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
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
Determining 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.
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.
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.
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.
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.
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.
Patent Term Expiration
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.
Obviousness
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.
Intervening Rights After Reinstatement
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.”
Citations
| Primary topic | Citation |
|---|---|
| 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.
Official MPEP § 804.05 — Impact of Patent Term Extension under 35 U.S.C. 156 on Nonstatutory Double Patenting
Source: USPTO804.05 Impact of Patent Term Extension under 35 U.S.C. 156 on Nonstatutory Double Patenting [R-10.2019]
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.