83 FR 7192 - Determination of Regulatory Review Period for Purposes of Patent Extension; DARZALEX
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 34 (February 20, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 34 (February 20, 2018)
| Page Range | 7192-7194 | |
| FR Document | 2018-03342 |
[Federal Register Volume 83, Number 34 (Tuesday, February 20, 2018)] [Notices] [Pages 7192-7194] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-03342] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-E-1888] Determination of Regulatory Review Period for Purposes of Patent Extension; DARZALEX AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for DARZALEX 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 April 23, 2018. 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 August 20, 2018. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 23, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 [[Page 7193]] 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 https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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-1888 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; DARZALEX.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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 Sec. 10.20 (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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 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 product 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 DARZALEX (daratumumab). DARZALEX is indicated for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or who are double-refractory to a proteasome inhibitor and an immunomodulatory agent. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Subsequent to this approval, the USPTO received a patent term restoration application for DARZALEX (U.S. Patent No. 7,829,673) from Genmab A/S, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated August 25, 2016, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of DARZALEX 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 DARZALEX is 1,939 days. Of this time, 1,808 days occurred during the testing phase of the regulatory review period, while 131 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: July 28, 2010. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on July 28, 2010. 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): July 9, 2015. FDA has verified the applicant's claim that the [[Page 7194]] biologics license application (BLA) for DARZALEX (BLA 761,036) was initially submitted on July 9, 2015. 3. The date the application was approved: November 16, 2015. FDA has verified the applicant's claim that BLA 761,036 was approved on November 16, 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 1,000 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, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in Sec. 60.30 (21 CFR 60.30), 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 comply with all the requirements of Sec. 60.30, including but not limited to: must be timely (see DATES), must be filed in accordance with Sec. 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (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 https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: February 13, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-03342 Filed 2-16-18; 8:45 am] BILLING CODE 4164-01-P
![7192 Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Notices
begins. The approval phase starts with application (BLA) for PORTRAZZA DEPARTMENT OF HEALTH AND
the initial submission of an application (BLA 125547) was initially submitted. HUMAN SERVICES
to market the human biological product However, FDA records indicate that
and continues until FDA grants BLA 125547 was submitted on Food and Drug Administration
permission to market the biological December 2, 2014. [Docket No. FDA–2016–E–1888]
product. Although only a portion of a
3. The date the application was
regulatory review period may count Determination of Regulatory Review
toward the actual amount of extension approved: November 24, 2015. FDA has
Period for Purposes of Patent
that the Director of USPTO may award verified the applicant’s claim that BLA
Extension; DARZALEX
(for example, half the testing phase must 125547 was approved on November 24,
be subtracted as well as any time that 2015. AGENCY: Food and Drug Administration,
may have occurred before the patent This determination of the regulatory HHS.
was issued), FDA’s determination of the review period establishes the maximum ACTION: Notice.
length of a regulatory review period for potential length of a patent extension. SUMMARY: The Food and Drug
a human biological product will include However, the USPTO applies several Administration (FDA or the Agency) has
all of the testing phase and approval statutory limitations in its calculations determined the regulatory review period
phase as specified in 35 U.S.C. of the actual period for patent extension. for DARZALEX and is publishing this
156(g)(1)(B). In its application for patent extension, notice of that determination as required
FDA has approved for marketing the
this applicant seeks 1,321 days of patent by law. FDA has made the
human biologic product PORTRAZZA
term extension. determination because of the
(necitumumab). PORTRAZZA is
submission of an application to the
indicated, in combination with III. Petitions Director of the U.S. Patent and
gemcitabine and cisplatin, for first-line
Anyone with knowledge that any of Trademark Office (USPTO), Department
treatment of patients with metastatic
squamous non-small cell lung cancer. the dates as published are incorrect may of Commerce, for the extension of a
Subsequent to this approval, the USPTO submit either electronic or written patent which claims that human
received a patent term restoration biological product.
comments and, under 21 CFR 60.24, ask
application for PORTRAZZA (U.S. DATES: Anyone with knowledge that any
for a redetermination (see DATES).
Patent No. 7,598,350) from Eli Lilly and Furthermore, as specified in § 60.30 (21 of the dates as published (see the
Company, and the USPTO requested SUPPLEMENTARY INFORMATION section) are
CFR 60.30), any interested person may
FDA’s assistance in determining this incorrect may submit either electronic
petition FDA for a determination
patent’s eligibility for patent term or written comments and ask for a
regarding whether the applicant for
restoration. In a letter dated August 30, redetermination by April 23, 2018.
extension acted with due diligence Furthermore, any interested person may
2016, FDA advised the USPTO that this during the regulatory review period. To
human biological product had petition FDA for a determination
meet its burden, the petition must regarding whether the applicant for
undergone a regulatory review period
comply with all the requirements of extension acted with due diligence
and that the approval of PORTRAZZA
§ 60.30, including but not limited to: during the regulatory review period by
represented the first permitted
commercial marketing or use of the Must be timely (see DATES), must be August 20, 2018. See ‘‘Petitions’’ in the
product. Thereafter, the USPTO filed in accordance with § 10.20, must SUPPLEMENTARY INFORMATION section for
requested that FDA determine the contain sufficient facts to merit an FDA more information.
