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INTELLECTUAL PROPERTYCourse Handbook Series

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36

Life Sciences Litigation: Trends and Trajectories (PowerPoint slides)

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1001


1002


1S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Bei

jing

/ Bos

ton

/ Bru

ssel

s / C

hica

go /

Fran

kfur

t / H

ong

Kon

g / H

oust

on /

Lond

on /

Los

Ang

eles

/ M

osco

w /

Mun

ich

/ New

Yor

kP

alo

Alto

/ P

aris

/ S

ão P

aulo

/ S

eoul

/ Sha

ngha

i / S

inga

pore

/ S

ydne

y / T

okyo

/ To

ront

o / W

ashi

ngto

n, D

.C. /

Wilm

ingt

on

Life

Sci

ence

s Li

tigat

ion

Tren

ds a

nd T

raje

ctor

ies

Dou

glas

R. N

emec

PLI

’s11

thA

nnua

l Pat

ent L

aw In

stitu

te

1003


2S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

The

Futu

re o

f Rev

erse

Pay

men

t Set

tlem

ents

in A

ND

ALi

tigat

ion

2Fa

cts

and

Stra

tegi

es fo

r Life

Sci

ence

s IP

Rs

3R

ecen

t Key

Life

Sci

ence

Liti

gatio

ns4

Rec

ent C

hang

es to

Hat

ch-W

axm

an A

ct R

egul

atio

ns5

Rec

ent K

ey B

iosi

mila

r Liti

gatio

ns1

1004


3S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Muc

h of

wha

t you

are

abo

ut th

e re

ad m

ay b

e m

oot

by th

e tim

e yo

u re

ceiv

e it

Ove

rvie

w

1005


4S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Ove

rvie

w•

The

Trum

p A

dmin

istra

tion’

s pu

sh fo

r rep

eal o

f the

A

fford

able

Car

e A

ct, w

hich

incl

udes

the

Bio

logi

cs

Pric

e C

ompe

titio

n an

d In

nova

tion

Act

(“B

PC

IA”),

may

up

end

the

bios

imila

r app

rova

l and

pat

ent c

halle

nge

fram

ewor

k

•N

ew a

dmin

istra

tion

may

take

mor

e co

nser

vativ

e ap

proa

ch to

ant

itrus

t enf

orce

men

t

•D

avid

Kap

pos

rece

ntly

cal

led

on C

ongr

ess

to a

bolis

h §

101

of th

e P

aten

t Act

1006


5S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Rec

ent K

ey B

iosi

mila

r Li

tigat

ion

Inte

rpre

ting

the

Bio

sim

ilars

Act

Rev

iew

of L

arge

Mol

ecul

e Li

tigat

ion

1

1007


6S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Glo

ssar

y•

BLA

: B

iolo

gics

Lic

ense

App

licat

ion

•R

P: R

efer

ence

Pro

duct

•R

PS:

Ref

eren

ce P

rodu

ct S

pons

or

•aB

LA:

Abb

revi

ated

Bio

logi

c Li

cens

e A

pplic

atio

n

•B

A:

aBLA

App

lican

t

•Pa

tent

Dan

ce:

Pre

-litig

atio

n, p

ost-a

BLA

exch

ange

of

info

rmat

ion

betw

een

the

RP

S a

nd th

e B

A

•Fi

rst W

ave

Litig

atio

n: R

PS

can

brin

g pa

tent

infri

ngem

ent

law

suit

over

neg

otia

ted

list o

f pat

ents

from

pat

ent d

ance

or

over

vio

latio

ns o

f BP

CIA

dur

ing

danc

e

•Se

cond

Wav

e Li

tigat

ion:

RP

S c

an p

ursu

e pr

elim

inar

y in

junc

tion

afte

r BA’

s no

tice

of c

omm

erci

al m

arke

ting

for p

aten

ts

iden

tifie

d du

ring

pate

nt d

ance

but

not

litig

ated

in F

irst W

ave

Ove

rvie

w: L

et’s

Lea

rn th

e Li

ngo

1008


7S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Ove

rvie

w: B

iosi

mila

r App

rova

l Pat

hway

and

the

“Pat

ent D

ance

”

The

bios

imila

r mar

ket i

s ex

pect

ed to

pla

y an

in

crea

sing

role

in th

e gl

obal

eco

nom

y.

•La

rge

proj

ecte

d m

arke

t sha

re.

•M

ay a

llevi

ate

impe

ndin

g sm

all-m

olec

ule

drug

“pat

ent

cliff

.”

•C

ost o

f bio

logi

cs c

an b

e en

orm

ous:

–S

pinr

azaT

M, $

375,

000

per p

atie

nt fo

r one

yea

r of t

reat

men

t–

Hum

ira®

, $14

Bgl

obal

sal

es in

201

5–

Enb

rel®

, $5B

glob

al s

ales

in 2

015

Maj

or G

loba

l Im

pact

1009


8S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Ove

rvie

w: B

iosi

mila

r App

rova

l Pat

hway

and

the

“Pat

ent D

ance

”

Abb

revi

ated

Lic

ensu

re fo

r Bio

sim

ilar B

iolo

gica

l Pr

oduc

ts

•Li

cens

ure

path

way

laid

out

in §

351(

k) o

f the

Pub

lic H

ealth

S

ervi

ce A

ct (“

PH

SA

”), a

s am

ende

d by

the

BP

CIA

.

•B

iolo

gica

l pro

duct

s m

ay re

ly o

n th

e FD

A de

term

inat

ions

m

ade

for s

imila

r, pr

evio

usly

lice

nsed

bio

logi

cal

prod

ucts

.

Legi

slat

ive

Bac

kgro

und

1010


9S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Ove

rvie

w: B

iosi

mila

r App

rova

l Pat

hway

and

the

“Pat

ent D

ance

”

FDA

shal

l lic

ense

a b

iolo

gica

l pro

duct

und

er

§35

1(k)

if:

•Th

e in

form

atio

n su

bmitt

ed is

suf

ficie

nt to

sho

w th

e bi

olog

ical

pro

duct

is b

iosi

mila

ror i

nter

chan

geab

le; a

nd

•Th

e ap

plic

ant c

onse

nts

to in

spec

tion

of th

e fa

cilit

y.

App

rova

l P

athw

ay

1011


10S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Ove

rvie

w: B

iosi

mila

r App

rova

l Pat

hway

and

the

“Pat

ent D

ance

”

Bio

sim

ilarit

y

•D

efin

ition

: the

bio

logi

cal p

rodu

ct is

–H

ighl

y si

mila

r to

the

refe

renc

e pr

oduc

t; A

ND

–Is

not

mea

ning

fully

diff

eren

t in

term

s of

saf

ety,

pur

ity a

nd p

oten

cy

from

the

refe

renc

e pr

oduc

t.

•D

emon

stra

ting

Bio

sim

ilarit

y:–

Ana

lytic

al s

tudy

incl

udin

g st

ruct

ural

and

func

tiona

l ana

lysi

s.–

Ani

mal

stu

dyin

clud

ing

toxi

colo

gy s

tudi

es, a

nim

al P

Kan

d P

D

mea

sure

s, a

nd a

nim

al im

mun

ogen

icity

ass

essm

ents

.–

Clin

ical

stu

dyto

dem

onst

rate

saf

ety,

pur

ity a

nd p

oten

cy.

