83_FR_7092 83 FR 7059 - Determination of Regulatory Review Period for Purposes of Patent Extension; HYMOVIS

83 FR 7059 - Determination of Regulatory Review Period for Purposes of Patent Extension; HYMOVIS

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 33 (February 16, 2018)

Page Range7059-7060
FR Document2018-03229

The Food and Drug Administration (FDA) has determined the regulatory review period for HYMOVIS 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 medical device.

Federal Register, Volume 83 Issue 33 (Friday, February 16, 2018) 
[Federal Register Volume 83, Number 33 (Friday, February 16, 2018)]
[Notices]
[Pages 7059-7060]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-03229]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-2477]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; HYMOVIS

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 HYMOVIS 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 medical device.

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 
17, 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 15, 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 17, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of April 17, 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 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-2477 for ``Determination of Regulatory Review Period for 
Purposes of Patent Extension; HYMOVIS.'' 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

[[Page 7060]]

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 medical devices, the testing 
phase begins with a clinical investigation of the device and runs until 
the approval phase begins. The approval phase starts with the initial 
submission of an application to market the device and continues until 
permission to market the device is granted. Although only a portion of 
a regulatory review period may count toward the actual amount of 
extension that the Director of USPTO may award (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 medical device will include all of the 
testing phase and approval phase as specified in 35 U.S.C. 
156(g)(3)(B).
    FDA has approved for marketing the medical device HYMOVIS. HYMOVIS 
is indicated for the treatment of pain in osteoarthritis of the knee in 
patients who have failed to respond adequately to conservative non-
pharmacologic therapy and to simple analgesics. Subsequent to this 
approval, the USPTO received a patent term restoration application for 
HYMOVIS (U.S. Patent No. 7,863,256) from Fidia Farmaceutici S.p.A., and 
the USPTO requested FDA's assistance in determining this patent's 
eligibility for patent term restoration. In a letter dated September 
26, 2016, FDA advised the USPTO that this medical device had undergone 
a regulatory review period and that the approval of HYMOVIS 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 
HYMOVIS is 1,845 days. Of this time, 1,665 days occurred during the 
testing phase of the regulatory review period, while 180 days occurred 
during the approval phase. These periods of time were derived from the 
following dates:
    1. The date an exemption under section 520(g) of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(g)) involving this 
device became effective: August 11, 2010. The applicant claims that the 
investigational device exemption (IDE) required under section 520(g) of 
the FD&C Act for human tests to begin became effective on January 7, 
2011. However, FDA records indicate that the IDE was determined 
substantially complete for clinical studies to have begun on August 11, 
2010, which represents the IDE effective date.
    2. The date an application was initially submitted with respect to 
the device under section 515 of the FD&C Act (21 U.S.C. 360e): March 2, 
2015. FDA has verified the applicant's claim that the premarket 
approval application (PMA) for HYMOVIS (PMA P150010) was initially 
submitted March 2, 2015.
    3. The date the application was approved: August 28, 2015. FDA has 
verified the applicant's claim that PMA P150010 was approved on August 
28, 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 938 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 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03229 Filed 2-15-18; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Notices 7059 of the Pediatric Advisory Committee Department of Commerce, for the • Mail/Hand delivery/Courier (for would be held on March 23, 2018. extension of a patent which claims that written/paper submissions): Dockets FDA will provide updates on the medical device. Management Staff (HFA–305), Food and following topics without vote by the DATES: Anyone with knowledge that any Drug Administration, 5630 Fishers committee: of the dates as published (see the Lane, Rm. 1061, Rockville, MD 20852. • Update regarding labeling change SUPPLEMENTARY INFORMATION section) are • For written/paper comments for inhaled corticosteroid long-acting b- incorrect may submit either electronic submitted to the Dockets Management 2 agonists (ICS/LABAs); or written comments and ask for a Staff, FDA will post your comment, as • Safety labeling for gadolinium redetermination by April 17, 2018. well as any attachments, except for products; Furthermore, any interested person may information submitted, marked and • Overview of the FDA Adverse Event petition FDA for a determination identified, as confidential, if submitted Reporting System (FAERS) and reports regarding whether the applicant for as detailed in ‘‘Instructions.’’ on reduced or lack of efficacy for certain extension acted with due diligence Instructions: All submissions received generic drugs; and during the regulatory review period by must include the Docket No. FDA– • Generic drug approval process; and August 15, 2018. See ‘‘Petitions’’ in the 2016–E–2477 for ‘‘Determination of discussion on the differences in the Regulatory Review Period for Purposes SUPPLEMENTARY INFORMATION section for approval process for brand name drugs of Patent Extension; HYMOVIS.’’ more information. versus generic drugs; exceptions. Received comments, those filed in a On page 126, in the third column, the ADDRESSES: You may submit comments timely manner (see ADDRESSES), will be CDRH products portion of the document as follows. Please note that late, placed in the docket and, except for is changed to read as follows: untimely filed comments will not be those submitted as ‘‘Confidential The PAC will meet to discuss the considered. Electronic comments must Submissions,’’ publicly viewable at following products (listed by FDA be submitted on or before April 17, https://www.regulations.gov or at the Center): 2018. The https://www.regulations.gov Dockets Management Staff between 9 electronic filing system will accept a.m. and 4 p.m., Monday through (2) Center for Devices and Radiological comments until midnight Eastern Time Friday. Health at the end of April 17, 2018. Comments • Confidential Submissions—To a. MEDTRONIC ACTIVA DYSTONIA received by mail/hand delivery/courier submit a comment with confidential THERAPY (Humanitarian Device (for written/paper submissions) will be information that you do not wish to be Exemption (HDE)) considered timely if they are made publicly available, submit your b. LIPOSORBER LA–15 SYSTEM postmarked or the delivery service comments only as a written/paper (HDE) acceptance receipt is on or before that submission. You should submit two CDRH will update the committee on the date. copies total. One copy will include the regulatory status of a previously information you claim to be confidential reviewed HDE. Electronic Submissions with a heading or cover note that states This notice is issued under the Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS Federal Advisory Committee Act (5 following way: CONFIDENTIAL INFORMATION.’’ The U.S.C. app. 2) and 21 CFR part 14, • Federal eRulemaking Portal: Agency will review this copy, including relating to the advisory committees. https://www.regulations.gov. Follow the the claimed confidential information, in Dated: February 12, 2018. instructions for submitting comments. its consideration of comments. The Leslie Kux, Comments submitted electronically, second copy, which will have the Associate Commissioner for Policy. including attachments, to https:// claimed confidential information [FR Doc. 2018–03231 Filed 2–15–18; 8:45 am] www.regulations.gov will be posted to redacted/blacked out, will be available the docket unchanged. Because your for public viewing and posted on BILLING CODE 4164–01–P comment will be made public, you are https://www.regulations.gov. Submit solely responsible for ensuring that your both copies to the Dockets Management DEPARTMENT OF HEALTH AND comment does not include any Staff. If you do not wish your name and HUMAN SERVICES confidential information that you or a contact information to be made publicly third party may not wish to be posted, available, you can provide this Food and Drug Administration such as medical information, your or information on the cover sheet and not anyone else’s Social Security number, or in the body of your comments and you [Docket No. FDA–2016–E–2477] must identify this information as confidential business information, such as a manufacturing process. Please note ‘‘confidential.’’ Any information marked Determination of Regulatory Review that if you include your name, contact as ‘‘confidential’’ will not be disclosed Period for Purposes of Patent information, or other information that except in accordance with § 10.20 (21 Extension; HYMOVIS identifies you in the body of your CFR 10.20) and other applicable AGENCY: Food and Drug Administration, comments, that information will be disclosure law. For more information HHS. posted on https://www.regulations.gov. about FDA’s posting of comments to ACTION: Notice. • If you want to submit a comment public dockets, see 80 FR 56469, with confidential information that you September 18, 2015, or access the SUMMARY: The Food and Drug do not wish to be made available to the information at: https://www.gpo.gov/ Administration (FDA) has determined public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015- daltland on DSKBBV9HB2PROD with NOTICES the regulatory review period for written/paper submission and in the 23389.pdf. HYMOVIS and is publishing this notice manner detailed (see ‘‘Written/Paper Docket: For access to the docket to of that determination as required by Submissions’’ and ‘‘Instructions’’). read background documents or the law. FDA has made the determination electronic and written/paper comments because of the submission of an Written/Paper Submissions received, go to https:// application to the Director of the U.S. Submit written/paper submissions as www.regulations.gov and insert the Patent and Trademark Office (USPTO), follows: docket number, found in brackets in the VerDate Sep<11>2014 19:24 Feb 15, 2018 Jkt 244001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\16FEN1.SGM 16FEN1

