Determination of Regulatory Review Period for Purposes of Patent Extension; KALYDECO, 31118-31119 [2014-12561]

Download as PDF mstockstill on DSK4VPTVN1PROD with NOTICES 31118 Federal Register / Vol. 79, No. 104 / Friday, May 30, 2014 / Notices FDASIA (Enhancement of Accelerated Approval Access to New Medical Treatments) within 1 year of the date the draft guidance issues. The discussions of accelerated approval, and other more broadly applicable provisions in this guidance, are intended to meet this requirement. Section 902(b)(1)(A) of FDASIA requires FDA to issue a guidance document to implement requirements of section 902 (Breakthrough Therapies) within 1 year of the date the comment period closes for the draft guidance. The breakthrough therapy discussion and other more broadly applicable provisions in this guidance are intended to meet this requirement. In the Federal Register of June 26, 2013 (78 FR 38349), FDA announced the availability of the draft guidance entitled ‘‘Expedited Programs for Serious Conditions—Drugs and Biologics.’’ The notice gave the public an opportunity to comment by August 26, 2013. FDA carefully considered all comments received in developing the final guidance. This guidance addresses the applicability of expedited programs to rare diseases, clarification on available therapy, and additional detail on possible flexibility in manufacturing and product quality. The guidance also includes clarification on the qualifying criteria for breakthrough therapy designation and examples of surrogate endpoints and intermediate clinical endpoints used to support accelerated approval. This guidance finalizes the draft guidance issued in June 2013. The provisions of this guidance relating to fast track development and other issues such as serious condition and unmet medical need, replace the guidance for industry entitled ‘‘Fast Track Drug Development Programs— Designation, Development, and Application Review.’’ The provisions of this guidance pertaining to available therapy replace the guidance for industry entitled ‘‘Available Therapy.’’ This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency’s current thinking on expedited programs for serious conditions—drugs and biologics. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This guidance contains information collection provisions that are subject to review by the Office of Management and VerDate Mar<15>2010 18:23 May 29, 2014 Jkt 232001 Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR 202.1, certain parts of 21 CFR part 314, 21 CFR part 601, and sections 506(b)(1), 735, and 736 of the FD&C Act (21 U.S.C. 356(b)(1), 379g, and 379h) have been approved under OMB control numbers 0910–0686, 0910–0001, 0910– 0338, 0910–0389, 0910–0297, and 0910– 0765. 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/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https://www.fda. gov/BiologicsBloodVaccines/Guidance ComplianceRegulatoryInformation/ default.htm, or https://www. regulations.gov. Dated: May 23, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–12534 Filed 5–29–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–E–1227] Determination of Regulatory Review Period for Purposes of Patent Extension; KALYDECO AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined the regulatory review period for KALYDECO 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 SUMMARY: PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 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 KALYDECO (ivacaftor). KALYDECO is indicated for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have a G551D mutation in the CFTR gene. E:\FR\FM\30MYN1.SGM 30MYN1 mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 79, No. 104 / Friday, May 30, 2014 / Notices Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for KALYDECO (U.S. Patent No. 7,495,103) from Vertex Pharmaceuticals 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 February 22, 2013, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of KALYDECO 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 KALYDECO is 2,121 days. Of this time, 2,015 days occurred during the testing phase of the regulatory review period, while 106 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: April 13, 2006. FDA has verified the applicant’s claim that the date the investigational new drug application became effective was on April 13, 2006. 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 18, 2011. FDA has verified the applicant’s claim that the new drug application (NDA) for KALYDECO (NDA 203188) was submitted on October 18, 2011. 3. The date the application was approved: January 31, 2012. FDA has verified the applicant’s claim that NDA 203188 was approved on January 31, 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 0 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 29, 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 VerDate Mar<15>2010 18:23 May 29, 2014 Jkt 232001 November 26, 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 27, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–12561 Filed 5–29–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–E–0851] Determination of Regulatory Review Period for Purposes of Patent Extension; PROGENSA PCA3 ASSAY AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined the regulatory review period for PROGENSA PCA3 ASSAY 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 medical device. 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 SUMMARY: PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 31119 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 medical devices, the testing phase begins with a clinical investigation of the device and runs until the approval phase begins. The 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 has approved for marketing the medical device, PROGENSA PCA3 ASSAY. PROGENSA PCA3 ASSAY is an in vitro nucleic acid amplification test. The assay measures the concentration of prostate cancer gene 3 (PCA3) and prostate specific antigen (PSA) ribonucleic acid (RNA) molecules and calculates the ratio of PCA3 RNA molecules to PSA RNA molecules (PCA3 Score) in post-digital rectal exam first catch male urine specimens. The PROGENSA PCA3 ASSAY is indicated for use in conjunction with other patient information to aid in the decision for repeat biopsy in men 50 years of age or older who have had one or more previous negative prostate biopsies and for whom a repeat biopsy would be E:\FR\FM\30MYN1.SGM 30MYN1

Agencies

[Federal Register Volume 79, Number 104 (Friday, May 30, 2014)]
[Notices]
[Pages 31118-31119]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-12561]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-E-1227]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for KALYDECO 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 KALYDECO 
(ivacaftor). KALYDECO is indicated for the treatment of cystic fibrosis 
(CF) in patients age 6 years and older who have a G551D mutation in the 
CFTR gene.

[[Page 31119]]

Subsequent to this approval, the Patent and Trademark Office received a 
patent term restoration application for KALYDECO (U.S. Patent No. 
7,495,103) from Vertex Pharmaceuticals 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 
February 22, 2013, FDA advised the Patent and Trademark Office that 
this human drug product had undergone a regulatory review period and 
that the approval of KALYDECO 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 
KALYDECO is 2,121 days. Of this time, 2,015 days occurred during the 
testing phase of the regulatory review period, while 106 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: April 13, 2006. FDA has verified the applicant's claim that 
the date the investigational new drug application became effective was 
on April 13, 2006.
    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 
18, 2011. FDA has verified the applicant's claim that the new drug 
application (NDA) for KALYDECO (NDA 203188) was submitted on October 
18, 2011.
    3. The date the application was approved: January 31, 2012. FDA has 
verified the applicant's claim that NDA 203188 was approved on January 
31, 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 0 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 29, 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 26, 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 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12561 Filed 5-29-14; 8:45 am]
BILLING CODE 4160-01-P
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