Grant of Interim Extension of the Term of U.S. Patent No. 7,259,184; Vernakalant Hydrochloride, 62713 [2020-21968]

Download as PDF jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 85, No. 193 / Monday, October 5, 2020 / Notices Atlantic Bluefish Fishery Management Plan in late 2017. A notice of intent to develop an environmental impact statement for this action was published in June 2018. However, following a second round of scoping meetings in February and March 2020, it has been determined that the range of proposed alternatives included in this amendment are not expected to have significant impacts on the fishery or affected environment. Therefore, NMFS is withdrawing the notice of intent and will continue development of an environmental assessment instead. FOR FURTHER INFORMATION CONTACT: Cynthia Ferrio, Fishery Policy Analyst, (978) 281–9180. SUPPLEMENTARY INFORMATION: In December 2017, the Council initiated a comprehensive amendment to the Bluefish Fishery Management Plan (FMP) to review and update the goals and objectives of this FMP, as well as reevaluate quota allocation and transfer provisions between sectors and states, in light of changing fishery conditions and stakeholder priorities. The Council published a notice of intent to develop an environmental impact statement for this amendment in accordance with the National Environmental Policy Act to analyze the impacts of any proposed management measures (83 FR 26267; June 6, 2018), and held a series of scoping hearings with the Atlantic States Marine Fisheries Commission’s Bluefish Board in June and July of 2018. Following this round of scoping, development on the amendment was put on hold until the results of the August 2019 operational stock assessment were available that incorporated revised Marine Recreational Information Program data into its model. The 2019 assessment determined that the bluefish stock is now overfished although overfishing is not occurring, and at its December 2019 meeting, the Council decided to add the rebuilding plan to Amendment 7. The Council must develop and implement a rebuilding plan within 2 years of notification that a stock is overfished, by the end of November 2021. Following a second round of scoping hearings in February and March 2020, the Council and NMFS have determined that the range of proposed alternatives included in this amendment are not expected to have significant impacts on the fishery or affected environment and that an environmental assessment will be developed. Therefore, this notice announces the Council’s withdrawal of the Notice of Intent to Prepare an Environmental Impact Statement for VerDate Sep<11>2014 23:42 Oct 02, 2020 Jkt 253001 Amendment 7 to the Bluefish FMP. Development of the amendment will continue with an environmental assessment instead. Authority: 16 U.S.C. 1801 et seq. Dated: September 29, 2020. Jennifer M. Wallace, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service. [FR Doc. 2020–21877 Filed 10–2–20; 8:45 am] BILLING CODE 3510–22–P DEPARTMENT OF COMMERCE Patent and Trademark Office [Docket No. PTO–P–2020–0047] Grant of Interim Extension of the Term of U.S. Patent No. 7,259,184; Vernakalant Hydrochloride United States Patent and Trademark Office, Department of Commerce. ACTION: Notice of interim patent term extension. AGENCY: The United States Patent and Trademark Office has issued an order granting a one-year interim extension of the term of U.S. Patent No. 7,259,184 (‘184 patent). FOR FURTHER INFORMATION CONTACT: Raul Tamayo, Senior Legal Advisor, Office of Patent Legal Administration, by telephone at 571–272–7728 or by email to raul.tamayo@uspto.gov. SUPPLEMENTARY INFORMATION: 35 U.S.C. 156 generally provides that the term of a patent may be extended for a period of up to five years, if the patent claims a product, or a method of making or using a product, that has been subject to certain defined regulatory review. 35 U.S.C. 156(d)(5) generally provides that the term of such a patent may be extended for no more than five interim periods of up to one year each, if the approval phase of the regulatory review period is reasonably expected to extend beyond the expiration date of the patent. On July 14, 2020, Correvio International Sa`rl, the owner of record of the ‘184 patent, timely filed an application under 35 U.S.C. 156(d)(5) for an interim extension of the term of the ‘184 patent. The ‘184 patent claims a method of using the product vernakalant hydrochloride. The application for interim patent term extension indicates that New Drug Application No. 22–034 for vernakalant hydrochloride was submitted to the Food and Drug Administration (FDA) on December 19, 2006, and that the FDA’s review thereof is ongoing. SUMMARY: PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 62713 Review of the interim patent term extension application indicates that, except for permission to market or use the product commercially, the ‘184 patent would be eligible for an extension of the patent term under 35 U.S.C. 156. Because it appears the approval phase of the regulatory review period will continue beyond the original expiration date of the patent, i.e., October 6, 2020, interim extension of the ‘184 patent’s term under 35 U.S.C. 156(d)(5) is appropriate. An interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. Patent No. 7,259,184 is granted for a period of one year from the original expiration date of the ‘184 patent. Robert Bahr, Deputy Commissioner for Patent Examination Policy, United States Patent and Trademark Office. [FR Doc. 2020–21968 Filed 10–2–20; 8:45 am] BILLING CODE 3510–1630–P DEPARTMENT OF COMMERCE Patent and Trademark Office [Docket No. PTO–P–2020–0049] Grant of Interim Extension of the Term of U.S. Patent No. 6,406,699; ECI® (ELIAS Cancer Immunotherapy) United States Patent and Trademark Office, Department of Commerce. ACTION: Notice of interim patent term extension. AGENCY: The United States Patent and Trademark Office has issued an order granting a one-year interim extension of the term of U.S. Patent No. 6,406,699 (’699 patent). FOR FURTHER INFORMATION CONTACT: Raul Tamayo, Senior Legal Advisor, Office of Patent Legal Administration, by telephone at 571–272–7728 or by email to raul.tamayo@uspto.gov. SUPPLEMENTARY INFORMATION: 35 U.S.C. 156 generally provides that the term of a patent may be extended for a period of up to five years, if the patent claims a product, or a method of making or using a product, that has been subject to certain defined regulatory review. 35 U.S.C. 156(d)(5) generally provides that the term of such a patent may be extended for no more than five interim periods of up to one year each, if the approval phase of the regulatory review period is reasonably expected to extend beyond the expiration date of the patent. On August 17, 2020, TVAX Biomedical I, LLC, the owner of record of the ’699 patent, timely filed an application under SUMMARY: E:\FR\FM\05OCN1.SGM 05OCN1

