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

Filing 272

MEMORANDUM OPINION. Signed by District Judge Glen E. Conrad on 3/2/17. (hnw)

I THE UN I
N
TED STATES DI
STRI COURT
CT
FOR THE W ESTERN DI
STRI OF V I GI I
CT
R NA
CHM LOTTESV I
LLE D I I ON
V SI

CL
ERKSOFFI u,s, ST
GE
AT RoANo DI , COURT
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:
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VA

qL
IED

MA2 22 21
27
BY

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CONCORDI PHARM ACEUTI
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CALS
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DL CL
EX ERK

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ERK
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vi ton
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6

Pl i if
a ntf ,

M EM OR ANDUM OPI ON
NI
M ETH OD PHA U ACEU TI LS,LLC,
CA
eta1,
.

By:Hon. l n E.Conr d
Ge
a
ChifUnie St t Diti tJ
e
t d aes src udge

D e e nt .
f nda s

On tef t' d y o abf rae til aj r rtr e avedc i fv ro t plitf
h o u h a f iuc td ra, u y eu n d r it n a o f he an if
t
Co c r i P n ma e tc l, I c (co c r i', o is cam ta t e d fn a t, M eh d
n o da h r c uias n . ç n o d a' n t li h t h ee d n s to
i
)
P r c u ias LLC (r e e d n M eho ' a d M ate Sc t Tuc e (r ee d n Tuc r
hama e tc l,
ç f n a t t d' n
)
th w o t k r ç f n a t ke,

a d c le tv l d eh d),e a e i fle a v riig i vo ain o t La hn Ac,1
n olciey, ç t o ' ng g d n as d e t n n ilto f he n m t 5
M
s
U. C. 1 2 ()1( .I t es bsq e td ma e p a eo tilt ejuyf t ta Co c r i
S. j 1 5 a( )B) n h u e u n n g s h s f ra,h t' omd h t n o da
wa e t ld t $ 3 ,0 0 i a ta o c mp n ao y d ma e . Ho v r tej r as f t
s n i e o 7 32 0.0 n cu l r o e st r n g s we e , h u y lo omd
t
t t M ehod' f le a ri i wa not wilul Conco di s e nty fl a moton f
ha
t s as dve tsng s
lf .
r a ubs que l ied
i or

j d me ta amatro 1w o a n w tilo t eis e o wi f le s a moin f rela c d
ug n s
te f a r e ra n h su f l un s, to o z n e
l
h
da ge a prj
ma s nd eudgme i ee t a amoto fratr ys fe and ltgai coss Thi
nt ntrs, nd
in o to ne ' e s
ii ton t.
s
me o a
m r ndum opi on s t f t t c tsnzi on Conc d a' m otons
ni es orh he our' lngs
or i s i .
B ackzround

l M a of201 Co or a a quiedt Donnaa@ lne o pr ucstt aa' fo
n y
4, nc di c r he
tl i f od t s
Dom1tl' r m
l

PBM Ph r c u ias I .(TBM ' . Domaa i a ln o c mbnain p e o a btla d
ama e tc l, nc :
'
)
l tl s ie f o i to h n b r i n
a

b la oma ak l i (TBA' p o ucs t ti u e a a jmci te a y i t te t n o
eld r laod û ' r d t ha s s d s dt tve h rp n he r ame t f
)

e c i i n he
i t bl bowe s om e a a ut e t r colts Do t li a lbl by pr s rpton i t
ni a e
l yndr
nd c e n e o ii. nnaa s vaia e
f
onn ofa t bl ta a e i r
a e nd n lxi .

Donnaalwa fr ti toduc i t 1 ,be o e dnz ma a tle s we e r r d t
t
s is n r ed n he 930s f r
g nuf c tr r r equie o
pr ve t tdr we ebo h s f a e f c i i or e t obt i a ovalby t Food a Dr g
o ha ugs r t a e nd fe tve n d r o an ppr
he
nd u

