Transcript Hatch-Waxman Reforms Under The 'Medicare Prescription Drug

Hatch-Waxman Reforms Under
The “Medicare Prescription Drug,
Improvement, And Modernization
Act 2003”
Brian V. Slater, Esq.
Fitzpatrick, Cella, Harper & Scinto
Law Seminars International, Raleigh, NC
May 3, 2004
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Hatch-Waxman Basics
• Drug Price Competition and Patent Term
Restoration Act of 1984 (“Hatch-Waxman”)
• NDA holder must inform FDA of patents covering
drug or method of using drug (not process
patents), including those issuing after NDA
approval (FDA publishes this in the “Orange
Book”)
• Generic applicant (either ANDA or 505(b)(2))
seeking to market prior to patent expiration, must
– certify listed patent is invalid, not infringed or
unenforceable (so-called “Paragraph IV”)
– notify NDA holder and patent owner and
provide detailed statement of factual and legal
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basis
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Hatch-Waxman Basics
• NDA holder/patent owner has 45 days from
receipt of Para IV notice to sue for patent
infringement
• If timely suit is brought, automatic 30-month stay
of FDA approval of generic application unless
“court” decision of invalidity, non-infringement or
unenforceability
– For certain ANDAs after 3/2000 FDA
interpreted “court” as “district court” [65 Fed.
Reg. 16922]
• Non-concurrent, multiple 30-month stays for
each Para IV sued on
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Hatch-Waxman Basics
• Filing generic application with a Para IV is an act
of infringement. [35 U.S.C. § 271(e)(2)]
• No declaratory judgment action re patent by
generic allowed until 45-day window has passed
• First ANDA Para IV filer obtains 180-day
exclusivity against other generic competitors
(triggered by earlier of commercial marketing or
“court” decision of non-infringement or invalidity)
– For certain ANDAs after 3/2000 FDA
interpreted “court” as “district court” [65 Fed.
Reg. 16922]
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Medicare Prescription Drug,
Improvement, And Modernization Act
2003
• Background:
– Criticisms of Hatch-Waxman scheme in
FTC 2002 “Generic Drug Entry” Study
– FDA 2003 regulations adopted some FTC
recommendations [68 FR 36676]
• Medicare Act signed into law December 8,
2003
• Title XI – “Access To Affordable
Pharmaceuticals” modifies aspects of HatchWaxman, codifies some F.D.A. practices,
reverses some and modifies others
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Effect Of Litigation On Final Approval
• Opportunity for one 30-month stay per generic
application limited to patent information
submitted by NDA holder prior to generic’s
original application
• For later-listed patents, generic applicant still
has to notify patent owner of Para IV and patent
owner can still sue, but no additional 30-month
stay
• Applies only to patent information submitted by
NDA holder on or after 8/18/03 (otherwise old
law applies, i.e., non-concurrent 30-month stays
for each Para IV sued on)
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Notice By Generic Applicant
For Para IV certifications on or after
8/18/03, generic must give notice to
NDA holder/patent owner:
• Within 20 days of postmark on FDA
letter confirming filing of generic
application [new]; or
• At same time generic submits
amendment or supplement (regardless
of whether applicant has previously
given notice of another Para IV)
[reverses FDA 2003 regulation]
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Section 283 only
provides
injunction to
prevent remedy
future
infringement so
would not Generic
cover
approval prior to expiry of 30-month stay if:
drug products
resulting from tool
use if tool •use
The district court decides patent is invalid or not
over
infringed; or
Effect Of Litigation On Final Approval
• In appeal from district court infringement
judgment, appeals court decides patent is invalid
or not infringed; or
• Settlement order or consent decree signed by
district or appellate court that patent is invalid or
not infringed
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Generic Causes of Action
• Changes to existing declaratory judgment
provisions
• New Orange Book “delisting” counterclaim
• Both provisions apply to “any proceedings”
pending on or after December 8, 2003
• No damages in either case
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Declaratory Judgment Actions
• Generic may bring declaratory judgment action
of non-infringement or invalidity if no suit brought
during 45 day period [change]
• “The courts of the United States shall, to the
extent consistent with the Constitution, have
subject matter jurisdiction” over such actions.
U.S.C. § 271(e)(5)] [new]
[35
• Action must be brought in judicial district where
defendant has principal or a regular and
established place of business [same]
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Declaratory Judgment Actions
• For declaratory judgment actions based on a noninfringement Para IV, the Para IV notice must
have been accompanied by offer of confidential
access to the generic’s application for the sole
purpose of evaluating possible infringement
[new]:
– Irrelevant information can be redacted by
generic
– Can be offered under protective order like
restrictions
– Request for access to generic application
under such an offer is considered an
enforceable contract
– What about DMFs?
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Declaratory Judgment Actions
Q. If generic applicant is not sued, why would it
file a declaratory judgment action?
• First generic filer probably would not.
• In past, subsequent generic filer sued to burn off
first ANDA filer’s 180-day exclusivity. See Teva
Pharms., USA, Inc. v. United States FDA, 182 F.3d 1003 (D.C. Cir.
1999)(dismissal of d.j. action was “court decision” triggering 180-days
exclusivity).
• Court decision is still a trigger of 180-days under
certain circumstances and is a forfeiture event
but now “decision” means a decision from which
no appeal has/can be taken. (see below)
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Declaratory Judgment Actions
Q.Can a generic that is not sued on Para IV
demonstrate an “actual controversy” under 28
U.S.C. § 2201(a)?
