[Federal Register Volume 79, Number 102 (Wednesday, May 28, 2014)]
[Notices]
[Pages 30625-30626]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-12277]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-E-0039]
Determination of Regulatory Review Period for Purposes of Patent
Extension; ADCETRIS--Biologics License Application 125388
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for ADCETRIS based on biologics license
application (BLA) 125388 and is publishing this notice of that
determination as required by law. FDA has made the determination
because of the submission of applications to the Director of Patents
and Trademarks, Department of Commerce, for the extension of patents
which claim that human biological product, ADCETRIS.
ADDRESSES: Submit electronic comments to http://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 http://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 biological products, the
testing phase begins when the exemption to permit
[[Page 30626]]
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 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 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 ADCETRIS
(brentuximab vedotin). ADCETRIS as approved under BLA 125388 is
indicated for treatment of patients with Hodgkin lymphoma after failure
of autologous stem cell transplant (ASCT) or after failure of at least
two prior multiagent chemotherapy regimens in patients who are not ASCT
candidates. Subsequent to this approval, the Patent and Trademark
Office received patent term restoration applications for ADCETRIS (U.S.
Patent Nos. 7,090,843 and 7,829,531) from Seattle Genetics, Inc., and
the Patent and Trademark Office requested FDA's assistance in
determining the patents' eligibility for patent term restoration. In a
letter dated February 4, 2013, FDA advised the Patent and Trademark
Office that this human biological product had undergone a regulatory
review period and that the approval of ADCETRIS under BLA 125388 and
BLA 125399 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
ADCETRIS is 1,851 days. Of this time, 1,678 days occurred during the
testing phase of the regulatory review period, while 173 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 27,
2006. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on July 27,
2006. This is the same investigational new drug application (IND) and
the same date FDA determined was the beginning of the regulatory review
period for ADCETRIS approved under BLA 125399. The regulatory review
period for ADCETRIS approved under BLA 125399 is publishing elsewhere
in this issue of the Federal Register.
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): February 28, 2011. FDA has verified the
applicant's claim that the BLA for ADCETRIS (BLA 125388) was initially
submitted on February 28, 2011.
3. The date the application was approved: August 19, 2011. FDA has
verified the applicant's claim that BLA 125388 was approved on August
19, 2011.
This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the 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 1,002 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 28, 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 24, 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
http://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and
petitions that have not been made publicly available on http://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 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12277 Filed 5-27-14; 8:45 am]
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