37 CFR § 1.720 — Conditions for extension of patent (MPEP Coverage Index) – BlueIron IP

This page consolidates MPEP guidance interpreting 37 CFR § 1.720, including 59 rules from the Manual of Patent Examining Procedure. It is provided as guidance, with links to the ground truth sources. This is information only, it is not legal advice.

Summary

This section outlines the eligibility requirements for extending a patent term based on regulatory review under section 515 of the Federal Food Drug and Cosmetic Act, focusing on products or methods claimed in the patent.

What this section covers

Defines the conditions for extending a patent term based on regulatory review under section 515 of the Federal Food Drug and Cosmetic Act.
Focuses on products or methods claimed in the patent, including physical structures for medical devices.

Key obligations

The patent must claim a product or method of using or manufacturing a product.
For medical devices, the patent claims must include a physical structure.
The term of the patent has never been previously extended.

Practice notes

Ensure the patent claims are clear and specific to meet eligibility for extension.
Avoid claims that are too broad, as they may not meet the eligibility criteria for extension.

Patents for Human Drugs and Medical Devices May Qualify for ExtensionMPEP 2751Permitted
Requirements for Patent Term ExtensionMPEP 2751Permitted
Permission for Commercial Use Required for PTE ExtensionMPEP 2751
No Patent Term Extension for Same Review PeriodMPEP 2751
Eligibility Requirements for Patent Term ExtensionMPEP 2751Permitted
Patent Term Extension Valid If Patent Otherwise ValidMPEP 2751
Patent Term Extension Cannot Be Negated by Obviousness-Type Double PatentingMPEP 2751Prohibited
Eligible Patents for Extension Must Claim Products or MethodsMPEP 2751Required
Claims a Product Is Not Synonymous with Infringed by a ProductMPEP 2751
Patent Claims Metabolite Not DrugMPEP 2751
Claims Must Not Infringe Approved Drug MetabolitesMPEP 2751
Patent Claims Must Include Device Structure for ExtensionMPEP 2751Required
Claims Requirement for Medical Device Patent ExtensionMPEP 2751
Definition of Product for Patent Term ExtensionMPEP 2751
PTE Not Available If Previously ExtendedMPEP 2751
Extension of Patent Due to Office DelayMPEP 2751
Patent Term Adjusted Not ExtendedMPEP 2751
Interim Extension Under 35 U.S.C. 156(e)(2)MPEP 2751
Interim Extension Under 35 U.S.C. 156(d)(5)MPEP 2751
Regulatory Review Period Requirement for PTEMPEP 2751
Regulatory Review Period Defined by Statute for PTE CalculationMPEP 2751Required
510(k) Review Not Eligible for PTEMPEP 2751
Regulatory Review Period Not Eligible for PTEMPEP 2751
Regulatory Review for Alleged Medical Devices Must Be Under Section 515MPEP 2751Required
Humanitarian Device Exemption Is Considered Section 515 ReviewMPEP 2751
Drug Products Not Reviewed Under Section 515MPEP 2751
First Permitted Marketing or Use Requirement for PTEMPEP 2751Required
First Permitted Marketing Or Use Requirement for Patent Term ExtensionMPEP 2751
First Commercial Use of Active Ingredient Required for Human DrugsMPEP 2751Required
Extension of Patent Term for New Animal Drugs and Biological ProductsMPEP 2751Permitted
Requirement for First Commercial Use of Drug on Food-Producing AnimalsMPEP 2751Permitted
Application Must Be Filed Within 60 Days of First Approval for Food-Producing AnimalsMPEP 2751Required

Eligible Patents for Extension Must Claim Products or MethodsMPEP 2751Required
Patent Claims Must Include Device Structure for ExtensionMPEP 2751Required
Active Ingredient Must Be Present In Final Dosage Form For PTEMPEP 2751Required
Active Ingredient of Drug Product Must Be Previously ApprovedMPEP 2751Required
Regulatory Review Period Defined by Statute for PTE CalculationMPEP 2751Required
Regulatory Review for Alleged Medical Devices Must Be Under Section 515MPEP 2751Required
Election Required for Multiple PTEs Based on Single Regulatory Review PeriodMPEP 2751Required
First Permitted Marketing or Use Requirement for PTEMPEP 2751Required
First Commercial Use of Active Ingredient Required for Human DrugsMPEP 2751Required
Application Must Be Filed Within 60 Days of First Approval for Food-Producing AnimalsMPEP 2751Required
Application Must Be Submitted Within 60 DaysMPEP 2753Required
Application Must Be Submitted by Next Business Day After HolidayMPEP 2753Required

No Concurrent Patent Term Extensions for Same Regulatory Review PeriodMPEP 2751
Patent May Extend Despite Terminal DisclaimerMPEP 2751Permitted
Patent Term Extension for Approved ProductMPEP 2751
Only One Patent May Be Extended Per ProductMPEP 2751Permitted
Patent Term Extension Beyond Terminal DisclaimerMPEP 2751Prohibited
Patent Term Extension Beyond Terminal DisclaimerMPEP 2751
Patent Term Extension Not Excluded by Double PatentingMPEP 2751
Definition of Drug Product for Patent Term ExtensionMPEP 2751Permitted
Different Drug Product Forms Qualify for PTEMPEP 2751Permitted
Ester vs Salt Forms of Active IngredientMPEP 2751
Different Drug Forms Qualify for PTEMPEP 2751
Deesterified Version of Approved Drug Not Same ProductMPEP 2751
Patent Term Extension for Unapproved Active Ingredients in Combination ProductsMPEP 2751Permitted
Requirement for Patent Claiming New Combination of Previously Approved Active IngredientsMPEP 2751
Ratio of Hormones Not a Different Active Ingredient for Patent Term ExtensionMPEP 2751
Combination of Previously Approved Active Ingredients Not Eligible for PTEMPEP 2751
Combination of Two Approved Active Ingredients Does Not Qualify for PTEMPEP 2751Permitted
Combination of Active Ingredients Not Eligible for PTEMPEP 2751
Enantiomer Can Receive Separate Patent Term ExtensionMPEP 2751
Multiple Active Ingredients Can Extend PatentMPEP 2751
Definition of Business Day for PTE ApplicationsMPEP 2753
Extension of Patent Term Must Be Filed Within 60 DaysMPEP 2753

