product life cycle management - fish & richardson life cycle management moderator gwilym atwell...
TRANSCRIPT
Product Life Cycle Management
Moderator Gwilym Atwell (Principal, Fish & Richardson)
Panelists
Lisa Greenwald-Swire (Principal, Fish & Richardson) Jeffery Grimes (Aradigm Corporation)
Len S. Smith (Medicis) Terry Mahn (Principal, Fish & Richardson)
Lisa
Gre
enw
ald-
Swire
Prot
ectin
g Yo
ur B
rand
Nam
e O
btai
ning
PTO
and
FD
A Ap
prov
al
Febr
uary
4, 2
010
Impo
rtan
ce o
f Tr
adem
arks
Prom
ote
bran
d na
me
awar
enes
s Cos
t-ef
fect
ive
mea
ns o
f m
arke
ting
Allo
w for
str
eam
lined
labe
ling
D
ecre
ase
the
conf
usio
n be
twee
n m
edic
atio
ns
Dec
reas
e th
e risk
of m
edic
atio
n er
rors
–
12.5
% o
f m
edic
atio
n er
rors
are
con
trib
uted
to
conf
usio
n of
one
nam
e w
ith a
noth
er b
y he
alth
pr
ofes
sion
al
–15
% o
f de
aths
fro
m m
edic
atio
n er
rors
are
due
to
bran
d na
me
mix
-up
“The
pro
prie
tary
nam
e is
like
an
unsl
eepi
ng sa
lesm
an th
at
ceas
eles
sly
prom
otes
the
prod
uct.”
-- B
rand
Inst
itute
, Inc
.
Trad
emar
ks a
nd L
ife C
ycle
M
anag
emen
t
Sea
rch
for
mar
ks e
arly
File
for
mar
ks e
arly
Cho
ose
a ba
ck-u
p m
ark
Tim
elin
es
0 2
3 4
5
PTO
1
Con
duct
tr
adem
ark
sear
ches
/file
“i
nten
t to
use
”
appl
icat
ion
Not
ice
of
Allo
wan
ce
Issu
ed
Fina
l 3 y
ear
dead
line
for
com
men
cing
us
e in
co
mm
erce
FDA
File
“re
ques
t fo
r re
view
” of
tr
adem
ark
afte
r Ph
ase
II
clin
ical
trial
s co
mpl
ete;
FD
A w
ill g
ive
“ten
tativ
e ap
prov
al”
FDA r
evie
w
agai
n 90
da
ys b
efor
e fin
al a
ppro
val
Sub
mit
Sta
tem
ent
of
Use
bas
ed o
n us
e of
mar
k in
Ph
ase
I cl
inic
al
tria
ls
6 7
File
app
licat
ion
with
FD
A
Trad
emar
k Bas
ics
Trad
emar
k J
-- Id
entif
ies
a so
urce
of go
ods
from
oth
er s
ourc
es
Ser
vice
mar
kK
-- D
istin
guis
hes
a so
urce
of se
rvic
es fro
m o
ther
sou
rces
Trad
e na
me/
“Hou
se M
ark”
-- Id
entif
ies
and
dist
ingu
ishe
s a
busi
ness
org
aniz
atio
n fr
om o
ther
com
pani
es
Type
s of
Mar
ks
Wor
d m
arks
:
Type
s of
Mar
ks (
cont
.)
