80_FR_25384 80 FR 25299 - Determination of Regulatory Review Period for Purposes of Patent Extension; CAMERON HEALTH S-ICD SYSTEM

80 FR 25299 - Determination of Regulatory Review Period for Purposes of Patent Extension; CAMERON HEALTH S-ICD SYSTEM

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 85 (May 4, 2015)

Page Range25299-25300
FR Document2015-10334

The Food and Drug Administration (FDA) has determined the regulatory review period for CAMERON HEALTH S-ICD SYSTEM 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 the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

Federal Register, Volume 80 Issue 85 (Monday, May 4, 2015) 
[Federal Register Volume 80, Number 85 (Monday, May 4, 2015)]
[Notices]
[Pages 25299-25300]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-10334]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2013-E-1299 and FDA-2013-E-1302]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; CAMERON HEALTH S-ICD SYSTEM

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for CAMERON HEALTH S-ICD SYSTEM 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 the U.S. Patent and Trademark Office (USPTO), 
Department of Commerce, for the extension of a patent which claims that 
medical device.

ADDRESSES: Submit electronic comments to http://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 http://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, 10001 New Hampshire Ave., Hillandale Building, Rm. 
3180, 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

[[Page 25300]]

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 USPTO 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 CAMERON HEALTH S-
ICD SYSTEM. CAMERON HEALTH S-ICD SYSTEM is indicated to provide 
defibrillation therapy for the treatment of life-threatening 
ventricular tachyarrhythmias in patients who do not have symptomatic 
bradycardia, incessant ventricular tachycardia, or spontaneous, 
frequently recurring ventricular tachycardia that is reliably 
terminated with antitachycardia pacing. Subsequent to this approval, 
the USPTO received patent term restoration applications for CAMERON 
HEALTH S-ICD SYSTEM (U.S. Patent Nos. 6,856,835 and 7,149,575) from 
Cameron Health Inc., and the USPTO requested FDA's assistance in 
determining the patents' eligibility for patent term restoration. In a 
letter dated March 18, 2014, FDA advised the USPTO that this medical 
device had undergone a regulatory review period and that the approval 
of CAMERON HEALTH S-ICD SYSTEM represented the first permitted 
commercial marketing or use of the product. Thereafter, the USPTO 
requested that the FDA determine the product's regulatory review 
period.
    FDA has determined that the applicable regulatory review period for 
CAMERON HEALTH S-ICD SYSTEM is 1,024 days. Of this time, 743 days 
occurred during the testing phase of the regulatory review period, 
while 281 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: December 11, 2009. FDA has verified the 
applicant's claim that the date the investigational device exemption 
(IDE) required under section 520(g) of the FD&C act for human tests to 
begin became effective December 11, 2009.
    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): December 
23, 2011. FDA has verified the applicant's claim that the premarket 
approval application (PMA) for CAMERON HEALTH S-ICD SYSTEM (PMA 
P110042) was initially submitted December 23, 2011.
    3. The date the application was approved: September 28, 2012. FDA 
has verified the applicant's claim that PMA P110042 was approved on 
September 28, 2012.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension. However, the USPTO 
applies several statutory limitations in its calculations of the actual 
period for patent extension. In its applications for patent extension, 
this applicant seeks 651 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 6, 2015. 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 2, 2015. 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 
http://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and 
petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: April 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-10334 Filed 5-1-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 85 / Monday, May 4, 2015 / Notices 25299 granted. Although only a portion of a 2. The date an application was DEPARTMENT OF HEALTH AND regulatory review period may count initially submitted with respect to the HUMAN SERVICES toward the actual amount of extension device under section 515 of the FD&C that the Director of USPTO may award Act (21 U.S.C. 360e): November 4, 2011. Food and Drug Administration (half the testing phase must be FDA has verified the applicant’s claim [Docket Nos. FDA–2013–E–1299 and FDA– subtracted as well as any time that may that the premarket approval application 2013–E–1302] have occurred before the patent was (PMA) for the RELAY THORACIC issued), FDA’s determination of the STENT–GRAFT WITH PLUS DELIVERY Determination of Regulatory Review length of a regulatory review period for SYSTEM (PMA P110038) was initially Period for Purposes of Patent a medical device will include all of the submitted November 4, 2011. Extension; CAMERON HEALTH S–ICD testing phase and approval phase as SYSTEM 3. The date the application was specified in 35 U.S.C. 156(g)(3)(B). approved: September 21, 2012. FDA has AGENCY: Food and Drug Administration, FDA has approved for marketing the verified the applicant’s claim that PMA HHS. medical device RELAY THORACIC P110038 was approved on September