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
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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).
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Hatch-Waxman Act (1984)
•
Abbreviated New Drug Application (“ANDA”)
― No need for clinical trials proving safety, efficacy; applicant need
only show
o
Same active ingredient
o
Same route of administration
o
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.
o
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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
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Hatch-Waxman Act – Patent Provisions
ANDA filer must make a certification with respect to each
Orange Book listed patent:
I.
No patents listed
II. The patent is expired
III. Applicant will not launch product until patent
expires
IV. 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)
•
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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).
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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
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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
•
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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.
•
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Speaker Biography
Michael P. Dougherty
Michael P. Dougherty
mdougherty@kslaw.com
(212) 556-2103
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.
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EDTX Patent Rule 3-8
DEADLINE
DISCLOSURE REQUIREMENT
Case Management
Conference (CMC)
Defendant(s) produce ANDA
14 days after CMC
Defendant(s) must disclose:
1. Invalidity contentions as per P.R. 3-3 and 3-4;
2. 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.
EDTX Patent Rule 3-8 (cont.)
DEADLINE
3 days of filing
ADDITIONAL NOTIFICATION AND DISCLOSURE
REQUIREMENTS
Defendant must notify the FDA of any and all
motions for injunctive relief;
7 days from date sent Defendant must produce a copy of all
or received
correspondence with the FDA pertaining to the
ANDA or set for the basis of any claim of privilege