Slo
gan:
“H
elpi
ng M
ake
Hai
r Lo
ss H
isto
ry”
“Life
sho
uld
take
you
r br
eath
aw
ay,
not
asth
ma”
Non
-fun
ctio
nal a
ppea
ranc
e:
Pe
pto-
Bis
mol
– P
ink
NO
T pr
otec
tible
beca
use
foun
d to
hav
e a
“soo
thin
g”
ther
apeu
tic v
alue
so
it w
as
cons
ider
ed f
unct
iona
l
Ben
efits
of
Reg
istr
atio
n w
ith t
he P
TO
Dis
cour
ages
oth
ers
from
usi
ng o
r re
gist
erin
g co
nfus
ingl
y si
mila
r m
arks
Tr
eats
the
mar
k as
if u
sed
natio
nwid
e as
of
the
appl
icat
ion
date
Pr
ovid
es n
atio
nwid
e no
tice
of o
wne
rshi
p of
the
mar
k as
of
the
regi
stra
tion
date
Ser
ves
as e
vide
nce
of t
he v
alid
ity a
nd e
xclu
sive
ow
ners
hip
of
the
mar
k fo
r go
ods
and
serv
ices
list
ed
Gra
nts
the
righ
t to
use
the
® s
ymbo
l, gi
ving
the
pro
duct
s m
ore
cach
et a
nd p
uttin
g co
mpe
titor
s on
not
ice
Gra
nts
the
righ
t to
sue
in c
ourt
Pr
ovid
es a
bas
is f
or f
orei
gn r
egis
trat
ions
, fa
cilit
atin
g
pr
otec
tion
of y
our
mar
ks w
orld
wid
e Em
pow
ers
US C
usto
ms
and
Bor
der
Prot
ectio
n to
blo
ck
impo
rts
that
infr
inge
the
mar
k
Goa
l is
to e
nsur
e th
at c
onsu
mer
s w
ill n
ot b
e co
nfus
ed
betw
een
the
prop
osed
mar
k an
d an
othe
r m
ark
alre
ady
in u
se
PT
O c
onsi
ders
sev
eral
fac
tors
whe
n de
term
inin
g w
heth
er a
bra
nd n
ame
is li
kely
to
be c
onfu
sed,
incl
udin
g:
–(1
) th
e si
mila
rity
of th
e go
ods;
–
(2)
the
chan
nels
of pr
oduc
t di
stribu
tion;
–
(3)
the
sim
ilarity
of th
e m
arks
in s
ight
,
soun
d, a
nd m
eani
ng;
and
–
(4)
the
soph
istic
atio
n of
the
con
sum
er
Obt
aini
ng R
egis
trat
ion
with
the
PTO
Obt
aini
ng R
egis
trat
ion
with
the
PTO
Con
t….
App
licat
ion
can
initi
ally
be
filed
bas
ed o
n “i
nten
t to
use
”
To o
btai
n re
gist
ratio
n, m
ust
show
use
in c
omm
erce
–
Clin
ical
tra
ils a
re s
uffic
ient
evi
denc
e of
use
PT
O a
ppro
val d
oes
not
guar
ante
e th
at F
DA
will
app
rove
of th
e na
me
for
use!
Reg
istr
atio
n w
ith t
he F
DA
MU
ST
rece
ive
FDA a
ppro
val p
rior
to
selli
ng p
rodu
ct
com
mer
cial
ly
FD
A g
oal i
s to
: –
eval
uate
the
saf
ety
of t
he p
ropo
sed
bran
d na
me;
–
pre
vent
con
fusi
on b
etw
een
phar
mac
eutic
al b
rand
s;
and
–
prev
ent
use
of a
nam
e th
at w
ould
mis
lead
or
fals
ely
impl
y so
met
hing
abo
ut t
he d
rug’
s ef
fect
iven
ess
or
com
posi
tion
Obt
aini
ng R
egis
trat
ion
with
the
FD
A
Sub
mis
sion
req
uire
s:
–Tw
o (a
nd o
nly
two)
nam
es,
in o
rder
of
pref
eren
ce.
If
first
is
reje
cted
, FD
A w
ill e
valu
ate
the
seco
nd
–Pr
opos
ed p
acka
ge la
belin
g (i
nser
ts a
nd o
uter
labe
ling)
Rev
iew
by
FDA:
–In
itial
“risk
-ben
efit”
eva
luat
ion
by a
DM
ETS s
afet
y ev
alua
tor
(60
days
for
rev
iew
)
–N
ames
tha
t pa
ss r
ecei
ve a
“te
ntat
ive
appr
oval
” an
d a
seco
nd
eval
uatio
n (i
n 30
day
s or
less
) 90
day
s be
fore
ND
A a
ppro
val t
o co
mpa
re w
ith d
rug
nam
es t
hat
have
bee
n ap
prov
ed s
ince
the
fir
st e
valu
atio
n
Not
a “
first
to
file”
sys
tem
! N
o pu
blic
dat
abas
e of
pend
ing
nam
es.
Obt
aini
ng R
egis
trat
ion
with
FD
A
Con
t….