FDA

guid

ance

to in

dust

ry o

n bi

osim

ilarit

y av

aila

ble

atht

tp://

ww

w.fd

a.go

v/do

wnl

oads

/Dru

gs/G

uida

nceC

ompl

ianc

eReg

ulat

oryI

nfor

mat

ion/

Gui

danc

es/U

CM

3970

17.p

df.

Bio

sim

ilarit

y

1012


11S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Ove

rvie

w: B

iosi

mila

r App

rova

l Pat

hway

and

the

“Pat

ent D

ance

”

Inte

rcha

ngea

bilit

y

•D

efin

ition

:the

bio

logi

cal p

rodu

ct is

:–

Bio

sim

ilar;

–E

xpec

ted

to p

rodu

ce th

e sa

me

clin

ical

resu

ltas

the

refe

renc

e pr

oduc

t in

any

give

n pa

tient

; and

–N

o in

crea

sed

risk

in te

rms

of s

afet

y or

effi

cacy

from

alte

rnat

ing

use

of th

e re

fere

nce

prod

uct a

nd b

iolo

gica

l pro

duct

.

•D

emon

stra

ting

Inte

rcha

ngea

bilit

y:–

Very

diff

icul

t whe

n fir

st fi

led.

–N

o bi

osim

ilar h

as y

et b

een

appr

oved

as

inte

rcha

ngea

ble.

Inte

rcha

ngea

bilit

y

1013


12S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Ove

rvie

w: B

iosi

mila

r App

rova

l Pat

hway

and

the

“Pat

ent D

ance

”

Excl

usiv

ity R

ules

for B

iosi

mila

rs

•12

yea

r bio

logi

c ex

clus

ivity

: No

appr

oval

of b

iosi

mila

r un

til 1

2 ye

ars

afte

r the

lice

nsin

g of

the

refe

renc

e pr

oduc

t.

•4

year

sub

mis

sion

exc

lusi

vity

: No

subm

issi

on o

f bi

osim

ilar a

pplic

atio

n un

til 4

yea

rs a

fter l

icen

sing

of t

he

refe

renc

e pr

oduc

t.

•Ex

clus

ivity

for I

nter

chan

geab

le B

iosi

mila

rs: E

xclu

sivi

ty

gran

ted

for f

irst i

nter

chan

geab

le b

iosi

mila

r.

Exc

lusi

vity

1014


13S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Ove

rvie

w: B

iosi

mila

r App

rova

l Pat

hway

and

the

“Pat

ent D

ance

”

•The

Pat

ent D

ance

FDA

acce

pts

abbr

evia

ted

appl

icat

ion.

App

lican

t mus

t pr

ovid

e sp

onso

r w

ith a

cces

s to

ap

plic

atio

n.

20 d

ay m

ax.

Spo

nsor

mus

t pro

vide

ap

plic

ant w

ith li

st o

f in

fring

ed p

aten

ts a

nd

licen

sing

pro

posa

ls.

60 d

ay m

ax.

App

lican

t mus

t pro

vide

spo

nsor

w

ith n

on-in

fring

emen

t and

in

valid

ity c

onte

ntio

ns a

nd a

co

unte

r lis

t of i

nfrin

ged

pate

nts.

60 d

ay m

ax.

1015


14S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Ove

rvie

w: B

iosi

mila

r App

rova

l Pat

hway

and

the

“Pat

ent D

ance

”

•The

Pat

ent D

ance

(con

tinue

d)

Spo

nsor

mus

t pr

ovid

e ap

plic

ant w

ith

non-

infri

ngem

ent a

nd

inva

lidity

con

tent

ions

.

60 d

ay m

ax.

Par

ties

mus

t ne

gotia

te to

co

mpi

le a

list

of

pate

nts

to li

tigat

e.

15 d

ay m

ax.

Agr

eem

ent

No

Agr

eem

ent

Spo

nsor

mus

t brin

g lit

igat

ion

on n

egot

iate

d lis

t.

30 d

ay m

ax.

Par

ties

exch

ange

pa

tent

list

s w

ithin

5

days

of n

otic

e of

ap

plic

ant’s

pat

ent

list s

ize.

Spo

nsor

mus

t brin

g lit

igat

ion

on a

ll pa

tent

s in

bot

h lis

ts.

30 d

ay m

ax.

1016


15S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Key

Bio

sim

ilar L

itiga

tion:

Inte

rpre

ting

the

Bio

sim

ilars

Act

Key

Cas

es

Inte

rpre

ting

BP

CIA

Key

Cas

es:

•A

mge

n v.

San

doz,

794

F.3

d13

47 (F

ed. C

ir. 2

015)

•A

mge

n v.

Apo

tex,

827

F.3

d10

52(F

ed. C

ir. 2

016)

•A

mge

n v.

San

doz,

No.

2:1

6-cv

-012

76(D

.N.J

. 201

6)

•A

mge

n v.

Hos

pira

, No.

1:1

5-cv

-008

39 (D

. Del

. 201

6)

1017


16S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Key

Bio

sim

ilar L

itiga

tion:

Inte

rpre

ting

the

Bio

sim

ilars

Act

Mus

t We

Dan

ce?

No

mor

e da

ncin

g po

st A

mge

n v.

San

doz?

•In

Am

gen,

the

Fede

ral C

ircui

t hel

d th

at th

e pa

tent

dan

ce

was

not

nec

essa

ry; i

nste

ad, a

pat

ent i

nfrin

gem

ent s

uit i

s th

e so

le re

lief a

vaila

ble

whe

re a

n ap

plic

ant c

hoos

es n

ot to

da

nce.

•U

nder

Am

gen,

an

appl

ican

t may

onl

y gi

ve it

s 18

0-da

y no

tice

of c

omm

erci

al m

arke

ting

afte

r the

FD

A ha

s ap

prov

ed

its p

rodu

ct.

1018


17S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Key

Bio

sim

ilar L

itiga

tion:

Inte

rpre

ting

the

Bio

sim

ilars

Act

Mus

t We

Dan

ce?

No

mor

e da

ncin

g po

st A

mge

n v.

San

doz?

•In

Jan

uary

201

7, th

e S

upre

me

Cou

rt gr

ante

d S

ando

z’s

petit

ion

for c

erta

nd A

mge

n’s

cros

s-pe

titio

n

•S

ando

z’s

petit

ion

aske

d th

e S

upre

me

Cou

rt to

revi

ew th

e Fe

dera

l Circ

uit’s

inte

rpre

tatio

n of

the

“not

ice

of c

omm

erci

al

mar

ketin

g” p

rovi

sion

•A

mge

n’s

cros

s-pe

titio

n as

ked

the

Sup

rem

e C

ourt

to re

view

th

e ho

ldin

g th

at th

e pa

tent

dan

ce is

opt

iona

l

1019


18S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Key

Bio

sim

ilar L

itiga

tion:

Inte

rpre

ting

the

Bio

sim

ilars

Act

Mus

t We

Dan

ce?

No

mor

e da

ncin

g po

st A

mge

n v.

San

doz?

