STR

ATE

GIE

S FO

R

MA

XIM

IZIN

G P

ATE

NT

TE

RM

SAM

UE

L S.

WO

OD

LE

Y, P

H.D

. Fi

sh &

Ric

hard

son

“Sta

ndar

d” P

aten

t Ter

m (3

5 U

.S.C

. §15

4(a)

) –

Beg

ins w

hen

pate

nt is

sues

–

Ends

“20

yea

rs fr

om fi

ling”

–

20 y

ears

from

dat

e w

hen

the

appl

icat

ion

for p

aten

t was

file

d in

the

Uni

ted

Stat

es, o

r –

20 y

ears

from

dat

e w

hen

first

non

-pro

visi

onal

, prio

rity

appl

icat

ion

filed

in

the

Uni

ted

Stat

es (f

or d

ivis

iona

l, co

ntin

uing

and

con

tinua

tion-

in-p

art a

pplic

atio

ns)

–Fi

ling

date

of U

.S. p

rovi

sion

al a

pplic

atio

n(s)

and

fore

ign

prio

rity

appl

icat

ions

und

er P

aris

Con

vent

ion

not c

onsi

dere

d w

hen

calc

ulat

ing

20

year

exp

iratio

n da

te

–“D

ate

whe

n fil

ed in

the

Uni

ted

Stat

es”

is

–D

ate

whe

n no

n-pr

ovis

iona

l app

licat

ion

filed

in th

e U

.S. P

aten

t and

Tra

dem

ark

Off

ice,

or

–D

ate

PCT

appl

icat

ion

desi

gnat

ing

Uni

ted

Stat

es w

as fi

led

2 2

Bey

ond

the

Stan

dard

20

Yea

rs

Pate

nt T

erm

Adj

ustm

ent (

PTA

) –

Gov

erne

d by

35

U.S

.C. §

154

(b)

–M

eant

to c

ompe

nsat

e fo

r USP

TO d

elay

s exa

min

ing

and

issu

ing

pate

nt

–En

sure

s tha

t “no

app

lican

t dili

gent

ly se

ekin

g to

obt

ain

a pa

tent

will

re

ceiv

e a

term

of l

ess t

han

17 y

ears

”

Pate

nt T

erm

Ext

ensi

on (P

TE)

–G

over

ned

by 3

5 U

.S.C

. § 1

56

–M

eant

to c

ompe

nsat

e fo

r del

ays i

n re

gula

tory

app

rova

l pro

cess

for

phar

mac

eutic

al a

nd o

ther

pro

duct

s sub

ject

to p

re-m

arke

t app

rova

l

Tota

l Pat

ent T

erm

= “

Stan

dard

Ter

m”

+ PT

A +

PTE

3

Pate

nt T

erm

Adj

ustm

ent (

PTA

)

PTA

= (D

ays o

f PTO

Del

ay) –

(Day

s of A

pplic

ant D

elay

) –

Can

hav

e da

ys a

dded

to p

aten

t ter

m, b

ut c

an n

ever

hav

e da

ys

subt

ract

ed (P

TA ≥

0)

–PT

A =

0 if

app

lican

t del

ay e

qual

s or e

xcee

ds P

TO d

elay

Elig

ibili

ty:

–A

vaila

ble

to a

pplic

atio

ns fi

led

on o

r afte

r May

29,

200

0 –

For U

.S. n

atio

nal p

hase

app

licat

ions

, PC

T fil

ing

date

mus

t be

on o

r af

ter M

ay 2

9, 2

000

Rul

es a

nd R

egul

atio

ns G

over

ning

PTA

: –

37 C

.F.R

. §§

1.70

2 –

1.70

5 –

M.P

.E.P

. §§

2730

- 27

36

4

The

AB

C’s

of P

aten

t Ter

m A

djus

tmen

t

35 U

SC 1

54(b

)(1)

(A) –

“A

Del

ay”

–PT

O fa

ilure

to ti

mel

y is

sue

Off

ice

Act

ions

, or

repl

y to

App

lican

t’s re

spon

ses t

o O

ffic

e A

ctio

ns

35 U

SC 1

54(b

)(1)

(B) –

“B

Del

ay”

–PT

O fa

ilure

to is

sue

pate

nt w

ithin

thre

e ye

ars f

rom

app

licat

ion

filin

g

35 U

SC 1

54(b

)(1)

(C) –

“C

Del

ay”

–D

elay

resu

lting

from

•

App

eal (

BPA

I or F

eder

al C

ourt)

•

Inte

rfer

ence

s •

Secr

ecy

Ord

ers

5

“A D

elay

” - 3

5 U

SC 1

54(b

)(1)

(A)