Ad nsrto (TDA' .Al o g Do naa p o ucsha b e a p o df rs ft , h FDA
miitain ç
' t u h n t l r d t ve e n p r ve o aey t e
) h
ha ye t dee mi t i efe tve s
s t o t r ne her f c i nes .
For m a yea s D o t l f c c
ny
r , nnaa a ed ompeii fom ge rc PBA pr t t t we e
tton r
ne i
oduc s ha
r
pha mac utc ly e valntt Domlt l I 2011 m a a t e s o t ge rcve sonsbe n
r e ia l qui e o
aa. n
, nuf c ur r f he ne i r i
ga
t t t i pr uc s of t m a ke . Onc t i nt i s of pr vi l m a a t e ge r c
o ake he r od t f he r t
e he nve or e
e ous y nuf c ur d ne i

pr ucswe ee i i t d,Do maa wa t onl lneofPBA pr t a ia ef pr c i n.
od t r lm na e
r tl s he y i
oducs va lbl or es dpto
De e ntM e hod i a whol a e dnz diti i c
f nda
t
s
es l
g srbuton ompa bas d i Ari o Te .
ny e n lngtn, xas
The c
ompa wa f unde by De e ntTuc ri 201 a he i t s e owne . Durng t
ny s o
d
f nda
ke n
2 nd
s he ol
r
i he
tm epe i a is ,Cl so rBoo s r ast c
i
rod t s ue ui t phe
ne e ved he ompa svi epr i ntofo r tons
ny' c esde
pe a i .
M e hod s ls a oxi at l t ry pha m ac utc lpr uc s t ta e m a a t e f t
t
e l ppr m e y hi t
r e i a od t ha r
nuf c ur d or he

c
ompan by c r c m a acurng o ga zai ns Rahe t n e oyi as l sf c M e hod
y
onta t nuf t i r ni to . t r ha mpl ng a e or e, t
utlze phn ma e i lda a e t pr
ii s r c utca t bas s o omot ispr t .M ehod' a ted busne ssr t
e t oduc s
t s dmit
i s taegy
i t e ur t tis pr ucs a e (i t d' t exitng dr i t da a e ,whih a e us d by
s o ns e ha t od t r t nle ' o si
l
ugs n he t bas s
c r e
me be s oft phn mac utca i usr t de e m i whe he ge rc s tt t s a e a ia e
m r
he r e i l nd ty o t r ne
t r ne i ubsiu e r va lbl

frb a dn mep o ucs Se Tr o Tra Te tmo yo M ate S o t c e (-u ke Tr' a
o rn a r d t. e . f il si n f th w c t Tu k r çf c r .) t
ç
'
5,Doc tNo.229 (ûM) busnes mode i t s la pr tt tweha Li ci qwoul
ke
$( y i s
l s o el ny oduc ha
ve. nlgng
d

betewa wed t t'.
h y
o ha.)
'
I 201 M e hod be n m a ng pl ns t m a ke a ne pr
n
3,
t
ga
ki
a
o
r t
w
oduc t t w o d be
t ha
ul
pha m a utc ly e va e t D o t . The ne pr uc w a e nt l na ed M e PB - yos
r ce i a l qui l nt o nna al
w od t s ve ualy m
- H .

2

M eh d c na td W id rLa o ao is LLC (W i e' a d e p e s d a itrs i h vn
t o o tce n e b rtre ,
C nd r' n x r s e n n ee t n a ig
G
)
W i rm amf c ur t ne pr t I De mbe of201 M ehod is apur has o dt f
nde r a t e he w oduc . n ce r
3, t
s ued
c e r r or
i ta sa lt t tng. Ho ve ,W i r ne r pe f me t sa lt t si ne es a y t
niil tbiiy esi
we r nde ve ror d he t biiy e tng c s r o
de l p M e- Hyos a no fnihe pr t was m a acur d by W i r or a o he
ve o
PB, nd
i s d oduc
nuf t e
nde
ny t r
ma at e.
nuf c ur r
N one he e s i M a c of 201 M e hod m oved f wa d w ih is pl ns t m a ke M et ls, n r h
4, t
or r t t a o r t
PB-

Hyos a a ge rc at r tvet Dom aal M e hod us d t pr tlbel a pa ka i e t
s
ne i le na i o l t . t
e he oduc a s nd c ge ns rs
f Donnaaltbl t a e i r t c eae lbe s a i e t f M e pB--yos t bl t a ei r
or
t a es nd lxi o r t a l nd ns rs or - l
l
a es nd lxi.

