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# More Comments on Patent Office/FDA Collaboration
- URL: https://www.fdaweb.com/more-comments-on-patent-office-fda-collaboration/
- Published: 2023-03-14T12:00:00.000Z
- Updated: 2026-09-14T18:19:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153972

The Biotechnology Innovation Organization (BIO) and Pharmaceutical Research and Manufacturers of America (PhRMA) have supplemented their comments to the U.S. Patent and Trademark Office (USPTO) about that agency’s collaboration with FDA. PhRMA’s [letter](https://www.regulations.gov/comment/PTO-P-2022-0037-0076?ref=fdaweb.com) was submitted to “address certain aspects of comments presented by **(1)** Fresenius Kabi regarding the patenting of ‘ancillary features’; **(2)** the Campaign for Sustainable Rx Pricing regarding additional review or scrutiny of applications for patents that may ultimately be listed in the *Orange Book*; and **(3)** the Initiative for Medicines, Access & Knowledge (I-MAK) regarding its claims about market exclusivity periods for biologics and its focus on abandoned patents.

The BIO supplementary [comment](https://www.regulations.gov/comment/PTO-P-2022-0037-0082?ref=fdaweb.com) is intended to “provide context for certain statements made by I-MAK and Fresenius Kabi elsewhere in the docket and to provide further clarity around the empirical ‘effective market life’ of originator drugs, i.e., the time from FDA approval of a reference drug until the entry of a competing generic or biosimilar product.”

A supplemental comment from [Novartis](https://www.regulations.gov/comment/PTO-P-2022-0037-0073?ref=fdaweb.com) adds to these points:

- systemic-level data on the effective patent term for small molecule and biologic medicines is important in assessing the status quo;
- benchmarks grounded in longstanding law and policy, such as the 14-year minimum post-approval term under patent-term extension, and the 20-year patent term, are highly relevant standards for evaluating effective patent terms for medicines; and
- abandoned patent applications are not patents, do not provide exclusivity, and help advance the public goals of the patent system.

In its initial comment, Amgen says:

- current USPTO rules deter inconsistent statements material to patentability and require their disclosure;
- court procedures facilitate the discovery of inconsistent statements in FDA filings; and
- granting the PTO access to FDA’s sensitive regulatory information is neither desirable nor practical.

Amgen [concludes](https://www.regulations.gov/comment/PTO-P-2022-0037-0079?ref=fdaweb.com) that it supports the collaboration between the USPTO and FDA to improve patent quality and to ensure that patent examiners are trained to find publicly available FDA information that could be material to patentability. “But,” it says, “we have seen no evidence of a need for FDA to share confidential regulatory submissions with the USPTO…. Nor has a systemic problem of patent applicants making inconsistent statements to the USPTO and FDA been identified…. In our view, the burden imposed on the examiners and the risks of disclosure of confidential information greatly outweigh the unlikely occurrence of finding material prior art or inconsistent statements in FDA submissions that are not otherwise disclosed to the USPTO.”