Indivior Suboxone - Complaint

IN

THE

UNITED

STATES

DISTRICT

COURT

FOR

THE

EASTERN

DISTRICT

OF

PENNSYLVANIA

STATE

OF

WISCONSIN

•

By

Attorney

General

Brad

D.

Schimel

'

STATE

OF

ALABAMA

STATE

OF

ALASKA

STATE

OF

ARKANSAS

STATE

OF

CALIFORNIA

STATE

OF

COLORADO

DISTRICT

OF

COLUMBIA

STATE

OF

CONNECTICUT

,

STATE

OF

DELAWARE

STATE

OF

FLORIDA

STATE

OF

HAWAII

STATE

OF

ILLINOIS

STATE

OF

IOWA

STATE

OF

KANSAS

COMMONWEALTH

OF

KENTUCKY

STATE

OF

LOUISIANA

STATE

OF

MAINE

STATE

OF

MARYLAND

COMMONWEALTH

OF

MASSACHUSETTS

STATE

OF

MICHIGAN

STATE

OF

MINNESOTA

STATE

OF

MISSISSIPPI

STATE

OF

MISSOURI

STATE

OF

NEBRASKA

STATE

OF

NEW

YORK

STATE

OF

NORTH

CAROLINA

STATE

OF

OHIO

STATE

OF

OKLAHOMA

COMMONWEALTH

OF

PENNSYLVANIA

.

STATE

OF

RHODE

ISLAND

STATE

OF

SOUTH

CAROLINA

STATE

OF

TENNESSEE

STATE

OF

UTAH

.

STATE

OF

VERMONT

COMMONWEALTH

OF

VIRGINIA

STATE

OF

WASHINGTON

Plaintiffs,

v.

INDIVIOR

INC.

f/k/a

RECKITT

BENCKISER

PHARMACEUTICALS,

INC.;

RECKITT

BENCKISER

HEALTHCARE

(UK)

LTD.;

INDIVIOR

PLC,

f/k/a

RECKITT

BENCKISER

GROUP

pic;

and

MONOSOL

RX,

LLC

No..

Defendants

COMPLAINT

The

States

of

Wisconsin,

Alabama, Alaska,

Arkansas,

California,

Colorado,

Connecticut,

Delaware,

Florida,

Hawaii,

Illinois,

Iowa,

Kansas,

Louisiana,

Maine,

Maryland,

Michigan,

Minnesota,

Mississippi,

Missouri,

Nebraska,

New

York,

North

Carolina,

Ohio,

Qklahotna,

Rhode

Island,

South

Carolina,

Tennessee,

Utah,

Vermont,

Washington,

the

Commonwealths

of

Kentucky,

Massachusetts,

Pennsylvatda,

and

Virginia,

and

the

District

of

Columbia,

by

their

Attorneys

General,

(collectively

"Plaintiff

States"),

complain

against

Defendants

Indivior

Inc.,

fi^k/a

Reckitt

Benckiser

Pharmaceuticals,

Inc.;

Reckitt

Benckiser

Healthcare

(UK)

LTD.;

and

Indivior

PLC,

f/k/a

Reckitt

Benckiser

Group,

pic

(collectively

"Reckitt"

or

''Reckitt

Defendants");

and

MonoSol

Rx,

LLC

("MonoSol")

as

follows:

Nature

of the

Action

1.

Plaintiff

States

bring

this

action

with

respect

to

the

prescription

ding

Suboxone®

("Suboxone")

and

its

generic

equivalent,

co-formulated

buprenoiphine

hydrochloride

and

naloxone

hydrochloride

dehydrate

("co-formulated

buprenorphine/n^loxdne").

2,

Co-formulated

buprenorphineAialoxone

is

a

combination

drug

product

consisting

of

two

active

pharmaceutical

ingredients

that

are

used

together

as

an

opioid

replacement

therapy

for

the

treatment

of

opioid

dependency

(e.g.,

heroin

addiction).

Defendants

are

engaged

in

the

manufacture

or

sale

of

co-formulated

buprenoiphine/naloxone

under

the

brand-name

Suboxone.

2

Plaintiff

States

allege

that

Defendants

employed

an

unlawful,

multi-pronged

scheme

designed

to

prevent

or

delay

less

expensive

generic

versions

of

Suboxone

from

entering

the

market

to

preserve

their

monopoly

profits

from

the

sale

of

Suboxone.

The

scheme

included

product

hopping,

unfounded

allegations

of

safety

issues

with

the

Tablet

form

of

Suboxone,

intentional

delays

involving

the

U.S.

Food

and

Drug

Administration's

(the

"FDA")

requirement

of

a

Risk

Evaluation

and

Mitigation

Strategy

("REMS"),

and

filing

a

sham

citizen

petition

to

delay

would-be

competitors.

4.

As

a

result

of

their unlawful

scheme

to

keep

generic

versions

of

Suboxone

off

the

market,

and

in

violation

of

federal

and

state

antitrust

laws

and

state

consumer-protection

laws,

Defendants

illegally

maintained

monopoly

power

in

the

market

for

co-formulated

buprenorphine/naloxone

opioid

treatments

in

the

United

States

from

October

8,

2009

until

generic

entry

in

March

2013,

and

continue

to

dominate

the

market

for

co-formulated

buprenorphine/naloxone

film.

Defendants'

scheme

to

delay

generic

competition

intended

and

had

the

purpose

of,

preventing

generic

substitution

to

Suboxone, and

denying

consumer

choice

for

generic

versions

of

Suboxone.

As

a

result

of

Defendants'

anticompetitive

conduct,

consumers

and

state

6.

governments

have

been

limited

in

their

treatment

options

for

opioid

addiction

and

continue

to

be

deprived

of

the

benefits

of

generic

competition

while

Defendants

continue

to

reap

monopoly

profits

from

the

sale

of Suboxone.

Defendants'

conduct

is

deceptive

and

unconscionable,

includes

unfair

trade

practices

and

unfair

methods

of

competition,

or

is

otherwise

unlawful

under

the

consumer

protection

laws

of

certain

of

the

Plaintiff

States.

Their

conduct

caused

harm

to

Plaintiff

States,

3

governmental entities,

and

consumers by

forcing

them

to

pay

more

for

Suboxone

than

they

otherwise

would

in

a

competitive

market

and

limits

their

options

for

the

treatment

of

opioid

addiction.

8.

Consequently

the

Plaintiff

States,

by

and

through

their

Attorneys

General,

bring

this

action

to

seek

injunctive

relief,

penalties,

and

disgorgement

for

the

Defendants'

unlawful

Hionopolizatxon

of

the

market

for using

co-formulated

buprenorphine/naloxone

for

treating

opioid

addiction.

Jurisdiction

&

Venue

9.

This

Court

has

subject

matter

jurisdiction

under

28

U.S.C.

§§

1331

and

1337

over

the

federal

antitrust

claims

under

the

Sherman

Act.

This

Court

also

has

supplemental

jurisdiction

over

the

state

law

claims

under

28

U.S.C.

§

1367

because

those

claims

are

so

the

federal

claims

that they

form

part

of

the

same

case

or

controversy.

The

exercise

of

supplemental

jurisdiction

avoids

unnecessary

duplication

and

multiplicity

of

actions

and

is

in

the

interests

of

judicial

economy,

convenience,

and

fairness.

10.

Venue

is

proper

in

the

Eastern

District

of

Pennsylvania

under

15

U.S.C.

§

22

and

28

U.S.C.

§§

1391(b)

and

(c).

Each

Defendant

transacts

business

or

committed

an

illegal

oi*

tortious

act

in

this

district,

or

has

an

agent

or

can

be

found

in

this

district,

and

the

interstate

trade

and

commerce,

hereinafter

described,

is

carried

out

in

substantial

part

in

this

district.

Parties

11.

Defendant

Indivior

Inc.

f/k/a

Reckitt

Benckiser Pharmaceuticals,

Inc.

("Reckitt")

.

is

a

Delaware

corporation

with

its

principal

place

of

business

located

at

10710

Midlothian

Turnpike,

Suite

430,

Richmond,

Virginia

23235.

Reckitt

Benckiser

Pharmaceuticals,

Inc.

was

demerged

from

its

prior

parent,

the

Reckitt

Benckiser

Group

pic,

into

Indivior

PLC

in

December

4

2014.

Indivior

Inc.

is

a

wholly-owned

subsidiary

of

Indivior

PLC.

Indivior

Inc.

is

engaged

in

the

development,

manufacture,

and

sale

of

pharmaceuticals,

including

Suboxone,

and

health

care

products

and

services

throughbut

the

United

States,

and

is

in

whole

or

in

part

responsible

for

some

or

all

of

the

conduct

alleged

in

this

Complaint

and

attributed

to

Reckitt.

Defendant

Reckitt

Benckiser

Healthcare

(UK)

Ltd.

is

a

British

corporation

12.

incoiporated

under

the

laws

of

England

and

Wales,

with

its

registered

office

located

at

103-105

Bath Road,

Slough,

Berkshire,

SL1

3UH.

This

defendant

is

engaged

in

the

development

and

manufacture

of

pharmaceuticals,

including

Suboxone,

and

health

care

products

and

services

'

made

and

sold

subject

to

FDA

approval,

and

is

in

whole

or

in

part

responsible

for

some

or

all

of

the

conduct

alleged

in

this

Complaint

and

attributed

to

Reckitt.

This

conduct

includes

but

is

not

limited

to

the

execution

of

the

initial

contract

with

Monosol

Rx,

LLC

in

December

2006 that

initiated

the

joint

venture

to

create

and

manufacture

Suboxone

Film.

13.

Defendant

Indivior

PLC,

was

formerly

part

of

Reckitt

Benckiser

Group

pic,

and

is

a

British

corporation

incoiporated

under

the

laws

of

England

and

Wales,

with

its

registered

office

located

at

103-105

Bath

Road,

Slough,

Berkshire,

SL1

3UH.

This

defendant

is

engaged

in

the

development,

manufacture,

and

sale

of

pharmaceuticals,

including

Suboxone,

and

health

care

products

and

services

throughout

the

United

States,

and

is

in

whole

or

in

part

responsible

for

some

or

all

of

the

conduct

alleged,

in

this

Complaint

and

attributed

to

Reckitt.

Indivior

PLC

is

the

successor

in

interest

to

Reckitt

Benckiser

Group

pic.

.The

Board

of

Directors

of

Indivior

PLC's

predecessor,

Reckitt

Benckiser

Group

pic,

were

advised

of

the

generic-impairing

purpose

of

and

anticompetitive

tactics

the

product-hopping

alleged

herein

and

approved

the

scheme

and

its

purposes.

Unless

identified

individually,

Indivior

Inc.

and

Indivior

PLC

are

collectively

referred

to

as

t(

Reckitt."

5

14.

Defendant

MoftoSol

Rx,

LLC

is

a

Delaware

limited

liability

company

witli

its

principal

place

of

business

located

at

6560

Melton

Road,

Portage,

Indiana,

46368.

This

defendant

is

engaged

in

tlie

development^

manufacture,

and

sale

of

pharmaceuticals

and

health

care

products

and services

throughout

the

United

States,

and

is

in

whole

or

in

part

responsible

for

some

or

all

of

the

conduct

alleged

in

this

Complaint

and

attributed

to MonoSol.

15.

Reckitt's

actions

described

in

this

Complaint

are

part,

and

in

furtherance

of,

the

illegal

monopolization,

attempted

monopolization

and

unfair

and

deceptive

trade

practices

alleged

herein.

All

actions

described

herein

were

authorized,

ordered,

or

performed

by

Reckitt's

various

officers,

agents,

employees

or

other

representatives

while

actively

engaged

in

the

management

of

Reckitt's

affairs,

or

that

of

their

predecessors-in-interest,

within

the

course

and

scope

of

their

duties and

employment,

and

with

the

actual,

apparent,

and

ostensible

authority

of

Reckitt.

16.

MonoSol's

actions

described

in

this

Complaint

are

part,

and

in

furtherance

of,

the

illegal

monopolization,

attempted

monopolization

and

unfair

and

deceptive

trade

practices

alleged

herein.

All

actions

described

herein

were

authorized,

ordered,

or

performed

by

MonoSol's

various

officers,

agents,

employees

or

other

representatives

while

actively

engaged

in

the

management

of

MonoSol's

affairs,

or

that

of

their

predecessors-in-interest,

within

the

course

and

scope

of

their

duties

and

employment,

and

with

the

actual,

apparent,

and

ostensible

authority

of

MonoSol.

17.

Each

of

the

Plaintiff

States

and

citizens

residing

therein

purchased

or

provided

reimbursement

for

Suboxone

Film

and

Suboxone

Tablets at

supra-competitive

prices

as

a

result

of

Defendants'

conduct

alleged herein.

6

18.

Plaintiff

States

bring

this

action,

by

and

through

their

Attorneys

General,

in

their

sovereign

capacities

to

enforce

their

own

laws

and

in

their

quasi-sovereign

capacities

to

protect

the

economic

well-being

of

the

States

and

their

residents

in

their

law

enforcement

and/or

sovereign

or

quasi-sovereign

capacities,

as

a

civil

law

enforcement

action

from

the

harm

that

results

from

the

violations

of

antitrust

and

consumer-protection

laws.

Relevant

Market

19,

The-

relevant

product

market

is

any

drug

with co-formulated

buprenorphine/naloxone

as

the

active

ingredients

for

the

treatment

of

opioid

addiction.

There

are

no

feasible

substitutes

for

co-formulated

buprenoiphine/naloxone

in

the

pharmacological

intervention

of

opioid

dependence.

This

market

includes

Suboxone

Film

and

Tablets

and

any

AB-rated

generics

that

can

be

substituted

for

them.

20.

Suboxone

Tablets

and

Suboxone

Film

do

not

exhibit

significant,

positive

price

cross-elasticity

of

demand

with

any

opioid

dependence

treatment

or

other

product

other

than

AB-

rated

generic

versions

of

buprenoiphine/naloxone

tablets.

Suboxone

is

categorized

as

a

schedule

IH

drug

and

co-formulated

with

an

opioid

antagonist

to

deter

abuse.

Until

2013,

Suboxone

was

the

only

replacement

maintenance

therapy

that

could

be

prescribed

in

an

office

setting

and

taken

by

patients

at

home.

By

contrast,

Methadone,

is

a

Schedule

11

drug

and

must

be

administered

in

a

clinic.

Subutex,

another

opioid

treatment

drug

marketed

by

RecMtt,

is

not

interchangeable

because

it

lacks

naloxone,

the

opioid

antagonist

that

deters

abuse.

Zubsolv

(a

generic

buprenorphine/naloxone

tablet)

and

Bunavail

(a

generic

buprenorphine/naloxone

film)

entered

the

market

after

generic

Suboxone

Tablets.

Zubsolv

and Bunavail

are

not

AB-rated

to

the

Film

or

Tablets.

21.

The

relevant

geographic

market

is

the

United

States

and

its

territories.

7

22.

Before

October

8,

2009,

Suboxone

was

the

only

co-formulated

buprenorphine/naloxone

opioid

treatment

because

of

its

orphan

drug

status,

so

Reckitt

enjoyed

100

percent

market

share

in

the

United

States

and

its

territories.

After

the

exclusivity

period

expired,

Reckitt's

branded

Suboxone

products,

including

the

Suboxone

Film

it

introduced

in

September

2010,

remained

the

sole

source

of

co-formulated

buprenorphine/naloxone

until two

generic

manufacturers

introduced

generic

tablets

in

March

2013.