FDA w
ill n
ot a
ppro
ve n
ame
if it:
–
(1)
sugg
ests
gre
ater
saf
ety
or e
ffic
acy
than
sup
port
ed b
y cl
inic
al d
ata;
–
(2)
incl
udes
or
sugg
ests
indi
catio
ns,
dosa
ge r
egim
ens,
do
sage
for
ms,
or
rout
es o
f ad
min
istr
atio
n ot
her
than
tho
se
for
whi
ch t
he p
rodu
ct is
labe
led;
–
(3)
has
the
pote
ntia
l to
cont
ribu
te t
o m
edic
atio
n er
rors
or
caus
e co
nfus
ion
beca
use
spel
ling
or p
ronu
ncia
tion
is s
imila
r to
oth
er p
rodu
cts
on t
he m
arke
t;
–(4
) in
clud
es o
r su
gges
ts a
n ac
tive
com
pone
nt t
hat
is n
ot
part
of
the
prod
uct;
and
–
(5)
is a
diff
eren
t na
me
for
a ne
arly
iden
tical
pr
oduc
t, b
ut a
diff
eren
t in
dica
tion.
Rec
omm
enda
tions
for
Bra
nd N
ames
Sea
rch
and
file
for
a to
p ch
oice
and
at
leas
t se
cond
choi
ce b
rand
nam
e w
ith t
he r
espe
ctiv
e tr
adem
ark
agen
cies
.
Tr
y to
mak
e up
a w
ord
to u
se a
s a
bran
d na
me
rath
er t
han
usin
g a
wor
d th
at is
alrea
dy k
now
n, a
nd m
ake
sure
tha
t it
does
not
look
or
soun
d si
mila
r to
exi
stin
g ph
arm
aceu
tical
m
arks
. –
Con
side
r so
und
of n
ame
whe
n sp
oken
–
Zan
tac
v. X
anax
–
Con
side
r ap
pear
ance
of
nam
e w
hen
prin
ted
–Cel
ebre
x v.
Cel
exa
–
Con
side
r ap
pear
ance
whe
n sc
ribb
led
by a
doc
tor
Rec
omm
enda
tions
for
Bra
nd N
ames
Con
t…
Avo
id u
sing
num
bers
or
lett
ers
that
cou
ld s
ugge
st p
rodu
ct
ingr
edie
nts
or d
osag
e.
–Ex
ampl
e 1:
BID
=tw
ice
daily
to
phar
mac
ists
–
Exam
ple
2: “X
L” m
ay s
ound
like
“SL,
” w
hich
indi
cate
s “s
ub li
ngua
l” t
o ph
arm
acis
ts
Sta
y aw
ay fro
m u
sing
a n
ame
that
sug
gest
s th
e pr
oduc
t’s
func
tion.
–Ex
ampl
e:
RO
GAIN
mar
ked
as R
EGAIN
E in
mos
t of
the
w
ord
Avo
id r
efer
ring
to
inac
tive
ingr
edie
nt t
hat
sugg
ests
ef
fect
iven
ess
Avo
id in
corp
orat
ing
gene
ric
nam
es
Than
k yo
u!
Que
stio
ns?
Life
Cyc
le M
anag
emen
t and
Pat
ents
Le
n S
. Sm
ith |
Febr
uary
4, 2
010
Whe
re a
re W
e?
•P
aten
ts a
re …
–
Har
der t
o ge
t
–H
arde
r to
enfo
rce
–
Ris
ky?
Our
Man
y C
halle
nges
The
Ris
ks o
f Pat
entin
g…?
The
LCM
Pla
yboo
k
&
Cha
lleng
es w
ith E
xecu
tion
New
The
rape
utic
Met
hods
•In
fring
ers?
–
Impl
icat
ions
•In
here
ncy
–“P
reve
ntio
n”
Com
bina
tions
Mor
e C
alls
from
the
LCM
Pla
yboo
k
•D
osag
es
▪U
SP
TO s
tarti
ng p
oint
op
timiz
atio
n is
“rou
tine”
•Fo
rmul
atio
ns
▪Is
the
subs
titut
ion
pred
icta
ble?
•D
eliv
ery
Rou
tes
Sum
min
g it
Up
•P
aten
ts a
re …
–
Har
der t
o ge
t
–H
arde
r to
enfo
rce
–
Ris
ky?
But
…
•th
e ty
pica
l pha
rma
pate
ntin
g M
O
rem
ains
the
sam
e:
1.
File
ear
ly, f
ile o
ften,
file
eve
ryth
ing
–W
e’ll
mak
e it
wor
k la
ter
2.
File
on
the
little
we
have
but
cla
im e
very
thin
g
3.R
eact
ive,
not
pro
activ
e
4.It’
s di
fficu
lt to
mea
sure
suc
cess
, so
don’
t bot
her…
▪
Res
ult -
- IP
“lot
tery
”
Wha
t to
Do?
