PBM Pharmaceuticals, Inc. v. Method Pharmaceuticals, LLC et al

Filing 188

MEMORANDUM OPINION. Signed by Chief District Judge Glen E. Conrad on 3/29/16. (hnw)

CLERK' OFFI U.S, SX COURT
B
CE
DI
AT ROANOKE,VA
FI
LED

I THE UN I
N
TED STA TES DI
STRI COU RT
CT
FOR TH E W ESTERN D I
STRI O F V I N A
CT
RG
CHA M O TTESVI
LLE D I I ON
V SI

MA2 2! 2 1
25
J
ULI , u
BY;
E

cLuax
ERK

CONCORDI PHARM ACEUTI
A
CALS,l C.
N ,
Ci lAci N o.3: 4CV00016
vi ton
1
Pl i tf ,
a n if
M EM O R AN DU M O PI I N
N O

M ETHOD PHARM ACEUTI
CALS,LLC,e a .
t 1,

H o Gl E.Conz
n. en
ad
ChifUnie Stt sDititJ
e
t d a e src udge

Dee
f ndan s
t.

I t i tn a to ,Co o daP r c uias I c (co o da' as rscamsu e
n he nsa t cin nc r i hama e tc l, n .t nc r i' se t li nd r
i
)
t La m Ac a Vigi alw a i tM eho Pha ma utc l , nc. ndM a t w Sc t Tuc r
he nha
t nd r ni a gans t d r ce i a s I a
the
o t ke

(o lciey ç eh d). Co c r i h smo e f rsl r j d me to t re o isca. ,
c le tv l, l t o '
M
n o da a v d o l
mma y u g n n h e f t li
ms

a dMeh dh smo e f rsl r j d me t st alcams Th c u t ed ah mi g o t
n to a v d o l
mmay u j n a o l li . e o r h l e n n he
he olowi e ons nc di s i
motons o M a c 3,201 1 Fort f l ng r as , Co or a' moton wilbe de e a
i
n zh
6.
l
ni d nd
M ehod' moton wilbegr nt d i pa ta de e i pa t
t s i
l
a e n r nd nid n r.

sum m ar oft Fact
v he
s
Pl nt f C onc di and t D onnat @ Pr
ai if
or a
he
al
oduc Li
t ne

Conc di i a i e nai lcompa i op or t d unde t lws ofBa bad ,whih
or a s n ntr tona
ny nc
ae
r he a
r os
c

makes s ls a d d srb ts p nn c u ia p o u t. On M a c 20 20 4, èo o d a
r t, el, n itiu e ha a e tc l r d cs
rh , 1
nc r i
n mc t t i ha e e e it a a r e e t a quie t Dor t l lne of pr t
nnot ed ha t d ntr d n o n g e m nt o c r he
ma a @ i
oduc s

(r onnaal' fom f merpli ifPBM Pha ma eui l,I .($ ' . Concodi c eed
t
t ' r or
)
antf
r c tcas nc çPBM '
)
r a omplt
t ac ston i M a of201
he quiii n y
4.

1Durng t M ar 3, 2016 hea i t cour alo he d or lar
i he
ch
rng, he
t s ar a gume on t pari 'motons t
nt
he tes
i o
e udeex twines es Thos m otonswilbeaddr s i ase aem e andum opi on.
xcl
per t s .
e i
l
e sed n par t mor
ni

Do naa i aln o c mbn to p e o abi l n beld n aakao d(TBA' p o u t
n tls i e f o iain h n b r t a d la o n l li $ ' r d cs
a
)
t t i us d a a jmci e t r p i te te t n o iia l b we s n r me a a u e
ha s e s dt tv hea y n h r ame t f n tb e o l y d o nd c t
e e oc ii . Doz t l i a lbl i t f
nt r olts
ma a s vaia e n wo onnulto : i e ae-eea e t blt a
a ins mm dit r l s a e s nd
a e s nd lxi e vaia e
es rp i n y
f s- tng ei r2 Thet blt a e i rar a lbl by pr c i to onl .
a taci lxi.

Do tl pr t ha a uni r gult y hit y a saus Donna a wa ûrt
nnaa oduc s ve
que e a or sor nd t t .
tl s s
i r uc d i t 1
ntod e n he 930sbyA. Robi Compa
H.
ns
ny. I 1
n 962,Congr s n e d t Fe r Food,
e s m nde he de al

Dr g a dCo mei Ac (TDCA' t r q ied u mamfct est p o et t e d g a esf
u , n s tc t C
' o e ur r g t a tr r o r v ha n w nzs r a e
)
l
a e f c i f t i l be e i c tons i or r t obt n a ovalby t Food a Dnz
nd f e tve or her a l d ndi a i
n de o ai ppr
he
nd
g

Ad n srto CTDA' . T n n me tas rq rd t F t c n u ta r to p cie
miitain
' he me d n lo e uie he DA o o d c er s e tv
)
e l ton ofdnz t tha pr vi l bee a oved unde t FDCA be we n ise t e i
va uai
gs ha d e ousy n ppr
r he
t e t nacm nt n
1 a 1
938 nd 962. Donnatlwa one yfm or t n 3, dnz a f c e by t a e
a s
e ha 400 gs fe t d he m ndme .
nt
I t 1
n he 970s t FDA be n a pr e s of e l tng t s f t a e fc c of PBA
, he
ga
oc s
vaua i he a ey nd fi a y

p o ucst e t Dr gEfia yStd hn lme tto (G 1'rv e p o rm. On Jme2 ,
r d t md r he u fc c u y p e n ain ç
DES ' e iw r g a
)
t 0
1
978,t FDA r uie a d gst we ei vol d i t r vi w pr e st obt i a a ove
he
eq r d ny nl hat r n ve n he e e oc s o an n ppr d

Ne Dr gAp lc to (&
w u p iain C
NDA' o Ab rv ae Ne Dr gAp lc to (W NDA' t rman o
' r b e it d w u piain C
)
'oe i n
)
t m ake . On De mbe 30, 1
he r t
ce r
980, A. .Robi ,PBM ' pr ec s -n-n e es,obt i
H
ns
S ed es ori i t r t
aned
c tona a ova ANDASf risDo t tbl t a e i r Dr n a a hae unde s h
ondii l ppr l
o t nnaal a es nd lxi. ugs a nuf c d
r uc

a c tonaly a ove ANDA c n be l ga l m a ke e t i t FDA r s ves quesi
ondii l ppr d
a
e ly r t d mtl he
e ol
tons
r ga di t d ugs e f c i ne s unde t FDCA. At t s tm e, at ug t FDA ha
e r ng he r ' fe tve s
r he
hi i
lho h he
s
c l dt tt Donna a pr ucsa e s f i ha ha ye t de e m i t i e f c i ne s
onc ude ha he
t l od t r a e, t s s t o t r ne her fe tve s .

2Anot f mul i , Doma t Extntbs,wasdic i
her or aton
aal e a
s ontnued by PBM and i notbei m a ketd by
s
ng r e
Concor a.
di

2

Foro rt ry ye r ,Dor t lf e co pe ii n fo ge rc PBA pr uc st twe e
ve hit a s
ma a ac d m tto r m ne i
od t ha r
phn ma u i al eq va e t Do maal Begi ng i Aug tof2011 mar a t e s oft
r ce tc ly ui l nt o r t .
nni n
us
, mf cm r
he
ge rcveri bega t t ket i pr t of t m a ke .3 O nce t i t i so pr vi l
ne i sons
n o a her oduc s f he r t
he nven ore f e ousy
m a a tle ge dc pr t we e e i na e Doz t lwast onl lne of PBA pr t
nuf c tr d ne
oduc s r lmi t d, ma a
he y i
oduc s
a lbl f pr c i i
vaia e or es rpton.
I o de t e e t PBA pr
n r r o nt r he
oduc m a ke ,Conc r apur has d t rg st m a and s l
t r t
o di c e he i ht o ke
el
Don t lfom PBM . Conc di c
na a r
or a omplt d t a uiii n o t Dor t lpr
e e he cq sto f he ma a oduc lne on M a
ti
y
1 201 The As e Pur ha e Agr e e tbewe n PBM a Co or ata f r e a va it of
5, 4.
st c s
em n t e
nd nc di r nse r d
rey
a s t,i l ngt c to ly-ppr ve ANDASf Dor t .
s e s ncudi he ondii nal a o d
or maal
I.
I

Dee
f ndantM e hod and isE f ort t D e l and M ar tM e- H vos
t
t f s o ve op
ke
PB-

De e ntM ehod i a whol s l dnz diti i c
f nda
t
s
e ae g srbuton ompa ba e i Ari on,Te s
ny s d n lngt
xa .

The c
ompany wa f
s ounde by Def nda Tuc r i Nove be o 201 Tuc r i a s t
d
e nt ke n
m r f 2.
ke s lo he
c
ompa spr i nt Prort sa tng M ehod, ke wo ke f ac
ny' esde . i o tri
t Tuc r r d or ompa t tmar a tze
ny ha
mf c l d
r
apr tc l Re PBoduc aled - Hyos whih co ane t s m eaci i ed e sasDonna a .
, c nt i d he n
tve ngr i nt
tl
I t s
n he umm e of 201 M ehod de i t l f a conta m a acur r f a ne
r
3, t
cded o ook or
r ct nuf t e or
w
pr tt twoul bepha mac utc l e vae t Donna a . Thene pr twase nt a l
oduc ha
d
r e ialy qui lnt o
tl
w oduc
ve u ly

n me M eP Hy s M eh d c n a td W i d r La r tre ,LLC (ï i d r',a Ge r i
a d - B- o . t o o tce
n e bo ao is
< n e'
W
)
oga
c
ompa t t ha pr vi l de l d ano he pr t f M ehod. I Dec mber of 201
ny ha d e ousy ve ope
t r oduc or t
n
e
3,
M ehod is f pur ha eor r t W i rf t de l e ofM e PBt
s ued our c s de s o nde or he veopm nt
- Hyos i l ng a
, nc udi
ptr ha e or r f sa lt t ss Ar
zc s de or t biiy e t .
ound t s me tme,W i r a M ehod dic s d
he a
i
nde nd
t
s us e

3 The pa te diput why t s occ r d. Concor a mai t ns t t t m a ac r s of ge i
ris s e
hi
ur e
nerc
di
n ai ha he nuf m er
veri ofDonnat pr t eihe vol a iy wihdr w orwe e f ce of t ma ketby t FDA,whie
sons
al oducs t r unt rl t e
r or d f he r
he
l
M et contndst tPBM f c iscompeior of t mar t Uli ael t sdiput i notm aeralt t
hod
e
ha
or ed t
tt s f he ke . tm t y, hi s e s
t i o he
diposton oft pa tes'motons.
s ii
he ri
i

ma acurng a ilta or rf t e co me calba c oft pr uc. W i ra M ehod
nuf t i n rii l de or hr e m r i t hes he od t
nde nd t
a s ag e d on t prcet tW i rwoul c r f rs yi M e PBlo r e
he i ha nde
d ha ge o uppl ng - Hyos
.
I M a c of201 M e hod us publcy- val bl c pis oft Donna alpr uc lbel
n rh
4, t
ed
i l a ia e o e
he
t od t a s
a pa kagei e t a t mplt f isM e- l yoslbesa i e t. Tuc rf wa dedc e
nd c
ns rs s e aes or t
pB-l a l nd ns rs
ke or r
opi s
oft Donna a lbel t Pltnum Pr s ,a heat a e pa kagi c
he
tl a s o ai
es
lhc r c ng ompany,a a ke t tt
'nd s d ha he

c
ompany c nge t nn e oft pr t t M e- Hyos a t nnme of t diz but r t
ha
he m
he oduc o
PBnd he
he s
o o
M et Phn mac utc s LLC. Afe maki a s re of a tonal r vii ns r quese by
hod
r e ial,
tr
ng
e is
ddii
e so e t d

Tu k r Pltnl P essn Tu k rproso t rq se Me/B-- o lb l o Mac 2 ,
c e, ait rs et c e o f f he e uetd - ly s a es n rh 4
m
l
201
4.

M e hod s eq nty lse t M e- Hyospr t wih t phn mac utc li ty
t
ubs ue l it d he
pBoduc s t wo r e i a ndusr

d tb s s M e is n a d Fis Daa n (olciey,t e S aa a e ' Ac o dn t t
aa a e , d - pa n rt tbn k c le tv l h l tb s s). c r ig o he
d
pl n if s e de e,t daa s s a e us d na i de by m a ke pa tcpa s t o ho t
aitf vi nc he tba e r e tonwi
r t rii nt hr ug ut he
phn ma e ial i ty, i l ng dnl m a a t e s whol s e s t r pa t pa s
r c utc ndusr nc udi
g
nuf c ur r ,
e alr , hid- ry yor ,

pha ma i s a pha
r c e , nd nnacss t e l t m e cai nst ta ec r l a ia eo t ma ke or
it, o va uae di to ha r urenty va lbl n he r t
wils n beaval bl The da a esar alo us t dee ne whet rg ne i s tt e a e
l oo
ia e.
t bas e s ed o tnni
he e rc ubsiut s r
a ia ef br nd na pr ucs.
va lbl or a
me od t
On M a ch 31,201 Chr s Boone,M e hod' vi e pr s de of o r tons f a de t
r
4, i
t s c e i nt
pe a i , om r d he

M e pB-l lbe pr spr pa edby Pltnlm Pr s .l wih ne pr ts bm ison f
- l yos a l oof e r
a i l es yaong t w oduc u s i onus
,
t M e - n. On or a
o dispa
boutAprl1 201 M e hod' M epB--yospr t we e lse i t
i , 4, t s - l
l
oduc s r it d n he
M edispa daa e. Bas d on t i onna i pr de by M ehod,t M e pB- n t bas
e
he nf
ton ovi d
t
he - Hyospr t
oduc s

weeasgnedt s Ge rcPr
r si
he ame nei oductI ni rC& ' asDo t . Themar tngsa tdae
de tse GP1'
)
nnaal
kei tr t

4

f t M e- lyospr t wa lse a J 1, 4,a t m a ke i c t gor wa lsed a
or he pB-l
oduc s s it d s une 201 nd he r tng a e y s it s

S n p r v dd u ohe. De s'S ae n o Un ip tdM ae l cs(G F'' K.
ç a p o e r g t r' f. ttme t f d s u e tda Fa t C
u
'
SUM 'Ex.
)
On Aprl1 201 PBM ,Conc di spr dec s o -n-nt r s,c a t d M e - n a
i 4, 4,
or a' e e s r i i e e t ont c e
dispa nd
a vie t tt e - n' publs d lsi ofM e pB-l Or Elxi a M e- l yosOr l
d s d ha d dispa s
M
ihe itngs
- l yos al i r nd
pB-l
a

Ta lt ae i c urt,c u d c us hnm t pain s a c ud e po e ( e is a t lg l
bes r na c ae o l a e r o te t, nd o l x s M d - p n) o e a
la lt f r dnma . De s. SUM F Ex. J PBM r que td t t M e i biiy o
ges'
'
f '
.
e se ha
dispan deit t
ls he

