federal
trade
commission
actavis
et
argued
march
decided
june
drug
price
competition
patent
term
restoration
act
act
act
creates
special
procedures
identifying
resolving
patent
disputes
generic
drug
manufacturers
one
requires
prospective
generic
manufacturer
assure
food
drug
administration
fda
infringe
patents
one
way
provide
assurance
paragraph
iv
route
certifying
listed
relevant
patent
invalid
infringed
manufacture
use
sale
generic
drug
vii
iv
respondent
solvay
pharmaceuticals
obtained
patent
approved
drug
androgel
subsequently
respondents
actavis
paddock
filed
applications
generic
drugs
modeled
androgel
certified
paragraph
iv
solvay
patent
invalid
drugs
infringe
solvay
sued
actavis
paddock
claiming
patent
infringement
see
fda
eventually
approved
actavis
generic
product
instead
bringing
drug
market
actavis
entered
reverse
payment
settlement
agreement
solvay
agreeing
bring
generic
market
specified
number
years
agreeing
promote
androgel
doctors
exchange
millions
dollars
paddock
made
similar
agreement
solvay
respondent
par
another
manufacturer
aligned
patent
litigation
paddock
federal
trade
commission
ftc
filed
suit
alleging
respondents
violated
federal
trade
commission
act
unlawfully
agreeing
abandon
patent
challenges
refrain
launching
generic
drugs
share
solvay
monopoly
profits
district
dismissed
complaint
eleventh
circuit
concluded
long
anticompetitive
effects
settlement
fall
within
scope
patent
exclusionary
potential
settlement
immune
antitrust
attack
noting
ftc
alleged
challenged
agreements
excluded
competition
greater
extent
patent
valid
affirmed
complaint
dismissal
recognized
parties
sort
case
settle
might
declare
patent
invalid
since
public
policy
favors
settlement
disputes
held
courts
require
parties
continue
litigate
order
avoid
antitrust
liability
held
eleventh
circuit
erred
affirming
dismissal
ftc
complaint
pp
although
anticompetitive
effects
reverse
settlement
agreement
might
fall
within
scope
exclusionary
potential
solvay
patent
immunize
agreement
antitrust
attack
one
thing
refer
simply
holder
valid
patent
answer
antitrust
question
paragraph
iv
litigation
put
patent
validity
preclusive
scope
issue
parties
settlement
ftc
alleges
plaintiff
agreed
pay
defendants
millions
stay
market
even
though
defendants
monetary
claim
plaintiff
ended
litigation
form
settlement
unusual
reason
concern
settlements
tend
significant
adverse
effects
competition
incongruous
determine
antitrust
legality
measuring
settlement
anticompetitive
effects
solely
patent
law
policy
procompetitive
antitrust
policies
well
relevant
determining
scope
monopoly
antitrust
immunity
conferred
patent
see
line
material
antitrust
question
answered
considering
traditional
antitrust
factors
another
thing
precedents
make
clear
settlement
agreements
sometimes
violate
antitrust
laws
see
singer
mfg
new
wrinkle
standard
oil
indiana
finally
act
general
procompetitive
thrust
facilitating
challenges
patent
validity
requiring
parties
paragraph
iv
dispute
report
settlement
terms
federal
antitrust
regulators
suggests
view
contrary
eleventh
circuit
pp
eleventh
circuit
conclusion
finds
support
general
legal
policy
favoring
settlement
disputes
related
underlying
practical
concern
consists
fear
antitrust
scrutiny
reverse
payment
agreement
require
parties
engage
complex
expensive
litigation
demonstrate
happened
competition
absent
settlement
however
five
sets
considerations
lead
conclusion
concern
determine
result
ftc
given
opportunity
prove
antitrust
claim
first
specific
restraint
issue
potential
genuine
adverse
effects
competition
ftc
indiana
federation
dentists
payment
staying
market
keeps
prices
levels
divides
benefit
patentee
challenger
consumer
loses
two
act
features
advantage
given
first
paragraph
iv
challenger
win
fda
approval
iv
roughly
period
subsequent
manufacturers
required
wait
winning
fda
approval
iii
mean
reverse
settlement
agreement
first
filer
removes
consideration
manufacturer
likely
introduce
competition
quickly
second
anticompetitive
consequences
least
sometimes
prove
unjustified
may
justifications
reverse
payment
result
sought
brought
anticompetitive
consequences
justify
dismissing
ftc
complaint
without
examining
potential
justifications
third
reverse
payment
threatens
work
unjustified
anticompetitive
harm
patentee
likely
power
bring
harm
practice
size
payment
branded
drug
manufacturer
generic
challenger
strong
indicator
power
fourth
antitrust
action
likely
prove
feasible
administratively
eleventh
circuit
believed
normally
necessary
litigate
patent
validity
answer
antitrust
question
large
unexplained
reverse
payment
provide
workable
surrogate
patent
weakness
without
forcing
conduct
detailed
exploration
patent
validity
fifth
fact
large
unjustified
reverse
payment
risks
antitrust
liability
prevent
litigating
parties
settling
lawsuits
industries
may
settle
ways
allowing
generic
manufacturer
enter
patentee
market
patent
expires
without
patentee
paying
challenger
stay
prior
point
pp
declines
hold
reverse
payment
settlement
agreements
presumptively
unlawful
courts
reviewing
agreements
proceed
applying
rule
reason
rather
quick
look
approach
see
california
dental
assn
ftc
pp
reversed
remanded
breyer
delivered
opinion
kennedy
ginsburg
sotomayor
kagan
joined
roberts
filed
dissenting
opinion
scalia
thomas
joined
alito
took
part
consideration
decision
case
opinion
notice
opinion
subject
formal
revision
publication
preliminary
print
reports
readers
requested
notify
reporter
decisions
washington
typographical
formal
errors
order
corrections
may
made
preliminary
print
goes
press
federal
trade
commission
petitioner
actavis
et
al
writ
certiorari
appeals
eleventh
circuit
june
justice
breyer
delivered
opinion
company
sues
company
patent
infringement
two
companies
settle
terms
require
company
claimed
infringer
produce
product
patent
term
expires
company
patentee
pay
many
millions
dollars
settlement
requires
patentee
pay
alleged
infringer
rather
way
around
kind
settlement
agreement
often
called
reverse
payment
settlement
agreement
basic
question
whether
agreement
sometimes
unreasonably