M eh d te p o e d d t ls t n n xitn Me p ly s p o u t wih t o te mao
t o h n r c e e o it he o e se t - B-l o r d cs t wo f h j r
phmn e ia daa s s M e - n a Fis Da a nk.
nac utc l tba e , dispa nd r t t bn
On M a c 31 201 M ehod s
r h , 4, t
ubmit t M e- l yospr tl bel,aong wih ne
ted he
pB-l
oduc a s l
t w
pr ts ison f m s t M edispan. Aspa tofise f t t ha M e- l yos lnked t
oduc ubm s i or , o
r
t fors o ve
pB-l
i
o

Do n tli t eM e is nd tb s , eh d lse Do naa' Naina Dr gCo e(NDC' a
n aa n h d- pa aa a e M to itd n tls to l u d G
$ 's
)
t Ree e e NDC. See Tr ofTra Tetmo ofChzsop rBoone (i ne Tr' a 27,
he fr nc
.
il si ny
it he
t
Boo
.) t
'

Do ke No 2 ( c n wld i t tM eh d i e tfe Do naa a t rfr n e d' f rM e
c t . 28 a k o e gng ha to d niid n tl s he ee e c l o ug
P lyo f rt ep r o eo h vn M epB-l o lse a isç e ei u e u v ln s eas Tr
B-- s o h u p s f a ig - ly s itd s t ç n rc q i ae f); e lo .
l
/
o Tra - Da Th e (ç y Th e Tr' a 7
f il
y re $
Da r e .) t 4,Do k tNo.26 (o fr n t a M eh d
'
ce
3 c n imig h t t o
s g e td t a M epB-- s s o l b ln e t Do n tl. M eh d as p o i e p iig
u g se h t - lyo h ud e ik d o n aa)
l
t o lo r v d d rcn
i or a i f t M e- l yospr uc s The lse prc sf t M e- l yospr
nf m ton or he
pB-l
od t .
it d i e or he
pB-l
oduc swe e
t r
l e t n t lsed pr c s f t Donna a pr
ow r ha he i t
i e or he
t l oduc s A lhoug M et kne t tt pr
t. t
h
hod
w ha he oduct
s

de c i d i t M e pB-- l be s a i ers di note s,a t tno sa lt t tng had
s rbe n he - lyos a l nd ns t d
l
xit nd ha
t biiy esi
be n pe f m e t d veop t pr t, M ehod i cae t t t prcng i bnnai n wa
e
ror d o e l he oduc s
t
ndi t d ha he i i nt
to
s
e f c i a ofA prl 1 201 B a e o t i or a i n pr vi d by M e hod,t M e- l yos
f e tve s
i , 4. s d n he nf m to o de
t
he
pB-l

3

pr t we else i t M e - n daaba ea a sg d t s me Ge rcPr tI ntfe
oduc s r it d n he dispa t s nd s i ne he a
ne i oduc de ii r

($ ' asDonnaal
çGPI'
)
t.
l a ton t M edispa M et unde t k t ha isM e- Hyospr ducs lse i
n ddii o
- n, hod
roo o ve t
pBo t it d n
Fis Daa nk' pha
r t tba s nnac utc da a s . Howe r Fis Daa rk r f s d t ls t M e PBe ial t ba e
ve , r t tbal e u e o it he Hyospr t wihoutva i ton fom Dal M ed,awe ie o r t d by t Na i nalLi a y of
oduc s t
lda i r
iy
bst pe a e
he to
br r
M e cne. Co e nty,M e hod e a r t ls t M e pB--yospr
di i
ns que l
t
nde vo ed o it he - l
l
oduc swih Da l ed.
t t iyM
M ehod s ntDal e t pr tl be s f r t nonexit ntM e pB--yospr uc s De pie
t
e
iyM d he oduc a l o he
se
- l
l
od t . s t
knowi t tt pr ucs de c i i t l be sdi note s,a t tno sa lt t si had
ng ha he od t s rbed n he a l d
xit nd ha
t biiy e tng

bee pefr dt de lp t pr t,M eéodi c tdt ti i e dt sa tmakei t
n ro me o veo he oducs t ndiae ha t ntnde o tr r tng he
pr
oduc s o J
t n une 1 201
, 4.

On J
une

201 a tr s e s u l lsi M e pB4, fe ucc s f ly itng
- Hyos wih Da l e M ehod
t
iyM d, t

rs
e ubmit t M e pB-- pr tlbest Fis Daa nk. M eho i c t d t tisplr e
ted he - lyos oduc a l o rt tba
l
t d ndia e ha t am d
l unc da e f r t pr
a h t o he oduc s w a J
t
s une 1 201 a da t t ha a r a pa s d. At t t tm e,
, 4,
y ha d l e dy s e
ha i
M e hod kne t tno M e- l yos pr
t
w ha
pB- l
oduc s w e e a ia e t l unc t f l w i da m uc
t r va l bl o a h he olo ng y,
h

l st da e rir Se Boo Tr a 46- M ehod as kne t tt i or ai n t ti
es wo ys a le . e
ne . t 47. t
lo w ha he nf m to ha t

