. Specifically, while the legislation would pre-empt or negate the rights of IP owners with IP related to treat COVID-19, the legislation would extend the patent term of pre-empted patents by a period of 10 years, wherein the 10-year extension would begin from the date on which the declaration of the national emergency is withdrawn. The Facilitating Innovation to Fight Coronavirus Act would impact the term of “a patent issued for a new or existing pharmaceutical, medical device, or other process, machine, manufacture, or composition of matter, or any new and useful improvement thereof used or intended for use in the treatment of the Coronavirus Disease 2019 (COVID–19).” 2
While the emergency legislation addresses important issues, it likely will be subject to further clarification and compromise if it proceeds through the legislative process. Among the issues to be clarified are whether the proposed legislation would apply to existing patents or only patents granted after its effective date, and what it means for a patent to be “used or intended for use in the treatment of … COVID–19.”3 Additionally, there needs to be a determination made on how owners of pre-empted patents regain exclusivity following the period of pre-emption.
Other branches of government are also working behind the scenes to facilitate a sharing of information between private actors. The National Institutes of Health (NIH) has created a partnership with the U.S. Food and Drug Agency (FDA), the European Medicines Agency (EMA), and 16 leading pharmaceutical companies, including Merck, AbbVie, Johnson & Johnson and Pfizer, “to develop an international strategy for a coordinated research response to the COVID-19 pandemic.”4 The partnership, called Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), does not specifically discuss intellectual property rights, but establishes among other cooperative efforts “a centralized process and repository for harmonizing and sharing methods and evaluating models.”5
Further, there are also a variety of private licensing groups attempting to tackle the COVID-19 pandemic. Companies and universities, including Intel and the Innovative Genomics Institute of UC Berkeley and UCSF, have signed on to the Open COVID Pledge, which provides a license that “make[s] intellectual property available free of charge for use in ending the COVID-19 pandemic and minimizing the impact of the disease.”6 The Universities of Harvard, Stanford and Yale, have joined the COVID-19 Technology Access Framework, which provides “royalty free licenses … for the purpose of making and distributing products to prevent, diagnose and treat the COVID-19 pandemic.”7 This type of corroboration between large universities and entities gives support to the promising search for a COVID-19 vaccine.
Nonetheless, it remains doubtful that congress will pass legislation extending the rights of patents that are related to treating COVID-19. Namely, because all new patent applications targeted at treating COVID-19 will take roughly three years to issue, at which point most experts agree the pandemic will be over. Moreover, it will be difficult to determine whether pre-existing patents cover technology that will be used to treat coronavirus. It is likely that private entities will continue to create intellectual property licensing groups, such as the Open COVID Pledge and ACTIV, to streamline the fight against COVID-19.
If you have any questions regarding licensing intellectual property, please feel free to contact SpencePC. We are also happy to discuss any IP issues you may face, including patent litigation, patent applications and prosecution, trademark applications and prosecution, copyright filings, trade secrets, or other complex litigation matters.
1 See https://www.natlawreview.com/article/sharing-ip-rights-fight-against-covid-19
2 See https://www.govtrack.us/congress/bills/116/s3630/text
3 See https://www.foley.com/en/insights/publications/2020/04/proposed-delay-then-extend-coronavirus-patents
4 See https://www.nih.gov/news-events/news-releases/nih-launch-public-private-partnership-speed-covid-19-vaccine-treatment-options
6 See https://www.wilsonelser.com/news_and_insights/insights/3787-sharing_ip_rights_in_the_fight_against_covid-19