81 FR 72060 - Determination of Regulatory Review Period for Purposes of Patent Extension; PRILOSEC OTC
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 202 (October 19, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 202 (October 19, 2016)
| Page Range | 72060-72062 | |
| FR Document | 2016-25220 |
[Federal Register Volume 81, Number 202 (Wednesday, October 19, 2016)] [Notices] [Pages 72060-72062] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-25220] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2004-E-0463] Determination of Regulatory Review Period for Purposes of Patent Extension; PRILOSEC OTC AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for PRILOSEC OTC 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. 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 December 19, 2016. 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 April 17, 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. [[Page 72061]] 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-2004-E-0463 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; PRILOSEC OTC.'' 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 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 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 PRILOSEC OTC (omeprazole magnesium). PRILOSEC OTC is indicated for treatment of frequent heartburn for consumers 18 years of age and older. Subsequent to this approval, the USPTO received a patent term restoration application for PRILOSEC OTC (U.S. Patent No. 5,817,338) from AstraZeneca AB, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated October 19, 2004, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of PRILOSEC OTC 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 PRILOSEC OTC is 2,045 days. Of this time, 804 days occurred during the testing phase of the regulatory review period, while 1,241 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: November 15, 1997. The applicant claims November 14, 1997, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was November 15, 1997, 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 27, 2000. FDA has verified the applicant's claim that the new drug application (NDA) for PRILOSEC OTC (NDA 21-229) was initially submitted on January 27, 2000. 3. The date the application was approved: June 20, 2003. FDA has verified the applicant's claim that NDA 21-229 was approved on June 20, 2003. 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 623 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 [[Page 72062]] 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: October 13, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-25220 Filed 10-18-16; 8:45 am] BILLING CODE 4164-01-P
![72060 Federal Register / Vol. 81, No. 202 / Wednesday, October 19, 2016 / Notices
A regulatory review period consists of 1. The date an exemption under DEPARTMENT OF HEALTH AND
two periods of time: A testing phase and section 505(i) of the Federal Food, Drug, HUMAN SERVICES
an approval phase. For human and Cosmetic Act (21 U.S.C. 355(i))
biological products, the testing phase became effective: June 14, 2009. FDA Food and Drug Administration
begins when the exemption to permit has verified the applicant’s claim that [Docket No. FDA–2004–E–0463]
the clinical investigations of the the date the investigational new drug
biological becomes effective and runs application became effective was on Determination of Regulatory Review
until the approval phase begins. The June 14, 2009. Period for Purposes of Patent
approval phase starts with the initial Extension; PRILOSEC OTC
submission of an application to market 2. The date the application was
the human biological product and initially submitted with respect to the AGENCY: Food and Drug Administration,
continues until FDA grants permission human biological product under section HHS.
to market the biological product. 351 of the Public Health Service Act (42 ACTION: Notice.
Although only a portion of a regulatory U.S.C. 262): August 27, 2014. FDA has
review period may count toward the verified the applicant’s claim that the SUMMARY: The Food and Drug
actual amount of extension that the biologics license application (BLA) for Administration (FDA) has determined
Director of USPTO may award (for REPATHA (BLA 125522) was initially the regulatory review period for
example, half the testing phase must be submitted on August 27, 2014. PRILOSEC OTC and is publishing this
subtracted as well as any time that may notice of that determination as required
3. The date the application was
have occurred before the patent was by law. FDA has made the
approved: August 27, 2015. FDA has determination because of the
issued), FDA’s determination of the
verified the applicant’s claim that BLA submission of an application to the
length of a regulatory review period for
a human biological product will include 125522 was approved on August 27, Director of the U.S. Patent and
all of the testing phase and approval 2015. Trademark Office (USPTO), Department
phase as specified in 35 U.S.C. This determination of the regulatory of Commerce, for the extension of a
156(g)(1)(B). review period establishes the maximum patent which claims that human drug
FDA has approved for marketing the potential length of a patent extension. product.
human biologic product REPATHA However, the USPTO applies several DATES: Anyone with knowledge that any
(evolocumab). REPATHA is indicated as statutory limitations in its calculations of the dates as published (see the
an adjunct to diet and maximally of the actual period for patent extension. SUPPLEMENTARY INFORMATION section) are
tolerated statin therapy for the treatment In its applications for patent extension, incorrect may submit either electronic
of adults with heterozygous familial this applicant seeks 895 days, 353 days, or written comments and ask for a
hypercholesterolemia or clinical or 164 days of patent term extension, redetermination by December 19, 2016.
atherosclerotic cardiovascular disease,
respectively. Furthermore, any interested person may
who require additional lowering of low
petition FDA for a determination
density lipoprotein cholesterol (LDL–C) III. Petitions regarding whether the applicant for
or as an adjunct to diet and other LDL-
Anyone with knowledge that any of extension acted with due diligence
lowering therapies for the treatment of
the dates as published are incorrect may during the regulatory review period by
patients with homozygous familial
hypercholesterolemia who require submit either electronic or written April 17, 2017. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
additional lowering of LDL–C. comments and ask for a redetermination
Subsequent to this approval, the USPTO more information.
