In the past few months, proposals from the United States Patent and Trademark Office (“USPTO”) have drawn the attention of organizations, companies, and individuals in the life sciences space. Together, the proposals have the potential to significantly affect life sciences companies’ patent and regulatory strategies in the United States—particularly, how they engage in patent prosecution before the USPTO and navigate the drug approval process with the United States Food & Drug Administration (“FDA”). The period for public comment on these proposals recently closed, and the industry now awaits the USPTO’s decisions.
These agency proposals arise out of a July 2021 executive order titled “Promoting Competition in the American Economy” (the “EO”). Among other things, the EO called for action to ensure that the United States’ patent system does not unduly delay generic drug and biosimilar competition beyond what is reasonably contemplated by applicable law. [1] Following the EO, the USPTO—along with the FDA and a number of United States members of Congress—began reviewing USPTO regulations and policies to assess how they might contribute to the purported issues of “patent thickets” (i.e., an overlapping set of patent rights ), “evergreening” (i.e., the alleged practice of effecting slight modifications to a pharmaceutical drug to extend patent protection for the drug), and “product hopping” (i.e., when a manufacturer ceases production of an older drug formulation and persuades patients to switch to a new formulation with greater patent protection). [2]
Late last year, the USPTO presented its responsive proposals, publishing requests for comments in the Federal Register on USPTO Initiatives to Ensure the Robustness and Reliability of Patent Rights (the “Draft Robustness and Reliability Initiatives”) [3] and Joint USPTO-FDA Collaboration Initiatives (the “Draft Collaboration Initiatives”). [4]
The Draft Robustness and Reliability Initiatives include 11 specific questions on which public comment is sought, including questions regarding (i) prior art searching, (ii) support for patent claims, (iii) request for continued examination (RCE) practice, and (iv) restriction, divisional, rejoinder, and non-statutory double patenting practice. [5] While at first blush many of these issues appear relevant only to those immersed in the technical aspects of patent prosecution practice, several stem directly from correspondence to the USPTO from six United States Senators. [6]
The second USPTO proposal, the Draft Collaboration Initiatives, represents a joint initiative between the USPTO and FDA. The FDA kickstarted the process in late 2021 by sending a letter to the USPTO identifying its concerns—and offering potential solutions—regarding patent thickets, evergreening, and product hopping. [7] The USPTO responded by (1) sharing information with the FDA about the resources that USPTO examiners use for prior art searching and examination and the use of publicly available FDA documents in the USPTO’s Patent Trial and Appeal Board proceedings [8] and (2) seeking public comment on proposed initiatives and nine specific questions on how best to achieve the agencies’ joint goals. [9]
Recognizing the potential effect that these initiatives may have on the life sciences industry at large, a variety of interested parties have submitted comments on both draft initiatives. Proponents of these initiatives generally assert that pharmaceutical companies make use of loopholes in the law to anticompetitively inflate drug prices and believe that enhanced patent examination and agency coordination can help to mitigate those problems. Those who oppose the initiatives argue, for example, that the proposals under consideration are unnecessary, will significantly increase the burden on applicants and examiners alike, and ultimately will not effectively address the purported issues they seek to resolve. Further detail for the arguments on both sides can be found in the public comments on the regulations.gov website here (for the Draft Robustness and Reliability Initiatives) and here (for the Draft Collaboration Initiatives).
United States congressional representatives have also weighed in on the debate regarding these initiatives. Senators on both sides of the aisle have sent public letters to the USPTO that have sought to influence the draft initiatives. [10] In addition, Senators Durbin and Tillis have sponsored the Interagency Patent Coordination and Improvement Act of 2023, which aims to establish an interagency task force between USPTO and FDA for purposes of sharing information and providing technical assistance with respect to patents. [11] Although the proposed legislation has not become law, it is clear that the legislative branch is also concerned about the present state of patent law and generic drug competition.
While it is difficult to predict the scope or consequences of any policy adopted by the USPTO or FDA (or Congress), life sciences companies who conduct any business in the United States should keep abreast of any developments and consider the impact on their actions before both the USPTO and the FDA—and, more broadly, on their United States patent and regulatory strategy—moving forward.
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[1] Executive Order on Promoting Competition in the American Economy | The White House.
[2] See, e.g., Letter from Dr. Janet Woodcock to Director Andrew Hirshfeld (September 10, 2021).
[3] Request for Comments on USPTO Initiatives To Ensure the Robustness and Reliability of Patent Rights, 87 Fed. Reg. 60130 (Oct. 4, 2022).
[4] Joint USPTO-FDA Collaboration Initiatives; Notice of Public Listening Session and Request for Comments, 87 Fed. Reg. 67019 (Nov. 7, 2022).
[5] See 87 Fed. Reg. 60133-34.
[6] See Letter from Senator Patrick Leahy, Senator John Cornyn, Senator Richard Blumenthal, Senator Susan Collins, Senator Amy Klobuchar, and Senator Mike Braun to Director Katherine Vidal (June 8, 2022) (the “June 8, 2022 Senators Letter”) (questions 6-11).
[7] See supra note 2.
[9] See 87 Fed. Reg. 67021-22.
[10] See Letter from Senator Patrick Leahy and Senator Thom Tillis to Mr. Andrew Hirshfeld (Sept. 9, 2021) (requesting that the USPTO “take steps to reduce patent applicants’ making inappropriate conflicting statements in submissions to the [USPTO] and other federal agencies”); June 8, 2022 Senators Letter (requesting that the USPTO consider changes to its practices in light of patent thickets, and raising six questions for consideration that the USPTO later adopted into the Draft Robustness and Reliability Initiatives); see also Letter from Senator Elizabeth Warren and Senator Pramila Jayapal to Director Katherine Vidal (Dec. 5, 2022) (following up on their June 30, 2021 letter to the USPTO and raising further questions on the “USPTO’s initiatives to address the shortcomings of our patent system” in light of their “ongoing concerns with the high cost of prescription drugs in America”).
[11] See Interagency Patent Coordination and Improvement Act of 2023, S. 79, 118th Cong. (2023).