MPEP Section	Rules
MPEP § 2751	Patents for Human Drugs and Medical Devices May Qualify for ExtensionMPEP 2751Permitted Requirements for Patent Term ExtensionMPEP 2751Permitted Permission for Commercial Use Required for PTE ExtensionMPEP 2751 No Patent Term Extension for Same Review PeriodMPEP 2751 Eligibility Requirements for Patent Term ExtensionMPEP 2751Permitted No Concurrent Patent Term Extensions for Same Regulatory Review PeriodMPEP 2751 Patent May Extend Despite Terminal DisclaimerMPEP 2751Permitted Patent Term Extension for Approved ProductMPEP 2751 Only One Patent May Be Extended Per ProductMPEP 2751Permitted Patent Term Extension Beyond Terminal DisclaimerMPEP 2751Prohibited Patent Term Extension Beyond Terminal DisclaimerMPEP 2751 Patent Term Extension Not Excluded by Double PatentingMPEP 2751 Patent Term Extension Valid If Patent Otherwise ValidMPEP 2751 Patent Term Extension Cannot Be Negated by Obviousness-Type Double PatentingMPEP 2751Prohibited Eligible Patents for Extension Must Claim Products or MethodsMPEP 2751Required Claims a Product Is Not Synonymous with Infringed by a ProductMPEP 2751 Patent Claims Metabolite Not DrugMPEP 2751 Claims Must Not Infringe Approved Drug MetabolitesMPEP 2751 Patent Claims Must Include Device Structure for ExtensionMPEP 2751Required Claims Requirement for Medical Device Patent ExtensionMPEP 2751 Definition of Product for Patent Term ExtensionMPEP 2751 Definition of Drug Product for Patent Term ExtensionMPEP 2751Permitted Active Ingredient Must Be Present In Final Dosage Form For PTEMPEP 2751Required Different Drug Product Forms Qualify for PTEMPEP 2751Permitted Ester vs Salt Forms of Active IngredientMPEP 2751 Different Drug Forms Qualify for PTEMPEP 2751 Deesterified Version of Approved Drug Not Same ProductMPEP 2751 Active Ingredient of Drug Product Must Be Previously ApprovedMPEP 2751Required PTE Not Available If Previously ExtendedMPEP 2751 Extension of Patent Due to Office DelayMPEP 2751 Patent Term Adjusted Not ExtendedMPEP 2751 Interim Extension Under 35 U.S.C. 156(e)(2)MPEP 2751 Interim Extension Under 35 U.S.C. 156(d)(5)MPEP 2751 Regulatory Review Period Requirement for PTEMPEP 2751 Regulatory Review Period Defined by Statute for PTE CalculationMPEP 2751Required 510(k) Review Not Eligible for PTEMPEP 2751 Regulatory Review Period Not Eligible for PTEMPEP 2751 Regulatory Review for Alleged Medical Devices Must Be Under Section 515MPEP 2751Required Humanitarian Device Exemption Is Considered Section 515 ReviewMPEP 2751 Drug Products Not Reviewed Under Section 515MPEP 2751 Election Required for Multiple PTEs Based on Single Regulatory Review PeriodMPEP 2751Required First Permitted Marketing or Use Requirement for PTEMPEP 2751Required First Permitted Marketing Or Use Requirement for Patent Term ExtensionMPEP 2751 First Commercial Use of Active Ingredient Required for Human DrugsMPEP 2751Required Patent Term Extension for Unapproved Active Ingredients in Combination ProductsMPEP 2751Permitted Requirement for Patent Claiming New Combination of Previously Approved Active IngredientsMPEP 2751 Ratio of Hormones Not a Different Active Ingredient for Patent Term ExtensionMPEP 2751 Combination of Previously Approved Active Ingredients Not Eligible for PTEMPEP 2751 Combination of Two Approved Active Ingredients Does Not Qualify for PTEMPEP 2751Permitted Combination of Active Ingredients Not Eligible for PTEMPEP 2751 Enantiomer Can Receive Separate Patent Term ExtensionMPEP 2751 Multiple Active Ingredients Can Extend PatentMPEP 2751 Extension of Patent Term for New Animal Drugs and Biological ProductsMPEP 2751Permitted Requirement for First Commercial Use of Drug on Food-Producing AnimalsMPEP 2751Permitted Application Must Be Filed Within 60 Days of First Approval for Food-Producing AnimalsMPEP 2751Required
MPEP § 2753	Application Must Be Submitted Within 60 DaysMPEP 2753Required Application Must Be Submitted by Next Business Day After HolidayMPEP 2753Required Definition of Business Day for PTE ApplicationsMPEP 2753 Extension of Patent Term Must Be Filed Within 60 DaysMPEP 2753

MPEP Section

Rules

MPEP § 2751