[Federal Register Volume 61, Number 155 (Friday, August 9, 1996)]
[Notices]
[Pages 41636-41637]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-20340]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96E-0154]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for DYNABAC 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 
Commissioner of Patents and Trademarks, Department of Commerce, for the 
extension of a patent which claims that human drug product.

ADDRESSES: Written comments and petitions should be directed to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Brian J. Malkin, Office of Health 
Affairs (HFY-20), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-443-1382.

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

[[Page 41637]]

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 
Commissioner 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 
DYNABAC (dirithromycin). DYNABAC is indicated for 
the treatment of individuals age 12 years and older with mild-to-
moderate infections caused by susceptible strains of designated 
microorganisms in the specific conditions: (1) Acute Bacterial 
Exacerbations of Chronic Bronchitis due to Moraxella catarrhalis or 
Streptococcus pneumoniae; (2) Secondary Bacterial Infection of Acute 
Bronchitis due to M. catarrhalis or S. pneumoniae; (3) Community-
Acquired Pneumonia due to Legionella pneumophila, Mycoplasma 
pneumoniae, or S. pneumoniae; (4) Pharyngitis/Tonsiletis due to S. 
pyogenes; or (5) Uncomplicated Skin and Skin Structure Infections due 
to  Staphylococcus aureus (methicillin-resistant strains). Subsequent 
to this approval, the Patent and Trademark Office received a patent 
term restoration application for DYNABAC (U.S. Patent No. 
4,048,306) from Boehringer Ingelheim GmbH, 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 28, 
1996, FDA advised the Patent and Trademark Office that this human drug 
product had undergone a regulatory review period and that the approval 
of DYNABAC 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 
DYNABAC is 2,469 days. Of this time, 1,687 days occurred 
during the testing phase of the regulatory review period, while 782 
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: September 
16, 1988. The applicant claims February 28, 1988, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was September 16, 
1988, the date the IND was removed from clinical hold via telephone 
conversation.
    2. The date the application was initially submitted with respect to 
the human drug product under section 507 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 357): April 29, 1993. The applicant claims 
April 27, 1993, as the date the new drug application (NDA) for 
DYNABAC (NDA 50-678) was initially submitted. However, FDA 
records indicate that NDA 50-678 was submitted on April 29, 1993, the 
date the resubmission for NDA 50-678 was received by FDA following a 
refusal to file letter.
    3. The date the application was approved: June 19, 1995. FDA has 
verified the applicant's claim that NDA 50-678 was approved on June 19, 
1995.
    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 1,726 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before October 8, 1996, submit to the Dockets 
Management Branch (address above) written comments and ask for a 
redetermination. Furthermore, any interested person may petition FDA, 
on or before February 6, 1997, for a determination regarding whether 
the applicant for extension acted with due diligence during the 
regulatory review period. 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 Dockets 
Management Branch (address above) in three copies (except that 
individuals may submit single copies) and identified with the docket 
number found in brackets in the heading of this document. Comments and 
petitions may be seen in the Dockets Management Branch between 9 a.m. 
and 4 p.m., Monday through Friday.

    Dated: July 26, 1996.
Stuart L. Nightingale,
Associate Commissioner for Health Affairs.
[FR Doc. 96-20340 Filed 8-8-96; 8:45 am]
BILLING CODE 4160-01-F