President Biden Issues a New Executive Order Potentially Affecting Patent Applications in the Healthcare Industry
On July 9, 2021, President Biden issued “Executive Order on Promoting Competition in the American Economy” (the “Executive Order”). This Executive Order establishes over 70 initiatives across over a dozen federal agencies.
Notably, many of these initiatives focus on the healthcare sector, and many of those affect patent applications for healthcare products. For example the Executive Order states that the Secretary of Health should, “ensure that the patent system, while incentivizing innovation, does not also unjustifiably delay generic drug and biosimilar competition.” The Order continues by mandating that the Secretary of Health should, by no later than August 23, 2021, “write a letter to the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office enumerating and describing any relevant concerns;” and “support the market entry of lower-cost generic drugs and biosimilars.”
The Executive Order also “encourage[s]” the Attorney General and the Secretary of Commerce to “consider whether to revise their position on the intersection of the intellectual property and antitrust laws.” It further instructs the Federal Trade Commission to exercise its statutory rulemaking authority with respect to “anticompetitive conduct or agreements in the prescription drug industries, such as agreements to delay the market entry of generic drugs or biosimilars.”
Although these mandates could become extremely significant, their impact will depend on the extent and timing of the actual responsive actions that the agencies at issue ultimately take. With respect to this Order’s actual effects on patentability of healthcare products, we will have a much clearer understanding of the potential effect once the Secretary of Health and Human Services releases his letter to the Under Secretary of Commerce for Intellectual Property and Director of the USPTO on or before August 23, 2021. Members of the healthcare industry should monitor this process carefully, including any future notifications from the federal government seeking public comments on any proposed rules and regulations.