Determination of Regulatory Review Period for Purposes of Patent Extension; NOVOLOG, 14121-14122 [E7-5445]

Download as PDF cprice-sewell on PROD1PC66 with NOTICES Federal Register / Vol. 72, No. 57 / Monday, March 26, 2007 / Notices 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 recently approved for marketing the medical device ONYX LES. ONYX LES is indicated for presurgical embolization of brain arteriovenous malformations. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for ONYX LES (U.S. Patent No. 5,667,767) from Micro Therapeutics, Inc., and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated June 14, 2006, FDA advised the Patent and Trademark Office that this medical device had undergone a regulatory review period and that the approval of ONYX LES represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that FDA determine the product’s regulatory review period. FDA has determined that the applicable regulatory review period for ONYX LES is 1,682 days. Of this time, 825 days occurred during the testing phase of the regulatory review period, while 857 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 act) (21 U.S.C. 360j(g)) involving this device became effective: December 14, 2000. FDA has verified the applicant’s claim that the date the investigational device exemption (IDE) required under section 520(g) of the act for human tests to begin became effective December 14, 2000. 2. The date the application was initially submitted with respect to the device under section 515 of the act (21 U.S.C. 360e): March 18, 2003. The applicant claims March 12, 2003, as the date the premarket approval application (PMA) for ONYX LES (PMA P030004) was initially submitted. However, FDA records indicate that PMA P030004 was submitted on March 18, 2003. VerDate Aug<31>2005 15:30 Mar 23, 2007 Jkt 211001 3. The date the application was approved: July 21, 2005. FDA has verified the applicant’s claim that PMA P030004 was approved on July 21, 2005. 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 1,271 days of patent term extension. Anyone with knowledge that any of the dates are published is incorrect may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments and ask for a redetermination by May 25, 2007. 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 24, 2007. 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. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: March 12, 2007. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E7–5444 Filed 3–23–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006E–0478] Determination of Regulatory Review Period for Purposes of Patent Extension; NOVOLOG AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for NOVOLOG and is publishing this notice PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 14121 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 human drug product. ADDRESSES: Submit written comments and petitions to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy (HFD–7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–594–2041. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98– 417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 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 human drug product 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 Patents and Trademarks 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 recently approved for marketing the human drug product NOVOLOG (insulin aspart (rDNA origin)). NOVOLOG is indicated for the treatment of adult patients with diabetes mellitus, for the control of hyperglycemia. Subsequent to this E:\FR\FM\26MRN1.SGM 26MRN1 cprice-sewell on PROD1PC66 with NOTICES 14122 Federal Register / Vol. 72, No. 57 / Monday, March 26, 2007 / Notices approval, the Patent and Trademark Office received a patent term restoration application for NOVOLOG (U.S. Patent No. 5,618,913) from Novo Nordisk A/S, and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated December 12, 2006, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of NOVOLOG represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that FDA determine the product’s regulatory review period. FDA has determined that the applicable regulatory review period for NOVOLOG is 1,776 days. Of this time, 1,145 days occurred during the testing phase of the regulatory review period, while 631 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 act) (21 U.S.C. 355(i)) became effective: July 30, 1995. FDA has verified the applicant’s claim that the date the investigational new drug application became effective was on July 30, 1995. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the act: September 16, 1998. The applicant claims September 15, 1998, as the date the new drug application (NDA) for NOVOLOG (NDA 20–986) was initially submitted. However, FDA records indicate that NDA 20–986 was submitted on September 16, 1998. 3. The date the application was approved: June 7, 2000. FDA has verified the applicant’s claim that NDA 20–986 was approved on June 7, 2000. 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 59 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) written or electronic comments and ask for a redetermination by May 25, 2007. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence VerDate Aug<31>2005 15:30 Mar 23, 2007 Jkt 211001 during the regulatory review period by September 24, 2007. 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. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: March 12, 2007. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E7–5445 Filed 3–23–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005E–0259] Determination of Regulatory Review Period for Purposes of Patent Extension; EMTRIVA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for EMTRIVA 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 human drug product. ADDRESSES: Submit written comments and petitions to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy (HFD–7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–594–2041. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98– 417) and the Generic Animal Drug and PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 Patent Term Restoration Act (Public Law 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 human drug product 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 Patents and Trademarks 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 recently approved for marketing the human drug product EMTRIVA (emtricitabine). EMTRIVA is indicated, in combination with other antiretroviral agents, for the treatment of HIV–1 infection in adults. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for EMTRIVA (U.S. Patent No. 5,914,331) from Emory University, 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 8, 2005, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of EMTRIVA represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that FDA determine the product’s regulatory review period. FDA has determined that the applicable regulatory review period for EMTRIVA is 2,114 days. Of this time, 1,811 days occurred during the testing phase of the regulatory review period, while 303 days occurred during the E:\FR\FM\26MRN1.SGM 26MRN1

Agencies

[Federal Register Volume 72, Number 57 (Monday, March 26, 2007)]
[Notices]
[Pages 14121-14122]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-5445]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006E-0478]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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

ADDRESSES: Submit written comments and petitions to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to https://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory 
Policy (HFD-7), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term 
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug 
and Patent Term Restoration Act (Public Law 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 human drug product 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 Patents and 
Trademarks 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 recently approved for marketing the human drug product NOVOLOG 
(insulin aspart (rDNA origin)). NOVOLOG is indicated for the treatment 
of adult patients with diabetes mellitus, for the control of 
hyperglycemia. Subsequent to this

[[Page 14122]]

approval, the Patent and Trademark Office received a patent term 
restoration application for NOVOLOG (U.S. Patent No. 5,618,913) from 
Novo Nordisk A/S, and the Patent and Trademark Office requested FDA's 
assistance in determining this patent's eligibility for patent term 
restoration. In a letter dated December 12, 2006, FDA advised the 
Patent and Trademark Office that this human drug product had undergone 
a regulatory review period and that the approval of NOVOLOG represented 
the first permitted commercial marketing or use of the product. 
Thereafter, the Patent and Trademark Office requested that FDA 
determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for 
NOVOLOG is 1,776 days. Of this time, 1,145 days occurred during the 
testing phase of the regulatory review period, while 631 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 act) (21 U.S.C. 355(i)) became effective: 
July 30, 1995. FDA has verified the applicant's claim that the date the 
investigational new drug application became effective was on July 30, 
1995.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the act: September 16, 
1998. The applicant claims September 15, 1998, as the date the new drug 
application (NDA) for NOVOLOG (NDA 20-986) was initially submitted. 
However, FDA records indicate that NDA 20-986 was submitted on 
September 16, 1998.
    3. The date the application was approved: June 7, 2000. FDA has 
verified the applicant's claim that NDA 20-986 was approved on June 7, 
2000.
    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 59 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) written or electronic comments and ask for a redetermination 
by May 25, 2007. 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 24, 
2007. 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.
    Comments and petitions should be submitted to the Division of 
Dockets Management. Three copies of any mailed information are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Comments and petitions may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: March 12, 2007.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E7-5445 Filed 3-23-07; 8:45 am]
BILLING CODE 4160-01-S

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