Firs
t, D
o N
o H
arm
:
•U
se p
rovi
sion
als
•
Max
imiz
e P
TA
•
Max
imiz
e P
TR/P
TE
–Th
ere
can
be o
nly
one…
–
Con
duct
a th
orou
gh a
naly
sis
–If
avai
labl
e, e
nsur
e ha
rmon
ized
with
IN
D/re
gula
tory
pro
gram
•E
nsur
e yo
u ha
ve y
our O
B p
ositi
on in
ord
er
–W
atch
out
for m
arki
ng is
sues
▪
Cla
im a
naly
sis
Beg
in L
CM
at t
he B
egin
ning
•E
mpl
oy ri
sk m
anag
emen
t-bas
ed ra
ther
than
trad
ition
-ba
sed
plan
ning
–O
nly
advi
sabl
e un
der s
ome
cond
ition
s ▪
How
is c
ompe
titio
n; h
ow d
omin
ant i
s yo
ur p
ositi
on?
–
Pita
lls
▪N
eed
time
to th
ink/
plan
!
▪B
est m
ode,
dou
ble
pate
ntin
g, in
here
ncy,
and
IC ri
sks
Port
folio
Pla
nnin
g 20
1
•E
mpl
oy a
mix
of c
laim
s an
d pa
tent
s
•S
ingl
es a
nd d
oubl
es
can
still
win
the
gam
e
(esp
ecia
lly p
ost e
Bay
/Sea
gate
)
•P
lan
for t
he p
endu
lum
to s
win
g
Cop
ing
with
KSR
•H
ave
your
KS
R s
tory
read
y –
Mak
e di
scov
ery
of th
e
prob
lem
par
t of t
he in
vent
ion!
•
Coo
rdin
ate
with
Mar
ketin
g –
Sho
win
g of
“nex
us” f
or
com
mer
cial
suc
cess
•E
nsur
e ab
ility
to d
iscl
ose
lic
ense
info
rmat
ion
–C
omm
erci
al s
ucce
ss
–C
RE
ATE
act
Failu
re [D
ata]
Dig
in N
ew P
lace
s an
d D
ig D
eep
•U
ntap
ped
oppo
rtuni
ties?
•P
ick
your
figh
ts, a
nd
fight
to w
in
–W
ill n
ot w
ork
with
pa
tent
man
agem
ent
by th
e nu
mbe
rs
Bac
k to
Rea
lity?
Reg
ulat
ory-
Pate
nt S
yner
gy
•O
btai
n no
n-pa
tent
exc
lusi
vity
–
Ped
iatri
c
•“C
laim
the
labe
l” –
If in
saf
ety
or e
ffica
cy
•C
laim
the
stan
dard
–
But
dis
clos
e, d
iscl
ose,
dis
clos
e
•Th
e pr
oduc
t for
pro
duct
sw
itch
•R
equi
res
regu
lato
ry a
nd le
gal t
o
com
e ou
t of s
ilos
•W
atch
out
for a
ntitr
ust i
ssue
s
Don
’t Fo
rget
Tra
de S
ecre
t Pro
tect
ion
Than
k Yo
u an
d G
ood
Luck
!
•Le
n S
. Sm
ith
–LS
mith
@M
edic
is.c
om
TE
RR
Y G
. MA
HN
Fe
brua
ry 4
, 201
0
LIF
E C
YC
LE
MA
NA
GE
ME
NT
PR
OT
EC
TIN
G N
EW
USE
S FO
R O
LD
DR
UG
S
BAY
AR
EA
PH
AR
MA
AN
D
LIF
E S
CIE
NC
ES
IP S
UM
MIT
LIFE
CY
CLE
MA
NA
GEM
ENT
OV
ERV
IEW
H-W
Exc
lusi
vity
(3
year
s) –
req
uire
s cl
inic
al s
tudi
es
─ne
w u
sers
─
new
pat
ient
pop
ulat
ions
─
adm
inis
trat
ive
and
dosa
ge c
hang
es
─ef
ficac
y im
prov
emen
ts
─ne
w for
mul
atio
ns
Pate
nt
─ge
nus/
spec
ies
─po
lym
orph
s (d
efen
sive
) ─
com
bina
tion
drug
s ─
form
ulat
ions
LIFE
CY
CLE
MA
NA
GEM
ENT
OV
ERV
IEW
(co
nt’
)
─re
leas
e pr
ofile
s ─
indi
catio
ns a
nd u
ses
─im
prov
emen
ts in
saf
ety/
effic
acy
─m
isc.
