/>iSenator Ben Sasse (R-NE) has introduced legislation that would delay and then extend the term of patents related to the treatment of COVID-19. The “Facilitating Innovation to Fight Coronavirus Act” also would shield health care providers from liability under any federal, state, or local civil law arising from treating COVID-19. While the emergency legislation addresses important issues, it likely will be subject to further clarification and compromise if it proceeds through the legislative process.
The Patent Provisions of “The Facilitating Innovation to Fight Coronavirus Act”
The proposed legislation would impact the term of the following categories of patents:
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).
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.”
The proposed legislation would delay the term of such patents “until the date on which the national emergency declared by the President under the National Emergencies Act (50 U.S.C. § 1601 et seq.) with respect to that disease terminates.”
The proposed legislation would extend the term of such patents thereafter, “for 10 years longer than it otherwise would” be under Title 35. Also among the issues to be clarified is whether the extended term could be added onto an FDA review-based patent term extension granted under 35 U.S.C. § 156.
The Broad Liability Shield of “The Facilitating Innovation to Fight Coronavirus Act”
The proposed legislation would shield health care providers from liability under any federal, state, or local civil law arising from treating COVID-19, with “health care provider” being defined in accordance with section 3000(j) of the Public Health Service Act (42 U.S.C. § 300jj(3)) The actions shielded from liability would be:
(1) using or modifying a medical device for an unapproved use or indication;
(2) 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
(3) conducting the testing of, or the provision of treatment to, a patient outside of the premises of standard health care facilities;
where such action was carried out to test, treat, or otherwise counter the effects of … COVID-19 during the duration of the national emergency declared by the President under the National Emergencies Act (50 U.S.C. § 1601 et seq.) with respect to that disease.