• Actual controversy requires, inter alia, an explicit
threat or other action by patentee giving rise to a
“reasonable apprehension” of suit? [Gen-Probe v. Vysis, 021617 (Fed. Cir. 3/5/04]
• Isn’t non-suit the antithesis of a threat of suit?
• Orange Book listing and refusal to grant covenant
not to sue do not give rise to “reasonable
apprehension” of suit [See Teva Pharms. USA, Inc. v. Pfizer Inc.,
2003 WL 22888848 (D. Mass. 12/8/03); Dr. Reddy’s Labs. v. Pfizer Inc., 2003
WL 21638254 (D.N.J. 7/28/03)]
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Declaratory Judgment Actions
Q.If there is an actual controversy, is a court
required to exercise declaratory judgment
jurisdiction?
• Declaratory judgment statute gives court
discretion whether to exercise its jurisdiction.
[28
U.S.C. § 2201(a) (“in a case of actual controversy . . .any court . . . may
declare the rights and other legal relations of any interested party . . .“)]
• One commentator has argued the “the federal
courts should take declaratory judgment
jurisdiction where they have discretion to do so”
• Act does not mandate that district court exercise
discretion in favor of entertaining declaratory
judgment action.
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Orange Book “Delisting” Counterclaim
• Previously, generic had no private cause of
action against NDA holder to delist patents from
Orange Book [See Mylan Pharmaceuticals, Inc. v. Thompson, 268
F.3d 1323, 1332 (Fed. Cir. 2001); see also Apotex v. Thompson, 349 F.3d
1335 (Fed. Cir. 2003)]
• Now, generic may bring a counterclaim in a an
infringement action for order requiring NDA
holder to correct or delete patent information
because it does not claim either the approved
drug or an approved method of using the drug
• Does not authorize independent Orange Book
delisting action (e.g., declaratory judgment)
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180-Day Exclusivity Eligibility
• A “first applicant” who submits a “substantially
complete” ANDA with a Para IV for a drug on the
first day that any applicant makes a Para IV
obtains 180-day exclusivity (i.e., unless forfeited)
– Exclusivity now tied to drug, not patents –
avoids situation where multiple generics file
Para IVs on different patents [D.C. Dist. (Roberts J.)
1/2/04 decision overturned FDA position that generics should share
exclusivity re PAXIL]
– Can be more than one “first applicant” –
avoids having to determine who filed first on a
particular day; results in shared exclusivity
• Applies only to ANDAs filed for a drug as to
which no Para IV was made before December 8,
2003
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180-Day Exclusivity Trigger
• For ANDAs where no Para IV prior to 12/8/03,
only trigger is first commercial marketing of
generic drug or brand drug by any first applicant
– Court decision is no longer a trigger but is
now a forfeiture event (see below)
– Includes marketing of brand drug under a
settlement agreement with innovator
• For ANDAs where was Para IV prior to 12/8/03
(where trigger has not already occurred), trigger
is commercial marketing or decision from which
no appeal has been/can be been taken [return to
FDA Practice before 3/2000 Guidance]
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180-Day Exclusivity Forfeiture
First applicant’s 180-day exclusivity forfeited by:
1. Failure to market under certain circs. (see next slide)
2. Withdrawal of ANDA (either voluntarily or by FDA)
3. Amendment or withdrawal of qualifying Para IV as to
all patents
4. Failure to obtain tentative approval within 30 months
5. Agreement with another ANDA applicant, NDA
holder or patent owner adjudicated to violate
antitrust laws
6. Expiration of all the patents that are the subject of
qualifying Para IV
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180-Day Exclusivity Forfeiture
1. Failure to market: A first applicant forfeits exclusivity
by failing to market by the later of:
• 75 days after FDA approval is made effective or 30
months after ANDA filing, whichever is earlier; or
• 75 days after one of the following has occurred with
respect to each patent in first applicant’s Para IV (in
an infringement or declaratory judgment action
involving first applicant or another applicant with
tentative approval)
– The court enters a final decision from which no
appeal has been/can be taken that the patent is
invalid or not infringed
– The court signs a settlement order or consent
decree that enters a final judgment that patent is
invalid or not infringed
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– NDA holder withdraws the patent information
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180-Day Exclusivity Forfeiture
• Only forfeiture by all first applicants means
subsequent applicants are not subject to 180-day
exclusivity
• If all first applicants forfeit 180-day exclusivity,
subsequent applicant does not inherit 180-day
exclusivity
• 180-day forfeiture provisions apply to ANDAs filed
for a drug as to which no Para IV was made before
December 8, 2003, except that
– Exclusivity is forfeited where first applicant enters
agreement violating antitrust laws (regardless of
when first Para IV was made)
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FTC Review Of Agreements
• The following agreements must be filed with the
Assistant Attorney General and the FTC:
– Agreements between ANDA Para IV filer and
brand name co. regarding (i) manufacture,
marketing or sale of brand name drug or generic
drug or (ii) the 180-day exclusivity period
– Agreements between two ANDA Para IV filers
regarding the 180-day exclusivity period
– Doesn’t apply to 505(b)(2) generic applicant
• Agreements must be filed by each party prior to first
commercial marketing of drug and no later than 10
business days after execution
• Applies to agreements entered into on or after 1/8/04
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Thank You
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