Determination of Regulatory Review Period for Purposes of Patent Extension; ZIOPTAN, 28735-28736 [2014-11517]

Download as PDF mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 79, No. 96 / Monday, May 19, 2014 / Notices HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for PERJETA (U.S. Patent Nos. 6,949,245; 7,560,111; 7,862,817) from Genentech, Inc., and the Patent and Trademark Office requested FDA’s assistance in determining these patents’ eligibility for patent term restoration. In a letter dated February 4, 2013, FDA advised the Patent and Trademark Office that this human biological product had undergone a regulatory review period and that the approval of PERJETA 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 PERJETA is 3,925 days. Of this time, 3,741 days occurred during the testing phase of the regulatory review period, while 184 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: September 11, 2001. FDA has verified the applicant’s claim that the date the investigational new drug application became effective was on September 11, 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): December 8, 2011. The applicant claims December 6, 2011, as the date the biologics license application (BLA) for PERJETA (BLA 125409) was initially submitted. However, FDA records indicate that BLA 125409 was submitted on December 8, 2011. 3. The date the application was approved: June 8, 2012. FDA has verified the applicant’s claim that BLA 125409 was approved on June 8, 2012. 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 1,317 or 624 or 354 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 VerDate Mar<15>2010 17:17 May 16, 2014 Jkt 232001 electronic or written comments and ask for a redetermination by July 18, 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 17, 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 13, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–11515 Filed 5–16–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–E–0056] Determination of Regulatory Review Period for Purposes of Patent Extension; ZIOPTAN AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined the regulatory review period for ZIOPTAN 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 SUMMARY: PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 28735 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 (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 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 has approved for marketing the human drug product ZIOPTAN (tafluprost). ZIOPTAN is indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Subsequent to this E:\FR\FM\19MYN1.SGM 19MYN1 mstockstill on DSK4VPTVN1PROD with NOTICES 28736 Federal Register / Vol. 79, No. 96 / Monday, May 19, 2014 / Notices approval, the Patent and Trademark Office received a patent term restoration application for ZIOPTAN (U.S. Patent No. 5,886,035) from Asahi Glass Company Ltd., and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated February 19, 2013, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of ZIOPTAN 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 ZIOPTAN is 3,881 days. Of this time, 3,481 days occurred during the testing phase of the regulatory review period, while 400 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 28, 2001. The applicant claims June 24, 2001, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was June 28, 2001, which was 30 days after FDA receipt of the IND. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: January 7, 2011. FDA has verified the applicant’s claim that the new drug application (NDA) for ZIOPTAN (NDA 202514) was submitted on January 7, 2011. 3. The date the application was approved: February 10, 2012. FDA has verified the applicant’s claim that NDA 202514 was approved on February 10, 2012. 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 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 July 18, 2014. Furthermore, any interested person may petition FDA for a determination VerDate Mar<15>2010 17:17 May 16, 2014 Jkt 232001 regarding whether the applicant for extension acted with due diligence during the regulatory review period by November 17, 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 14, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–11517 Filed 5–16–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0176 (Formerly Docket No. 2008N–0011)] Defining Small Numbers of Animals for Minor Use Designation; Periodic Reassessment AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing its periodic reassessment for defining the small numbers of animals for minor use in major species. DATES: Submit either electronic or written comments at any time. ADDRESSES: Submit electronic comments to https:// www.regulations.gov/. Submit 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: Margaret Oeller, Center for Veterinary Medicine (HVF–50), Food and Drug Administration, 7500 Standish Pl., SUMMARY: PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 Rockville, MD 20855, 240–402–0566, email: margaret.oeller@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background The Minor Use and Minor Species Animal Health Act of 2004 (Pub. L. 108– 282) (the MUMS Act), defines the term minor use to mean the intended use of a new animal drug in a major species for an indication that occurs infrequently and in only a small number of animals annually, or in limited geographical areas and in only a small number of animals annually (21 U.S.C. 321(pp)). As provided by the MUMS Act, major species of animals are dogs, cats, horses, cattle, pigs, turkeys, and chickens (21 U.S.C. 321(nn). This statutory definition of minor use creates the need for FDA to establish a small number of animals for each of the major species of animals (small number). In accordance with the provisions of the MUMS Act, the small number is used to determine whether an intended use of a new animal drug in a major species of animal qualifies as a minor use. FDA established the small numbers by a final rule published in the Federal Register on August 26, 2009 (74 FR 43043). In the preamble for the final rule FDA responded to comments with the following: ‘‘FDA agrees that there is a need to periodically reevaluate the definition of ‘‘small number of animals.’’ Because Congress did not establish by statute what a ‘‘small number’’ is, it affords FDA the opportunity to periodically reevaluate and update the definition of ‘‘small number’’ as necessary. We further agree that such a reevaluation should take into account the potential for increases in the development cost of new animal drugs, but note that it also should take into account potential increases in the cost that animal owners are willing to pay to treat affected animals as well as other factors involved in establishing ‘‘small numbers,’’ such as changes in the total population of major animal species.’’ This is the first time FDA is reassessing the small numbers. II. Processes Used to Determine Small Numbers of Animals for Minor Use in Major Species The process used to establish small numbers of animals in major species of food-producing animals is different from the process used to establish small numbers of companion animals (nonfood-producing). The processes FDA uses to establish the small numbers were published in the preamble to the proposed rule (73 FR 14411). E:\FR\FM\19MYN1.SGM 19MYN1

Agencies

[Federal Register Volume 79, Number 96 (Monday, May 19, 2014)]
[Notices]
[Pages 28735-28736]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-11517]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-E-0056]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for ZIOPTAN 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 (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 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 has approved for marketing the human drug product ZIOPTAN 
(tafluprost). ZIOPTAN is indicated for reducing elevated intraocular 
pressure in patients with open-angle glaucoma or ocular hypertension. 
Subsequent to this

[[Page 28736]]

approval, the Patent and Trademark Office received a patent term 
restoration application for ZIOPTAN (U.S. Patent No. 5,886,035) from 
Asahi Glass Company Ltd., and the Patent and Trademark Office requested 
FDA's assistance in determining this patent's eligibility for patent 
term restoration. In a letter dated February 19, 2013, FDA advised the 
Patent and Trademark Office that this human drug product had undergone 
a regulatory review period and that the approval of ZIOPTAN 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 
ZIOPTAN is 3,881 days. Of this time, 3,481 days occurred during the 
testing phase of the regulatory review period, while 400 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 28, 2001. The applicant claims June 24, 2001, as the 
date the investigational new drug application (IND) became effective. 
However, FDA records indicate that the IND effective date was June 28, 
2001, which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the FD&C Act: January 7, 
2011. FDA has verified the applicant's claim that the new drug 
application (NDA) for ZIOPTAN (NDA 202514) was submitted on January 7, 
2011.
    3. The date the application was approved: February 10, 2012. FDA 
has verified the applicant's claim that NDA 202514 was approved on 
February 10, 2012.
    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 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 July 18, 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 17, 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 14, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-11517 Filed 5-16-14; 8:45 am]
BILLING CODE 4160-01-P
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