An

additional

generic

tablet

manufacturer

was

approved

in

September

2016.

When

Suboxone-branded

Tablets

and

Film

were

sold

alongside

one

another,

Reckitt

successfully

converted

most

of

the

Suboxone

market

to

its

Film,

for

which

there

are

no

generic

substitutes.

After

the

introduction

of

the

two

generic

tablet products

in

2013,

Reckitt's

market

share

for

co-formulated

buprenorphine/naloxone

dropped

to

68

percent.

Trade

and

Commerce

23.

Since

2002,

Reckitt

has

sold

Suboxone

in

interstate

commerce

throughout

the

United

States.

Reckitt

sold

Suboxone

in

interstate

commerce

in

each

of

the

States.

Reckitt's

24.

unlawful

activities

alleged

in

this

Complaint

occurred

in

and

had

a

substantial

effect upon

interstate

commerce.

According

to

Reckitt's

own

annual

reports,

Reckitt's

revenues

for

Suboxone

sold

in

the

United

States

surpassed

$2

billion.

MonoSol

entered

into

a

series

of agreements

with

Reckitt,

beginning

in

2006, for

25.

the

development and

manufacture

of

Suboxone

Film.

MonoSol

manufactures

all

Suboxone

Film

sold

in

interstate

commerce

in

each

of

the

States.

MonoSol's

unlawful

activities

alleged

in

this

Complaint

have

occurred

in

and

have

had

a

substantial

effect

on

interstate

commerce.

MonoSol

has

received

fixed

payments

as

well

as

royalties

associated

with

the

sales

of

Suboxone

Film.

8

Factual

Background

I.

Generic

Drug

Approval

Process

26.

The

manufacture

and

commercial

sale

of

pharmaceutical

drugs

are

regulated

by

the

FDA

under

the

Federal

Food,

Drug,

and

Cosmetic

Act,

21

U.S.C.

§

301

et

seq.

The

manufacturer

of

a

new

drug

must submit

a

new

drug

application

("NDA")

that

demonstrates,

among

other

things,

a

drug's

safety, clinically

proven

effectiveness,

composition,

and

patent

coverage.

27.

To

speed

the

entry

of

generic

drugs

and

to

facilitate

price

competition

with

branded

drugs.

Congress

passed

the

Drug

Price

Competition

and

Patent

Term

Restoration

Act

of

1984

(the

"Hatch-Waxman

Act").

Under

the

Hatch-Waxman

Act,

generic

drug

manufacturers

may

receive

FDA

approval

for

generic

drugs

without

replicating

the

costly

and

time-consuming

clinical

trials

involved

in

an

NDA.

28.

Instead

of

submitting

an

NDA,

a

generic

ding

manufacturer

may

submit

an

abbreviated

new

drug

application

("ANFDA")

and

incoiporate

data,

such

as

clinical

studies,

that

the

NDA

filer

submitted

to

the

FDA.

29,

To

be

approved,

an

ANDA

must

demonstrate

that

the

generic

drug:

(a)

has

the

same

active

ingredients

as;

(b)

is

pharmaceutically equivalent

to

(same

dosage

form

and

strength);

and

(c)

is

bioequivalent

to

(exhibiting

the

same

drug

absorption

characteristics)

the

previously

approved

drug.

Oral

drags

that

are

proven

to

be

both pharmaceutically

equivalent

and

bioequivalent

to

a

branded oral

drug

receive

an

"AB"

rating

from

the

FDA,

indicating

they

are

therapeutically

equivalent

to

other

drugs

with

the

same

rating

in

the

same

category.

In

most

circumstances,

only

oral

drugs

that

carry

the

FDA's

AB

generic

rating

in

a

particular

category

30.

9

may

be

substituted

by

pharmacists

for

a

physician's

prescription

for

a

brand-name

drug

without

the

physician's

approval.

.

"*

31.

The

FDA

publishes

a

list

of

all

approved

drugs

and

therapeutic

equivalents

in

the

Approved

Drug

Products

with

Therapeutic

Equivalence

Evaluations

(commonly

referred

to

as

the

"Orange

Book").

32.

Once

the

FDA

approves

an

ANDA'fof

a

generic

drug

and

determines

that

it

is

AB-rated

to

the

branded

drug,

state

laws

govern

how

the

generic

may

be

substituted

for

the

brand

name

drug,

prescribed

by

physicians.

In

most

States

and

under

most

health

plans,

a

pharmacist

may

(and

often

must)

substitute

an

AB-rated

generic

drug

for

a

prescribed

brand

name

drug.

.

'

11.

Suboxone's

Orphan

Drug

Designation

33.

In

2002,

Reckitt

introduced

Suboxone

as

a

sublingual

tablet

("Suboxone

Tablets").

At

that

time,

the

two

component

ingredients

of

Suboxone

were

not

subject

to

any

patent

protection.

Naloxone

was

first

approved

by

the

FDA

in

1971,

and

buprenotphine

was

first

approved

by

the

FDA

in

1982

as

an

injectable

analgesic

drug.

Reckitt

acknowledged

that

it

had

no

knowledge

of

any

existing

patent

protection

for

Suboxone

Tablets

at

the

time

of

its

FDA

application.

34.

•

Instead

of

exclusivity

through

patent

protection,

RecMtt's

Suboxone

Tablets

were

granted

a

7-year

period

of

exclusivity

as

an

"orphan

drug"

by

the

FDA.

35.

A

drug

can

be

designated

as

an

"orphan

drug"

when

the

FDA

determines

that

either

(a)

the

drug

is

intended

for

the

safe

and

effective

treatment,

diagnosis

or

prevention

of

a

rare

disease

or

disorder

that

affects

fewer

than

200,000

people

in

the

United

States;

or

(b)

the

disease

or

disorder affects

greater

than

200,000

people,

but

the

manufacturer

is

not

reasonably

10

expected

to

recover

the

costs

of

developing

and

marketing

the

treatment

drug

from

sales

in

the

United

States.

36.

Reckitt

argued

that

its

drug

Suboxone

would

be

used

for

the

treatment

of

fewer

than

200,000

people,

but

the

FDA

rejected

that

argument.

Instead,

the

FDA

granted

oiphan

drug

status

to

Suboxone

Tablets

based

on

Reckitfs

representations

that

it

would

be

unlikely

to

recover

the

costs

of

developing

and

marketing

the

drug.

After

designation

as

an

orphan

drug

by

the

FDA,

the

FDA

approves

the

drug

for

marketing.

It

is

then

eligible

for

a

period

of

orphan

drug

regulatory

exclusivity

for

7

years,

allowing

it

to

be

marketed

as

a

brand-name

drug,

free

from

generic

competition.

37.

Suboxone

was

designated

as

an

oiphan

drug

in

1994,

but

was

not

approved

for

7-

year

marketing

exclusivity

until

2002.

Reckitt's

7-year

exclusivity

expired

on

October

8,

2009.

During

that

time,

Reckitt was

able

to

market

sublingual

tablet

Suboxone

without

any

threat

of

competition

from

any

generic

co-formulated

buprenoiphine/naloxone

for

the

treatment

of

opioid

addiction.

38.

Although

Reckitt

secured

an

oiphan

drug

designation

for

Suboxone

Tablets

on

the

basis

of

a

cost

recovery

designation,

Reckitt

quickly

began

earning

profits

on

Suboxone

Tablets,

earning

more

than

$2

billion

by

2010.

Its

successor

in

interest,

Indivior

Inc.,

derived

almost

all

of

its

revenue

from

the

sales

of

Suboxone.

.

r

vV—

III.

Reckitt's

Product-Hopping

Scheme

A.

Suboxone

Tablet

Market

Share

Threatened

by

Generic

Entry

39.

As

the

oiphan

ding

exclusivity

period

for

Suboxone

Tablets

neared expiration,

Reckitt

knew

generic

manufacturers

would

seek

FDA approval

to

sell

lower-priced

generic

versions

of

co-formulated

buprenorphine/naloxone

in

direct

competition

to

Suboxone

Tablets.

11

40.

As

AB-rated

generic

drugs

become

available,

lower-priced

generic

competitors

are

rapidly

substituted

for

their

brand-name

counterparts

because

the

Hatch-Waxman

Act

and

most state

drug

product

selection

laws

permit

(or

require)

pharmacists

to

substitute

an

AB-rated

generic

drug

for

the

branded

version

unless

the

prescription

is

specifically

designated

otherwise.

41.

Manufacturers

of

brand-name

drugs

typically

lose

80

percent

or

more

of

their

sales

to

AB-rated

generic

competition

soon

after

a

generic

competitor

enters

the

market.

Until

an

AB-rated

generic becomes

PDA approved, however,

a

branded

manufacturer

may

continue

to

charge

supra-competitive

prices.

42.

Reckitt was

concerned

that

generic

entry

would

significantly

reduce

the

company's

sales and

revenue

of

its

Suboxone

Tablets.

In

its

annual

reports

between

2008

and

2010,

Reckitt

stated:

•

"As

with

all

prescription

drugs,

the

protection

of

this

business

has

a

finite

term

unless

replaced

with

new

treatments

or

forms.

Therefore,

the

revenue and

income

of

this

business

may

not

be

sustained

going

forward

unless

replaced

with

new

treatments or

forms,

on

which

the

Company

is

actively

working

"

•

"The

Group

continues

to

search

for

ways

to

offset the

impact

of

the

loss

of

exclusivity

[of

Suboxone]

in

the

USA

at

the

end

of

September

2009,

up

to

80%

of

the

revenues

and

profits

of

that

business

might be

lost

to

generic

competition

in

2010,

with

the

possibility

of

further

erosion

thereafter."

•

"It

is

well

known

that

by

far

the

largest

part

of

the

Pharmaceuticals

business,

the

Suboxone

Tablets

in

the

USA,

can

become

subject

to

generic

competition

at

any

time."

12

•

"The

expiry

of

the

Group's

exclusive

license

for

S^boxone

in

the

United

States

in

2009

and

in

the

rest

of

the

world

in

2016

could

expose

the

business

to

competition

from

generic

variants."

'

43.

FDA

regulations

allow

branded

manufacturers

to

seelc

FDA

approval

to

modify

the

dosage

form

and

strength

of

their

existing

products.

Changing

the

dosage

form

and

strength

of

a

branded

drug

changes

its

pharmaceutical

equivalence

and will

alter

the

AB-rating

of

any

proposed

or

available

generic

substitutes.

44.

Faced

with

the

impending

loss

of

exclusivity

and

in

profit,

45.

B.

Suboxone

film

Enters

the

Market

In

July

2007,

Reckitt

informed

the

FDA

that

it

planned

to

file

a

new

drug

46.

application

to

market

Suboxone

in

a

sublingual

Film.

13

47.

48.

MonoSol

encouraged

Reckitt

and

other

pharmaceutical

companies

to

engage

in

illegal

and

anticompetitive

product-hopping

on

its

website:

•

"Patient-friendly

delivery

with

no

generic

substitution"

•

"Partnering

with

MonoSol

Rx

offers

pharmaceutical

companies

the

ability

to

introduce

products

that

are

highly

differentiated

from

other

dosage

forms,

both

in

performance

and

marketability,

creating

fresh,

dynamic

revenue-

generating

opportunities."

•

Mock

quote

used

in

"We

launched

this

brand

5

years

ago.

We're

not

just

letting

it

go

over

the

cliff.

It's

time

for

the

new

strategy."

•

"PharmKlm

formulations

represent

revenue-life

cycle

extensions

for

products

.

•

with

patent

lives

that

have

expired

or

are

approaching

expiration."

•

"If

patient-friendly

delivery,

patent

expiry,

or

launching

the

is

on

your

agenda,

the

time

is

right

to

consider

the

advantages

of

PharmFilm

•

'^Because

PharmFilm

is

a

unique,

patent-protected

delivery

technology,

it

can

be

an

ideal

strategy

for

extending

the

life

of

a

brand

as

generic

incursion

approaches."

•

'ThannFilm

drug

technology

allows:

no

generic

substitution."

14

49.

Reckitt

and

MonoSol's

development

of

the

new

sublingual

Film

was

intended

to

thwart

generic

entry,

and

to

maintain

Suboxone's market

share

by

extending

Reckitt's

exclusivity

on

a

co-formulated

buprenorphine/naloxone

product.

In

April

2008,

MonoSol

applied

for

a

patent,

wMch

was

issued

as

patent

number

8,017,150

entitled

"Polyethylene

Oxide-Based

Films

and

Drag

Delivery

Systems

Made

Therefrom"

and

was

listed

by

Reckitt

in

the

FDA's

Orange

Book.

50.

51.

52.

Reckitt

listed

the

*

150

patent

as

well

as

patent

numbers

8,475,832,

and

8,603,514

in

the

FDA

Orange

Book,

and

alleged

that

they

cover

Suboxone

Film.

The

earliest

patent

expires

in

2023,

and

all

are

the

subject

of

several

lawsuits

brought

by

MonoSol

and

Reckitt

against

the

many

companies

that

sought

FDA

approval

to

make

generic

Suboxone

Film.

These

patents

are

also

the

subject

of

multiple

inter-partes

proceedings

challenging

their

validity.

Reckitt

and

MonoSol

have

also

sued

their

potential

Suboxone

Film rivals

for

infringement

on

two

additional

patents,

patent

numbers

8,900,497,

and

8,906,277,

which

were

not

listed

in

the

Orange

Book.

The

U,S,

District

Court

of

Delaware

has

invalidated

the

'832

patent.

53.

54.

Throughout

the

Suboxone

Film

development

process,

MonoSol

was

aware

that

the

timing

of

both

FDA

approval

and

final

product

development

was

crucial

to

bring

the

Suboxone

Film

to

market

prior

to

the

entry

of

generic

co-formulated

buprenorphine/naloxone

15

tablets.

MonoSol

actively

strategized

-with

Reckitt

to

minimize

various

manufacturing

delays

to

beat

the

generic

tablets

to

market.

On

October

20,

2008,

Reckitt

submitted

NDA

022410

to

the

FDA

to

market

the

55.

sublingual

Film

version

of

Suboxone,

which

was

received

by

the

FDA

on

October

21,

2008.

Because

Suboxone

Film

is

in

a

different

dosage

form

than

Suboxone

Tablets,

the

two

are

not

pharmaceutically

equivalent.

"

56.

Without

pharmaceutical equivalency,

drugs

cannot

be

AB-rated

substitutes

for-

'

one

another.

Thus,

any

tablet

form

of

generic

co-formulated

buprenoj^hine/naloxone

would

not

be

an

AB-rated

generic

substitute

for

Suboxone

Film,

and

typically

a

pharmacist

may

not

automatically

provide

a

patient

with

generic

co-fomiulated

buprenorphine/naloxone

tablets

when

presented

with

a

prescription

for

Suboxone

Film,

i

57.

On

August

21,

2009,

less

than

two

months

before

the

October

2009

expiration

of

exclusivity

on

the

tablet

formulation,

the

FDA

rejected

Reckitt's

application

to

market

Suboxone

Film

due

to

concerns

that

the

Film

could

be

abused

by

patients

or

others

and

could

result

in

accidental

exposure

to

children.

58.

