Theo3 schreef op 2 oktober 2017 15:37:
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beeldscherm schreef op 2 okt 2017 om 13:57:
SEP 2 0 2017
Re: RUCONEST
Patent Nos. 7,067,713 and RE43,691
Docket Nos. FDA-2015-E-2663
and FDA-2015-E-2890
Acting Director
United States Patent and Trademark Office
Mail Stop Hatch-Waxman PTE
P.O. Box 1450
Alexandria, VA 223 13-1450
Dear Acting Director:
SEP 2 0 2017
Re: RUCONEST
Patent Nos. 7,067,713 and RE43,691
Docket Nos. FDA-2015-E-2663
and FDA-2015-E-2890
This is in regard to the patent term extension applications for U.S. Patent Nos. 7,067,7 13 andRE
43,691 filed by Phanning Intellectual Prope11y B.V. under 35 U.S.C. § 156. The patents claim
RUCONEST (rhC1INH), a human biological product reviewed in biologics license application
(BLA) 125495.
In the November 22, 2016, issue ofthe Federal Register (81 Fed. Reg. 83850), the Food and
Drug Administration published its determination of this product's regulatory review period, as
required under 35 U.S.C. § 156(d)(2)(A). The notice provided that on or before May 22, 2017,
180 days after the publication of the detennination, any interested person could file a petition
with FDA under 35 U.S.C. § 156(d)(2)(B)(i) for a detennination of whether the patent tenn
extension appli cant acted with due diligence during the regulatory review period.
The 180-day period for filing a due diligence petition pursuant to this notice has expired and
FDA has received no such petition. Therefore, FDA considers the regulatory review period
determination to be final.