diminish
competition
violation
antitrust
laws
see
sherman
act
prohibition
restraint
trade
commerce
cf
palmer
brg
per
curiam
invalidating
agreement
compete
case
eleventh
circuit
dismissed
federal
trade
commission
ftc
complaint
claiming
particular
reverse
payment
settlement
agreement
violated
antitrust
laws
circuit
stated
reverse
payment
settlement
agreement
generally
immune
antitrust
attack
long
anticompetitive
effects
fall
within
scope
exclusionary
potential
patent
ftc
watson
pharmaceuticals
since
alleged
infringer
promise
enter
patentee
market
expired
patent
term
ended
circuit
found
agreement
legal
dismissed
ftc
complaint
view
however
reverse
payment
settlements
agreement
alleged
complaint
us
violate
antitrust
laws
consequently
hold
eleventh
circuit
allowed
ftc
lawsuit
proceed
apparently
reverse
payment
settlement
agreements
arise
context
pharmaceutical
drug
regulation
specifically
context
suits
brought
statutory
provisions
allowing
generic
drug
manufacturer
seeking
speedy
marketing
approval
challenge
validity
patent
owned
drug
owner
see
brief
petitioner
areeda
hovenkamp
antitrust
law
ed
hereinafter
areeda
hovenkamp
sensible
antitrust
rules
pharmaceutical
competition
rev
consequently
describe
four
key
features
relevant
framework
established
drug
price
competition
patent
term
restoration
act
stat
amended
act
commonly
known
act
first
drug
manufacturer
wishing
market
new
prescription
drug
must
submit
new
drug
application
federal
food
drug
administration
fda
undergo
long
comprehensive
costly
testing
process
successful
manufacturer
receive
marketing
approval
fda
see
requiring
among
things
full
reports
investigations
safety
effectiveness
full
list
articles
used
components
full
description
drug
manufactured
processed
packed
second
fda
approved
drug
marketing
manufacturer
generic
drug
obtain
similar
marketing
approval
use
procedures
act
permits
generic
manufacturer
file
abbreviated
new
drug
specifying
generic
active
ingredients
biologically
equivalent
drug
caraco
pharmaceutical
laboratories
novo
nordisk
slip
citing
ii
iv
way
generic
manufacturer
obtain
approval
avoiding
costly
studies
needed
obtain
approval
pioneer
drug
see
eli
lilly
medtronic
process
allowing
generic
pioneer
approval
efforts
speed
introduction
generic
drugs
market
caraco
supra
slip
thereby
furthering
drug
competition
third
act
sets
forth
special
identifying
resolving
related
patent
requires
pioneer
manufacturer
list
new
drug
application
number
expiration
date
relevant
patent
see
requires
generic
manufacturer
abbreviated
new
drug
application
assure
fda
generic
infringe
patents
see
caraco
supra
slip
generic
provide
assurance
one
several
ways
see
vii
certify
manufacturer
listed
relevant
patents
certify
relevant
patents
expired
request
approval
market
beginning
patents
expire
certify
listed
relevant
patent
invalid
infringed
manufacture
use
sale
drug
described
abbreviated
new
drug
application
see
vii
iv
taking
route
called
paragraph
iv
route
automatically
counts
patent
infringement
see
supp
often
means
provoking
litigation
caraco
supra
slip
patentee
brings
infringement
suit
within
days
fda
must
withhold
approving
generic
usually
period
parties
litigate
patent
validity
infringement
courts
decide
matter
within
period
fda
follows
determination
fda
may
go
forward
give
approval
market
generic
product
see
iii
fourth
provides
special
incentive
generic
first
file
abbreviated
new
drug
application
taking
paragraph
iv
route
applicant
enjoy
period
days
exclusivity
first
commercial
marketing
drug
see
iv
establishing
exclusivity
period
period
exclusivity
generic
compete
drug
generic
manufacturer
overcome
patent
obstacle
bring
generic
market
period
exclusivity
prove
valuable
possibly
worth
several
hundred
million
dollars
hemphill
paying
delay
pharmaceutical
patent
settlement
regulatory
design
problem
rev
indeed
generic
pharmaceutical
association
said
majority
potential
profits
generic
drug
manufacturer
materialize
exclusivity
period
brief
petitioner
quoting
statement
exclusivity
period
however
belong
first
generic
file
generic
forfeit
exclusivity
right
one
ways
specified
statute
generic
obtain
see
solvay
pharmaceuticals
respondent
filed
new
drug
application
drug
called
androgel
fda
approved
application
solvay
obtained
relevant
patent
disclosed
fact
fda
requires
see
requiring
addition
fda
must
publish
new
patent
information
upon
submission
later
year
another
respondent
actavis
known
watson
pharmaceuticals
filed
abbreviated
new
drug
application
generic
drug
modeled
androgel
subsequently
paddock
laboratories
also
respondent
separately
filed
abbreviated
new
drug
application
generic
product
actavis
paddock
certified
paragraph
iv
solvay
listed
patent
invalid
drugs
infringe
fourth
manufacturer
par
pharmaceutical
likewise
respondent
file
application
joined
forces
paddock
agreeing
share
patent
litigation
costs
return
share
profits
paddock
obtained
approval
generic
drug
solvay
initiated
paragraph
iv
patent
litigation
actavis
paddock
thirty
months
later
fda
approved
actavis
generic
product
parties
settled
terms
settlement
actavis
agreed
bring
generic
market
august
months
solvay
patent
expired
unless
someone
else
marketed
generic
sooner
actavis
also
agreed
promote
androgel
urologists
generic
manufacturers
made
roughly
similar
promises
solvay
agreed
pay
millions
dollars
generic
million
total
paddock
million
total
par
estimated
million
annually
nine
years
actavis
see
app
complaint
companies
described
payments
compensation
services
generics
promised
perform
ftc
contends
services
little
value
according
ftc
true
point
payments
compensate
generics
agreeing
compete
androgel
see
complaint
january
ftc
filed
lawsuit
settling
parties
namely
solvay
actavis
paddock
par
ftc
complaint
since
amended
alleged
respondents
violated
federal
trade
commission
act
unlawfully
agreeing
share
solvay
monopoly
profits
abandon
patent
challenges
refrain
launching
generic
products
compete
androgel
nine
years
app
complaint
see
generally
ftc
indiana
federation
dentists
section
encompass
es
practices
violate
sherman
act
antitrust
laws