The

Food

and

Drug

Administration

Amendments

Act

of

2007

gives

the

FDA

the

authority

to

require

a

Risk

Evaluation

and

Mitigation

Strategy

("REMS"),

which

is

a

document

submitted

by

the

manufacturer

that

contains

a

risk

management

plan

or

risk-minimization

strategy

that

goes

beyond

the

professional

labeling

to

ensure

that

the

benefits

of

a

drug

outweigh

the

risks.

'

59.

In

response

to

the

FDA's

rejection

of

the

Suboxone

Film

application,

Reckitt

submitted

a

revised

REMS

to

the

FDA

to

address

safety

concerns

the

Film

form.

60,

The

FDA

approved

Reckitt's

NDA

for

Suboxone

Film

on

August

30,

2010.

16

61.

MonoSol

remained

active

in

the

NDA-approvai

process

and

committed

to

doing

everything

possible

to

enable

FDA

approval

as

quickly

as

possible,!

62.

Reckitfs

Film

offers

no

significant

actual

benefits

for

patients

over

its

Tablet.

FDA

approval

of

Suboxone

Film

was

based

on

the

studies

Reckitt

used

to

establish

safety

and

efficacy

of

the

Tablets,

and

Reckitt's

representation

that

the

Film

had

sufficient

equivalent

bioavailability

to

the

Tablets.

The

FDA

confirmed

that

Reckitt's

NDA

contained

no

new

efficacy

studies.

In

fact,

Reckitt

even

represented

to

the

FDA

.that

any

differences

between

the

two

formulations

were

"clinically

insignificant."

Until

August

2012,

the

dosage

strengths

of

the

two

Suboxone

products

were

identical.

63.

The

most

important

factor

identified

by

Reckitt

in

bringing

Suboxone

Film

to

market

was

avoiding

competition

from

generic

entrants.

64.

Suboxone

Film

has

disadvantages

compared

to

Suboxone

Tablets:

*

Film

is

easier

to

conceal

and

smuggle

into

jails

and

prisons;

•

Increased

naloxone

bioavailability

in

the

Film

version,

increasing

the

risk

of

unwanted

opioid

withdrawal

symptoms;

•

Film's

rapid

dissolution

creates barriers

to

removal

if

accidentally

ingested.

•

Film

is

more

dangerous

because

less

unpleasant

taste

compared

to

Tablets,

making

children

less

likely

to

spit

it

out;

-

•

Film

is

more

likely

to

become

stuck

on

the

tongue

if

accidentally

ingested

by

a

child;

•

Film's

increased

strength

of

12mg

increased

dosage

exposure

to

children;

17

65.

The

FDA

found

that

Siiboxone

Film

had

no

demonstrable

safety

advantage

over

Suboxone

Tablets.

The

FDA

also

concluded

that

the

studies

Reckitt

offered

to

the

contrary

were

flawed,

stating:

•

"Almost all

of

the

safety

experience

with

the

proposed

new

formulation

was

derived

from

a

single

study.

This

study

had

a

number

of

flaws,

including

inadequate

training

of

personnel

conducting

safety

exams,

inconsistent

recording

of

findings,

treatment

of

participants

with

dosing

regimens

not

recommended

in

the

proposed

labeling,

and

a

high

drop-out

rate;"

•

"After review

of

the

clinical

study

report

and

database

for

the

study

RB-US-

07-0001

[used

to

support

Recldtt's

NDA

for

Suboxone

Film],

our

overall

conclusion

is

that

the

study

was

poorly

designed

and

conducted

and

was

not

usefiil

for

demonstrating

any

difference

in

the

safety

profile

or

abuse potential

of

the

two

formulations;"

and

•

"There

was

no

positive

control

arm

(Suboxone

Tablet

group)

in

this

study.

So

it

would

be

impossible

to

claim

any

potential

advantages

of

Suboxone

strip

[Film]

over

the

current

Suboxone

Tablet

product."

Furthermore,

the

FDA

expressed

concerns

that

the

Suboxone

Film

actually

presented

increased

safety

issues:

"It

should

be

noted

that

the

proposed

filmstrip

product

cannot

be

spit

out

easily

and

dissolves

quickly.

Therefore,

to

the

extent

that

some

cases

may

be

mitigated

by

the

child

spitting

out

the

Tablet

before

full

absorption,

the

filmstrip

product

could

be

more

hazardous

than

the

Tablet,"

This

concern

was

based

upon

the

fact

that

once

in

the

mouth,

the

Suboxone

Film

hydrates

into

a

gel

in

30

Seconds

and

is

completely

absorbed

in

3

minutes,

releasing

all

of

the

buprenorphine

contained

in

the

Film.

Suboxone Tablets,

however.

66.

18

may

take

up

to

10

minutes

to

fully

dissolve.

Many

children

who

accidentally

ingest

Suboxone

Tablets

spit

them

out

quickly,

biit

even

when

they

do

succeed

in

swallowing

the

Tablets,

the

buprenorphine

is

absorbed

to

a

far

lesser

extent

in

the

tablet

formulation

than

in

the

Film.

These

factors

make

Suboxone

Tablets

potentially

less

dangerous

than

Film

in

accidental

pediatric

exposure.

67.

The

FDA

also

noted

the

possible

increase

of

potential

for

abuse

with

the

Film;

that

the

Fihn

is

both

easier

to

conceal

or

divert,

and

that

it

is

easier

to

dissolve

and

iiyect.

'Taken

together,

these

findings

suggest

that

expanded

use

of

this

product will

result

in

significant

abuse

and

diversion

that

needs

to

be

considered

with

any

anticipated

benefits

the

drug

may

offer."

In

fact,

almost

6,000

Suboxone

Film

strips

(46

percent

of

those

dispensed

to

study

subjects)

were

"missing"

after

the

limited

clinical

studies

performed

by

Reckitt

to

gain

FDA

approval.

68.

Reckitt

is

aware

of

the

advantages

that

Suboxone

Tablets

have

over

Suboxone

Film,

as

evidenced

by

the

fact

that

Reckitt

markets

Suboxone

exclusively

in

tablet

form

in

almost

all

of

the

countries

where

it

is

sold. This

continues

to

be

true

even

after

Reckitt

removed

the

Tablets

from

the

U.S.

market.

For

instance,

Reckitt

is

currently applying

to

sell

Suboxone

Tablets

in

China,

rather

than

in

the

Film.

C«

Reckitt

Converts

the

Market

From

Tablets

to

Film

69,

Reckitt's

reformulation,

as

devised

by

MonoSol,

was

designed

for

the

purpose

of

defeating

the

AB-rated

substitutability

that

generic

co-formulated

buprenorphine/naloxone

tablets

would

enjoy

once

Suboxone's

orphan

drug

exclusivity

period expired

October

8,

2009.

19

70.

71.

72.

To

complete

their

plan

to

extend

Suboxone's

exclusivity

by

the

patent

protection

claimed

for

the

Film,

Recldtt

then

engaged

in

a

multi-faceted

campaign

to

convert

the

co-

formulated

buprenorphine/naloxone

market

to

Suboxone

Film.

73.

Reckitt

purposeMly

based

its

campaign

to

convert

the

market

on

unfounded

safety

concerns about

the

Tablets,

including

concerns

regarding

accidental

exposure

to

children.

These

concerns

were

a

sham

developed

to

convince

prescribers

and

payors

that

the

Suboxone

Film

provided

increased

safety

and

efficacy

over

the

Tablets,

20

74.

Reckitt

conuiumicated

to

the

public

and

to

the

medical

commxmity

that

single-

dose

or

unit-dose

packaging

was

necessary

to

prevent

potential

exposure

to

multiple

doses

in

the

case

of

accidental

pediatric

exposure.

Recldtt

then

began

marketing

Suboxone

Film

in

unit-dose

packaging.

75.

Reckitt partnered

with

consulting

firm

Venebio

Group,

LLC

to

develop

its

"Film

is

safer"

platform.

Venebio's

website

states

that

the

project

"evaluated

effectiveness

of

innovative

pharmaceutical

packaging

in

reducing

pediatric

exposure."

76.

Reckitt's

Suboxone

Tablets

have

been

sold

in

unit-dose

packaging

outside

of

the

United

States

since

2005.

Reckitt

did

not

make

any

attempt

to

convert

its

tablet

packaging

to

unit-dose

packaging

in

the

United

States.

Rather,

despite

its

claimed

safety

concerns,

Reckitt

continued

to

sell

Tablets

in

multi-unit

bottles,

contrary

to

its

practices

in

other

countries,

until

it

•

withdrew

its

Tablets

from

the

United

States

market

upon

the

entry

of

generic

versions.

77.

Reckitt

began

a

multi-front

offensive

to

drive the

Film

to

market

before

the

generics

could

enter

with

their

version

of

the

Suboxone Tablet.

21

78.

79.

80.

In

September

2012,

Recldtt

issued

a

press

release

advising

the

public

and

prescribing

physicians

that

Recldtt

intended

to

withdraw

the

Tablets

from

the

market

within

the

months.

Reckitt's

press

release

falsely

stated

that

the

withdrawal

was

due

to

the

"pediatric

exposure

safety

issue."

Recldtt

was

aware

that

its

assertions

of

pediatric

safety

concerns

regarding

the

Tablet

formulation

were

unfounded.

81.

22

82.

Reckitt

also

sought

a

declaration

from

the

FDA

that

Suboxone

Tablets

.were

being

volimtarily

pulled

irom

the

market

by

Reckitt

due

to

safety

issues.

83.

As

another

part

of

its

plan

to

convert

the

market

from

Tablets

to

Film,

Reckitt

utilized

a

patient

assistance

program

called

"Here

to

Help,"

that

provided

qualified

individuals

with

free

of

low-cost

drugs.

84.

Finally,

Reckitt

induced

conversion

of

the

market

to

the

Film

by

raising

the

price

of

its

Suboxone

Tablets

before

the

introduction

of

the

AB-rated

generic

tablet

product

into

the

market.

As

a

result,

the

Film

was

initially

cheaper

than

the

branded

tablets.

Reckitt

also

developed

programs

that

provided

discounts

and

rebates

to

consumers

who

purchased

the

Film.

85.

86.

Reckitt

engaged

in

each

of

these

actions

with

the

purpose

of

converting

the

prescription

market

for

Suboxone

from

Tablets

to

the

Film

to

thwart

generic

competition

once

AB-rated

generic

substitutes

became

available

for

Suboxone

Tablets.

23

87.

Reckitt's

product-hopping

scheme

was

successful.

By

imd-2012,

the

Film

accounted

for

over

70

percent

of

Suboxone

prescriptions,

and

by-the

time

the

generic

tablets

received

FDA

approval

in

February

2013,

85

percent

of

Suboxone

prescriptions

were

written

for

the

Film

instead

of

for

Suboxone

Tablets.

88.

Reckitt

withdrew

Suboxone

Tablets

from

the

market

on

March

18,2013.

IV.

Reckitt

Delays

Generic

Entry

89.

AKDAs

for

approval

to

sell

generic

Suboxone

were

filed

in

2009.

Although

the

orphan

drug

exclusivity

period

on

branded

Suboxone

Tablets

expired

on

October

8,

2009,

generic

buprenoiphine/naloxone tablets

did

not

gain

FDA

approval

until

February

2013.

This

delay

was

due

in

large

part

to

Reckitt's

tactics,

which

were

intended

to

delay

generic

entry

while

Reckitt

continued

and

completed

its

product-hopping scheme.

90.

In

late

2011,

while

certain

potential

generic

competitors

(referred

to

collectively

as

"Buprenorphine

Products

Manufacturers

Group") were

awaiting

FDA

approval

of

their

ANDAs

for

generic

co-formulated

buprenorphine/naloxone

tablets,

Reckitt

submitted

a

REMS

for

Suboxone

Tablets,

which

was

approved

by

the

FDA

in

December

2011.

91.

On

January

6,

2012,-

the

FDA

ordered

Reckitt

to

cooperate

with

the

Buprenorphine

Products

Manufacturers

Group

in

a

shared

REMS.

Shared

REMS

are

utilized

like

individual

REMS—to

address

safety

concerns

of

pharmaceutical

products.

When

multiple

manufacturers

are

marketing

a

generic

product

that

is

an

AB-rated

substitute

for

a

reference

24

drug.

Hie

FDA

requires

that

the

manufacturers

work

together

to

submit

a

shared

REMS.

The

companies'

filing

ANDAs

and

comprising

the

Buprenorpliine

Products

Manufacturers

Group

were

Actavis,

Inc.;

Amneal

Pharmaceuticals

LLC;

Ethypharm

USA

Coip.;

Mylan

Inc.;

Roxane

Laboratories

Inc.;

Sandoz

Inc.;

Sun

Pharmaceuticals

Industries,

Ltd;

and

Teva

Pharmaceuticals

USA,

Inc.

92.

Approved

NDA

holders

must

participate

in

a

shared

REMS

process

with

ANDA

applicants,

and

NDA

holders

may

not

use

safety

concerns

to

block

or

delay

ANDA-

approval

under

21

U.S.C,

§

355-l(f).

Although

Reckitt's

Suboxone

Tablet

REMS

was

only

approved

by

the

FDA

in

93.

December

2011,

RecMtt

did

not

cooperate

with

the

generic

manufacturers

in

the

finalization

and

submission

of

a

shared

REMS.

Reckitt

also

did

not

indicate

outright

that

it

refused

to

participate

in

the

shared

REMS

process.

Instead,

Reckitt

engaged

in

multiple

delay

tactics

and

made

misleading

statements

to

conceal

its

true

intent,

which

was

to

prolong

the

approval

of

the

AHDAs

for

generic

Suboxone

Tablets.

94.

25

95.

Reckitt

falsely

represented

to

the

FDA

and

the

Buprenorphine

Products

Manufacturers

Group

that

it

would

cooperate.

Reckitt never

intended

to

participate

in

a

single

shared

REMS

program

with

the

generic

manufacturers,

engaging

in

the

process

for

the

sole

purpose

of

delaying

generic

approval.

96.

Because

the

FDA

could

not

approve

the

ANDA

applications

without

an

approved

REMS,

Reckitt's

refusal

to

cooperate

was

intended

to

and

did

in

fact

delay

generic

entry past

the

date

when

entry

otherwise

would

have

occurred.

97.

Reckitt's

refusal

to

cooperate

successfully

delayed

submission

of

the

shared

REMS

until

August

of 2012,

when

the

generic

ANDA

filers

finally

obtained

an

unprecedented

waiver

allowing

them

to

submit

a

shared

REMS

program

of

their

own

without

Reckitt's

26

cooperation.

Absent

such

delay

tactics,

the

shared

REMS

program

would

have

been

completed

no

later

than

May

6,2012.

98.

'

Recidtt

Icaew

that

once

the

FDA

approved

the

ANDAs,

generic

Suboxone

Tablets

would

become

available

and

immediately

substitutable

for

branded

Suboxone

Tablets.

To

gain

•

more

time

to

complete

its

product

hop

scheme,

Recidtt

engaged

in

another

delay

tactic

by

filing

a

•

citizen

petition

with

the

FDA.

99.-

Under

§

5p5(q)

of

the

Food,

Drug

and

Cosmetic

Act,

any

individual

may

submit

a

petition,

commonly

known

as

a

"citizen

petition,"

asking

the

FDA

take,

or

refrain

from

taking,

certain

administrative

action.

Citizen

petitions

are

commonly

used

to

express

concerns

about

the

safety

or

legality

of

a

product.

100.

The

FDA

is

granted

a

150-day

period

to

respond

to

each

citizen

petition

under

21

C.F.R.

