Determination of Regulatory Review Period for Purposes of Patent Extension; RECOTHROM, 38658-38659 [E9-18528]

Download as PDF 38658 Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices mstockstill on DSKH9S0YB1PROD with NOTICES materially false laboratory entries and altered information from a radiology display report, which were critical factors in determining whether the individual was eligible to participate in the clinical study. He also admitted to knowingly and willfully misrepresenting the results of a blood chemistry analysis related to the participation of a study subject who would not otherwise have met the criteria for that study. The subject was administered chemotherapeutic drugs in connection with the clinical study and died as a result thereof. Mr. Kornak’s failure to perceive a substantial and unjustifiable risk that death would occur when he knowingly and willingly made and used such false documents constituted a gross deviation from the standard of care that a reasonable person would observe in the situation. Mr. Kornak further admitted to knowingly and willfully using interstate mail for the purpose of executing the aforesaid scheme and artifice to defraud, deprive, and obtain money and property. As a result of these convictions, FDA sent Mr. Kornak by certified mail on May 4, 2009, a notice proposing to permanently debar him from providing services in any capacity to a person that has an approved or pending drug product application. The proposal was based on a finding, under section 306(a)(2)(A) and (a)(2)(B) of the act, that Mr. Kornak was convicted of felonies under Federal law for conduct relating to the development or approval of a drug product, and for conduct otherwise relating to the regulation of a drug product under the act. The proposal also offered Mr. Kornak an opportunity to request a hearing, providing him 30 days from the date of receipt of the letter in which to file the request, and advised him that failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. Mr. Kornak did not request a hearing and has, therefore, waived his opportunity for a hearing and any contentions concerning his debarment (21 CFR part 12). II. Findings and Order Therefore, the Acting Director, Office of Enforcement, Office of Regulatory Affairs, under section 306(a)(2)(A) and (a)(2)(B) of the act, and under authority delegated to the Acting Director (Staff Manual Guide 1410.35), finds that Mr. Kornak has been convicted of felonies under Federal law for conduct relating to the development of approval of a drug product and conduct otherwise relating to the regulation of a drug product under the act. VerDate Nov<24>2008 16:07 Aug 03, 2009 Jkt 217001 As a result of the foregoing finding, Mr. Kornak is permanently debarred from providing services in any capacity to a person with an approved or pending drug product application under sections 505, 512, or 802 of the act (21 U.S.C. 355, 360b, or 382), or under section 351 of the Public Health Service Act (42 U.S.C. 262), effective (see DATES) (see sections 306(c)(1)(B) and (c)(2)(A)(ii) and 201(dd) of the act (21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(ii), and 321(dd)). Any person with an approved or pending drug product application who knowingly employs or retains Mr. Kornak as a consultant or contractor, or otherwise uses in any capacity the services of Mr. Kornak during Mr. Kornak’s permanent debarment, will be subject to civil money penalties (section 307(a)(6) of the act (21 U.S.C. 335b(a)(6))). If Mr. Kornak, during his period of debarment, provides services in any capacity to a person with an approved or pending drug product application, he will be subject to civil money penalties (section 307(a)(7) of the act). In addition, FDA will not accept or review any abbreviated new drug applications submitted by or with the assistance of Mr. Kornak during his period of debarment (section 306(c)(1)(B) of the act). Any application by Mr. Kornak for special termination of debarment under section 306(d)(4) of the act should be identified with Docket No. 2007–N– 0501 and sent to the Division of Dockets Management (see ADDRESSES). All such submissions are to be filed in four copies. The public availability of information in these submissions is governed by 21 CFR 10.20(j). Publicly available submissions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: July 20, 2009. Alyson L. Saben, Acting Director, Office of Enforcement, Office of Regulatory Affairs. [FR Doc. E9–18619 Filed 8–3–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–E–0258; FDA–2008– E–0260; and FDA–2008–E–0261] Determination of Regulatory Review Period for Purposes of Patent Extension; RECOTHROM AGENCY: Food and Drug Administration, HHS. PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for RECOTHROM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of three applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human biological product. ADDRESSES: Submit written comments and petitions to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6222, Silver Spring, MD 20993– 0002, 301–796–3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98– 417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 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 human biological product becomes effective and runs until the approval phase 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 human biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks 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 E:\FR\FM\04AUN1.SGM 04AUN1 mstockstill on DSKH9S0YB1PROD with NOTICES Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the human biological product RECOTHROM (Thrombin, topical (Recombinant)). RECOTHROM is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical. Subsequent to this approval, the Patent and Trademark Office received patent term restoration applications for RECOTHROM (U.S. Patent Nos. 5,476,777, 5,502,034, and 5,527,692) from ZymoGenetics, Inc., and the Patent and Trademark Office requested FDA’s assistance in determining the patents’ eligibilities for patent term restoration. In a letter dated February 26, 2009, FDA advised the Patent and Trademark Office that this human biological product had undergone a regulatory review period and that the approval of RECOTHROM represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that FDA determine the product’s regulatory review period. FDA has determined that the applicable regulatory review period for RECOTHROM is 1,511 days. Of this time, 1,115 days occurred during the testing phase of the regulatory review period, while 396 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 (the act) (21 U.S.C. 355(i)) became effective: November 30, 2003. FDA has verified the applicant’s claims that the date the investigational new drug application became effective was on November 30, 2003. 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): December 18, 2006. FDA has verified the applicant’s claims that the biologics license application (BLA) for RECOTHROM (BLA 125248/0) was initially submitted on December 18, 2006. 3. The date the application was approved: January 17, 2008. FDA has verified the applicant’s claims that BLA 125248/0 was approved on January 17, 2008. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and VerDate Nov<24>2008 16:07 Aug 03, 2009 Jkt 217001 Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 952 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments and ask for a redetermination by October 5, 2009. 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 February 1, 2010. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (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. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: June 8, 2009. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E9–18528 Filed 8–3–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–E–0551] Determination of Regulatory Review Period for Purposes of Patent Extension; XIENCE V EECSS AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for XIENCE V EECSS 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 Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that medical device. PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 38659 ADDRESSES: Submit written comments and petitions to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6222, Silver Spring, MD 20993– 0002, 301–796–3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98– 417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 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 Patents and Trademarks 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 recently approved for marketing the medical device, XIENCE V EECSS. XIENCE V EECSS is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length = 28 millimeters (mm)) with reference vessel diameters of 2.5 mm to 4.25 mm. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for XIENCE V EECSS (U.S. Patent No. 5,451,233) from Abbott Cardiovascular Systems, Inc., and the Patent and Trademark Office requested E:\FR\FM\04AUN1.SGM 04AUN1