district
held
allegations
set
forth
antitrust
law
violation
androgel
antitrust
litigation
ii
supp
nd
accordingly
dismissed
ftc
complaint
ftc
appealed
appeals
eleventh
circuit
affirmed
district
wrote
absent
sham
litigation
fraud
obtaining
patent
reverse
payment
settlement
immune
antitrust
attack
long
anticompetitive
effects
fall
within
scope
exclusionary
potential
patent
recognized
antitrust
laws
typically
prohibit
agreements
one
company
pays
potential
competitor
enter
market
citing
valley
drug
geneva
pharmaceuticals
see
also
palmer
agreement
divide
territorial
markets
held
unlawful
face
found
reverse
payment
settlements
patent
litigation
presen
atypical
cases
one
parties
owns
patent
internal
quotation
marks
second
alteration
omitted
patent
holders
lawful
right
exclude
others
market
ibid
internal
quotation
marks
omitted
thus
patent
conveys
right
cripple
competition
internal
quotation
marks
omitted
recognized
parties
sort
case
settle
might
declare
patent
invalid
light
public
policy
favoring
settlement
disputes
among
considerations
held
courts
require
parties
continue
litigate
order
avoid
antitrust
liability
ftc
sought
certiorari
different
courts
reached
different
conclusions
application
antitrust
laws
patent
settlements
granted
ftc
petition
compare
case
settlements
generally
immune
antitrust
attack
ciprofloxacin
hydrochloride
antitrust
litigation
ca
fed
similar
tamoxifen
citrate
antitrust
litigation
similar
antitrust
litigation
settlements
presumptively
unlawful
ii
solvay
patent
valid
infringed
might
permitted
charge
drug
prices
sufficient
recoup
reverse
settlement
payments
agreed
make
potential
generic
competitors
willing
take
fact
evidence
agreement
anticompetitive
effects
fall
within
scope
exclusionary
potential
patent
agree
fact
characterization
immunize
agreement
antitrust
attack
one
thing
refer
circuit
referred
simply
holder
valid
patent
answer
antitrust
question
patent
may
may
valid
may
may
infringed
valid
patent
excludes
except
owner
use
protected
process
product
line
material
emphasis
added
exclusion
may
permit
patent
owner
charge
price
patented
product
invalidated
patent
carries
right
even
valid
patent
confers
right
exclude
products
processes
actually
infringe
paragraph
iv
litigation
case
put
patent
validity
issue
well
actual
preclusive
scope
parties
settlement
ended
litigation
ftc
alleges
substance
plaintiff
agreed
pay
defendants
many
millions
dollars
stay
market
even
though
defendants
claim
plaintiff
liable
damages
form
settlement
unusual
reasons
discussed
part
infra
reason
concern
settlements
taking
form
tend
significant
adverse
effects
competition
given
factors
incongruous
determine
antitrust
legality
measuring
settlement
anticompetitive
effects
solely
patent
law
policy
rather
measuring
procompetitive
antitrust
policies
well
indeed
contrary
circuit
view
pertinent
question
whether
settlement
agreement
fall
within
legitimate
scope
patent
exclusionary
potential
indicated
patent
antitrust
policies
relevant
determining
scope
patent
monopoly
consequently
antitrust
law
immunity
conferred
patent
thus
line
material
explained
improper
use
patent
monopoly
invalid
antitrust
laws
resolved
antitrust
question
case
seeking
accommodation
lawful
restraint
trade
patent
monopoly
illegal
restraint
prohibited
broadly
sherman
act
strike
balance
asked
questions
whether
patent
statute
specifically
gives
right
restrain
competition
manner
challenged
whether
competition
impeded
greater
degree
restraint
issue
restraints
previously
approved
reasonable
see
also
gypsum
courts
must
balance
privileges
patent
holder
licensees
patent
grants
prohibitions
sherman
act
combinations
attempts
monopolize
walker
process
equipment
food
machinery
chemical
nforcement
patent
procured
fraud
may
violate
sherman
act
short
rather
measure
length
amount
restriction
solely
length
patent
term
earning
potential
appeals
apparently
answered
antitrust
question
considering
traditional
antitrust
factors
likely
anticompetitive
effects
redeeming
virtues
market
power
potentially
offsetting
legal
considerations
present
circumstances
related
patents
see
part
infra
whether
particular
restraint
lies
beyond
limits
patent
monopoly
conclusion
flows
analysis
chief
justice
suggests
starting
point
post
dissenting
opinion
another
thing
precedents
make
clear
settlement
agreements
sometimes
violate
antitrust
laws
singer
mfg
example
two
sewing
machine
companies
possessed
competing
patent
claims
third
company
sought
patent
circumstances
might
lead
disclosure
information
invalidate
two
firms
patents
three
firms
settled
disagreements
assigning
broadest
claims
firm
best
able
enforce
patent
yet
potential
competitors
examine
whether
assumption
three
patents
valid
patent
law
allowed
patents
holders
rather
emphasizing
sherman
act
imposes
strict
limitations
concerted
activities
patent
owners
may
lawfully
engage
held
agreements
although
settling
patent
disputes
violated
antitrust
laws
important
part
public
interest
granting
patent
monopolies
exists
extent
public
given
novel
useful
invention
consideration
grant
white
concurring
see
also
new
wrinkle
applying
antitrust
scrutiny
patent
settlement
standard
oil
indiana
similarly
within
settlement
context
without
struck
overly
restrictive
patent
licensing
agreements
irrespective
whether
agreements
produced
revenues
concede
general
elec
permitted
single
patentee
grant
single
licensee
license
containing
minimum
resale
price
requirement
line
material
supra
held
antitrust
laws
forbid
group
patentees
owning
one
patents
insist
licensee
maintain
retail
prices
set
collectively
patent
holders
willing
presume
practice
approved
general
electric
reasonable
restraint
accords
patent
monopoly
granted
patent
law
declined
extend
conclusion
agreements
sherman
act
prohibits
agreements
fix
prices
arrangement
patentees
runs
afoul
prohibition
outside
patent
monopoly
ibid
new
wrinkle
held
roughly
time
respect
similar
arrangement
settlement
litigation
two
patentees
contended
patent
gave
exclusive
right
control
production
one
company
may
presume
right
patent
lead
confer
antitrust