product’s regulatory review period. investigation, and must certify that a ADDRESSES: You may submit comments
true and complete copy of the petition as follows. Please note that late,
II. Determination of Regulatory Review has been served upon the patent untimely filed comments will not be
Period applicant. (See H. Rept. 857, part 1, 98th considered. Electronic comments must
FDA has determined that the Cong., 2d sess., pp. 41–42, 1984.) be submitted on or before April 23,
applicable regulatory review period for Petitions should be in the format 2018. The https://www.regulations.gov
PORTRAZZA is 2,533 days. Of this specified in 21 CFR 10.30. electronic filing system will accept
time, 2,175 days occurred during the comments until midnight Eastern Time
Submit petitions electronically to
testing phase of the regulatory review at the end of April 23, 2018. Comments
http://www.regulations.gov at Docket
period, while 358 days occurred during received by mail/hand delivery/courier
No. FDA–2013–S–0610. Submit written
the approval phase. These periods of (for written/paper submissions) will be
time were derived from the following petitions (two copies are required) to the
considered timely if they are
dates: Dockets Management Staff (HFA–305),
postmarked or the delivery service
1. The date an exemption under Food and Drug Administration, 5630
acceptance receipt is on or before that
section 505(i) of the Federal Food, Drug, Fishers Lane, Rm. 1061, Rockville, MD date.
and Cosmetic Act (21 U.S.C. 355(i)) 20852.
became effective: December 19, 2008. Electronic Submissions
Dated: February 13, 2018.
FDA has verified the applicant’s claim Leslie Kux, Submit electronic comments in the
that the date the investigational new following way:
Associate Commissioner for Policy. • Federal eRulemaking Portal:
drug application became effective was
[FR Doc. 2018–03345 Filed 2–16–18; 8:45 am] https://www.regulations.gov. Follow the
sradovich on DSK3GMQ082PROD with NOTICES
on December 19, 2008.
2. The date the application was BILLING CODE 4164–01–P instructions for submitting comments.
initially submitted with respect to the Comments submitted electronically,
human biological product under section including attachments, to https://
351 of the Public Health Service Act (42 www.regulations.gov will be posted to
U.S.C. 262): December 2, 2014. The the docket unchanged. Because your
applicant claims October 22, 2014, as comment will be made public, you are
the date the biologics license solely responsible for ensuring that your
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![7194 Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Notices
biologics license application (BLA) for and Policy, Food and Drug greatly enhances command and control
DARZALEX (BLA 761,036) was initially Administration, HHS. of laboratory functions.
submitted on July 9, 2015. ACTION: Notice. The Food and Drug Administration,
3. The date the application was Office of Global Regulatory Operations
approved: November 16, 2015. FDA has SUMMARY: The Food and Drug
Administration (FDA), Office of Global and Policy, Office of Regulatory Affairs
verified the applicant’s claim that BLA (ORA), Office of Regulatory Science
761,036 was approved on November 16, Regulatory Operations and Policy,
Office of Regulatory Affairs (ORA), (ORS) has been restructured as follows:
2015.
This determination of the regulatory Office of Regulatory Science (ORS), and DLLRK. ORGANIZATION. The Office of
review period establishes the maximum all ORA Laboratories have modified the Regulatory Science is headed by the Director,
potential length of a patent extension. structure. This new organizational Office of Regulatory Science and includes the
However, the USPTO applies several structure was approved by the Secretary following organizational units:
statutory limitations in its calculations of Health and Human Services and Office of Regulatory Science (DLLRK)
of the actual period for patent extension. effective on June 6, 2016. Automated Laboratory Management Staff
In its application for patent extension, FOR FURTHER INFORMATION CONTACT: Paul (DLLRK1)
this applicant seeks 1,000 days of patent Norris, DVM, MPA, Director, Office of Safety and Risk Management Staff (DLLRK2)
Office of Research Coordination and
term extension. Regulatory Science, Office of Regulatory
Evaluation (DLLRKA)
III. Petitions Affairs, Office of Global Regulatory Scientific Research Staff (DLLRKA1)
Operations and Policy, Food and Drug Evaluation Staff (DLLRKA2)
Anyone with knowledge that any of Administration, NCTR–50 Room 404, Office of Medical Products, Tobacco, and
the dates as published are incorrect may Jefferson, Arkansas 72079, Phone: 870– Specialty Laboratory Operations (DLLRKB)
submit either electronic or written 543–4099. Medical Products and Tobacco Scientific
comments and, under 21 CFR 60.24, ask Staff (DLLRKB1)