(pa
rtic
le s
ize,
mol
ecul
ar w
eigh
t, e
tc)
TM
─Str
ong
bran
ding
and
DTC
adv
ertis
ing
─Can
ove
rcom
e ge
neric
subs
titut
ion
THE
CO
MP
ETIT
IVE
ENV
IRO
NM
ENT
Gen
eric
s to
day
acco
unt
for
60%
of al
l “sc
ript
s”;
20%
of al
l $ s
ales
$74
Bill
ion
in a
nnua
l pio
neer
dru
g sa
les
com
ing
off pa
tent
by
2012
– D
eloi
tte
& T
ouch
e (2
009)
THE
LCM
CH
ALL
ENG
E
Prot
ectin
g m
arke
t sh
are
for
“old
dru
gs”
Re-
form
ulat
ions
and
ingr
edie
nt c
hang
es
New
use
s
•Add
ing
nove
l fea
ture
s or
new
indi
catio
ns
•Im
prov
ing
safe
ty o
r ef
ficac
y pr
ofile
s
•Add
ing
new
pat
ient
pop
ulat
ions
LCM
– P
RO
TEC
TIO
NS
AV
AIL
AB
LE
•3
year
or
orph
an e
xclu
sivi
ty
•Pa
tent
s Add
ing
drug
cla
ims
to la
bel (
re-
form
ulat
ions
, ph
ysic
al a
nd c
hem
ical
fe
atur
es,
etc.
) –
evid
ence
of di
rect
in
frin
gem
ent
Add
ing
use
clai
ms
to la
bel (
indi
catio
ns,
dosa
ge a
nd a
dmin
istr
atio
n, w
arni
ngs,
AD
R,
etc.
) –
gene
ric
labe
l inf
ring
es b
y in
duce
men
t
LCM
– T
HE
GEN
ERIC
RES
PO
NS
E
•“S
kinn
y” la
belin
g
carv
ing
excl
usiv
ity o
r pa
tent
pro
tect
ion
out
of t
he
gene
ric
labe
l
•O
ff la
bel a
ctiv
ities
mar
ketin
g –
proh
ibite
d by
FD
A
pres
crib
ing
– pr
actic
e of
med
icin
e
disp
ensi
ng –
gov
erne
d by
Sta
te la
w
GEN
ERIC
LA
BEL
ING
RU
LES
•“S
tatu
tory
sam
enes
s” r
equi
rem
ent
gene
ric
mus
t tr
ack
pion
eer
labe
l wor
d fo
r w
ord
•Li
mite
d ex
cept
ions
suita
bilit
y pe
titio
ns –
to
chan
ge d
osag
e, s
tren
gth,
ro
ute
of a
dmin
istr
atio
n or
AI
in c
ombi
natio
n dr
ug
form
ulat
ion
chan
ges
– tr
ials
oft
en r
equi
red
for
BE
“asp
ects
of la
belin
g” p
rote
cted
by
pate
nt o
r ex
clus
ivity
can
be
carv
ed o
ut o
f a
gene
ric
labe
l b
ut
only
if t
he g
ener
ic is
“no
less
saf
e or
ef
fect
ive
than
pio
neer
for
all
rem
aini
ng n
on-
prot
ecte
d co
nditi
ons
of u
se.”
