Determination of Regulatory Review Period for Purposes of Patent Extension; RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM, 30623-30624 [2014-12295]

Download as PDF emcdonald on DSK67QTVN1PROD with NOTICES Federal Register / Vol. 79, No. 102 / Wednesday, May 28, 2014 / Notices frequency. Subsequent to this approval, the Patent and Trademark Office received patent term restoration applications for MYRBETRIQ (U.S. Patent Nos. 6,346,532; 7,342,117; 7,750,029) from Astellas Pharma Inc., and the Patent and Trademark Office requested FDA’s assistance in determining the patents’ eligibility for patent term restoration. In a letter dated July 10, 2013, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of MYRBETRIQ represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that FDA determine the product’s regulatory review period. FDA has determined that the applicable regulatory review period for MYRBETRIQ is 2,213 days. Of this time, 1,908 days occurred during the testing phase of the regulatory review period, while 305 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: June 9, 2006. The applicant claims May 10, 2006, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was June 9, 2006, which was 30 days after FDA receipt of the IND. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: August 29, 2011. FDA has verified the applicant’s claim that the new drug application (NDA) for MYRBETRIQ (NDA 202611) was submitted on August 29, 2011. 3. The date the application was approved: June 28, 2012. FDA has verified the applicant’s claim that NDA 202611 was approved on June 28, 2012. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 515, 938, or 1,259 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments and ask for a redetermination by July 28, 2014. Furthermore, any interested person may petition FDA for a determination VerDate Mar<15>2010 16:58 May 27, 2014 Jkt 232001 regarding whether the applicant for extension acted with due diligence during the regulatory review period by November 24, 2014. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) electronic or written comments and written or electronic petitions. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. If you submit a written petition, two copies are required. A petition submitted electronically must be submitted to https:// www.regulations.gov, Docket No. FDA– 2013–S–0610. Comments and petitions that have not been made publicly available on https://www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: May 21, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–12292 Filed 5–27–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–E–1246] Determination of Regulatory Review Period for Purposes of Patent Extension; RESOLUTE INTEGRITY ZOTAROLIMUS–ELUTING CORONARY STENT SYSTEM AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined the regulatory review period for RESOLUTE INTEGRITY ZOTAROLIMUS–ELUTING CORONARY STENT SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that medical device. ADDRESSES: Submit electronic comments to https:// www.regulations.gov. Submit written SUMMARY: PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 30623 petitions (two copies are required) and written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Management, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6257, Silver Spring, MD 20993–0002, 301– 796–7900. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100–670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product’s regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For medical devices, the testing phase begins with a clinical investigation of the device and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA’s determination of the length of a regulatory review period for a medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B). FDA has approved for marketing the medical device, RESOLUTE INTEGRITY ZOTAROLIMUS–ELUTING CORONARY STENT SYSTEM. RESOLUTE INTEGRITY ZOTAROLIMUS–ELUTING CORONARY STENT SYSTEM is indicated for improving coronary luminal diameters in patients, including those with diabetes mellitus, with symptomatic ischemic heart disease due to de novo lesions of length less than or equal to 27 millimeters (mm) in native E:\FR\FM\28MYN1.SGM 28MYN1 emcdonald on DSK67QTVN1PROD with NOTICES 30624 Federal Register / Vol. 79, No. 102 / Wednesday, May 28, 2014 / Notices coronary arteries with reference vessel diameters of 2.25 mm to 4.2 mm. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for RESOLUTE INTEGRITY ZOTAROLIMUS–ELUTING CORONARY STENT SYSTEM (U.S. Patent No. 7,419,696) from Medtronic, Inc., and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated March 4, 2013, FDA advised the Patent and Trademark Office that this medical device had undergone a regulatory review period and that the approval of RESOLUTE INTEGRITY ZOTAROLIMUS–ELUTING CORONARY STENT SYSTEM represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that FDA determine the product’s regulatory review period. FDA has determined that the applicable regulatory review period for RESOLUTE INTEGRITY ZOTAROLIMUS–ELUTING CORONARY STENT SYSTEM is 1,586 days. Of this time, 1,263 days occurred during the testing phase of the regulatory review period, while 323 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 520(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) involving this device became effective: October 17, 2007. The applicant claims that the investigational device exemption (IDE) required under section 520(g) of the FD&C Act for human tests to begin became effective on June 13, 2008. However, FDA records indicate that the IDE was determined substantially complete for clinical studies to have begun on October 17, 2007, which represents the IDE effective date. 2. The date an application was initially submitted with respect to the device under section 515 of the FD&C Act (21 U.S.C. 360e): April 1, 2011. FDA has verified the applicant’s claim that the premarket approval application (PMA) for RESOLUTE INTEGRITY ZOTAROLIMUS–ELUTING CORONARY STENT SYSTEM (PMA P110013) was initially submitted April 1, 2011. 3. The date the application was approved: February 17, 2012. FDA has verified the applicant’s claim that PMA P110013 was approved on February 17, 2012. VerDate Mar<15>2010 16:58 May 27, 2014 Jkt 232001 This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 794 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments and ask for a redetermination by July 28, 2014. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by November 24, 2014. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) electronic or written comments and written or electronic petitions. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. If you submit a written petition, two copies are required. A petition submitted electronically must be submitted to https:// www.regulations.gov, Docket No. FDA– 2013–S–0610. Comments and petitions that have not been made publicly available on https://www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: May 21, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–12295 Filed 5–27–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–E–0034] Determination of Regulatory Review Period for Purposes of Patent Extension; ADCETRIS—Biologics License Application 125399 AGENCY: Food and Drug Administration, HHS. ACTION: PO 00000 Notice. Frm 00086 Fmt 4703 Sfmt 4703 The Food and Drug Administration (FDA) has determined the regulatory review period for ADCETRIS based on biologics license application (BLA) 125399 and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human biological product, ADCETRIS. ADDRESSES: Submit electronic comments to https:// www.regulations.gov. Submit written petitions (two copies are required) and written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Management, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6257, Silver Spring, MD 20993–0002, 301– 796–7900. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100–670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product’s regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the SUMMARY: E:\FR\FM\28MYN1.SGM 28MYN1