M epB- Hyospr t i ditl
oducs mmq aey.
Tha s meda ar pr s nt tveofM edispa c t td Boonea i uied a t whe he
ta
y, e e e ai
- n on ace
nd nq r s o
t r
6 t M e pB--yospr t a e a ia e f rpa i n us , tt stm e. P1' SUM F Ex.5. I
+0 h - l
l
oducs r va lbl o te t e a hi i ' .s
'
n
rs
e pons ,Boone a s t M e - n r pr s nt tve t t t pr
e
dvied he dispa e e e ai ha he oduct we e i c r nty
s r i
not ure l

a ia ey a t tM e hod hoped t ha mor i or ton t f l ng we k a t whe i
valbl ' nd ha
'
t
o ve
e nf ma i he olowi
e so
n t
woul begn s ppi t pr t . P1' SUM F Ex.6.
d i hi ng he oduc s .s
I addii n t M ed - n,M ehod s
n
to o
ispa
t
oughtt ha isM e- l yospr uc slsed i Fis
o ve t
pB-l
od t it n r t
Da a nk' phn mac utc daa s . Howe r Fis Da a nk r us t ls t M e- lyos
t bn s r e ial tba e
ve , rt t bn ef ed o it he
pB-l
pr t wihout vai to fo DaiyM e
oduc s t
lda in r m
l d,a we ie o r t d by t Na i l Li a y of
bst pe a e
he tona br r
M e cne whih pr de i o ma i r ga di m a ke e dnl i t Unied St t s i l ng
di i , c ovi s nf r ton e r ng r t d gs n he t
a e , ncudi
FDA l be i or ton and pac ge i e t Co eq nty, et s ntt M e pBa l nf ma i
ka ns rs. ns ue l M hod e he - Hyost blt
a e

a elxi l be st I ag a ,a co pa t tpr vi d Dal ed lsi s r i e t M e hod,a
nd i r a l o nt r s
m ny ha o de
iyM
itng e v c s o t
nd

a v s dt ec mpa yt ti n e e t ç v f r r wi lsigt e ep o ucswi E e F
d ie h o n ha t e d d o & e o wad t itn h s r d t t t q DA
mo
h
h h
and D aiyM ed.' Pl' SU M F Ex.36.
l
' .s

On M a 27,201 I agr s a s d M ehod t ti woul ne d addii li o ma i
y
4, nt a dvie
t
ha t
d e
tona nf r ton
r ga di t M e pBe r ng he - Hyospr t ,ncl ngt m a ke i caeg y, hema kei sar da e a
oduc s i udi he r tng t or t
r tng t t t ,
5

des rpton oft t blt a t nn eoft ma a t e . l r s ns Tuc rs ntI a a a
ci i
he a e , nd he m
he nuf cur r n e po e, ke e nt gr s n

e a llsi t m a ke i c t r f t pr t asCma ove dr g/ he ';t m a ke i
m i itng he r tng aego y or he oduc s ç ppr d u ot r' he r tng
t
sa tda ea : 01 201 ' a t m a acur rasçW i rLa .' P1' SUM F Ex.1
tr t s 1
06/ / 4'; nd he nuf t e
i nde bs' .s
8.
TheM e pB--yospr t we es e nty lse wih Da l ed. Co it ntwih t
- l
l
oduc s r ubs que l it d t iyM
nsse
t he
i o ma i pr de by M e hod,t Da l ed lsi f t M e pB-- t bl t a e i r
nf r ton ovi d
t
he iyM
itngs or he - lyos a es nd lxi
l

lse aç a ke i sa tdae'of: / / 4'and a G r tng c t gor 'ofç ppr d dr g
it d d r tng tr t ' G 01 201 '
m
06
l kei a e y' ç
ma
una ove u
ot .' P1' SUM F Exs 45 & 46. The i c tonsa us ge s to oft Dal M e lsi .
her' .s
.
ndi ai
nd a eci n he iy- d itngs

f rt M e pB--yospr t pr vi d asf l :
o he - l
l
oduc s o de
olows

Ba e o ar v e o t i d z b t Nain lAc é my o S in e - to a
sd n e iw f h s n g y he to a a e f ce c sNain l
Res a c Counc l a o ot r i or ton, FDA ha cas ii d t f l ng
e r h'
i nd/ r he nf ma i
s l sfe he olowi

id c to sa ç sil 'efcie Fo us a a jmciet ea yi tete t n o
n iain sç sb y' fe tv : r e s dt tv h rp n h r ame t f
po
i tb eb we s nd o (nia l c ln, pa tcc l n muc u c lts a d a u e
nia l o l y rme i tbe oo s si oo , o s o i ) n c t
i
e tr c lts M a as b u eu a a j n t t rp i t te t n o
n eo o i . y lo e s f l s du ci hea y n he rame t f
i
ve
duode ul r....
nal ce

J Thes mei or to wasco ane i t pr ti e t frt M epB--yospr t.
.
Z
a nf main
nti d n he oduc nsrs o he - l
l
oducs
On Jme 3,201 M ehod r s itd t M e- l yospr tlbe st Fis Daa mk.
t
4, t
e ubm te he
pB-l
oduc a l o r t tbr
M ehod' s iso lse a tplnned l unc dae' of J
t s ubm s i n it d G n
a h t'
une 1,201 Pl' SUM F Ex. 1
4. .s
5.
M ehod' s isonwa pr e s d byFis Daa nk,a t M e pB-l pr t we else
t s ubm s i
s oc s e
r t tbn
nd he - l yos oduc s r it d
i t Fis Daa nk pha c utca da a e i e ry J 201
n he rt tbn
nna e i l t bas n a l vne 4.
I a ton t t pr uc lbe sa i e t,M ehod pr vi d prcng ilor ai n f t
n ddii o he od t a l nd ns rs t
o de ii zf m to or he
M e pB- Hyospr t t M ed - n a Fis D aa
oduc s o
ispa nd r t t bnnk. Thelse prc f rt M e pB-it d i es o he - l yos
l
pr t we e l rt n t lse prce f t r a e Donna a pr ucs M e hod i caed
oduc s r owe ha he it d i s or he elt d
t l od t.
t
ndi t
t tt prci i or ton wa e f c i a o Aprl1 201
ha he i ng nf ma i
s fe tve s f i , 4.

6

On Se e be 1 201 afe t i tnt a ton wa fl d,Tuc r e al d W i r t
ptm r 5, 4, tr he nsa c i
s ie
ke m ie
nde o

e p e s( o c r s' e adn t t ly sPrj c ' Pl' S F Ex. . Thee ip o i e ,
x r s G n en 'r g r ig he TB-l o o e t' .s UM
c
21
mal r v d d
i pe tne tpa t a f l
n ri n r, s olows:

Th l iain o t i p oe tha be n g ig o snc M a a d weha ei u 'd
e i g to n hs r jc s e on n i e y n
t
v nc ne
s b tnillg lf e . W ej te trd a s c n r t o ds o e y fo t e
u sa ta e a e s
us ne e e o d omd f ic v r r m h
c u t. Ik o t a W i e h s tsa tda yti go t i p oe t tti tmea d
o rs n w h t nd r an' tre n h n n h s rj c a h s i n
wea ed susi itm al a o t h v a it o t ep oe t o teln nm. W e
r ic sng ne l b u t e ibl y f h rj c f r h o g
y
i
t n imih beb s t b i o t sp o e t t id ra dno b igW id rit t e
hik t g t e t o al n hi rj c a W n e n t rn n e n o h
ltgai n. W ih t t we know t r i r w m ae i l a yo f c lt a
ii to
t ha ,
he e s a
tra t ur a iiy nd
de l e f est tha be n pa d. Si no hi ha be n do t da e we
veopm nt e ha ve e i
nce t ng s e ne o t ,

wo l lk t c e i t e d v lp n f e a an tt eI p oe ta d Iwila k
ud ie o rdt h e eo me t e s g i s h DA rj c n
l s
Ant
hony t ha t r w ma e i lr tr e
o ve he a
t ra e t d.
=
I
d
Tha s m e da i r pons t a i uiy fom M e - n r ga di t sa s of
t n
y, n es e o n nq r r
dispa e r ng he tm

M e PB- Hyos Boone a s d M e - n t t : e PB,
dvie
dispa ha ç - Hyos i a aci pr t a wilbè
M
s n tke oduc nd l

a ia et s pb 1 / 5 1 1 Pl' SUM F Ex. Bo n as id c tdta tth p ii a d
valbl o hi y 11 /4. .s
'
7. o e lo n iae h t t q e rcng n
g
l be o fl a e c r nt a co r t' Pl' SUM F Ex.7. I r po e t a f l w- e a l
a l n ie r ure nd rec ' .s
n es ns o olo up m i

r ue tngc a ii a i ofwha Boonem e ntb Ga ia et s p by 11 15 1 'Booner ple a
eq si l rfc ton
t
a y tval bl o hi
/ / 4,'
e id s
f l s
olow :

The pr t we e ne r lunc d. W ili da ofour lsi wih M edispa
oduc s r ve a he
tln ys
itng t
- n
bac i Aprl M e hod wa s d by a co pe io ,PBM Phn ma e i l . PBM
k n
i, t
s ue
m tt r
r c utca s

s u h ap ei n r ij ncin t prv n M eh d' lt h. Th c u tdd n t
o g t r l ay nu to o e e t to s amc
mi
e or i o
gr ntPBM ' r ue t butdi o dere die d s r i l i a de ii n ofa
a
S eq s,
d r xpe t d icove y, ncud ng posto

M e is a rp e e ttv . Th p risweej s a anb f r t ec u tntec s ,
d - p n e r sn aie e a t r u t g i e o e h o r i h a e
e
whih i silpe ng. Ba edont sa usoft ca e, ehodi e t lunc i
c s tl ndi
s
he t t
he s M t nt nds o a h n
m i N o mbe .
d- ve r

L. I rpl,Me is n i q etd ta M eh d rs bmi t Nain lDnl Co e (1 '
1 n e y d- pa e u se h t to eu t he to a
J
g d ç
NDC'
)
ntm berf r M e- l yosw he M e hod l unche t pr
t
o
pB-l
n t
a
d he oduc s
t.

7

Uli a ey,M ehod ne rlunc d t M e pBtm t l
t
ve a he he - Hyospr t ,a t pr ucswe eno
oduc s nd he od t r t
ma a tled by W i rora ot rc
nuf ctr
nde
ny he ompa
ny. I mi oc obe 201 M e - n r m o d t
n d- t r 4, dispa e ve he
lsi f t M e pB--yospr t . Ar md t s m etme,Fis Da a nk m ove islsi
itngs or he - l
l
oduc s
ot he n i
r t t bn
d t itngs
f t M e- l yospr ucsfom a i lsi t a c ve lsi .
or he pB-l
od t r ctve itngs o r hi d itngs
11
1.

The Ef e s oft Li t nes
f ct
he s i

Afe M e hod' M e- Hyos pr t we e lse wih M e - n a Fis Daa nk,
tr t s
pBoduc s r it d t
dispa nd r t tbn
M e pB-l waslrkedt Donna a a a a ia epr ti t dipensng s t r utlz d by
- lyos
il o
t l s n valbl oduc n he s i ofwa e ii e
lie Ai Addii l i or a i obt i
tt - d.
tonaly, nf m ton
aned fo Sy phony He t Sol i n' i ty
r
'm
m
alh
uto s ndusr

d tb s ( l y ho y d t' r v ast a b t ewe k e dngJ ne1 , 4, h r cssha
aa a e t G mp n aa' e e l h t y h e n i u 3 201 p nma it d
he s
)
be m s itng cli f M e- Hyos The Sympho da a as r ve si tnc si whi
gt ubm ti a ms or PB.
ny t lo e al nsa e n ch
i ur nc co r ge f Do maa wasr f s d f l ng t lsi ofM e PBns a e ve a or r tl
e u e olowi he itng
- Hyos On a las
.
te t
one oc son,a cai f Donna a wa r us whie a s eq ntc am f rM e- lyoswa
ca i
l m or
t l s ef ed
l ubs ue l i o
pB-l
s
a oved. Howe r be us M e pB-l wast valbl a t tme, hepa intwass t he
ppr
ve , ca e - l yos
ma ia e t he i t
te
wic d
t d fe e m e c tonsat et ra di notr c i apr c i i n f rDor t l
o if r nt di ai
log he nd d
e e ve es rpto o
ma a .
Ac or ng t Conc di s e de ,t r pa t pa s beg plci M e pBc di o
or a' vi nce hid- ry yor
an a ng - Hyos on
t rf mul resasa ge rcat r tvet Dor t l I a las o c e, ma a wasa ua l
hei or a i
ne i le na i o ma a . n t e t ne as Dor t l
ct ly
r m ove fo af
e
d r m onnulr wih M e- l yoslse a t pr e r d ge rc at m a i
ay t
pB-l it d s he ef re ne i le tve.
Conc di ha alo pr f r d e de i c tng t ts e doc o s so
or a s s ofe e vi nce ndi a i ha om
t r t pped pr s rbi
e c i ng
Donnaalat t rba e on t m it ke bei ft ti wa no l nge a lbl ' Fo i t nc
t logehe s d
he sa n le ha t s
o r vaia e. r nsa e,
one pr s r be ,Cole n N a ur t s i i d t 11 or 1 pr s rptons...we e fl l do n' i
e ci r
le
kum a, e tfe hat : 2
4 e ci i
r nrn
ed w ' n

Jmeo 2 4 a dta s eç lwl so p dwrtn (r s rp in )b c u eghe dd t n t g t
t f 01 , n h t h c o y tp e iig p e cito s e a s s j in'wa t o e
s

8

t phone c lsba k'fom phn ma e i cai t tDonna a wasnota lbl Pl' SUM F
he
al c ' r
r cis ndi tng ha
tl
vaia e. .s
Ex.8 a 26;De s'M e .n Opp' t Pl' M o . orSlmm . Ex. a 22.
7 t
f. m i
n o .s t f l J. R t
The Sympho da apr f r d by Conco di i c t t tt t t ntmbe ofpr crbe s
ny t ofe e
r a ndia es ha he o al l r
es i r
who wr e pr s rptonsf Dor t ldec e e by ne ry ei ee pe c ti t t ve- on h
ot e c i i
or ma a
r as d
a l ght n r en n he wel m t
pe i f l ng M ehod' cai
rod olowi
t s l med lt c dae. Li wie, we l pr s rpton c t f
am h t
ke s
edy e c i i oun s or
Doz t l dec e e a tr t lsi f M e pBma a
r as d fe he itngs or - Hyos we e pose on t pr s rpton d ug
r
td
he e c i i r

da a s s The pa te diput ,howe r whehe t deci i t numbe ofpr s rbe sa
tba e .
ris s e
ve , t r he lne n he
r
e c i r nd
pr s rpton c swa c us byt lsi f M ehod' M e- l yospr t .
e c i i ount s a ed he itngs or t s
pB-l
oduc s
Conc di s l Donna a t t r pa t whol ae sa r pac ge s Fr m J nua y 201
or a els
t l o hid- ry
es lr nd e ka r . o a r
2
t J 201 t prc ofDonna a pr t i r as d by 1480% . On J ne 11 201 a tr
o une
4, he ies
t l oduc s nc e e
,
u
, 4, fe
a quii t rght t Donna a fo PBM ,Co r a i r as t prc ag n by 1 . I i
c rng he i s o
tl r m
nco di nc e ed he i es ai
00% t s
undiput d t tConc di spr s a pr k m a gi f r Do t lt blt a ei r i r as d
s e ha
or a' oft nd of
r n o
nnaa a e s nd lxi nc e e
a tr M ehod' M e pB-- pr t we e lse wih t da a es Ho ver Conc di
fe
t s - lyos oduc j r it d t he t bas .
l
we ,
or a
c am st tis pr ks woul ha be n e n hi ri M ehod ha notlse t M e- Hyos
l i ha t oi
d ve e ve ghe f t
d
it d he
pBpr uc s a t ,ha i e re d l tpr isa a r s toft lsi .
od t, nd, hus t t t xpe ince os oft s e ul he itngs
Pr e alH i t v
oc dur
s or

PBM c
omm e edt sa ton a i tdefnda M ehod onApll29,201 as e tngcli s
nc hi c i gans e nt t
'
i
4, s ri am
off s adve tsng a unf rcompe ii unde t Ln m Ac a r lt d c am sl rsae
ale
rii nd ai
tton
r he nha
t nd e ae l i mde t t
l
aw. On Jme 2,201 PBM fl d a n e d c
t
4,
ie n m nde ompl i t t a d Co or a a a pl ntf.
ant ha dde
nc di s
ai if
Thepl i tf st n n e d t i co pl ntt na e asa tonal e nt Tuc r W i , nd
a n if he m nde he r m ai o m
ddii def nda s ke , nder a
St ve Pr s m a t m a gi m e be o W i r
e n e s n, he na ng m r f nde .

