Determination of Regulatory Review Period for Purposes of Patent Extension; BENLYSTA, 27878-27879 [2014-11176]

Download as PDF 27878 Federal Register / Vol. 79, No. 94 / Thursday, May 15, 2014 / Notices 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 14, 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 12, 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 https:// www.regulations.gov, Docket No. FDA– 2013–S–0610. 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: May 9, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–11175 Filed 5–14–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2011–E–0711; FDA– 2011–E–0712; FDA–2011–E–0715] Determination of Regulatory Review Period for Purposes of Patent Extension; BENLYSTA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined the regulatory review period for BENLYSTA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the TKELLEY on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 18:18 May 14, 2014 Jkt 232001 extension of a patent which claims that human biological product. ADDRESSES: 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 https:// 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 human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological 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 biological 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 biologic product, BENLYSTA (belimumab). BENLYSTA is indicated for treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus who are receiving standard therapy. Subsequent to this PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 approval, the Patent and Trademark Office received patent term restoration applications for BENLYSTA (U.S. Patent Nos. 6,403,770; 7,138,501; and 7,879,328) from Human Genome Sciences Inc., and the Patent and Trademark Office requested FDA’s assistance in determining the patents’ eligibility for patent term restoration. In a letter dated July 2, 2012, FDA advised the Patent and Trademark Office that this human biological product had undergone a regulatory review period and that the approval of BENLYSTA 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 BENLYSTA is 3,426 days. Of this time, 3,152 days occurred during the testing phase of the regulatory review period, while 274 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 (21 U.S.C. 355(i)) became effective: October 23, 2001. FDA has verified the applicant’s claim that the date the investigational new drug application became effective was on October 23, 2001. 2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): June 9, 2010. The applicant claims June 10, 2010, as the date the biologics license application (BLA) for BENLYSTA (BLA 125370/0) was initially submitted. However, FDA records indicate that BLA 125370/0 was submitted on June 9, 2010. 3. The date the application was approved: March 9, 2011. FDA has verified the applicant’s claim that BLA 125370/0 was approved on March 9, 2011. 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 applications for patent extension, this applicant seeks 1,733 days or 610 days or 37 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 14, 2014. Furthermore, any interested person may E:\FR\FM\15MYN1.SGM 15MYN1 Federal Register / Vol. 79, No. 94 / Thursday, May 15, 2014 / Notices petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by November 12, 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 https:// www.regulations.gov, Docket No. FDA– 2013–S–0610. 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. 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: May 9, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–11176 Filed 5–14–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–E–0132] Determination of Regulatory Review Period for Purposes of Patent Extension; PALLADIA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined the regulatory review period for PALLADIA 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 animal drug product. ADDRESSES: Submit electronic comments to https:// TKELLEY on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 18:18 May 14, 2014 Jkt 232001 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 https:// 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 animal drug products, the testing phase begins on the earlier date when either a major environmental effects test was initiated for the drug or when an exemption under section 512(j) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b(j)) became effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the animal 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 an animal drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(4)(B). FDA has approved for marketing the animal drug product PALLADIA (toceranib phosphate). PALLADIA is indicated for the treatment of Patnaik grade II or III, recurrent, cutaneous mast cell tumors with or without regional lymph node involvement in dogs. PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 27879 Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for PALLADIA (U.S. Patent No. 6,573,293) from Sugen, Inc., and Pharmacia & Upjohn Company LLC, and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated May 3, 2011, FDA advised the Patent and Trademark Office that this animal drug product had undergone a regulatory review period and that the approval of PALLADIA 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 PALLADIA is 2,711 days. Of this time, 2,681 days occurred during the testing phase of the regulatory review period, while 30 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 21, 2001. The applicant claims November 23, 2001, as the date the investigational new animal drug application (INAD) became effective. However, Food and Drug Administration (FDA) records indicate that the INAD effective date was December 21, 2001, which was the received date of the first submission that includes a study with substantial data (submission of a major health test) or the first submission containing a Notice of Claimed Investigational Exemption. 2. The date the application was initially submitted with respect to the animal drug product under section 512 of the FD&C Act (21 U.S.C. 360b): April 23, 2009. The applicant claims April 22, 2009, as the date the new animal drug application (NADA) for Palladia (NADA 141–295) was initially submitted. However, FDA records indicate that NADA 141–295 was submitted on April 23, 2009. 3. The date the application was approved: May 22, 2009. FDA has verified the applicant’s claim that NADA 141–295 was approved on May 22, 2009. 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 E:\FR\FM\15MYN1.SGM 15MYN1

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[Federal Register Volume 79, Number 94 (Thursday, May 15, 2014)]
[Notices]
[Pages 27878-27879]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-11176]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2011-E-0711; FDA-2011-E-0712; FDA-2011-E-0715]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for BENLYSTA and is publishing this notice of 
that determination as required by law. FDA has made the determination 
because of the submission of applications to the Director of Patents 
and Trademarks, Department of Commerce, for the extension of a patent 
which claims that human biological product.

ADDRESSES: 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 https://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 human biological products, the 
testing phase begins when the exemption to permit the clinical 
investigations of the biological becomes effective and runs until the 
approval phase begins. The approval phase starts with the initial 
submission of an application to market the human biological product and 
continues until FDA grants permission to market the biological 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 biological 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 biologic product, BENLYSTA 
(belimumab). BENLYSTA is indicated for treatment of adult patients with 
active, autoantibody-positive, systemic lupus erythematosus who are 
receiving standard therapy. Subsequent to this approval, the Patent and 
Trademark Office received patent term restoration applications for 
BENLYSTA (U.S. Patent Nos. 6,403,770; 7,138,501; and 7,879,328) from 
Human Genome Sciences Inc., and the Patent and Trademark Office 
requested FDA's assistance in determining the patents' eligibility for 
patent term restoration. In a letter dated July 2, 2012, FDA advised 
the Patent and Trademark Office that this human biological product had 
undergone a regulatory review period and that the approval of BENLYSTA 
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 
BENLYSTA is 3,426 days. Of this time, 3,152 days occurred during the 
testing phase of the regulatory review period, while 274 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 (21 U.S.C. 355(i)) became effective: October 23, 
2001. FDA has verified the applicant's claim that the date the 
investigational new drug application became effective was on October 
23, 2001.
    2. The date the application was initially submitted with respect to 
the human biological product under section 351 of the Public Health 
Service Act (42 U.S.C. 262): June 9, 2010. The applicant claims June 
10, 2010, as the date the biologics license application (BLA) for 
BENLYSTA (BLA 125370/0) was initially submitted. However, FDA records 
indicate that BLA 125370/0 was submitted on June 9, 2010.
    3. The date the application was approved: March 9, 2011. FDA has 
verified the applicant's claim that BLA 125370/0 was approved on March 
9, 2011.
    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 
applications for patent extension, this applicant seeks 1,733 days or 
610 days or 37 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 14, 2014. Furthermore, any interested person 
may

[[Page 27879]]

petition FDA for a determination regarding whether the applicant for 
extension acted with due diligence during the regulatory review period 
by November 12, 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 
https://www.regulations.gov, Docket No. FDA-2013-S-0610. 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.
    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: May 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-11176 Filed 5-14-14; 8:45 am]
BILLING CODE 4160-01-P
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