•Th

e S

olic

itor G

ener

al fi

led

a br

ief b

efor

e th

e S

upre

me

Cou

rt gr

ante

d ce

rt, s

idin

g w

ith S

ando

z on

the

mer

its o

f bot

h is

sues

:

–A

gree

d th

at th

e “p

aten

t dan

ce” d

iscl

osur

e pr

ovis

ions

are

not

m

anda

tory

, but

with

diff

eren

t rea

soni

ng th

an th

e Fe

dera

l Circ

uit

–A

rgue

d th

at C

ongr

ess

did

not i

nten

d a

furth

er 1

80-d

ay d

elay

af

ter t

he b

iosi

mila

r rec

eive

s ap

prov

al, a

nd th

at fa

ilure

to c

ompl

y w

ith th

is n

otic

e pr

ovis

ion

shou

ld n

ot g

ive

a rig

ht to

an

inju

nctio

n

1020


19S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Key

Bio

sim

ilar L

itiga

tion:

Inte

rpre

ting

the

Bio

sim

ilars

Act

Not

ice

of

Com

mer

cial

M

arke

ting

Am

gen

v. A

pote

x, 8

27 F

.3d

1052

(Fed

. Cir.

201

6)

•N

otic

e of

com

mer

cial

mar

ketin

g ef

fect

ive

only

afte

r FD

A lic

ensi

ng, e

ven

whe

re a

pplic

ant p

erfo

rmed

pa

tent

dan

ce

•N

otic

e pr

ovis

ion

is e

nfor

ceab

le b

y in

junc

tion

•S

upre

me

Cou

rt de

nied

cer

tin

Dec

embe

r 201

6,

thou

gh it

cou

ld a

ddre

ss th

ese

issu

es in

Am

gen

v.

San

doz—

espe

cial

ly c

onsi

derin

g th

at th

e S

upre

me

Cou

rt gr

ante

d A

pote

x's

mot

ion

for l

eave

to fi

le a

brie

f as

am

ici c

uria

ein

that

cas

e

1021


20S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Key

Bio

sim

ilar L

itiga

tion:

Inte

rpre

ting

the

Bio

sim

ilars

Act

Stil

l Mor

e D

anci

ng

Aro

und

The

Dan

ce

Am

gen

v. S

ando

z, N

o. 2

:16-

cv-0

1276

(D.N

.J. 2

016)

•A

mge

n so

ught

a d

ecla

rato

ry ju

dgm

ent t

hat S

ando

z vi

olat

ed

the

BP

CIA

by

refu

sing

to p

artic

ipat

e in

ste

ps o

f the

pat

ent

danc

e.

•S

ando

z la

ter r

eeng

aged

in th

e pa

tent

dan

ce, a

nd th

e co

mpl

aint

was

dis

mis

sed.

1022


21S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Key

Bio

sim

ilar L

itiga

tion:

Inte

rpre

ting

the

Bio

sim

ilars

Act

Sco

pe o

f D

isco

very

Am

gen

v. H

ospi

ra, N

o. 1

:15-

cv-0

0839

(D. D

el. 2

016)

•Th

e D

istri

ct C

ourt

held

that

spe

cific

man

ufac

turin

g in

form

atio

n re

gard

ing

Hos

pira

’spr

opos

ed b

iosi

mila

r nee

d on

ly b

e pr

oduc

ed if

it re

late

s to

cla

ims

alre

ady

asse

rted

•A

ppea

l pen

ding

with

Fed

eral

Circ

uit,

cons

ider

ing:

–W

heth

er th

e Fe

dera

l Circ

uit h

as ju

risdi

ctio

n to

revi

ew o

rder

s on

su

ch d

isco

very

dis

pute

s–

Whe

ther

the

rulin

g on

dis

cove

ry ru

ns a

foul

of t

he F

eder

al

Circ

uit’s

gui

danc

e in

Am

gen

v. S

ando

z th

atan

RP

S “c

anac

cess

th

e re

quire

d in

form

atio

n th

roug

h di

scov

ery”

in a

n in

fring

emen

t su

it w

hen

appl

ican

ts d

o no

t mak

e al

l dis

clos

ures

in p

aten

t dan

ce

1023


22S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Key

Bio

sim

ilar L

itiga

tion:

Lar

ge M

olec

ule

Litig

atio

n

Larg

e M

olec

ule

Litig

atio

n

Key

Bio

sim

ilar C

halle

nges

:•

Am

gen

v. A

pote

x,N

o.15

-cv-

6163

1 (S

.D. F

la.)

(Neu

last

a® (p

egfil

gras

tim) a

nd

Neu

poge

n® (f

ilgra

stim

); de

crea

se in

fect

ion

in p

atie

nts

rece

ivin

g an

ti-ca

ncer

dr

ugs)

•Ja

nsse

n v.

Cel

ltrio

n, N

o. 1

:15-

cv-1

0698

(D. M

ass.

) (R

emic

ade®

(inf

lixim

ab);

rheu

mat

oid

arth

ritis

and

oth

er a

utoi

mm

une

dise

ase)

•A

mge

n v.

Hos

pira

, No.

1:1

5-cv

-008

39 (D

. Del

.) (E

poge

n®/P

rocr

it® (e

poet

inal

fa);

anem

ia)

•A

mge

n v.

San

doz,

Nos

.3:1

4-cv

-047

41, 3

:16-

cv-0

2581

(N.D

. Cal

.) (N

eula

sta®

(peg

filgr

astim

) and

Neu

poge

n® (f

ilgra

stim

))

•Im

mun

exv.

San

doz,

No.

2:1

6-cv

-111

8 (D

.N.J

.) (E

nbre

l® (e

ntan

erce

pt);

rheu

mat

oid

arth

ritis

and

oth

er a

utoi

mm

une

dise

ases

)

•A

bbVi

e v.

Am

gen,

No.

1:1

6-cv

-006

66 (D

. Del

.) (H

umira

® (a

dalim

umab

); rh

eum

atoi

d ar

thrit

is a

nd o

ther

aut

oim

mun

e di

seas

es)

1024


23S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Key

Bio

sim

ilar L

itiga

tion:

Lar

ge M

olec

ule

Litig

atio

n

Larg

e M

olec

ule

Litig

atio

n

Am

gen

v. A

pote

x, N

o.15

-cv-

6163

1 (S

.D. F

la.)

(Neu

last

a®

(peg

filgr

astim

) and

Neu

poge

n® (f

ilgra

stim

))

•Fi

rst f

inal

judg

men

t and

tria

l und

er th

e B

PC

IA

•A

fter a

ben

ch tr

ial i

n Ju

ly 2

016,

the

Dis

trict

Cou

rt fo

und

all

clai

ms

not i

nfrin

ged

•Fe

dera

l Circ

uit a

ppea

l pen

ding

on

judg

men

t of n

on-

infri

ngem

ent

•Th

e pa

tent

-at-i

ssue

is a

lso

the

subj

ect o

f a p

endi

ng IP

R

petit

ion

1025


24S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Key

Bio

sim

ilar L

itiga

tion:

Lar

ge M

olec

ule

Litig

atio

n

Larg

e M

olec

ule

Litig

atio

n

Jans

sen

v. C

elltr

ion,

No.

1:1

5-cv

-106

98 (D

. Mas

s.)

(Rem

icad

e® (i

nflix

imab

))

•Fi

rst j

ury

trial

und

er th

e B

PC

IA s

et fo

r Feb

ruar

y 20

17

•D

istri

ct C

ourt

ente

red

parti

al fi

nal j

udgm

ent o

f inv

alid

ity fo

r do

uble

pat

entin

g on

one

of t

he tw

o pa

tent

s-in

-sui

t

•Fe

dera

l Circ

uit a

ppea

ls p

endi

ng o

n D

istri

ct C

ourt

judg

men

t of

dou

ble

pate

ntin

g an

d ex

par

tere

exam

inat

ion

rulin

g fin

ding

pat

ent i

nval

id fo

r dou

ble

pate

ntin

g

•P

fizer

ann

ounc

ed in

tent

ion

to la

unch

its

bios

imila

r In

flect

ra®

at-r

isk

by N

ovem

ber 2

016

1026


25S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Key

Bio

sim

ilar L

itiga

tion:

Lar

ge M

olec

ule

Litig

atio

n

Larg

e M

olec

ule

Litig

atio

n

Am

gen

v. H

ospi

ra, N

o. 1

:15-

cv-0

0839

(D. D

el.)

