Determination of Regulatory Review Period for Purposes of Patent Extension; SAPIEN TRANSCATHETER HEART VALVE, 12330-12331 [2013-04016]

Download as PDF 12330 Federal Register / Vol. 78, No. 36 / Friday, February 22, 2013 / Notices a product enhancement, a firm must make a separate assessment on whether it is required to report the change to FDA. The guidance is organized in a question-and-answer format, providing responses to questions that FDA believes are helpful in properly identifying medical device recalls and applying the reporting requirements. II. Significance of Guidance The draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency’s current thinking on the difference between a recall and an enhancement to an existing premarket approval application (PMA) or 510(k). It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. sroberts on DSK5SPTVN1PROD with NOTICES III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. A search capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov. To receive ‘‘Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements,’’ you may either send an email request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 301–847–8149 to receive a hard copy. Please use the document number 1819 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 The draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR part 7, subpart C have been approved under OMB control number 0910–0249; the collections of information in 21 CFR part 801 and 21 CFR 809.10 have been approved under OMB control number 0910–0485; the collections of information in 21 CFR part 803 have been approved under OMB control number 0910–0437; and the collections of information in 21 CFR part 810 have VerDate Mar<15>2010 16:18 Feb 21, 2013 Jkt 229001 been approved under OMB control number 0910–0432. V. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). 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. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http:// www.regulations.gov. Dated: February 15, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–04060 Filed 2–21–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–E–0196] Determination of Regulatory Review Period for Purposes of Patent Extension; SAPIEN TRANSCATHETER HEART VALVE AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined the regulatory review period for SAPIEN TRANSCATHETER HEART VALVE 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 http:// www.regulations.gov. Submit written petitions along with three copies and written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6284, Silver Spring, MD 20993– 0002, 301–796–3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term SUMMARY: PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 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 recently approved for marketing the medical device, SAPIEN TRANSCATHETER HEART VALVE. SAPIEN TRANSCATHETER HEART VALVE is indicated for transfemoral delivery in patients with severe symptomatic native aortic valve stenosis who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement and in whom existing comorbidities would not preclude the expected benefit from correction of the aortic stenosis. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for SAPIEN TRANSCATHETER HEART VALVE (U.S. Patent No. 5,411,552) from Edwards Lifesciences AG and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated July 10, 2012, FDA advised the Patent and Trademark Office that this medical device had undergone a regulatory review period and that the approval of SAPIEN TRANSCATHETER HEART VALVE represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that the E:\FR\FM\22FEN1.SGM 22FEN1 Federal Register / Vol. 78, No. 36 / Friday, February 22, 2013 / Notices sroberts on DSK5SPTVN1PROD with NOTICES FDA determine the product’s regulatory review period. FDA has determined that the applicable regulatory review period for SAPIEN TRANSCATHETER HEART VALVE is 2,473 days. Of this time, 2,106 days occurred during the testing phase of the regulatory review period, while 367 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: January 26, 2005. 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 March 24, 2003. However, FDA records indicate that the IDE was determined substantially complete for clinical studies to have begun on January 26, 2005, 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): November 1, 2010. The applicant claims October 29, 2010, as the date the premarket approval application (PMA) for SAPIEN Transcatheter Heart Valve (PMA P100041) was initially submitted. However, FDA records indicate that PMA P100041 was submitted on November 1, 2010. 3. The date the application was approved: November 2, 2011. FDA has verified the applicant’s claim that PMA P100041 was approved on November 2, 2011. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. 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 1,757 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 April 23, 2013. 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 August 21, 2013. 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 petitions. It is only necessary to send one set of comments. However, if you submit a written petition, you must submit three copies of the petition. Identify comments with the docket number found in brackets in the heading of this document. 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: February 15, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–04016 Filed 2–21–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Request for Nominations for Voting and/or Nonvoting Consumer Representatives on Public Advisory Committees or Panels and Request for Notification From Consumer Organizations Interested in Participating in the Selection Process for Nominations for Voting and/or Nonvoting Consumer Representatives on Public Advisory Committees or Panels AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in SUMMARY: writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may either be selfnominated or may be nominated by a consumer organization. Nominations will be accepted for current vacancies and for those that will or may occur through December 2013. DATES: Any consumer organization interested in participating in the selection of an appropriate voting or nonvoting member to represent consumer interests on an FDA advisory committee or panel may send a letter or email stating that interest to FDA by March 25, 2013, for vacancies listed in this notice. Concurrently, nomination materials for prospective candidates should be sent to FDA by March 25, 2013. All statements of interest from consumer organizations interested in participating in the selection process and consumer representative nominations should be sent electronically to CV@OC.FDA.GOV, by mail to Advisory Committee Oversight and Management Staff, 10903 New Hampshire Ave., Bldg. 32, rm. 5129, Silver Spring, MD 20993–0002, or by fax to 301–847–8640. Information about becoming a member of an FDA advisory committee can be obtained by visiting FDA’s Web site at http://www.fda.gov/ AdvisoryCommittees/default.htm. FOR FURTHER INFORMATION CONTACT: Dornette Spell-LeSane, Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5129, Silver Spring, MD 20993– 0002, 301–796–8224, dornette.spelllesane@fda.hhs.gov. For questions relating to specific advisory committees or panels, contact the appropriate person listed in table 1 in the SUPPLEMENTARY INFORMATION section of this document. SUPPLEMENTARY INFORMATION: For questions relating to specific advisory committees or panels, contact the appropriate person listed in table 1 of this document. ADDRESSES: TABLE 1—ADVISORY COMMITTEE CONTACTS Contact person Committee/panel Diane Goyette, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2408, Silver Spring, MD 20993–0002, 301–796–9014, FAX: 301–847–8533, Diane.Goyette@fda.hhs.gov. VerDate Mar<15>2010 16:18 Feb 21, 2013 Jkt 229001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 12331 Anti-Infective Drugs. E:\FR\FM\22FEN1.SGM 22FEN1

