Determination of Regulatory Review Period for Purposes of Patent Extension; LASTACAFT, 26291-26292 [2012-10694]

Download as PDF wreier-aviles on DSK7SPTVN1PROD with NOTICES Federal Register / Vol. 77, No. 86 / Thursday, May 3, 2012 / Notices 6,783,965) from Mountain View Pharmaceuticals, Inc., and Duke University, and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated June 8, 2011, FDA advised the Patent and Trademark Office that this human biological product had undergone a regulatory review period and that the approval of KRYSTEXXA 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 KRYSTEXXA is 3,193 days. Of this time, 2,509 days occurred during the testing phase of the regulatory review period, while 684 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: December 19, 2001. FDA has verified the applicant’s claim that the date the investigational new drug application became effective was on December 19, 2001. 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): October 31, 2008. FDA has verified the applicant’s claim that the biologics license application (BLA) for KRYSTEXXA (BLA 125293) was initially submitted on October 31, 2008. 3. The date the application was approved: September 14, 2010. FDA has verified the applicant’s claim that BLA 125293 was approved on September 14, 2010. 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 1,445 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) either electronic or written comments and ask for a redetermination by July 2, 2012. 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 VerDate Mar<15>2010 15:32 May 02, 2012 Jkt 226001 October 30, 2012. 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. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) electronic or written comments and written petitions. It is only necessary to send one set of comments. However, if you submit a written petition, you must submit three copies of the petition. Identify comments with the docket number found in brackets in the heading of this document. Comments and petitions that have not been made publicly available on https://www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: April 16, 2012. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. 2012–10697 Filed 5–2–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–E–0141] Determination of Regulatory Review Period for Purposes of Patent Extension; LASTACAFT AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined the regulatory review period for LASTACAFT 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 human drug product. ADDRESSES: Submit electronic comments to https://www.regulations. gov. Submit written petitions along with three copies and written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, SUMMARY: PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 26291 10903 New Hampshire Ave., Bldg. 51, Rm. 6284, Silver Spring, MD 20993– 0002, 301–796–3602. SUPPLEMENTARY INFORMATION: 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 drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug 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 drug 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 drug product LASTACAFT (alcaftadine ophthalmic solution). LASTACAFT is indicated for prevention of itching associated with allergic conjunctivitis. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for LASTACAFT (U.S. Patent No. 5,468,743) from Janssen Pharmaceutica N.V., and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated May 3, 2011, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of LASTACAFT 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. E:\FR\FM\03MYN1.SGM 03MYN1 wreier-aviles on DSK7SPTVN1PROD with NOTICES 26292 Federal Register / Vol. 77, No. 86 / Thursday, May 3, 2012 / Notices FDA has determined that the applicable regulatory review period for LASTACAFT is 2,189 days. Of this time, 1,886 days occurred during the testing phase of the regulatory review period, while 303 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 FD&C Act) (21 U.S.C. 355(i)) became effective: August 1, 2004. The applicant claims July 31, 2004, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was August 1, 2004, which was 30 days after FDA receipt of the IND. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: September 29, 2009. The applicant claims September 28, 2009, as the date the new drug application (NDA) for LASTACAFT (NDA 22–134) was initially submitted. However, FDA records indicate that NDA 22–134 was submitted on September 29, 2009. 3. The date the application was approved: July 28, 2010. FDA has verified the applicant’s claim that NDA 22–134 was approved on July 28, 2010. 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 1,246 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) either electronic or written comments and ask for a redetermination by July 2, 2012. 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 October 30, 2012. 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. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) electronic or written comments and written petitions. It is only necessary to send one set of comments. However, if you submit a written petition, you must submit three copies of the petition. Identify VerDate Mar<15>2010 15:32 May 02, 2012 Jkt 226001 comments with the docket number found in brackets in the heading of this document. Comments and petitions that have not been made publicly available on https://www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: April 16, 2012. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. 2012–10694 Filed 5–2–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0408] Risk Evaluation and Mitigation Strategy Assessments: Social Science Methodologies to Assess Goals Related to Knowledge; Public Workshop; Issue Paper AGENCY: Food and Drug Administration, HHS. Notice of public workshop; request for comments. ACTION: The Food and Drug Administration (FDA) is announcing a public workshop entitled ‘‘Risk Evaluation and Mitigation Strategy Assessments: Social Science Methodologies to Assess Goals Related to Knowledge.’’ The purpose of the public workshop is to initiate constructive dialogue and informationsharing among regulators, researchers, the pharmaceutical industry, health care organizations, health care providers, and others from the general public about survey methodologies and instruments that can be used to evaluate patients’ and health care providers’ knowledge about the risks of drugs marketed with an approved Risk Evaluation and Mitigation Strategy (REMS). The input from this workshop will be used to develop guidance for industry describing the best practices for conducting an assessment of a REMS goal regarding patient and/or health care provider knowledge about a drug’s risk(s). To assist in the workshop discussion and the ultimate development of the guidance, FDA is making available an issue paper that discusses our experience with knowledge assessments for REMS and contains specific questions we hope to receive input on. FDA is also opening a public docket to receive written comments. SUMMARY: PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 Date and Time: The public workshop will be held on June 7, 2012, from 8 a.m. to 5 p.m. Location: The public workshop will be held at FDA’s White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993– 0002. Entrance for the public workshop participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. For parking and security information, please refer to https://www. fda.gov/AboutFDA/WorkingatFDA/ BuildingsandFacilities/ WhiteOakCampusInformation/ ucm241740.htm. Participants are encouraged to arrive early to ensure time for parking and security screening before the workshop. Contact Person: Colleen O’Malley, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4305, Silver Spring, MD 20993–0002, 301–796–1786, FAX: 301–796–9832, email: colleen.omalley@ fda.hhs.gov. Registration and Requests for Oral Presentations: There is no fee to attend the workshop, and attendees who do not wish to make a formal presentation do not need to register. Seating will be on a first-come, first-served basis. Individuals who wish to make a presentation at the public workshop must register and provide an abstract of your presentation by 5 p.m. on May 21, 2012. Submit electronic registration requests to make a presentation to KnowledgeAssessmentWorkshop@fda. hhs.gov. Submit written registration requests to make a presentation to Colleen O’Malley (see Contact Person). Please provide your name, title, business affiliation (if applicable), address, telephone, FAX number, and email address. Identify the Panel number(s) for the question(s) you will discuss in your presentation (see section IV of this document). FDA will do its best to accommodate requests to speak. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations and request time for a joint presentation. FDA will determine the amount of time allotted to each presenter and the approximate time that each oral presentation is scheduled to begin. Persons registered to make a formal presentation should check in before the workshop. Time will be allowed during the scheduled agenda for attendees to ask questions of the panelists. In addition, we strongly E:\FR\FM\03MYN1.SGM 03MYN1

