Document ID: FDA-2012-E-0851-0007
Agency: fda
Document Type: Notice
Title: Determination of Regulatory Review Period for Purposes of Patent
Extension; PROGENSA PCA3 ASSAY
Posted Date: 2014-05-30T04:00Z

[Federal Register Volume 79, Number 104 (Friday, May 30, 2014)]
[Notices]
[Pages 31119-31120]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-12562]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-E-0851]

Determination of Regulatory Review Period for Purposes of Patent 
Extension; PROGENSA PCA3 ASSAY

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 PROGENSA PCA3 ASSAY 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, 301-796-7900.

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 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, PROGENSA PCA3 
ASSAY. PROGENSA PCA3 ASSAY is an in vitro nucleic acid amplification 
test. The assay measures the concentration of prostate cancer gene 3 
(PCA3) and prostate specific antigen (PSA) ribonucleic acid (RNA) 
molecules and calculates the ratio of PCA3 RNA molecules to PSA RNA 
molecules (PCA3 Score) in post-digital rectal exam first catch male 
urine specimens. The PROGENSA PCA3 ASSAY is indicated for use in 
conjunction with other patient information to aid in the decision for 
repeat biopsy in men 50 years of age or older who have had one or more 
previous negative prostate biopsies and for whom a repeat biopsy would 
be

[[Page 31120]]

recommended by a urologist based on current standard of care, before 
consideration of PROGENSA PCA3 ASSAY results. A PCA3 score <25 is 
associated with a decreased likelihood of a positive biopsy. Prostatic 
biopsy is required for diagnosis of cancer. Subsequent to this 
approval, the Patent and Trademark Office received a patent term 
restoration application for PROGENSA PCA3 ASSAY (U.S. Patent No. 
7,008,765) from The Johns Hopkins University & The Stichting Katholieke 
Universiteit, The University Medical Centre Nijmegen, and the Patent 
and Trademark Office requested FDA's assistance in determining this 
patent's eligibility for patent term restoration. In a letter dated 
February 1, 2013, FDA advised the Patent and Trademark Office that this 
medical device had undergone a regulatory review period and that the 
approval of PROGENSA PCA3 ASSAY 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 
PROGENSA PCA3 ASSAY is 936 days. Of this time, 383 days occurred during 
the testing phase of the regulatory review period, while 553 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 or if an exemption is not required, the 
date an institutional review board under section 520(g)(3) of the FD&C 
Act (21 U.S.C. 360j(g)(3)) approved the clinical investigation of the 
device in humans: July 24, 2009. FDA has confirmed the applicant's 
claim that no investigational device exemption (IDE) was required under 
section 520(g) of the FD&C Act for human tests to begin. Institutional 
review board (IRB) approval was required under section 520(g)(3) of the 
FD&C Act and became effective on July 24, 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): August 
10, 2010. FDA has verified the applicant's claim that the premarket 
approval application (PMA) for PROGENSA PCA3 ASSAY (PMA 100033) was 
initially submitted August 10, 2010.
    3. The date the application was approved: February 13, 2012. FDA 
has verified the applicant's claim that PMA P100033 was approved on 
February 13, 2012.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension. However, the 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 745 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 29, 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 November 26, 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: May 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12562 Filed 5-29-14; 8:45 am]
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