For The Defense, October 2010 - DRI Today
For The Defense, October 2010 - DRI Today
For The Defense, October 2010 - DRI Today
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D R U G A N D M E D I C A L D E V I C Eunder its “official” generic name, which itreceived when the FDA first approved it, ora company manufacturing a generic versioncan create its own trade name, referredto as a branded generic, but it cannot usethe trade name developed by the originalpatent holder. Once a drug patent expires,the original innovator may market thecompany’s original product under eitherOccasionally the mostcost- effective route todismissal is conductinglimited, productidentification-only discovery.the generic name or the trade name. As aresult, the same generic drug may be soldunder either the official generic name orone of many trade names.Occasionally, you can simply tell anopponent that your client never sold thetype of product at issue or, at least, did notsell it during the relevant time frame. Mostcompanies publish a product guide, whichlists all of the products sold and distributedby a particular company and their NationalDrug Code numbers. Much of this informationis also available in the Physicians’Desk Reference (PDR), a widely available,annually updated, commercially publishedcompilation of manufacturers’ prescribinginformation on prescription medications.<strong>The</strong> Orange BookA lesser known source of product identificationinformation than the PDR is theApproved Drug Products with <strong>The</strong>rapeuticEquivalence Evaluations—commonlyknown as the “Orange Book.” Under federallaw, no one may market or distribute a drugthat it is not authorized to market or distribute.21 U.S.C. §355(a). <strong>The</strong> companies authorizedto market and distribute particulardrugs are listed in the Orange Book, whichfederal law requires the FDA to publish andupdate every 30 days. 21 U.S.C. §355(j)(7)(A)(ii); Eisai Co., Ltd. v. Mut. Pharm. Co.Inc., 2007 WL 4556958, at *1 (D.N.J. Dec.22 n <strong>For</strong> <strong>The</strong> <strong>Defense</strong> n <strong>October</strong> <strong>2010</strong>20, 2007) (explaining that all drug manufacturersmust submit a new drug applicationto the FDA for approval and that onceapproved, the FDA lists the drug informationin the “Approved Drug Products with<strong>The</strong>rapeutic Equivalence Evaluations, commonlyknown as the ‘Orange Book’”); In reK-Dur Antitrust Litig., 2009 WL 508869, at*2 (D.N.J. Feb. 6, 2009). <strong>The</strong> informationmaintained in the Orange Book is basedon the FDA’s own records and research.21 U.S.C. §355(j)(7)(A); 45 Fed. Reg. 72582(“[a]ll drug products on the List have beenfully reviewed and approved for safety andeffectiveness by the FDA”); see also Merck &Co. Inc. v. Hi-Tech Pharmacal Co., Inc., 482F.3d 1317, 1318 (Fed. Cir. 2007) (recognizingthat the Orange Book is a register publishedby the FDA that provides notice of patentscovering name brand drugs).<strong>The</strong> Orange Book can be very helpful indemonstrating to opposing counsel, or acourt, that your client did not market, sellor distribute either the compound at issueor a particular trade name product in therelevant time frame, but rather, the relevantproduct was sold in the United Statesexclusively by others. <strong>The</strong> Orange Bookprimarily lists all prescription drugs bychemical name. Under each chemical namecategory the book lists the various tradenames and formulations and the distributorsof each. It also includes an appendixsorting product names by applicant, listingall of the products that a particular manufactureris authorized to distribute.<strong>The</strong> Electronic Orange Book (EOB) isupdated daily and is searchable by activeingredient, proprietary name, patent,applicant holder, and application Number.U.S. Food and Drug Admin., ElectronicOrange Book: Approved Drug Products with<strong>The</strong>rapeutic Equivalence Evaluations, http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm. <strong>The</strong> most recent Annual Edition andthe Current Cumulative Supplement arealso available in PDF on the FDA website.U.S. Food and Drug Admin., Orange BookPublications, http://www.accessdata.fda.gov/scripts/cder/ob/eclink.cfm. Prior to 2005, whichis when the Annual Edition and CurrentCumulative Supplement were made availableexclusively electronically, librariesdesignated as federal repositories receiveda copy of the Orange Book on microfiche.Subsequently, many of these libraries continuedto print and maintain copies fromthe Internet. Interested parties can obtaincopies of the relevant years’ Orange Booksdirectly from those libraries for copyingcosts or through the Freedom of InformationAct (FOIA), although these requestsoften take several months to process. FederalDepository Library Directory, http://catalog.gpo.gov/fdlpdir/FDLPdir.jsp.Courts may take judicial notice of theOrange Book because it is “not subject toreasonable dispute in that it is… capable ofaccurate and ready determination by resortto sources whose accuracy cannot reasonablybe questioned.” Fed. R. Evid. 201(b);see also Timmons, 263 F.R.D. at 585 (takingjudicial notice of the Orange Book andholding that “judicially- noticeable factsdemonstrate that AstraZeneca did notmanufacture or sell Marcaine in the UnitedStates during the relevant time period”);Horne v. Novartis Pharm. Corp., 541 F.Supp. 2d 768, 777 (W.D.N.C. 2008) (statingthat a court “may take judicial notice of andconsider the public records of the FDA…without transforming this motion into amotion for summary judgment”).National Drug Code SystemAnother useful tool in identifying a specificproduct and seller of a product at issue in asuit is the National Drug Code (NDC) number.<strong>The</strong> Drug Listing Act of 1972 requiresregistered drug establishments to providethe FDA with a current list of all drugsmanufactured, prepared, propagated, compounded,or processed by it for commercialdistribution. 21 U.S.C. §360. Drug productsare identified and reported using a unique,three- segment number, the NDC number,which is a universal product identifier forhuman drugs. 21 C.F.R. §§207.25, 207.35.A drug’s NDC number identifies thelabeler, product, and trade package size.<strong>The</strong> first segment, the labeler code, isassigned by the FDA. 21 C.F.R. §207.35(b)(2)(i). A labeler is any entity that manufactures,including a repacker or relabeler, ordistributes, under its own name, a drug.<strong>The</strong> second segment, the product code,identifies a specific strength, dosage form,and formulation for a particular firm. <strong>The</strong>third segment, the package code, identifiespackage sizes and types. <strong>The</strong> product andpackage codes are assigned by the entity. 21C.F.R. §207.35(b)(2)(ii). Information about