MPEP § 804.05 — Impact of Patent Term Extension under 35 U.S.C. 156 on Nonstatutory Double Patenting (Annotated Rules)

§804.05 Impact of Patent Term Extension under 35 U.S.C. 156 on Nonstatutory Double Patenting

USPTO MPEP version: BlueIron's Update: 2025-12-31

This page consolidates and annotates all enforceable requirements under MPEP § 804.05, including statutory authority, regulatory rules, examiner guidance, and practice notes. It is provided as guidance, with links to the ground truth sources. This is information only, it is not legal advice.

Impact of Patent Term Extension under 35 U.S.C. 156 on Nonstatutory Double Patenting

This section addresses Impact of Patent Term Extension under 35 U.S.C. 156 on Nonstatutory Double Patenting. Primary authority: 35 U.S.C. 156. Contains: 1 guidance statement and 8 other statements.

Key Rules

Topic

Determining Expiration Date

6 rules
StatutoryInformativeAlways
[mpep-804-05-5810f32e75aa0aa0b11109cd]
Patent Term Extension Not Invalidated by Nonstatutory Double Patenting
Note:
A patent term extension granted under 35 U.S.C. 156 remains valid even if it creates a potential nonstatutory double patenting issue, provided the claims are otherwise valid before the PTE expiration date.

Nonstatutory double patenting does not invalidate any patent term extension (PTE) granted under 35 U.S.C. 156, if the claims are otherwise valid under its pre-PTE expiration date. See Novartis AG v. Ezra Ventures LLC, 909 F.3d 1367, 128 USPQ2d 1752 (Fed. Cir. 2018). “For example, if a patent, under its original expiration date without a PTE, should have been (but was not) terminally disclaimed because of obviousness-type double patenting, then this court’s obviousness-type double patenting case law would apply, and the patent could be invalidated. However, if a patent, under its pre-PTE expiration date, is valid under all other provisions of law, then it is entitled to the full term of its PTE.” Id. at 1374, 128 USPQ2d at 1757. The Novartis court upheld the validity of a PTE even when the PTE created a potential nonstatutory double patenting issue due to the later date of enforceability of applicable claims of the patent resulting from the PTE finding that the earlier-expired, patentably indistinct patent was “not a double patenting reference” to extended patent. Id. at 1375, 128 USPQ2d at 1757. Specifically, the court held “[b]y applying statutory construction principles, following this court’s precedent in [Merck & Co. v. Hi-Tech Pharmacal Co., 482 F.3d 1317, 82 USPQ2d 1203 (Fed. Cir. 2007)], and addressing traditional obviousness-type double patenting principles, we hold that a PTE pursuant to § 156 is valid so long as the extended patent is otherwise valid without the extension.” Id. Thus, the court declined to allow “a judge-made doctrine” regarding double patenting to “cut off a statutorily-authorized time extension.” Id. at 1375, 128 USPQ2d at 1757.

Jump to MPEP SourceDetermining Expiration DatePatent Term ExpirationPatent Term
StatutoryInformativeAlways
[mpep-804-05-01e468b43f54c2169f328ffb]
Patent Term Extension Does Not Invalidate Due to Nonstatutory Double Patenting
Note:
A patent term extension remains valid even if it creates a potential nonstatutory double patenting issue due to the later enforceability date.