(Epo

gen®

/Pro

crit®

(epo

etin

alfa

), an

emia

)

•Ju

ry tr

ial s

et fo

r Sep

tem

ber 2

017

•H

ospi

ra’s

disc

losu

re o

f man

ufac

turin

g in

form

atio

n du

ring

pate

nt d

ance

at i

ssue

in p

endi

ng F

eder

al C

ircui

t app

eal,

disc

usse

d ab

ove

•C

ourt

deni

ed H

ospi

ra’s

mot

ion

to d

ism

iss

Am

gen’

s re

ques

t fo

r dec

lara

tory

judg

men

t tha

t Hos

pira

’spr

e-ap

prov

al n

otic

e of

com

mer

cial

mar

ketin

g is

lega

lly in

effe

ctiv

e

•H

ospi

ra’s

bios

imila

r is

not y

et a

ppro

ved

1027


26S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Key

Bio

sim

ilar L

itiga

tion:

Lar

ge M

olec

ule

Litig

atio

n

Larg

e M

olec

ule

Litig

atio

n

Am

gen

v. S

ando

z,N

os.3

:14-

cv-0

4741

, 3:1

6-cv

-025

81

(N.D

. Cal

.) (N

eula

sta®

(peg

filgr

astim

) and

Neu

poge

n®

(filg

rast

im))

•Ju

ry tr

ial s

et fo

r Dec

embe

r 201

7.

•S

ando

z’s

cond

uct d

urin

g pa

tent

dan

ce fo

r bio

sim

ilars

to

thes

e R

Ps

was

at i

ssue

in th

e D

.N.J

. cas

e an

d th

e pe

ndin

g S

upre

me

Cou

rt ca

se, d

iscu

ssed

abo

ve.

•O

ne o

f San

doz’

s bi

osim

ilars

, Zar

xio®

, was

the

first

bi

osim

ilar a

ppro

ved

by th

e FD

A an

d is

on

the

mar

ket.

The

ot

her b

iosi

mila

r is

not y

et a

ppro

ved.

1028


27S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Key

Bio

sim

ilar L

itiga

tion:

Lar

ge M

olec

ule

Litig

atio

n

Larg

e M

olec

ule

Litig

atio

n

Imm

unex

v. S

ando

z, N

o. 2

:16-

cv-1

118

(D.N

.J.)

(Enb

rel®

(e

ntan

erce

pt))

•B

ench

tria

l set

for A

pril

2018

; Mar

kman

hear

ing

set f

or

Febr

uary

201

7

•S

ando

z ag

reed

to Im

mun

ex’s

pate

nt li

st a

nd w

aive

d its

righ

t to

rece

ive

stat

emen

t on

infri

ngem

ent/v

alid

ity, a

llege

dly

asse

rting

that

the

pate

nt d

ance

was

com

plet

e an

d th

at

Imm

unex

mus

t brin

g su

it w

ithin

30

days

•S

ando

z’s

bios

imila

r Ere

lzi®

is a

ppro

ved,

but

San

doz

stip

ulat

ed n

ot to

laun

ch it

s pr

oduc

t bef

ore

a da

te th

at is

not

pu

blic

1029


28S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Key

Bio

sim

ilar L

itiga

tion:

Lar

ge M

olec

ule

Litig

atio

n

Larg

e M

olec

ule

Litig

atio

n

Abb

Vie

v. A

mge

n, N

o. 1

:16-

cv-0

0666

(D. D

el.)

(Hum

ira®

(a

dalim

umab

))

•B

ench

tria

l set

for N

ovem

ber 2

019

•A

mge

n id

entif

ied

61 p

aten

ts in

fring

ed b

y A

bbVi

e, w

hich

the

parti

es n

arro

wed

to 1

0 pa

tent

s fo

r thi

s Fi

rst W

ave

litig

atio

n

•A

mge

n’s

bios

imila

r Am

jevi

ta®

is a

ppro

ved,

but

Am

gen

asse

rted

in it

s an

swer

that

it w

ill n

ot la

unch

its

prod

ucts

for

180

days

afte

r app

rova

l

1030


29S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Key

Bio

sim

ilar L

itiga

tion

Larg

e M

olec

ule

Litig

atio

n

Pote

ntia

l New

Bio

sim

ilar L

itiga

tion

base

d on

FD

A Fi

lings

•FD

A ac

cept

ed fo

r rev

iew

Sam

sung

Bio

epis

/Mer

ck’s

aB

LAfo

r bio

sim

ilar t

o R

emic

ade®

•FD

A ac

cept

ed fo

r rev

iew

Coh

erus

Bio

scie

nces

’ aB

LAfo

r bi

osim

ilar t

o N

eula

sta®

•M

ylan

/Bio

con

subm

itted

aB

LAfo

r bio

sim

ilar t

o H

erce

ptin

®

•A

mge

n/A

llerg

an s

ubm

itted

aB

LAfo

r bio

sim

ilar t

o Av

astin

®

1031


30S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Key

Bio

sim

ilar L

itiga

tion

Con

clus

ions

Bou

nds

of B

PCIA

are

Rel

ativ

ely

Uns

ettle

d

•S

upre

me

Cou

rt co

uld

prov

ide

clar

ity in

its

first

cha

nce

to

revi

ew B

PC

IA re

quire

men

ts

•Th

reat

of r

epea

l of t

he B

PC

IA b

y th

e ne

w a

dmin

istra

tion

adds

mor

e un

certa

inty

1032


31S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

The

Futu

re o

f Rev

erse

P

aym

ent S

ettle

men

ts in

A

ND

ALi

tigat

ion

2

1033


32S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Futu

re o

f Rev

erse

Pay

men

t Set

tlem

ents

in A

ND

ALi

tig.

Rev

erse

Pay

men

t Set

tlem

ents

Dis

favo

red

•Fe

dera

l Tra

de C

omm

issi

on v

. Act

avis

(U.S

. 201

3)

•R

ule

of re

ason

app

lied

to p

harm

aceu

tical

pat

ent

settl

emen

ts e

ven

whe

n w

ithin

the

scop

e of

the

pate

nt.

Rev

erse

Pay

men

t S

ettle

men

t C

ase

Law

1034


33S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Futu

re o

f Rev

erse

Pay

men

t Set

tlem

ents

in A

ND

ALi

tig.

Rec

ent C

ircui

t Cas

e La

w

•In

re: N

exiu

m®

(Eso

mep

razo

le) A

ntitr

ust L

itiga

tion

(1st

Cir.

20

16)

–A

ffirm

ed fi

rst j

ury

verd

ict o

n ph

arm

aceu

tical

com

pany

se

ttlem

ents

sin

ce A

ctav

is.

–Fo

und

antit

rust

vio

latio

n in

reve

rse

paym

ent b

ut n

o in

jury

, be

caus

e th

e re

taile

rs h

ad n

ot s

how

n th

at R

anba

xy c

ould

hav

e la

unch

ed it

s ge

neric

soo

ner.