§

10,30.

101.

During

the

150-day

period,

FDA approval

of

any

ANDA

pending

for

a

product

that

is

the

subject

of

the

citizen

petition

is

typically

delayed.

Although

21

U.S.C.

§

355(q)(l)(A)

provides

that

the

Secretary

"shall

not

delay

approval"

of

a

pending ANDA,

subpart

(ii)

requires

that

"the

Secretary,

upon

reviewing

the

petition,"

must

determine

whether

a

further

delay

is

necessary

to

protect

public

health,

Thus,

the

filing

of

a

citizen

petition

in

and

of

itself

creates

a

delay

insofar

as

the

FDA

must

actually

review

the

allegations

made

in

the

petition,

enabling

brand-name

manufacturers

to

file

a

baseless

citizen

petition

to

prolong

their

monopoly

on

a

particular

branded

drug.

This

abuse

of

the

petition

process

has

been

repeatedly

acknowledged

by

FDA officials.

On

September

25,

2012,

Reckitt

filed

a

citizen

petition

asking

the

FDA

to

withhold

approval

of

the

ANDAs

for

generic

Suboxone

Tablets

unless:

(1)

the

ANDA

contained

102.

27

a

targeted

pediatric

exposure

education,

program;

(2)

the

ANDA

product

had

child-resistant

unit-

dose

packaging;

and

(3)

the

FDA

had

determined

whether

Reckitt

had

discontinued

Suboxone

Tablets

for

safety

reasons.

'

103.

In

the

same

week

that

it

filed

the

citizen

petition,

Reckitt

announced

its

intent

to

permanently

withdraw

Suboxone

Tablets

from

the

market

for

purported

safety

reasons

even

though

the

FDA

stated

that

it

could

not

determine

whether

the

Film

was

safer,

and

that

the

cause

for

any

alleged

decline

in

unintended

pediatric

exposures

to

the

Film

was

unverified.

104.

Reckitt

did

not

disclose these

alleged

safety

concerns

about

Suboxone

Tablets

to

the

generic

manufacturers

during

the

shared

REMS

negotiation

process,

and

refused

to

engage

in

any

meaningful

way

with

the

generics

during

that

process

even

after

being

ordered

to

do

so

by

the

FDA.

In

fact,

Reckitt

used

information

gained

from

the

generic

manufacturers

through

the

shared

REMS

negotiation

to

form

its

citizen

petition

and

time

its

filing

to

increase

delay.

The

same

alleged

safety

concerns

raised

in

its

citizen petition

regarding

the

generic

manufacturers'

tablet

product

was

dismissed

by

Reckitt

less

than

a

month

prior

with

regard

to

its

own

Suboxone

Tablets.

Specifically,

on

August

30,

2012

Reckitt

represented

to

the

FDA

in

a

combined

RBMS

assessment

that

its

tablet

REMS

was

successful

and

needed

no

105.

further

changes.

In

fact,

Reckitt

considered

and

rejected

converting

its

Suboxone

Tablets

to

unit-

dose

packaging

for

pediatric

safety

reasons

as

early

as

February

2008.

106.

28

107.

The

FDA

ultimately

denied

Reckitt's

citizen petition

on

February

22,

2013,

108.

noting

that

it

was

not

supported

by

evidence

and

was

inconsistent

with

Reckitt's

own

behavior,

The

FDA

also

said

that

it

did

not

have

the

authority

to

issue

some

of

the

relief

requested

by

Reckitt.

The

FDA

acknowledged

in

its

ruling

that

it

had

no

authority

to

grant

Reckitt's

request

to

have

Suboxone

AND

As

contain

targeted

pediatric

exposure

program

because

the

labeling

for

an

ANDA

must

be

the

same

as

the

labeling

for

the

approved

listed

drug,

pursuant

to

21

U.S.C.

§

355(j)(2)(A)(v)

and

(4)(G).

The

FDA

further

stated

in

its

denial

that

the

close

proximity

of

Reckitt's

109.

withdrawal

of

Suboxone

Tablets

to

the

"period

in

which

generic

competition

for

this

product

was

expected

to

begin

cannot

be

ignored."

110.

The

FDA

referred

Reckitt's

conduct

to

the

FTC

for

antitrust investigation.

111.

Reckitt's

baseless

citizen

petition

did,

in

fact,

delay

the

approval

of

the

pending

ANDAs—even

though

the

FDA

ultimately

determined

that

a

further

delay

was

not

necessary

to

protect

public

health—due

to

the

passage

of

the

150-day

period

allowed

for

the

FDA

to

review

the

petition

under

21

U.S.C,

§

355(q)(l)(A)(ii).

112.

29

113.

Reckitt's

conduct

in

submitting

and

pursuing

the

baseless

citizen

petition

had

the

intended

effect

of

delaying

FDA

approval

of

the

pending

ANDAs

and

the

entry

of

generic

competition

for

co-formulated

buprenorphine/naloxone

tablets.

But

for

Reckitt's

baseless

citizen

petition,

coupled

with

its

dilatory

and

deceptive

conduct

with

regard

to

the

shared

REMS

that

caused

the

generic

group's

REMS

approval

to

be

delayed,

competitors

would have

marketed

generic

co-formulated

buprenorphine/naloxone

tablets

before

they

actually

did.

114.

On

February

22,

2014,

the

FDA

granted

the

generics-only,

waiver-based

REMS

and

approved

Amneal

and

Activis'ANDAs

for

tablet

sales.

115.

On

March

6,2013,

generic

co-formulated

buprenoiphine/naloxone

tablets

entered

the

market.

By

that

time,

Reckitt

had

successfully

converted

the

vast

majority

of

co-formulated

buprenorphine/naloxone

prescriptions

being

written

in

the

United

States

from

its

branded

Suboxone

Tablet

to

the

patent-protected

Film,

for

which

the

newly

approved

generic

competitors

are

not

AB-rated

substitutes.

Effects

on

Competition

116.

Generic

versions

of

brand-name

drugs

are

typically

priced

significantly

lower

than

the

brand-name

versions.

As

AB-rated

generic

competition

enters

the

market

for

a

particular

drug,

the

brand-name versions

are

quickly

replaced

by

the

lower-priced

generics.

Under

most

state

laws,

this

generic

substitution

occurs

automatically,

unless

the

prescribing

physician

has

indicated

that

the

brand-name

product

must

be

"dispensed

as

written."

117.

The

introduction

of

generic

competition

results

in

significant

losses

in

profit

for

the

brand-name

manufacturers

as

consumers

are

switched

to

the

lower-priced

generics

and

the

brand-name

drug

is

no

longer

able

to

command

a

higher

price.

Conversely,

the

longer

a

branded

manufacturer

is

able

to

delay

the

entry

of

generic

competition

to

the

market,

the

longer

it

can

30

continue

to

charge

supra-competitive

prices

profitably

without

losing

all

or

a

substantial

portion

of

its

brand-name

sales.

118.

Reckitt's

conspiracy

with

MonoSol

and

its

acts,

practices,

and

scheme

described

herein

were

for

the

purposes

of,

and

had

the

effect

of,

restraining

competition

unreasonably

by

preventing

the

entry

of

generic

co»foitmilated

buprenorphine/naloxone

and

destroying

the

market

for

the

tablet

formulation

by

the

time

the

generic

competitors

gained

FDA

approval.

119.

But

for

Reckitt

and

MonoSol's

illegal

conduct,

generic

competition

to

Suboxone

Tablets

would

have

been

available

when

orphan

exclusivity

expired

in

October,

2009.

Tims,

Defendants'

conduct

delayed

and

prevented

the

savings

that

Suboxone

purchasers

would

have

.

enjoyed

from

that

point

until

present

date.

120.

By

causing

a

hard

product

switch,

Reckitt

avoided,

and

continues

to

avoid,

automatic

substitution

of

AB-rated

generics

under

state

generic

substitution

laws

and,

therefore,

has

limited,

and

continues

to

limit,

competition

with

generic

substitutes

for

Suboxone

Tablets,

121.

Had

generic

competition

to

Suboxone

Tablets

entered

the

market

earlier—and

not

been

delayed

while

Defendants

converted

the

market

to

Suboxone

Film—Plaintiff

States

and

citizens

of

the

States

would

have

substituted

lower-priced

generic

Suboxone

Tablets

for

the

higher-priced

branded

Suboxone

Tablets,

and

would

have

paid

lower

prices

for

some

or

all

of

their

branded

Suboxone

purchases.

122.

Reckitt's

anticompetitive

scheme

to

delay

FDA

approval

of

generic

Suboxone

Tablets

while

converting

the

Suboxone

market

to

its

patent-protected

Suboxone

Film unlawfully

enabled,

and

continues

to

enable,

Reckitt

to

sell

Suboxone

at

supra-competitive

prices,

and

allowed,

and

continues

to

allow,

Reckitt

and

MonoSol

to

enjoy

ill-gotten

gains

from

the

sales

of

Suboxone

Film

and

branded

Tablets,

while

Suboxone

tablets

were

on

the

market.

31

123.

By

delaying

generic

competitors'

entry

into

the

market, Reckitt

and

MonoSol

have

deprived

Plaintiff

States

and

consumers

the

benefits

of

competition

in

violation

of

the

federal

and

state

antitrust

laws,

consumer

protection

laws,

unfair

competition

statutes.

Iniurv

124.

As

a

direct

arid

proximate

result

of

the

unlawful

conduct

alleged

above,

Plaintiff

States

and

consumers

were

not

and

are

not

able

to

purchase,

or

pay

reimbursements

for

market

purchases

of

co-formulated

buprenorphine/naloxone

at

prices

determined

by

unhindered

by

the

impact

of

Defendants'

anticompetitive

behavior.

Instead,

they

have

been

and

continue

to

be

forced

to

pay

artificiaHy

high

monopoly

prices.

Consequently,

they

have

suffered

substantial

injury

in

their

business

and

property

in

that,

inter

alia,

they

have

paid

more

and

continue

to

pay

more

for

co-formulated

buprenorphine/naloxone

than

they

would

have

paid

in

a

competitive

market

125.

As

a

direct

and

proximate

result

of

the

unlawful

conduct

alleged

above,

the

general

economies

of

the

States

have

sustained

injury

and

the

Plaintiff

States

are

threatened

with

continuing

injury

to

their

business

and

property

unless

Reckitt

and

MonoSol

are

enjoined

from

this

unlawful

conduct.

126.

As

a

direct

and

proximate result

of

the

unlawful

conduct

alleged

above,

Reckitt'

and

MonoSol

have

unjustly

profited

through

inflated

profit

margins

aiid

will

continue

to

do

so.

127.

Reckitt's

unlawful

conduct

is

continuing

and

will

continue

unless

the

injunctive

and

equitable

relief

requested

by

the

Plaintiff

States

is

granted.

128.

MonoSol's

unlawful

conduct

is

continuing

and

will

continue

unless

the

injunctive

and

equitable

relief

requested

by

the

Plaintiff States

is

granted.

129.

'

Plaintiff

States

do

not

have

an

adequate

remedy

at

law.

32

130.

AU

conditions

precedent

necessary

to

the

filing

of

this

action

have

been

fulfilled,

waived

or

excused,"

Count

I:

MoBQPolizatioH

under

Sherman

Act

§

2

Against

Reckirt

Defendants

131.

The

preceding

paragraphs

are

incoiporated

as

if

set

forth

herein.

132.

From

2002

until

the

present,

Reckitt

has

possessed

monopoly

power

in

the

relevant

marlcet

of

co-formulated

buprenorphine/naloxone

in

the

United

States,

133.

The

relevant

product

market

for

the

conspiracy

is

all

co-formulated

buprenorphine/naloxone

and

their

AB-rated

equivalents

which

can

be

prescribed

for

home

use

as

part

of

maintenance

therapy

for

opiate

addiction.

The

market

includes

Suboxone

in

all

of

its

forms,

including

both

the

Tablets

and

Film,

and

all

dosage

strengths.

134.

The

relevant

geographic

market

is

the

United

States

and

its

territories.

135.

The

conspiracy

substantially

affected

and

still

affects

interstate

commerce.

136.

Reckitt

willfully

and

unlawfully

maintained

its

monopoly

power

by

engaging

in

exclusionary

conduct

which

had

the

intent,

pmpose,

and

effect

of

illegally

preventing

and

blocking

competition

in

the

United

States

co-formulated

buprenorphine/naloxone

market

in

violation

of

Section

2

of the

Sherman

Act,

15

U.S.C.

§

2.

137.

Beginning

in

2002,

Reckitt

engaged

in

exclusionary

conduct

including,

but

not

limited

to:

devising

and

implementing

an

anti-generic

strategy

by

intentionally

causing

delays

to

FDA

approval

of

ANDAs

for

generic

co-formulated

buprenorphine/naloxone,

filing

a

baseless

citizen

petition

to

delay

ANDA

approval,

and

alleging

unfounded

concerns

regarding

the

safety

of

the

generic

product

while

engaging

in

a

campaign

to

convert

the

co-formulated

buprenorphine/naloxone

market

from

tablet

formulations

to

their

patent-protected

Film.

33

138.

As

a

direct

and

proximate

result

of

Recldtt's

exclusionary

scheme.

Plaintiff

States

and

consumers

have

been

injured

in

their

business

or

property because

they

have

had

to

purchase

Suboxone

at

supra-competitive

prices

without

the

reasonable

availability

of

a

lower-priced

generic

alternative,

and

Reckitt

and

MonoSol

have

enjoyed

ill-gotten

gains

from

the

sales

of

Suboxone

Film

and

Tablets.

Count

II:

Attempted

Monopolization

Under

Sherman

Act

§

2

Against

Reckitt

Defendants

139.

Plaintiffs

hereby

incoiporate

each

preceding

and

succeeding

paragraph

as

though

fully

set

forth

herein.

140.

The

relevant

product

market

for

the

conspiracy

is

all

co-formulated

buprenoiphine/naloxone

and

their

AB-rated

equivalents

that

can

be

prescribed

for

home

use

as

part

of

maintenance

therapy

for

opiate

addiction.

The

market

includes

Suboxone

Tablets

and

Suboxone

Film

in

all

dosage

strengths.

142.

Reckitt,

through

its

overarching

anticompetitive

scheme,

specifically

intended

to

maintain

its

pre-existing

monopoly

power

in

the

relevant

market.

It

was

Reckitt's

conscious

objective

to

control

prices

or

to

exclude

competition

in

the relevant

market.

142.

The

natural,

intended and

foreseeable

consequence

of

Reckitt's

overarching

anticompetitive

scheme

was

to

control

prices

and

exclude

competition

in

the

relevant

market.

There

was,

and

continues

to

be,

a

substantial

and

real

chance,

a

reasonable

•

143.

likelihood,

or

a

dangerous

probability

that

Reckitt

will

succeed

in

and

achieve

its

goal

of-

maintaining

monopoly

power

in

the

relevant

market.

144.

As

a

direct

and

proximate

result

of

Reckitt's

exclusionary

scheme,

Plaintiff

States

and

consumers

have

been

injured

in

their

business

or

property

because

they

have

had

to

purchase

Suboxone

at

supra-competitive

prices

without

the

reasonable

availability

of

a

lower-priced

34

generic

alternative,

and

Reckitt

and

MonoSol

have

enjoyed

ill-gotten

gains

from

the

sales

of

Suboxone

Film

and

Tablets.

Count

1X1:

Conspiracy

to

Monopolize

under

Sherman

Act

§

2

Against

AH

Defendants

145.

