11th Annual Patent Law...
Transcript of 11th Annual Patent Law...
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11th Annual Patent Law Institute
INTELLECTUAL PROPERTYCourse Handbook Series
Number G-1316
Co-ChairsScott M. Alter
Douglas R. NemecJohn M. White
© Practising Law Institute
36
Life Sciences Litigation: Trends and Trajectories (PowerPoint slides)
Douglas R. Nemec
Skadden, Arps, Slate, Meagher & Flom LLP
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1001
© Practising Law Institute
1002
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
8S
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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
© Practising Law Institute
9S
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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
© Practising Law Institute
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
© Practising Law Institute
11S
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en, A
rps,
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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
© Practising Law Institute
12S
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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
© Practising Law Institute
13S
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en, A
rps,
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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
© Practising Law Institute
14S
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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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
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
© Practising Law Institute
NOTES
1067
© Practising Law Institute
NOTES
1068