80_FR_18479 80 FR 18414 - Determination of Regulatory Review Period for Purposes of Patent Extension; JUXTAPID

80 FR 18414 - Determination of Regulatory Review Period for Purposes of Patent Extension; JUXTAPID

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 65 (April 6, 2015)

Page Range18414-18414
FR Document2015-07809

The Food and Drug Administration (FDA) has determined the regulatory review period for JUXTAPID 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 Issue 65 (Monday, April 6, 2015) 
[Federal Register Volume 80, Number 65 (Monday, April 6, 2015)]
[Notices]
[Page 18414]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-07809]



[[Page 18414]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-E-1657]


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

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 JUXTAPID 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 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 the U.S. Patent and 
Trademark Office (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 JUXTAPID 
(lomitapide mesylate). JUXTAPID is indicated as an adjunct to a low-fat 
diet and other lipid-lowering treatments, including LDL apheresis where 
available, to reduce low-density lipoprotein cholesterol, total 
cholesterol, apolipoprotein B, 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 JUXTAPID (U.S. Patent No. 5,712,279) from 
Aegerion Pharmaceuticals, Inc., and the USPTO requested FDA's 
assistance in determining this patent's eligibility for patent term 
restoration. In a letter dated January 31, 2014, FDA advised the USPTO 
that this human drug product had undergone a regulatory review period 
and that the approval of JUXTAPID 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 
JUXTAPID is 6,002 days. Of this time, 5,705 days occurred during the 
testing phase of the regulatory review period, while 297 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: July 18, 1996. FDA has verified the applicant's claim that 
the date the investigational new drug application became effective was 
on July 18, 1996.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the FD&C Act: February 
29, 2012. FDA has verified the applicant's claim that the new drug 
application (NDA) for Juxtapid (NDA 203-858) was submitted on February 
29, 2012.
    3. The date the application was approved: December 21, 2012. FDA 
has verified the applicant's claim that NDA 203-858 was approved on 
December 21, 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 5 years 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 5, 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 5, 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 1, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07809 Filed 4-3-15; 8:45 am]
BILLING CODE 4164-01-P