The

preceding

paragraphs

are incorporated

as

if

set

forth

herein.

146.

The

relevant

product

market

for

the

conspiracy

is

all

co-formulated

buprenorphine/naloxone

and

AB-rated

equivalents

that

may

be

prescribed

for

home

use

as

part

of

maintenance

therapy

for

opiate

addiction.

The

market

includes

Suboxone

in

all

of

its

forms,

including

both

Tablets

and

Film

in

all

dosage

strengths,

147.

The

relevant

product

market

is

the

United

States

and

its

territories.

148.

The

conspiracy

substantially

affected

and

still

affects

interstate

commerce.

149.

Defendants

Reckitt

and

MonoSol

conspired

to

monopolize

and

did

unlawfully

monopolize

the

relevant

market

for

co-fomiukted

buprenorphine/naloxone

products

in

the

United

States,

thereby

violating

Section

2

of

the

Sherman

Act,

15

U.S.C.

§

2.

150.

Defendants

Reckitt

Benckiser

Healthcare

UK,

Ltd.

and

MonoSol

entered

into

a

development

agreement

whereby

MonoSol

granted

Reckitt

the

right

to

use

its

patented

sublingual

film

technology

to

manufacture

Suboxone

in

a

film

version.

151.

Defendant

MonoSol

marketed

itself

specificaily

to

companies

looking

to

extend

their

period

of

exclusivity

in

an

illegal

and

anticompetitive

manner,

152,

Defendants

Reckitt.

and

MonoSol

entered

into

the

agreement

with

the

specific

intent

and

for

the

purpose

of

extending

Reckitfs

monopoly

power,

which

was

due

to

expire

at

the

end

of

Reckitt's

FDA-granted

"oiphan

status"

period,

and

for

the

puipose

of

preventing

generic

competition

with

its

branded

product.

35

153.

Defendants

have

acted

in

concert

to

willfully

and

unlawfully

maintain

Reckitt's

monopoly

power

in

the

relevant

market

for

co-formulated

buprenorphine/naloxone

drugs

in

the

United

States

by

engaging

in

unlawful

exclusionary conduct,

which

had

the

purpose

and

effect

of

unreasonably

restraining

competition.

154.

Defendants

Reckitt

and

MonoSol

engaged

in

their

conspiracy

with

the

specific

intent

to

prevent

generic

competition

in

the

United

States

co-formulated

buprenorphine/naloxone

raarket

155.

Defendant

Reckitt

had

the

specific

intent

to

monopolize

the

Suboxone

market

when

it

conspired

with

and

utilized

MonoSors

services

to

extend

its

monopoly

power

through

the

use

of

sublingual film

because

this

technology

would

not

allow

automatic

retail

generic

substitution

for

Suboxone

Tablets.

156.

Defendant

RecMtt

committed

a

series

of

acts

in

furtherance

of

the

conspiracy.

including,

but

not

limited

to:

devising

and

implementing

an

anti-generic

strategy

by

intentionally

causing

delays

to

FDA

approval

of

ANDAs

for

generic

co-formulated

buprenorphine/naloxone,

filing

a

baseless

citizen

petition

to

delay

ANDA

approval, alleging

unfounded

concerns

regarding

the

safety of

the

generic

product

while

engaging

in

a

campaign

to

convert

the

co-

formulated

buprenoiphine/naloxone

market

from

tablet

formulations

to

its

patent-protected

Film,

and

ultimately

announcing

the

withdrawal

of

Suboxone

Tablets

from

the

market.

157.

The

Defendants'

conspiracy

created

a

realistic threat

to

competition

in

the

United

States

co-formulated

buprenorphine/naloxone

market.

158.

As

a

direct

and

proximate

result

of

Defendants'

exclusionary

scheme, Plaintiff

States

and

consumers

have

been

injured

in

their

business

or

property

because

they

have

had

to

purchase

Suboxone

at

supra-competitive

prices

without

the

reasonable

availability

of

a

lower-

36

priced

generic

alternative

and

Recldtt

and

MonoSol

have

enjoyed

ill-gotten

gains

from

the

sales

of

Suboxone

Film

and

Tablets.

Count

IV:

Illegal

Restraint

of Trade

under

Sherman

Act

$

1

Against

AU

Defendants

159.

The

preceding

paragraphs

are

incorporated

as

if

set

forth

herein.

160.

The

relevant

product

market

for

the

conspiracy

is

all

co-formulated

buprenorphine/naloxone

and

their

AB-rated

equivalents

that

can

be

prescribed

for

home

use

as

part

of

maintenance

therapy

for

opiate

addiction.

The

market includes

Suboxone

Tablets

and

Suboxone

Film

in

all

dosage

strengths.

161.

From

2006

to

the

present,

the

Reckitt

Defendants

entered

into

and

maintained

a

.

contract,

combination,

or

conspiracy

with

MonoSol

to

restrain

trade

in

the

U.S.

market

for

co-

formulated

buprenoiphine/naloxone

drugs,

and

thereby

violated

Section

1

of

the Sherman

Act,

15

U.S.C.

§

1.

162.

From

2006

to

the

present,

MonoSol

entered

into

and

maintained

a

contract,

combination,

or

conspiracy

with

the

Reckitt

Defendants

to

restrain

trade;

in

the

U.S.

market

for

co-formulated

buprenorphine/naloxone

drugs,

and

thereby

violated

Section

1

of

the

Sherman

Act,

15

U.S.C.

§1.

163.

The

.contract,

combination

or

conspiracy

substantially

affected

and

still

affects

interstate

commerce.

As

a

direct

and

proximate

result

of

Defendants'

exclusionary

contract,

combination,

or

conspiracy,

Plaintiff

States

and

consumers

have

been

injured

in

their

business

or

property

because

they

have

had

to

purchase

Suboxone

at

supra-competitive

prices

without

the

reasonable

availability

of

a

lower-priced

generic

alternative,

and

Reckitt

and

MonoSol

have

enjoyed

ill-gotten

gains

from

the

sales

of

Suboxone

Film

and

Tablets.

..

164.

37

165.

Tfie

anti-competitive

effects

of

Defendants'

conspiracy

outweigh

pro-competitive

effects,

if

any,

that

their

conduct

may

Have

had;

Count

V:

State

Law

Claims

Against

Reckitt

and

MonoSoi

Defendants

Alabama

166.

Plaintiff

State

of

Alabama

repeats and

realleges every

preceding

allegation.

167.

The

acts

and

practices

by

Defendants

constitute

unconscionable

acts

in

violation

of

the

Alabama

Deceptive

Trade

Practices

Act,

Code

of

Alabama,

1975,

§

8-19-5(27)

for

which

the

State

of

Alabama

is

entitled

to

relief.

.

"

Alaska

168.

The

State

of

Alaska

repeats

and

realleges every

preceding

allegation.

169.

The

aforementioned

practices by

Defendants

are

in

violation

of

the

Alaska

Restraint

of

Trade

Act,

AS

45.50.562

etseq.,

and

Plaintiff

State

of

Alaska

is

entitled

to

relief

for

these

violations

under

AS

45.50.576

-

.578.

170.

The

aforementioned

practices

by

Defendants

are

in

violation

of

the

Alaska

Unfair

Trade

Practices

and

Consumer

Protection

Act,

AS

45.50.471

etseq.,

and

Plaintiff

State

of

Alaska

is

entitled

to

relief

for

these

violations

under

AS

45.50.501,

.531,

and

.537.

Arkansas

171.

The

Plaintiff

State

of

Arkansas

repeats

and

realleges

each

and

every

allegation

contained

in

paragraphs

1

through

165.

172.

Defendants'

acts

violate,

and

Plaintiff

State

of

Arkansas

is

entitled

to

relief

under,

The

Arkansas

Unfair

Practices

Act,

Arkansas

Code

Annotated

§

4-75-201

et

seq.,

The

Arkansas

.

Statute

on

Monopolies,

Ark.

Code

Ann.

§7-55-301

et

seq.,

The

Arkansas

Deceptive

Trade

Practices

Act,

§4-88-101

etseq.,

and

the

Common

Law

of

Arkansas,

38

*

California

173.

California

realleges

and

incoiporates

all

of

the

allegations

above

from

paragraphs

'

1

through

165.

174.

The

aforementioned

conduct

practices

by

Defendants

were

and

are

in

violation

of

'

the

Cartwright

Act,

Cal.

Bus.

&

Prof.

Code

sections

16700,

et

seqand

the

California

Unfair

Competition

Act,

Cal.

Bus.

&

Prof.

Code

sections

17200,

et

seq.

175.

Accordingly,

the

State

of

California

in

its

law

enforcement

capacity,

seeks

all

relief

available

under

California's

Cartwright

Act

and

the

Unfair

Competition

Act,

including

all

available

monetary

and

equitable

relief,

injunctive

relief

pursuant

to

Cal.

Bus

&

Prof.

Code

§

16754.5

to

restore

and

preserve

fair

competition

and

bar

any

continued

conduct

that

is

wrongful,

among

other

things,

civil

penalties

pursuant

to

Cal.

Bus.

&

Prof.

Code

§

17206

of

$2,500

per

each

and

eveiy

act,

prescription

and

victim

of

any

violation

of

the

California

Unfair

Competition

Act

(and

under

Cal.

Civil

Code

§

3345,

trebled

for

senior

citizens

and

disabled

victims

of

thp

violation),

and

disgorgement

of

all

revenues,

profits,

and

gains

achieved

in

whole

or

in

part

through the

violations

of

the

Acts

complained

of

herein,

including

disgorgement,

unjust

enrichment,

injunctions,

costs,

reasonable

attorneys'

fees,

and

civil

penalties,

and

any

such

other

relief

that

might

be

available

under

statute

or

equity,

penalties,

and

any

such

other

equitable

or

monetary

relief

that

might

be

available

under

statute

or

equity.

Colorado

176.

Plaintiff

State

of

Colorado

repeats

and

realleges each

and

every

allegation

contained

in

paragraphs

1

through

165.

.

177.

Defendants'

acts

violate,

and

Plaintiff

State

of

Colorado

is

entitled

to

relief

under,

"

the

Colorado

Antitrust

Act

of

r992

J

§

6-4-101,

et

seq.,

Colo:

Rev.

Stat

39

Connecticut

178.

Plaintiff

State

of

Connecticut

repeats

and

re-alleges

each

and

every

allegation

contained

in

paragraphs

1

through

165.

179.

Defendants'

actions

as

alleged

herein

violate

the

Connecticut

Antitrust

Act,

Conn.

Gen.

Stat

§§

35-26

and

35-28,

in

that

they

have

the

purpose

and/or

effect

of

unreasonably

.

—

*:

„

.,

restraining

trade

and

commerce

within

the

State

of

Connecticut

and

elsewhere.

180.

Defendants'

actions

as

alleged

herein

violate

Conn.

Gen.

Stat

§§

35-27

and

35-29

in

that

they

represent

monopolization

of

or

attempts

to

monopolize

trade

or

commerce

within

the

State

of

Connecticut

and

elsewhere

and/or

have the

purpose

and

effect

of

substantially

lessening

competition

within

the State

of

Connecticut

and

elsewhere.

181.

Defendants'

acts

and

practices

as

alleged

herein

constitute

unfair

methods

of

competition

in

violation

of

the

Connecticut

Unfair

Trade

Practices

Act,

Conn.

Gen.

Stat

§

42-

110b.

182.

The

State

of

Connecticut

seeks

injunctive

relief

pursuant

to

Conn.

Gen.

Stat.

§

35-

34,

civil

penalties

pursuant

to

Conn.

Gen.

Stat.

§

35-38

for

each

and

every

violation

of

the

Connecticut

Antitrust

Act,

civil

penalties

pursuant

to

Conn.

Gen.

Stat.

§

42-110o

of

$5,000

for

each

and

every

willful

violation

of

the

Connecticut

Unfair

Trade

Practices

Act,

and

disgorgement

of

all

revenues, profits,

and

gains

achieved

in

whole

or

in

part

through

the

unfair

methods

of

competition

complained

of

herein,

pursuant

to

Conn.

Gen.

Stat.

§

42-110m.

Delaware

183.

Plaintiff

State

of

Delaware

repeats

and

re-alleges

each

and

every

allegation

contained

in

paragraphs

1

through

165.

40

184.

The

aforementioned

practices

by

Defendants

are

in

violation

of

Section

2103

of

the

Delaware

Antitrust

Act,

6

Del.

c.

§

2101,

etseq.

185.

TTie

State

of

Delaware

thr ough

the

Attorney General

brings

this

action

pursuant

to

Sections

2105

and

2107,.

and

seeks

civil

penalties

and

equitable

relief

pursuant

to

Section

2107

of

the

Delaware

Antitrust

Act,

6

Del.

C;

§

2101,

et

seq.

District

of

Columbia

186.

Plaintiff

District

of

Columbia

repeats

and

re-alleges

each

and

every

allegation

contained

in

paragraphs

1

through

165.

187.

The

aforementioned

practices

by

Defendants

are

in

violation

of

the

District

of

Columbia

Antitrust

Act,

D.C.

Code

§

28-4502

and

28-4503.

188.

Plaintiff

District

of

Columbia

has

been

and

continues

to

be

injured

by

Defendants'

actions,

and

is

entitled

to

relief

for

these

violations

under

D.C.

Code

§

28-4507(a).

Florida

189.

Plaintiff

State

of

Florida

repeats and

re-alleges

each

and

every

allegation

contained

in

paragraphs

1

through

165.

190.

Defendants'

acts

violate

Section 542.18,

Florida

Statutes,

for

their

contract.

combination,

or

conspiracy

in

restraint

of

trade

or

commerce

in

Florida

as

alleged

in

Count

HI.

Plaintiff

State

of

Florida

is

entitled

to

relief

under

the

Florida

Antitrust

Act

of

1980,

Section

542.15,

Florida

Statutes,

etseq.

191.

Defendants'

acts

violate

Section

542,19,

Florida

Statutes,

because

they

monopolized,

attempted

to

monopolize,

and

combined

or

conspired

with

each

other

to

monopolize

any

part

of

trade

or

commerce

in

Florida

as

alleged

in

Counts

I,

H,

and

IV.

Plaintiff

41

State

of

Florida

is

entitled

to

relief

under

the

Florida

Antitrust

Act

of

1980,

Section

542.15,

Florida

Statutes,

et

seq.

192.

Defendants'

acts

violate

Florida

Deceptive

and

Uafak

Trade

Practices

Act

s

Section

501.204,

Florida

Statutes,

because

they

constituted

unfair

methods

of

competition.

unconscionable

acts

or

practices,

and

unfair

or

deceptive

acts

or

practices

in

the

conduct

of

trade

or

commerce

in

Florida,

as

alleged

in

Counts

I

through

IV.

Plaintiff

State

of

Florida

is

entitled

to

relief

under

the

Florida

Deceptive

and

Unfair

Trade

Practices

Act,

Section

501.201,

Florida

Statutes,

etseq.

Hawaii

Plaintiff

State

of

Hawaii

repeats

and

re-alleges

each

and

every

allegation

193.

contained

in

paragraphs

1

through

165.

194,

The

aforementioned

practices

by

Defendants

were

and

are

in

violation

of

the

Hawaii

Antitrust

Act,

Hawaii

Revised

Statutes

section

480-1

et

seq.

195.