pr de woul berledupo byme r oft phama uia i ty.J sM ehod' e frs
ovi d
d ei
n
mbes he r ce tc l ndusr #. t s fo t
we e once a n s e s ul a t M e- l yos pr ucs we e lse i Fis Daa nk'
r
gai ucc s f , nd he
pB- l
od t
r it d n rt tba s
pha m a e i lda a e i e ry J 201
r c utca t bas n a l une 4.
By t tpoi ,t M e - n lsi a s s
ha
nt he dispa itng l o howe a ma kei s a tda e ofJ 1 201
d
r tng tr t
une , 4
f t M e- H yospr uc s. M e hod w asa a e oft sf t a e n r vi w e t M e - n
or he
pBod t
t
w r
hi ac , nd ve e e d he di spa

lsi o J 3,201 t c im t tt ma kei sa tda e ha be n a
itng n une
4 o onfl ha he r tng t r t d e dded. See Tuc rTr
'
ke .
at2526.

4

On Se e r 1 201 a t t i tnta ton wasfl d,M e hod c a t d W i rvi
pt mbe 5, 4, fer he nsa c i
ie
t
ont c e
nde a

e i rg r ig t M epB-- sp oe t M eh d i dc td t a i k w ta W id rha no
mal e a dn he - lyo rj c. t o n iae h t t ne h t n e d t
l
satda ytigo t prj c, ndt a t ec mpa yh dd cd dt a iG g tb b s t b i o
tre n hn n he oe ta h t h o n a e ie h t tl h e e t o al n
mi
Eh )p o e t' P1' Tra Ex.2 . No tee s ta s me d y i rs o s t a iq iyfo
t e rj c. . il
' s
5 neh ls , h t n a , n e p n e o n n ur r m
M e - n r ga di t saus o M e PBdispa e r ng he t t f - Hyos M ehod a s M e - n t t; e PB, t
dvied dispa ha ( - Hyos
M
i a a tve pr t a wilbe a lbl t s p by N o mbe 1 201 ' Boo Tr a 40.
s n ci
oduc nd l
vaia e o hi
ve r 5, 4.
'
ne . t

M eh das c n ime t ts q ep iiga d lb l. . r c re ta d c re t' l
t o lo o fr d ha çth rcn n a e . ae u r n n o rc. d.
g
'
Uli t l M ehod neve l unc d t M e pB-- pr t ,a t pr
tma ey, t
r a he he - lyos oduc s nd he oducswe e no
l
t r t
m a a t e by W i rora o he c
nuf c ur d
nde
ny t r ompa
ny. I m i ocobe 201 M e - n r m o d t
n d- t r 4, dispa e ve he
ls i s f r t M e pB-- pr uc s Ar und t s m e tm e,Fis D a a nk m o d is ls i
itng o he - l yos od t . o
l
he a
i
r t t bn
ve t i tngs
f t M e pB--yos pr
or he - l
l
oduc sf om ac i ls i t a c ve ls i .
t r
tve i tngs o r hi d i tngs
A fe t M e pBtr he
- Hyos pr uc s w e e ls e w ih M e - pa a Fi s D a a nk,
od t
r it d t
di s n nd r t t bn

Doz t lpr s rptonsa t ts l dec e s d. Durng t co ls o t ltgai n,t pa tes
ma a e c i i
nd mi aes r a e
i he tr e f he ii to he ri
sr nuo l di put w he he t ls i we e t s e c us of t r duc i n i pr c i i
te usy s ed
t r he i tngs r he ol a e
he e to n es rptons

a uni s l s Atti l Conc di pr s nt d e de i c tngt ti e re ed l ts l i
nd t a e .
ra,
or a e e e vi nce ndia i ha t xpe i nc os aes n

e e s of$29. m ilon dola s a trt M e- l yospr uc swe e lse wih t da a s s
xc s
4 li
lr fe he pB-l
od t r it d t he t ba e .
Co or a m a nt i
nc di
i a ned t t t da a s ls i
ha he t ba e itngs f t no xi t nt pr
or he ne s e
oduc s w e e s el
t
r ol y

rs
e ponsbl f t deci i s es M ehod,on t ot rha pr s nt e de e i c tng
i e or he lne n al . t
he he nd, e e ed vi nc ndi a i
t t a num be of ot r f c or c rbut d t t r duc i i D o m a a uni s l s i l ng
ha
r
he a t s onti e o he e ton n r t l t a e , nc udi
s g fc nti r a e i t pr c ofD or a a pr
i nii a nc e s s n he i es
m t l oduc s
t.
Conco di a s pr s nt e de
r a l o e e ed vi nce r ga di t e f t i unde t k t ale a e
e r ng he f ors t
r oo o l vi t
c nf li n i t m a ke pl c r ga di t e s e e a a ia lt of a ge r c a t m a i t
o ls o n he r t a e e r ng he xi t nc nd va l biiy
ne i le tve o