PTO

has

: –

14 m

onth

s to

issu

e 1st

Off

ice

Act

ion

•A

Res

trict

ion

Req

uire

men

t or O

A o

n m

erits

, not

Not

ice

to F

ile M

issi

ng P

arts

•

Mea

sure

d fr

om a

ctua

l fili

ng d

ate

for a

pplic

atio

ns u

nder

35

USC

111

(a)

•Fo

r app

licat

ions

und

er 3

5 U

SC 3

71 (P

CT

Nat

iona

l Pha

se)

–M

easu

red

from

dat

e on

whi

ch P

CT

appl

icat

ion

“ful

fille

d th

e re

quire

men

ts

of se

ctio

n 37

1” 3

5 U

SC 1

54(b

)(1)

(A)(

i)(II

) –

PTO

mea

sure

s fr

om c

ompl

etio

n of

all

§ 37

1(c)

requ

irem

ent

(can

be

late

r tha

n da

te N

atio

nal P

hase

com

men

ces)

–4

mon

ths t

o •

repl

y to

resp

onse

or a

ppea

l by

appl

ican

t •

issu

e ac

tion

afte

r BPA

I dec

isio

n •

issu

e pa

tent

afte

r iss

ue fe

e pa

ymen

t

Star

ts a

ccum

ulat

ing

day

afte

r dea

dlin

e 6

“B D

elay

” –

35 U

SC 1

54(b

)(1)

(B)

For d

elay

due

to P

TO fa

ilure

to is

sue

pate

nt w

ithin

3 y

ears

of

“act

ual f

iling

dat

e of

the

appl

icat

ion

in th

e U

nite

d St

ates

” 35

USC

154

(b)(

1)(B

) –

Star

ts a

ccum

ulat

ing

on d

ay a

fter a

pplic

atio

n pe

ndin

g fo

r 3 y

ears

Even

ts th

at st

op th

e “3

yea

r clo

ck”

–Fi

ling

an R

CE

stop

s 3 y

ear c

lock

fore

ver

•C

an g

et “

B D

elay

” on

ly fo

r tim

e be

fore

RC

E fil

ing

date

–In

terf

eren

ce (m

ay re

cove

r tim

e as

“C

Del

ay”)

–

Secr

ecy

Ord

er (m

ay re

cove

r tim

e as

“C

Del

ay”)

–

Not

ice

of A

ppea

l •

May

reco

ver t

ime

as “

C D

elay

” on

ly fo

r “su

cces

sful

” ap

peal

7

“Jap

an T

obac

co”

Issu

e H

ow to

mea

sure

3 y

ear p

ende

ncy

(for

“B

Del

ay”)

–

For a

pplic

atio

ns u

nder

35

USC

111

(a)

•M

easu

red

from

act

ual f

iling

dat

e in

USP

TO

–Fo

r app

licat

ions

und

er 3

5 U

SC 3

71 (P

CT

Nat

iona

l Pha

se)

•R

egul

atio

ns sa

y m

easu

re fr

om w

hen

“nat

iona

l sta

ge c

omm

ence

d un

der 3

5 U

SC

371(

b) o

r (f)

” 3

7 C

FR 1

.702

(b) (

emph

asis

add

ed)

–PT

O p

ract

ice

had

been

to m

easu

re fr

om w

hen

natio

nal s

tage

co

mpl

eted

und

er 3

5 U

SC 3

71(c

)!!

F&R

cha

lleng

ed fo

r US

7,46

5,44

4 (J

apan

Tob

acco

) –

PTO

gra

nted

pet

ition

, adj

uste

d PT

A

–PT

O is

sues

form

al n

otic

e ac

know

ledg

ing

“Jap

an T

obac

co”

erro

r •

“in

proc

ess”

of c

orre

ctin

g th

e pr

oble

m

•Pa

tent

ees m

ust f

ile re

ques

t for

cor

rect

ion

with

in 2

mon

ths a

fter p

aten

t gra

nt

•N

o pr

ovis

ion

for r

etro

activ

e re

med

y 8

“C D

elay

” –

35 U

SC 1

54(b

)(1)

(C)

For d

elay

s due

to

–In

terf

eren

ces

–Se

crec

y or

ders

–

App

eals

•

App

eal m

ust r

esul

t in

final

dec

isio

n by

Boa

rd o

r Fed

eral

Cou

rt, re

vers

ing

the

reje

ctio

n of

at l

east

one

cla

im

9

Cal

cula

ting

PTA

: O

verla

ppin

g D

elay

Per

iods

Th

e st

atut

e [3

5 U

SC 1

54(b

)(2)

(A)]

: –

To th

e ex

tent

that

per

iod

of “

A D

elay

” an

d “B

Del

ay”

over

lap,

the

perio

d of

adj

ustm

ent s

hall

not e

xcee

d th

e ac

tual

num

ber o

f day

s the

is

suan

ce o

f the

pat

ent w

as d

elay

ed

–Pr

even

ts d

oubl

e co

untin

g w

here

ther

e is

ove

rlap

in “

A”

and

“B”