PJaintiff

State

of

Hawaii

is

entitled

to

injunctive

relief,

disgorgement

to

deprive

defendants

of

ill-gotten

gains

unjustly

obtained,

civil

penalties

of

not

less

than

$500

nor

more

than

$10,000

for

each

violation

pursuant

to

Hawaii

Revised

Statuses

section

480-3.1,

attorney's

fees

together

with

the

costs

of

suit,

and

any

other

remedies

available

under

the

Hawaii Antitrust

Act,

Hawaii

Revised

Statutes

section

480-1

et

seq.

and

any

other

provision

in

the

Hawaii'

Revised

Statutes.

Illinois

196.

Plaintiff

State

of

Illinois

repeats

and

re-alleges

each

and

every

allegation

contained

in

paragraphs

1

through

165.

42

197.

By

engaging

in

the

conduct

described

above,

the

Defendants

violate

sections

3(2)

and

3(3)

of

the

Illmois

Antitrust

Act,

740

ILCS

10/1

ei

seq.

and

cause

the

State

and

its

residents

to

pay

more

for

Suboxone.

198.

Plaintiff

State

of

Illinois,

under

its

antitrust

enforcement

authority

in

740

ILCS

10/7,

is

entitled

to

an

injunction,

disgorgement,

civil

penalties,

and

any

other

remedy

available

at

law

for

these

violations

under

sections

7(1), 7(2),

and

7(4)

of

the

Illinois

Antitrust

Act,

Iowa

199.

Plaintiff

State

of

Iowa

repeats

and

re-alleges

each

and

every

allegation

contained

in

paragraphs

1

through

165.

200,

The

alleged

practices

by

Defendants

violate

the

Iowa

Competition

Law,

Iowa

Code

Chapter

553.

201.

Iowa

seeks

an

injunction

and

divestiture

of

profits

resulting

from

these

practices

pursuant

to

Iowa

Code

§

553.12,

and

civil

penalties

pursuant

to

Iowa

Code

§

553.13.

202.

Defendants'

acts

and

practices

as

alleged

herein

also

constitute

an

unfair

practice

in

violation

of

the

Iowa

Consumer

Fraud

Act,

Iowa

Code

§

714.16(l)(n)

203.

Pursuant

to

Iowa

Code

§

714.16(7),

the

State

of

Iowa,

seeks

disgorgement,

restitution,

and

other

equitable

relief

for

these

violations.

In

addition,

pursuant

to

Iowa

Code

§

714.16(11)

the

Attorney

General

seeks

reasonable

fees

and

costs

for

the

investigation

and

court

action.

Kansas

204.

Plaintiff

State

of

Kansas

repeats

and

re-alleges

each

and

every

allegation

contained

in

paragraphs

1

through

165.

43

205.

The

aforementioned

acts

and

practices

by

the

Defendants

violate

the

Kansas

Restraint

of

Trade

Act,

Kan.

Stat

Ann.

§§

50-101,

et

seqand

Plaintiff

State

of

Kansas

is

entitled

to

relief

under

Kan.

Stat.

Ann.

§§

50-103,

50-160,

50-161,

and

50-163.

Kentucky

206.

Plaintiff

Commonwealth

of

Kentucky

repeats

and

re-alleges

each

and

every

allegation

contained

in

paragraphs

1

through 165.

207.

The

aforementioned

acts

or

practices

by

Defendants

violate

the

Consumer

Protection

Act

Kentucky

Rev.

Stat.

Ann.

367.110

et

seq.

The

violations

were

willfuliy

done.

208.

Plaintiff

Commonwealth

of

Kentucky,

under

its

statutes,

is

entitled

to

injunction,

disgorgement,

civil penalties,

and

any

other

relief

the

court

deems

proper.

Louisiana

209.

The

State

of

Louisiana

repeats

and

re-alleges

each

and

every

allegation

contained

in

paragraphs

1

through

165,

210.

The

practices

of

Defendants

described

herein

are

in

violation

of

the

Louisiana

Monopolies

Act,

LSA-R.S.

51:121

et

seqand

the

Louisiana

Unfair

Trade Practices

Act,

LSA-

R.S.

51:1401

etseq.

211.

The

State

of

Louisiana

is

entitled

to

injunctive

relief

and

civil

penalties

under

LSA-R.S.

51:1407

as

well

as

disgorgement

and

any

other

equitable

relief

that

the

court

deems

proper

under

LSA-R.S.

51:1408.

Maine

212.

Plaintiff

State

of

Maine

repeats and

re-alleges

each

and

every

allegation

contained

in

paragraphs

1

through

165.

44

The

aforementioned

practices

by

Defendants are

in

violation

of

the

Maine

213.

Monopolies

and

Profiteering

Law,

10

M.R.S.

§§

1101

and

1102,

and

Plaintiff

State

of

Maine

is

entitled

to

relief

for

these

violations

under

10M.R.S.

§

1104.

214.

The

aforementioned

practices

by

Defendants

are

intentional

and

in

violation

of

the

Maine

Unfair

Trade

Practices

Act,

5

M.R.S.

§

207,

and

Plaintiff

State

of

Maine

is

entitled

to

relief

for

these

violations

under

5

M.R.S.

§

209.

Maryland

215.

Plaintiff

State

of

Maryland

repeats

and

re-alleges

each

and

every

allegation

contained

in

paragraphs

1

through

165.

216.

The

aforementioned

practices by

Defendants

are

in

violation

of

the

Maryland.

Antitrust

Act,

Md.

Commercial

Law

Code

Ann.

§

11-201

et

seq.

217.

Further,

§

11-209(a)(3)

provides

that

the

court

may

exercise

all

equitable

powers

necessary

to

remove

the

effects

of

any

violation

including

injunction,

restitution,

disgorgement

and

divestiture.

The

Plaintiff

State

of

Maryland

is

entitled

to

costs,

reasonable

attorney's

fees

and

civil

penalties.

§§

11-20900(3),

ll-209(a)(4).

Massachusetts

218.

Plaintiff Commonwealth

of

Massachusetts

repeats

and

re-alleges

each

arid

every

allegation

contained

in

paragraphs

1

through

165.

219.

The

aforementioned

practices by

Defendants

constitute

unfair

methods

of

competition

or

unfair

or

deceptive

acts

or

practices

in

violation

of

the

Massachusetts

Consumer

Protection

Act,

M.GX

c.

93

A,

§

2

et

seq.

220.

Plaintiff

Commonwealth

of

Massachusetts

is

entitled

to

relief

under

M.GX.

c.

93A,

§

4.

45

221.

Plaintiff

Commonwealth

of

Massachusetts

notified

the

defendants

of

this

intended

action

more

than

five

days

prior

to

the

commencement

of

this

action

and

gave

the

Defendants

an

opportunity

to

confer

in

accordance

with

M.G.

L.

c.

93A,

§-

4.

Michigan

222.

Plaintiff

State

of

Michigan

repeats

and

re-alleges

each

and

every

allegation

contained

in

paragraphs

1

througiiT65.

223.

The

aforementioned

practices

by

Defendants

constitute

violations

of

the

Michigan

Antitrust

Reform

Act,

MCL

445.771

et

seq.

224.

Plaintiff

State

of

Michigan

is

entitled

to

disgorgement

of

profits,

penalties,

costs,

and

fees

under

Section

8

of

the

Michigan

Antitrust

Reform

Act,

MCL

445.778.

Minnesota

225.

Plaintiff

State

of

Minnesota

repeats

and

re-alleges

each

and

every

allegation

contained

in

paragraphs

1

through

165.

226.

Defendants'

acts

violate,

and

Plaintiff

State

of

Minnesota

is

entitled

to

an

injunction,

disgorgement,

and

civil

penalties

and

any

other

remedy

available

at

law

for

these

violations

under

the

Minnesota

Antitrusi:

Law

of

1971,

Minn.

Stat

§§

325D.46-.66,

the

Uniform

Deceptive

Trade

Practices

Act

of

1973,

Minn.

Stat.

§§

325D.43~.48,

Minn.

Stat.

Ch.

8,

and

Minnesota

common

law

for

unjust

enrichment.

Mississippi

227.

Plaintiff

State

of

Mississippi

repeats

and

re-alleges

each

and

every

allegation

contained

in

paragraphs

1

through

165.

228.

Defendants'

acts

violate

Miss. Code

Ann.

§

75-

21-1

et

seq.,

and

Plaintiff

State

of

Mississippi

is

entitled

to

relief

under

Miss. Code Ann.

§

75-

21-1

etseq.

46

229-

Defendants*

acts

violate

the Mississippi

Consumer

Protection

Act,

Miss. Code

•

Ann.

§

75-24-1,

et

seq.,

and

Plaintiff

State

of

Mississippi

is

entitled

to

relief

under

the

Mississippi

Consumer

Protection

Act,

Miss.

Code

Ann.

§

75-24-1,

et

seq.

230.

Pursuant

to

Miss.

Code

Ann.

§

75-21-1

et

seq.,

and

the Mississippi

Consumer

Protection

Act,

Miss.

Code

Ann.

§

75-24-1,

et

seq..

Plaintiff

State

of Mississippi

seeks

and

is

entitled

to

injunctive

relief,

disgorgement,

civil

penalties,

costs,

and

any

other

just

and

equitable

relief

which

.this

Court

deems

appropriate.

Missouri

Plaintiff

State

of

Missouri

repeats and

re-alleges

each

and

every

allegation

231.

contained

in

paragraphs

1

through

165.

232.

The

aforementioned

practices

by

Defendants

violate

the

Missouri

Antitrust

Law,

Missouri

Rev.

Stat.

§§

416.011

et

seq.,

and

Missouri's

Merchandising

Practices

Act,

Missouri

Rev.

Stat.

§§

407.010

et

seq.,

as

further

interpreted

by

15

CSR

60-8.010

et

seq.

and

15

CSR

60-

9.01

et

seq.,

and

the

State

of Missouri

is

entitled

to

an

injunction,

disgorgement,

civil

penalties

and

any

other

relief

available

under

the

aforementioned

Missouri

statutes

and

regulations.

The

State

of Missouri

also

seeks

its

costs

and

attorney

fees

incurred

in

the

233.

prosecution

of

this

action.

Nebraska

234.

Plaintiff

State

of

Nebraska

repeats and

re-alleges

each

and

every

allegation

contained

in

paragraphs

1

through

165.

235.

The

aforementioned

acts

and

practices

by

Defendants

were,

and

are,

in

violation

of

the

following

Nebraska

statutes:

Unlawful

Restraint

of

Trade

Act,

Neb.

Rev. Stat.

§

59-801

et

seq.',

Consumer

Protection

Act,

Neb.

Rev.'Stat.

§

59-1601

et

seq.;"tod

Uniform

Deceptive

Trade

47

,

.%•

Ul

Practices

Act,

Neb.

Rev.

Stat.

§

87-301

etseq.

Specifically,

Defendants'

acts-and

practices

were,

and

are,

in

violation

of

Neb.

Rev.

Stat

§§

59-801,

59-802,

59-1602,

59-1603,

59-1604,

87-

302(5),

87-302(6),

87-302(8),

87-303,01.

Defendants'

acts

and

practices

as

alleged

herein

have

had

an

impact,

directly

and

indirectly,

upon

the

public

interest

of

the

State

of

Nebraska.

236.

Accordingly,

Plaintiff

State

of

Nebraska

seeks

all

relief

available

under

the

Unlawful

Restraint

of

Trade

Act,

the

Consumer

Protection

Act,

the

Uniform

Deceptive

Trade

Practices

Act,

and

Neb.

Rev.

Stat.

§

84-212.

Plaintiff

State

of

Nebraska

is

entitled

to

relief

including

but

not

limited

to:

disgorgement,

injunctions,

civil penalties,

and

its

costs

and

attorney's

fees

pursuant

to

Neb.

Rev.

Stat.

§§

59-803, 59-819,

59-821, 59-1608,

59-1609,

59-

1614,

84-212,

87-303,

87-303.05,^

87-303.JL1.,

New

York

237.

Plaintiff

State

of

New

York

realleges

and

incorporates

each

and

every

allegation

contained

in

paragraphs

1

through

165

as

if

fully

set

forth

herein.

238.

Defendants*

acts

violate

the

Donnelly

Act,

New

York's

antitrust

law,

N.Y.

Gen.

Bus.

Law

§

340

et

seq.

239.

Defendants

have

engaged

in

repeated

fraudulent

or

illegal

acts

in

the

carrying

on,

conducting,

or

transaction

of

business,

in

violation

of

Section

63(12)

of

the

New

York

Executive

Law,

N.Y.

Exec.

Law

§

63(12).

240.

Because

of

Defendants'

illegal

conduct,

New

York

State

is

entitled

to

legal

and

equitable

remedies

including

but

not

limited

to

injunctive

relief,

equitable

monetary

relief,

and

penalties

pursuant

to

Sections

340-342(c)

of

the

New

York

General

Business

Law

and

Section

63(12)

of

the

New

York

Executive

Law.

48

North Carolina

241.

Plaintiff

State

of

North

Carolina

repeats

and

re-alleges

each

and

every

allegation

contained

in

paragraphs

1

through

165.

.

242.

Defendants'

acts

violate

North

Carolina's

Unfair

and

Deceptive

Trade Practices

Act,

N.C.

Gen.

Stat.

§

75-1

et

seq.

Plaintiff

State

of

North

Carolina

is

entitled

to

relief

under

N.C.

Gen.

Stat.

§

75-1

etseq.

243.

Plaintiff

State

of

North

Carolina

is

entitled

to

recover

its

costs

and

attorneys*

fees

pursuant

to

N.C.

Gen.

Stat.

§

75-16.1.

Ohio

244,

Plaintiff

State

of

Ohio

repeats

and

re-alleges

each

and

every

allegation

contained

in

paragraphs

1

through

165.

245.

The

Attorney

General

brings

this

action

in

his

sovereign

capacity

as

the

chief

law

enforcement

officer

of

the

State

of

Ohio.

246.

Pursuant

to

Ohio

Rev.

Code

§

1331.11,

the

Ohio

Attorney

General

is

authorized

to

institute

and

prosecute

actions

on

behalf

of

the State

to

enforce

the

provisions

and

remedies

of

Ohio's

antitrust

law,

the

Ohio

Valentine

Act,

codified

in

Ohio

Rev. Code

Chapter

1331.

247.

The

aforementioned

practices

by

Defendants

violate

Ohio

Rev.

Code

§§

1331.01

et

seq.

These

violations

substantially

affect

the

people

of

Ohio

and

have

impacts

within

the

State

of

Ohio.

248.

Pursuant

to

Ohio

Rev.

Code

§

109.81,

the

Ohio

Attorney General

is

authorized

to

do

all

things

necessary

to

properly

conduct

any

antitrust

case

and

to

seek

equitable

relief

as

provided

in

Revised

Code

§§

109.81

and

1331.11.

Based

on

Defendant's

conduct,

the

State

of

49

Ohio

is

entitled

to

an

injunction,

disgorgement,

and

civil

penalties

and

any

other

remedy

available

at

law

or

equity

for

these

violations

under

Ohio

law

or

the

laws

of

the

United

States.

OMahoiua"

'

249.

Plaintiff

State

of

Oklahoma

repeats and

re-alleges

each

and

every

allegation

contained

in

paragraphs

1

through

165.

250.

The

aforementioned

practices

by

the

Defendants

are

in

violation

of

the

Oklahoma

Antitrust

Reform

Act,

79

O.S.