ACTION: Notice. STENT–GRAFT WITH PLUS DELIVERY 21, 2012. SYSTEM. RELAY THORACIC STENT– SUMMARY: The Food and Drug GRAFT WITH PLUS DELIVERY This determination of the regulatory review period establishes the maximum Administration (FDA) has determined SYSTEM is indicated for the the regulatory review period for endovascular repair of fusiform potential length of a patent extension. CAMERON HEALTH S–ICD SYSTEM aneurysms and saccular aneurysms/ However, the USPTO applies several and is publishing this notice of that penetrating atherosclerotic ulcers in the statutory limitations in its calculations determination as required by law. FDA descending thoracic aorta in patients of the actual period for patent extension. has made the determination because of having appropriate anatomy. In its application for patent extension, the submission of applications to the Subsequent to this approval, the USPTO this applicant seeks 225 days of patent Director of the U.S. Patent and received a patent term restoration term extension. Trademark Office (USPTO), Department application for the RELAY THORACIC Anyone with knowledge that any of of Commerce, for the extension of a STENT–GRAFT WITH PLUS DELIVERY the dates as published are incorrect may patent which claims that medical SYSTEM (U.S. Patent No. 8,062,345 B2) submit to the Division of Dockets device. from Bolton Medical Inc., and the Management (see ADDRESSES) either USPTO requested FDA’s assistance in ADDRESSES: Submit electronic electronic or written comments and ask comments to http:// determining this patent’s eligibility for for a redetermination by July 6, 2015. patent term restoration. In a letter dated www.regulations.gov. Submit written Furthermore, any interested person may petitions (two copies are required) and March 18, 2014, FDA advised the petition FDA for a determination written comments to the Division of USPTO that this medical device had regarding whether the applicant for Dockets Management (HFA–305), Food undergone a regulatory review period extension acted with due diligence and Drug Administration, 5630 Fishers and that the approval of the RELAY during the regulatory review period by Lane, Rm. 1061, Rockville, MD 20852. THORACIC STENT–GRAFT WITH November 2, 2015. To meet its burden, Submit petitions electronically to PLUS DELIVERY SYSTEM represented the first permitted commercial the petition must contain sufficient facts http://www.regulations.gov at Docket marketing or use of the product. to merit an FDA investigation. (See H. No. FDA–2013–S–0610. Thereafter, the USPTO requested that Rept. 857, part 1, 98th Cong., 2d sess., FOR FURTHER INFORMATION CONTACT: FDA determine the product’s regulatory pp. 41–42, 1984.) Petitions should be in Beverly Friedman, Office of review period. the format specified in 21 CFR 10.30. Management, Center for Drug FDA has determined that the Interested persons may submit to the Evaluation and Research, Food and applicable regulatory review period for Division of Dockets Management (see Drug Administration, 10001 New RELAY THORACIC STENT–GRAFT ADDRESSES) electronic or written Hampshire Ave., Hillandale Building, WITH PLUS DELIVERY SYSTEM is comments and written or electronic Rm. 3180, Silver Spring, MD 20993– 2,852 days. Of this time, 2,529 days petitions. It is only necessary to send 0002, 301–796–7900. occurred during the testing phase of the one set of comments. Identify comments SUPPLEMENTARY INFORMATION: The Drug regulatory review period, while 323 with the docket number found in Price Competition and Patent Term days occurred during the approval brackets in the heading of this Restoration Act of 1984 (Pub. L. 98–417) phase. These periods of time were document. If you submit a written and the Generic Animal Drug and Patent derived from the following dates: petition, two copies are required. A Term Restoration Act (Pub. L. 100–670) 1. The date an exemption under petition submitted electronically must generally provide that a patent may be section 520(g) of the Federal Food, Drug, be submitted to http:// extended for a period of up to 5 years and Cosmetic Act (the FD&C Act) (21 www.regulations.gov, Docket No. FDA– so long as the patented item (human U.S.C. 360j(g)) involving this device 2013–S–0610. Comments and petitions drug product, animal drug product, became effective: December 2, 2004. The that have not been made publicly medical device, food additive, or color applicant claims that the investigational available on http://www.regulations.gov additive) was subject to regulatory device exemption (IDE) required under may be viewed in the Division of review by FDA before the item was mstockstill on DSK4VPTVN1PROD with NOTICES section 520(g) of the FD&C Act for Dockets Management between 9 a.m. marketed. Under these acts, a product’s human tests to begin became effective and 4 p.m., Monday through Friday. regulatory review period forms the basis on December 3, 2004. However, FDA Dated: April 28, 2015. for determining the amount of extension records indicate that the IDE was an applicant may receive. Leslie Kux, determined substantially complete for A regulatory review period consists of clinical studies to have begun on Associate Commissioner for Policy. two periods of time: A testing phase and December 2, 2004, which represents the [FR Doc. 2015–10338 Filed 5–1–15; 8:45 am] an approval phase. For medical devices, IDE effective date. BILLING CODE 4164–01–P the testing phase begins with a clinical VerDate Sep<11>2014 19:40 May 01, 2015 Jkt 235001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\04MYN1.SGM 04MYN1