Agencies

[Federal Register Volume 77, Number 86 (Thursday, May 3, 2012)]
[Notices]
[Pages 26291-26292]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10694]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-E-0141]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for LASTACAFT 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 human drug product.

ADDRESSES: Submit electronic comments to https://www.regulations.gov. 
Submit written petitions along with three copies and written comments 
to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 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. 6284, Silver Spring, MD 20993-0002, 301-796-3602.

SUPPLEMENTARY INFORMATION: 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 drug products, the 
testing phase begins when the exemption to permit the clinical 
investigations of the drug becomes effective and runs until the 
approval phase begins. The approval phase starts with the initial 
submission of an application to market the human drug product and 
continues until FDA grants permission to market the drug 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 drug 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 drug product 
LASTACAFT (alcaftadine ophthalmic solution). LASTACAFT is indicated for 
prevention of itching associated with allergic conjunctivitis. 
Subsequent to this approval, the Patent and Trademark Office received a 
patent term restoration application for LASTACAFT (U.S. Patent No. 
5,468,743) from Janssen Pharmaceutica N.V., and the Patent and 
Trademark Office requested FDA's assistance in determining this 
patent's eligibility for patent term restoration. In a letter dated May 
3, 2011, FDA advised the Patent and Trademark Office that this human 
drug product had undergone a regulatory review period and that the 
approval of LASTACAFT 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.

[[Page 26292]]

    FDA has determined that the applicable regulatory review period for 
LASTACAFT is 2,189 days. Of this time, 1,886 days occurred during the 
testing phase of the regulatory review period, while 303 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 FD&C Act) (21 U.S.C. 355(i)) became 
effective: August 1, 2004. The applicant claims July 31, 2004, as the 
date the investigational new drug application (IND) became effective. 
However, FDA records indicate that the IND effective date was August 1, 
2004, which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the FD&C Act: September 
29, 2009. The applicant claims September 28, 2009, as the date the new 
drug application (NDA) for LASTACAFT (NDA 22-134) was initially 
submitted. However, FDA records indicate that NDA 22-134 was submitted 
on September 29, 2009.
    3. The date the application was approved: July 28, 2010. FDA has 
verified the applicant's claim that NDA 22-134 was approved on July 28, 
2010.
    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 1,246 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) either electronic or written comments and ask for a 
redetermination by July 2, 2012. 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 October 30, 2012. 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.
    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) electronic or written comments and written petitions. 
It is only necessary to send one set of comments. However, if you 
submit a written petition, you must submit three copies of the 
petition. Identify comments with the docket number found in brackets in 
the heading of this document.
    Comments and petitions that have not been made publicly available 
on  https://www.regulations.gov may be viewed in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: April 16, 2012.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2012-10694 Filed 5-2-12; 8:45 am]
BILLING CODE 4160-01-P

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