Determination of Regulatory Review Period for Purposes of Patent Extension; XELJANZ, 33527-33528 [2015-14433]

Download as PDF Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Notices pre- or post-conception exposure of a male to an API. Such male-mediated developmental toxicity may result from an effect of the API on the male germ cell before conception or occur as a result of direct exposure of the conceptus to the pharmaceutical following seminal transfer and vaginal uptake in a pregnant partner. This draft guidance provides recommendations for addressing the potential for male-mediated adverse effects on pregnancy outcome for sponsors developing an investigational drug. Topics covered include: (1) Factors that investigators should consider when testing a new API in males, (2) nonclinical studies relevant to the assessment of male-mediated developmental risks, and (3) measures to prevent pregnancy or seminal transfer to a pregnant sexual partner when risk is either unknown or anticipated. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on the assessment of male-mediated developmental risk for pharmaceuticals. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. mstockstill on DSK4VPTVN1PROD with NOTICES II. The Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR part 312 have been approved under OMB control number 0910–0014. III. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). 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. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/ VerDate Sep<11>2014 19:05 Jun 11, 2015 Jkt 235001 GuidanceCompliance RegulatoryInformation/Guidances/ default.htm or https:// www.regulations.gov. Dated: June 8, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–14363 Filed 6–11–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–E–1656] Determination of Regulatory Review Period for Purposes of Patent Extension; XELJANZ AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined the regulatory review period for XELJANZ 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 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, 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 SUMMARY: PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 33527 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 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 XELJANZ (tofacitinib citrate). XELJANZ is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. Subsequent to this approval, the USPTO received a patent term restoration application for XELJANZ (U.S. Patent No. RE41,783) from Pfizer Inc., and the USPTO requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated March 26, 2014, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of XELJANZ 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 XELJANZ is 3,947 days. Of this time, 3,564 days occurred during the testing phase of the regulatory review period, while 383 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: January 18, 2002. FDA has verified the applicant’s claim that the date the investigational new drug application became effective was on January 18, 2002. E:\FR\FM\12JNN1.SGM 12JNN1 mstockstill on DSK4VPTVN1PROD with NOTICES 33528 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Notices 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 21, 2011. FDA has verified the applicant’s claim that the new drug application (NDA) for XELJANZ (NDA 203214) was submitted on October 21, 2011. 3. The date the application was approved: November 6, 2012. FDA has verified the applicant’s claim that NDA 203214 was approved on November 6, 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 August 11, 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 December 9, 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 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: June 9, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–14433 Filed 6–11–15; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 19:05 Jun 11, 2015 Jkt 235001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–0928] Recommendations for Preparation and Submission of Animal Food Additive Petitions; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (GFI) #221 entitled ‘‘Recommendations for Preparation and Submission of Animal Food Additive Petitions.’’ This guidance describes the types of information that FDA’s Center for Veterinary Medicine recommends for inclusion in food additive petitions submitted for food additives intended for use in food for animals. It is intended to help the petitioner submit this information in a consistent and appropriate manner. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Policy and Regulations Staff (HFV–6), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance 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: Center for Veterinary Medicine, Division of Animal Feeds (HFV–220), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240– 402–7077; AskCVM@fda.hhs.gov, in the subject line please include ATTN: Division of Animal Feeds. SUPPLEMENTARY INFORMATION: SUMMARY: interested persons until November 12, 2013, to comment on the draft guidance. In the Federal Register of December 10, 2013 (78 FR 74154), FDA published a notice reopening the comment period for the draft guidance giving interested persons until January 9, 2014, to comment on the draft guidance. FDA received four comments on the draft guidance and considered those comments as we finalized the guidance. The guidance announced in this notice finalizes the draft guidance dated September 2013. II. Significance of Guidance This level 1 guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on recommendations for preparation and submission of animal food additive petitions. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. III. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR 571.1 and 571.6 have been approved under OMB control number 0910–0546. IV. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). 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. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. I. Background V. Electronic Access In the Federal Register of September 11, 2013 (78 FR 55727), FDA published the notice of availability for a draft guidance entitled ‘‘Recommendations for Preparation and Submission of Animal Food Additive Petitions’’ giving Persons with access to the Internet may obtain the guidance at either https:// www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm or https://www.regulations.gov. PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\12JNN1.SGM 12JNN1

Agencies

[Federal Register Volume 80, Number 113 (Friday, June 12, 2015)]
[Notices]
[Pages 33527-33528]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14433]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-E-1656]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for XELJANZ 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 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, 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 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 XELJANZ 
(tofacitinib citrate). XELJANZ is indicated for the treatment of adult 
patients with moderately to severely active rheumatoid arthritis who 
have had an inadequate response or intolerance to methotrexate. 
Subsequent to this approval, the USPTO received a patent term 
restoration application for XELJANZ (U.S. Patent No. RE41,783) from 
Pfizer Inc., and the USPTO requested FDA's assistance in determining 
this patent's eligibility for patent term restoration. In a letter 
dated March 26, 2014, FDA advised the USPTO that this human drug 
product had undergone a regulatory review period and that the approval 
of XELJANZ 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 
XELJANZ is 3,947 days. Of this time, 3,564 days occurred during the 
testing phase of the regulatory review period, while 383 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: January 18, 2002. FDA has verified the applicant's claim 
that the date the investigational new drug application became effective 
was on January 18, 2002.

[[Page 33528]]

    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 
21, 2011. FDA has verified the applicant's claim that the new drug 
application (NDA) for XELJANZ (NDA 203214) was submitted on October 21, 
2011.
    3. The date the application was approved: November 6, 2012. FDA has 
verified the applicant's claim that NDA 203214 was approved on November 
6, 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 August 11, 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 December 9, 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 
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: June 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14433 Filed 6-11-15; 8:45 am]
 BILLING CODE 4164-01-P
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