[Federal Register Volume 83, Number 21 (Wednesday, January 31, 2018)]
[Notices]
[Pages 4486-4487]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01891]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2015-E-2570; FDA-2015-E-2577]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has 
determined the regulatory review period for SAPIEN XT 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 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.

DATES: Anyone with knowledge that any of the dates as published (in the 
SUPPLEMENTARY INFORMATION section) are incorrect may submit either 
electronic or written comments and ask for a redetermination by April 
2, 2018. 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 July 30, 2018. See 
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more 
information.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before April 2, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of April 2, 2018. Comments received by 
mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos. 
FDA-2015-E-2570 and FDA-2015-E-2577 for ``Determination of Regulatory 
Review Period for Purposes of Patent Extension; SAPIEN XT TRANSCATHETER 
HEART VALVE.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff . If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 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. 6250, Silver Spring, MD 20993, 301-796-3600.

SUPPLEMENTARY INFORMATION: 

I. Background

    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.

[[Page 4487]]

    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 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 SAPIEN XT 
TRANSCATHETER HEART VALVE. SAPIEN XT TRANSCATHETER HEART VALVE is 
indicated for relief of aortic stenosis in patients with symptomatic 
heart disease due to severe native calcific aortic stenosis (aortic 
valve area <=1.0 cm2 or aortic valve area index <=0.6 cm2/m2, a mean 
aortic valve gradient of >=40 mmHg, or a peak aortic-jet velocity of 
>=4.0 m/s), and with native anatomy appropriate for the 23, 26, or 29 
mm valve system, who are judged by a heart team, including a cardiac 
surgeon, to be at high or greater risk for open surgical therapy (i.e., 
Society of Thoracic Surgeons operative risk score >=8% or at a >=15% 
risk of morality at 30 days). Subsequent to this approval, the USPTO 
received a patent term restoration application for SAPIEN XT 
TRANSCATHETER HEART VALVE (U.S. Patent Nos. 7,510,575 and 7,585,321) 
from Edwards Lifesciences PVT, Inc., and the USPTO requested FDA's 
assistance in determining the patents' eligibility for patent term 
restoration. In a letter dated October 15, 2015, FDA advised the USPTO 
that this medical device had undergone a regulatory review period and 
that the approval of SAPIEN XT TRANSCATHETER HEART VALVE represented 
the first permitted commercial marketing or use of the product. 
Thereafter, the USPTO requested that FDA determine the product's 
regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for 
SAPIEN XT TRANSCATHETER HEART VALVE is 1,370 days. Of this time, 959 
days occurred during the testing phase of the regulatory review period, 
while 411 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: September 17, 2010. FDA has verified the 
applicant's claim that the date the investigational device exemption 
became effective was on September 17, 2010.
    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): May 2, 
2013. FDA has verified the applicant's claim that the premarket 
approval application (PMA) for SAPIEN XT TRANSCATHETER HEART VALVE (PMA 
P130009) was initially submitted on May 2, 2013.
    3. The date the application was approved: June 16, 2014. FDA has 
verified the applicant's claim that PMA P130009 was approved on June 
16, 2014.
    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 889 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are 
incorrect may submit either electronic or written comments and, under 
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as 
specified in 21 CFR 60.30, any interested person may petition FDA for a 
determination regarding whether the applicant for extension acted with 
due diligence during the regulatory review period. To meet its burden, 
the petition must comply with all the requirements of 21 CFR 60.30, 
including but not limited to: Must be timely (see DATES), must be filed 
in accordance with 21 CFR 10.20, must contain sufficient facts to merit 
an FDA investigation, and must certify that a true and complete copy of 
the petition has been served upon the patent applicant. (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.
    Submit petitions electronically to https://www.regulations.gov at 
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are 
required) to the Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: January 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01891 Filed 1-30-18; 8:45 am]
 BILLING CODE 4164-01-P