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ollusion
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hand
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dissenting
solvay
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drug
manufacturers
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companies
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patent
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products
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parties
litigated
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years
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solvay
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years
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claim
patent
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law
encourage
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markets
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consumer
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point
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grant
limited
monopolies
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grants
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dawson
chemical
rohm
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scope
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liability
go
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many
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food
machinery
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line
material
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terms
grant
define
limits
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patentee
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within
operation
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union
oil
similar
thus
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per
se
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fix
prices
antitrust
law
long
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patent
holder
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general
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never
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standard
oil
indiana
legitimately
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claims
threatened
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act
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time
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include
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violate
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licenses
fix
prices
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among
competitors
divide
territory
ordinarily
subject
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liability
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hovenkamp
janis
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ip
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pp
ed
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hovenkamp
key
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two
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cf
professional
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estate
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ed
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next
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aggregating
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conduct
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patent
see
within
limits
patentee
rights
patent
monopoly
process
product
authorized
patent
statutes
price
limitations
patented
devices
beyond
limits
patent
monopoly
violate
sherman
act
emphasis
added
majority
suggests
hether
particular
restraint
lies
limits
patent
monopoly
conclusion
flows
applying
traditional
antitrust
principles
ante
seems
mind
regime
courts
ignore
patent
simply
conduct
antitrust
analysis
settlement
without
regard
validity
patent
patent
holder
acting
within
scope
patent
engage
unlawful
anticompetitive
behavior
simply
exercising
monopoly
rights
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government
behavior
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patent
invalid
infringed
scope
patent
rights
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patent
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reference
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law
conceivable
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system
assess
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patents
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suit
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majority
government
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congress
done
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majority
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antitrust
laws
ante
carefully
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cites
singer
manufacturing
new
wrinkle
standard
oil
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cases
stands
uncontroversial
point
patent
holder
acts
outside
scope
patent
longer
protected
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patent
begin
majority
description
singer
inaccurate
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several
patent
holders
competing
claims
entered
settlement
agreement
patents
order
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finding
agreement
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purpose
suppress
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machine
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law
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majority
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agreement
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laws
important
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public
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novel
useful
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grant