§

201

et

seq.,

and

the

Oklahoma

Consumer

Protection

Act,

15

O.S.

§

751

et

seq.,

and

Plaintiff

State

of

Oklahoma

is

entitled

to

relief

under

79

O.S.

§

205

and

15

O.S.

§

756.1

respectively.

Pennsylvania

251.

Plaintiff

Commonwealth of

Pennsylvania

repeats

and

re-alleges

each

and

every

allegation

contained

in

paragraphs

1

through 165.

252.

The

aforementioned

practices

by

Defendants

violate

the

Pennsylvania

Unfair

Trade

Practices

and

Consumer

Protection

Law,

73

P,S.

§

201-1,

et

seq. ("PUTPCPL")

and

Pennsylvania

antitrust

common

law.

The

Pennsylvania

Office of

Attorney

General

has

reason

to

believe

that

the

Defendants

have

engaged

in

a

method,

act

or

practice

declared

by

73

P.S.

§

201-

3

to

be

unlawful,

and

that

this

proceeding

would

be

in

the

public

interest

pursuant

to

71

P.S.

§

201-4.

253.

On

behalf

of

the

Commonwealth

and

its

citizens pursuant

to

71

Pa.

C.S.A.

§

732-

204

(c),

Pennsylvania

seeks

injunctive

relief,

restoration,

disgorgement

and

attomeys'

fees

and

costs

pursuant

to

73

P.S.

§

201-4

and

4.1

and

civil

penalties

of

not

exceeding

$3,000

for

each

such

wilful

violation

pursuant

to

73

P.S.

§

201-8

(b).

Pennsylvania

also

seeks

injunctive

relief

and

disgorgement

under

antitrust

common

law.

50

Rhode

Island

Rhode

Islarid

realleges

arid

incorporates

all

of'

the

allegations

above

from

254.

paragraphs

1

through

165.

255.

Plaintiff

State

of

Rhode

Island

has

been

injured

as

a

result

of

Defendant's

actions

and

represents

itself,

its

State

Agencies,

Political

Subdivisions

and

Rhode

Island

consumers

in

this

action.

256.

Defendant's

acts

violate

the

Rhode

Island

Antitrust

Act,

and

Plaintiff

State

of

Rhode

Island

on

behalf

of

itself,

its

State

Agencies,

Political

Subdivisions

and

as

parens

patriae

on

behalf

of

persons

residing

in

Rhode

Island,

is

entitled

to

injunctive

relief,

civil

penalties,

reasonable

attorneys'

fees,

costs

and-statu£o^..in1^reslpursuant

to

R.L

Gen.

Laws

§

6-36-1

et

seq.

257.

Defendant's

acts

violate

the

Rhode

Island

Deceptive

Trade

Practices

Act,

and

Plaintiff

State

of

Rhode

Island

on

behalf

of

itself,

its

State

Agencies,

Political

Subdivisions

and

as

parens

patriae

on

behalf

of

persons

residing

in

Rhode

Island,

is

entitled

to

injunctive

relief,

civil

penalties,

reasonable

attorneys'

fees,

costs

and

statutory

interest

pursuant

to

R.L

Gen.

Laws

§

6-13.1-1

etseq.

South

Carolina

253."

Plaintiff

State

of

South

Carolina

repeats

and

realleges

every

preceding

allegation.

" "

259.

The

aforementioned

practices

by

Defendants

constitute

an

"unfair,

method

of

•

'

competition

and

unfair

or

deceptive

acts

or

practices"

under

§39-5-20

of

the

South

Carolina

Code

of

Laws.

Plaintiff

State

of

South

Carolina,

as

parens

patriae

for

the

citizens

of

South

Carolina,

is

entitled

to

relief

for

these

violations

under

§39-5-50,

§39-5-110(a)

and

any

other

remedy

available

at

law

oY-equity.

51

260.

South

Carolina

seeks

attorneys'

fees

and

costs

under

§39'-5-50(a).

Tennessee

261.

Plaintiff

State

of

Tennessee

repeats

and

re-alleges

each

and

every

allegation

contained

in

paragraphs

1

through

165.

262.

The

aforementioned

practices

by

Defendants

are

in

violation

of

Tennessee's

antitrust

law,

the

Tennessee

Trade

Practices

Act,

Tenn.

Code Ann.

§§

47-25-101

etseq.

263,

Defendants'

aforementioned

practices

are

in

violation

of

the

Tennessee

Consumer

Protection

Act

of

1977,

Tenn.

Code

Ann.

§ §

47-18-101

et

seq.

264.

By

Defendants'

actions

or

omissions during

the

FDA

approval

process

and

by

Defendants'

actions

or

omissions

when

converting

the

market

from

Suboxone

Tablets

to

Suboxone

Film,

Defendants

in

numerous

instances

represented,

directly

or

indirectly,

expressly

or

by

implication,

that

there

were

legitimate

health

and

safety

concerns

with

Suboxone

Tablets

that

warranted

a

switch

to

Suboxone

Film,

which

Defendants

represented

did

not

pose

similar

health

and

safety

risks.

These

representations

were

made

in

connection

with

the

federal

approval

application,

advertising,

marketing,

promotion,

offering

for

sale,

or

sale

of

Suboxone

Film.

265.

In

truth

and

in

fact,

the

health

and

safety

concerns

that

Defendants

represented

with

respect

to

Suboxone

Tablets

were

inaccurate

and

unfounded,

the

Suboxone

Tablets

did

not

present

the

negative

characteristics

that

the

Defendants

represented,

the

Suboxone

Film

did

present

health

and

safety

concerns,

and

the

Suboxone

Tablets

were

potentially

safer

than

the

Suboxone

Film.

.

266.

Defendants

failed

to

accurately

and

reasonably

represent

the

characteristics

of

Suboxone

Tablets

and

Suboxone

Film

to

the

FDA,

doctors,

payers,

and

pharmacists.

52

267.

Defendants'

practices

caused

or

are

likely

to

cause

substantial

injury

to

consumers

that

consumers

cannot

reasonably

avoid

themselves

and

that

is

not

outweighed

by

countervailing

benefits

to

consumers

or

competition.

268.

Specifically,

Defendants

violated

the

following

statutory

provisions:

•

Term.

Code Ann.

§

47-18~104(a),

which

prohibits

unfair

or

deceptive

acts

or

practices

affecting

the.

conduct

of

any

trade

or

commerce;

•

Tenn.

Code

Ann.

§

47-18404(b)(5),

which

prohibits

representing

that

goods

or

services

•

have

sponsorship,

approval^

characteristics,

ingredients,

uses,

benefits

or

quantities

that

they

do

not

have,

or

that

a

person

has

a

sponsorship

approval,

status,

affiliation

or

connection

that

the

person

does

not

have;

'

•

Tenn.

Code

Ann.

§

47~18-104(b)(7),

which

prohibits

representing

that

goods

or

services

are

of

a

particular

standard,

quality,

or

grade,

if

they

are

of

another;

and

•

Tenn.

Code Ann.

§

47~18~104(b)(27)

}

which

prohibits

engaging

in

any

other

act

or

practice

which

is

deceptive

to

the

consumer

or

to

any

other

person.

Utah

269.

Plaintiff

State

of

Utah

repeats

and

re-alleges

each

and

every

allegation

contained

in

paragraphs

1

through

165.

270.

Defendants'

acts

violate

the

Utah

Ajxtitrust

Act,

Utah

Code

§§

76-10-3101,

etseq,

.

(the

"Act"),

and

Plaintiff

State

of

Utah

is

entitled

to

all

relief

available

under

the

Act

for

those

violations,

including,

but

not

limited

to,

injunctive

relief,

civil

penalties,

disgorgement,

attomeys

,

fees,

and

costs.

53

Vermont

271.

Plaintiff

State

of

Vermont

repeats

and

re-alleges

each

and

every

allegation

contained

in

paragraphs

1

through

165.

272,

The

aforementioned

practices.

by

Defendants

are

in

violation

of

the

Vermont

Consumer

Protection

Act,

9

V.S.

A

§

2453,

and

Plaintiff

State

of

Vermont

is

entitled

to

relief

for

these

violations

under

9

V,S.A.

§§

2458

and

2465.

Virginia

273,

The

aforementioned

practices

by

Defendants

are

in

violation

of

the

Virgima

Antitrust

Act,

Va.

Code

Ana.

§§

59.1-9.1

et

seq.

These violations

had

impacts

within

the

Commonwealth

of

Virginia

and

substantially

affected

the

people

of

Virgima.

274.

Plaintiff

Commonwealth

of

Virginia

is

entitled

to

relief

under

the

Virginia

Antitrust

Act,

Va.

Code

Ann.

§§

59.1-9.11

and

59.1-9.15.

Washington

.

275.

Plaintiff

State

of

Wasliington

repeats

and

re-alleges

each

and

every

allegation

contained

in

paragraphs

1

through

165.

276.

The

aforementioned

practices

by

Defendants

were,

and

are

in,

violation

of

the

Washington

Consumer

Protection

Act,

Wash.

Rev.

Code

19.86

et

seq.

These

violations

had

impacts

within

the

State

of-

Washington

and

substantially

affected

the

people

of

Washington.

Plaintiff

State

of

Washington

is

entitled

to

an

injunction,

disgorgement,

and

civil

penalties

under

the

Consumer

Protection

Act,

Wash.

Rev.

Code

19.86.080

and

19.86.140.

Wisconsin

277.

Plaintiff

State

of

Wisconsin

repeats

and

re-alleges

each

and

every

allegation

contained

in

paragraphs

1

through

165.

54

278.

Hie

aforementioned

practices

by

Defendants

are

in

violation

of

Wisconsin's

Antitrust

Act,

Wis.

Stat

Ch.

§

133.03

et

seq.

These

violations

substantially

affect

the

people

of

Wisconsin

and

have

impacts

within

the

State

of

Wisconsin.

279.

Plaintiff

State

of

Wisconsin,

under

its

antitrust

enforcement

authority

in

Wis.

Stat.

Ch.

133,

is

entitled

to

an

injunction,

disgorgement,

and

civil

penalties

and

any

other

remedy

available

at

law

for

these

violations

under

Wis.

Stat.

§§

133.03,

133.14,

133.16,

133.17,

and

133.18.

Praver

for

Relief

Accordingly,

the

Plaintiff

States

request

that

this

Court:

Adjudge

and

decree

that

Defendants

violated

sections

1

and

2

of

the

Sherman

Act,

1.

15U.S.C.

§§

1,2;

Adjudge

and decree

that

the

foregoing

activities

violated

each

of

the

State

statutes

2.

enumerated

in

this

Complaint;

Bnjoin

and

restrain,

pursuant

to

federal

and

state

law.

Defendants,

their

affiliates,

3.

assignees,

subsidiaries,

successors,

and

transferees,

and

their

officers,

directors,

partners,

agents

and

employees,

and

all

other

persons

acting

or

claiming

to

act

on

their

behalf

or

in

concert

with

them,

from

continuing

to

engage

in

any

anticompetitive

conduct

and

from

adopting

in

the

future

any-practice,

plan,

program,

or

device

having

a

similar

purpose

or

effect

to

the

anticompetitive

actions

set

forth

above;

Award

to

Plaintiff

States

any

other

equitable

relief

as

the

Court

finds

appropriate

4.

to

redress

Defendants*

violations

of

federal

or

state

antitrust

laws

and

state

consumer

protection

laws

or

restore

competition;

55

5.

'

Award

to

each

Plaintiff

State

the

maximum

civil

penalties

allowed

by

law;

Award to

each

Plaintiff

State

statutory

or

equitable

disgorgement,

or

any

other

6.

equitable

relief

for

the

benefit

of

the

state

and

its

consumers

as

appropriate

under

each

state

laws;

7.

Award,

to

each

Plaintiff

State

its

costs,

including

reasonable

attorneys'

fees;

and

8.

Order

any

other

relief

that

this

Court

deems

proper.

56

tFurv

Demand

Pursuant

to

Fed.

R.

Civ.

P.

39(b),

Plaintiff

States

request

atrial

by

the

Court.

280.

.

Respectfully

Submitted,

Dated

September

,2016

COMMONWEALTH

OF

PENNSYLVANIA

Office

of

the

Attorney

General

BRUCE

R.

BEEMER

Attorney

General

JAMES

A.

DONAHUE,

III

Acting

Chief

of

Staff'

Executive

Deputy

Attorney

General

Public

Protection

Division

idonahue(fl),attomevgeneral.gov

PA

42624

TRACY

W.WERTZ

•

Chief

Deputy

Attorney General

Antitrust

Section

twertzffitattomevgeneral.gov

PA

69164

.

JOSEPHS.

BETSKO

Senior

Deputy

Attorney

General

Antitrust

Section

[email protected]

PA

82620

By:

AARON

L.

SCHWARTZ

Deputy.

Attortiey

General

Antitrust

Section

14

th

Floor

Strawberry Square

Harrisburg,

PA 17120

(717)

787-4530

(phone)

(717)

705-1190

(fax)

aschwartz(@attomeygeneral.goy

PA

319615

ATTORNEYS

FOR

THE

COMMONWEALTH

OF

PENNSYLVANIA

•

57

FOR

PLAINTIFF

STATE

OF

WISCONSIN

BRADD.

SCHIMEL

ATTORNEY

GENERAL

'endolyn

J.

Cooley

Assistant

Attorney

Gend&K

Wisconsin

Department

of

Justice

17

W.

Main

St

Madison,

WI53707

Telephone:

(608)261-5810

Fax:

(608)

266-2250

Email:

[email protected]

FOR

PLAINTIFF

STATE

OF

ALABAMA

LUTHER

STRANGE

ATTORNEY

GENERAL

<0"*

BillingtoiLMjGan'ett

Assistant

Aftomey

General

Office

of

the

Attorney

General

501

Washington

Avenue

Montgomery,

AL

36130

Telephone:

(334)

242-7300

Fax:

(334)

242-2433

Email:

[email protected],iis

FOR

PLAINTIFF

STATE

GK

ALASKA

JAHNA

LINDEMCJTH

ATTORNEY

GENERAL

•

Clyde

E

Sniffen,

xx.

Chief

Assistant

Attorney

General

Alaska

Department

of

Law

1031

W.4

ffi

Ave.

#200

Anchorage,

AK

99501

Telephone:

(907)

269-5100

Fax:

(907)

375-8282

Email:

[email protected]

.-

-

.-.8-,-A^.T.f.-

SsStti

-

^-r'r'fi

FOR

PLAINTIFF

STATE

OF

ARKANSAS

LESLIE

RUTLEDGE

ATTORNEY

GENERAL

John

Alexander

Assistant

Attorney

General

Arkansas

Attorney

General's

Office

323

Center

Street,

Suite

200

Little

Rock,

AR

72201

Telephone;

(501) 682-8063

Fax:

(50!)

682-8118

Email;

John.AlexandferffflArkanfra'sA-G.Oftv

\

FOR

PLAINTIFF

STATE

OF

CALIFORNIA

KAMALAD.

HARMS

ATTORNEY GENERAL

_/s/Cheryl

Lee

Johnson

Cheryl

Lee

Johnson

Deputy

Attorney

General

California

Department

of

Justice

300

S.

Spring

Street,

Suite

1700

Los

Angeles, California,

90013

Telephone;

(213)

897-2688

Fax:

(213)

620-6005

Email:

[email protected]

FOR

PLAINTIFF

STATE

OF

COLORADO

CYNTHIA

H.