Nonstatutory double patenting does not invalidate any patent term extension (PTE) granted under 35 U.S.C. 156, if the claims are otherwise valid under its pre-PTE expiration date. See Novartis AG v. Ezra Ventures LLC, 909 F.3d 1367, 128 USPQ2d 1752 (Fed. Cir. 2018). “For example, if a patent, under its original expiration date without a PTE, should have been (but was not) terminally disclaimed because of obviousness-type double patenting, then this court’s obviousness-type double patenting case law would apply, and the patent could be invalidated. However, if a patent, under its pre-PTE expiration date, is valid under all other provisions of law, then it is entitled to the full term of its PTE.” Id. at 1374, 128 USPQ2d at 1757. The Novartis court upheld the validity of a PTE even when the PTE created a potential nonstatutory double patenting issue due to the later date of enforceability of applicable claims of the patent resulting from the PTE finding that the earlier-expired, patentably indistinct patent was “not a double patenting reference” to extended patent. Id. at 1375, 128 USPQ2d at 1757. Specifically, the court held “[b]y applying statutory construction principles, following this court’s precedent in [Merck & Co. v. Hi-Tech Pharmacal Co., 482 F.3d 1317, 82 USPQ2d 1203 (Fed. Cir. 2007)], and addressing traditional obviousness-type double patenting principles, we hold that a PTE pursuant to § 156 is valid so long as the extended patent is otherwise valid without the extension.” Id. Thus, the court declined to allow “a judge-made doctrine” regarding double patenting to “cut off a statutorily-authorized time extension.” Id. at 1375, 128 USPQ2d at 1757.

Jump to MPEP SourceDetermining Expiration DateIntervening Rights After ReinstatementPatent Term Expiration
StatutoryRecommendedAlways
[mpep-804-05-618286f0f63ba8d373746260]
Patent Term Extension Valid Despite Nonstatutory Double Patenting
Note:
A patent with a PTE is valid even if it would have been invalid due to obviousness-type double patenting without the extension.

Nonstatutory double patenting does not invalidate any patent term extension (PTE) granted under 35 U.S.C. 156, if the claims are otherwise valid under its pre-PTE expiration date. See Novartis AG v. Ezra Ventures LLC, 909 F.3d 1367, 128 USPQ2d 1752 (Fed. Cir. 2018). “For example, if a patent, under its original expiration date without a PTE, should have been (but was not) terminally disclaimed because of obviousness-type double patenting, then this court’s obviousness-type double patenting case law would apply, and the patent could be invalidated. However, if a patent, under its pre-PTE expiration date, is valid under all other provisions of law, then it is entitled to the full term of its PTE.” Id. at 1374, 128 USPQ2d at 1757. The Novartis court upheld the validity of a PTE even when the PTE created a potential nonstatutory double patenting issue due to the later date of enforceability of applicable claims of the patent resulting from the PTE finding that the earlier-expired, patentably indistinct patent was “not a double patenting reference” to extended patent. Id. at 1375, 128 USPQ2d at 1757. Specifically, the court held “[b]y applying statutory construction principles, following this court’s precedent in [Merck & Co. v. Hi-Tech Pharmacal Co., 482 F.3d 1317, 82 USPQ2d 1203 (Fed. Cir. 2007)], and addressing traditional obviousness-type double patenting principles, we hold that a PTE pursuant to § 156 is valid so long as the extended patent is otherwise valid without the extension.” Id. Thus, the court declined to allow “a judge-made doctrine” regarding double patenting to “cut off a statutorily-authorized time extension.” Id. at 1375, 128 USPQ2d at 1757.

Jump to MPEP SourceDetermining Expiration DatePatent Term ExpirationObviousness
StatutoryInformativeAlways
[mpep-804-05-8bfdd45804f9731c0f006ccb]
Patent Term Extension Not Invalidated by Nonstatutory Double Patenting
Note:
A patent term extension is valid even if it creates a potential nonstatutory double patenting issue, as long as the extended patent meets all other legal requirements.