Domz t l For i t nce Co or a s nt $885 015. on a c
aa.
nsa , nc di pe
, 00
oupon buy- wn pr n
do
ogr m

5

i eme e t co ba t ne tve e f t o t lsi sf rM e PBmpl nt d o m t he ga i fecs f he itng o
- Hyos The c
.
ompa alo
ny s
r mpe is m a ke i sr t gy a e ged i i r s d pr m otona e f rs t r tng
eva d t
r tng ta e
nd nga
n nc ea e
o i l f o t a ge i
pha m a i s a pr c i r .
r c e nd es r be s
ProceduralH i orv
st

PBM c
omm e ed t s a ton a ns M ehod o Aprl29,201 as e tng cli s unde
nc hi c i gai t t
n
i
4, s ri
am
r

t e Ln h m Ac a d Vigna lw. PBM fld a moin f rprl n r ijmcin o Ma 6
h na
t n rii a
i
e
to o ei a y n t to n y ,
mi
201 Tha moihwa utmaeywih rwnwih u p eu ieo Se tmb r1 , 01
4. t to s li tl t d a
t o t rj dc n p e e 6 2 4.
Folowi a s re of n e
l ng
eis
m ndmen s Conc di purue ca ms f r dama
t,
or a
s d li
o
ges a ns
gai t
De e ntM e hod a De e ntTuc r Afe t c
f nda
t
nd f nda
ke . tr he omplton ofdi c ve y t pa te fld
ei
s o r a he ris ie
h
a'
i or umm y
co smoin f rs mma yj d me t On M arc 29,2016,Concordi s m oton f s ar
r s- to s o u r u g n .

j d me twa d nid a d M eho ' moin f rs mmay j g n wa g a td i pata d
ug n s e e n
t d s to o u r ud me t s rn e n r n
de ed i pa t
ni n r .

Pro t ti ,Conco di a M e hod moved t e l ce t n opi ons ofe ed by t
i r o ral
r a nd t
o xcude rai
ni
fr
he
opposng s de' expertw inesses. On Aprl 1 201 t co t gr nt M e hod' m oton t
i i s
t
i 3, 6, he ur a ed t s
i o

e l I n H of n s o ni o t n ot t of l tpr i dn a i uae by Conc di
xc ude va
m nn' pi on n he m m
os oft m ges nc d.
or a.

Specfcal t c ul e l d Hof n s o ni n t tCo lor a s f r d no l s t n $29.
i ly, he o ' xcude
t
m nn' pi o ha tc di ufe e
e s ha
4
m ilon do l r i l tpr ft asa r s toft phn m a e i alda a e ls i f M e PBli
la s n os o is
e ul he r c utc
t bas i tngs or - Hyos.

Theco tc l d t tConc d aha f l t mee isbtr e ofs wi t tHof n sl t
ur onc ude ha
or i d aied o
t t td n ho ng ha
m nn' os
pr ft c c ai r se u a s fc e f cualbassal ar la e a i a i ofe t bls d
o is alul tons e t d pon ufi int a t
i rd e ibl pplc ton
sa ihe
pr nc pl s a m e hods i of r a t y a ti e al oft m e s ze l tpr st t da a s
i i e nd t , ns a s he trbut d 1 he a lr d os oût o he t ba e

lsi f r M ePBitngs o
- Hyos Acc di y,t c tr ed t tHof m ' opi on a t t t a
.
or ngl he our ul ha
mar s ni s o he ot l
a ount of l tpr i da age i un'd by Conco di m us be e l d t de Fe r l Rul of
m
os oft m s nc e
r a
t
xc ude m r de a
e

6

Ev d n e 7 2 Da b r v.M erl Do Ph r c u ias I c,5 9 U. 5 ( 9 3 ,a d is
ie c 0 , u et
rel w n ma e tc l. n . 0 S. 79 1 9 ) n t
Pr ny.
oge

Conc di sca m f f le a rii unde t Ln m Ac pr e d t ti lo Aprl
or a' li or a s dve tsng
r he nha
t oc ede o ra n
i

1 , 01 Th is so la iiya d d ma e weep e e tdt t ejzyi abf r ae fs in.
8 2 6. e sue f ib l n n g s r r s ne o h l n iuc t d a ho
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