(see DATES). Furthermore, any interested
received patent term restoration person may petition FDA for a ADDRESSES: You may submit comments
applications for REPATHA (U.S. Patent determination regarding whether the as follows:
Nos. 8,030,457; 8,829,165; and applicant for extension acted with due Electronic Submissions
8,981,064) from Amgen Inc., and the diligence during the regulatory review
USPTO requested FDA’s assistance in Submit electronic comments in the
period. To meet its burden, the petition
determining the patents’ eligibility for following way:
must be timely (see DATES) and contain • Federal eRulemaking Portal: http://
patent term restoration. In a letter dated sufficient facts to merit an FDA
April 29, 2016, FDA advised the USPTO www.regulations.gov. Follow the
investigation. (See H. Rept. 857, part 1, instructions for submitting comments.
that this human biological product had
98th Cong., 2d sess., pp. 41–42, 1984.) Comments submitted electronically,
undergone a regulatory review period
Petitions should be in the format including attachments, to http://
and that the approval of REPATHA
represented the first permitted specified in 21 CFR 10.30. www.regulations.gov will be posted to
commercial marketing or use of the Submit petitions electronically to the docket unchanged. Because your
product. Thereafter, the USPTO http://www.regulations.gov at Docket comment will be made public, you are
requested that FDA determine the No. FDA–2013–S–0610. Submit written solely responsible for ensuring that your
product’s regulatory review period. petitions (two copies are required) to the comment does not include any
Division of Dockets Management (HFA– confidential information that you or a
II. Determination of Regulatory Review third party may not wish to be posted,
Period 305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, such as medical information, your or
FDA has determined that the anyone else’s Social Security number, or
sradovich on DSK3GMQ082PROD with NOTICES
MD 20852.
applicable regulatory review period for confidential business information, such
REPATHA is 2,267 days. Of this time, Dated: October 13, 2016. as a manufacturing process. Please note
1,901 days occurred during the testing Leslie Kux, that if you include your name, contact
phase of the regulatory review period, Associate Commissioner for Policy. information, or other information that
while 366 days occurred during the [FR Doc. 2016–25221 Filed 10–18–16; 8:45 am] identifies you in the body of your
approval phase. These periods of time BILLING CODE 4164–01–P
comments, that information will be
were derived from the following dates: posted on http://www.regulations.gov.
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![72062 Federal Register / Vol. 81, No. 202 / Wednesday, October 19, 2016 / Notices
comments and ask for a redetermination ADDRESSES: You may submit comments comments only as a written/paper
(see DATES). Furthermore, any interested as follows: submission. You should submit two
person may petition FDA for a copies total. One copy will include the
Electronic Submissions
determination regarding whether the information you claim to be confidential
applicant for extension acted with due Submit electronic comments in the with a heading or cover note that states
diligence during the regulatory review following way: ‘‘THIS DOCUMENT CONTAINS
period. To meet its burden, the petition • Federal eRulemaking Portal: http:// CONFIDENTIAL INFORMATION.’’ The
must be timely (see DATES) and contain www.regulations.gov. Follow the Agency will review this copy, including
sufficient facts to merit an FDA instructions for submitting comments. the claimed confidential information, in
investigation. (See H. Rept. 857, part 1, Comments submitted electronically, its consideration of comments. The
98th Cong., 2d sess., pp. 41–42, 1984.) including attachments, to http:// second copy, which will have the
Petitions should be in the format www.regulations.gov will be posted to claimed confidential information
specified in 21 CFR 10.30. the docket unchanged. Because your redacted/blacked out, will be available
Submit petitions electronically to comment will be made public, you are for public viewing and posted on http://
http://www.regulations.gov at Docket solely responsible for ensuring that your www.regulations.gov. Submit both
No. FDA–2013–S–0610. Submit written comment does not include any copies to the Division of Dockets
petitions (two copies are required) to the confidential information that you or a Management. If you do not wish your
Division of Dockets Management (HFA– third party may not wish to be posted, name and contact information to be
305), Food and Drug Administration, such as medical information, your or made publicly available, you can
5630 Fishers Lane, Rm. 1061, Rockville, anyone else’s Social Security number, or provide this information on the cover
MD 20852. confidential business information, such sheet and not in the body of your
Dated: October 13, 2016. as a manufacturing process. Please note comments and you must identify this
Leslie Kux, that if you include your name, contact information as ‘‘confidential.’’ Any
Associate Commissioner for Policy.