9

Thepl i if fld at r a e d c
antfs ie hid m nde ompli o Fe u r 10, 5,whi h co tmt st
ant n br a y 201
c nsi e he
ope a i c m pl nti t c s Thet r n e d c
r tve o ai n he a e.
hid m nde ompl i a s rst f l ngcli sunde
ant s e t he olowi am
r

fd r la d saelw: I flea ve t igi v oain o j43a o t Ln h m Ac;(1 u fi
e e a n tt a () as d ri n n i lto f () f he n a
s
t 1) n ar
c mpeiin i v oain o j4 ()o t eLn h m Ac;(1)v oain o t eVign aCo l r
o t o n i lto f 3 a f h n a t 11 i lto f h r ii nsl
t
me
Pr tci Ac;(V)ci lc pia y i vi ai ofVigi ac
oe ton t I vi ons rc n olton
r ni ommon lw;( vi ai oft
a V) olton he

Vign aBu i s Co s ia y'c ;V1 unu te c me t d r r ii c mmo lw; nd( 1
r ii sne s n pr c A t ( ) j s mi h n un e Vigna o n a a V1)
t tousi e fr ncewih c r c o busne se c a y i vi a i ofVigilaco mon l w.
ori ntre e
t onta t r i s xpe t nc n olton
r ri m
a
M ehod sld a a we t t t r n nd c
t
e n ns r o he hid me ed ompl i o Fe a y 27,201 Tucke
ant n bnz r
5.
r
fl hi a we o Aprl2,2015. 0n J y 1 201 W i ra Pr s ma wer dim is d f o
ied s ns r n
i
ul , 5, nde nd e s n
e s se rm

t e c s f rlc o p ro a j rs ito On J l 2,2 1 ,
h a e o a k f es n l u id cin.
uy 0 5 PBM wa ds s e fo t c s
s imis d r m he a e
u ntej itrq e to tepa t s Ac o dn l, n o dai t s l rmarngplitf, n
po h on e u s f h ri . c r igy Co c r i s he oe e ii an if a d
e
l
M ehod a Tuc ra et s er m ani de e nt .
t
nd
ke r he ol e i ng f nda s
Folowi t c
l ng he ompl ton of dic r t pa te fl c os - o i ns f s
ei
s ove y, he ris ied r sm to or umm a y
r

j d me t Th moinsh veb e f l b ifda da erp frr ve
u g n . e to a e n ul ree n r ie o e iw.
y
St
andard ofR evi w
e

An a r o sl r j d me ti a p o rae tfte mo a ts o t a t ee i no
wa d f l
mmay u g n s p r p it i h
i
v n h ws h t h r s

g n i ds t a t a ymaeil a ta dt mo a ti e t ldt j d me t samatro lw.
e une ipue s o n tra fc n he v n s ni e o u g n a
t
te f a '
'
F d R. v. 5 () I d tr nn wh t rag nun d s u eo maeilfc e it, h c u t
e . Ci P. 6 a . n eemiig ehe e ie ip t f tra a t x ss t e o r
mu tG iw t fcsa d al u tfa l ifrnc saii te er m i telg tmo tfv rb et
s û e he a t n lj siibe n e e e rsng h r fo n h ih s a o a l o
v
t no o ng pa t ' Lie tra Pa t o Va v.J d ,71 F.d 3 8 31 (t Ci.2 3 .
he nm vi
r y.
' b rain ry f . u d 8 3 0 , 3 4 h r 01 )

S h nfc dwihco smoi n f rsl r u g n,Eo rs c nsd re c moins p rtl
d e a e t r s - tp s o l
W
mmayj d me t c u t) o i e a h to e aaey
o iso meist d tr n whehe et ro t pate d sr e j g n a ama tr flw.
n t wn rt o eemie t r i f he ris e e v s ud me t s te o a '
he
'
10

Ba o v. t o Rih n , 5F.d 6 3 6 6 3 ( t Ci. 0 7 . S c u tmu td n boh
c n Civ f c mo d 47 3 3 , 3 - 7 4h r 2 0 ) The o r s e y t
motonsi i fndst tt r i a ge ne d s eofma e i f t bu i t r i no ge ne is
i f t i ha he e s
nui iput
t ral ac , t f he e s
nui s ue

a do eo t oh rp ryi e tte t p e al samatro lw,h c u t l rn e j g n '
n n r he t e a t s n ild o r v i a
te f a te o r wil e d r ud me t'
S v Ang lU. .LLC v.Dic v r Co 's.LLC,9 F.S p 3 8 0 8 9 ( M d 2 5
k
e S.
s o e y mmcn .
5 u p. d 6 , 6 D. . 01 )
(n en lctto a q tto mak o te )
itr a i in nd uoain r s mitd .
a
D i si
scus on

Co c r i h smo e f rsl r j dg n o iscamsf rfle a v riig t us
n oda a v d o l
mma y u me t n t li o as d e t n , mj t
s

e ih n y ndtriu itree c . Meho h smo e f rs mmayj d me ta t al li .
m' me ta o t s ne frn e t d a v d o u r u g n s o t- tms
C
o
c
Theco twila r se c ca m i tun.
ur l dd es a h li n t'
1.

Fal A dvertsi under t Lanham A ct
se
i ne
he

I Coun 1oft t r a
n
t
he hid mende c pli t Conco di as e t a cai f f lead rii
d om a n ,
r a s rs l m or as ve tsng

u d rt Ln h m Ac. S cin43 a()B)o t eLn h m Ac pr hbt a idv d a o e tt
n e he n a
t e to ()1( f h n n
t o iis n n ii u l r n i
y
fom maki a G as ormil a ng de c i i off c ,o f le ormil adng r pr e ai n of
r
ng t le
f
se di
s rpton
a t r as
se i e es nt to
f c ,whih ...i commer i ad rii o pr m oto mir pr en st naur ,c r c e itc ,
at
c
n
cal ve tsng r o i n, se es t he t e ha a t rsi s
qua ii s o ge a c o n ofhi o he ora he pe s sgoods s r i e ,orc
lte , r ow phi dgi
s r r not r r on'
, e vc s
omm e cil
r a
, antf e i
am or a s
ri ng
a tvte . 1 U. C.j 1 25a ( )B) Thus a pl i ifass rtng a cl i f f le adve tsi
ciiis' 5 S.
'
1 () 1( .
unde t ssa uem us esa ih t :
r hi tt t
t tbls hat

()t d fn a t d afleo mila i d srpto o fc o rp e e tto o
1 he e e d n ma e as r se dng e ci in f a t r e rs n ain f
fc i a c mmeca a ve t e n a o ths o o a oh rsp o uc;()te
a t n o r il d ri me t b u i wn r n t e ' r d t 2 h
s
mir pr e ai i m a e i , i t t i i lkel t i l nc t pur hasng
se es nt ton s t ral n ha t s i y o nfue e he
c i

d cso ( )hemirp e e tto a t lyd c i so ha t etn e c t d c ie
e iin; 3 t se r s nain cual e eve r s h e d n y o e ev
a s b tn il s g n o is a d e c ;( ) t e d fn a t p a e t f le o
u sa ta e me t f t u in e 4 h ee d n lc d he as r
mila ig sae n i itrtt c mmec ;a ()teplitf ha be n o i
se dn ttme t n n esae o r e nd 5 h an if s e r s
lk l t beij rda ar s lo temir p e e tto ete b dr c dv rino
iey o nu e s e ut f h se rs n ain, i r y ie t ie so f
h
s l s orby a l s ni ofgoodwila s i t d w ih ispr
ae
es e ng
l s oc a e t t oduc s
t.

Sc tsCo. . tdI us Cop.31 F.d2 4 2 2( t Ci. 0 )(uoigCa h r &
ot v Uni nd . r , 5 3 6 , 7 4h r 20 2 q tn s mee
e

Cn lHarM gs I t v. k Fit Av .28 F.d3 2 31 - 1( s Ci. 0 2 ) s eas PBM
me i
. ns. Sa s fh e, 4 3 0 , 0 1 1 t r 2 0 ); e lo
Pr d .LLC v M e dJ l o & Co.6 9F.d 1 1 1 (t Ci. 01 )
o s.
. a oms n
, 3 3 1 , 20 4 h r 2 1 .
A.

Fal e St em e i a C o m e i A dver i e e
s at nt n
m rc al
ts m nt

Thefrtee n o acam f rflea vetsngu d rj4 ()o t Ln ha Ac r q rs
is lme t f li o as d rii n e 3 a f he n m t e uie
apl ntf t de onsr t t tt de e ntm a af lesa e e ti ac me cilad ri e e
ai if o m ta e ha he f nda
de a s tt m n n om r a ve ts m nt
a
boutiso pr ucspra he ' pr ucs Sc l Co.31 F. a 272; e aloC. Fle Co.
t wn od t
not rs od t. ots , 5 3d t
s e s B. e t

v. mi Kl Be c m Co st rHe lh a e L. ,1 1F.d43 4 4 (t Ci.1 9 )(und r
S t i e ha n t
h ne
me at c r , P. 3 3 0, 3 4h r 9 7 ç e
ç
( 43a o t eLa h m Acj b t flea v riigo ac mp ttrs r d t a flea ve t i
j () f h n n t, oh as d e t n f o eio ' p o ucs nd as d ri ng
s
s

o o ' o p o ucsaea to a e' . Fo et r y eo a ve t e n t c n t ueav oain
f nes wn r d t r cin bl.) r i t p f d ri me t o o si t i lto
'
he
s
t
o j4 () Eh c n etd sae n o rp e e tto mu t eet e f leo isf c o , l ug
f 3 a ,t e o tse ttme t r e rs n ain s b ih r as n t a e r at h
t
ho
lt r l t e, i l t m iladandt c ls c um e sgi nt me c ndii c e .' C.
ie aly nz lkey o se
o onfle ons r ve he r ha sng ontxt' B.

F e t Co. 1 F.d a 43 ( tr a ctto a d q oain maks o te ) ç hee te
le
, 31 3 t 4 i en l iain n u tto
n
r mitd . ç r h
W
a rie t i ltr ly f le,a vi a n m a be e t bls wihoutevi nc of co umer
dve ts men s ie al as
oldo
y
sa ihed t
de e
ns

d c pin. PBM P o s,6 8 F.d a 1 0 (nena ctto a d q oain mak o te )
e e to '
'
r d . 3 3 t 2 itr l iai n n u tto
r s mitd .
Howe r i fa pli ifs t oz ofr ove y i pr mied u n a cam ofi i f le
ve , s
i
antf he y
ec r s e s po
li
mpled a s hood,a

panifmus d mo srt,b e tisc e i e c ,t tt e c alng d gd rie n s tnd t
litf
t e n tae y x rn i v d n e ha h h le e a ve t me t) e o
s
m i l a orc u e co um e s ' I
se d
onf s ns r .' d.

I mo n f rsl r j d me to Co c r i' f lea vetsngcam, eho ag e
n vig o l
mmay u g n n n o das as d rii li M t d r u s
ta i ma nof leormil di sae nt r r ngt V epB-- pr ucs l rs e
h t t de as
sea ng ttme s ega' he - lyos od t. n e pons
di
l

t M eh d' moin, n i s p o t fiso moin frs mma yj dg n , n o daag e
o t o s to a d n u p r o t wn to o u r u me t Co c r i r u s
t tt pr t lbel,i e t,a daa e lsi f t M e pB--yos pr
ha he oduc a s ns rs nd t bas itngs or he - l
l
oduc s co ane
t nt i d
lt r l f s sae e s r ga di pr t a ia lt FDA a o l phn mac utc l
ie aly ale t tm nt e r ng oduc valbiiy,
ppr va,
r e ia
12

e valnc a prc I r pl M e hod mai ans t tt alega i of lt r f st a e
qui e e, nd ie. n e y, t
nt i ha he l tons
ie al aliy r
t uppore byt r c d.4
ms
td he e or
Gl a l ng whehe a a ve ts m e i lt r l f le,.. ac t us dee mi fr t
in nayzi
t r n d rie nt s ie aly a s . our m t t r ne, is,
t unn bi
he m guous cai made by t a rie e ...,a s cond,whehe t e cl ms a e
l ms
he dve ts m nt
nd e
t r hos ai r
f le. Sc t Co. 31 F.d a 274. $ lt r l f le m e s ge ma eihe be e plct o
as '
' ots , 5 3 t
W ie aly a s
sa
y t r
x ii r
c
onve d by ne es a y i plc ton whe c i rng t a ve ts me i is e iey,t
ye
c s r m iai
n, onsde i he d ri e nt n t ntr t he
a e ewoul r cog z t c am asr a l asi iha be n e i il sa e ' l Uli a ey,
udinc
d e nie he l i
e diy f t d e xplcty tt d. d. tm t l
'

twl te a a vetsme t sltr l f lei a is eo fc. C. F e tCo,1 1F.da 4 4.
s heh r n d rie n i i al as s n su f a t' B. le . 3 3 t 3
g
e y
'
1.

A vaiabii o M e pB- l
l lW f - l vos

Conco di fr t cli s t t M e hod m a ltr ly f s sa e nt r ga di t
r a is am ha
t
de ie al ale tt me s e r ng he
a ia lt of t M e pB--yos p oduds Co or a e
valbiiy
he - l
l
r
.
nc di mpha ies t t M ehod i ntfe a
sz ha
t
de iid
pl nne lunc daeofJ 1 201 i iss isonst Fis Da a nk, ndt ti lke s lse
n da h t
une , 4 n t ubm s i o rt t bn a ha t i wie it d
am a kç i sa tda e ofJme 1 201 i iss
r tng t r t
t , 4 n t ubmisonst t FDA . Co or anot st tt
s i o he
nc di
e ha he
Jme 1 201 m a ke i sa tdaewast n i
t , 4 r tng t r t
he mpore i ot M e - n lsi f M e pBtd nt he dispa itngs or - Hyos
t blt a ei r Dlrng hi de ii Tuc r de c i t Jme 1 201 da e as t i t
a es nd lxi. zi
s poston, ke s rbed he t , 4 t
he i e
da

( eh d a tcp tdha igt epr d c ra yt b a l t mak t. .o qs 1. Pl' S
M t o ) niiae vn h o u t e d o e b e o r e . gr e1' .s UMF Ex.
'
8 a 11
4 t 6. Co or a e phasze , ho ve , t t no M e pB--yos pr t we e e r
nc di m
i s we r ha
- l
l
oduc s r ve

4Att ssageoft pr eedi ,M ehoddoesno diput t tpr
hi t
he oc ngs t
t s e ha oductl sa i erspr ded t a
abel nd ns t ovi o
pha mac i da a seca consiut comm e ci a tsng f pur esoft La
r eutcal t ba
n
tt e
r al dverii or pos
he nham Ac . Se e. .
t
e. z.