COFFMAN

ATTORNEY

GENERAL

/JXs

^

Uevin

M.

Lalho

Senior

Assistant

Attorney

General

Colorado

Department

of

Law

Consumer

Protection

Section

1300

Broadway,

Seventh

Floor

Denver,

Colorado

80203

Telephone:

(720)

508-6219

Fax:

(720)

508-6040

Email:

[email protected]

FOR

PLAINTIFF

STATE

OF

CONNECTICUT

GEORGE

JEPSEN

ATTORNEY

GENERAL

'W'y^/

GaryMrBecker

Assistant

Attorney

General

55

Elm

Street

Hartford,

CT

06106

Tei:

860-808-5040

Fax:

860-808-5391

gai'v.becker

(cp.ct

gov

FOR

PLAINTIFF

STATE

OF

DELAWARE

MATTHEW

P.

DENN

ATTORNEY

GENERAL

Michael

A.

Undorf

Deputy

Attorney

General

Delaware

Department

of

Justice

820

N.

French

St.,

5

th

Floor

Wilmington,

DE

19801

Telephone:

(302)

577-8924

Fax:

(302)

577-6499

Email:

[email protected]

FOR

PLAINTIFF

DISTRICT OF

COLUMBIA

KARL

A.

RACINE

ATTORNEY

GENERAL

fiLIZABJZTO

SARAH

OffiS

(D.C.

Bar

#

186585)

Assistant

Deputy

Attorney

General

Public

Interest

Division

PWft/V/'vA

CATHERINE

A.

JACK&ON

(D.C

Bar

#

1005415)

Assistant

Attorney

General

Offi.ce

of

the

Attorney

General

441

Fourth

Street, N.W.,

Suite

630-$

Washington,

DC

20001

Telephone:

(202)

442-9864

Fax:

(202)

741-0655

Email:

[email protected]

FOR

PLAEVTIFF

STATE

OF

FLORIDA

PAMELA

JO

BOND!

ATTORNEY

GENERAL

Patricia

A. Corners

Deputy

Attorney

General

R.

Scott

Palmer

Chief

of

Complex

Enforcement

Nicholas

J.

Weilhamtner

Assistant

Attorney

General

Timothy

Eraser

Assistant

Attorney

General

Office

of

the

Attorney

General

PL-01

The

Capitol

Tallahassee,

Florida

32399-1050

Telephone;

(850)414-3921

Fax:

(850)

488-9134

Email:

Nichoias.weilhainmer@myfloi

,

idaleg'al.com

FOR

PLAINTIFF

STATE

OF

HAWAII

DOUGLAS

S.

CHIN

ATTORNEY

GENERAL

OF

HAWAII

7^

BRYAN

C.YEE

RODNEY

I.

KJMURA

Deputy

Attorneys

General

Department

of the

Attorney

General

425

Queen

Street

Honolulu,

HI 96813

Tel:

808-586-1180

Fax; 808-586-1205

bryan.c,yee@hawaii,gov

[email protected]

FOR

PLAINTIFF

STATE

OF

ILLINOIS

USA

MADIGAN

ATTORNEY

GENERAL

Chadwick

0,

Brooker

Assistant

Altomey

General

Office

of

the

Illinois

Attorney

General

100

W.

Randolph

Si.

Chicago,

IL

6060}

Telephone; (312)

793-3891

Fax:

(312)

814-4209

Email:

[email protected]

FOR

PLAINTIFF

STATE

OF

IOWA

THOMAS

J.

MILLER

ATTORNEY

GENERAL

u-

.^y"

"

y

indebak

Assistant

Attorney

General

Iowa

Department

of Justice

Special

Litigation

Division

1305

East

Walnut

Street,

2nd

Floor

Des

Moines,

Iowa

50319

Telephone;

(515)

281-7054

Fax;

(515)

281-4902

Email:

[email protected]

§

s

I

FOR

PLAINTIFF

STATE

OF

KANSAS

DEREK

SCHMIDT

ATTORNEY

GENERAL

Lynette

R.

Bakker

Assistant

Attorney

General

Office

of

the

Kansas

Attorney

General

120

S.W.

10th

Avenue,

2nd

Floor

Topeka,

KS

66612-1597

Telephone:

(785)

368-8451

Fax:

(785)

291-3699

Email:

[email protected]

Respectfully

submitted,

ANDYBESHEAJR.

Attorney

General

of

Kentucky

{

LeeAnne

Applegate

'

Charles

W.

Rowland-

Assistant

Attorneys

General

Ofiice

of the

Attorney

General

of

Kentucky

1024

Capital

Center

Drive,

Suite

200

Frankfort,

KY

40601

Tel:

502-696-5300

•

Fax:

502-573-8317

LeeAnne.

Apple

gate(5).kv.

gov

Chai'lie.Ro

wland(g)Jcv.

gov

ATTORNEYS

FOR

THE

STATE

OF

KENTUCKY

FOR

PLAINTIFF

STATE

OF

LOUISIANA

JEFF

LANDRY

Attorney

General

State

of

Louisiana

ST

A

CIE

L.

DEBLIEUX

LA

Bar

#29142

Assistant

Attorney

General

Public

Protection

Division

1885

North

Third

St

Baton

Rouge,

LA

70802

Tel:

(225)

326-6400

Fax:

(225)

326-6499

Email:

[email protected]

STATE

OF

MAINE

JANET

T.

MILLS

ATTORNEY

GENERAL

BY:

CHRISTINA

M.

MOYLAN

Assistant

ATTORNEY

GENERAL

OFFICE

OF

MAINE

ATTORNEY

GENERAL

CONSUMER

PROTECTION

DIVISION

6

STATE

HOUSE

STATION

AUGUSTA,

ME

04333-0006

207/626-8800

Christina.

MOYLAN@MAINE.

GOV

FOR

PLAINTIFF

STATE

OF

MARYLAND

BRIAN

E.

FROSH

ATTORNEY

GENERAL

Ellen

S.

Cooper

Assistant

Attorney General

Chief,

Antitrust

Division

Office

of the

Attorney

General,

State

of

Maryland

200

St.

Paul

Place,

19

,h

Floor

Baltimore,

MD

21202

Telephone:

(410)

576-6470

Fax:

(410)

576-7830

Email:

[email protected]

FOR

PLAINTIFF

COMMONWEALTH

OF

MASSACHUSETTS

MAURA

HBALEY

ATTORNEY

GENERAL

"2^

William

T.

Matlack

(MA

BBO

No.

552109)

Assistant

Attorney

General

Chief,

Antitrust

Division

Matthew

M.

Lyons

(MA

BBO

No.

657685)

Carol

E.

Head

(MA

BBO

No.

652170)

Assistant

Attorneys

General

Antitrust

Division

One

Ashburton

Place

Boston,

MA

02308

Tel:

(617)

727-2200

Fax; (617)

722-0184

(fax)

[email protected]

Matthew.Lyons@state,ma.us

Carol,Head@state,nia.us

FOR

PLAINTIFF

STATE

OF

MICHIGAN

BILL

SCHUETTE

ATTORNEY

GENERAL

A

^V

Damn

F.

Fowler

(P53464)

Assistant

Attorney

General

P.O.

Box

30755

Lansing,-MI

48909

Telephone:

(517)

373-1160

Fax:

(517)

335-6755

Email:

[email protected]

Suboxone

Multistaie

Litigation

FOR

PLAINTIFF

STATE

OF

MINNESOTA

LORISWANSON

ATTORNEY

GENERAL

Justin

R,

Erickson

Assistant

Attorney

General

Office

of

the

Minnesota

Attorney

General

1400

Bremer

Tower

445

Minnesota

Street

St

Paul,

MN

55101

Telephone:

(651)

757-U19

Fax:

(651)296-9663

Email:

[email protected]

BY;

JIM1I00D,

ATTORNEY

GENERAL

STATB

OFMISSISSIOT

SPEa^^SK^xTTOEkiY

GENERAL

A

z

State

of

Mississippi

FOR

PLAINTOT

STATE

OF

MISSOURI

CHRIS

KOSTER

ATTORNEY

GENERAL

TTJ

Oi

AMY

HAYWOOD

Assistant

Attorney

General

Missouri

Attorney

General's

Office

P.O.

Box

861

St.

Louis,

MO

63188

Telephone:

(314)

340-4902

Fax:

(314)

340-7957

Email:

amy.haywood@ago,mo.gov

FOR

PLAINTIFF

STATE

OF

NEBRASKA,

ex

rel.

DOUGLAS

J.

PETERSON,

ATTORNEY

GENERAL

Abigail

M,

Stempson

Collin

Kessner

Assistant

Attorneys

General

Nebraska

Attorney

General's

Office

2115

State

Capitol

Lincoln,

NE

68509

Tel:

402-471-3833

Fax:

402-471-4725

abigail.stempson@nebraslca.

gov

[email protected]

FOR

PLAINTIFF

STATE

OF

NEW

YORK

ERIC

T.

SCHNEIDERMAN

Attorney

General

of

the

State

of

New

York

BY:

Elinor

R,

Hoffmanp/

Deputy

Bureau

Chief,

Antitrust

Bureau

Amy

E.

McFarlane

Saami

Zain

Assistant

Attorneys

General

Attorneys

for

Plaintiff

State

of

New

York

120

Broadway,

26

lh

Floor

New

York,

NY

10271

(212)

416-8269

(voice)

(212)

416-6015

(fox)

Elinor,

Hoffmann@ag.

ny.

gov

FOR

PLAINTIFF

STATE

OF

NORTH

CAROLINA

Respectfully

submitted.

ROY

COOPER

Attorney

General

of

North

Carolina

X:

Kimberley

A,

D'Arruda

Special

Deputy

Attorney

General

North

Carolina

Dept.

of

Justice

Consumer

Protection

Division

114

West

Edenton

Street

Raleigh,

NC

27603

Telephone:

(919)

716-6013

Fax:

(919)

716-6050

Email:

[email protected]

FOR

PLAINTIFF

STATE

OF

OHIO

MIKEDEWINE

ATTORNEY

GENERAL

Beth

A.

Finnerty

Assistant

Section

Chief

Thomas

N.

Anger

Associate

Assistant

Attorney

General

Brian

F.

Jordan

Assistant

Attorney

General

Ohio

Attorney

General's

Office

Antitrust

Section

150

East

Gay

Street,

22

t

"

1

Floor

Columbus,

OH

43215

Telephone:

(614)

466-4328

Fax:

(614)

995-0266

Email:

beth,finnerty@ohioattomeygeneral,gov

[email protected]

OH

Suboxone

Complaint

Signature

Block:

12218384_l

FOR

PLAINTIFF

STATE

OF

OKLAHOMA

E. SCOTT

PRUITT

ATTORNEY

GENERAL

Julie

A.

Bays,

OKBarNo.

17516

Assistant

Attorney

General

•

Malisa

Mcpherson,

OK

Bar

No.

32070

Assistant

Attorney

General

313

NE

21

st

Street

Oklahoma

City,

OK

73105

Telephone:

(405)

522-3082

Fax;

(405)

522-0085

'

Email:

Julie,[email protected]

FOR

PLAINTIFF

STATE

OF

RHODE

ISLAND

PETER

F.

KIL3VIARTIN

ATTORNEY

GENERAL

Edmund

F.

Murray,

Jr.

Special

Assistant

Attorney

General

Rhode

Island

Department

of

Attorney

General

150

South

Main

Street

Providence,

RI02903

Telephone;

(401)

274-4400

ext.

2401

Fax:(401)222-2995

Email:

[email protected]

/

BY:

ALAN

WILSON

!

Attorney

General

for

the

State

of

South

Carolina

Federal

ID

No.

10457

Email:

[email protected]

JOHN

W.

MCINTOSH

Chief

Deputy

Attorney

General

Federal

ID

No.

2842

,

Email;

[email protected]

ROBERT

D.COOK

Solicitor

General

Federal

ID

No.

285

Email:

[email protected]

C.

HA

ViRD

JONES,

JR.

Senior

Assistant

Deputy

Attorney

General

Federal

ID

No.

2227

Email:

[email protected]

CHANTELLB

L.

NEESE

Assistant

Attorney

General

Federal

ID

No.

12412

Email:

[email protected]

CLARK

KIRKLAND,

JR.

Assistant

Attorney

General

Federal

ID

No.

32410

Email:

[email protected]

OFFICE

OF

THE

ATTORNEY

GENERAL

1000

Assembly

Street

Rembert

C.

Dennis

Building

Post Office

Box

11549

Columbia,

South

Carolina

29211-1549

Phone:

803.734.3970

Attorneys

for

Alan

Wilson,

in

his

official

capacity

as

Attorney

General

of

the State

of

South

Carolina.

ON

BEHALF

OF

THE

STATE

OF

TENNESSEE:

HERBERT

H.

SLATERY

III

Attorney

General

and

Reporter

of

Tennessee

MERRICK

•<

Byi

ERIN

Assistant

Attorney

General

JENNIFER

PEACOCK

Senior

Counsel

CYNTHIA

E.KINSER

Deputy

Attorney

General

Office

of

the

Attorney

General

and

Reporter

P.O.

Box

20207

Nashville,

TO

37202

Tel:

(615)

741-8722

l^i

'iM

.MemcMaff.tn.Rov

J6niillbi

,

'.PetockfgtELa;ta;aov

Cvhlhia.Kinsei-t@au,tn.gQY

FOR

PLAINTIFF

STATE

OF

UTAH

SEAN

D.

REYES

ATTORNEY

GENERAL

Pete

David'^onnem-eidi,

Deputy

Attorney

General

Ronald

J.

Ockey,

Assistant

Attorney

General,

Antitrust

Section

Chief

Edward

Vasquez,

Assistant

Attorney

General

Brian

Christensen,

Assistant

Attorney

General

?

By:,

Office

of

the

Attorney

General

of

Utah

Tax,

Financial

Services

and

Antitrust

Division

160

East

300

South,

5

th

Floor

P.O.

Box

140874

Salt

Lake

City, UT

84114-0874

Tel:

801-244-4636

Fax:

801-366-0315

[email protected]

roclcevf%utah.KOv

[email protected]

bclri'[email protected]

ATTORNEYS

FOR

THE

STATE

OF

UTAH

FOR

PLAINTIFF

STATE

OF

VERMONT

WILLIAM

H.

SORHELL

ATTORNEY

GENERAL

Jill

S.

Abrams

Assistant

Attorney

General

Vermont

Attorney

General's

Office

109

State

Street

Montpelier,

Vermont

05609

Telephone:

802-828-1106

Email:

[email protected]

FOR

PLAINTIFF

COMMONWEALTH

OF

VIRGINIA

MARK

R.

HERRING

ATTORNEY

GENERAL

Sarah

Oxenham

Allen

Senior

Assistant

Attorney

General

Office

of

the

Attorney

General

202

North

9

,h

Street

Richmond,

VA

23219

Telephone:

(804) 786-6557

Fax:

(804)

786-0012

Email:

[email protected]

FOR

PLAINTIFF

STATE

OF

WASHINGTON

ROBERT

W.

FERGUSON

ATTORNEY

GENERAL

.

Mi

CHIEDZA

NZIRMASANGA

Assistant

Attorney

General

State

of

Washington

Attorney

General's

Office

800

Fifth

Avenue,

Suite

2000

Seattle,

WA

98104

Telephone:

206.442.4499

Fax:

206.464.6338

Email:

[email protected]