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white
concurring
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law
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sherman
act
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holding
limitations
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case
emphasis
added
internal
quotation
marks
omitted
see
also
hovenkamp
citing
singer
quintessential
case
patent
holders
subject
antitrust
liability
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agreement
went
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scope
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thus
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power
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lawfully
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justice
white
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relies
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holders
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art
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laws
new
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holders
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products
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sherman
act
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added
explained
patent
holder
may
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members
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issue
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industry
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industry
completely
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products
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class
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products
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quoting
gypsum
majority
however
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instead
categorizes
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antitrust
scrutiny
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ante
standard
oil
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regarding
competing
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processes
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exchange
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patents
majority
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right
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make
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laws
ante
emphasis
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key
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made
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settlements
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patents
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scrutiny
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makes
sense
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exempts
holder
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laws
insofar
holder
operates
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scope
patent
holder
steps
outside
scope
patent
longer
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patent
defense
majority
points
case
patent
settlement
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scrutiny
merely
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patent
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one
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years
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law
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majority
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general
procompetitive
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act
fact
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patent
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provisions
requiring
parties
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report
settlement
terms
ftc
antitrust
division
department
justice
ante
act
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drug
market
like
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law
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example
allow
generic
manufacturers
enter
market
without
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duplicative
application
process
also
grant
monopoly
first
qualifying
generic
commercially
market
competing
product
see
ii
iv
iv
yes
point
provisions
encourage
competition
trite
unnecessary
say
legislation
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rather
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relationship
patent
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law
ante
indeed
whatever
may
worth
congress
repeatedly
declined
enact
legislation
addressing
issue
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today
see
brief
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citing
bills
introduced
house
senate
since
addition
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settlement
terms
must
reported
ftc
department
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requirement
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role
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law
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settlements
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terms
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consistent
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words
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ftc
antitrust
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review
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make
sure
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power
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scope
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suggests
pparently
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payment
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drug
regulation