Sa d P r . r v. c a d o - c s I c, 2F.d2 2, ( Ci. 9 )(ii c s sta s p r te
n oz hams Co p. Rih r s n vik .n .90 3 2 231 3d r 1 90 ctng a e h t up o th
pr ii t tSa adverii cai i nots el fom t Lanha Ac me el by a rng onl on a
oposton ha çn
tsng l m s
hi ded r he
m t ry
ppea i
y

p o uc' lb l) M ec Ep o aAG v. oo stnePhams. .2 F.S pp 2 4 , 4( D. Y. 01 )
r d ts a e'; r k r v
'
Br k o
r .LLC, 0 u . d 04 42 S. N. 2 3
9
( odn ta lb l a p c a is rsditiue t p ama e tc l aa ssK o siuea v riigu e te
h lig h ta es nd a k ge n e t srb td o h r c u ia d tba e s n ttt d e t n nd r h
c
s
La ha Ac' . Ise d Meh a g e t tima enole al flesae nsa t tmei s p idte
n m t' n ta , tod r u s ha t d
)
i rly as ttme t t he i t u pl h
t
e
l s i ers a ohe pr ti or ton t t da a es
abel, ns t, nd t r oduc nf mai o he t bas .

1
3

m amf t e a t ,t tpr t c d notha be n a ia e f rpr s rpton asofJm e 1
r acur d nd, hus ha oduc s oul
ve e val bl o e c i i
t ,
201
4.

I r pons M e hod a guest tConco di i una et poi t a sngl i t nc i whi h
n es e, t
r
ha
r a s bl o nt o i e nsa e n c

M e hod cai t tispr t woul becomme caly a ia ea ofapa tc a dae, t t
t
l med ha t oduc s
d
r i l va lbl s
riul r t and ha
Co o di i opery e t st daeonwhi hapr twil m a ke e wiht ton whi ht
nc r a mpr l qua e he t
c
oduc l be r t d t ha
c he
pr twilbe c
oduc l
omm e c al a ia et t publc. M ehodno est twihi t we ksofis
r i ly va lbl o he
i
t
t ha t n wo e
t
pr t beng lsed wih M e - n,M e hod a s M e - n t tisM e- l yospr t
oduc s i it
t
dispa
t
dvied dispa ha t
pB-l
oduc s
we enotye a lbl M ehod f rhe a gue t tt me ee senc ofa lsi f rapr
r
t vaia e.
t
u t r r s ha he r xit e
itng o
oducti
n
apha ma utc ldnz da a ei notar pr s ntton ofc r ntc
r ce i a g t bas s
e e e ai
ure omm e c a a l lt a t t
r i l vaiabiiy, nd ha
a las one pha mac utc l i usr r pr s nttve de e by Conco di t tfed t ti was
te t
r e i a nd ty e e e a i
pos d
r a esi
ha t
c mon t fnd a da a s lsi f r a pr tt twa notye co me caly a ia e See
om
o i
tba e itng o
oduc ha s
t m r i l va lbl .

Des' e i Op nt P .sM o. o S mm. . ., p. fLa aF ika 3 (1 1 t ep s Iv
f.M m.n p' o 1' t fr u J Ex 1 De o r rc t 3 ç1n h at ' e
(

e o nee d g ta we e lse gn M e is n t a wee n t c mmecal a ia l.)
nc u tr d nz s h t r itd i d- pa l h t r o o ril valbe'.
y
'
M ehodnot t tt si c itntwih Conco di sownpl a ngs whih i c t t tda a s s
t
es ha hi s ohsse
t
r a'
e di , c ndi a e ha t ba e
a e E e ...t e l t media i t ta e c r nty orwils beon t m a ke .' 3d Am .
r l d
us
o vauae
c tons ha r ure l
l oon
he r t'

Co . 3 (mp a i a d d .
mpl! 0 e h ss d e )
Appl ng t a o it sa r ofr vi t c tc l st ta g nui is of
yi he ppr pra e t nda d
e ew, he our onc ude ha e ne s ue

maeilfc e ssast whehe V ehodmadeltrlyflecamsrgadi a ia lt wheni
tra a t xit o t r t
ieal as li e r ng valbiiy
t
lse t M e pB--yospr t . Alhough M ehod di note e sy i ca et tM e pB--yos
it d he - l
l
oduc s
t
t
d
xpr s l ndi t ha
- l
l
w oul be c m e c aly a iab e asofJ
d
om r i l va l l
une 1 201 r as bl m i c d dif r a t w he he
, 4, e ona e nds oul f e s o
t r

s h m e s e wa t
uc
s ag
s t
conve d by ne s a y i i ai n. Sco t Co. 31 F. a 274.
ye
ce s r mplc to '
'
ts
, 5 3d t

14

Ac o dn l,aj r mus d cd wh t rM eho ma eltr l flesae nsr g r ig t e
c r i gy u y t e i e ehe t d d i al as ttme t e adn h
e y
a ia lt oft M e pB--yospr t .
kal biiy he - l
l
oduc s
2.

FD A A pproval

Co o di as ca ms t t M e hod m a lt r ly f le sa e nt i i a i t t t
nc r a lo li ha
t
de ie al a s t t me s nd c tng ha he
M e pB-- pr duc shadbe n a ove by t FDA. To s
- lyos o t
l
e ppr d
he
uppo tt scl m ,Conc di poi s
r hi ai
or a nt
t t M e- Hyospa ka i e t pr de t M e - n, rtD aa
o he pBc ge ns rs ovi d o dispa Fis tbnnk, Da l e whi h
and iyM d, c
i l
ncudedt f l ng s c i on i c tonsa us
he olowi e ton ndi ai
nd age:
Bas d on a r viw oft s dr by t Na i lAc demy of Sc e esN ai na
e
e e
hi ug
he tona a
i nc - to l
Res a c Cot i a o ot r i or ton, FDA ha cas ii d t f l ng
erh
mcl nd/ r he nf ma i
s l sfe he olowi

i dc to sa ç o gbl'ef ci : o us a ajmciete a i t te t n o
n iain ss si y' fe tve F r e s dt tv h rpy n he r ame t f
p
i ia ebo ls n r me(nia l c ln s a tcc ln muc u c l i)a a u e
n tbl we y d o i tb e oo , p si oo , o s oi s nd c t
t
e e oc o i ...
nt r ol t s .
Pl' SU M F Ex.1.
.s

I r po e,M ehod a guest ti ne rc am e t tisown pr t M e PBn es ns
t
r
ha t ve l i d ha t
dduc , - Hyos ha
, d
bee a ove by t FDA . I t a M ehod s ik al a s d t lsi s r i es t t
n ppr d
he
nse d, t
pecf ly dvie he itng e v c ha
M e pB- Hyosha no r ceved FDA a oval M e hod no e t tbe o eispr ucsw e e e r
d te i
ppr .
t
t s ha f r t od t r ve
lse wih Fis Da a
it d t r t t bank,M eho a s t c
t d dvied he ompany t t M e pB-- pr t we e
hat he - lyos oduc s r
l
t ppr ve Li wie,t M edispa lsi f r M e pB-ma o d. ke s he
- n itng o
- lyos i ca e t t is m a ke i
l
ndi t d ha t
r tng
c t or wa I ppr d d g ot r' De s'SUM F Ex.K. Asf t i cai a us
a eg y s K
una ove nz he .' f .
or he ndi tons nd age
s c i oft pa kage i e t,M ehod a g st tt phr e t hi dnz 'e ompas e a1PBA
e ton he c
ns rs t
r ue ha he as t s g' nc
t
ss 1
dnl pr t i ntc l r a e orsm ia t Do t l a t tt pr tlbe sand pa kage
g oduc s de i a, elt d, i l r o nnaa , nd ha he oduc a l
c
i e t f ro he ge rcPBA d ugpr uc spr vi l o t m ake con ai d sm ia lngu .
ns rs o t r ne i
r
od t e ousy n he r t t ne i l r a age
Ba e on t c tsr vi w oft r or t c tconc udest ta f c t ldi put e s s
sd
he our ' e e
he ec d, he our
l
ha a tl s e xi t
a

a t whehe M ehodm a ltr ly f s sae e si i a i t tisM e pB--yospr ucsha
so
t r t
de ie al ale t tm nt nd c tng ha t - l
l
od t d
15

be n a ove by t FDA. Alhough M ehod expr s l a s d t lsi s r i s t t is
e ppr d
he
t
t
e sy dvie he itng e vce ha t

pr t hadnotbe n a ovedby t VDA,r a ona emi c d dif ra t whehe FDA
oducs
e ppr
he
e s bl nds oul fe s o t r
a oval c
ppr was onve by nec s a yi ia i asar s toft i c tonsa us ges c i of
yed
e s r mplc ton
e ul he ndi a i nd a e ton

te pa k g is hs Ac o dn l a juy mu t d cd wh t e M eh ma e l e al f le
h c a e n e . c r igy, t' s e i e eh r tod d i r l as
t y
sae e sr r ng FDA a o l
t tm nt ega di
ppr va .
3.

Phar ac i ale va e e
m eutc qui l nc

Conc di alo c am s t t M ehod ma lt r ly f s sa e e s i c tng t t t
or a s l i ha
t
de ie a l ale tt m nt ndia i ha he
M e pB- Hyos pr ucs we e pha ce tc ly e vae t Doz t . Conco di e pha i s
od t r
nna u i a l qui lnt o
maal
r a m sze
t t t pr uc lbes and pac ge i e t pr de t t lsi s rvc i i a e t t
ha he od t a l
ka ns rs ovi d o he itng e ies nd c t d ha

M e- Hyost blt a ei rwoul co an t s m eaci i e e si t s m e a mt a
pBa es nd lxi
d nt i he n
tve ngr di nt n he n
mot s q
Do t lt blt a ei r Be a et M e pB--yospr t we enotye a lbl a t tme
nnaa a e s nd lxi. c us he - l
l
oduc s r
t vaia e t he i
t lbesa i e t we e s itd by M e hod,Co o di a gue t tM e hod had no bassf r
he a l nd ns rs r ubm te
t
nc r a r s ha t
i o
t i o m ai c ai d i t l bel a i e t,i l ng t i br to i cai t tt
he nf r ton ont ne n he a s nd ns rs ncudi he nt ma i n ndi tng ha he
M e pB--yospr uc swe ephar ce i a l e vae t Donnaal
- l
l
od t r
ma utc ly qui lnt o
t .
I rs
n e pons ,M e hod ar st tt t s ed f t s
e t
gue ha he mdiput acs how t ti i e d t diti e a
ha t ntnde o srbut
pr uc t twa phn ma u i a l e va e t Donna a ,a t ti wa m n ng plnst do s
od t ha s r ce tc ly qui l nt o
t l nd ha t s ki
a o
o
b f r t e pl ns we e hat d by t s lws t M e hod e
e o e hos a
r le
hi a ui.
t
mphaszes t t bo h i a W i r
i ha t t nd nde
unde sood t tM e hod i e d t ha W i rm a a t e t phn mac utc e valntof
rt
ha
t
ntnde o ve nde
nuf cur he r e ial qui e

Domaa. S e ec, f .S F. B, id rRul 3 ( )6 De 3 (GW j weec nr ce
r tl e e ..De s' UM Ex. W n e e 0 b () p. 2 < e r o ta td
(
t ma t phnmac utc e vae ofDomaa.l De s'SUM F Ex.A,Tuc rDe 79
o ke he r e ial qui lnt
r tl' ; f .
'
ke p.

(n iaig t a Tu ke t l W id rt a heG n e a p o u twi t e s me ig e in s a
i dc tn h t c r od n e h t t td r d c t h a n rd e t s
wa
h

1
6

Domaa'. M eh d ag st tt r i no e i e c t tM epB-- swo d n th v b e
r tl)
'
t o r ue ha hee s v d n e ha - lyo ul o a e e n
l
phn
nnac utc l e valntt Donna a,i M e hodhadbee a et f l t oughwihispl s
e ialy qui e o
tl f t
n bl o olow hr
t t r .
Afe c i rng t pa te 'a gum e t ,t c r co udest tt is ofwhehe t
tr onsde i he ri s r
n s he ou t ncl
ha he s ue
t r he

p od t lbel a pa kage i e t c t ne lt r ly f le r pr e ai of pha ma u i a
r uc a s nd c
ns rs on ai d ie al a s e es nt tons
r ce tc l

e uv ln emu tbep e e td t t ej r f rd tnnnain a c n o b d cd d o sl r
q iae c s r s ne o h u y o ee i to nd n n t e e ie n l
mma y
j d me t Th r s lto o t i is e hn e ,t a c ran e tn ,o wh t e M eh d f ley
u g n . e e ouin f hs su ig s o eti x e t n eh r t o as l
rp e e tdt a tep o u t wee c mmecal a alb e I ajly f st a Meh d f ley
e r s n e h t h r d cs r o ril v ia l. f t i h t to as l
y
r nd
r pr s nt d t t t M e pB--yos pr ucs we e c
e e e e ha he - l
l
od t
r omm e c al a ia e whe i lse t
r i ly va lbl
n t itd he

p od cs t e tej r c ud as fn ta t e d s rp in o t epr d cs ig e in swee
r u t, h n h u y o l lo id h t h e cito s f h o u t' n rd e t r
l eal fle sn et p o ucsh dn t t e ma u a t rd. I, nt eoh rh n a u ysnd
i rly as , ic he r d t a o ye be n n fcu e fo h te a d, j r
t
s
t t t lsi f r M e hod' pr uc s di not i y t t t pr t we e c
ha he itngs o
t s od t d
mpl ha he oduc s r omm e c al
r i ly
a ia e, a m e ey i caed t t M e hod i e d t ma ke a pr
val bl nd
r l ndi t
ha
t
nt nde o
r t
oduc t t was
t ha

p r c u ial e uv ln t Domtlte aju c udas fn t t eho ' cams e adng
hnma e tc ly q iae to z a,h n ty o l lo i d ha M t ds li r g r i
t i r di nt o ispl nne pr
he ng e e s f t n d oduc sw e e notlt r ly f l e.
t r
ie a l a s
4.

Pr c ne
ii

I is fnalcli of lt r l f liy,Co or a a s rs t t M ehod made ltr ly f le
n t i
am
ie a a st
nc di s e t ha
t
ie al as
sae e s i c i t t t M e- Hyos pr t w e e prc d l r t n t Donnaal
t tm nt ndiatng ha he
pBoduc s r i e owe ha he
t
pr t . Bec us t M e- Hyospr t we e noty aval bl a t tm et y we else
oduc s
a e he
pBoducs r
et ia e t he i he
r it d

wih M è - n a Fis Da a nk,Conc di a gue t tM ehod had no bassf t prcng
t
dispa nd r t t bn
or a r s ha
t
i or he i i
i o m a i pr vi t t ls i s r c .
nf r ton o ded o he i tng e vi es
l r pons M e hod ac
n es
e, t
know l s t t t prc ng i o m a i pr de t M e - n
edge ha he i i nf r ton ovi d o di spa

a Fis Daa nk i c t d t tt prc s ofM e pB-- pr t wo d be l rt n t
nd rt t bn ndi a e ha he i e
- lyos oduc s ul
l
owe ha he
17

prc ofDonnaa pr t . Ho ve ,M ehod a gue t tConco di i t bl t ct t a
ies
t l oduc s
we r t
r s ha
r a s ma e o ie o ny
e de e de
vi nc monsr tng t tt prci i or to wa f le. M ehod e
ta i ha he i ng nf mai n s a s
t
mpha i est ti lsed
sz ha t it

tep ie a wh c i itn e t o frM epB-l o p o u t t c tmes a ta ttwa j t
h rc s t ih t ne d d o fe - ly s r d cs o uso r, nd h t ç s us
i
ne ra et ac l ofe t pr t a t pr pos dpdc sbec us Pl i if a t sltgai
ve bl o maly f r he oducs t he o e
e
a e antf, nd hi ii ton,
i e ve ' De .sM e .i Opp' t P1' M . orSlm m . .25.
nt r ned.
' f' m n
n o .s f l J
Aswa t ewih t is ofphn ma e i le vae ,t c ti oft o ni t t
s nz t he s ue
r c utca qui lnce he our s he pi on ha
t d t nni ton of whe he M ehod pr ded lt r ly f le prci i or to hi s o
he e e nai
t r t
ovi
ie a l as i ng nf mai n nge n
whehe M e hod f lel r pr e e t tt M e pB-- pr t we ec me ca l a ia e.
t r t
a s y e es nt d ha he - lyos oduc s r om r ily val bl
l

I ajzy fn st a t e lsig f rM epB-- o tb esa d ei i fley r p e e td t tte
f l i d h t h itn s o - ly s a lt n lxr as l e rs n e ha h
r
l
p od t we ec mmecal a albe t e t ej r c u dfndt ttep ii i o main wa
r ucs r o rily v ia l, h n h u y o l i ha h rcng nf r to s
l eal f le sn et p o u t dd no y te it I,o te oh rh n aj r fn t a t e
i rly as , ic he r d cs i t e x s. f n h te a d, u y ids h t h
t
lsi m a no r pm s t ton of c
itngs de
e en a i
omm e c a a ia lt a me ey i c t d t tM ehod
r i l val biiy, nd r l ndia e ha
t

itn e t ma k t p o uc ta wa p nn c uial e uv ln t Do n a,h nt j r c ud
n e d d o r e a r d th t s ha a e tc ly q iae t o n tlt e he u y o l
a s fnd t tM ehod' lse prc sf t M e pB--yospr t we enotlt al f le.
lo i ha t s it d i e or he - l
l
oduc s r
ier ly as

Fort s r as , hec tc l st tge neis ofm ae ilf te s wih r s c
he e e ons t opr oncude ha nui s ues
tra ac xit t e pe t
t whehe M ehod m a lt r ly f le sa e e s r r ng t M e- l yos pr t .
o
t r
t
de ie a l a s t t m nt ega di he
pB-l
oduc s

Ac o dngy net rsd i e t ldt s mmayj g n o t sis .
c r i l , i ie s ni e o u r ud me t n hi sue
he
t
B.