–P

etiti

on fo

r reh

earin

g an

d re

hear

ing

enba

ncde

nied

in J

anua

ry

2017

.

Rev

erse

Pay

men

t S

ettle

men

t C

ase

Law

1035


34S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Futu

re o

f Rev

erse

Pay

men

t Set

tlem

ents

in A

ND

ALi

tig.

Rec

ent C

ircui

t Cas

e La

w

•In

re L

oest

rin24

Fe

Ant

itrus

t Liti

gatio

n(1

st C

ir. 2

016)

–H

oldi

ng A

ctav

isco

ntro

ls a

set

tlem

ent a

gree

men

t whi

ch a

llow

s de

laye

d en

try o

f a g

ener

ic in

retu

rn fo

r fav

orab

le p

rom

otio

nal

deal

s an

d th

e br

and

mak

er’s

pro

mis

e no

t to

intro

duce

a g

ener

ic.

•K

ing

Dru

g C

o. o

f Flo

renc

e, In

c. v

. Sm

ithK

line

Bee

cham

C

orp.

(3d

Cir.

201

5)–

Hol

ding

con

side

ratio

n in

the

form

of a

n ag

reem

ent b

y th

e br

and

not t

o la

unch

an

“aut

horiz

ed g

ener

ic” d

urin

g th

e ge

neric

’s 1

80-

day

excl

usiv

ity p

erio

d ca

n be

a re

vers

e pa

ymen

t und

er A

ctav

is–

Pet

ition

for c

ertd

enie

d N

ovem

ber 2

016

Rev

erse

Pay

men

t S

ettle

men

t C

ase

Law

1036


35S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Futu

re o

f Rev

erse

Pay

men

t Set

tlem

ents

in A

ND

ALi

tig.

Sta

tistic

s Fo

llow

ing

Act

avis

*

21 S

ettle

men

ts p

oten

tially

invo

lvin

g pa

y fo

r del

ay•

20 d

iffer

ent b

rand

ed p

rodu

cts.

•10

incl

ude

com

pens

atio

n so

lely

in th

e fo

rm o

f cas

h.–

9 pu

rpor

tedl

y co

verin

g lit

igat

ion

fees

.–

1 in

the

form

of d

ebt f

orgi

vene

ss.

•6

incl

ude

com

pens

atio

n in

the

form

of a

sid

e bu

sine

ss d

eal.

•5

incl

ude

bran

d m

anuf

actu

rer's

pro

mis

e no

t to

mar

ket a

n au

thor

ized

gen

eric

for s

ome

perio

d of

tim

e.

•111

of th

e 16

0 fin

al s

ettle

men

ts re

stric

t the

gen

eric

m

anuf

actu

rer's

abi

lity

to m

arke

t its

pro

duct

but

con

tain

no

expl

icit

or p

ossi

ble

com

pens

atio

n.

*Sta

tistic

s co

ver F

Y 20

14, t

he m

ost r

ecen

t dat

a fro

m th

e FT

C

1037


36S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Futu

re o

f Rev

erse

Pay

men

t Set

tlem

ents

in A

ND

ALi

tig.

Upc

omin

g ca

ses

Two

Cas

es in

the

Third

Circ

uit M

ay C

larif

y Pl

eadi

ng

Stan

dard

s

–In

re: W

ellb

utrin

XL

Ant

itrus

t Liti

gatio

n, N

os. 1

5-28

75 1

5-35

59, 1

5-35

91, 1

5-36

81, a

nd 1

5-36

82

»D

eal a

llow

ed p

aten

t dis

pute

to c

ontin

ue a

nd g

ener

ics

mak

ers

to la

unch

pro

duct

s ei

ther

whe

neve

r the

ge

neric

s m

aker

s pr

evai

led

in th

e pa

tent

sui

t or b

y a

set

date

–In

re: E

ffexo

r XR

Ant

itrus

t, N

o. 1

5-13

42

»“N

o-au

thor

ized

gen

eric

” dea

l

1038


37S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Futu

re o

f Rev

erse

Pay

men

t Set

tlem

ents

in A

ND

ALi

tig.

Adm

inis

tratio

n C

hang

e

Pres

iden

t-ele

ct T

rum

p’s

appo

inte

es m

ay s

igna

l re

lief o

n pa

y-fo

r-de

lay

polic

y:

•S

elec

ted

form

er F

TC c

omm

issi

oner

Jos

hua

Wrig

ht to

lead

th

e tra

nsiti

on o

n an

titru

st a

nd th

e FT

C

•W

right

has

crit

iciz

ed th

e FT

C's

app

roac

h to

pay

-for-d

elay

se

ttlem

ents

and

sug

gest

ed h

e w

ould

take

a m

ore

cons

erva

tive

appr

oach

1039


38S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Futu

re o

f Rev

erse

Pay

men

t Set

tlem

ents

in A

ND

ALi

tig.

Con

clus

ions

Avai

labl

e re

vers

e pa

ymen

t set

tlem

ents

:

•P

aym

ents

to re

imbu

rse

atto

rney

s’ fe

es.

•Ea

rly e

ntry

by

the

gene

ric w

ithou

t any

pay

men

t.

N.B

. Va

riatio

ns o

f bot

h of

thes

e sc

enar

ios

may

giv

e ris

e to

an

titru

st s

crut

iny

1040


39S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Fact

s an

d S

trate

gies

for

Life

Sci

ence

s IP

Rs

3

1041


40S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Fact

s an

d St

rate

gies

for L

ife S

cien

ces

IPR

s

App

rox.

of

all

life

scie

nces

IP

Rs

wer

e

filed

in 2

015

and

2016

Life

Sci

ence

s IP

Rs

Are

Gro

win

g M

ore

Com

mon

•O

ver 5

30 li

fe s

cien

ces

IPR

s ha

ve b

een

filed

in to

tal s

ince

th

e po

st-g

rant

opp

ositi

on p

roce

dure

s to

ok e

ffect

.

•~1

70 o

f the

se li

fe s

cien

ces

IPR

sw

ere

filed

in 2

016,

and

~1

90 w

ere

filed

in 2

015.

1042


41S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Fact

s an

d St

rate

gies

for L

ife S

cien

ces

IPR

s

Ana

tom

y of

Li

fe S

cien

ces

IPR

s

•94

% fi

led

by p

harm

aceu

tical

and

bio

logi

cal c

ompa

nies

•6%

file

d by

hed

ge fu

nds

–N

early

all

filed

by

Coa

litio

n fo

r Affo

rdab

le D

rugs

(hed

ge fu

nd

crea

ted

by K

yle

Bas

s).

–O

nly

thre

e su

cces

sful

cha

lleng

es fr

om B

ass:

»S

hire

's p

aten

t cov

erin

g G

atte

x®; o

n ap

peal

in th

e Fe

dera

l Circ

uit

»Tw

o C

elge

ne p

aten

ts c

over

ing

thre

e O

rang

e B

ook

Dru

gs: T

halo

mid

®,

Pom

alys

t®, a

nd R

evlim

id®

; req

uest

s fo

r reh

earin

g pe

ndin

g–

Last

IPR

file

d by

Bas

s in

Sep

t. 20

15.

–Fe

dera

l Circ

uit p

rece

dent

requ

iring

sta

ndin

g fo

r IP

R a

ppea

ls m

ay

furth

er d

isco

urag

e pe

titio

ns fr

om h

edge

fund

s. S

ee P

hige

nix,

Inc.

v.

