80_FR_23113 80 FR 23034 - Determination of Regulatory Review Period for Purposes of Patent Extension; FLUBLOK

80 FR 23034 - Determination of Regulatory Review Period for Purposes of Patent Extension; FLUBLOK

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 79 (April 24, 2015)

Page Range23034-23035
FR Document2015-09521

The Food and Drug Administration (FDA) has determined the regulatory review period for FLUBLOK 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 the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

Federal Register, Volume 80 Issue 79 (Friday, April 24, 2015) 
[Federal Register Volume 80, Number 79 (Friday, April 24, 2015)]
[Notices]
[Pages 23034-23035]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-09521]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-0130]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for FLUBLOK 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 the U.S. 
Patent and Trademark Office (USPTO), Department of Commerce, for the 
extension of a patent which claims that human biological product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written petitions (two copies are required) and written comments 
to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 
Submit petitions electronically to http://www.regulations.gov at Docket 
No. FDA-2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of 
Management, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Campus, Rm. 3180, Silver Spring, MD 20993, 301-796-7900.

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

[[Page 23035]]

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 USPTO 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 has approved for marketing the human biological product FLUBLOK 
(A/California/7/2009(h1N1), A/Victoria/361/2011(H3N2), B/Wisconsin/1/
2010). FLUBLOK is a vaccine indicated for active immunization against 
disease caused by influenza virus subtypes A and type B contained in 
the vaccine. Subsequent to this approval, the USPTO received a patent 
term restoration application for FLUBLOK (U.S. Patent No. 5,762,939) 
from Protein Sciences Corporation, and the USPTO requested FDA's 
assistance in determining this patent's eligibility for patent term 
restoration. In a letter dated March 26, 2014, FDA advised the USPTO 
that this human drug product had undergone a regulatory review period 
and that the approval of FLUBLOK represented the first permitted 
commercial marketing or use of the product. Thereafter, the USPTO 
requested that FDA determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for 
FLUBLOK is 3,010 days. Of this time, 1,275 days occurred during the 
testing phase of the regulatory review period, while 1,735 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: October 22, 2004. The applicant claims September 23, 2004, 
as the date the investigational new drug application (IND) became 
effective. However, FDA records indicate that the IND effective date 
was October 22, 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: April 18, 
2008. FDA has verified the applicant's claim that the biologics license 
application (BLA) for FLUBLOK (BLA 125285/0) was submitted on April 18, 
2008.
    3. The date the application was approved: January 16, 2013. FDA has 
verified the applicant's claim that BLA 125285/0 was approved on 
January 16, 2013.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension. However, the USPTO 
applies several statutory limitations in its calculations of the actual 
period for patent extension. In its application for patent extension, 
this applicant seeks 5 years 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 June 23, 2015. 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 21, 2015. 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 or 
electronic petitions. It is only necessary to send one set of comments. 
Identify comments with the docket number found in brackets in the 
heading of this document. If you submit a written petition, two copies 
are required. A petition submitted electronically must be submitted to 
http://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and 
petitions that have not been made publicly available on http://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 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-09521 Filed 4-23-15; 8:45 am]
 BILLING CODE 4164-01-P

