Determination of Regulatory Review Period for Purposes of Patent Extension; LUCENTIS, 30949-30950 [E8-12007]

Download as PDF Federal Register / Vol. 73, No. 104 / Thursday, May 29, 2008 / Notices are entered into the system for a period of 20 years. Records are housed in both active and archival files. All claimsrelated records are encompassed by the document preservation order and will be retained until notification is received from the Department of Justice. a person with Medicare could be identified because the sample is small enough to identify participants. CMS would make exceptions if the information is needed for one of the routine uses or if it’s required by law. POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM: SYSTEM MANAGER AND ADDRESS: STORAGE: Records are stored on both tape cartridges (magnetic storage media) and in a DB2 relational database management environment (DASD data storage media). RETRIEVABILITY: Information is most frequently retrieved by HICN, provider number (facility, physician, IDs), service dates, and beneficiary state code. jlentini on PROD1PC65 with NOTICES Jkt 214001 [Docket Nos. FDA–2007–E–0461 (formerly Docket No. 2007E–0424), FDA–2007–E–0165 (formerly Docket No. 2007E–0425), FDA– 2007–E–0459 (formerly Docket No. 2007E– 0146)] NOTIFICATION PROCEDURE: HHS. For purpose of notification, the subject individual should write to the system manager who will require the system name, and the retrieval selection criteria (e.g., HICN, facility/pharmacy number, service dates, etc.). RECORD ACCESS PROCEDURE: For purpose of access, use the same procedures outlined in Notification Procedures above. Requestors should also reasonably specify the record contents being sought. (These procedures are in accordance with Department regulation 45 CFR 5b.5 (a)(2).) CONTESTING RECORD PROCEDURES: The subject individual should contact the system manager named above, and reasonably identify the record and specify the information to be contested. State the corrective action sought and the reasons for the correction with supporting justification. (These procedures are in accordance with Department regulation 45 CFR 5b.7.) RECORD SOURCE CATEGORIES: Summary prescription drug claim information contained in this system is obtained from the Part D Sponsor daily and monthly drug event transaction reports, Medicare Beneficiary Database (09–70–0530), and other payer information to be provided by the TROOP Facilitator. SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT: None. [FR Doc. E8–11949 Filed 5–28–08; 8:45 am] BILLING CODE 4120–03–P Records are maintained with identifiers for all transactions after they 17:45 May 28, 2008 Food and Drug Administration Determination of Regulatory Review Period for Purposes of Patent Extension; LUCENTIS RETENTION AND DISPOSAL: VerDate Aug<31>2005 DEPARTMENT OF HEALTH AND HUMAN SERVICES Director, Centers for Beneficiary Choices, CMS, Mail stop C5–19–07, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. SAFEGUARDS AND PROTECTIONS: CMS has protections in place for authorized users to make sure they are properly using the data and there is no unauthorized use. Personnel having access to the system have been trained in the Privacy Act and information security requirements. Employees who maintain records in this system cannot use or disclose data until the recipient agrees to implement appropriate management, operational and technical safeguards that will protect the confidentiality, integrity, and availability of the information and information systems. This system would follow all applicable Federal laws and regulations, and Federal, HHS, and CMS security and data privacy policies and standards. These laws and regulations include but are not limited to: the Privacy Act of 1974; the Federal Information Security Management Act of 2002 (when applicable); the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the E-Government Act of 2002, the Clinger-Cohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. OMB Circular A–130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources also applies. Federal, HHS, and CMS policies and standards include but are not limited to all pertinent National Institute of Standards and Technology publications, the HHS Information Systems Program Handbook, and the CMS Information Security Handbook. 30949 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 AGENCY: ACTION: Food and Drug Administration, Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for LUCENTIS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human biological product. Submit written or electronic 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 http://www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Center for Drug Evaluation and Research, 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 biological product becomes effective ADDRESSES: E:\FR\FM\29MYN1.SGM 29MYN1 jlentini on PROD1PC65 with NOTICES 30950 Federal Register / Vol. 73, No. 104 / Thursday, May 29, 2008 / Notices 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 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 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 biologic product LUCENTIS (ranibizumab). LUCENTIS is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration. Subsequent to this approval, the Patent and Trademark Office received patent term restoration applications for LUCENTIS (U.S. Patent Nos. 6,407,213; 6,884,879; and 7,060,269) from Genentech, Inc., and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In letters dated July 24, 2007, and November 21, 2007, FDA advised the Patent and Trademark Office that this human biological product had undergone a regulatory review period and that the approval of LUCENTIS represented the first permitted commercial marketing or use of the product. Shortly 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 LUCENTIS is 2,430 days. Of this time, 2,247 days occurred during the testing phase of the regulatory review period, while 183 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: November 6, 1999. The applicant claims October 7, 1999, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was November 6, 1999, which was 30 days after FDA receipt of the IND. 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 VerDate Aug<31>2005 17:45 May 28, 2008 Jkt 214001 U.S.C. 262): December 30, 2005. The applicant claims December 29, 2005, as the date the biologics license application (BLA) for LUCENTIS (BLA 125156/0) was initially submitted. However, FDA records indicate that BLA 125156/0 was submitted on December 30, 2005. 3. The date the application was approved: June 30, 2006. FDA has verified the applicant’s claim that BLA 125156/0 was approved on June 30, 2006. 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 applications for patent extension for U.S. Patent Nos. 6,407,213; 6,884,879; and 7,060,269, this applicant seeks 378 days; 307 days or 17 days, respectively, 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 July 28, 2008. 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 November 25, 2008. 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. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at http://www.regulations.gov. PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 Dated: May 8, 2008. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E8–12007 Filed 5–28–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–M–0467] (formerly Docket No. 2007M–0408), [Docket No. FDA– 2007–M–0481] (formerly Docket No. 2007M– 0467), [Docket No. FDA–2007–M–0480] (formerly Docket No. 2007M–0409), [Docket No. FDA–2007–M–0472] (formerly Docket No. 2007M–0413), [Docket No. FDA–2007– M–0468] (formerly Docket No. 2007M–0446), [Docket No. FDA–2007–M–0494] (formerly Docket No. 2007M–0380), [Docket No. FDA– 2007–M–0493] (formerly Docket No. 2007M– 0411), [Docket No. FDA–2007–M–0492] (formerly Docket No. 2007M–0410), [Docket No. FDA–2007–M–0490] (formerly Docket No. 2007M–0415), [Docket No. FDA–2007– M–0491] (formerly Docket No. 2007M–0447] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency’s Division of Dockets Management. Submit written requests for copies of summaries of safety and effectiveness data to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Please cite the appropriate docket number as listed in Table 1 of this document when submitting a written request. See the SUPPLEMENTARY INFORMATION section for electronic access to the summaries of safety and effectiveness. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Samie Allen, Center for Devices and Radiological Health (HFZ–402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240–276–4013. SUPPLEMENTARY INFORMATION: E:\FR\FM\29MYN1.SGM 29MYN1

