80 FR 23035 - Determination of Regulatory Review Period for Purposes of Patent Extension; KYNAMRO

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 79 (April 24, 2015)

The Food and Drug Administration (FDA) has determined the regulatory review period for KYNAMRO 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 human drug product.

[Federal Register Volume 80, Number 79 (Friday, April 24, 2015)]
[Notices]
[Pages 23035-23036]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-09522]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-0299]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; KYNAMRO

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 KYNAMRO 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 human drug product.

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 human drug products, the 
testing phase begins when the exemption to permit the clinical 
investigations of the drug becomes effective and runs until the 
approval

[[Page 23036]]

phase begins. The approval phase starts with the initial submission of 
an application to market the human drug product and continues until FDA 
grants permission to market the drug product. Although only a portion 
of a regulatory review period may count toward the actual amount of 
extension that the Director of USPTO may award (for example, 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 human drug product will 
include all of the testing phase and approval phase as specified in 35 
U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product KYNAMRO 
(mipomersen sodium). KYNAMRO is indicated as an adjunct to lipid-
lowering medications and diet to reduce low density lipoprotein-
cholesterol, apolipoprotein B, total cholesterol, and non-high density 
lipoprotein-cholesterol in patients with homozygous familial 
hypercholesterolemia. Subsequent to this approval, the USPTO received a 
patent term restoration application for KYNAMRO (U.S. Patent No. 
7,511,131) from Genzyme Corporation, and the USPTO requested FDA's 
assistance in determining this patent's eligibility for patent term 
restoration. In a letter dated March 27, 2014, FDA advised the USPTO 
that this human drug product had undergone a regulatory review period 
and that the approval of KYNAMRO 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 
KYNAMRO is 2,601 days. Of this time, 2,294 days occurred during the 
testing phase of the regulatory review period, while 307 days occurred 
during the approval phase. These periods of time were derived from the 
following dates:
    1. The date an exemption under section 505(i) of the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became 
effective: December 18, 2005. FDA has verified the applicant's claim 
that the date the investigational new drug application became effective 
was on December 18, 2005.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the FD&C Act: March 29, 
2012. FDA has verified the applicant's claim that the new drug 
application (NDA) for KYNAMRO (NDA 203568) was submitted on March 29, 
2012.
    3. The date the application was approved: January 29, 2013. FDA has 
verified the applicant's claim that NDA 203568 was approved on January 
29, 2013.
    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 853 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 23, 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 October 21, 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: April 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-09522 Filed 4-23-15; 8:45 am]
 BILLING CODE 4164-01-P