Agencies

[Federal Register Volume 78, Number 36 (Friday, February 22, 2013)]
[Notices]
[Pages 12330-12331]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04016]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-E-0196]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; SAPIEN TRANSCATHETER HEART VALVE

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for SAPIEN TRANSCATHETER HEART VALVE 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 http://www.regulations.gov. 
Submit written petitions along with three copies and written comments 
to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory 
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 6284, Silver Spring, MD 20993-0002, 301-796-3602.

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 recently approved for marketing the medical device, SAPIEN 
TRANSCATHETER HEART VALVE. SAPIEN TRANSCATHETER HEART VALVE is 
indicated for transfemoral delivery in patients with severe symptomatic 
native aortic valve stenosis who have been determined by a cardiac 
surgeon to be inoperable for open aortic valve replacement and in whom 
existing comorbidities would not preclude the expected benefit from 
correction of the aortic stenosis. Subsequent to this approval, the 
Patent and Trademark Office received a patent term restoration 
application for SAPIEN TRANSCATHETER HEART VALVE (U.S. Patent No. 
5,411,552) from Edwards Lifesciences AG and the Patent and Trademark 
Office requested FDA's assistance in determining this patent's 
eligibility for patent term restoration. In a letter dated July 10, 
2012, FDA advised the Patent and Trademark Office that this medical 
device had undergone a regulatory review period and that the approval 
of SAPIEN TRANSCATHETER HEART VALVE represented the first permitted 
commercial marketing or use of the product. Thereafter, the Patent and 
Trademark Office requested that the

[[Page 12331]]

FDA determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for 
SAPIEN TRANSCATHETER HEART VALVE is 2,473 days. Of this time, 2,106 
days occurred during the testing phase of the regulatory review period, 
while 367 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: January 26, 2005. 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 
March 24, 2003. However, FDA records indicate that the IDE was 
determined substantially complete for clinical studies to have begun on 
January 26, 2005, 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): November 
1, 2010. The applicant claims October 29, 2010, as the date the 
premarket approval application (PMA) for SAPIEN Transcatheter Heart 
Valve (PMA P100041) was initially submitted. However, FDA records 
indicate that PMA P100041 was submitted on November 1, 2010.
    3. The date the application was approved: November 2, 2011. FDA has 
verified the applicant's claim that PMA P100041 was approved on 
November 2, 2011.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension. However, the U.S. 
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 1,757 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 April 23, 2013. 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 August 21, 2013. 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 petitions. 
It is only necessary to send one set of comments. However, if you 
submit a written petition, you must submit three copies of the 
petition. Identify comments with the docket number found in brackets in 
the heading of this document. 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: February 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04016 Filed 2-21-13; 8:45 am]
BILLING CODE 4160-01-P