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# Comments on FDA/Patent Office Collaboration
- URL: https://www.fdaweb.com/comments-on-fda-patent-office-collaboration/
- Published: 2023-02-07T12:00:00.000Z
- Updated: 2026-09-14T18:14:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153722

In response to a request for comment from the United States Patent and Trademark Office (USPTO) on collaboration with FDA, the Biotechnology Innovation Organization (BIO) challenges “some of the misconceptions and unwarranted concerns that were raised at the 1/19 Listening Session.” BIO [says](https://www.regulations.gov/comment/PTO-P-2022-0037-0054?ref=fdaweb.com) the empirical data do not support allegations of “evergreening,” “patent thickets,” and “product hopping.” Rather, the comment letter says, the data suggest that the compromises Congress reached in the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act, as amended, are working “efficiently and effectively to promote continued innovation in the drug and biopharmaceutical industry while at the same time providing generic and biosimilar manufacturers incentives and mechanisms to enter the marketplace and provide competitively priced drugs.”

BIO says the stated purpose of the Request for Comment and the proposed collaboration “lacks focus and seems misdirected given the separate and distinct missions and roles of the PTO and FDA.”

In its [comment](https://www.regulations.gov/comment/PTO-P-2022-0037-0062?ref=fdaweb.com), the advocacy group Doctors for America (DFA) says that direct communication between the USPTO and FDA over key pharmaceutical patents has historically been limited. “This, along with differences between the scientific and technical ‘languages’ employed at each agency, has resulted in opportunities for drug sponsors to claim aspects of drug development as novel and warranting of patent protection, while simultaneously representing them to FDA as well-established processes requiring minimum scrutiny…. Such patent maneuvers have real impacts on our patients.”

DFA says it agrees with calls to strengthen USPTO and FDA cooperation in assessing patent claims over previously approved drugs and biologics. It says that while broader changes to pharmaceutical patent practices may require congressional action, it welcomes efforts by the USPTO and FDA to harmonize their actions and limit the use of patents to indefinitely extend monopolies over drugs and biologics.

Pharmaceutical Research and Manufacturers of America [says](https://www.regulations.gov/comment/PTO-P-2022-0037-0058?ref=fdaweb.com) it has not seen reliable evidence of systemic issues within the U.S. patent system or the FDA drug approval process that would warrant substantial changes in intellectual property laws. It supports training USPTO examiners on relevant and publicly available FDA resources if helpful to examiners and believes that changes to intellectual property laws and policies on use codes, method-of-use patents, and “skinny labeling” are unjustified.

Finally, the American Intellectual Property Law Association (AIPLA) says it is “fully supportive” of USPTO and FDA efforts to train patent examiners on publicly available FDA information and resources in an effort to supplement, but not replace, current patent searching requirements and criteria. “AIPLA believes the existing duty of candor to the USPTO provides the necessary deterrent not to make a material, inconsistent statement,” the legal advocacy group continues. “AIPLA submits that a disclosure of confidential information held by FDA is not only impractical for use in patent examination and associated public disclosure in a prosecution file history, but the disclosure of FDA confidential information through any mechanism has not been shown to be necessary. The duty of candor and rules related thereto are sufficient. The system is working.”