information, or other information that information marked as ‘‘confidential’’
identifies you in the body of your will not be disclosed except in
[FR Doc. 2016–25220 Filed 10–18–16; 8:45 am]
comments, that information will be accordance with 21 CFR 10.20 and other
BILLING CODE 4164–01–P
posted on http://www.regulations.gov. applicable disclosure law. For more
• If you want to submit a comment information about FDA’s posting of
with confidential information that you comments to public dockets, see 80 FR
DEPARTMENT OF HEALTH AND
do not wish to be made available to the 56469, September 18, 2015, or access
HUMAN SERVICES
public, submit the comment as a the information at: http://www.fda.gov/
Food and Drug Administration written/paper submission and in the regulatoryinformation/dockets/
manner detailed (see ‘‘Written/Paper default.htm.
[Docket Nos. FDA–2015–E–2780; FDA– Submissions’’ and ‘‘Instructions’’).
2015–E–2778; FDA–2015–E–2779] Docket: For access to the docket to
Written/Paper Submissions read background documents or the
Determination of Regulatory Review Submit written/paper submissions as electronic and written/paper comments
Period for Purposes of Patent received, go to http://
follows:
Extension; PLEGRIDY • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
AGENCY: Food and Drug Administration, written/paper submissions): Division of docket number, found in brackets in the
HHS. Dockets Management (HFA–305), Food heading of this document, into the
ACTION: Notice. and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets
SUMMARY: The Food and Drug • For written/paper comments Management, 5630 Fishers Lane, Rm.
Administration (FDA) has determined submitted to the Division of Dockets 1061, Rockville, MD 20852.
the regulatory review period for Management, FDA will post your FOR FURTHER INFORMATION CONTACT:
PLEGRIDY and is publishing this notice comment, as well as any attachments, Beverly Friedman, Office of Regulatory
of that determination as required by except for information submitted, Policy, Food and Drug Administration,
law. FDA has made the determination marked and identified, as confidential, 10903 New Hampshire Ave., Bldg. 51,
because of the submission of if submitted as detailed in Rm. 6250, Silver Spring, MD 20993,
applications to the Director of the U.S. ‘‘Instructions.’’ 301–796–3600.
Patent and Trademark Office (USPTO), Instructions: All submissions received
Department of Commerce, for the must include the Docket Nos. FDA– SUPPLEMENTARY INFORMATION:
extension of a patent which claims that 2015–E–2780; FDA–2015–E–2778; and I. Background
human biological product. FDA–2015–E–2779 for ‘‘Determination
DATES: Anyone with knowledge that any of Regulatory Review Period for The Drug Price Competition and
of the dates as published (see the Purposes of Patent Extension; Patent Term Restoration Act of 1984
SUPPLEMENTARY INFORMATION section) are PLEGRIDY.’’ Received comments will (Pub. L. 98–417) and the Generic
incorrect may submit either electronic be placed in the docket and, except for Animal Drug and Patent Term
or written comments and ask for a those submitted as ‘‘Confidential Restoration Act (Pub. L. 100–670)
redetermination by December 19, 2016. Submissions,’’ publicly viewable at generally provide that a patent may be
Furthermore, any interested person may extended for a period of up to 5 years
sradovich on DSK3GMQ082PROD with NOTICES
http://www.regulations.gov or at the
petition FDA for a determination Division of Dockets Management so long as the patented item (human
regarding whether the applicant for between 9 a.m. and 4 p.m., Monday drug product, animal drug product,
extension acted with due diligence through Friday. medical device, food additive, or color
during the regulatory review period by • Confidential Submissions—To additive) was subject to regulatory
April 17, 2017. See ‘‘Petitions’’ in the submit a comment with confidential review by FDA before the item was
SUPPLEMENTARY INFORMATION section for information that you do not wish to be marketed. Under these acts, a product’s
more information. made publicly available, submit your regulatory review period forms the basis
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Document Created: 2016-10-19 02:12:17
Document Modified: 2016-10-19 02:12:17
| 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 December 19, 2016. 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 April 17, 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 72060 |
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