Del

ay

–PT

O in

terp

rete

d as

ent

ire p

erio

d w

hen

appl

icat

ion

is p

endi

ng

•G

rant

ed p

aten

tees

A D

elay

or B

Del

ay, w

hich

ever

was

larg

er, b

ut n

ot b

oth

Wye

th v

. Kap

pos (

591

F.3d

136

4 (F

ed. C

ir., J

an. 2

010)

): –

Ove

rrul

ed P

TO in

terp

reta

tion

of st

atut

e –

Pate

ntee

is e

ntitl

ed to

the

addi

tion

of “

A”

and

“B”

Del

ay to

ext

ent

they

do

not o

ccur

on

the

sam

e ca

lend

ar d

ay(s

) 10

Wye

th v

. Kap

pos

Incr

ease

s PTA

for m

any

pate

nts p

endi

ng m

ore

than

thre

e ye

ars

–“B

” D

elay

doe

s not

beg

in to

acc

rue

until

app

licat

ion

is p

endi

ng m

ore

than

thre

e ye

ars

–A

pplic

ant a

lso

entit

led

to a

ny “

A”

Del

ay o

ccur

ring

durin

g fir

st th

ree

year

s of p

rose

cutio

n Ja

n. 2

0, 2

010:

PTO

and

DO

J ann

ounc

e th

ey w

ill n

ot a

ppea

l, m

akin

g Fe

d. C

ir. d

ecis

ion

final

Ja

n. 2

6, 2

010:

PTO

pub

lishe

s int

erim

pro

cedu

re fo

r cal

cula

ting

PTO

per

Wye

th

–Pr

ovid

es te

mpo

rary

gra

ce p

erio

d fo

r sel

ecte

d pa

tent

s –

Onl

y ap

plic

able

to p

aten

ts is

sued

prio

r to

Mar

. 2, 2

010

whe

re re

ques

t fo

r rec

alcu

latio

n is

file

d w

ithin

180

day

s of g

rant

•

i.e.,

for p

aten

ts g

rant

ed fr

om a

bout

Sep

t. 3,

200

9 to

Mar

. 2, 2

010

11

App

lican

t Del

ays

PTA

redu

ced

by “

the

perio

d of

tim

e du

ring

whi

ch th

e ap

plic

ant f

aile

d to

eng

age

in re

ason

able

eff

orts

to c

oncl

ude

pros

ecut

ion

of th

e ap

plic

atio

n” 3

5 U

SC 1

54(b

)(2)

(C)

12

Com

mon

App

lican

t Del

ays

Filin

g re

spon

se m

ore

than

thre

e m

onth

s afte

r PTO

Off

ice

Act

ion

mai

led

•Ev

ery

day

afte

r 3- m

onth

dat

e co

unts

(wee

kend

s, ho

liday

s, et

c.)

•E.

g., f

iling

resp

onse

on

Mon

day

whe

n th

ree

mon

th d

ue d

ate

is S

atur

day

coun

ts a

s 2

days

of A

pplic

ant D

elay

Inco

mpl

ete

repl

y •

e.g.

, non

-res

pons

ive

and

non-

com

plia

nt a

men

dmen

ts

Subm

ittin

g su

pple

men

tal r

eply

Su

bmitt

ing

IDS

afte

r res

pons

e to

Off

ice

Act

ion,

unl

ess

•Fi

led

w/in

30

days

of a

ctio

n in

cou

nter

part

fore

ign

appl

icat

ion,

and

•

All

art f

irst c

ited

in th

e fo

reig

n ac

tion

13

Rev

iew

and

Cor

rect

ion

of P

TA

At A

llow

ance

–

PTO

cal

cula

tes P

TA “

to d

ate”

and

indi

cate

s on

Not

ice

of A

llow

ance

•

Onl

y A

and

C D

elay

cal

cula

ted

at th

is st

age

–A

pplic

ant m

ust c

halle

nge

any

PTA

err

ors b

y pe

titio

n on

or b

efor

e pa

ymen

t of t

he Is

sue

Fee

(37

CFR

1.7

05(b

))

•Pa

tent

gen

eral

ly d

oes n

ot is

sue

until

PTO

dec

ides

pet

ition

At I

ssua

nce

–PT

O c

alcu

late

s any

oth

er d

elay

that

has

occ

urre

d af

ter a

llow

ance

(in

clud

ing

any

B D

elay

) –

Pate

ntee

mus

t cha

lleng

e an

y ad

ditio

nal P

TA a

war

ded

at is

suan

ce

with

in 2

mon

ths o

f iss

ue d

ate

(37

CFR

1.7

05(d

))