M at i i v
er alt

M ehod as ar ue t t e n a s i Conc di c d pr t t i m a f le
t
lo g s ha, ve s um ng
or a oul ove ha t de a s
s a e e s r gar ng t M e pB--yos pr uc s t r or e t bls s t t a s h s a e e s
t t m nt e di he - l
l
od t , he ec d s a ihe ha ny uc t t m nt
w e e i m a e i la t ,t tConc di ' c a m f f l e ad ri i f l a t s ond t e e .
r m t r a nd, hus ha
or a s l i or a s ve tsng ais t he ec
l m nt

I r s e,Conc d a a guest tma e i lt c n be pr lmed fom a lt r ly f l e sae e ,
n e pons
or i r
ha t raiy a
esz
r
ie a l a s tt m nt
18

a t t t r o d no t e s demonsr t s t t M ehod' a lgedl f le'tt me s we e
nd ha he ec r
nehels
ta e ha
t s le y a s sa e nt
r
m ae i l
tra .

The Unie St t Cour ofAppe sf t Fo t Cic tha nota es e t is of
t d aes
t
al or he urh r ui s
ddr s d he s ue
whehe m a e i iy ca bepr s
t r t ralt n
e umedwhe asa e nti pr
n t t me s ovent belt r ly f le. Thec r '
o ie a l a s
ou ts
L
,
.

r vi w oft ca ea r ve l t tt r i as i i t cr uisont sis
e e
he s lw e as ha he e s plt n he ic t
hi s ue. TheFit Cic t a
fh r ui, s
Conco di no esi isbre s ha hed t tapl i ifne d no i r uc e de e ofma e i iy
r a t n t if , s l ha
antf e t ntod e vi nc
t ralt

whe t sa e e tof f c a is i s
n he tt m n
a t t sue s hown t be ltr ly f le. Se Pi za Hut l v.Pa
o
ie al a s
e z
. nc.
pa

J h sItl I c,2 7F.d48 ,4 7( t Ci. 0 0 ; e as X-T P o s.LLC v W atrKid
o n' n '. n . 2 3 9 9 5h r 2 0 ) s e lo I r d .
. le d e
Po tb eEq i . n . 1 5 F. u p. d 5 7 6 0( D. . 0 )(ii Piz Hu , up a f rte
ra l up.I c, 5 S p 2 7 , 3 E. Va 2 01 ctng z a t s r, o h
pr ii t tapl i ifC a notne d t i r
oposton ha
antf l y
m
e o ntoducee de e ofma e i lt ' fi ç a pr vet
vi nc
t raiy'i t E n o o
c

tes tsa to o t e u yt a tecamsa is ea eltr l fle'. Ont eoh rh n ,h F rt
h aifcin f h j r h th li tsu r i al as '
e y
)
h t e a d t e is,
Se ond,a El ve h Cic t ha hel t te n whe a sa e nti ltr ly f s ,a pli tf
c
nd e nt r uis ve d ha ve
n t t me s ie al ale
a n if
mus sile tbls m a e i iy. Se J
t tl sa ih t ralt
e ohns & J
on ohns n V i i Ca e. nc. 1 800 Con ac s l ,
o s on r I v. t t . nc.

2 9F.d 1 4 ,1 5 - ( 1h Ci. 0 2 (e o nii gt ecruts i a dee tn t Etn wi
9 3 2 2 2 0 51 1 t r 2 0 ) rc g zn h ic i pl n lcig o ç a d t
i
s
h
t Fis a Se nd Cic t ,c l ngt tt pl ntf m us e tbls ma e i iy e n whe a
he r t nd co
r uis oncudi ha he ai if t sa ih t ralt ve
n

d f n a tsa v rie n h sb e ft l eal f le).
ee d n ' d e tsme t a e n omd i r l as '
t y
Att s sa oft pr e ngs t co twila s e wihoutde i ng,t tt Fourh
hi t ge he oc edi , he ur l s um , t
c di ha he
t
Cicui woul c trwih t poston oft Fis,Se ond, nd Elve h Cicuis a hol t ta
r t
d oncl t he ii
he r t c
a
e nt r t, nd d ha
pl ntf m us e t bls m a e i iy e n whe a de e n ' a rie t ha be n f
ai if
t sa ih t ralt ve
n
f nda ts dve ts men s e ound t
o
c a n a lt r ly f l e s a e e . Fort f low i r a ons how e r t c tconc udest t
ont i ie a l a s t t m nt
he o l ng e s ,
ve , he our
l
ha

t e de cie by Conco di c eae a ge ne diput off twih r pe tt t elm e tof
he vi nce t d
r a r ts
nui
s e ac t es c o he e n
.

'
'

matraiya t ,ha M ehodi no e ildt s
eilt nd,hus t t t s t ntte o umma yj
r udgme onCot 1
nt
mt .
1
9

As s tf t a
e orh bove,t ma e i lt pr r quie t pl i ift de onsr t t tt
he t raiy ong e r s he antf o m ta e ha he
de e nt ' f le s ae e s or r pr s nttons we e lkel t i l nce pur ha i decsons
f nda s as tt m ht
e e e ai
r i y o nfue
c sng
ii .

S ot Co, 5F.da 2 2. I ti c s,a ra o a l j r c u d fn t a a rp e e tto o
c ts .31 3 t 7 n h s a e e s n b e u y o l i d h t e r sn ain f
phn mac utc le vae ewoul lkey i l nc pur ha i de ii ns be a ei t elt st a
r e ia qui lnc
d i l nfue e c sng c so , c us t i a e o n
r
i r ntqua iy or c r c e itc oft pr t' Ca hme e,284 F. a 31 s e as Re l
nhe e
lt
ha a trsi
he oduc .' s r
3d t 2; e lo xal

S n o .l c v.P ni o Co,6 F.S p 2 9 3 ( D. Y.2 0 )( odng t tsl r
u d wn n . e g . 51 u p. 0 , 0 E. N. 0 9 h li ha l
mmay
j g n o t is eo maeil ywa u warn e sn e& r to lre o fc c udc n l d
ud me t n he su f trai s n ra td ic $ aina tir f a t o l o cu e
t
a
t tted s ue is e r lt t c r i r de t a d o efc c ' M e c Ep o aAG v. o i
ha h ip td su s eae o o e ng e in s n /r fia y); r k r v
Gn ss
S. A, 01F.S p 2 4 6 4 ( D. Y. 01 )(mp a ii t tihev r n t r o wha a
P. 9
u p. d 3 , 51 S. N. 2 2 e h szng ha i ey au e f t
t
mmmfcu e i sli gi maeil) Lie s ,ara o a l jlyc u dfn t a r p e e tto
a t rr s eln s tra' . k wie e s n b e t o l id h t e rs n ains
'
r
r r ng a pha ma u i a pr ts prc , a ova ,a a ia lt woul lkey i l nc
ega di
r ce tc l oduc ' i e ppr l nd val biiy
d i l nfue e
pur ha i de sons i t r lva m a ke . Se e. ,N ozh Am . M e Cop .v. Axi
c sng cii
n he ee nt r t
e. c.
'
t
d.
om

W o lwie I c,5 2 F,d 1 1 1 26 ( 1h Ci.2 0 )(bsr i t ta fle cam o FDA
rd d s n . 2 3 21 , 2 1 t r 0 8 o e vng ha as li f
a p o lGo ial wo l i fu n ead co ' d cso t p rh s ( d vie o e ac mp tn
p r va ç gc l u d nl e c o trs e iin o u c a e a e c l v r o eig
l
y

ma hi wi u ( t q l gq'; h t M e e . n . . r n 6 F.d 9 9 9 2( t Ci. 1 )
c ne t t t ) uai y ' P o o d x I c v lwi, 01 3 1 , 3 9h r 20 0
ho ha
t )
(o ig t ta itnina mirp e e tto rg r ig apr d tsr la e d t mih p rua e
n tn ha n n e to l se r sn ai n e a dn
o uc' ee s ae g t e s d
purha esno t buyade c t ti ar dya ia e. Ac o dn l s mmayj g n i n t
c sr t o
vie ha s lea valbl) c r igy, u r ud me t s o
a oprae o t se e e .
ppr it n hi l m nt
C.

C onsum er decepton
i

Thet r e e e ofa c a m f f l e a ri i unde t Ln m A c r uiesapl i if
hid l m nt
l i or a s dve tsng
r he nhn
t eq r
a ntf

t de
o monsr t t tt a l d f le sa e nta t ly de i d o ha t t nde y t de i a
ta e ha he lege a s t t me c ua l ceve r d he e nc o ceve

s b tn ilsg n o t plitf a de c . Sc t' Co.31 F.d a 2 2. ç-l e ie e
u sa ta e me t f he an ifs u in e o ts , 5 3 t 7 ilhe vd nc
g20

r uie ofa f le adve tsng pli ifi de nde upo whe he t c e i vesa rii
eq r d
a s - rii
antf s pe nt n
t r he as nvol
dve tsng

t ti lt r ly f le ora tsng t ti onl i idl f le. l a 274. I t a rii at
ha s ie a l a s
dverii ha s y mple y as ' d. t
'
f he dve tsng
i s i ltr ly f le,co m e de epton i pr s e a t ,ç e de e of c lm e
s ue s ie al as
nmz r c i s e um d nd, hus l vi nc
no
onsl r
conf i i r uie ' I I,ont ot rha t pl i ifst yofr c r i bas d upon
uson s eq r d. d. f
'
he he nd, he antf heor
e ove y s e
a cai o i ple f s hood, a pl i if mus de onsr t , by e rnsc e d nc , t t t
l m f m id ale
antf
t m ta e
xti i vi e e ha he

c le dad rie nt tndt c us c lmes J a 273.
halnge vetsme s e o onf e onsl r. Z t

Tot ee tn M eho se s mmayj g n o t b sst a Co o dai t bl t
h x e t t d e ks u r ud me t n he a i h t nc r i s ma e o
esa ih t elm e ofc lm e dec pton,M ehod' m o i mus bede e Fort r as
t bls he e nt onsl r e i
t s ton
t
nid.
he e ons

s tfrh a o ,te c u ti o t eo i in ta ar a o bej r c u d fndt tM eh d ma e
e o t b ve h o r s f h pz o h t e s na l u y o l i ha t o d
l
ltr ly f le sae e sr ga di t M e pB--yospr t . Be aus Conco d a C y be ft
ie al a s t tm nt e r ng he - l
l
oduc s
c e
ri t
ma ne i

fo a p e u to o c n u r d c p in'a til s mmay j d me t i i pp o dae
rm
r s mp in f o s me e e to ' t ra, u r u g n s na rp t.
Cas er ,284 F. a 316.
hm e
3d t
D.

D i t i i n i i er t e c m e e
s r but o n nt s at om rc

The f t elm e of a c am f f le a rii t r t Ln m Ac r uie a
ourh e nt
l i or a s dve tsng mde he nha
t eq r s
pl i ift de onsr t t tM ehodpl c t al ge y f s sa e
antf o m ta e ha
t
a ed he le dl ale t t ment i i e sa eco m e c
s n nt r tt m r e.

S ot Co, 5F.da 2 2 Tot e tn Meh ds e ss mma yj d me to teb sso ti
c ts .31 3 t 7 . he x e t t o e k u r u g n n h a i f h s
e e nt t moton m us bede e The da a s lsi f M e hod' M e pB--yospr
l me , he
i
t
nid.
t ba e itngs or t s - l
l
oducs
t
we e plce on t i e ne a t de e n s' be s. tf i t r t i consde e a
r a d
he ntr t t he f nda t
he t ç he n e ne s
i rd n
Snsr m e aiy ofi e sae c
i tu nt lt
ntr t t omm e ce'a a s h,s ts st f t e e e t'oft t s f
r , nd s uc a ife he ourh l m n ' he e t or
f l e a r ii
a s dve ts ng. Ve i i I .v. YZ. om .LLC, o.1; 4- - 749,201 U . D i t LEX I
r s gn. nc X
c
N
1 CV 01
5 S. s .
S

1 7 71 a * 2 ( D. . v. ,2 5 (uoig Av pon I . Po rTo lsI c,98 F.
5 4 , t 1 E. Va No 20 01 ) q tn e it nc v. we os n . 1

21

S p . d4 6 51 ( . Va 201 :. Ac o dngy M eh di n te t ldt sl r u g n
u p 2 9 , 2 W D. . 3
c r i l, to s o ni e o l
t
mmayj d me t
on t sg ound.
hi r

E.