Nonstatutory double patenting does not invalidate any patent term extension (PTE) granted under 35 U.S.C. 156, if the claims are otherwise valid under its pre-PTE expiration date. See Novartis AG v. Ezra Ventures LLC, 909 F.3d 1367, 128 USPQ2d 1752 (Fed. Cir. 2018). “For example, if a patent, under its original expiration date without a PTE, should have been (but was not) terminally disclaimed because of obviousness-type double patenting, then this court’s obviousness-type double patenting case law would apply, and the patent could be invalidated. However, if a patent, under its pre-PTE expiration date, is valid under all other provisions of law, then it is entitled to the full term of its PTE.” Id. at 1374, 128 USPQ2d at 1757. The Novartis court upheld the validity of a PTE even when the PTE created a potential nonstatutory double patenting issue due to the later date of enforceability of applicable claims of the patent resulting from the PTE finding that the earlier-expired, patentably indistinct patent was “not a double patenting reference” to extended patent. Id. at 1375, 128 USPQ2d at 1757. Specifically, the court held “[b]y applying statutory construction principles, following this court’s precedent in [Merck & Co. v. Hi-Tech Pharmacal Co., 482 F.3d 1317, 82 USPQ2d 1203 (Fed. Cir. 2007)], and addressing traditional obviousness-type double patenting principles, we hold that a PTE pursuant to § 156 is valid so long as the extended patent is otherwise valid without the extension.” Id. Thus, the court declined to allow “a judge-made doctrine” regarding double patenting to “cut off a statutorily-authorized time extension.” Id. at 1375, 128 USPQ2d at 1757.

Jump to MPEP SourceDetermining Expiration DateIntervening Rights After ReinstatementPatent Term Expiration
StatutoryInformativeAlways
[mpep-804-05-1b25c0d730c634e6d9bcd48d]
Patent Term Extension Not Invalidated by Nonstatutory Double Patenting
Note:
A patent term extension remains valid even if it creates a potential nonstatutory double patenting issue.

Nonstatutory double patenting does not invalidate any patent term extension (PTE) granted under 35 U.S.C. 156, if the claims are otherwise valid under its pre-PTE expiration date. See Novartis AG v. Ezra Ventures LLC, 909 F.3d 1367, 128 USPQ2d 1752 (Fed. Cir. 2018). “For example, if a patent, under its original expiration date without a PTE, should have been (but was not) terminally disclaimed because of obviousness-type double patenting, then this court’s obviousness-type double patenting case law would apply, and the patent could be invalidated. However, if a patent, under its pre-PTE expiration date, is valid under all other provisions of law, then it is entitled to the full term of its PTE.” Id. at 1374, 128 USPQ2d at 1757. The Novartis court upheld the validity of a PTE even when the PTE created a potential nonstatutory double patenting issue due to the later date of enforceability of applicable claims of the patent resulting from the PTE finding that the earlier-expired, patentably indistinct patent was “not a double patenting reference” to extended patent. Id. at 1375, 128 USPQ2d at 1757. Specifically, the court held “[b]y applying statutory construction principles, following this court’s precedent in [Merck & Co. v. Hi-Tech Pharmacal Co., 482 F.3d 1317, 82 USPQ2d 1203 (Fed. Cir. 2007)], and addressing traditional obviousness-type double patenting principles, we hold that a PTE pursuant to § 156 is valid so long as the extended patent is otherwise valid without the extension.” Id. Thus, the court declined to allow “a judge-made doctrine” regarding double patenting to “cut off a statutorily-authorized time extension.” Id. at 1375, 128 USPQ2d at 1757.

Jump to MPEP SourceDetermining Expiration DateIntervening Rights After ReinstatementPatent Term Expiration
StatutoryInformativeAlways
[mpep-804-05-f1466be34b8bef18a277b174]
Patent Term Extension Valid Despite Potential Nonstatutory Double Patenting
Note:
A patent term extension is valid even if it creates a potential nonstatutory double patenting issue, as long as the extended patent meets all other legal requirements.

