Notice2022-16504
Determination of Regulatory Review Period for Purposes of Patent Extension; ROZLYTREK TABLETS, New Drug Application 212725
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 2, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ROZLYTREK TABLETS new drug application (NDA) 212725 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 the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claim that human drug product.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 147 (Tuesday, August 2, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 147 (Tuesday, August 2, 2022)]
[Notices]
[Pages 47217-47218]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-16504]
[[Page 47217]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2020-E-2325; FDA-2020-E-2326; FDA-2020-E-2335; FDA-
2020-E-2338]
Determination of Regulatory Review Period for Purposes of Patent
Extension; ROZLYTREK TABLETS, New Drug Application 212725
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 ROZLYTREK TABLETS new drug
application (NDA) 212725 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 the U.S.
Patent and Trademark Office (USPTO), Department of Commerce, for the
extension of patents which claim that human drug product.
DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by October 3, 2022.
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 January 30, 2023. 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 October 3, 2022. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of October 3, 2022. 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 Nos.
FDA-2020-E-2325; FDA-2020-E-2326; FDA-2020-E-2335; and FDA-2020-E-2338
for ``Determination of Regulatory Review Period for Purposes of Patent
Extension; ROZLYTREK TABLETS NDA 212725.'' 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 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
[[Page 47218]]
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, ROZLYTREK
TABLETS (entrectinib). ROZLYTREK TABLETS (entrectinib) is indicated for
the treatment of adult patients with metastatic non-small cell lung
cancer (NSCLC) whose tumors are ROSI--positive and adult and pediatric
patients 12 years of age and older with solid tumors that:
<bullet> have a neurotrophic tyrosine receptor kinase gene fusion
without a known acquired resistance mutation;
<bullet> are metastatic or where surgical resection is likely to
result in severe morbidity; and
<bullet> have progressed following treatment or have no
satisfactory alternative therapy.
This indication is approved under accelerated approval based on
tumor response rate and durability of response. Continued approval for
this indication may be contingent upon verification and description of
clinical benefit in the confirmatory trials.
Subsequent to this approval, the USPTO received patent term
restoration applications for ROZLYTREK TABLETS NDA 212725 (U.S. Patent
Nos. 8,299,057; 8,673,893; 9,029,356; and 9,085,565) from Genentech,
Inc. and the USPTO requested FDA's assistance in determining the
patents' eligibility for patent term restoration. In a letter dated
March 1, 2021, FDA advised the USPTO that this human drug product had
undergone a regulatory review period and that the approval of ROZLYTREK
TABLETS 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
ROZLYTREK TABLETS is 1,968 days. Of this time, 1,727 days occurred
during the testing phase of the regulatory review period, while 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 (FD&C Act) (21 U.S.C. 355(i)) became effective:
March 28, 2014. The applicant claims March 29, 2014, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was March 28, 2014,
which was the first date after receipt of the IND that the
investigational studies were allowed to proceed.
2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: December 18,
2018. FDA has verified the applicant's claims that the new drug
application (NDA) for ROZLYTREK TABLETS (NDA 212725) was initially
submitted on December 18, 2018.
3. The date the application was approved: August 15, 2019. FDA has
verified the applicant's claims that NDA 212725 was approved on August
15, 2019.
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 applications for patent extension,
this applicant seeks 864 days, 899 days, or 1,104 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: July 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-16504 Filed 8-1-22; 8:45 am]
BILLING CODE 4164-01-P
</pre></body>
</html>Indexed from Federal Register on August 2, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.