I ur and Ca aton
ni v
us i

The fna ee e o a c am f f s a rii t r t Ln m Ac r quies t
i l lm nt f l i or ale dve tsng mde he nha
t e r he

panift d mo srt ta i h sbe n o i l ey t b ij r da ars l o t ealg dy fle
litf o e n tae h t t a e r s i l o e nu e s e ut f h le e l as
k
a v riig. Sc ts Co,31 F.d a 27 I mo ig f r s mma. j d me b s d o t s
d et n
s
o t . 5 3 t 2. n vn o u z u g nt a e n hi
y
e e nt M ehod a gue t t Concor a' pr is fom t s l ofDonna a i r a e a tr t
l me , t
r s ha
di s oft '
r he ae
t l nc e s d fe he
I

lsi f M e- l yosa a e a t , ha Concor ai una et s
itngs or pB-l
ppe r d nd,hus t t
di s bl o how t ti hasbe n ori
ha t
e
s

lk l t beij r d b a y alg dmirp e e tto ma ei c nt to wih te l t s I
i ey o nu e y n le e se r sn ai n d n o jmcin t h i i . n
s ng
r s n e Co c r i ag e t a ij r i prs me i c s siv li rp e e tto t a ae
epo s , n o da r u s h t n u y s e u d n a e n ovng e r s nains h t r
lt r l f le,a t te n wihou t be fto s h pr umpton,her co dde onsr t st t
ie aly a s nd ha ve t t he ne i f uc es
i t e r m ta e ha

M ehod' al ge y f le sa e e t a e lkey t c us ,a ha a t ly ca e dn a t
t s le dl as t t m n s r i l o a e nd ve cual us d, m ge o
Conco di .
r a
TheFourh Cic tha ye t decdewhehe andunde wha cr um sa sapr sl i
t r ui s t o i
t r
r t ic t nce
e lmpton

Ofhnm s d be a id i fle a rii c esunde t Lnnhn Act Se j. a 273
r houl
pple n as dve tsng as
r he
m
. e /a t

(x r sl d cii t d cd t e eis s;P r neis I c v. e tsPh r .I c,1 2 F.
e p e sy e lnng o e i e h s sue l hama tc s n . Av ni n ms. n . 8

Ap x2 7 2 3(t Ci. 0 6 (su n , t u d cd n ,h tap e t to o h r a ple i
p' 6 , 7 4h r2 0 ) à s mi g wi t e ii g ta r sl in f a m p id n
ho
mp
a f le a rii ca e i whi h t de e an ' sae e swer f md t be lt r ly f le,but
as dve tsng s n
c he f nd ts t tm nt
e ot o
ie a l as

no tee safr ngt eg a t fsl r u g n wh r te ewa n e d nc a t tee tn
neh ls fimi h rn o l
mmayj d me t ee h r s o vie e s o h x e t
oft pli i sdn es. I t i tntc s ,t c t ncudest te nwiho t benek
he antY mag ) n he nsa a e he our co l ha, ve t ut he f
o a pr s
f
e umpton, Conc di ha pr ed s tc e e de
i
or a s oduc ufi int vi nce t c eae a g nui diput
o r t
e ne s e

r gadi t lkei ofij y.
e r ng he i lhood nur
22

Forpur e ofe t bls ng la lt f ravi l ton oft Ln
pos s sa ihi ibiiy o
o ai
he nhnm Ac ' f s a rii
ts ale dve tsng

p o ii n tth saued ma so l p o fp o i ig ara o a l b ssf rt beift a t e
r v so ,t j e ttt e nd ny r o r v dn e s n b e a i o he le h t h
g
pl i if i lkel t be dn a d as a r s t oft f le ad rii ' J m s & J hns v.
antf s i y o
m ge
e ul
he a s ve tsng. ol on
'
o on

CatrW alc sI c,6 1 F.d 1 6 1 0 ( Ci.1 8 ) se as 1 U.. j 1 25 a (as
re- la e n . 3 2 8 , 9 2d r 9 0 ; e lo 5 SC. 1 () fle
ad rii cai m a be br
ve tsng l m
y
ought ç a pe s n who bei ve t the i or i lkey t be
l ny r o
by
le s ha
s
s i l o

d ma e 'b teus o afleo mila igd s rp ino f c) Th s f rla iiyp r o e ,h
a g d' y h e f as r se dn e cito f a t. u ,o ib l u p s s t e
t
a opra esa r i whehe i i lke yt tM e hod' a rii hasc us orwilc us al s
ppr it tnda d s t r t s i l ha t s dve tsng
a ed
l a e os
of s l , not whehe Conc di ha c e f r r wih s ii e de e t t M ehod'
aes
t r
or a s om o wa d t pecfc vi nc ha
t s

a rii acual rs td i s mede t l so s ls J .s eas Cas r,284 F. at
dvetsng t ly e ule n o
fnie os f ae . #=; e lo hmee
3d

31 ( p e ies o n o (c lh r i n tr q rd a d adv rin o s ls f re mpl,
8 E r cs h wi g f a ma n m) s o e uie , n ieso f ae , o xa e
W

wo l s fi e' (n en l iaina dq o ainmak o te )
ud u fc .) itr a ctto n u tto r s mitd .
'
To s ts y t see e ,Conc di haspr f r e de e de
a if hi lm nt
or a
ofe ed vi nc monsr tngt tmembe sof
tai ha
r
t phn mac utc li tyr le upon t i o ton c ai d i t lsi f M e PBhe r e ia ndusr ei d
he nf nna i ont ne n he itngs or - Hyos
,
and te t d M e- l yos as a ge rc at m a i t Do maal As a r s t M epB--yos was
rae
pB-l
ne i le tve o r t .
e ul, - l
l

l k d t bo aa a a a alb ep o uc i t e d s e i s fwae u i z d b p r ce ,
i e o nn tl s n v ia l r d t n h ip nsng o t r tl e y hnma is
n
i
i l ngt s t r utlz by lie Ai
ncudi he ofwa e iied tt - d.

Co o di ha as pr
nc r a s lo oduce Symphony d t i cai t tby t we k e ng Jm e 1
d
a a ndi tng ha
he e ndi t 3,
201 pha m a it we e ar ady s m itng,a tzr paly pam r we e a ovi c am s f
4, r css r le
ub ti
nd lid- '
t
s r ppr ng, l i or
M e PB- Hyos The Sympho da a alo r ve l i t nc whe e i tr e co r c am sf
.
ny t s e a s nsa es
r nslanc ve age l i or
D onna a w e e r f e w hie c a m s f M e pBt l r e us d
l l i or - Hyos w e e a ove A ddii ly,i a l s
r ppr d.
tona l n t ea t

one c e, Do t was a maly r m o d fom a i ur nc co ny' f m ulr wih
as
nnaal
c l e ve r
n ns a e mpa s or a y t
M e pB--yoslse ast pr f red at r tve.
- l
l it d he e e r le na i
23

Co o di ha alo pr
nc r a s s oduce e de
d vi nce de
monsr tng t t doc or eve
ta i ha
t s nmaly soppe
l t d
pr c i ng Do t ba e o t mit ke bei ft ti wa t val bl orcozd no l nge be
es rbi
nnaal s d n he sa n le ha t s ma ia e
ll
o r
di pe ed by a pha m ac Fo i t nc Colee N ak t ur t tfed t t s s o l s o d
s ns
r y. r ns a e, l n
tm a es ii ha he l w y t ppe

wrtng pr s rptons f Donnaala tr beng t d t tDonna a wa no l nge a ia e f
ii
e ci i
or
t fe i ol ha
tl s
o r va lbl or
dipe i N agl laesi t dt ta oxi t l t l orf ure npr c i i we etl e
s nsng. l mtr tma e ha ppr ma ey weve o te es rptons r t d
m
downi t frtmont a trt a ia lt is a os Conco d ae
n he is
h fe he va lbiiy s ue r e.
r i mpha iest tNa
sz ha kumur s
a'
t tmony i c it ntwih we kl pr c i i n da a o aned f o Sympho whih i c t s
esi
s onsse
t e y es rpto t bt i
rm
ny, c ndi a e
t t pr s rptons f Donna a be n t dr a mos i e a ey afe t lsi s f
ha e c i i
or
t l ga o op l t mm dit l tr he itng or
M e pB- Hyospr
oduc sw e e a d t t pha m a eu i lda a e
t r dde o he r c tca t bas s.

I r s e,M ehod c le st a s i lt oft Sym phony daa on t basst t
n e pons
t
hal nge he dmisbiiy he
t
he i ha
De a Dr ke t Sympho r pr s nt tve who pr vi d a de l r ton i s
bor h a , he
ny e e e a i
o de
c a a i n uppo t of t
r
he
r por' a y i t sii d a he de ii t ts di no have pe s na kno e oft
e ts dmison, e tfe t r poston ha he d t
r o l wl dge he
f ct l daa c ai i t r por. A s Conco di not i r pl ho e r i i cla f o
a ua t ont ned n he e t
r a es n e y, w ve , t s e r r m
Dr ke' de l r ton a de ii n tsi onyt ts pe s nal e m i d t Sy phony r po t
a s c a a i nd posto e tm
ha he r o ly xn ne he m
e r.

Th ,t t e tn M eh d o jcst te a misb l y o t e rpo tun e Fe e a Rue o
us o he x e t t o b e t o h d siii f h e r d r d r l l f
t
Evi nc 60 t c tagr e wih Co di t tDr le spe s na e m i ton of1 r por i
de e 2, he our e s t ncor a ha ac ' r o l xn na i
he e t s
s fc e t s tsy t r e' pe s
ufi i nt o aif he ul s r onalknowl dger quie e . Se e. ,Br ntv.Fam e sI .
e
e r m nt
e. c, ya
r r ns

Ex h.4 2F.d 1 1 ,1 2 ( 0h Ci. 0 5 Cs n e(h a dtr pes n l e mi dt e ea dt
c , 3 3 1 4 1 3 1 t r 2 0 ) sic t e u io j ro al xn ne h s u i
y

rp rs s eh dpes na k o e g o t erc ne tgo p r o e o Rul 6 Q .)
e o t, h a r o l n wld e f h i o tn f r u p s s f e 0 ' .
'
W ih r pe t t t lnks t M epBt es c o he i
o
- Hyos i Rie- d' dipe i s t r ,M ehod
n t Ai s s nsng ofwa e
t
e pha i es t t t s m e e pl e who r l ye t s i or a i t Conco di a s d t t
m
s z ha he a
m oye
e a d hi nf m ton o
r a dvi e ha

ç nei e r hme onDor tl...sno a is wih CVS,W amatE qW agee ,' nd
t rc ncoac nt
ge
maa i t n sue t
l r or lr ns'a
24

t td
ha s
Donna a wa pule up wih no ge rcpr ts
t l s ld
t
ne i oduc howi ' te c oft ephn ma y c i .
ng'a a h hos
r c hans
P1' SUM F Ex.82. Addii l t Conco di e oye f t rr l yed t ti M e pB--yos
.s
tonaly, he
r a mpl e urhe e a
ha f - l
l
wa or r d fr t by Rie- d pha m a it, t phn ma it woul G t a r pons of E OT
s de e is
t Ai
r c ss he
r cs s
d G
ge
es e
N

AVAI
LABLE'o t i c
n her omputrs ren.' Je ce ' .s
/
M ehodf rt a gte t tnet rt Symphonyda anorNa l ur st si onypr de
t
u her r z s ha ihe he
t
ktm a' e tm
ovi s
a s fce lnk be wee al ge co m e c u i a a al ge f le o mil a ng
ufi int i
t n le d nml r onf son nd ny le d as r se di
sa e e t by M ehod. W ih r s c t Na tr s t si o
ttm n
t
t e pe t o kum la' e tm ny, M ehod e
t
mpha i s t t
sze ha
Nagl la i c t t ts wast d t tDo t wa no l rbeng ma
l mtr ndia ed ha he
ol ha nnaal s
onge i
de. M ehod not s
t
e
t tDor t Ext nt bs ha i f c ,be n dic i d a f w ye r e rir a t tt sco d
ha
maal e a
d, n a t e s ontnue
e
a s a le , nd ha hi ul

e an whyNak m awasa s d bypha mac sst tDbnnaalwasno l ra ia e.
xpl i
um
dvi e
r it ha
t
onge valbl
Afe c i rng t e de pr s nt by t pa te , hec tc l st tag ne
tr onsde i he vi nce e e ed he ri s t our oncude ha enui

ds ue o mae ilfc e it a t wh t e Co c r i h sbe n ijle b M eh d salg dy
ip t f tra a t x ss s o eh r n o d a a e n t d y t o ' l e l
r
e
f le r pr s nt tons The r pr e a i we e m a whe M e hod e a i t ls is
a s e e e ai .
e es nt tons r
de
n t
nde vor d o it t
M e pB--yos pr t wih t phn mac utc da a s s nd i i undiput d t t we l
- l
l
oduc s t he
r e ial t ba e ,a t s
s e ha
edy

pr s rpton c s f Do tl de r as d afe t M e- Hyos lsi a a ed. W hie
e c i i ount or nnaa c e e tr he
PBitngs ppe r
l

M eho ma utmaey c n ic aj r t a t o l c r cin bewe n t lsig a d te
t d y li tl o vn e u y h t he n y ome to t e he itn s n h
de i i Dol a a pr s rptons wa a t mpo a o ,a t tt de i r s t d fom ot :
clne n m t l e c i i
s e r l ne nd ha he clne e ule r
he

fco s a ra o a l j r c ul as fn t t Co c r i wa ij rd a a r s t o te
a t r, e s n b e u y o d lo id ha n o d a s nu e s eul f h
rp e e tto s a is e Ac o dngy M eh d i n t e tte t sI r j d me t o t
e rs n ai n t su . c r i l, t o s o nild o '
mmay u g n n Ms
gr md.
ot

25

F.

Ext ntofC onc di s dam aze
e
or a'
s

M eh d' fn lag n i s p o to i moi n fr s mmay j g n o t e f le
to s ia rume t n u p r f t to o u r ud me t n h as
s
a rii c am i t tConco di i una et pr t e e ofisda geswih a de e of
dve tsng l i s ha
r a s bl o ove he xt nt t ma
t
gr e

c ranyta c ul s p o t j r v r it I madn t sa g me tM eh dr l so t era o s
e ti t h t o d u p r a u y e dc. n l g hi r u n , t o ei n h e s n
e
s tf t i s
e orh n uppo tofism o i t e udeConc di sda a e r,I Hofm a
r t ton o xcl
or a' m ges xpe t van f n.
Aswilbee aned i as pa a em e andl opi on,pori o Ho f a sda a s
l
xpl i n e r t mor lm
ni
tons f fm n' m ge
r por mus bee ude i l ngHofm a sc l i r ga di t t al m ountofl tpr i
e t t xcl d, nc udi
f n' onc usons e r ng he ot n
os oft
da a s i ure by Co or a. Howe r t s does not sgniy t t Conc di ' cai f
m ge nc r d
nc di
ve , hi
i f ha
or a s l m or
dn a s ne s a iy f is Co or a c n silr y on s l a pr s rpto da a a do al
m ge ce s rl al . nc di a tl el
aes nd e c i i n t , nec t
e de e,a t f c ua t tmony of Hofma a ot r wines e t s
vi nc nd he a t l esi
f n nd he t s s o uppor is cli f
t t a m or
dn a s Acc di y,t c tsdecson t lmi t o ni ofe e by Hofman doe no
m ge .
or ngl he our'
ii o i t he pi ons f r d
f
s t
ne s a iy pr ve Conc di fom pr ng isdn a wih r as bl c rant Uli ae y,
ce s rl e nt
or a r
ovi t m ges t e ona e e ti y. tm tl

t c ur i co nc t tt e e of a da a s s f r d by Conco d a i a q si of
he o t s nvi ed ha he xt nt
ny m ge ufe e
r i s ue ton

ds u e fc t a i betlf t t j r t d cd .
ip td a t h t s s eto he u y o e i e
Fo a1 f h s ra o s net rsd i e t ldt sl r u g n o Co c r i' cam
r 1o t e e e s n , i ie s n i e o l
he
t
mmayj d me t n n o das li
f f s a rii unde t Ln m Ac . Ac r ngl t c os - otons f r s
or ale dve tsng
r he nha
t
co di y, he r sm i
o umm a y
r

j d me t l b d n e wihr s c t ti cam.
u g n wi e e id t epe t o h s li
l
I.
I

U nf r C om pe ii C l m
ai
tton ai

I Cot 1 of t t r n e
n
mt 1
he hid m nded c
ompl i , Conc di as e t a c am f S ai
ant
or a s rs l i or ç r
unf

c
ompeii i vi ainofSe i 43()oft Ln m Ac.' 3dAm.Compl !67. Conc di
tton n olto
cton a he nhn t'
.
or a
algest tGDonnaa hasbe meuni l asocaedwih a i ntfe Plitfl ast onl
le ha t
tl
co
quey s it t nd de iis anifq he y

FDA-p r v d p o i e g fPBA p n ma e tc ly a t tM eh d' çe r sn ai n ta
a p o e r v d r)o
h r c u ias' nd ha to s ç p e e tto s h t
'
r
26

M e pB-d
- lyos i pha ma utc ly equi l nt t Dor t l a i a FDA- ppr d PBA
s
r ce i a l
va e o
ma a , nd s n
a ove
pha mac utc l ha de i d,m ild a co us c ume sa e bl De e nt t ta
r e ia , ve ceve
se nd nf ed ons r nd na ed f nda s o r de

Ofo Plitfls r p tto a g o wil' I . 6 .
f f anifG) e uain nd o d l.s d ! 6
'
I mo i gf rs mmayj d me to t scam, eh dag e , sid dwi r s c t te
n v n o u r u g n n hi li M to r u s a t i t epe t o h
h
cam f f le a rii t ti ma no f lesa e nt r ga di phn mac utc e va e e
li or a s dve tsng, ha t de
as t t me s e r ng r e ial qui lnc

orFDA a ova . Fo t r a onss tf t a
ppr l
r he e s
e orh bove t c t sc nc dt ta g nui diput of
, he our i onvi e ha e ne s e
matra f te sswih r s c t t si'ue. Ac or ng y,M ehod i note ild t sl ma y
e i l ac xit t e pe t o hi s
s
c di l
t
s
ntte o lm r

j g n o Co n I.
ud me t n u t I
1 1.
1

V i l t on oft Vi zi a Cons e Pr ec i A c
oa i
he r ni
um r ot ton t

I Co t11 Conc di ale st tM ehodvi a e t Vigni Cons e Pr t c i Act
n un 1 ,
or a l ge ha t
olt d he r i a
um r o e ton

(VCPA' byf ley rprs ni t tM epB- osi ph r c u ial e uiae tt Do n tl
C
I
' as l e e e t ha - Hy s nma e tc l q v ln o n aa
)
ng
y
a d a prve b teFDA. M eh d la mo d frsl r j dg n o t i cam. M eh d
n p o d yh
to is ve o l
mmay u me t n hs li
to
a g st tConc di i no ei bl f r le t rt VCPA, ca et sc edoesnoti ve
r ue ha
or a s t lgi e or e if mde he
be us hi as
nvol
t t peofc ume ta a tonco e a e byt sa e. Fort f l wi r as ns t c t
he y
ons r r ns c i
nt mplt d he t mt
he olo ng e o , he our
agl
fcs.