Nonstatutory double patenting does not invalidate any patent term extension (PTE) granted under 35 U.S.C. 156, if the claims are otherwise valid under its pre-PTE expiration date. See Novartis AG v. Ezra Ventures LLC, 909 F.3d 1367, 128 USPQ2d 1752 (Fed. Cir. 2018). “For example, if a patent, under its original expiration date without a PTE, should have been (but was not) terminally disclaimed because of obviousness-type double patenting, then this court’s obviousness-type double patenting case law would apply, and the patent could be invalidated. However, if a patent, under its pre-PTE expiration date, is valid under all other provisions of law, then it is entitled to the full term of its PTE.” Id. at 1374, 128 USPQ2d at 1757. The Novartis court upheld the validity of a PTE even when the PTE created a potential nonstatutory double patenting issue due to the later date of enforceability of applicable claims of the patent resulting from the PTE finding that the earlier-expired, patentably indistinct patent was “not a double patenting reference” to extended patent. Id. at 1375, 128 USPQ2d at 1757. Specifically, the court held “[b]y applying statutory construction principles, following this court’s precedent in [Merck & Co. v. Hi-Tech Pharmacal Co., 482 F.3d 1317, 82 USPQ2d 1203 (Fed. Cir. 2007)], and addressing traditional obviousness-type double patenting principles, we hold that a PTE pursuant to § 156 is valid so long as the extended patent is otherwise valid without the extension.” Id. Thus, the court declined to allow “a judge-made doctrine” regarding double patenting to “cut off a statutorily-authorized time extension.” Id. at 1375, 128 USPQ2d at 1757.

Jump to MPEP SourceDetermining Expiration DateIntervening Rights After ReinstatementPatent Term Expiration
Topic

Patent Term Expiration

1 rules
StatutoryInformativeAlways
[mpep-804-05-9cabbcccb70b9ff798bbb635]
PTE Valid Despite Potential Double Patenting Issue
Note:
The Novartis court upheld a PTE's validity even if it creates a potential nonstatutory double patenting issue due to the later date of enforceability of claims.

Nonstatutory double patenting does not invalidate any patent term extension (PTE) granted under 35 U.S.C. 156, if the claims are otherwise valid under its pre-PTE expiration date. See Novartis AG v. Ezra Ventures LLC, 909 F.3d 1367, 128 USPQ2d 1752 (Fed. Cir. 2018). “For example, if a patent, under its original expiration date without a PTE, should have been (but was not) terminally disclaimed because of obviousness-type double patenting, then this court’s obviousness-type double patenting case law would apply, and the patent could be invalidated. However, if a patent, under its pre-PTE expiration date, is valid under all other provisions of law, then it is entitled to the full term of its PTE.” Id. at 1374, 128 USPQ2d at 1757. The Novartis court upheld the validity of a PTE even when the PTE created a potential nonstatutory double patenting issue due to the later date of enforceability of applicable claims of the patent resulting from the PTE finding that the earlier-expired, patentably indistinct patent was “not a double patenting reference” to extended patent. Id. at 1375, 128 USPQ2d at 1757. Specifically, the court held “[b]y applying statutory construction principles, following this court’s precedent in [Merck & Co. v. Hi-Tech Pharmacal Co., 482 F.3d 1317, 82 USPQ2d 1203 (Fed. Cir. 2007)], and addressing traditional obviousness-type double patenting principles, we hold that a PTE pursuant to § 156 is valid so long as the extended patent is otherwise valid without the extension.” Id. Thus, the court declined to allow “a judge-made doctrine” regarding double patenting to “cut off a statutorily-authorized time extension.” Id. at 1375, 128 USPQ2d at 1757.

Jump to MPEP SourcePatent Term ExpirationLate Payment and ReinstatementDetermining Expiration Date
Topic

Obviousness

1 rules
StatutoryInformativeAlways
[mpep-804-05-53ec909910d1ee73d3300737]
Patent Term Extension Valid Despite Nonstatutory Double Patenting
Note:
The court holds that a patent term extension is valid even if it creates a potential nonstatutory double patenting issue, as long as the extended patent meets all other legal requirements.