14

App

eal o

f PTA

Det

erm

inat

ion

App

lican

t dis

satis

fied

with

fina

l det

erm

inat

ion

of P

TA b

y Pa

tent

and

Tra

dem

ark

Off

ice

–M

ay a

ppea

l by

civi

l act

ion

in D

.D.C

. –

App

eal m

ust b

e m

ade

with

in 1

80 d

ays a

fter t

he g

rant

of t

he p

aten

t –

No

appe

al o

r cha

lleng

e of

PTA

by

third

par

ties

PTO

ofte

n ha

s not

con

clud

ed fi

nal r

evie

w o

f PTA

mat

ters

ra

ised

at i

ssua

nce

by th

e 18

0-da

y de

adlin

e –

App

lyin

g 18

0-da

y de

adlin

e to

B D

elay

mat

tes w

ould

ofte

n ca

use

civi

l act

ion

to b

e fil

ed b

efor

e re

ceiv

ing

PTO

’s fi

nal d

ecis

ion

15

App

eal A

fter P

aten

t Iss

ues

The

Stat

ute:

–

35 U

SC 1

54(b

)(4)

(A):

“app

lican

t dis

satis

fied

with

a d

eter

min

atio

n m

ade

by th

e D

irect

or u

nder

par

agra

ph (3

) sha

ll ha

ve re

med

y by

a c

ivil

actio

n ag

ains

t the

Dire

ctor

fled

in th

e U

nite

d St

ates

Dis

trict

Cou

rt fo

r the

D

istri

ct o

f Col

umbi

a” (e

mph

asis

add

ed)

–35

USC

154

(b)(

3): “

Dire

ctor

shal

l – (i

) mak

e a

dete

rmin

atio

n of

the

perio

d of

any

pat

ent t

erm

adj

ustm

ent u

nder

this

subs

ectio

n, a

nd sh

all

tran

smit

a no

tice

of th

at d

eter

min

atio

n w

ith th

e w

ritte

n no

tice

of

allo

wan

ce.”

(em

phas

is a

dded

) N

ovar

tis v

. Kap

pos

–C

ivil

actio

n fil

ed Ju

ly 6

, 201

0 –

Cha

lleng

es P

TA c

alcu

late

d fo

r pat

ents

issu

ed b

efor

e W

yeth

•

All

pate

nts-

in-s

uit i

ssue

d m

ore

than

180

day

s bef

ore

civi

l act

ion

filed

16

Nov

artis

v. K

appo

s

Lega

l The

ory

Pres

ente

d by

Nov

artis

–

Stat

ute’

s 180

-day

dea

dlin

e fo

r app

eal a

pplie

s onl

y to

PTA

det

erm

inat

ion

mad

e in

con

junc

tion

with

not

ice

of a

llow

ance

•

PTA

cal

cula

tion

at is

suan

ce is

not

a d

eter

min

atio

n “u

nder

par

agra

ph (3

) of s

tatu

te

•18

0-da

y de

adlin

e in

appl

icab

le to

B-D

elay

det

erm

inat

ions

–N

ovar

tis la

cked

kno

wle

dge

of P

TO’s

impr

oper

inte

rpra

tatio

n of

stat

ute

–D

isco

very

of e

rror

cou

ld n

ot h

ave

occu

rred

prio

r to

Wye

th

–A

dmin

istra

tive

Proc

edur

e A

ct (A

PA) b

arrs

civ

il ac

tion

com

men

ced

mor

e th

an si

x ye

ars a

fter r

ight

of a

ctio

n ac

crue

s (pa

tent

issu

es)

Succ

ess w

ould

mea

n pa

tent

s with

Wye

th e

rror

s cou

ld b

e co

rrec

ted

even

if n

ot d

isco

vere

d un

til m

ore

than

180

day

s afte

r pat

ent

issu

ance

17

Pate

nt T

erm

Ext

ensi

on (P

TE)

Purp

ose

is to

rem

edy

loss

of p

aten

t ter

m d

ue to

del

ays i

n re

gula

tory

pro

cess

es fo

r pha

rmac

eutic

als a

nd o

ther

pro

duct

s su

bjec

t to

pre-

mar

ket a

ppro

val

Gov

erne

d by

: –

Stat

ute:

35

USC

§15

6 –

PTO

Rul

es a

nd R

egul

atio

ns

•37

CFR

§§

1.71

0 - 1

.791

•

MPE

P §§

275

0-27

64

18

Elig

ibili

ty fo

r PTE

Elig

ible

pat

ents

mus

t cla

im:

–A

pro

duct

subj

ect t

o re

gula

tory

revi

ew b

efor

e co

mm

erci

al m

arke

ting

or u

se

•H

uman

dru

gs, a

ntib

iotic

dru

gs a

nd h

uman

bio

logi

cs

•Fo

od a

dditi

ves a

nd c

olor

add

itive

s •

Med

ical

dev

ices

•

Ani

mal

dru

g pr

oduc

ts

•V

eter

inar

y bi

olog

ical

pro

duct

s

–M

etho

d of

usi

ng p

rodu

ct su

bjec

t to

regu

lato

ry re

view

–

Met

hod

of m

anuf

actu

ring

prod

uct s

ubje

ct to

regu

lato

ry re

view

19

Elig

iblit

y fo

r PTE

(con

t’d)

Prod

uct m

ust h

ave

been

subj

ect t

o re

gula

tory

revi

ew b

efor

e co

mm

erci

al m

arke

ting

or u

se

Prod

uct m

ust b

e sp

ecifi

cally

reci

ted

in th

e cl

aim

–

Can

not r

ely

on “

com

pris

ing”

lang

uage

to a

rgue

pro

duct

is in

here

ntly

in

clud

ed.