The VCPA pr bis 1 s ir i c
ohi t G upple n onneci n wih a c lme ta a ton' fom
a
to
t
onsl r r ns c i ' r
mir pr s ntng <hes c s orhi a ovalorc tfc ton ofg
s e e e i ç our e, pons s p, ppr
t
erii a i
oodso s r i es' o çha
r e v c ,' r t t
t
goods or s r i e ha c ran qua iis c r c e itc ,i e e s us s o be t .' Va.
e v c s ve e ti
ntte , ha a t rsi s. ngr dint , e , r neks'
5Bas on t f t ale d i s
ed he ac s lge n uppor ofCount1, i appea st tt cai i t
t
It
r ha he l m s echni l onef f s
caly
or ale

us cai i volto o j4 ()1( o t Ln ha Ac. AsteFo rhCic irc nl e li d,ç 43a
o iton n i ain f 3 a( )A) fhe n m t
h u t r ut e e ty xpane $ ()
j
s s f t unf rcompeii c es of a i f f le a sociton and f se adveri ng.' Bel a LLC v.
et orh ai
tton aus
cton or as s ai
al
tsi '
mor

Ba e Co s me Ca eAG, F.d ,201 U. Ap .LEXI 5 80 a # 1 1 (t Ci. a . ,201 )
vr n u r r
3
6 S. p
S 3 , t 1 -2 4h r M r 23 6 .
d ub e to A ( fj4 () 1),S ihce tsl blt a t Sfiito ,c nn cin, rm s cai o g od ,
t s cin o 3 a() f c rae i iiy s o aflain o e to o so iton' f o s
s
wh
a
des i s t ca e ofaci known as çale as ociton.' I çsubs ton B,whi cr t la lt f
crbe he us
ton
f s s a i '' d. s ec i
ch eaes ibiiy or

S se rs n g )t e n t e c a a trsis q lte ,orge g a hc o i n'o go d ,dei st c us o
mirp e e ti h aur, h rceitc , uaiis
ng
o r p i rgi f o s fne he a e f
ac i f dale adveri ng.' 1 ;s alo Le a k I 'sl v.St i ContolCompone s.l ,1 S.Ct
ton or f s
tsi '' d. ee s xm r ntl nc.
atc
r
nt nc. 34
.

1 7 1 4 ( 4 (bs r n t a j 4 a o te La h m Ac ' r ae t dsic b s so la iiy:fle
37 , 38 201 ) o evig h t 3() f h n a
t s e ts wo itn t a e f iblt as
c
a s cai , n flea v rii ' (nena ctto so te )
so iton a d as d e t ng' itr l i in mitd .
s )
a
27

Co ej5 .- 0A)'l e a t t eVCPA,h Vig naGe e a As e l itnd dt ttC
d 9 120 ( . n n ci h
ng
t e r i i n rl s mby ne e ha i i
be
a id a r medillgilto t pr
pple s e
a e sai n o omot f ra ehia sa r ofde lngsbewe n s i r
e ai nd t c l t nda ds
ai
t e upple s

a t c umi publc. Va.Cod j59.-1
nd he ons ng i '
'
e
1 97.
Ba e on t e e s d pu pos oft sa e co t ha r pe t dl hed t tt VCPA
sd
he xpr s e r e he t mt , urs ve e a e y l ha he
G sde i ned t pr de m e r oft c umi publc,no c me cilc
ç sg
i
o ovi
mbe s he ons ng
i t om r a ompett s wih a
ior , t
saut y r m e 'a t ,t t c
t t or e dy' nd, hus ha ompeior E a k sa ng t pr e e a c am unde t
tt s s c t ndi o os cut
l
li
r he
VCPA . Di monds Diec U SA.I .v.BFJ Ho di .I ,No.3:2CV303' n
'
r t
nc
l ncs nc.
1
HEH,201 U.
2 S.

Dit LEXI 9 2 2, t* - 0( D. . u e2 , 01 ) s eas H. Olv rF ea Ap s.n .
s.
S 0 2 a 9 1 E. Va J n 8 2 2 ; e lo D. ie un rl t.I c v.

Dini Fme a S r s.n .9 4F. u p 1 3 , 0 9( D. . 9 7 (mp szn t th itn
a t l rl e v .I c, 6 S p . 0 3 1 3 E. Va 1 9 ) e ha ii g ha te n e t
y
oft VCPA i ç o pr
he
s s omot f i a eli a sanda ds bewe s ir a t c tmi
t
e ar nd t c l t r
l
t en upple s nd he onsl ng

p bl y a t tSa c mpeio d e n tfti t a e uain'; ir s f Co p v./ So t r .
u i ' nd ha i j o t r o s o i n h t q to ' M co o t r . /9 fwae
c'
l
t
)

I .No 4:5 v1 6 2 0 U. DitLEXI 3 71 , t* 1( D. . c 1 , 0 5 ( od n t a
nc, . 0 c 0 , 0 5 S. s.
S 6 0 a 1 E. Va De . 5 2 0 ) h li g h t
a c mpeio lc e sa d n t s e t e t VCP ;Po toi Re o ey As o s,I c v.
o t r a k d tn i g o u md r he
t
A) rf lo c v r s c . n .

Po toi Re o r Gp.LLC, . 1 v6 9 2 3U. Dit LEXI 1 0 9 , t* 3 ( D. .
rf lo c vev .
No 2:2c 4 , 01 S. s.
S 5 9 8 a 2 E. Va
Oc. 8 2 3 ( odngta t eplitf wa no e t ldt d fulj d me to iscam t e t
t2 , 01 ) h li h t h an if s t ni e o ea t u g n n t li md r he
t
VCPA,snc t pl i ifdi notal t ti wasa c um e oft de e n ' s r ies a
i e he antf d
lege ha t
ons r he f nda ts e vc nd

ise dalg dt t à d fnd n wa ac mpei re a igi u f i c mpei o )
n ta le e ha t e e e a t s o tt ng gn n n ar o tt n .
o
i
I t i t t a ton,Conco di doe no cai t t i was a pot nta co um e of
n he nsan c i
r a s t l m ha t
e i l ns r
r a s rs ha t s he c i
ar
M ehod' M e pBt s - Hyos pr t . I t d,Conco di as e t t t i wa t vitm of unf i
oduc s nsea
c petton by M e hod. Cons s e w ih t f e ng de i i ns t c t c l s t t
om ii
t
i t nt t he or goi
c s o , he our onc ude ha

Conc di ,asa c me calco pe ior lc sa ng t pr e ut aVCPA c am i t i t nt
or a
om r i m tt , a ks t ndi o os c e
l i n he nsa

a to Ac o dngy, eh d' moi nfrs mmayj g n wil eg a t da t Co n 11
cin. c r i l M t o s to o u r ud me t lb r ne s o u t 1.
28

I .
V

Cons r v C l m s
pi ac ai

I Cot I oft t r n nde c
n mt V
he hid me d ompli ,Conc di a s rsa c
ant
or a s e t omm o 1w c piac
n a ons r y
cli a i tt de e nt . I CountV,Conco di as e t ar lt d c am t rt Vigi a
am gans he f nda s n
r a s rs e ae l i mde he r ni
Bus nes Cons r c A c .
i s
pia y t

Topr valon t cvi c pia y cai Conco d am us s w t tçt orm o epe s
e i
he i l ons r c l m,
ri
t ho ha Gwo
r r ons
c bi d t a ompls by s e c nc re ac i s
om ne o cc
ih, om o e td ton, ome c i na o unl wf pur e ors e
rmi l r a ul pos
om
unl wf l pur e by c i i l o unl w fz m ea . Co m e c alBus Sys .I v. Be l ut
a u
pos
r m na r a tl
ns '
' m ri
. . nc.
lso h

Se v .I .4 3S. 2 2 , 6 ( .1 9 :. Th f t aino ack l o pr c cam i She
r s.nc, 5 E.d 61 2 7 Va 9 5
e omd to f ii c ns ia y li s t
t
da a ca e by t a t c
m ge us d
he c s omm itd i pur ua oft f m e c pia y a no t mer
te n s nce he or d ons r c nd t he
e
c bi ton oft ormor pe s t a ompls a t a ulptt e o us lnlwf lmea .
om na i
wo
e r ons o cc
ih n ml wf tpos r e l a u
ns'
'

Caeco I c v. trncCo c p s I c, 31S. 2d2 7 2818 ( .1 9 )( tr a ctto
tr p. n . Caei
n e t. n .4 E. 7 , -2 Va 9 3 i en l iain
n
a dq o ain mak o te )
n u tto r s mitd .

Und rt Vigni Busn s Co s ia y Ac,ijle p risc n o ti te l d ma e
e he r i a i e s n pr c t n t d a t a b an r be n g s
r
e
a an tCanyt o mo ep ro swh c mbn , so it, g e , t l t e tk o c n e t
g is ç q wo r r es n o o ie a s cae a re muual md ra e r o c r
l
y
tg t e f rt p r s o . . wilul a dmaiiusyij rn a t e i h srp tto ,r d ,
o eh r o he u po e f . . lf l n lco l nu ig noh r n i e u ain ta e
y
busnes orpr e so bya me whae r' Va.Codejj 1 2- & 1 2i s ofs in ny ans tve .
'
8. 499 8. 500. l or rt
n de o
pr vai on issa u or co pia y c am ,Conco d a mus pr t f l ng ee e sby cea
e l t t t t y ns r c l i
ri
t ove he olowi lm nt
l r

a dc n i ige i e c : 1 t tted f n a t a re o c n prdwi a o h rp ryo pate ;
n o vncn v d n e () ha h e e d ns g e d r o s ie t n t e a t r ris
h
( )t a t c n piao sa td wi lg lmaie t a i,itn in l ,p po e ul a dwih u
2 h t he o s rtr ce t e a l , h t s ne to al u s f l n t o t
h
c
y
y,
lwf lj siiain;a d ( )t a te itnina a to so t ec n piao sp o i tl c u e
a u u tfc to n 3 h t h n e to l cin f h o s rtr r xmaey a s d
ij r t Co c r i. DAG Per lu S p ir. v. PLC, 6 F. p' 2 6 2 ( t Ci.
n u y o n o da
to e m u pl s LLC BP
e
2 8 Ap x 3 , 43 4h r
2 08 (iigSi n v. ilr 5 4S. 2d6 6 6 6 7 ( . 0 1
0 ) ctn mmo s M le, 4 E. 6 , 7 - 7 Va 2 0 :.
29

l mo n f rs mma yj d me to t c ns ia ydams t d f n a t ag et t h
n vig o u r u g n n he o pr c i ,he e e d n s r u ha t e
cli s a i tM ehod a Tuc r M ehod' pr sde ,f mde ,and owne ,ar ba e by t
am gans
t
nd
ke , t s e i nt ot r
r e n'd
he
ita r r t i t t docrne. Unde tlsdocti ,
n r co po ae mm miy ti
r li
rne

acsofco o aeage saeati e t t co ai is tt rbyne tngt
t
p r t nt r trbutd o he porton tell hee
gai he
muli i iy ofa t sne es a y f t f m ai n o a c pia y. l e s nce t s
tplct
c or c s r or he or to f ons r c n s e , hi
m e ns t t a c por t o c nnot c ns r w ih is e pl yee ,a is e pl e ,
a ha
or a i n n
o pi e t t m o s nd t m oye s
whe a tng i t s opeoft i e o e , nnotc pien o t m s l s
n c i n he c
he r mpl ym nt ca
ons r m ng he eve .

Batmo eW ahiao Te. v. t a sCo.
l r- s n t n lCo. Ho Le d .LLC, 4F. u p. d73 ,7 4 ( M d 2 0 )
i
58 S p 2 6 4 D. . 0 8 9
s e as Bufao W ic F co y I c v. o d 6 2 F.S p 2 3 5 3 5 ( D. .2 0 ) As
e lo fl n s a t r . n . M h , 2
u p. d 2 , 3 E. Va 0 7 .
M ehod e
t
mpha i s t i uniy a f r
sze , he mm t f o ded under t s dodrne ti no de toye e n i
hi
i çs t sr d ve f

(o rtla e t aes d i t i idv d lc p ct ' Ch v sv. dny e 4 4 F. u p.2
c po ae g n s r ue n her n iiua a a i ' a e M tr , 2 S p d
y.