Imm

unog

en, I

nc.,

No.

201

6-15

44 (F

ed. C

ir. J

an. 9

, 201

7).

1043


42S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Fact

s an

d St

rate

gies

for L

ife S

cien

ces

IPR

s

Con

clus

ion

Take

away

s

•Li

fe s

cien

ces

IPR

sar

e he

atin

g up

.

•H

edge

fund

s ar

e no

t dom

inat

ing

life

scie

nces

IPR

s in

ge

nera

l; K

yle

Bas

s ha

s be

en th

e pr

ime

driv

er b

ehin

d he

dge

fund

initi

ated

life

sci

ence

s IP

R p

etiti

ons.

•S

tatis

tics

show

that

life

sci

ence

s IP

Rs

are

less

like

ly to

be

inst

itute

d an

d cl

aim

s, o

nce

inst

itute

d, a

re m

ore

likel

y to

su

rviv

e.

1044


43S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Rec

ent K

ey L

ife S

cien

ces

Litig

atio

ns4

1045


44S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Rec

ent K

ey L

ife S

cien

ces

Litig

atio

ns

U.S

. Life

-Sci

ence

s In

nova

tion

Glo

bal

Impa

ct

#1 Ran

king

in w

orld

-w

ide

inno

vatio

n

> of IP

rela

ted

to

wor

ld’s

new

med

icin

e in

vent

ed in

Am

eric

a

The

U.S

. has

led

the

wor

ld in

glo

bal m

edic

al

inno

vatio

n.

•R

anke

d fir

st in

con

tribu

tions

to g

loba

l life

-sci

ence

s in

nova

tion.

•M

ore

than

½ o

f IP

rela

ted

to th

e w

orld

’s n

ew m

edic

ines

w

as in

vent

ed in

Am

eric

abe

twee

n 19

97 a

nd 2

012.

•In

the

2000

s, U

.S. b

ioph

arm

aceu

tical

com

pani

es

intr

oduc

ed m

ore

new

che

mic

al e

ntiti

es th

an c

ompa

nies

fro

m th

e ne

xt fi

ve n

atio

ns c

ombi

ned.

1046


45S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Rec

ent K

ey L

ife S

cien

ces

Litig

atio

ns

The

§10

1 Tr

end

May

S

pell

Trou

ble

Rec

ent j

udic

ial d

ecis

ions

on

§10

1 m

ay a

lter t

his

tren

d

1047


46S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Rec

ent K

ey L

ife S

cien

ces

Litig

atio

ns

The

Shi

ft To

war

d S

trict

A

pplic

atio

n of

§

101

May

o C

olla

bora

tive

Serv

ices

v. P

rom

ethe

us

Labo

rato

ries,

Inc.

(U.S

. 201

1)

•P

aten

ted

met

hod

for o

ptim

izin

g tre

atm

ent o

f cer

tain

ga

stro

inte

stin

al d

isea

ses

by a

djus

ting

the

amou

nt

adm

inis

tere

d ba

sed

on th

e m

edic

ine'

s in

tera

ctio

n w

ith th

e bo

dy.

•U

nder

§10

1, a

pro

cess

whi

ch m

erel

y ap

plie

s a

natu

ral l

aw

with

out a

n in

vent

ive

conc

ept i

s pa

tent

inel

igib

le.

1048


47S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Rec

ent K

ey L

ife S

cien

ces

Litig

atio

ns

The

Shi

ft To

war

d S

trict

A

pplic

atio

n of

§

101

Ass

ocia

tion

for M

olec

ular

Pat

holo

gy v

. Myr

iad

Gen

etic

s (U

.S. 2

013)

•P

aten

ted

isol

ated

form

s of

gen

es th

at in

dica

te a

hig

h ris

k of

de

velo

ping

bre

ast c

ance

r.

•U

nder

§10

1, n

atur

ally

occ

urrin

g ge

ne s

eque

nces

are

not

pa

tent

elig

ible

; how

ever

, mol

ecul

es th

at d

o no

t occ

ur

natu

rally

are

pat

ent e

ligib

le.

1049


48S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Rec

ent K

ey L

ife S

cien

ces

Litig

atio

ns

The

Shi

ft To

war

d S

trict

A

pplic

atio

n of

§

101

Ario

saD

iagn

ostic

s, In

c. v

. Seq

ueno

m, I

nc. (

Fed.

Cir.

20

15) (

enba

nc)

•P

aten

ted

met

hods

of m

akin

g a

pren

atal

dia

gnos

is b

ased

on

non-

inva

sive

test

ing

usin

g ce

ll fre

e fe

tal D

NA

.

•U

nder

§10

1, th

e ap

plic

atio

n of

a w

ell-k

now

n m

etho

d us

ed

for a

new

pur

pose

doe

s no

t con

tain

the

inve

ntiv

e co

ncep

t re

quire

d un

der t

he M

ayo-

Alic

e fra

mew

ork.

•Ju

dge

Lour

iew

arns

: "a

cris

is o

f pat

ent l

aw a

nd m

edic

al

inno

vatio

n m

ay b

e up

on u

s.”

•S

upre

me

Cou

rt de

nied

cer

tin

June

201

6.

1050


49S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Rec

ent K

ey L

ife S

cien

ces

Litig

atio

ns

The

Shi

ft To

war

d S

trict

A

pplic

atio

n of

§

101

Gen

etic

Tec

hnol

ogie

s Lt

d. v

. Mer

ialL

LC(F

ed. C

ir.

2016

)

•P

aten

ted

met

hod

of a

naly

zing

seq

uenc

es o

f gen

omic

DN

A by

am

plify

ing

the

exon

DN

A an

d th

en a

naly

zing

the

linke

d in

tron

regi

on.

•U

nder

May

o, A

lice

and

Ario

sa, u

sing

a w

ell-k

now

n m

etho

d in

a n

ew c

onte

xt b

ased

on

disc

over

y of

exo

n-in

tro li

nkag

es

was

insu

ffici

ent t

o ad

d th

e in

vent

ive

conc

ept r

equi

red

to

satis

fy §

101

pate

nt e

ligib

ility.

1051


50S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Rec

ent K

ey L

ife S

cien

ces

Litig

atio

ns

The

Tren

d M

ay B

e S

low

ing

Rap

id L

itiga

tion

Man

agem

ent L

TD v

. Cel

lzdi

rect

, Inc

.(F

ed. C

ir. 2

016)

•P

aten

ted

met

hod

of a

n im

prov

ed p

roce

ss o

f pre

serv

ing

hepa

tocy

tes

(live

r cel

ls).

•R

ever

sed

dist

rict c

ourt’

s fin

ding

of p

aten

t ine

ligib

ility

—fir

st

elig

ibili

ty fi

ndin

g si

nce

Alic

e on

cla

ims

rela

ting

to a

"law

of

natu

re" o

r "na

tura

l phe

nom

enon

.”

•H

eld

clai

ms

wer

e no

t dire

cted

to in

elig

ible

law

of n

atur

e, b

ut

rath

er “

a ne

w a

nd u

sefu

l lab

orat

ory

tech

niqu

e.”

Furth

er,

the

clai

ms

refle

cted

a “s

igni

fican

t” im

prov

emen

t tha

t was

no

t rou

tine

or c

onve

ntio

nal g

iven

unp

redi

ctab

ility

in fi

eld.