•Se

e, fo

r exa

mpl

e, V

usio

n (U

S 4,

911,

932)

, Mar

ch 1

9, 2

009.

–Pa

tent

cla

imin

g m

etab

olite

of a

ppro

ved

prod

rug

is n

ot e

ligib

le

•Th

e cl

aim

ed in

gred

ient

mus

t be

pres

ent i

n dr

ug-p

rodu

ct w

hen

adm

inis

tere

d •

Hoe

schs

t-Rou

ssel

Pha

rmac

eutic

als,

Inc.

v. L

ehm

an, 1

09 F

.3d

756

(Fed

. Cir.

199

7)

–U

ncle

ar if

pat

ent o

nly

clai

min

g pr

oduc

t/use

/man

ufac

ture

by

equi

vale

nts (

but n

ot li

tera

lly) i

s elig

ible

for P

TE

20

Elig

ibili

ty fo

r PTE

(con

t’d)

Onl

y gr

ante

d pa

tent

s elig

ible

for P

TE

–C

an n

ot fi

le P

TE a

pplic

atio

n un

til p

aten

t iss

ues

Mus

t file

app

licat

ion

for P

TE b

efor

e pa

tent

exp

ires

–C

an fi

le b

efor

e re

gula

tory

app

rova

l if p

aten

t wou

ld e

xpire

bef

ore

end

of re

view

per

iod

Mus

t file

app

licat

ion

for P

TE w

/in 6

0 da

ys a

fter a

ppro

val

Onl

y on

e PT

E gr

ante

d pe

r pro

duct

per

pat

ent

–Pa

tent

mus

t not

hav

e be

en p

revi

ousl

y gr

ante

d PT

E un

der §

156

–

If p

aten

t cov

ers t

wo

dist

inct

pro

duct

s, an

d bo

th a

re su

bjec

t to

regu

lato

ry re

view

, onl

y on

e ex

tens

ion

of th

e pa

tent

is p

ossi

ble

21

Reg

ulat

ory

Del

ay P

erio

d

Leng

th o

f reg

ulat

ory

revi

ew p

erio

d ca

lcul

ated

by

FDA

It is

the

sum

of:

–T

estin

g Ph

ase

= D

ate

IND

bec

ame

effe

ctiv

e fr

om d

ate

ND

A fi

led

-- a

nd --

–

App

rova

l Pha

se =

Dat

e N

DA

file

d un

til d

ate

appr

oved

22

Cal

cula

ting

PTE

USP

TO c

alcu

late

s PTE

bas

ed o

n re

gula

tory

revi

ew p

erio

d –

Subt

ract

s fro

m re

gula

tory

revi

ew p

erio

d:

•Ti

me

appl

ican

t did

not

act

with

due

dili

genc

e •

Tim

e be

fore

pat

ent i

ssue

d

–PT

E =

(½ x

Tes

ting

Phas

e) +

App

rova

l Pha

se

–M

axim

um P

TE =

5 y

ears

–

Can

not r

esul

t in

tota

l rem

aini

ng p

aten

t ter

m o

f mor

e th

an 1

4 ye

ars

•M

easu

red

from

dat

e of

regu

lato

ry a

ppro

val t

o da

te o

f exp

iratio

n w

ith P

TE a

nd

any

PTA

Exte

nsio

n pe

riod

runs

from

exp

iratio

n da

te o

f pat

ent

–A

s sho

rtene

d by

any

term

inal

dis

clai

mer

, or

–A

s ext

ende

d by

Pat

ent T

erm

Adj

ustm

ent

23

One

PTE

per

Pro

duct

per

Pat

ent

Onl

y on

e PT

E gr

ante

d pe

r pro

duct

per

pat

ent

–Pa

tent

mus

t not

hav

e be

en p

revi

ousl

y gr

ante

d PT

E un

der §

156

–

If p

aten

t cov

ers t

wo

dist

inct

pro

duct

s, an

d bo

th a

re su

bjec

t to

regu

lato

ry re

view

, onl

y on

e ex

tens

ion

of th

e pa

tent

is p

ossi

ble

If a

ppro

ved

prod

uct c

over

ed b

y m

ultip

le p

aten

ts, o

nly

one

can

be e

xten

ded

–B

ut, p

aten

tee

can

subm

it m

ore

than

one

app

licat

ion

base

d on

sam

e re

gula

tory

per

iod

–PT

O w

ill a

sk a

pplic

ant t

o ch

oose

whi

ch p

aten

t to

exte

nded

–

If a

pplic

ant d

oes n

ot re

spon

d, fi

rst p

aten

t to

expi

re is

ext

ende

d

24

Firs

t Com

mer

cial

Mar

ketin

g or

Use

Prod

uct m

ust h

ave

been

subj

ect t

o re

gula

tory

revi

ew b

efor

e co

mm

erci

al m

arke

ting

or u

se

–N

o PT

E w

here

pat

ent c

laim

s com

bina

tion

of tw

o pr

evio

usly

ap

prov

ed d

rugs

•

Arno

ld P

artn

ersh

ip v

. Dud

as, 3

62 F

.3d

1338

(Fed

. Cir.

200

4)

•N

o PT

E fo

r Vic

opro

fen

(com

bina

tion

of ib

upro

fen

and

hydr

ocod

one)

•

At l

east

one

of t

wo

activ

e in

gred

ient

s in

com

bina

tion

mus

t be

new

to m

arke

tpla

ce

as a

dru

g pr

oduc

t

–N

o PT

E w

here

pat

ent c

laim

s new

form

ulat

ion

of p

revi

ousl

y ap

prov

ed “

prod

uct”

•

Fiso

ns P

LC v

. J. Q

uigg

, 876

F.2

d 99

(Fed

. Cir.

198

9)

25

Act

ive

“Ing

redi

ent”

“Dru

g pr

oduc

t” =

act

ive

ingr

edie

nt o

f new

dru

g –

“inc

ludi

ng a

ny sa

lt or

est

er o

f the

act

ive

ingr

edie

nt”

[35

USC

§ 1

56(f

)(2)

]

PTE

not p

ossi

ble

whe

re a

“sa

lt” o

r “es

ter”

of a

ctiv

e in

gred

ient

was

pre

viou

sly

appr

oved

B

ut, w

here

“sa

lt” o

f act

ive

ingr

edie

nt h

ad b

een

prev

ious

ly

appr

oved

, pat

ent c

over

ing

an “

este

r” o

f the

act

ive

ingr

edie

nt

still

elig

ible

for e

xten

sion

–

New

pro

duct

not

a “

salt”

or “

este

r” o

f the

pre

viou

sly

appr

oved

pr

oduc

t –

Gla

xo O

pera

tions

UK

Ltd

. v. Q

uigg

, 894

F.2

d 39

2 (F

ed. C

ir. 1

990)

26

Scop

e of

Pro

tect

ion

Dur

ing

PTE

Onl

y “u

se a

ppro

ved

for t

he p

rodu

ct”

is p

rote

cted

dur

ing

PTE

(35

USC

§ 1

56(b

)(1)

) Fo

r pat

ent c

over

ing

met

hod

of m

anuf

actu

ring

prod

uct,

prot

ectio

n lim

ited

to m

etho

d us

ed in

mak

ing

the

appr

oved

pr

oduc

t –

To in

frin

ge p

rodu

ct-b

y-pr

oces

s cla

ims,

mus

t man

ufac

ture

pro

duct

by

proc

ess r

ecite

d in

cla

ims.

Mus

t ND

A h

olde

r man

ufac

ture

pro

duct

by

sam

e pr

oces

s?

–Pr

obab

ly n

ot

27

Scop

e of

Pro

tect

ion

Und

er P

TE (c

ont’d

) A

ctiv

e “m

oiet

y” v

. Act

ive

“ing

redi

ent”

–

Act

ive

“moi

ety”

app

roac

h fo

r PTE

enf

orce

men

t doe

s not

requ

ire

sam

e ac

tive

ingr

edie

nt in

as t

he a

ppro

ved

prod

uct

Pfiz

er, I

nc. v

. Dr.

Redd

y’s L

abs.

Ltd.

, 359

F.3

d 16

1 (F

ed. C

ir. 2

004)

–

PTE

for p

aten

t cov

erin

g am

lodi

pine

bes

ylat

e an

d am

lodi

pine

m

alea

te (s

alts

of a

mlo

dipi

ne)

–A

ppro

ved

prod

uct w

as N

orva

sc®

(am

lodi

pine

bes

ylat

e)

–D

r. R

eddy

’s so

ught

app

rova

l of a

mlo

dipi

ne m

alea

te

–PT

E co

vere

d pr

oduc

ts w

ith a

ctiv

e m

oiet

y (a

mlo

dipi

ne) a

nd sa

lts

(bes

ylat

e an

d m

alea

te)

Inco

nsis

tent

with

Gla

xo O

pera

tions

UK

Ltd

. v. Q

uigg

, 894

F.2

d 39

2 (F

ed. C

ir. 1

990)

? 28

Act

ive

“Ing

redi

ent”

v. A

ctiv

e “M

oiet

y”

Phot

ocur

e AS

A v.