8 ,8 ( . Va 2 0 ) s e as Bu cl v.Kiv n 7 5 F.d 1 4 ,1 51 ( t Ci.1 8 )
58 61 W D. . 0 6 ; e lo s l
i
r e , 7 2 2 0 2 4h r 9 5
(Gi yj ii c po aeo fc r a d fn a t i t eridvd lc pa iisi n te ug t
s mpl onng o rt fies s e e d n s n h i n iiua a cte s o no h o
s
ma et m p ro sspaaefo t c r o aini lg l o tmpain.)
k he es n e rt r m he o p rto n e a c ne lto ' .
'
I r s ns t t de e nt 'moton,Conco di a gue t tis c piac cai ar
n e po e o he f nda s
i
r a r s ha t ons r y l ms e
bas d, on aco pia y be we n M ehod a Tuc r bu on ac pia y be we n M ehod a
e not
ns r c t e
t
nd ke , t
ons r c t e
t
nd
W i r t co ny t tM e hod ho d woul m a a t e isM e pB-- pr uc s Ba e
nde , he mpa ha
t
pe
d nuf c ur t
- lyos od t . s d
l
on t e de e pr s nt d,howe r t c tc l
he vi nc e e e
ve , he our oncudes t t t s a gume i wihoutm e i.
ha hi r
nt s t
rt
W hie Conco di m a sm uc oft f c t tW i rkne t tM ehod wantd i t m a a t e
l
r a ke
h he a t ha nde
w ha t
e t o nuf c ur
apr duc t twasphn ma utc ly eq va e tt Do t ,Conc di ha f l t e ai how
o t ha
r ce i a l ui l n o nnaal
or a s aied o xpl n
s h kno e
uc
wl dge on t pa t of W i r gve rs t a a tona e c piac cai . l i
he r
nde i s ie o n c i bl ons r y l m
t s

u ds ue t a M eho n ve padW id rt mamfcl eap o u tt a wa p a ma e tc ly
n ip td h t t d e r i n e o r a t r r d c h t s h r c uial
z
e vae t Donna a ,a t tno s h pr twase rm amf c ur d by W i r M or ve ,
qui lnt o
t l nd ha
uc oduc
ve r a t e
nde .
eo r
t d ges t t Co c di cai i t i t nta ton a e a l d t ha r s t d fom t
he nma
ha r or a l ms n he nsa c i r lege o ve e ule r he
30

lsi f M e pB--yosi t pha mac utc ldaa s s t t rt n a a ton t ke byW i r
itngs or - ll n he r e i a t ba e , a he ha ny c i a n
nde .

Be a et r c r i d v i o a ye i e c fo wlc ara o bej c tl fn ta W id r
c us he e o d s e o d f n v d n e r m l h e s na l my ol i d h t n e
i
d
ha knowldg ofM e hod' e f t t ls t M e- l yos pr t ,muc ls t t W i r
d
e e
t s fors o it he
pB-l
oduc s
h e s ha
nde

pa e ar l i t s e frs t c u t o l e ta a yij r t a Co c r i ma h v s fee
ly d o e n ho e fo t,he o r c ncud s h t n n u y h t n o d a y a e u frd
a a r s toft lsi i no a tona e unde t Vigi a Busne s Cons r c Ac ort
s e ul
he itngs s t c i bl
r he r ni
i s
pia y t he

c mmo lw O c n p ic . Ac o dn l ,M eh d' moin fr s mmay j d me t wilb
o n a f o s ra y
c r ig y to s t o u r u g n l e
o
g a edwih r s c t Cot sI a V.
r nt
t e pe t o mt V nd

V.

Uni tEnr c e
us
i hm nt

I Co t V1 o t e t r a n e c mp an ,Co c r i a s rs a cam f r t u t
n un
f h hid me d d o lit n o da s et li o mj s
e rc me t Un u t e c me ti a e utb e t e r o r c v r G a e u n a i le
n ih n . j s mi h n s n q ia l h o y f e o e y d s d po n mpid
b
c r tt pa t r s bl vaueofs r i sr nde e ' M onc d v.W oods 677 S. 2d 288
ontac o y he ea ona e l
e vce e r d.
'
ol
,
E.
,

2 2( . 0 9 . Tor c v rt e at o yo u j t mi h n , p an ifmu t r v : 1 t a i
9 Va 2 0 )
e o e md r he r f nus e c me ta litf s p o e ( ) h tt
t o f re abe ei o 't e d fn a t ()t a t ed f n a tC n w o t eb neh a d s o l
s n er d n tt n' h ee d n ; 2 h t h e e d n t e f h e f n h ud
c
k
ra o a l h v e p ce t rpa 't p an iff ri;a ( )ta t dee d n ç c e td o
e s n by a e x e t d o e y'he litf o t nd 3 h t he fn a t t c p e r
a
r t ne t be ft wihoutpa ng f is va ue. Sc dtv.Hous hol Fi Co p. 1,661
eai d he ne i t
yi or t l ' hmi
'
e d n. r s 1

s. 2 8 4, 3 ( . 0 ) Th n t o rc v r fru j t mi h n i lmi dt t v le
E.d 3 8 8 ka 2 08 . e momt f e o ey o nus e c me t s i t o he au
e
oft be ftgane byt def nda ,r ga dl s o t e e oft pl i ifsl s Se M erc
he nei i d
he e nt e r e s f he xt nt he antf os . e ti

Co sr co s I . Bn ko To y - tu ih. d.7 F. p' 91 , 2 (t Ci. 0 3 ; ik
n tu tr.nc v. n f k o Mis bs iLt , 2 Ap x 6 9 3 4h r 2 0 ) Ouc
S r eCo c p s LLC v. d rFar LP, 3Va Ci. 9 6 ( . r Ct 2 1.
e v n e t.
Ce a i. 8 . r 5 , 7 Va Ci. . 01 )
Appl ng t s prncpl y t co t c udes t t M ehod i e ild t sz ma y
yi he e i i e , he ur oncl
ha
t
s ntte o lm r

j g n o t e cam f runu te c me t W ll Co c r i a g e t a M eh d b neitd
ud me t n h li o j s mi h n . l e n o d a r u s h t t o e fte
i
f o beng a et us t Doz aa pr tlbe st c e t t l be sf M e PB' m i bl o e he m t l oduc a l o r a e he a l or - Hyos t r i no
r
,he e s
31

e de e t tM ehod ac nz any vaue fom t spu ored be ft The t s t e de
vi nc ha
t
c ed
l r hi p t
ne i.
mdipu ed vi nce
e tbls s t tM e hod ne rm a a t r d o s d t M e pBsa ihe ha
t
ve
nuf c u e r ol he - Hyospr uc safe t y wer
od t tr he
e
lse a t ,t ti ma nopr i fom utlzngt Do t lbes Acc di l t co t
it d, nd,hus ha t de
oft '
r
iii he nnaal a l.
or ng y, he ur

i c n ic dt t to i e tte t sl r ud me t nComt . S e eR, h snz rv.
s o vn e ha Meh d s n ild o l
mmayj g n o t VI e s ..Sc wa i e
P ie 78 F. p 3 7, 51( Ka 1 9 )(wadn s mma yj dg n t t d fn a to t
rc , 9 Su p. 4 3 D. n. 9 2 a r ig u r u me t o he e e d n n he
panifscam f rt vs e zc me t r ted fnd nsr c ie n p o isfo t p ân ifs
lit li o mj t n ih n whee h ee a t e ev d o r ft r m he litf
f
wok a d t u , r n t mi he b t ep an ifsef rs; e aDaln . n . Bo S c u
r n , h s wee o e c d y h litf fo t) Brnd re e I c v. n e o r
F s de .I c,1 S .3 1 4 ,1 5 ( a Ci App 2 2 (f nn n te e ty o ml r
ihe s n . 01 o d 2 2 2 5 A1. v. . 01 ) at i g h n r f mmay
i
j d me to t panif 't us e rc me tcam,wheet epanif p e e td n e d nc
u g n n he litfs mj t n ih n li
r h litfs r sn e o vie e
rg r i t ev leo t b n ft e eve a drti e b ted fn a t)
e adng h au f he e ei r c i d n ean d y h ee d n s.
VI
.

Tor i i e f r nce
tous nt r e e

I t s ve h a fna c
n he e nt nd i l ountoft t r n e d c
he hid m nde ompl i ,Conco d a a s t a c am
ant
r i s ers l i
f t ri i t re e e wih c r t o busne s e c a y. To pr vai on s h cai
or o tous n e f r nc
t ontac r
i s xpe t nc
e l
uc l m,

Co c r i mu t r ve ( )hee itnc o av l c nr cu leain hpo b ie se p ca c ;
n od a s p o : 1 t xse e f ai o ta ta r lto s i r usn s x e tn y
d

( )k o e g o t tr lto s p O e p ca c o t epa to t itre o ;( )itnin l
2 n wld e f ha eain hi r x e tn y n h r f he n efr r 3 ne t a
o
ifr n ei ucn o c usngab e c o tr n to o t r lto s i o e p ca y a d ( )
n e e c nd ig r a i
ra h r emiai n f he eain hp r x e tnc ; n 4
r s tng da
e uli
mage t t pa t whos r ltons p or e c a y hasbee dir pt d. Cha s v.
o he ry
e ea i hi
xpe t nc
n su e
ve

J hn o ,3 5 S. 2 9 ,1 2 ( .1 8 ) s eas Co reFt i Co p v W o lwie S c
o s n 3 E.d 7 0 Va 9 5 ; e lo mmec mdng r . . rd d e .

Sev . m .2 F.d2 4 21 ( t Ci. 0 )
r s Co , 49 3 0 , 0 4h r 2 01.
l movi frs
n
ng o ummayj me o t cli f t tousi efrnce M ehod ague
r udg nt n he am or ori ntree , t r s
t tt r i no e de e of a s cii co r c o busne s e
ha he e s
vi nc
ny pe fc nta t r i s xpeca y wih whih M ehod
tnc
t
c
t
a l ge y i e f r d,m uc l s a e de t tM e hod ha knowl dge ofs h s c f c c r c
le dl nt r e e
h e s ny vi nce ha
t
d
e
uc pe ii ont a t
32

o e p ca c Absn s c e d n e M eho c n e d t a i i e tte t sl r j d me t
r x e tn y. e t u h vie c , t d o tn s h t t s n ild o l
mma y u g n.
Fort f l wi r a ons t c tag ee .
he olo ng e s , he our r s
çf epup os ofl wsagans t to i e e ei nott pr ec c ume sort o r ton
ç'
rh
e a
i t orius nf r nc s
o ot t ons r he pe a i

oft m a kepl ege r ly. M as Conta t Se vs Eas.I . Be l , F.Supp. 699,
he r t ac ne al '
'
co
r c or r . t nc v. a s 279
2d

7 9( D. . 0 3 . I ta ,ûh s c u e o a to p o iealg lrme ywh r ap riu a
0 E. Va 2 0 ) nse d ç e e a s s f cin r vd e a e d e e a t lr
t
c
pa y' s ii .e si c r to busne se
rt s pecfc xitng ontac r i s xpeca y oroppo t t hasbee i e f r d wih
tnc
runiy
n nt r e e t

i at riu mn ne . I (mp a i i o iia) Ac o dn l tefrtee n o acam f r
n o t s n r' d. e h ss n rgn l. c r igy,h is lme t f li o
o
'
t tous i e f r nce r quie t pli if t e t bls t e se e of a s ik c ta m a
ori
nt re e
e r s he a ntf o sa ih he xit nc
pect on r c l
r lto hi orbusnes e
e ai ns p
i s xpeca
tncy. I ;s e a s 2- Vigi a M odelJ y I t u tons- Ci l
d. e l o 40 r ni
ur nsr c i
vi

l tu to No.4 25 (e u rn te p an ift p o e Eh tt ee wa a c n rc e p ca y
nsr cin
0. 0 rq iig h litf o r v ç a h r s o ta t x e tnc
t
gr s e t b i s rlto hp,o e o mi a v n a e c nr cjb t e t e panifa
p o p ci usne s eains i r c no c d a tg ; o ta t ewe n h litf nd
ve

( meo t r p ry ' . Falr t p o eas e i , x sigc nr c l eains i o b sn s
nn f hid a t)' i e o r v p csc e itn o ta ma r lto hp r u ie s
)
u
e t ncy i f t lt at tousi e f r e cai . Se M a c 279 F.Supp.2d a 709;s ealo
xpeca
s a a o ori nt re enc l m
e s o,
t
e s

Go t ly e I s Co v Go l.nc, 3 F. u p. d7 0 7 5 0 ( D. . 0 4 (Be a s
v'Empo e s n . . . oge I .3 0 S p 2 0 , 0 - 6 E. Va 2 0 ) i c u e
ç
GEI S a l a i a e t br d a c l or t pl a a s c f ,exitng co r c or
CO' leg tons r oo oa nd oncus y o e d pe ik
si
nta t
e t nc wih a s c fc pa t pl i ifs cai f t to i e f r nc wih pr peci
xpeca y t
pe ii ry, antf' l m or ori us nt re e e t os tve

e o o c a v tg wil be d s se .l Eu oe h. I c v. Co mo Et o e n Trv l
c n mi d r a e l
imis d'; r tc n .
'
s s l p a a es
r

Ak ing s l c a t 1 9F. u p. d3 5 3 ( D. . 0 )(Be a epli t f d n t d niy
te eel h f, 8 S p 2 8 , 91 E. Va 20 2 C c us ani s o o i e tf
s
ç
f
t s cfc busne s r a i hi wih wlih de e n ha i e f r d, pl i if ' t ri
he pe ii
i s eltons ps t
lc
f nda t s ntr e e
antfs o tous

i ef rnc cam f l ' .
ntree e li ais.)
'
I t i t nt c s Conco di ha not c t d t any s ii c r c u r l to hi o
n he ns a a e,
r a s
ie o
pec fc ont a t al e a i ns p r
bus ne s e c anc w ih w hi h M e hod know i y i e f r d. l t ad,r l ng o a a f da t
i s xpe t y t
c
t
ngl nt r e e
ns e
e yi n n f i vi
33

fom J a paulLà li t c pa svi pr s de ofbusnes de l e ,Co or a a gue
r e ntrn, he om ny' ce e i nt
i s veopm nt nc di r s
t ti hasbusne sa conta m a r ltons pswihlni ntfedç
ha t
i s nd
r c l ea i hi
t l de ii E e ae sa r pa kage s'
whol s lr nd e c
r,
'
a t ti t xpe t t mai ai c i ngpr ksfom t s whol s lr a r pac ge s' P1'
nd ha t ç c s o nt n ontnui ot r he e
e
e ae s nd e ka r .
' .s
SUM F Ex.80. The co ta e wih M e hod t ts h e de i i ufk i t e t bls t
ur gr es t
t
ha uc vi nce s ns t ent o sa ih he
t of s c fc e s i c r c ua r l t o li or busne s e
ype
pe i i , xitng ont a t l e a i nslp
i s xpec anc r quied t s t i a
t y e r o us a n

c am f t ri i e e e. Se e. ,Adva br Co. I ' Re sre .l , 1 1 CVl i or o tous nf r nc
es c.
nf t v. ntl Riti s nc.No. : 5- 220,

2 5 U. Dit LEXI 6 2 ,a *1 ( D.Va M a 1 2 5 (o dn t a t e p an if'
01 S. s.
S 21 5 t 2 E.
. y 2, 01 ) h l ig h t h litfs
a lga i we ei ufi i ntt sa eaca m f t to i ere e whe et pl ntfsC aiedt
le tons r ns fc e o t t li or ori us nt f r nce r he ai if ç l o
f
i n iy a s ii c r c o busne s e c a y' wih whi h t de e n s a lgedl
de tf ny pecfc onta t r i s xpe t nc ' t
c he f nda t le y

i efrd a ti tad onl algeg t t t t d co rcua rlto hi wih vai
ntree nd lnse
y le dj ha hey ha nta t l eains ps t rous

c so r')(mp ssi o iia) Ac o dngy tec u t o cud sta M eho i e tte t
u tmes' e ha i n rgn l. c r i l ,h o r c n l e h t t d s n ild o
'
s mma yj d me to Co n V1.
u r ug n n ut 1
Concl on
usi

/

Fo t ra o s sae ,Co o da smo in fr s mmayj d me twi be d n e a d
r he e s n ttd nc r i' to o u r u g n l
l e id n
M eho ' mo inf rs mmayj dg n wil eg a t di p r a dd nidi p r. theClr i
t d s to o u r u me t lb r ne n a t n e e n a t - ek s
die t dt s ndco esoft sme or ndlm opi o a t a o pa ng o de t a1c
r ce o e
pi
hi m a z
ni n nd he cc m nyi r r o 1 ouns lof
e
r or
ec d.

l
DATED: Thi :e d y o M a c , 201
s l a r zh 6.

Chi fU nie St t sD i t i tJ
e
t d a e sr c udge

34