81 FR 92832 - Determination of Regulatory Review Period for Purposes of Patent Extension; COSENTYX
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 244 (December 20, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 244 (December 20, 2016)
| Page Range | 92832-92833 | |
| FR Document | 2016-30528 |
[Federal Register Volume 81, Number 244 (Tuesday, December 20, 2016)] [Notices] [Pages 92832-92833] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-30528] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-E-0626] Determination of Regulatory Review Period for Purposes of Patent Extension; COSENTYX AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for COSENTYX 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 biological product. DATES: Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by February 21, 2017. 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 June 19, 2017. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http:// www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2016-E-0626 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; COSENTYX.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper [[Page 92833]] submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http:// www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/ regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 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. 6250, Silver Spring, MD 20993, 301-796-3600. SUPPLEMENTARY INFORMATION: I. Background 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 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 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 COSENTYX (secukinumab). COSENTYX is indicated for treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. Subsequent to this approval, the USPTO received a patent term restoration application for COSENTYX (U.S. Patent No. 7,807,155) from Novartis AG, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated May 2, 2016, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of COSENTYX represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period. II. Determination of Regulatory Review Period FDA has determined that the applicable regulatory review period for COSENTYX is 3,381 days. Of this time, 2,926 days occurred during the testing phase of the regulatory review period, while 455 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 21, 2005. The applicant claims December 17, 2006, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was October 21, 2005, which was thirty days after FDA receipt of an earlier IND. 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): October 24, 2013. FDA has verified the applicant's claim that the biologics license application (BLA) for COSENTYX (BLA 125504/0) was initially submitted on October 24, 2013. 3. The date the application was approved: January 21, 2015. FDA has verified the applicant's claim that BLA 125504/0 was approved on January 21, 2015. 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 629 days of patent term extension. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see DATES). 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. To meet its burden, the petition must be timely (see DATES) and 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. Submit petitions electronically to http://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: December 14, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-30528 Filed 12-19-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 244 / Tuesday, December 20, 2016 / Notices 92833
submission. You should submit two A regulatory review period consists of which was thirty days after FDA receipt
copies total. One copy will include the two periods of time: A testing phase and of an earlier IND.
information you claim to be confidential an approval phase. For human 2. The date the application was
with a heading or cover note that states biological products, the testing phase initially submitted with respect to the
‘‘THIS DOCUMENT CONTAINS begins when the exemption to permit
human biological product under section
CONFIDENTIAL INFORMATION.’’ The the clinical investigations of the
351 of the Public Health Service Act (42
Agency will review this copy, including biological becomes effective and runs
until the approval phase begins. The U.S.C. 262): October 24, 2013. FDA has
the claimed confidential information, in
its consideration of comments. The approval phase starts with the initial verified the applicant’s claim that the
second copy, which will have the submission of an application to market biologics license application (BLA) for
claimed confidential information the human biological product and COSENTYX (BLA 125504/0) was
redacted/blacked out, will be available continues until FDA grants permission initially submitted on October 24, 2013.
for public viewing and posted on http:// to market the biological product. 3. The date the application was
www.regulations.gov. Submit both Although only a portion of a regulatory approved: January 21, 2015. FDA has
copies to the Division of Dockets review period may count toward the verified the applicant’s claim that BLA
Management. If you do not wish your actual amount of extension that the 125504/0 was approved on January 21,
name and contact information to be Director of USPTO may award (for 2015.
made publicly available, you can example, half the testing phase must be
subtracted as well as any time that may This determination of the regulatory
provide this information on the cover
have occurred before the patent was review period establishes the maximum
sheet and not in the body of your
comments and you must identify this issued), FDA’s determination of the potential length of a patent extension.
information as ‘‘confidential.’’ Any length of a regulatory review period for However, the USPTO applies several
information marked as ‘‘confidential’’ a human biological product will include statutory limitations in its calculations
will not be disclosed except in all of the testing phase and approval of the actual period for patent extension.
