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6262 Federal Register / Vol. 62, No. 28 / Tuesday, February 11, 1997 / Noticeswhen caused by susceptible strains ofthe following designatedmicroorgranisms: Intra-abdominalInfections: Complicated appendicitisand peritonitis caused by viridans groupstreptococci, Escherichia coli, Klebsiellapneumoniae, Pseudomonas aeruginosa,Bacteroides fragilis, B.thetaiotaomicron, andPeptostreptococcus species. BacterialMeningitis (pediatric patients ≥ 3months only): Bacterial meningitiscaused by Streptococcus pneumoniae,Haemophilus influenzae (β-lactamaseand non-β-lactamase-producing strains),and Neisseria meningitidis. Subsequentto this approval, the Patent andTrademark Office received a patent termrestoration application for MERREM®I.V. (U.S. Patent No. 4,943,569) fromSumitomo Pharmaceutical Co., Ltd., andthe Patent and Trademark Officerequested FDA’s assistance indetermining this patent’s eligibility forpatent term restoration. In a letter datedNovember 4, 1996, FDA advised thePatent and Trademark Office that thishuman drug product had undergone aregulatory review period and that theapproval of MERREM® I.V. representedthe first permitted commercialmarketing or use of the product. Shortlythereafter, the Patent and TrademarkOffice requested that FDA determine theproduct’s regulatory review period.FDA has determined that theapplicable regulatory review period forMERREM® I.V. is 2,608 days. Of thistime, 1,640 days occurred during thetesting phase of the regulatory reviewperiod, while 968 days occurred duringthe approval phase. These periods oftime were derived from the followingdates:1. The date an exemption undersection 505(i) of the Federal Food, Drug,and Cosmetic Act (21 U.S.C. 355(i))became effective: May 3, 1989. FDA hasverified the applicant’s claim that thedate that the investigational new drugapplication became effective was onMay 3, 1989.2. The date the application wasinitially submitted with respect to thehuman drug product under section 507of the Federal Food, Drug, and CosmeticAct (21 U.S.C. 357): October 28, 1993.FDA has verified the applicant’s claimthat the new drug application (NDA) forMERREM® I.V. (NDA 50–706) wasinitially submitted on October 28, 1993.3. The date the application wasapproved: June 21, 1996. FDA hasverified the applicant’s claim that NDA20–506 was approved on June 21, 1996.This determination of the regulatoryreview period establishes the maximumpotential length of a patent extension.However, the U.S. Patent andTrademark Office applies severalstatutory limitations in its calculationsof the actual period for patent extension.In its application for patent extension,this applicant seeks 1,063 days of patentterm extension.Anyone with knowledge that any ofthe dates as published is incorrect may,on or before April 14, 1997, submit tothe Dockets Management Branch(address above) written comments andask for a redetermination. Furthermore,any interested person may petition FDA,on or before August 11, 1997, for adetermination regarding whether theapplicant for extension acted with duediligence during the regulatory reviewperiod. To meet its burden, the petitionmust contain sufficient facts to merit anFDA investigation. (See H. Rept. 857,part 1, 98th Cong., 2d sess., pp. 41–42,1984.) Petitions should be in the formatspecified in 21 CFR 10.30.Comments and petitions should besubmitted to the Dockets ManagementBranch (address above) in three copies(except that individuals may submitsingle copies) and identified with thedocket number found in brackets in theheading of this document. Commentsand petitions may be seen in theDockets Management Branch between 9a.m. and 4 p.m., Monday throughFriday.Dated: January 31, 1997.Stuart L. Nightingale,Associate Commissioner for Health Affairs.[FR Doc. 97–3313 Filed 2–10–97; 8:45 am]BILLING CODE 4160–01–F[Docket No. 96E–0360]Determination of Regulatory ReviewPeriod for Purposes of PatentExtension; DIFFERIN Topical GelAGENCY: Food and Drug Administration,HHS.ACTION: Notice.SUMMARY: The Food and DrugAdministration (FDA) has determinedthe regulatory review period forDIFFERIN Topical Gel and is publishingthis notice of that determination asrequired by law. FDA has made thedetermination because of thesubmission of an application to theCommissioner of Patents andTrademarks, Department of Commerce,for the extension of a patent whichclaims that human drug product.ADDRESSES: Written comments andpetitions should be directed to theDockets 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 DrugAdministration, 5600 Fishers Lane,Rockville, MD 20857, 301–443–1382.SUPPLEMENTARY INFORMATION: The DrugPrice Competition and Patent TermRestoration Act of 1984 (Pub. L. 98–417)and the Generic Animal Drug and PatentTerm Restoration Act (Pub. L. 100–670)generally provide that a patent may beextended for a period of up to 5 yearsso long as the patented item (humandrug product, animal drug product,medical device, food additive, or coloradditive) was subject to regulatoryreview by FDA before the item wasmarketed. Under these acts, a product’sregulatory review period forms the basisfor determining the amount of extensionan applicant may receive.A regulatory review period consists oftwo periods of time: A testing phase andan approval phase. For human drugproducts, the testing phase begins whenthe exemption to permit the clinicalinvestigations of the drug becomeseffective and runs until the approvalphase begins. The approval phase startswith the initial submission of anapplication to market the human drugproduct and continues until FDA grantspermission to market the drug product.Although only a portion of a regulatoryreview period may count toward theactual amount of extension that theCommissioner of Patents andTrademarks may award (for example,half the testing phase must besubtracted as well as any time that mayhave occurred before the patent wasissued), FDA’s determination of thelength of a regulatory review period fora human drug product will include allof the testing phase and approval phaseas specified in 35 U.S.C. 156(g)(1)(B).FDA recently approved for marketingthe human drug product DIFFERINTopical Gel (adapalene). DIFFERINTopical Gel is indicated for the topicaltreatment of acne vulgaris. Subsequentto this approval, the Patent andTrademark Office received a patent termrestoration application for DIFFERINTopical Gel (U.S. Patent No. 4,717,720)from Centre International de RecherchesDermatologiques (CIRD), and the Patentand Trademark Office requested FDA’sassistance in determining this patent’seligibility for patent term restoration. Ina letter dated October 24, 1996, FDAadvised the Patent and TrademarkOffice that this human drug product hadundergone a regulatory review periodand that the approval of DIFFERINTopical Gel represented the firstpermitted commercial marketing or useof the product. Shortly thereafter, the