18414 Federal Register / Vol. 80, No. 65 / Monday, April 6, 2015 / Notices DEPARTMENT OF HEALTH AND with the initial submission of an 3. The date the application was HUMAN SERVICES application to market the human drug approved: December 21, 2012. FDA has product and continues until FDA grants verified the applicant’s claim that NDA Food and Drug Administration permission to market the drug product. 203–858 was approved on December 21, [Docket No. FDA–2013–E–1657] Although only a portion of a regulatory 2012. review period may count toward the This determination of the regulatory Determination of Regulatory Review actual amount of extension that the review period establishes the maximum Period for Purposes of Patent Director of the U.S. Patent and potential length of a patent extension. Extension; JUXTAPID Trademark Office (USPTO) may award However, the USPTO applies several (for example, half the testing phase must statutory limitations in its calculations AGENCY: Food and Drug Administration, be subtracted as well as any time that of the actual period for patent extension. HHS. may have occurred before the patent In its application for patent extension, ACTION: Notice. was issued), FDA’s determination of the this applicant seeks 5 years of patent length of a regulatory review period for term extension. SUMMARY: The Food and Drug a human drug product will include all Administration (FDA) has determined Anyone with knowledge that any of of the testing phase and approval phase the dates as published are incorrect may the regulatory review period for as specified in 35 U.S.C. 156(g)(1)(B). JUXTAPID and is publishing this notice submit to the Division of Dockets FDA has approved for marketing the of that determination as required by Management (see ADDRESSES) either human drug product JUXTAPID law. FDA has made the determination electronic or written comments and ask (lomitapide mesylate). JUXTAPID is because of the submission of an for a redetermination by June 5, 2015. indicated as an adjunct to a low-fat diet application to the Director of the U.S. Furthermore, any interested person may and other lipid-lowering treatments, Patent and Trademark Office (USPTO), petition FDA for a determination including LDL apheresis where Department of Commerce, for the regarding whether the applicant for available, to reduce low-density extension of a patent which claims that lipoprotein cholesterol, total extension acted with due diligence human drug product. cholesterol, apolipoprotein B, and non- during the regulatory review period by high-density lipoprotein cholesterol in October 5, 2015. To meet its burden, the ADDRESSES: Submit electronic patients with homozygous familial petition must contain sufficient facts to comments to http:// hypercholesterolemia. Subsequent to merit an FDA investigation. (See H. www.regulations.gov. Submit written this approval, the USPTO received a Rept. 857, part 1, 98th Cong., 2d sess., petitions (two copies are required) and patent term restoration application for pp. 41–42, 1984.) Petitions should be in written comments to the Division of JUXTAPID (U.S. Patent No. 5,712,279) the format specified in 21 CFR 10.30. Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers from Aegerion Pharmaceuticals, Inc., Interested persons may submit to the Lane, Rm. 1061, Rockville, MD 20852. and the USPTO requested FDA’s Division of Dockets Management (see Submit petitions electronically to assistance in determining this patent’s ADDRESSES) electronic or written http://www.regulations.gov at Docket eligibility for patent term restoration. In comments and written or electronic No. FDA–2013–S–0610. a letter dated January 31, 2014, FDA petitions. It is only necessary to send advised the USPTO that this human one set of comments. Identify comments FOR FURTHER INFORMATION CONTACT: drug product had undergone a with the docket number found in Beverly Friedman, Office of regulatory review period and that the brackets in the heading of this Management, Food and Drug approval of JUXTAPID represented the document. If you submit a written Administration, 10001 New Hampshire first permitted commercial marketing or petition, two copies are required. A Ave., Hillandale Campus, Rm. 3180, use of the product. Thereafter, the petition submitted electronically must Silver Spring, MD 20993, 301–796– USPTO requested that FDA determine be submitted to http:// 7900. the product’s regulatory review period. www.regulations.gov, Docket No. FDA– SUPPLEMENTARY INFORMATION: The Drug FDA has determined that the 2013–S–0610. Comments and petitions Price Competition and Patent Term applicable regulatory review period for that have not been made publicly Restoration Act of 1984 (Pub. L. 98–417) JUXTAPID is 6,002 days. Of this time, available on http://www.regulations.gov and the Generic Animal Drug and Patent 5,705 days occurred during the testing may be viewed in the Division of Term Restoration Act (Pub, L. 100–670) phase of the regulatory review period, Dockets Management between 9 a.m. generally provide that a patent may be while 297 days occurred during the and 4 p.m., Monday through Friday. extended for a period of up to 5 years approval phase. These periods of time Dated: April 1, 2015. so long as the patented item (human were derived from the following dates: Leslie Kux, drug product, animal drug product, 1. The date an exemption under medical device, food additive, or color Associate Commissioner for Policy. section 505(i) of the Federal Food, Drug, additive) was subject to regulatory and Cosmetic Act (the FD&C Act) (21 [FR Doc. 2015–07809 Filed 4–3–15; 8:45 am] review by FDA before the item was U.S.C. 355(i)) became effective: July 18, BILLING CODE 4164–01–P marketed. Under these acts, a product’s 1996. FDA has verified the applicant’s regulatory review period forms the basis claim that the date the investigational for determining the amount of extension new drug application became effective DEPARTMENT OF HEALTH AND an applicant may receive. was on July 18, 1996. HUMAN SERVICES A regulatory review period consists of 2. The date the application was Indian Health Service tkelley on DSK4VPTVN1PROD with NOTICES two periods of time: A testing phase and initially submitted with respect to the an approval phase. For human drug human drug product under section Office of Direct Service and products, the testing phase begins when 505(b) of the FD&C Act: February 29, Contracting Tribes; National Indian the exemption to permit the clinical 2012. FDA has verified the applicant’s Health Outreach and Education II investigations of the drug becomes claim that the new drug application effective and runs until the approval (NDA) for Juxtapid (NDA 203–858) was Announcement Type: New Limited phase begins. The approval phase starts submitted on February 29, 2012. Competition. VerDate Sep<11>2014 18:14 Apr 03, 2015 Jkt 235001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\06APN1.SGM 06APN1


Document Created: 2015-12-18 11:18:14
Document Modified: 2015-12-18 11:18:14
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactBeverly Friedman, Office of Management, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Campus, Rm. 3180, Silver Spring, MD 20993, 301-796-7900.
FR Citation80 FR 18414 
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