Determination of Regulatory Review Period for Purposes of Patent Extension; INVEGA SUSTENNA, 37128-37129 [2011-15905]

Download as PDF 37128 Federal Register / Vol. 76, No. 122 / Friday, June 24, 2011 / Notices 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 245 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 August 23, 2011. 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 December 21, 2011. 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 petitions. It is only necessary to send one set of comments. It is no longer necessary to send three copies of mailed comments. However, if you submit a written petition, you must submit three copies of the petition. Identify comments with the docket number found in brackets in the heading of this document. Comments and petitions that have not been made publicly available on https://www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: June 2, 2011. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. 2011–15910 Filed 6–23–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–E–0541] srobinson on DSK4SPTVN1PROD with NOTICES Determination of Regulatory Review Period for Purposes of Patent Extension; INVEGA SUSTENNA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined the regulatory review period for INVEGA SUSTENNA and is publishing SUMMARY: VerDate Mar<15>2010 19:06 Jun 23, 2011 Jkt 223001 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 electronic comments to https:// www.regulations.gov. Submit written petitions along with three copies and written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6222, Silver Spring, MD 20993– 0002, 301–796–3602. 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 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 INVEGA SUSTENNA (paliperidone palmitate). INVEGA SUSTENNA is indicated for PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 the acute and maintenance treatment of schizophrenia in adults. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for INVEGA SUSTENNA (U.S. Patent No. 5,254,556) from Janssen, L.P., and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration and that FDA determine the product’s regulatory review period. In a letter dated June 1, 2011, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of INVEGA SUSTENNA represented the first permitted commercial marketing or use of the product. FDA has determined that the applicable regulatory review period for INVEGA SUSTENNA is 2,253 days. Of this time, 1,608 days occurred during the testing phase of the regulatory review period, while 645 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: June 2, 2003. FDA has verified the applicant’s claim that the date the investigational new drug application became effective was on June 2, 2003. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: October 26, 2007. FDA has verified the applicant’s claim that the new drug application (NDA) for Invega Sustenna (NDA 22– 264) was submitted on October 26, 2007. 3. The date the application was approved: July 31, 2009. FDA has verified the applicant’s claim that NDA 22–264 was approved on July 31, 2009. 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 1,449 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 August 23, 2011. Furthermore, any interested person may petition FDA for a determination regarding whether the E:\FR\FM\24JNN1.SGM 24JNN1 Federal Register / Vol. 76, No. 122 / Friday, June 24, 2011 / Notices applicant for extension acted with due diligence during the regulatory review period by December 21, 2011. 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 petitions. It is only necessary to send one set of comments. It is no longer necessary to send three copies of mailed comments. However, if you submit a written petition, you must submit three copies of the petition. Identify comments with the docket number found in brackets in the heading of this document. Comments and petitions that have not been made publicly available on https://www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: June 2, 2011. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. 2011–15905 Filed 6–23–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0428] Determination That SODIUM FLUORIDE F 18 (Sodium Fluoride F– 18) Injection, 10 to 200 Millicuries per Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined that SODIUM FLUORIDE F 18 (sodium fluoride F–18) injection, 10 to 200 millicuries per milliliter (mCi/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for SODIUM FLUORIDE F 18 injection, 10 to 200 mCi/mL, if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Reena Raman, Center for Drug Evaluation and Research, Food and srobinson on DSK4SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 19:06 Jun 23, 2011 Jkt 223001 Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6238, Silver Spring, MD 20993–0002, 301– 796–7577. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the ‘‘listed drug,’’ which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The only clinical data required in an ANDA are data to show that the drug that is the subject of the ANDA is bioequivalent to the listed drug. The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations,’’ which is known generally as the ‘‘Orange Book.’’ Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (§ 314.162 (21 CFR 314.162)). A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale but must be made prior to approving an ANDA that refers to the listed drug (21 CFR 314.161). FDA may not approve an ANDA that does not refer to a listed drug. SODIUM FLUORIDE F 18 (sodium fluoride F–18) injection, 10 to 200 mCi/ mL, is the subject of NDA 22–494, held by National Cancer Institute, National Institutes of Health, and initially approved on January 26, 2011. SODIUM FLUORIDE F 18 (sodium fluoride F–18) is indicated for diagnostic positron emission tomography imaging of bone to define areas of altered osteogenic activity. The NDA holder has never marketed SODIUM FLUORIDE F 18 (sodium PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 37129 fluoride F–18) injection, 10 to 200 mCi/ mL, and in a letter dated May 2, 2011, the NDA holder requested that FDA move the product to the ‘‘Discontinued Drug Product List’’ section of the Orange Book. In previous instances (see, e.g., 72 FR 9763, March 5, 2007; 61 FR 25497, May 21, 1996), the Agency has determined that, for purposes of §§ 314.161 and 314.162, never marketing an approved drug product is equivalent to withdrawing the drug from sale. FDA has reviewed its records and, under § 314.161, has determined that SODIUM FLUORIDE F 18 (sodium fluoride F–18) injection, 10 to 200 mCi/ mL, was not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list SODIUM FLUORIDE F 18 (sodium fluoride F–18) injection, 10 to 200 mCi/mL, in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to SODIUM FLUORIDE F 18 (sodium fluoride F–18) injection, 10 to 200 mCi/mL, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: June 20, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–15815 Filed 6–23–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–D–0012] International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 7(R2) on Dissolution Test General Chapter; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the SUMMARY: E:\FR\FM\24JNN1.SGM 24JNN1