Agencies

[Federal Register Volume 73, Number 104 (Thursday, May 29, 2008)]
[Notices]
[Pages 30949-30950]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-12007]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2007-E-0461 (formerly Docket No. 2007E-0424), FDA-
2007-E-0165 (formerly Docket No. 2007E-0425), FDA-2007-E-0459 (formerly 
Docket No. 2007E-0146)]


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

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) has determined the 
regulatory review period for LUCENTIS and is publishing this notice of 
that determination as required by law. FDA has made the determination 
because of the submission of 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 or electronic 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 http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:  Beverly Friedman, Center for Drug 
Evaluation and Research, 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 biological product becomes effective

[[Page 30950]]

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 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 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 biologic product 
LUCENTIS (ranibizumab). LUCENTIS is indicated for the treatment of 
patients with neovascular (wet) age-related macular degeneration. 
Subsequent to this approval, the Patent and Trademark Office received 
patent term restoration applications for LUCENTIS (U.S. Patent Nos. 
6,407,213; 6,884,879; and 7,060,269) from Genentech, Inc., and the 
Patent and Trademark Office requested FDA's assistance in determining 
this patent's eligibility for patent term restoration. In letters dated 
July 24, 2007, and November 21, 2007, FDA advised the Patent and 
Trademark Office that this human biological product had undergone a 
regulatory review period and that the approval of LUCENTIS represented 
the first permitted commercial marketing or use of the product. Shortly 
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 
LUCENTIS is 2,430 days. Of this time, 2,247 days occurred during the 
testing phase of the regulatory review period, while 183 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: November 6, 
1999. The applicant claims October 7, 1999, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was November 6, 1999, 
which was 30 days after FDA receipt of the IND.
    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 30, 2005. The applicant claims 
December 29, 2005, as the date the biologics license application (BLA) 
for LUCENTIS (BLA 125156/0) was initially submitted. However, FDA 
records indicate that BLA 125156/0 was submitted on December 30, 2005.
    3. The date the application was approved: June 30, 2006. FDA has 
verified the applicant's claim that BLA 125156/0 was approved on June 
30, 2006.
    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 
applications for patent extension for U.S. Patent Nos. 6,407,213; 
6,884,879; and 7,060,269, this applicant seeks 378 days; 307 days or 17 
days, respectively, 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 July 28, 2008. 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 November 25, 
2008. 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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: May 8, 2008.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E8-12007 Filed 5-28-08; 8:45 am]
BILLING CODE 4160-01-S