GEN
ERIC
CA
RV
E O
UT
RU
LE
•M
etho
d of
Use
Pat
ents
Onl
y
Pate
nt m
ust
be li
sted
in O
rang
e Boo
k
Ora
nge
Boo
k “u
se c
ode”
det
erm
ines
sco
pe o
f ca
rve
out
Pion
eer
sele
cts
its u
se c
ode
GEN
ERIC
CA
RV
E O
UT
RU
LE –
(co
nt’
)
•C
ase
Stud
y: P
rand
in (2
009)
Ora
nge
Boo
k pa
tent
use
cod
e (n
arro
w) –
use
of “
repa
glin
ide
in
com
bina
tion
with
Met
form
in to
trea
t dia
bete
s”
Gen
eric
soug
ht c
arve
out
– re
ques
ted
appr
oval
for m
onot
hera
py
only
FDA
allo
wed
car
ve o
ut o
f com
bina
tion
ther
apy;
wou
ld b
e S&
E as
pio
neer
for m
onot
hera
py
Pion
eer a
men
ded
use
code
(bro
aden
ed) t
o in
clud
e m
onot
hera
py –
us
e of
“re
pagl
inid
e to
trea
t dia
bete
s”
FDA
reve
rsed
– g
ener
ic w
ould
hav
e to
cer
tify
to O
rang
e B
ook
pate
nt
MEC
HA
NIC
S O
F C
AR
VE
OU
T R
ULE
AN
DA file
s a
“sec
tion
viii”
rat
her
than
ce
rtifi
catio
n fo
r th
e O
rang
e Boo
k pa
tent
No
notic
e to
pio
neer
No
oppo
rtun
ity f
or 3
0 m
onth
sta
y of
gen
eric
ap
prov
al
•Citi
zen
Petit
ion
– on
ly w
eapo
n fo
r pi
onee
r to
st
op g
ener
ic la
belin
g ca
rve
out
befo
re it
occ
urs
HIS
TOR
Y O
F C
AR
VE
OU
T D
ISP
UTE
S
9 Pi
onee
r CPs
file
d be
twee
n 20
02 a
nd 2
009
asse
rtin
g “s
kinn
y” la
belin
g w
ould
be
“le
ss s
afe
or
effe
ctiv
e” t
han
pion
eer
Gen
eric
s w
on 8
tim
es!
Sol
e pi
onee
r vi
ctor
y de
alt
with
a “
mig
ratin
g pa
tient
pop
ulat
ion
Pion
eers
Fai
l to
Gra
sp F
DA C
arve
Out
Rul
e:
Ste
p 1
– id
entif
y pr
otec
ted
lang
uage
on
pion
eer
labe
l
Ste
p 2
– ca
rve
prot
ecte
d la
ngua
ge o
ut o
f ge
neric
labe
l lea
ving
onl
y “n
on-p
rote
cted
con
ditio
ns o
f us
e” o
n ge
neric
labe
l
Ste
p 3
– co
mpa
re S
&E
of g
ener
ic la
bel v
s. p
ione
er
la
bel
Ste
p 4
– if
gene
ric
is le
ss S
or
E no
car
ve o
ut a
llow
ed
if ex
clus
ivity
– A
ND
A ca
nnot
be
appr
oved
if pa
tent
– for
ces
gene
ric
labe
l to
infr
inge
WH
Y D
O G
ENER
ICS
KEE
P W
INN
ING
?
FDA
CH
ALL
ENG
ES I
N C
AR
VE
OU
T C
AS
ES
Iden
tifyi
ng n
on-p
rote
cted
“co
nditi
ons
of u
se”
on
a dr
ug la
bel –
i.e.
, ca
rvin
g ou
t la
bel l
angu
age
mat
chin
g th
e O
B “
use
code
”
App
lyin
g th
e “l
ess
safe
or
less
effec
tive”
st
anda
rd t
o ge
neric
drug
eas
y ca
se –
sig
nific
ant
S&
E im
prov
emen
t in
si
gnifi
cant
% o
f ta
rget
ed p
atie
nt p
opul
atio
n
FDA
CH
ALL
ENG
ES I
N C
AR
VE
OU
T C
AS
ES
– (c
ont’
)
mor
e di
ffic
ult
case
– s
igni
fican
t S&
E im
prov
emen
t in
sm
all %
of pa
tient
pop
ulat
ion
mor
e di
ffic
ult
case
– s
mal
l S&
E im
prov
emen
t in
larg
e %
of
pat
ient
pop
ulat
ion
PIO
NEE
R C
HA
LLEN
GES
– “
EVER
GR
EEN
ING
” TH
E LA
BEL
WIT
H P
ATE
NTS
TH
AT
CA
NN
OT
BE
CA
RV
ED O
UT
Cla
ims
deal
ing
with
new
ly d
isco
vere
d sa
fety
issu
es:
adm
inis
tering
the
dru
g to
tre
at [
the
cond
ition
] m
onito
ring
the
pat
ient
for
the
[sa
fety
-rel
ated
ris
k]
dete
rmin
ing
if pa
tient
is a
t risk
co
ntin
uing
/dis
cont
inui
ng a
dmin
istr
atio
n of
dru
g ba
sed
on t
he d
eter
min
atio
n
PIO
NEE
R C
HA
LLEN
GES
– (
con
t’)
Cla
ims
deal
ing
with
new
ly d
isco
vere
d ef
ficac
y is
sues
adm
inis
tering
the
dru
g to
tre
at [
the
cond
ition
] ad
min
iste
ring
[se
cond
dru
g/su
bsta
nce]
to
patie
nt
dete
rmin
ing
if pa
tient
’s [
cond
ition
] im
prov
es
cont
inui
ng/d
isco
ntin
uing
adm
inis
trat
ion
of d
rug
base
d on
det
erm
inat
ion
PIO
NEE
R C
HA
LLEN
GES
– (
con
t’)
Are
the
se t
ypes
of cl
aim
s pa
tent
able
sub
ject
mat
ter?
