[Federal Register Volume 79, Number 63 (Wednesday, April 2, 2014)]
[Notices]
[Pages 18567-18568]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-07329]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-E-0716]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; NOVOTFF-100A 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 NOVOTFF-100A 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 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, 10903 New Hampshire Ave. Bldg. 51, Rm. 6257, 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

[[Page 18568]]

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, NOVOTFF-100A 
SYSTEM. NOVOTFF-100A SYSTEM is indicated for treatment of adult 
patients (22 years of age or older) with histologically-confirmed 
glioblastoma multiforme (GBM), following histologically- or 
radiologically-confirmed recurrence in the supratentorial region of the 
brain after receiving chemotherapy. The device is intended to be used 
as a monotherapy, and is intended as an alternative to standard medical 
therapy for GBM after surgical and radiation options have been 
exhausted. Subsequent to this approval, the Patent and Trademark Office 
received a patent term restoration application for NOVOTFF-100A SYSTEM 
(U.S. Patent No. 7,136,699) from Novocure Limited, 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 NOVOTFF-100A SYSTEM represented the first permitted 
commercial marketing or use of the product. Thereafter, the Patent and 
Trademark Office requested that the FDA determine the product's 
regulatory review period.
    FDA has determined that the applicable regulatory review period for 
NOVOTFF-100A SYSTEM is 1,704 days. Of this time, 1,468 days occurred 
during the testing phase of the regulatory review period, while 236 
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: August 10, 2006. 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 August 10, 2006.
    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): August 
16, 2010. The applicant claims December 30, 2009, as the date the 
premarket approval application (PMA) NOVOTFF-100A System] (PMA P100034) 
was initially submitted. However, FDA records indicate that PMA P100034 
was a modular submission and the final module was received by FDA on 
August 16, 2010.
    3. The date the application was approved: April 8, 2011. FDA has 
verified the applicant's claim that PMA P100034 was approved on April 
8, 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 807 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 June 2, 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 September 29, 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 
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: March 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07329 Filed 4-1-14; 8:45 am]
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