for a redetermination (see DATES). I. Summary
Forensic Chemistry Center (DLLRKBA)
Furthermore, as specified in § 60.30 (21 Part D, Chapter D–B (Food and Drug Inorganic Branch (DLLRKBA1)
CFR 60.30), any interested person may Administration), the Statement of Organic Branch (DLLRKBA2)
petition FDA for a determination Organization, Functions, and Winchester Engineering and Analytical
regarding whether the applicant for Delegations of Authority for the Center (DLLRKBB)
extension acted with due diligence Department of Health and Human Analytical Branch (DLLRKBB1)
during the regulatory review period. To Services 35 FR 3685, dated February 25, Engineering Branch (DLLRKBB2)
meet its burden, the petition must 1970; 60 FR 56605, dated November 9, Detroit Laboratory (DLLRKBC)
comply with all the requirements of 1995; 64 FR 36361, dated July 6, 1999; Northeast Medical Products Laboratory
§ 60.30, including but not limited to: 72 FR 50112, dated August 30, 2007; 74 (DLLRKBD)
must be timely (see DATES), must be FR 41713, dated August 18, 2009; and Pacific Southwest Medical Products
filed in accordance with § 10.20, must Laboratory (DLLRKBE)
76 FR 45270, dated July 28, 2011, is
Philadelphia Laboratory (DLLRKBF)
contain sufficient facts to merit an FDA amended to reflect the reorganization of San Juan Laboratory (DLLRKBG)
investigation, and must certify that a the Office of Regulatory Affairs and the Southeast Tobacco Laboratory (DLLRKBH)
true and complete copy of the petition Office of Regulatory Science (ORS), and Office of Food and Feed Laboratory
has been served upon the patent all ORA Laboratories in this Operations (DLLRKC)
applicant. (See H. Rept. 857, part 1, 98th consolidation. Food and Feed Scientific Staff (DLLRKC1)
Cong., 2d sess., pp. 41–42, 1984.) This organization expands current Arkansas Laboratory (DLLRKCA)
Petitions should be in the format activities in the Office of Regulatory Chemistry Branch I (DLLRKCA1)
specified in 21 CFR 10.30. Science and ORA’s Laboratories in Chemistry Branch II (DLLRKCA2)
Submit petitions electronically to support of the Agency’s Program Microbiology Branch (DLLRKCA3)
https://www.regulations.gov at Docket Alignment Initiative. One of the key Denver Laboratory (DLLRKCB)
No. FDA–2013–S–0610. Submit written elements outlined in the initiative is to Chemistry Branch (DLLRKCB1)
petitions (two copies are required) to the transition to distinct commodity-based Microbiology Branch (DLLRKCB2)
Dockets Management Staff (HFA–305), and vertically integrated regulatory Kansas City Laboratory (DLLRKCC)
Food and Drug Administration, 5630 programs with well-defined leads, Chemistry Branch I (DLLRKCC1)
Fishers Lane, Rm. 1061, Rockville, MD promoting coherent policy and strategic Chemistry Branch II (DLLRKCC2)
Northeast Food and Feed Laboratory
20852. development. This transforms the
(DLLRKCD)
Dated: February 13, 2018. regionally organized laboratory system Chemistry Branch I (DLLRKCD1)
Leslie Kux,
into a true national resource with Chemistry Branch II (DLLRKCD2)
enhanced ability to meet its public Microbiology Sciences Branch (DLLRKCD3)
Associate Commissioner for Policy.
health mission to provide diverse Pacific Northwest Laboratory (DLLRKCE)
[FR Doc. 2018–03342 Filed 2–16–18; 8:45 am]
scientific expertise, leadership, and Chemistry Branch (DLLRKCE1)
BILLING CODE 4164–01–P
responsive quality analytical services to Microbiology Branch (DLLRKCE2)
safeguard public health in a global Applied Technology Branch (DLLRKCE3)
environment and foster continued San Francisco Laboratory (DLLRKCF)
DEPARTMENT OF HEALTH AND Chemistry Branch (DLLRKCF1)
flexibility across its functions and
HUMAN SERVICES Microbiology Branch (DLLRKCF2)
programs. It also centralizes and
streamlines laboratory operations, Southeast Food and Feed Laboratory
sradovich on DSK3GMQ082PROD with NOTICES
Food and Drug Administration (DLLRKCG)
scientific research, and support
[Docket No. FDA–2017–N–XXXX] Microbiology Branch (DLLRKCG1)
functions into one Office of Regulatory Nutrient Analysis Branch (DLLRKCG2)
Science. Operationally this facilitates a Chemistry Branch (DLLRKCG3)
Statement of Organization, Functions,
more efficient and strategic deployment Pacific Southwest Food and Feed Laboratory
and Delegations of Authority
of these resources during public health (DLLRKCH)
AGENCY: Office of Regulatory Affairs, emergencies and food borne outbreaks. Chemistry Branch (DLLRKCH1)
Office of Global Regulatory Operations Centralizing the laboratory system Microbiology Branch (DLLRKCH2)
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Document Created: 2018-02-17 02:29:25
Document Modified: 2018-02-17 02:29:25
| 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 April 23, 2018. 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 August 20, 2018. 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 | 83 FR 7192 |
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