23034 Federal Register / Vol. 80, No. 79 / Friday, April 24, 2015 / Notices regulatory action’’ as an action likely to Information and Regulatory Affairs of your search to documents published by result in a rule that may— OMB has emphasized that these the Department. (1) Have an annual effect on the techniques may include ‘‘identifying Dated: April 21, 2015. economy of $100 million or more, or changing future compliance costs that John Tschida, adversely affect a sector of the economy, might result from technological Director, National Institute on Disability, productivity, competition, jobs, the innovation or anticipated behavioral Independent Living, and Rehabilitation environment, public health or safety, or changes.’’ Research. State, local, or tribal governments or We are issuing this final priority only [FR Doc. 2015–09606 Filed 4–23–15; 8:45 am] communities in a material way (also on a reasoned determination that its BILLING CODE 4154–01–P referred to as an ‘‘economically benefits justify its costs. In choosing significant’’ rule); among alternative regulatory (2) Create serious inconsistency or approaches, we selected those DEPARTMENT OF HEALTH AND otherwise interfere with an action taken approaches that maximize net benefits. HUMAN SERVICES or planned by another agency; Based on the analysis that follows, the (3) Materially alter the budgetary Administration for Community Living Food and Drug Administration impacts of entitlement grants, user fees, (ACL), Department of Health and or loan programs or the rights and Human Services believes that this [Docket No. FDA–2014–E–0130] obligations of recipients thereof; or regulatory action is consistent with the (4) Raise novel legal or policy issues principles in Executive Order 13563. Determination of Regulatory Review arising out of legal mandates, the We also have determined that this Period for Purposes of Patent President’s priorities, or the principles regulatory action does not unduly Extension; FLUBLOK stated in the Executive order. interfere with State, local, and tribal AGENCY: Food and Drug Administration, This final regulatory action is not a governments in the exercise of their HHS. significant regulatory action subject to governmental functions. ACTION: Notice. review by OMB under section 3(f) of In accordance with both Executive Executive Order 12866. orders, ACL assessed the potential costs SUMMARY: The Food and Drug We have also reviewed this final and benefits, both quantitative and Administration (FDA) has determined regulatory action under Executive Order qualitative, of this regulatory action. the regulatory review period for 13563, which supplements and The potential costs are those resulting FLUBLOK and is publishing this notice explicitly reaffirms the principles, from statutory requirements and those of that determination as required by structures, and definitions governing we have determined as necessary for law. FDA has made the determination regulatory review established in administering the ACL’s programs and because of the submission of an Executive Order 12866. To the extent activities. application to the Director of the U.S. permitted by law, Executive Order The benefits of the Disability and Patent and Trademark Office (USPTO), 13563 requires that an agency— Rehabilitation Research Projects and Department of Commerce, for the (1) Propose or adopt regulations only Centers Program have been well extension of a patent which claims that upon a reasoned determination that established over the years, as projects human biological product. their benefits justify their costs similar to the one envisioned by the ADDRESSES: Submit electronic (recognizing that some benefits and final priority have been completed comments to http:// costs are difficult to quantify); successfully, and the proposed priority www.regulations.gov. Submit written (2) Tailor its regulations to impose the will generate new knowledge through petitions (two copies are required) and least burden on society, consistent with research. The new DRRP will generate, written comments to the Division of obtaining regulatory objectives and disseminate, and promote the use of Dockets Management (HFA–305), Food taking into account—among other things new information that would improve and Drug Administration, 5630 Fishers and to the extent practicable—the costs outcomes for individuals with Lane, Rm. 1061, Rockville, MD 20852. of cumulative regulations; disabilities in the areas of community Submit petitions electronically to (3) In choosing among alternative living and participation, employment, http://www.regulations.gov at Docket regulatory approaches, select those and health and function. No. FDA–2013–S–0610. approaches that maximize net benefits Electronic Access to This Document: FOR FURTHER INFORMATION CONTACT: (including potential economic, The official version of this document is the document published in the Federal Beverly Friedman, Office of environmental, public health and safety, Register. Free Internet access to the Management, Food and Drug and other advantages; distributive official edition of the Federal Register Administration, 10001 New Hampshire impacts; and equity); (4) To the extent feasible, specify and the Code of Federal Regulations is Ave., Hillandale Campus, Rm. 3180, performance objectives, rather than the available via the Federal Digital System Silver Spring, MD 20993, 301–796– behavior or manner of compliance a at: www.gpo.gov/fdsys. At this site you 7900. regulated entity must adopt; and can view this document, as well as all SUPPLEMENTARY INFORMATION: The Drug (5) Identify and assess available other documents of ACL published in Price Competition and Patent Term alternatives to direct regulation, the Federal Register, in text or Adobe Restoration Act of 1984 (Pub. L. 98–417) including economic incentives—such as Portable Document Format (PDF). To and the Generic Animal Drug and Patent user fees or marketable permits—to use PDF you must have Adobe Acrobat Term Restoration Act (Pub. L.100–670) encourage the desired behavior, or Reader, which is available free at the generally provide that a patent may be tkelley on DSK3SPTVN1PROD with NOTICES provide information that enables the site. extended for a period of up to 5 years public to make choices. You may also access documents of the so long as the patented item (human Executive Order 13563 also requires Department published in the Federal drug product, animal drug product, an agency ‘‘to use the best available Register by using the article search medical device, food additive, or color techniques to quantify anticipated feature at: www.federalregister.gov. additive) was subject to regulatory present and future benefits and costs as Specifically, through the advanced review by FDA before the item was accurately as possible.’’ The Office of search feature at this site, you can limit marketed. Under these acts, a product’s VerDate Sep<11>2014 17:30 Apr 23, 2015 Jkt 235001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 E:\FR\FM\24APN1.SGM 24APN1

