---
kind: "section"
citation: "9 C.F.R. § 124.1"
title: "9"
number: "124.1"
heading: "Scope."
url: "https://uscodex.org/cfr/9/124.1"
---

# §124.1. Scope.

- (a) This parts sets forth procedures and requirements for APHIS review of applications for the extension of the term of certain patents for veterinary biological products pursuant to [35 U.S.C. 156](/usc/35/156.md)—Extension of patent term. Responsibilities of APHIS include:
  - (1) Assisting PTO in determining eligibility for patent term restoration;
  - (2) Determining the length of a product's regulatory review period;
  - (3) If petitioned, reviewing and ruling on due diligence challenges to APHIS's regulatory review period determinations; and
  - (4) **Conducting hearings to review initial APHIS findings on due diligence challenges.**
- (b) The regulations in this part are designed to be used in conjunction with regulations issued by PTO concerning patent term extension which may be found at [37 CFR 1.710 through 1.791](/cfr/37/1.710..1.791.md).

## Notes

### Amendments

[58 FR 11369, Feb. 25, 1993, as amended at 64 FR 43045, Aug. 9, 1999]

### Authority

Authority: 35 U.S.C. 156; 7 CFR 2.22, 2.80, and 371.4.

### Source

Source: 58 FR 11369, Feb. 25, 1993, unless otherwise noted.

### Amendments

[58 FR 11369, Feb. 25, 1993, as amended at 64 FR 43045, Aug. 9, 1999]