Nonstatutory double patenting does not invalidate any patent term extension (PTE) granted under 35 U.S.C. 156, if the claims are otherwise valid under its pre-PTE expiration date. See Novartis AG v. Ezra Ventures LLC, 909 F.3d 1367, 128 USPQ2d 1752 (Fed. Cir. 2018). “For example, if a patent, under its original expiration date without a PTE, should have been (but was not) terminally disclaimed because of obviousness-type double patenting, then this court’s obviousness-type double patenting case law would apply, and the patent could be invalidated. However, if a patent, under its pre-PTE expiration date, is valid under all other provisions of law, then it is entitled to the full term of its PTE.” Id. at 1374, 128 USPQ2d at 1757. The Novartis court upheld the validity of a PTE even when the PTE created a potential nonstatutory double patenting issue due to the later date of enforceability of applicable claims of the patent resulting from the PTE finding that the earlier-expired, patentably indistinct patent was “not a double patenting reference” to extended patent. Id. at 1375, 128 USPQ2d at 1757. Specifically, the court held “[b]y applying statutory construction principles, following this court’s precedent in [Merck & Co. v. Hi-Tech Pharmacal Co., 482 F.3d 1317, 82 USPQ2d 1203 (Fed. Cir. 2007)], and addressing traditional obviousness-type double patenting principles, we hold that a PTE pursuant to § 156 is valid so long as the extended patent is otherwise valid without the extension.” Id. Thus, the court declined to allow “a judge-made doctrine” regarding double patenting to “cut off a statutorily-authorized time extension.” Id. at 1375, 128 USPQ2d at 1757.

Jump to MPEP SourceObviousnessDetermining Expiration DateIntervening Rights After Reinstatement
Topic

Intervening Rights After Reinstatement

1 rules
StatutoryInformativeAlways
[mpep-804-05-039126afa86f0ba3c4c16c5a]
Patent Term Extension Valid Even With Nonstatutory Double Patenting Issues
Note:
A patent term extension is valid even if it creates a potential nonstatutory double patenting issue, as long as the extended patent meets all other legal requirements.

Nonstatutory double patenting does not invalidate any patent term extension (PTE) granted under 35 U.S.C. 156, if the claims are otherwise valid under its pre-PTE expiration date. See Novartis AG v. Ezra Ventures LLC, 909 F.3d 1367, 128 USPQ2d 1752 (Fed. Cir. 2018). “For example, if a patent, under its original expiration date without a PTE, should have been (but was not) terminally disclaimed because of obviousness-type double patenting, then this court’s obviousness-type double patenting case law would apply, and the patent could be invalidated. However, if a patent, under its pre-PTE expiration date, is valid under all other provisions of law, then it is entitled to the full term of its PTE.” Id. at 1374, 128 USPQ2d at 1757. The Novartis court upheld the validity of a PTE even when the PTE created a potential nonstatutory double patenting issue due to the later date of enforceability of applicable claims of the patent resulting from the PTE finding that the earlier-expired, patentably indistinct patent was “not a double patenting reference” to extended patent. Id. at 1375, 128 USPQ2d at 1757. Specifically, the court held “[b]y applying statutory construction principles, following this court’s precedent in [Merck & Co. v. Hi-Tech Pharmacal Co., 482 F.3d 1317, 82 USPQ2d 1203 (Fed. Cir. 2007)], and addressing traditional obviousness-type double patenting principles, we hold that a PTE pursuant to § 156 is valid so long as the extended patent is otherwise valid without the extension.” Id. Thus, the court declined to allow “a judge-made doctrine” regarding double patenting to “cut off a statutorily-authorized time extension.” Id. at 1375, 128 USPQ2d at 1757.
, we hold that a PTE pursuant to § 156 is valid so long as the extended patent is otherwise valid without the extension.” Thus, the court declined to allow “a judge-made doctrine” regarding double patenting to “cut off a statutorily-authorized time extension.”

Jump to MPEP SourceIntervening Rights After ReinstatementDetermining Expiration DatePatent Term Expiration

Citations

Primary topicCitation
Determining Expiration Date
Intervening Rights After Reinstatement
Obviousness
Patent Term Expiration
35 U.S.C. § 156
Determining Expiration Date
Intervening Rights After Reinstatement
Obviousness
Patent Term Expiration
See Novartis AG v. Ezra Ventures LLC, 909 F.3d 1367, 128 USPQ2d 1752 (Fed. Cir. 2018)

Source Text from USPTO’s MPEP

This is an exact copy of the MPEP from the USPTO. It is here for your reference to see the section in context.

BlueIron Last Updated: 2025-12-31