[Federal Register Volume 80, Number 88 (Thursday, May 7, 2015)]
[Notices]
[Pages 26275-26276]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11001]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-E-1652]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; HVAD ROTARY BLOOD PUMP

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 HVAD ROTARY BLOOD PUMP 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 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, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Campus, Rm. 3180, Silver Spring, MD 20993, 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 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 HVAD ROTARY BLOOD 
PUMP. HVAD ROTARY BLOOD PUMP is indicated for use as a bridge to 
cardiac transplantation in patients who are at risk of death from 
refractory end-stage left ventricular heart failure. Subsequent to this 
approval, the USPTO received a patent term restoration application for 
HVAD ROTARY BLOOD PUMP (U.S. Patent No. 6,234,772) from HeartWare, 
Inc., and the USPTO requested FDA's assistance in determining this 
patent's 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 HVAD 
ROTARY BLOOD PUMP represented the first permitted commercial marketing 
or use of the product. Thereafter, the USPTO requested that FDA 
determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for 
HVAD ROTARY BLOOD PUMP is 1,667 days. Of this time, 973 days occurred 
during the testing phase of the regulatory review period, while 694 
days occurred during the approval phase. These periods of time were 
derived from the following dates:

[[Page 26276]]

    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: April 30, 2008. FDA has verified the 
applicant's claim that the date the investigational device exemption 
required under section 520(g) of the FD&C act for human tests to begin 
became effective April 30, 2008.
    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 28, 2010. The applicant claims December 23, 2010, as the date 
the premarket approval application (PMA) for HVAD ROTARY BLOOD PUMP 
(PMA P100047) was initially submitted. However, FDA records indicate 
that PMA P100047 was submitted on December 28, 2010.
    3. The date the application was approved: November 20, 2012. FDA 
has verified the applicant's claim that PMA P100047 was approved on 
November 20, 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 application for patent extension, 
this applicant seeks 818 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 3, 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: May 1, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11001 Filed 5-6-15; 8:45 am]
 BILLING CODE 4164-01-P