Agencies

[Federal Register Volume 74, Number 148 (Tuesday, August 4, 2009)]
[Notices]
[Pages 38658-38659]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-18528]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-E-0258; FDA-2008-E-0260; and FDA-2008-E-0261]


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

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) has determined the 
regulatory review period for RECOTHROM and is publishing this notice of 
that determination as required by law. FDA has made the determination 
because of the submission of three applications to the Director of 
Patents and Trademarks, Department of Commerce, for the extension of 
patents which claim that human biological product.

ADDRESSES:  Submit written comments and petitions to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:  Beverly Friedman, Office of 
Regulatory Policy, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 51, rm. 6222, Silver Spring, MD 20993-0002, 301-796-3602.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term 
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug 
and Patent Term Restoration Act (Public Law 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 human biological product becomes effective and 
runs until the approval phase 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 human 
biological product. Although only a portion of a regulatory review 
period may count toward the actual amount of extension that the 
Director of Patents and Trademarks 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

[[Page 38659]]

all of the testing phase and approval phase as specified in 35 U.S.C. 
156(g)(1)(B).
    FDA recently approved for marketing the human biological product 
RECOTHROM (Thrombin, topical (Recombinant)). RECOTHROM is indicated as 
an aid to hemostasis whenever oozing blood and minor bleeding from 
capillaries and small venules is accessible and control of bleeding by 
standard surgical techniques is ineffective or impractical. Subsequent 
to this approval, the Patent and Trademark Office received patent term 
restoration applications for RECOTHROM (U.S. Patent Nos. 5,476,777, 
5,502,034, and 5,527,692) from ZymoGenetics, Inc., and the Patent and 
Trademark Office requested FDA's assistance in determining the patents' 
eligibilities for patent term restoration. In a letter dated February 
26, 2009, FDA advised the Patent and Trademark Office that this human 
biological product had undergone a regulatory review period and that 
the approval of RECOTHROM represented the first permitted commercial 
marketing or use of the product. Thereafter, the Patent and Trademark 
Office requested that FDA determine the product's regulatory review 
period.
    FDA has determined that the applicable regulatory review period for 
RECOTHROM is 1,511 days. Of this time, 1,115 days occurred during the 
testing phase of the regulatory review period, while 396 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 (the act) (21 U.S.C. 355(i)) became effective: 
November 30, 2003. FDA has verified the applicant's claims that the 
date the investigational new drug application became effective was on 
November 30, 2003.
    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): December 18, 2006. FDA has verified the 
applicant's claims that the biologics license application (BLA) for 
RECOTHROM (BLA 125248/0) was initially submitted on December 18, 2006.
    3. The date the application was approved: January 17, 2008. FDA has 
verified the applicant's claims that BLA 125248/0 was approved on 
January 17, 2008.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension. However, the U.S. 
Patent and Trademark Office applies several statutory limitations in 
its calculations of the actual period for patent extension. In its 
application for patent extension, this applicant seeks 952 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published are 
incorrect may submit to the Division of Dockets Management (see 
ADDRESSES) written or electronic comments and ask for a redetermination 
by October 5, 2009. 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 February 1, 
2010. To meet its burden, the petition must contain sufficient facts to 
merit an FDA investigation. (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.
    Comments and petitions should be submitted to the Division of 
Dockets Management. Three copies of any mailed information are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document.
    Comments and petitions may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: June 8, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E9-18528 Filed 8-3-09; 8:45 am]
BILLING CODE 4160-01-S

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