Kap

pos,

603

F.3d

137

2 (F

ed. C

ir. 2

010)

–

Prev

ious

ly m

arke

ted

drug

pro

duct

was

Lev

ulan

Ker

astic

k®

(am

inol

evul

inic

aci

d H

Cl o

r “A

LA h

ydro

chlo

ride”

) top

ical

solu

tion

–Ph

otoc

ure

soug

ht P

TE fo

r reg

ulat

ory

appr

oval

of M

etvi

xia®

(m

ethy

l am

inol

evul

inat

e H

Cl o

r “M

AL

hydr

ochl

orid

e”)

•M

ethy

l est

er o

f ALA

hyd

roch

lorid

e

–PT

O d

enie

d PT

E ap

plic

atio

n •

Sam

e ac

tive

moi

ety

(am

inol

evul

inat

e or

“A

LA”)

in b

oth

prod

ucts

–C

ourt

reve

rses

•

“Act

ive

ingr

edie

nt”

in 3

5 U

SC 1

56 d

oes n

ot m

ean

“act

ive

moi

ety”

•

Act

ive

ingr

edie

nt w

as M

AL

hydr

ochl

orid

e, a

new

dru

g (d

iffer

ent f

rom

ALA

hyd

roch

lorid

e)

29

Act

ive

“Ing

redi

ent”

v. A

ctiv

e “M

oiet

y”

(con

t’d)

Mus

t wha

t is e

xten

ded

be th

e sa

me

as w

hat i

s cov

ered

dur

ing

the

exte

nsio

n?

–PT

E gr

ante

d if

no p

revi

ous c

omm

erci

al m

arke

ting

or u

se o

f the

ac

tive

ingr

edie

nt (i

nclu

ding

its s

alts

and

est

ers)

as a

dru

g pr

oduc

t •

Phot

ocur

e AS

A v.

Kap

pos,

603

F.3d

137

2 (F

ed. C

ir. 2

010)

-- b

ut --

–

PTE

enfo

rced

aga

inst

all

prod

ucts

con

tain

ing

the

sam

e ac

tive

moi

ety

as p

rodu

ct su

bjec

t to

regu

lato

ry re

view

•

Pfiz

er, I

nc. v

. Dr.

Redd

y’s L

abs.

Ltd.

, 359

F.3

d 16

1 (F

ed. C

ir. 2

004)

30

Stra

tegi

es to

Max

imiz

e Pa

tent

Ter

m

Max

imiz

e PT

A b

y m

inim

izin

g ap

plic

ant d

elay

–

File

resp

onse

s on

or b

efor

e th

ree-

mon

th d

eadl

ine

•A

void

usi

ng w

eeke

nd/h

olid

ay c

arry

-ove

rs

•U

se o

f ful

l 3 m

onth

per

iod,

with

out e

xcee

ding

, may

incr

ease

pen

denc

y tim

e w

ithou

t pen

aliz

ing

for A

pplic

ant D

elay

–A

void

inco

mpl

ete/

non-

com

plia

nt re

plie

s –

Avo

id su

pple

men

tal a

men

dmen

ts/re

spon

ses

–Fi

le e

lect

roni

cally

–

File

Info

rmat

ion

Dis

clos

ure

Stat

emen

ts

•B

efor

e re

ceip

t of f

irst o

ffic

e ac

tion

•W

ith re

ply

to n

on-f

inal

off

ice

actio

n (I

DS

filed

afte

r res

pons

e is

trea

ted

as “

supp

lem

enta

l rep

ly”)

•

With

in 3

0 da

ys o

f for

eign

off

ice

actio

n (w

ith c

ertif

icat

ion

unde

r 37

CFR

1.7

04(d

))

31

Stra

tegi

es fo

r Max

imiz

ing

Pate

nt T

erm

(c

ont’d

) A

void

Req

uest

ing

Con

tinue

d Ex

amin

atio

n (R

CEs

) –

Filin

g R

CE

perm

anen

tly st

ops t

he 3

yea

r clo

ck fo

r PTA

–

Petit

ion

to h

ave

final

ity o

f off

ice

actio

n w

ithdr

awn

(if a

ppro

pria

te)

•Fi

nal O

ffic

e A

ctio

n in

appr

opria

te if

exa

min

er m

akes

a n

ew re

ject

ion

not

nece

ssita

te b

y A

pplic

ant’s

pre

viou

s am

endm

ent

•E.