Agencies

[Federal Register Volume 85, Number 193 (Monday, October 5, 2020)]
[Notices]
[Page 62713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21968]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No. PTO-P-2020-0047]


Grant of Interim Extension of the Term of U.S. Patent No. 
7,259,184; Vernakalant Hydrochloride

AGENCY: United States Patent and Trademark Office, Department of 
Commerce.

ACTION: Notice of interim patent term extension.

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SUMMARY: The United States Patent and Trademark Office has issued an 
order granting a one-year interim extension of the term of U.S. Patent 
No. 7,259,184 (`184 patent).

FOR FURTHER INFORMATION CONTACT: Raul Tamayo, Senior Legal Advisor, 
Office of Patent Legal Administration, by telephone at 571-272-7728 or 
by email to [email protected].

SUPPLEMENTARY INFORMATION: 35 U.S.C. 156 generally provides that the 
term of a patent may be extended for a period of up to five years, if 
the patent claims a product, or a method of making or using a product, 
that has been subject to certain defined regulatory review. 35 U.S.C. 
156(d)(5) generally provides that the term of such a patent may be 
extended for no more than five interim periods of up to one year each, 
if the approval phase of the regulatory review period is reasonably 
expected to extend beyond the expiration date of the patent.
    On July 14, 2020, Correvio International S[agrave]rl, the owner of 
record of the `184 patent, timely filed an application under 35 U.S.C. 
156(d)(5) for an interim extension of the term of the `184 patent. The 
`184 patent claims a method of using the product vernakalant 
hydrochloride. The application for interim patent term extension 
indicates that New Drug Application No. 22-034 for vernakalant 
hydrochloride was submitted to the Food and Drug Administration (FDA) 
on December 19, 2006, and that the FDA's review thereof is ongoing.
    Review of the interim patent term extension application indicates 
that, except for permission to market or use the product commercially, 
the `184 patent would be eligible for an extension of the patent term 
under 35 U.S.C. 156. Because it appears the approval phase of the 
regulatory review period will continue beyond the original expiration 
date of the patent, i.e., October 6, 2020, interim extension of the 
`184 patent's term under 35 U.S.C. 156(d)(5) is appropriate.
    An interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. 
Patent No. 7,259,184 is granted for a period of one year from the 
original expiration date of the `184 patent.

Robert Bahr,
Deputy Commissioner for Patent Examination Policy, United States Patent 
and Trademark Office.
[FR Doc. 2020-21968 Filed 10-2-20; 8:45 am]
BILLING CODE 3510-1630-P