25300 Federal Register / Vol. 80, No. 85 / Monday, May 4, 2015 / Notices investigation of the device and runs 2. The date an application was DEPARTMENT OF HEALTH AND until the approval phase begins. The initially submitted with respect to the HUMAN SERVICES approval phase starts with the initial device under section 515 of the FD&C submission of an application to market Act (21 U.S.C. 360e): December 23, Food and Drug Administration the device and continues until 2011. FDA has verified the applicant’s [Docket No. FDA–2014–E–0154] permission to market the device is claim that the premarket approval granted. Although only a portion of a application (PMA) for CAMERON Determination of Regulatory Review regulatory review period may count HEALTH S–ICD SYSTEM (PMA Period for Purposes of Patent toward the actual amount of extension P110042) was initially submitted Extension; NESINA that the Director of USPTO may award December 23, 2011. (half the testing phase must be AGENCY: Food and Drug Administration, 3. The date the application was HHS. subtracted as well as any time that may approved: September 28, 2012. FDA has ACTION: Notice. have occurred before the patent was verified the applicant’s claim that PMA issued), FDA’s determination of the length of a regulatory review period for P110042 was approved on September SUMMARY: The Food and Drug a medical device will include all of the 28, 2012. Administration (FDA) has determined testing phase and approval phase as This determination of the regulatory the regulatory review period for specified in 35 U.S.C. 156(g)(3)(B). review period establishes the maximum NESINA and is publishing this notice of FDA has approved for marketing the potential length of a patent extension. that determination as required by law. medical device CAMERON HEALTH However, the USPTO applies several FDA has made the determination S–ICD SYSTEM. CAMERON HEALTH statutory limitations in its calculations because of the submission of an S–ICD SYSTEM is indicated to provide of the actual period for patent extension. application to the Director of the U.S. defibrillation therapy for the treatment In its applications for patent extension, Patent and Trademark Office (USPTO), of life-threatening ventricular this applicant seeks 651 days of patent Department of Commerce, for the tachyarrhythmias in patients who do term extension. extension of a patent which claims that not have symptomatic bradycardia, human drug product. Anyone with knowledge that any of incessant ventricular tachycardia, or ADDRESSES: Submit electronic the dates as published are incorrect may comments to http:// spontaneous, frequently recurring submit to the Division of Dockets ventricular tachycardia that is reliably www.regulations.gov. Submit written Management (see ADDRESSES) either petitions (two copies are required) and terminated with antitachycardia pacing. electronic or written comments and ask Subsequent to this approval, the USPTO written comments to the Division of for a redetermination by July 6, 2015. Dockets Management (HFA–305), Food received patent term restoration Furthermore, any interested person may applications for CAMERON HEALTH S– and Drug Administration, 5630 Fishers petition FDA for a determination Lane, Rm. 1061, Rockville, MD 20852. ICD SYSTEM (U.S. Patent Nos. regarding whether the applicant for Submit petitions electronically to 6,856,835 and 7,149,575) from Cameron extension acted with due diligence http://www.regulations.gov at Docket Health Inc., and the USPTO requested during the regulatory review period by No. FDA–2013–S–0610. FDA’s assistance in determining the November 2, 2015. To meet its burden, FOR FURTHER INFORMATION CONTACT: patents’ eligibility for patent term restoration. In a letter dated March 18, the petition must contain sufficient facts Beverly Friedman, Office of 2014, FDA advised the USPTO that this to merit an FDA investigation. (See H. Management, Food and Drug medical device had undergone a Rept. 857, part 1, 98th Cong., 2d sess., Administration, 10001 New Hampshire regulatory review period and that the pp. 41–42, 1984.) Petitions should be in Ave., Hillandale Bldg., Rm. 3180, Silver approval of CAMERON HEALTH S–ICD the format specified in 21 CFR 10.30. Spring, MD 20993, 301–796–7900. SYSTEM represented the first permitted Interested persons may submit to the SUPPLEMENTARY INFORMATION: The Drug commercial marketing or use of the Division of Dockets Management (see Price Competition and Patent Term product. Thereafter, the USPTO ADDRESSES) electronic or written Restoration Act of 1984 (Pub. L. 98–417) requested that the FDA determine the comments and written or electronic and the Generic Animal Drug and Patent product’s regulatory review period. petitions. It is only necessary to send Term Restoration Act (Pub. L. 100–670) FDA has determined that the one set of comments. Identify comments generally provide that a patent may be applicable regulatory review period for with the docket number found in extended for a period of up to 5 years CAMERON HEALTH S–ICD SYSTEM is brackets in the heading of this so long as the patented item (human 1,024 days. Of this time, 743 days document. If you submit a written drug product, animal drug product, occurred during the testing phase of the petition, two copies are required. A medical device, food additive, or color regulatory review period, while 281 petition submitted electronically must additive) was subject to regulatory days occurred during the approval be submitted to http:// review by FDA before the item was phase. These periods of time were www.regulations.gov, Docket No. FDA– marketed. Under these acts, a product’s derived from the following dates: 2013–S–0610. Comments and petitions regulatory review period forms the basis 1. The date an exemption under that have not been made publicly for determining the amount of extension section 520(g) of the Federal Food, Drug, available on http://www.regulations.gov an applicant may receive. and Cosmetic Act (the FD&C Act) (21 may be viewed in the Division of A regulatory review period consists of mstockstill on DSK4VPTVN1PROD with NOTICES U.S.C. 360j(g)) involving this device Dockets Management between 9 a.m. two periods of time: A testing phase and became effective: December 11, 2009. and 4 p.m., Monday through Friday. an approval phase. For human drug FDA has verified the applicant’s claim Dated: April 28, 2015. products, the testing phase begins when that the date the investigational device the exemption to permit the clinical Leslie Kux, exemption (IDE) required under section investigations of the drug becomes 520(g) of the FD&C act for human tests Associate Commissioner for Policy. effective and runs until the approval to begin became effective December 11, [FR Doc. 2015–10334 Filed 5–1–15; 8:45 am] phase begins. The approval phase starts 2009. BILLING CODE 4164–01–P with the initial submission of an VerDate Sep<11>2014 19:40 May 01, 2015 Jkt 235001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\04MYN1.SGM 04MYN1


Document Created: 2018-02-21 10:22:58
Document Modified: 2018-02-21 10:22:58
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactBeverly Friedman, Office of Management, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, Rm. 3180, Silver Spring, MD 20993-0002, 301-796-7900.
FR Citation80 FR 25299 
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