83 FR 52839 - Determination of Regulatory Review Period for Purposes of Patent Extension; AFSTYLA

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 202 (October 18, 2018)

The Food and Drug Administration (FDA or the Agency) has

[Federal Register Volume 83, Number 202 (Thursday, October 18, 2018)]
[Notices]
[Pages 52839-52840]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-22696]



-----------------------------------------------------------------------



DEPARTMENT OF HEALTH AND HUMAN SERVICES



Food and Drug Administration



[Docket No. FDA-2016-E-3918]




Determination of Regulatory Review Period for Purposes of Patent 

Extension; AFSTYLA



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 AFSTYLA 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 

December 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 April 16, 

2019. 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 December 17, 2018. The https://www.regulations.gov electronic filing system will accept comments until 

11:59 p.m. Eastern Time at the end of December 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-3918 for ``Determination of Regulatory Review Period for 

Purposes of Patent Extension; AFSTYLA.'' 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



[[Page 52840]]



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 AFSTYLA 

(Antihemophilic Factor (Recombinant), Single Chain). AFSTYLA is 

indicated in children and adults with hemophilia A (congenital Factor 

VIII deficiency) for: (1) On-demand treatment and control of bleeding 

episodes, (2) routine prophylaxis to reduce the frequency of bleeding 

episodes, and (3) perioperative management of bleeding. Subsequent to 

this approval, the USPTO received a patent term restoration application 

for AFSTYLA (U.S. Patent No. 7,041,635) from SK Chemicals Co, LTD., and 

the USPTO requested FDA's assistance in determining this patent's 

eligibility for patent term restoration. In a letter dated August 1, 

2017, FDA advised the USPTO that this human biological product had 

undergone a regulatory review period and that the approval of AFSTYLA 

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 

AFSTYLA is 1,734 days. Of this time, 1,371 days occurred during the 

testing phase of the regulatory review period, while 363 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: August 28, 

2011. FDA has verified the applicant's claim that the date the 

investigational new drug application became effective was on August 28, 

2011.

    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): May 29, 2015. FDA has verified the 

applicant's claim that the biologics license application (BLA) for 

AFSTYLA (BLA 125591) was initially submitted on May 29, 2015.

    3. The date the application was approved: May 25, 2016. FDA has 

verified the applicant's claim that BLA 125591 was approved on May 25, 

2016.

    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 1,047 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: October 12, 2018.

Leslie Kux,

Associate Commissioner for Policy.

[FR Doc. 2018-22696 Filed 10-17-18; 8:45 am]

 BILLING CODE 4164-01-P