1. An Introduction to the Hatch-Waxman Act and ANDA Litigation
Eastern District of Texas 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)
DMSLIBRARY

2. 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).

3. 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.

4. 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

5. 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)

6. 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).

7. 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

8. 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

9. 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.

10. 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
(212)

11. 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

12. 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