Prom
ethe
us v
. M
ayo
(CAFC
9/2
009)
•Adm
inis
trat
ion
and
dete
rmin
atio
n st
eps
are
part
of
the
trea
tmen
t pr
otoc
ol a
nd a
re t
rans
form
ativ
e m
etho
ds o
f tr
eatin
g th
e pa
tient
.
•CAFC
: “
series
of tr
ansf
orm
ativ
e st
eps
that
opt
imiz
e ef
ficac
y an
d re
duce
tox
icity
of a
met
hod
of t
reat
men
t fo
r pa
rtic
ular
dis
ease
s us
ing
part
icul
ar d
rugs
” ar
e pa
tent
able
sub
ject
mat
ter.
PIO
NEE
R C
HA
LLEN
GES
– (
con
t’)
Are
the
se t
ypes
of cl
aim
s en
forc
eabl
e un
der
the
CAFC
’s
“joi
nt in
frin
gem
ent
doct
rine
”?
Yes,
pro
vide
one
act
or (
doct
or)
cont
rols
the
oth
ers
(pat
ient
)
PIO
NEE
R C
HA
LLEN
GES
– D
ISC
OV
ERIN
G
PA
TEN
TAB
LE U
SES
REL
ATE
D T
O S
AFE
TY
AN
D E
FFIC
AC
Y
Clin
ical
trial
s fo
r ne
w in
dica
tions
Phas
e IV
Stu
dies
REM
S r
epor
ts
Fiel
d re
port
s fr
om d
octo
rs,
patie
nts,
hos
pita
ls
PIO
NEE
R C
HA
LLEN
GES
– (
con
t’)
Post
Mar
ketin
g Req
uire
men
ts (
PMR)
2007
Am
endm
ents
giv
e FD
A b
road
dis
cret
ion
to o
rder
PM
Rs
1531
PM
Rs
curr
ently
in e
ffec
t
“req
uire
men
ts”
can
incl
ude
full
rang
e of
stu
dies
, tr
ials
, et
c.
PIO
NEE
R C
HA
LLEN
GES
– (
con
t’)
base
d on
mer
e “s
igna
l” o
f se
riou
s risk
or
effe
ctiv
enes
s of
REM
S
cost
s fa
ll on
pio
neer
s
PIO
NEE
R C
HA
LLEN
GES
– C
OO
RD
INA
TIN
G
PA
TEN
T A
ND
REG
ULA
TOR
Y F
UN
CTI
ON
S
Dev
elop
inte
rnal
gui
delin
es t
o co
ordi
nate
pat
ent,
cl
inic
al a
nd r
egul
ator
y fu
nctio
ns t
o fo
cus
on
“car
ve o
ut”
issu
es
Reg
ulat
ory
pers
onne
l nee
d to
und
erst
and
the
kind
s of
labe
ling
prot
ectio
ns li
kely
to
surv
ive
gene
ric
“car
ve o
ut”
effo
rts
Clin
ical
trial
s an
d PM
Rs
shou
ld b
e de
sign
ed w
ith
carv
e ou
t ru
les
in m
ind
PIO
NEE
R C
HA
LLEN
GES
– (
con
t’)
Pate
nts
shou
ld b
e pr
osec
uted
with
car
ve o
ut r
ules
in m
ind
Inve
ntor
ship
issu
es n
eed
to b
e an
ticip
ated
in li
cens
es a
nd
cont
ract
Ora
nge
Boo
k “u
se c
odes
” sh
ould
be
care
fully
rev
iew
ed
with
car
ve o
ut r
ules
in m
ind
Than
k Y
ou
Terr
y G
. Mah
n m
ahn@
fr.co
m
202-
626-
6421