Agencies

[Federal Register Volume 79, Number 102 (Wednesday, May 28, 2014)]
[Notices]
[Pages 30623-30624]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-12295]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-E-1246]

Determination of Regulatory Review Period for Purposes of Patent
Extension; RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING
CORONARY STENT SYSTEM and is publishing this notice of that
determination as required by law. FDA has made the determination
because of the submission of an application to the Director of Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that medical device.

ADDRESSES: Submit electronic comments to https://www.regulations.gov.
Submit written petitions (two copies are required) and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Submit petitions electronically to https://www.regulations.gov at Docket
No. FDA-2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of
Management, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6257, Silver
Spring, MD 20993-0002, 301-796-7900.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of Patents and Trademarks may award (half
the testing phase must be subtracted as well as any time that may have
occurred before the patent was issued), FDA's determination of the
length of a regulatory review period for a medical device will include
all of the testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
FDA has approved for marketing the medical device, RESOLUTE
INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM. RESOLUTE INTEGRITY
ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM is indicated for improving
coronary luminal diameters in patients, including those with diabetes
mellitus, with symptomatic ischemic heart disease due to de novo
lesions of length less than or equal to 27 millimeters (mm) in native

[[Page 30624]]

coronary arteries with reference vessel diameters of 2.25 mm to 4.2 mm.
Subsequent to this approval, the Patent and Trademark Office received a
patent term restoration application for RESOLUTE INTEGRITY ZOTAROLIMUS-
ELUTING CORONARY STENT SYSTEM (U.S. Patent No. 7,419,696) from
Medtronic, Inc., and the Patent and Trademark Office requested FDA's
assistance in determining this patent's eligibility for patent term
restoration. In a letter dated March 4, 2013, FDA advised the Patent
and Trademark Office that this medical device had undergone a
regulatory review period and that the approval of RESOLUTE INTEGRITY
ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM represented the first
permitted commercial marketing or use of the product. Thereafter, the
Patent and Trademark Office requested that FDA determine the product's
regulatory review period.
FDA has determined that the applicable regulatory review period for
RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM is 1,586
days. Of this time, 1,263 days occurred during the testing phase of the
regulatory review period, while 323 days occurred during the approval
phase. These periods of time were derived from the following dates:
1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) involving
this device became effective: October 17, 2007. The applicant claims
that the investigational device exemption (IDE) required under section
520(g) of the FD&C Act for human tests to begin became effective on
June 13, 2008. However, FDA records indicate that the IDE was
determined substantially complete for clinical studies to have begun on
October 17, 2007, which represents the IDE effective date.
2. The date an application was initially submitted with respect to
the device under section 515 of the FD&C Act (21 U.S.C. 360e): April 1,
2011. FDA has verified the applicant's claim that the premarket
approval application (PMA) for RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING
CORONARY STENT SYSTEM (PMA P110013) was initially submitted April 1,
2011.
3. The date the application was approved: February 17, 2012. FDA
has verified the applicant's claim that PMA P110013 was approved on
February 17, 2012.
This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the Patent and
Trademark Office applies several statutory limitations in its
calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 794 days of
patent term extension.
Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by July 28, 2014. Furthermore, any interested person
may petition FDA for a determination regarding whether the applicant
for extension acted with due diligence during the regulatory review
period by November 24, 2014. To meet its burden, the petition must
contain sufficient facts to merit an FDA investigation. (See H. Rept.
857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should
be in the format specified in 21 CFR 10.30.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written or
electronic petitions. It is only necessary to send one set of comments.
Identify comments with the docket number found in brackets in the
heading of this document. If you submit a written petition, two copies
are required. A petition submitted electronically must be submitted to
https://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and
petitions that have not been made publicly available on https://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

Dated: May 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12295 Filed 5-27-14; 8:45 am]
BILLING CODE 4160-01-P

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