1052


51S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Rec

ent K

ey L

ife S

cien

ces

Litig

atio

ns

Bew

are

The

Slip

pery

S

lope

Rec

ent j

udic

ial o

pini

ons

at th

e di

stric

t lev

el s

igna

l th

e si

tuat

ion

Judg

e Lo

urie

war

ned

mig

ht e

nsue

—bu

t Cel

lzdi

rect

and

com

pute

r-ba

sed

§10

1 pr

eced

ent s

ugge

st c

ourt

s ar

e ta

ppin

g th

e br

akes

.

1053


52S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Rec

ent K

ey L

ife S

cien

ces

Litig

atio

ns

Dis

trict

Cou

rts

Cau

tious

Bris

tol-M

yers

Squ

ibb

Co.

v. M

erck

& C

o., I

nc.(

D.

Del

. Mar

. 17,

201

6) (S

leet

, J.)

(Key

trud

a®

(pem

brol

izum

ab))

•P

aten

ted

met

hod

of c

ance

r tre

atm

ent u

sing

the

body

's im

mun

e sy

stem

via

the

PD

-1 p

athw

ay.

•D

enie

d th

e 12

(b)(6

) mot

ion

to d

ism

iss

upon

find

ing

that

“[w

]hen

the

fact

ual a

llega

tions

. . .

[are

] rea

d in

the

light

mos

t fav

orab

le to

[the

pl

aint

iff],

ther

e ar

e . .

. m

ater

ial f

actu

al d

ispu

tes

. . .

.”

•N

onet

hele

ss, t

he c

ourt

held

that

the

pate

nt fa

iled

step

one

of t

he

Alic

e te

st “c

oncl

ud[in

g] th

at .

. . th

e [p

aten

t] to

uche

s up

on a

nat

ural

ph

enom

enon

by

usin

g T

cells

to a

ctiv

ate

the

imm

une

syst

em.”

1054


53S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Rec

ent K

ey L

ife S

cien

ces

Litig

atio

ns

Dis

trict

Cou

rts

Cau

tious

Vand

a Ph

arm

s., I

nc. v

. Rox

ane

Labs

., In

c. (D

. Del

. A

ug. 2

6, 2

016)

(Sle

et, J

.) (F

AN

APT

® (i

lope

ridon

e))

•In

clud

es p

aten

ted

pers

onal

ized

med

icin

e m

etho

d cl

aim

s di

rect

ed to

di

agno

sing

cer

tain

gen

etic

pol

ymor

phis

ms

and

trea

ting

thos

e w

ith

parti

cula

r pol

ymor

phis

ms

with

spe

cific

dos

ages

of i

lope

ridon

e

•E

nter

ed ju

dgm

ent f

or p

aten

tee

afte

r ben

ch tr

ial,

incl

udin

g a

findi

ng

of p

aten

t elig

ibilit

y

•Fo

und

that

met

hod

of tr

eatm

ent c

laim

s w

ere

dire

cted

to la

ws

of

natu

re.

•B

ut d

raw

ing

on C

ellz

dire

ct, f

ound

that

“usi

ng th

is g

enet

ic te

st to

in

form

the

dosa

ge a

djus

tmen

t rec

ited

in th

e cl

aim

s w

as n

ot

rout

ine

or c

onve

ntio

nal”

and

pass

ed s

tep

2

1055


54S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Rec

ent K

ey L

ife S

cien

ces

Litig

atio

ns

Dis

trict

Cou

rts

Cau

tious

Oxf

ord

Imm

unot

ecLt

d. v

. Qia

gen

NV

(D. M

ass.

Sep

t. 30

, 201

6) (G

orto

n, J

.)

•P

aten

ted

“kit”

and

“met

hod”

cla

ims

rela

ting

to T

B te

sts.

“Kit”

cla

ims

cove

r kits

for d

iagn

osin

g TB

infe

ctio

n co

mpr

ised

of a

spe

cific

pan

el

of p

eptid

es, a

nd “m

etho

d” c

laim

s co

ver m

etho

ds o

f usi

ng th

ese

kits

in

vitr

o.

•D

enie

d th

e 12

(b)(6

) mot

ion

to d

ism

iss

for b

oth

“kit”

cla

ims

and

“met

hod”

cla

ims

(ove

rrulin

g m

agis

trate

’s re

com

men

datio

n to

gra

nt

mot

ion

as to

“kit”

cla

ims)

•D

istin

guis

hed

“kit”

cla

ims

from

Myr

iad

beca

use

“they

are

alle

ged

to

be c

hem

ical

ly d

iffer

ent t

han

the

natu

rally

occ

urrin

g am

ino

acid

s.”

“Met

hod”

cla

ims

surv

ived

as

they

“im

prov

e on

the

curre

nt te

stin

g m

etho

ds fo

r tub

ercu

losi

s.”

1056


55S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Rec

ent K

ey L

ife S

cien

ces

Litig

atio

ns

But

Pat

ents

R

emai

n Vu

lner

able

Rec

ent F

eder

al C

ircui

t §10

1 Pr

eced

ent o

n C

ompu

ter-

Bas

ed C

laim

s M

ay P

rote

ct L

ife S

cien

ces

Pate

nts

Cle

vela

nd C

linic

Fou

ndat

ion

v. T

rue

Hea

lth D

iagn

ostic

s LL

C,

No.

1-1

5-cv

-023

31 (N

.D. O

hio

Feb.

23,

201

6)

•P

aten

ted

test

for a

sses

sing

car

diov

ascu

lar d

isea

se ri

sk b

y an

alyz

ing

infla

mm

atio

n of

the

bloo

d ve

ssel

s

•Fo

und

thre

e of

four

pat

ents

inva

lid u

nder

§10

1 at

mot

ion

to d

ism

iss

stag

e (a

nd fo

und

infri

ngem

ent p

lead

ing

insu

ffici

ent f

or fo

urth

pat

ent)

•A

ppea

l pen

ding

in th

e Fe

dera

l Circ

uit (

No.

16-

1766

), w

ith th

e pa

tent

ee d

raw

ing

from

arg

umen

ts in

McR

Oan

dB

AS

CO

Min

add

ition

to

ana

logi

zing

pat

ent c

laim

s to

Cel

lzdi

rect

1057


56S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Rec

ent K

ey L

ife S

cien

ces

Litig

atio

ns

Take

away

s on

S

ubje

ct M

atte

r E

ligib

ility

The

wea

kene

d §

101

fram

ewor

k ha

s de

ep e

ffect

s on

th

e lif

e sc

ienc

es in

dust

ry.

•Li

fe s

cien

ces

are

parti

cula

rly re

liant

on

pate

nt p

rote

ctio

n du

e to

eno

rmou

s in

nova

tion

cost

s, lo

ng R

&D

tim

esca

le,

rela

tivel

y lo

w c

ost o

f cop

ying

and,

unl

ike

mos

t ind

ustri

es,

the

pres

ence

of b

oth

stat

utor

y an

d m

arke

t inc

entiv

es to

co

py.

•Li

fe s

cien

ces

pate

nts

are

mor

e lik

ely

to re

sem

ble

nake

d ap

plic

atio

ns o

f sci

entif

ic d

isco

verie

s.

Thou

gh th

e m

ost r

ecen

t cas

essu

gges

t the

tren

d is

sl

owin

g, §

101

may

stil

l hin

der U

.S. c

ontr

ibut

ions

to

med

ical

inno

vatio

ns, a

nd th

eref

ore

glob

al m

edic

al

inno

vatio

n.

