Presentation on theme: "An Introduction to the Hatch-Waxman Act and ANDA Litigation"— Presentation transcript:
1An Introduction to the Hatch-Waxman Act and ANDA Litigation Eastern District of Texas Bench Bar ConferenceOctober 24, 2014An Introduction to the Hatch-Waxman Act and ANDA LitigationMichael P. Dougherty Partner King & Spalding 1185 Avenue of the Americas New York, NY (212)DMSLIBRARY
2ANDA OverviewPre-1984 problem: no way to get cheap, generic versions of drugs on market once brand patents expiredRequired New Drug Application: clinical trials (i.e., trials in humans) to prove safety and efficacyGenerics couldn’t begin development until after patents expired. Roche Prods. v. Bolar Pharm. Co. 733 F.2d 858 (Fed. Cir. 1984).
3Hatch-Waxman Act (1984) Abbreviated New Drug Application (“ANDA”) No need for clinical trials proving safety, efficacy; applicant need only showSame active ingredientSame route of administrationSame indications, labeling“Bioequivalent” to branded drug, i.e., behaves in equivalent way in the body21 U.S.C. §355(j)(2)(A)(i)-(v)Use of patented drug for purposes reasonably related to obtaining FDA approval not infringing. 35 U.S.C. § 271(e)(1). Allows generic to begin bioequivalence testing before patents expire.
4Hatch-Waxman Act – Patent Provisions NDA holder (the brand) must file list of patents claiming the drug or method of using the drug. 21 U.S.C. §355(b)(1).Published in “Orange Book”Types of patents commonly listed: patents claimingThe active moleculeMethods of treatment of specific medical conditions using the active moleculeThe formulation of the branded product (i.e., active molecule plus specified inactive ingredients)Various crystalline forms of the active molecule
5Hatch-Waxman Act – Patent Provisions ANDA filer must make a certification with respect to each Orange Book listed patent:No patents listedThe patent is expiredApplicant will not launch product until patent expiresPatent invalid or will not be infringed21 U.S.C. §355(j)(2)(A)(vii)ANDA filer must provide notice of ¶IV to brand; must include a detailed statement of factual and legal basis for generic’s opinion that patent invalid or not infringed. 21 U.S.C. §355(j)(2)(B)(i)-(iv)
6Hatch-Waxman Act – Patent Provisions Filing ANDA with ¶IV certification is “artificial” act of infringement for purposes of creating case or controversy jurisdiction. 35 U.S.C. §271(e)(2); Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 676 (1990).“30 month stay”: If brand files infringement suit within 45 days of receiving ¶IV notice, FDA cannot approve the ANDA for 30 months. 21 U.S.C. §355(j)(5)(B)(iii). Allows time for patent issues to be litigated.Once suit filed, patentee has burden of showing that the product that is likely to be sold following ANDA approval will infringe in traditional sense under §§271(a), (b), (c), or (g). Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1365 (Fed. Cir. 2003).
7Hatch-Waxman Act – Patent Provisions Generics are encouraged to file ¶IV challengesFirst ¶IV filer (if successful) receives 180 day market exclusivity (i.e., for 6 months, it is the only generic on the market). 21 U.S.C. §355(j)(5)(B)(iv).Big incentive to be first successful ¶IV filer
8Hatch-Waxman Suits – Differences From Typical Patent Cases Usually, no sales of accused productNo sales = no damages; patentee is usually just seeking order that FDA can’t approve the generic until patent expiresBecause no damages, no juryPersonal jurisdiction issue often different from typical patent cases because no sales of accused product in forum (or anywhere else)Pressure to decide case before expiration of 30 month stay
9Hatch-Waxman Suits – Differences From Typical Patent Cases Often, infringement not disputed (e.g., if patent claims the active molecule), leaving invalidity as only issue; can result in court reversing the normal order of proof at trialBecause of requirement for ¶IV notice, defendant has well-developed invalidity/noninfringement theories before case is filed; brand has had time to study defendant’s theories during 45 day period for filing suit. Allows for streamlined procedures, e.g., E.D. Texas and D.N.J. Local Rules for ANDA cases.
10Speaker Biography Michael P. Dougherty Mike Dougherty has over 25 years of experience litigating patent cases in bench and jury trials in the U.S. District Courts and the U.S. International Trade Commission. He has focused especially on the representation of brand pharmaceutical companies in suits against generic drug makers under the Hatch-Waxman Act. In the last three years, he has represented major brand companies such as Hoffmann-La Roche, Merck, and Schering in eleven district court actions against various generic ANDA filers.Michael P. Dougherty(212)
11Disclosure Requirement EDTX Patent Rule 3-8DeadlineDisclosure RequirementCase Management Conference (CMC)Defendant(s) produce ANDA14 days after CMCDefendant(s) must disclose:Invalidity contentions as per P.R. 3-3 and 3-4;Non-infringement contentions, including element-by-element claim charts and all documents relied upon in defense any infringement allegation.45 days laterPlaintiff must disclose its asserted claims and infringement contentions as per P.R. 3-1 and 3-2.Note: Please include explanatory notes here
12EDTX Patent Rule 3-8 (cont.) DeadlineAdditional notification and disclosure requirements3 days of filingDefendant must notify the FDA of any and all motions for injunctive relief;7 days from date sent or receivedDefendant must produce a copy of all correspondence with the FDA pertaining to the ANDA or set for the basis of any claim of privilegeNote: Please include explanatory notes here