7060 Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Notices heading of this document, into the device had undergone a regulatory comply with all the requirements of ‘‘Search’’ box and follow the prompts review period and that the approval of § 60.30, including but not limited to: and/or go to the Dockets Management HYMOVIS represented the first Must be timely (see DATES), Must be Staff, 5630 Fishers Lane, Rm. 1061, permitted commercial marketing or use filed in accordance with § 10.20, must Rockville, MD 20852. of the product. Thereafter, the USPTO contain sufficient facts to merit an FDA FOR FURTHER INFORMATION CONTACT: requested that FDA determine the investigation, and must certify that a Beverly Friedman, Office of Regulatory product’s regulatory review period. true and complete copy of the petition Policy, Food and Drug Administration, II. Determination of Regulatory Review has been served upon the patent 10903 New Hampshire Ave., Bldg. 51, Period applicant. (See H. Rept. 857, part 1, 98th Rm. 6250, Silver Spring, MD 20993, Cong., 2d sess., pp. 41–42, 1984.) FDA has determined that the Petitions should be in the format 301–796–3600. applicable regulatory review period for specified in 21 CFR 10.30. SUPPLEMENTARY INFORMATION: HYMOVIS is 1,845 days. Of this time, 1,665 days occurred during the testing Submit petitions electronically to I. Background phase of the regulatory review period, https://www.regulations.gov at Docket The Drug Price Competition and No. FDA–2013–S–0610. Submit written while 180 days occurred during the Patent Term Restoration Act of 1984 petitions (two copies are required) to the approval phase. These periods of time (Pub. L. 98–417) and the Generic Dockets Management Staff (HFA–305), were derived from the following dates: Animal Drug and Patent Term 1. The date an exemption under Food and Drug Administration, 5630 Restoration Act (Pub. L. 100–670) section 520(g) of the Federal Food, Drug, Fishers Lane, Rm. 1061, Rockville, MD generally provide that a patent may be and Cosmetic Act (FD&C Act) (21 U.S.C. 20852. extended for a period of up to 5 years 360j(g)) involving this device became Dated: February 12, 2018. so long as the patented item (human effective: August 11, 2010. The Leslie Kux, drug product, animal drug product, applicant claims that the investigational Associate Commissioner for Policy. medical device, food additive, or color device exemption (IDE) required under additive) was subject to regulatory [FR Doc. 2018–03229 Filed 2–15–18; 8:45 am] section 520(g) of the FD&C Act for review by FDA before the item was human tests to begin became effective BILLING CODE 4164–01–P marketed. Under these acts, a product’s on January 7, 2011. However, FDA regulatory review period forms the basis records indicate that the IDE was for determining the amount of extension DEPARTMENT OF HEALTH AND determined substantially complete for HUMAN SERVICES an applicant may receive. clinical studies to have begun on August A regulatory review period consists of 11, 2010, which represents the IDE Food and Drug Administration two periods of time: A testing phase and effective date. an approval phase. For medical devices, 2. The date an application was the testing phase begins with a clinical [Docket No. FDA–2013–D–0077] initially submitted with respect to the investigation of the device and runs device under section 515 of the FD&C Early Alzheimer’s Disease: Developing until the approval phase begins. The Act (21 U.S.C. 360e): March 2, 2015. Drugs for Treatment; Draft Guidance approval phase starts with the initial FDA has verified the applicant’s claim for Industry; Availability submission of an application to market that the premarket approval application the device and continues until (PMA) for HYMOVIS (PMA P150010) AGENCY: Food and Drug Administration, permission to market the device is was initially submitted March 2, 2015. HHS. granted. Although only a portion of a 3. The date the application was regulatory review period may count approved: August 28, 2015. FDA has ACTION: Notice of availability. toward the actual amount of extension verified the applicant’s claim that PMA that the Director of USPTO may award P150010 was approved on August 28, SUMMARY: The Food and Drug (half the testing phase must be 2015. Administration (FDA or Agency) is subtracted as well as any time that may This determination of the regulatory announcing the availability of a draft have occurred before the patent was review period establishes the maximum guidance for industry entitled ‘‘Early issued), FDA’s determination of the potential length of a patent extension. Alzheimer’s Disease: Developing Drugs length of a regulatory review period for However, the USPTO applies several for Treatment.’’ This guidance is a medical device will include all of the statutory limitations in its calculations intended to assist sponsors in the testing phase and approval phase as of the actual period for patent extension. clinical development of drugs for the specified in 35 U.S.C. 156(g)(3)(B). In its application for patent extension, treatment of the stages of sporadic FDA has approved for marketing the this applicant seeks 938 days of patent Alzheimer’s disease (AD) that occur medical device HYMOVIS. HYMOVIS is term extension. before the onset of overt dementia. This indicated for the treatment of pain in guidance revises the draft guidance for osteoarthritis of the knee in patients III. Petitions industry entitled ‘‘Alzheimer’s Disease: who have failed to respond adequately Anyone with knowledge that any of Developing Drugs for the Treatment of to conservative non-pharmacologic the dates as published are incorrect may Early Stage Disease’’ issued February 8, therapy and to simple analgesics. submit either electronic or written 2013. Subsequent to this approval, the USPTO comments and, under 21 CFR 60.24, ask DATES: Submit either electronic or received a patent term restoration for a redetermination (see DATES). daltland on DSKBBV9HB2PROD with NOTICES written comments on the draft guidance application for HYMOVIS (U.S. Patent Furthermore, as specified in § 60.30 (21 by May 17, 2018 to ensure that the No. 7,863,256) from Fidia Farmaceutici CFR 60.30), any interested person may Agency considers your comment on this S.p.A., and the USPTO requested FDA’s petition FDA for a determination draft guidance before it begins work on assistance in determining this patent’s regarding whether the applicant for the final version of the guidance. eligibility for patent term restoration. In extension acted with due diligence a letter dated September 26, 2016, FDA during the regulatory review period. To ADDRESSES: You may submit comments advised the USPTO that this medical meet its burden, the petition must on any guidance at any time as follows: VerDate Sep<11>2014 19:24 Feb 15, 2018 Jkt 244001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\16FEN1.SGM 16FEN1


Document Created: 2018-02-16 00:55:18
Document Modified: 2018-02-16 00:55:18
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesAnyone 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 17, 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 15, 2018. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information.
ContactBeverly 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 Citation83 FR 7059 
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