1058


57S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Rec

ent K

ey L

ife S

cien

ces

Litig

atio

ns

Juris

dict

ion

&

Venu

e

Rec

ent J

uris

dict

ion

& V

enue

Cas

elaw

•Th

e S

upre

me

Cou

rt de

clin

ed to

revi

ew th

e Fe

dera

l Circ

uit’s

ho

ldin

g th

at a

gen

eric

’s p

lan

to n

atio

nally

mar

ket a

pro

pose

d ge

neric

dru

g is

suf

ficie

nt fo

r min

imum

con

tact

s fo

r per

sona

l ju

risdi

ctio

n in

Aco

rda

Ther

apeu

tics,

Inc.

v. M

ylan

Pha

rms.

, In

c., 8

17 F

.3d

755

(Fed

. Cir.

201

6).

•In

TC

Hea

rtlan

dth

e S

upre

me

Cou

rt m

ay c

hang

e th

e lo

ng-

stan

ding

test

that

cas

es c

an b

e br

ough

t any

whe

re a

de

fend

ant i

s su

bjec

t to

pers

onal

juris

dict

ion.

TC

Hea

rtlan

d LL

C v

. Kra

ft Fo

od B

rand

s G

rp. L

LC, N

o. 1

6-34

1.

1059


58S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Rec

ent C

hang

es to

H

atch

-Wax

man

Act

R

egul

atio

ns5

1060


59S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Rec

ent C

hang

es to

Hat

ch-W

axm

an A

ct R

egul

atio

ns

Sum

mar

y of

C

hang

es

The

FDA

issu

ed n

ew re

gula

tions

, effe

ctiv

e D

ecem

ber 5

, 201

6

•N

ew re

gula

tions

app

ly to

new

ND

As,

AN

DA

s, a

nd 5

05(b

)(2)

appl

icat

ions

, and

to e

xist

ing

subm

issi

ons

in c

erta

in

circ

umst

ance

s

•N

DA

hold

ers

mus

t pro

vide

spe

cific

use

cod

esfo

r the

ir dr

ugs

that

des

crib

e on

ly th

e sp

ecifi

c m

etho

d of

use

cla

imed

by

the

pate

nt in

the

Ora

nge

Boo

k

•Th

ird p

artie

s ca

n ch

alle

nge

pate

nt in

form

atio

n in

the

Ora

nge

Boo

k by

sub

mitt

ing

a w

ritte

n re

ques

t to

the

FDA

to

disp

ute

the

accu

racy

or r

elev

ancy

of p

aten

t inf

orm

atio

n

1061


60S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Rec

ent C

hang

es to

Hat

ch-W

axm

an A

ct R

egul

atio

ns

Sum

mar

y of

C

hang

es

The

FDA

issu

ed n

ew re

gula

tions

, effe

ctiv

e D

ecem

ber 5

, 201

6

•M

arke

ting

notic

e re

quire

men

t: F

irst a

pplic

ant i

s re

quire

d to

not

ify th

e FD

A w

ithin

30

days

of f

irst c

omm

erci

al

mar

ketin

g, o

r ris

k lo

sing

som

e of

the

180-

day

excl

usiv

ity

•N

DA

hold

ers

mus

t sub

mit

“am

endm

ent t

o th

e de

scrip

tion

of

the

appr

oved

met

hod(

s) o

f use

cla

imed

by

the

pate

nt []

w

ithin

30

days

of a

dec

isio

ns b

y th

e U

SP

TO, o

r by

a Fe

dera

l Dis

trict

Cou

rt, th

e . .

. Fe

dera

l Circ

uit,

or th

e U

.S.

Sup

rem

e C

ourt

that

is s

peci

fic to

the

pate

nt a

nd a

lters

the

cons

truc

tion

of a

met

hod-

of-u

se c

laim

(s)”

to a

void

bei

ng

cons

ider

ed la

te-li

sted

—co

uld

exte

nd to

cla

im c

onst

ruct

ions

1062


61S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Rec

ent C

hang

es to

Hat

ch-W

axm

an A

ct R

egul

atio

ns

Impa

ct o

n H

atch

-W

axm

an

Litig

atio

n

Cla

rific

atio

n on

Ava

ilabi

lity

of 3

0-M

onth

Sta

y

•In

tent

ion

is to

enc

oura

ge N

DA

hold

ers

to m

ove

for P

Is in

ad

vanc

e of

exp

iratio

n of

30-

mon

th s

tay

•If

PI e

nter

ed p

rior t

o ex

pira

tion:

FD

A w

ill e

xten

d st

ay u

ntil

cour

t dec

ides

infri

ngem

ent a

nd v

alid

ity

•If

cour

t ord

er re

quire

s te

rmin

atio

n of

30-

mon

th s

tay,

ap

plic

atio

n m

ay b

e ap

prov

ed

•Vo

lunt

ary

agre

emen

t not

to m

arke

t will

not h

ave

sam

e ef

fect

as

PI a

nd w

ill no

t req

uire

sta

y be

yond

30

mon

ths

•Vo

lunt

ary

agre

emen

t con

sent

ing

to a

ppro

val w

ill te

rmin

ate

30-m

onth

sta

y

1063


62S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Rec

ent C

hang

es to

Hat

ch-W

axm

an A

ct R

egul

atio

ns

Impa

ct o

n H

atch

-W

axm

an

Litig

atio

n

Para

grap

h IV

Not

ice

Lette

rs

•A

para

grap

h IV

not

ice

lette

r mus

t be

sent

no

late

r tha

n tw

enty

day

s af

ter t

he d

efin

ed p

ostm

arke

d da

te o

f a

“par

agra

ph IV

ack

now

ledg

men

t let

ter”

(as

defin

ed in

re

gula

tions

)

•P

arag

raph

IV re

certi

ficat

ions

are

requ

ired

afte

r cer

tain

am

endm

ents

, suc

h as

to in

dica

tions

or c

ondi

tions

of u

se o

r ad

ding

new

stre

ngth

s—an

d re

certi

ficat

ions

do

not f

orfe

it 18

0-da

y ex

clus

ivity

1064


63S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Rec

ent C

hang

es to

Hat

ch-W

axm

an A

ct R

egul

atio

ns

Con

clus

ion

Take

away

s

•Lo

ng d

ue u

pdat

es c

hang

e re

spon

sibi

litie

s fo

r bot

h br

and

and

gene

ric c

ompa

nies

•N

ew re

gula

tions

on

spec

ific

use

code

s pr

ovid

e op

portu

nitie

s fo

r AN

DA

and

505(

b)(2

) app

lican

ts to

targ

et

indi

catio

ns th

at d

o no

t inf

ringe

•C

ompa

nies

with

pen

ding

sub

mis

sion

s m

ust c

aref

ully

revi

ew

new

obl

igat

ions

1065


64S

kadd

en, A

rps,

Sla

te, M

eagh

er &

Flo

m L

LP a

nd A

ffilia

tes

Ska

dden

, Arp

s, S

late

, Mea

gher

& F

lom

LLP

and

Affi

liate

s

•Que

stio

ns o

r Com

men

ts?

Dou

glas

R. N

emec

Par

tner

, New

Yor

k O

ffice

Tel:

+1

(212

) 735

.241

9E

mai

l: d

ougl

as.n

emec

@sk

adde

n.co

m

1066


NOTES

1067


NOTES

1068

11th annual patent law...

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