Traditionally, it has been fairly uncommon to see new legislation in intellectual property (IP) law, compared to other areas of law. Instead, courts have generally been the avenue through which changes in IP law have been brought about and, for some, the Leahy-Smith America Invents Act of 2012 is the most recent IP legislation of particular relevance. This can provide a certain confidence to companies exploring or entering the IP field. However, developments associated with the coronavirus pandemic have, for some, highlighted issues with balancing the rights of a patent owner with a protection of the national interest.
As an example of the issues highlighted by the coronavirus pandemic, on January 21, 2020, the Wuhan Institute of Virology filed a Chinese patent application directed to the use of remdesivir in the treatment of coronavirus. Previously, in 2016, Gilead had also filed a Chinese patent application directed to a similar use of remdesivir in the treatment of coronavirus. The issue for the Chinese Patent Office was in balancing the traditional intellectual property rights of Gilead with the national interests at stake due to the coronavirus pandemic as proposed by the Wuhan Institute of Virology. While the Chinese Patent Office ultimately granted the patent to Gilead, it highlighted the potential for conflicts in IP law due to the coronavirus pandemic and further illustrated the need for a proper balancing of the rights of the patent owner with the protection of the national interest.
In an effort to balance the dual interests, numerous legislation has been proposed to modify the patent system in response to the coronavirus pandemic. Specifically in the US, Senator Ben Sasse recently introduced a bill dubbed the “Facilitating Innovation to Fight Coronavirus Act” designed to limit IP liability for healthcare professionals who are fighting coronavirus.
Under the Facilitating Innovation to Fight Coronavirus Act, healthcare providers would be protected from liability for:
- Using or modifying a medical device for an unapproved use or indication;
- Practicing without a license or outside of an area of specialty if instructed to do so by an individual with such a license or within such an area of specialty; or
- Conducting the testing of, or the provision of treatment to, a patient outside of the premises of the standard health care facilities.
The Facilitating Innovation to Fight Coronavirus Act would further limit the rights of a patent owner to protect the patent from unauthorized use as the effective date of eligible patents (e.g., pharmaceutical patents, medical device patents, or other patents related to the coronavirus) would be delayed until the cessation of the National Emergency corresponding to the coronavirus. The aforementioned portions of the Bill seek to protect the national interest by providing numerous protections to healthcare providers. However, the bill also seeks to balance the interests of the patent owners by providing for the extension of the term of each eligible patent for 10 years.
In defense of the Facilitating Innovation to Fight Coronavirus Act, Senator Sasse is quoted as saying “These heroes need a common-sense liability shield so that they don’t have to worry about lawsuits while they’re scrambling to save lives. This legislation gives emergency liability and patent protections to health care professionals who are innovating on the frontlines.”
Other examples of legislation in response to the coronavirus include the Covid-19 Emergency Response Act in Canada. Under this emergency legislation, the Canadian Patent Act has been amended to recite “The Commissioner shall, on the application of the Minister of Health, authorize the Government of Canada and any person specified in the application to make, construct, use and sell a patented invention to the extent necessary to respond to the public health emergency described in the application.” The compulsory licensing of the Act allows the Commissioner to take steps to protect the national interest. The Act further seeks to balance the rights of the patent owner by authorizing the government of Canada and other authorized persons to pay the patent owner any amount that the Commissioner considers to be adequate compensation under the circumstances, including the extent of use and the economic value of the authorization.