g., a

men

dmen

t onl

y ca

ncel

ing

depe

nden

t cla

ims a

nd a

men

ding

inde

pend

ent

clai

ms t

o re

cite

the

canc

eled

dep

ende

nt c

laim

lim

itatio

ns

32

Stra

tegi

es fo

r Max

imiz

ing

Pate

nt T

erm

Pros

ecut

ion

by A

ppea

l: –

Con

side

r fili

ng a

Not

ice

of A

ppea

l and

App

eal B

rief i

nste

ad o

f RC

E –

If a

ppea

l goe

s to

Boa

rd, C

-Del

ay a

vaila

ble

if de

cisi

on fa

vora

ble

to

App

lican

t •

Onl

y ne

ed to

reve

rse

one

clai

m re

ject

ion

–Ex

amin

er m

ay re

open

pro

secu

tion,

issu

e ne

w O

ffic

e A

ctio

n •

Can

resp

ond

to n

ew O

ffic

e A

ctio

n or

rein

stat

e ap

peal

•

If A

pplic

ant r

espo

nds,

any

C-d

elay

acc

rued

dur

ing

appe

al p

roce

ss is

lost

, but

A-

and

B-D

elay

still

ava

ilabl

e

–In

terv

iew

Exa

min

er to

strik

e de

al

–Ex

amin

er “

thro

ws i

n th

e to

wel

” an

d al

low

s

33

Stra

tegi

es fo

r Max

imiz

ing

PTA

Avo

id U

nnec

essa

ry T

erm

inal

Dis

clai

mer

s –

Filin

g Te

rmin

al d

iscl

aim

er m

ay li

mit

or e

limin

ate

PTA

–

Con

side

r fili

ng st

rate

gies

to m

inim

ize

over

lap

that

mig

ht c

reat

e do

uble

pat

entin

g •

E.g.

, fili

ng to

incr

ease

Res

trict

ion

Req

uire

men

ts a

nd re

spon

ding

with

out t

rave

rse

•D

oubl

e pa

tent

ing

reje

ctio

n ov

er d

ivis

iona

l app

licat

ions

not

app

ropr

iate

(w

ith so

me

exce

ptio

ns)

File

com

plet

e N

atio

nal P

hase

app

licat

ions

–

14-m

onth

clo

ck fo

r firs

t Off

ice

Act

ion

does

not

star

t unt

il ap

plic

atio

n is

“co

mpl

ete”

–

Con

side

r fili

ng a

con

tinua

tion,

rath

er th

an N

atio

nal P

hase

, of P

CT

34

Pate

nt F

iling

Stra

tegi

es

File

new

app

licat

ions

as p

rodu

cts d

evel

oped

and

impr

oved

–

New

form

ulat

ions

of e

xist

ing

drug

s –

New

com

bina

tions

of e

xist

ing

drug

s –

Ster

eose

lect

ivity

, sin

gle

enan

tiom

ers

–N

ew in

dica

tions

Mus

t be

new

and

non

-obv

ious

ove

r exi

stin

g pa

tent

ap

plic

atio

ns a

s prio

r art

–U

npub

lishe

d U

S ap

plic

atio

n no

t prio

r art

if sa

me

inve

ntor

s or s

ame

oblig

atio

n to

ass

ign

[35

USC

103

(c)]

–

Publ

ishe

d ap

plic

atio

ns m

ay b

e pr

ior a

rt un

der §

102(

a) o

r §10

2(b)

35

Pate

nt F

iling

Stra

tegi

es (c

ont’d

)

File

firs

t as p

rovi

sion

al a

pplic

atio

ns

–Fi

le a

s non

-pro

visi

onal

one

yea

r lat

er

–Pa

tent

term

20-

year

s fro

m fi

rst n

on-p

rovi

sion

al fi

ling

–B

uys a

n ex

tra y

ear o

f pat

ent t

erm

Avo

id fi

ling

Con

tinua

tions

-in-P

art (

CIP

s)

–C

IP p

aten

t ter

m is

20-

year

s fro

m fi

rst n

on-p

rovi

sion

al to

whi

ch it

cl

aim

s prio

rity

•ev

en if

firs

t non

-pro

visi

onal

doe

s not

des

crib

e or

ena

ble

the

CIP

’s in

vent

ion

–Pr

iorit

y ap

plic

atio

n m

ay b

e “p

rior a

rt” a

gain

st C

IP if

prio

rity

does

no

t des

crib

e an

d en

able

inve

ntio

n cl

aim

ed in

CIP

•

e.g.

, CIP

cla

ims o

bvio

us o

ver p

ublis

hed

prio

rity

appl

icat

ion

or o

ver u

npub

lishe

d pr

iorit

y ap

plic

atio

n w

ith d

iffer

ent i

nven

tors

(and

diff

eren

t obl

igat

ions

to a

ssig

n) 36

Que

stio

ns?

Sam

uel S

. Woo

dley

, Ph.

D.

Prin

cipa

l Fi

sh &

Ric

hard

son

N

ew Y

ork,

NY

(2

12) 6

41-2

363

woo

dley

@fr

.com