An Introduction to the Hatch-Waxman Act and ANDA Litigation Eastern District of Texas 2014 Bench Bar Conference October 24, 2014 An Introduction to the Hatch-Waxman Act and ANDA Litigation Michael P. Dougherty Partner King & Spalding 1185 Avenue of the Americas New York, NY (212) 556-2100 mdougherty@kslaw.com DMSLIBRARY01-24049430.1

ANDA Overview Pre-1984 problem: no way to get cheap, generic versions of drugs on market once brand patents expired Required New Drug Application: clinical trials (i.e., trials in humans) to prove safety and efficacy Generics couldn’t begin development until after patents expired. Roche Prods. v. Bolar Pharm. Co. 733 F.2d 858 (Fed. Cir. 1984).

Hatch-Waxman Act (1984) Abbreviated New Drug Application (“ANDA”) No need for clinical trials proving safety, efficacy; applicant need only show Same active ingredient Same route of administration Same indications, labeling “Bioequivalent” to branded drug, i.e., behaves in equivalent way in the body 21 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.

Hatch-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 claiming The active molecule Methods of treatment of specific medical conditions using the active molecule The formulation of the branded product (i.e., active molecule plus specified inactive ingredients) Various crystalline forms of the active molecule

Hatch-Waxman Act – Patent Provisions ANDA filer must make a certification with respect to each Orange Book listed patent: No patents listed The patent is expired Applicant will not launch product until patent expires Patent invalid or will not be infringed 21 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)

Hatch-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).

Hatch-Waxman Act – Patent Provisions Generics are encouraged to file ¶IV challenges First ¶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

Hatch-Waxman Suits – Differences From Typical Patent Cases Usually, no sales of accused product No sales = no damages; patentee is usually just seeking order that FDA can’t approve the generic until patent expires Because no damages, no jury Personal 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

Hatch-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 trial Because 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.

Speaker 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 mdougherty@kslaw.com (212) 556-2103

Disclosure Requirement EDTX Patent Rule 3-8 Deadline Disclosure Requirement Case Management Conference (CMC) Defendant(s) produce ANDA 14 days after CMC Defendant(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 later Plaintiff must disclose its asserted claims and infringement contentions as per P.R. 3-1 and 3-2. Note: Please include explanatory notes here

EDTX Patent Rule 3-8 (cont.) Deadline Additional notification and disclosure requirements 3 days of filing Defendant must notify the FDA of any and all motions for injunctive relief; 7 days from date sent or received Defendant must produce a copy of all correspondence with the FDA pertaining to the ANDA or set for the basis of any claim of privilege Note: Please include explanatory notes here