Federal Register / Vol. 80, No. 79 / Friday, April 24, 2015 / Notices 23035 regulatory review period forms the basis date was October 22, 2004, which was DEPARTMENT OF HEALTH AND for determining the amount of extension 30 days after FDA receipt of the IND. HUMAN SERVICES an applicant may receive. 2. The date the application was A regulatory review period consists of Food and Drug Administration initially submitted with respect to the two periods of time: A testing phase and human drug product under section [Docket No. FDA–2014–E–0299] an approval phase. For human drug 505(b) of the FD&C Act: April 18, 2008. products, the testing phase begins when FDA has verified the applicant’s claim Determination of Regulatory Review the exemption to permit the clinical that the biologics license application Period for Purposes of Patent investigations of the drug becomes (BLA) for FLUBLOK (BLA 125285/0) Extension; KYNAMRO effective and runs until the approval was submitted on April 18, 2008. phase begins. The approval phase starts AGENCY: Food and Drug Administration, with the initial submission of an 3. The date the application was HHS. application to market the human drug approved: January 16, 2013. FDA has ACTION: Notice. product and continues until FDA grants verified the applicant’s claim that BLA 125285/0 was approved on January 16, SUMMARY: The Food and Drug permission to market the drug product. Administration (FDA) has determined Although only a portion of a regulatory 2013. the regulatory review period for review period may count toward the This determination of the regulatory KYNAMRO and is publishing this actual amount of extension that the review period establishes the maximum notice of that determination as required Director of USPTO may award (for potential length of a patent extension. by law. FDA has made the example, half the testing phase must be However, the USPTO applies several determination because of the subtracted as well as any time that may statutory limitations in its calculations submission of an application to the have occurred before the patent was of the actual period for patent extension. Director of the U.S. Patent and issued), FDA’s determination of the In its application for patent extension, Trademark Office (USPTO), Department length of a regulatory review period for this applicant seeks 5 years of patent of Commerce, for the extension of a a human drug product will include all term extension. patent which claims that human drug of the testing phase and approval phase product. Anyone with knowledge that any of as specified in 35 U.S.C. 156(g)(1)(B). the dates as published are incorrect may ADDRESSES: Submit electronic FDA has approved for marketing the submit to the Division of Dockets human biological product FLUBLOK comments to http:// Management (see ADDRESSES) either www.regulations.gov. Submit written (A/California/7/2009(h1N1), A/Victoria/ electronic or written comments and ask petitions (two copies are required) and 361/2011(H3N2), B/Wisconsin/1/2010). for a redetermination by June 23, 2015. written comments to the Division of FLUBLOK is a vaccine indicated for Furthermore, any interested person may Dockets Management (HFA–305), Food active immunization against disease petition FDA for a determination and Drug Administration, 5630 Fishers caused by influenza virus subtypes A regarding whether the applicant for Lane, Rm. 1061, Rockville, MD 20852. and type B contained in the vaccine. extension acted with due diligence Submit petitions electronically to Subsequent to this approval, the USPTO during the regulatory review period by http://www.regulations.gov at Docket received a patent term restoration October 21, 2015. To meet its burden, No. FDA–2013–S–0610. application for FLUBLOK (U.S. Patent the petition must contain sufficient facts FOR FURTHER INFORMATION CONTACT: No. 5,762,939) from Protein Sciences to merit an FDA investigation. (See H. Beverly Friedman, Office of Corporation, and the USPTO requested FDA’s assistance in determining this Rept. 857, part 1, 98th Cong., 2d sess., Management, Food and Drug patent’s eligibility for patent term pp. 41–42, 1984.) Petitions should be in Administration, 10001 New Hampshire restoration. In a letter dated March 26, the format specified in 21 CFR 10.30. Ave., Hillandale Campus, Rm. 3180, 2014, FDA advised the USPTO that this Interested persons may submit to the Silver Spring, MD 20993, 301–796– human drug product had undergone a Division of Dockets Management (see 7900. regulatory review period and that the ADDRESSES) electronic or written SUPPLEMENTARY INFORMATION: The Drug approval of FLUBLOK represented the comments and written or electronic Price Competition and Patent Term first permitted commercial marketing or petitions. It is only necessary to send Restoration Act of 1984 (Pub. L. 98–417) use of the product. Thereafter, the one set of comments. Identify comments and the Generic Animal Drug and Patent USPTO requested that FDA determine with the docket number found in Term Restoration Act (Pub. L. 100–670) the product’s regulatory review period. brackets in the heading of this generally provide that a patent may be FDA has determined that the document. If you submit a written extended for a period of up to 5 years applicable regulatory review period for petition, two copies are required. A so long as the patented item (human FLUBLOK is 3,010 days. Of this time, petition submitted electronically must drug product, animal drug product, 1,275 days occurred during the testing be submitted to http:// medical device, food additive, or color phase of the regulatory review period, www.regulations.gov, Docket No. FDA– additive) was subject to regulatory while 1,735 days occurred during the 2013–S–0610. Comments and petitions review by FDA before the item was approval phase. These periods of time that have not been made publicly marketed. Under these acts, a product’s were derived from the following dates: available on http://www.regulations.gov regulatory review period forms the basis 1. The date an exemption under may be viewed in the Division of for determining the amount of extension section 505(i) of the Federal Food, Drug, Dockets Management between 9 a.m. an applicant may receive. tkelley on DSK3SPTVN1PROD with NOTICES and Cosmetic Act (the FD&C Act) (21 and 4 p.m., Monday through Friday. A regulatory review period consists of U.S.C. 355(i)) became effective: October Dated: April 20, 2015. two periods of time: A testing phase and 22, 2004. The applicant claims an approval phase. For human drug Leslie Kux, September 23, 2004, as the date the products, the testing phase begins when investigational new drug application Associate Commissioner for Policy. the exemption to permit the clinical (IND) became effective. However, FDA [FR Doc. 2015–09521 Filed 4–23–15; 8:45 am] investigations of the drug becomes records indicate that the IND effective BILLING CODE 4164–01–P effective and runs until the approval VerDate Sep<11>2014 17:30 Apr 23, 2015 Jkt 235001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 E:\FR\FM\24APN1.SGM 24APN1


Document Created: 2015-12-16 08:43:33
Document Modified: 2015-12-16 08:43:33
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactBeverly Friedman, Office of Management, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Campus, Rm. 3180, Silver Spring, MD 20993, 301-796-7900.
FR Citation80 FR 23034 
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