accordance with 21 CFR 10.20 and other phase as specified in 35 U.S.C. In its application for patent extension,
applicable disclosure law. For more 156(g)(1)(B). this applicant seeks 629 days of patent
information about FDA’s posting of FDA has approved for marketing the term extension.
comments to public dockets, see 80 FR human biologic product COSENTYX
(secukinumab). COSENTYX is indicated III. Petitions
56469, September 18, 2015, or access
the information at: http://www.fda.gov/ for treatment of moderate to severe
Anyone with knowledge that any of
regulatoryinformation/dockets/ plaque psoriasis in adult patients who
the dates as published are incorrect may
default.htm. are candidates for systemic therapy or
phototherapy. Subsequent to this submit either electronic or written
Docket: For access to the docket to comments and ask for a redetermination
read background documents or the approval, the USPTO received a patent
term restoration application for (see DATES). Furthermore, any interested
electronic and written/paper comments person may petition FDA for a
received, go to http:// COSENTYX (U.S. Patent No. 7,807,155)
from Novartis AG, and the USPTO determination regarding whether the
www.regulations.gov and insert the applicant for extension acted with due
docket number, found in brackets in the requested FDA’s assistance in
determining this patent’s eligibility for diligence during the regulatory review
heading of this document, into the
patent term restoration. In a letter dated period. To meet its burden, the petition
‘‘Search’’ box and follow the prompts
May 2, 2016, FDA advised the USPTO must be timely (see DATES) and contain
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm. that this human biological product had sufficient facts to merit an FDA
undergone a regulatory review period investigation. (See H. Rept. 857, part 1,
1061, Rockville, MD 20852.
and that the approval of COSENTYX 98th Cong., 2d sess., pp. 41–42, 1984.)
FOR FURTHER INFORMATION CONTACT: represented the first permitted Petitions should be in the format
Beverly Friedman, Office of Regulatory commercial marketing or use of the
Policy, Food and Drug Administration, specified in 21 CFR 10.30.
product. Thereafter, the USPTO
10903 New Hampshire Ave., Bldg. 51, Submit petitions electronically to
requested that FDA determine the
Rm. 6250, Silver Spring, MD 20993, product’s regulatory review period. http://www.regulations.gov at Docket
301–796–3600. No. FDA–2013–S–0610. Submit written
SUPPLEMENTARY INFORMATION: II. Determination of Regulatory Review petitions (two copies are required) to the
Period Division of Dockets Management (HFA–
I. Background 305), Food and Drug Administration,
FDA has determined that the
The Drug Price Competition and applicable regulatory review period for 5630 Fishers Lane, Rm. 1061, Rockville,
Patent Term Restoration Act of 1984 COSENTYX is 3,381 days. Of this time, MD 20852.
(Pub. L. 98–417) and the Generic 2,926 days occurred during the testing Dated: December 14, 2016.
Animal Drug and Patent Term phase of the regulatory review period,
Restoration Act (Pub. L. 100–670) Leslie Kux,
while 455 days occurred during the
generally provide that a patent may be approval phase. These periods of time Associate Commissioner for Policy.
extended for a period of up to 5 years were derived from the following dates: [FR Doc. 2016–30528 Filed 12–19–16; 8:45 am]
so long as the patented item (human 1. The date an exemption under BILLING CODE 4164–01–P
drug product, animal drug product, section 505(i) of the Federal Food, Drug,
mstockstill on DSK3G9T082PROD with NOTICES
medical device, food additive, or color and Cosmetic Act (21 U.S.C. 355(i))
additive) was subject to regulatory became effective: October 21, 2005. The
review by FDA before the item was applicant claims December 17, 2006, as
marketed. Under these acts, a product’s the date the investigational new drug
regulatory review period forms the basis application (IND) became effective.
for determining the amount of extension However, FDA records indicate that the
an applicant may receive. IND effective date was October 21, 2005,
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Document Created: 2018-02-14 09:10:28
Document Modified: 2018-02-14 09:10:28
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by February 21, 2017. 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 June 19, 2017. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information. | |
| Contact | Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600. | |
| FR Citation | 81 FR 92832 |
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