Agencies

[Federal Register Volume 76, Number 122 (Friday, June 24, 2011)]
[Notices]
[Pages 37128-37129]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-15905]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-E-0541]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; INVEGA SUSTENNA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for INVEGA SUSTENNA 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 electronic comments to https://www.regulations.gov. 
Submit written petitions along with three copies and written comments 
to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory 
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, rm. 6222, Silver Spring, MD 20993-0002, 301-796-3602.

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 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 INVEGA 
SUSTENNA (paliperidone palmitate). INVEGA SUSTENNA is indicated for the 
acute and maintenance treatment of schizophrenia in adults. Subsequent 
to this approval, the Patent and Trademark Office received a patent 
term restoration application for INVEGA SUSTENNA (U.S. Patent No. 
5,254,556) from Janssen, L.P., and the Patent and Trademark Office 
requested FDA's assistance in determining this patent's eligibility for 
patent term restoration and that FDA determine the product's regulatory 
review period. In a letter dated June 1, 2011, FDA advised the Patent 
and Trademark Office that this human drug product had undergone a 
regulatory review period and that the approval of INVEGA SUSTENNA 
represented the first permitted commercial marketing or use of the 
product.
    FDA has determined that the applicable regulatory review period for 
INVEGA SUSTENNA is 2,253 days. Of this time, 1,608 days occurred during 
the testing phase of the regulatory review period, while 645 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: June 2, 2003. FDA has verified the applicant's claim that 
the date the investigational new drug application became effective was 
on June 2, 2003.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the FD&C Act: October 
26, 2007. FDA has verified the applicant's claim that the new drug 
application (NDA) for Invega Sustenna (NDA 22-264) was submitted on 
October 26, 2007.
    3. The date the application was approved: July 31, 2009. FDA has 
verified the applicant's claim that NDA 22-264 was approved on July 31, 
2009.
    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 1,449 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 August 23, 2011. Furthermore, any interested person 
may petition FDA for a determination regarding whether the

[[Page 37129]]

applicant for extension acted with due diligence during the regulatory 
review period by December 21, 2011. 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 petitions. 
It is only necessary to send one set of comments. It is no longer 
necessary to send three copies of mailed comments. However, if you 
submit a written petition, you must submit three copies of the 
petition. Identify comments with the docket number found in brackets in 
the heading of this document.
    Comments and petitions that have not been made publicly available 
on https://www.regulations.gov may be viewed in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: June 2, 2011.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2011-15905 Filed 6-23-11; 8:45 am]
BILLING CODE 4160-01-P

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