# The Impacts of Enhanced Drug-Patent Examination

> **NIH NIH R01** · NATIONAL BUREAU OF ECONOMIC RESEARCH · 2024 · $316,620

## Abstract

OTHER PROJECT INFORMATION – Project Summary/Abstract
THE IMPACTS OF ENHANCED DRUG-PATENT EXAMINATION
The legal patentability requirements are designed to respect the balance between patient access to existing
longevity-improving drugs and incentivizing their existence in the first place. However, the patent system may
fail to achieve this balance if it does not provide patent examiners with the resources—mainly, time—needed to
apply these patentability standards. Given the legal presumption of validity of incoming patent applications,
insufficient examination time may lead to concerns that the U.S. Patent and Trademark Office (PTO) will issue
patents on non-novel or obvious innovations, a result which may unnecessarily inhibit patient access and
thereby compromise patient outcomes. Patent quality concerns of this nature have been particularly
paramount in the case of “secondary” patents—i.e., patents on subsidiary drug features such as on routes of
administration. Given that secondary patent applications are often filed years after the issuance of the active-
ingredient patent, they have the potential to meaningfully extend the effective patent lives of given drug
products, potentially limiting access on the margin to clinically valuable drugs. In this project, we propose to
investigate the full extent to which secondary patenting practices may be extending effective patent lives of
FDA-approved drugs. Further, drawing on certain PTO reforms and features, we will investigate the impacts of
increasing examination time on drug-patent examination quality. In particular, we will address four aims:
  Compiling, reviewing and coding data from both the PTO and the FDA, we will build a database of
 small-molecule drug patents associated with FDA-approved drug products from the mid-1980s to the
 present, containing various information associated with each such patent, including information (if any)
 on claims associated with secondary drug features.
  We will similarly build a database of large-molecule drug patents, though this effort will likely require a
 deeper and more extensive review of raw PTO materials given the lack of a congressionally mandated
 list of biologics-related patents associated with FDA-approvals.
  Using these data and employing various quasi-experimental approaches, we will estimate the
 relationship between the examination time allotted to examiners and the likelihood that the patents they
 issue meet the legal patentability requirements.
  Drawing on the results from Aim #3, we will run simulation exercises to assess the degree to which an
 increase in examination time will shorten the effective patent lives of approved FDA drug products and
 thereafter draw on various estimated moments from the generic-entry literature to estimate the resulting
 effects on increased/accelerated patient access to approved medications.

## Key facts

- **NIH application ID:** 10786092
- **Project number:** 5R01AG076586-02
- **Recipient organization:** NATIONAL BUREAU OF ECONOMIC RESEARCH
- **Principal Investigator:** MICHAEL D. FRAKES
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $316,620
- **Award type:** 5
- **Project period:** 2023-02-15 → 2027-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10786092

## Citation

> US National Institutes of Health, RePORTER application 10786092, The Impacts of Enhanced Drug-Patent Examination (5R01AG076586-02). Retrieved via AI Analytics 2026-06-12 from https://api.ai-analytics.org/grant/nih/10786092. Licensed CC0.

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