ante
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simply
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holder
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mayer
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scores
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iii
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million
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fees
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hovenkamp
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name
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million
per
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herman
note
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generic
incentives
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resolution
pharmaceutical
patent
litigation
colum
rev
citing
goodman
nachman
chen
morgan
stanley
equity
research
quantifying
impact
authorized
generics
acknowledges
problems
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offers
five
sets
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tells
us
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ante
emphasis
added
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holder
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government
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acknowledges
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antitrust
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cash
payments
may
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consideration
alternative
brief
petitioner
example
patent
holder
licenses
product
licensee
fixed
monopoly
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takes
away
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majority
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scope
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effects
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legal
considerations
present
circumstances
ante
see
pacific
bell
telephone
linkline
communications
repeatedly
emphasized
importance
clear
rules
antitrust
law
iv
majority
invokes
procompetitive
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policies
ante
misses
basic
point
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laws
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protection
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treatise
explains
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rule
reason
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whether
balance
practice
reasonably
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whether
yields
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judgments
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run
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rule
reason
designed
judgments
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hovenkamp
omitted
majority
recognizes
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reverse
payment
may
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make
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two
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food
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ten
generics
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market
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drug
first
day
considered
first
applicants
see
iv
ii
bb
see
also
fda
guidance
industry
exclusivity
multiple
andas
submitted
day
july
unusual
occurrence
see
brief
generic
pharmaceutical
association
amicus
curiae
citing
ftc
data
indicating
drugs
subject
many
sixteen
generic
applications
average
number
applications
per
drug
yearly
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majority
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days
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ante
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iii
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months
district
decides
patent
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iii
even
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majority
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discourage
generics
challenging
pharmaceutical
patents
first
place
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litigation
costly
time
consuming
uncertain
see
cybor
fas
ca
fed
opinion
rader
en
banc
discussing
study
showing
federal
circuit
wholly
partially
reversed
almost
percent
claim
construction
appeals
period
brief
generic
pharmaceutical
association
amicus
curiae
citing
study
analyzing
prior
decade
cases
showing
generics
prevailed
cases
lost
cases
generics
enter
risky
terrain
careful
analysis
potential
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prevail
potential
exposure
lose
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prospect
settlements
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settlements
earlier
entry
date
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many
years
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litigation
decreases
incentive
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first
place
majority
assures
us
support
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parties
settle
simply
negotiating
earlier
entry
date
generic
drug
manufacturer
rather
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money
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matter
common
sense
confirmed
experience
parties
likely
settle
broader
set
valuable
things
trade
see
brief
mediation
negotiation
professionals
amici
curiae
majority
today
departs
settled
approach
separating
patent
antitrust
law
weakens
protections
afforded
innovators
patents
frustrates
public
policy
favor
settling
likely
undermines
policy
seeks
promote
forcing
generics
step
litigation
ring
without
prospect
cash
settlements
keep
things
subject
basic
questions
patent
law
unbounded
inquiry
antitrust
law
treble
damages
famously
burdensome
discovery
see
bell
atlantic
twombly
respectfully
dissent