Shire Development LLC et al v. Watson Pharmaceuticals, Inc. et al

Filing 246

*ORDER FINDINGS OF FACTS AND CONCLUSIONS OF LAW Signed by Judge Donald M. Middlebrooks on 5/9/2013. (sw)

UNI
TED STATES DI
STRI COURT
CT
SOUTH ERN DI
STRI OF FLORI
CT
DA
Cas No.12- 86 Cl M I
e
60 2- V- DDLEBROO KS& M NNON
SHI DEVELOPM ENT LLC, /al,
RE
e .
Pl ntfs
ai if ,
V S.

W ATSON PHARM ACEUTI
CALS,I ,e al,
NC. / .
Def nda s
e nt .
/

OPI ON AND O RDER
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THI CAUSE c e bef r t Cour f fna diposton oft is spr e eddurnga
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ic n itn wihto es tf t h r i a erj ce
n o sse t t h s e orh een r ee td.
1
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BACK GROUND

The ' Pae i lse i t FDA ' publcai n tte û ppr d Dr Pr t wih
720 tnt s it d n he
S
i to ild W ove
ug oduc s t

Th rpe tc Eq i ln e Evau t n ' (o ny k o a te S a g Bo k' a c e ig
ea ui uvae c
lai s' c mmo l n wn s h ç n e o ' s ov rn
o
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FDA- ppr d f t manuf cur a s l ofme an i delyed-e e s t blt c ani 12
a ove or he
a t e nd ae
s lm ne a r l a e a es ont i ng .
1 i whih a e c
ne
c r ommer i i d t rt ta nn Li l
calze mde he r de me ada* Li l * i i cae f
ada s ndi td or

g m es n
a m

N

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t i uci n ofr m ison i adulswih a tve,m id-o- ode a e ule ai colts a f t
he nd to
e si n
t t ci
l t m r t c r tve ii nd or he
ma ntna eofr s i oful e a i c ii .
i e nc
emison
c r tve olts
On M a 8,201 Pl n if fl t saci f r i rnge ntoft ' Pa e a ns
y
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he 720 t nt gai t

De e d n su d rt Hac W a ma Ac (h S lth W a ma Ac'o t ed c' , 5U. C.
f n a t n e he th- x n t te û ac - x n t r h W t' 3 S. j
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hes a e y nd fc y e t , he ne i nuf cur r t ubm t n
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ug

3ti undiput t tt ' Pa e wasi s d byt Unie St t sPa e a Tr de a k
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s ue
he t d a e t nt nd a m r

Ofie(E PTO' o Au u t1 , 0 4 t Ro e t Vil, si Pe rn , u oAj n , n
fc S
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p i n u mi eald
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xpli ng he acual nd eg
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iv l o t a te g n rcp o u twi n tifig te p tn . I j 3 5 ( )B) s ealo 21
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da ofr ceptofaPa agr ph I notc I t owne fl s t t n t FDA m a no a ove
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t ANDA f t ry m ont or l i a Unied St t co tfnds f t def nda bas d o
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n
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fn n
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i

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rd c ) o h
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ton'
ncudedat r r ph1 ' e tfc ton s e ng FDA appr lbef r t
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e eit he rgrph V ie e r, nd ie n
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f n a t comt ) a d n u e n /r o tiuo y n rng me t t e 7 0 tn b to
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c
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ton
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t
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t te'2 Pae t Plitfsa sr ta t e ea t c nsi t ifig me tu d r3 U. C. 27 .
o h 7 0 tn . an if se th t h s cs o tt e n rn e n n e 5 S. j 1
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OnAu u t , 01 Dee da t fldt erAn we ( 5 ) W ihnteAn we , as n
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Flxd a srst c u trli f rd caao yr l f ( ) de lrto ta terANDA p o u t
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e
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u d o ifi e n li f he 7 0 tn ,s e 2 t 5 1 ) a d 2 e lrto h t h
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7 0 tn nd t li r n l md r 5 S.
d
1 , o a k f i n s rpi n n
t
l c o e bl m e t t t e e t cl ms a e aleg t c rany pr ucs s tf t i t
a k f na e n , o he xt nt he ai r l ed o ove
od t e orh n he

W as nANDA. ( e DE 5 a 1 - 7 .
to
Se
2 t 61)
Pl i if ar a s tngi rnge ntofonl Cli s1a 3 oft ' Pa e . Cl i 1i
antfs e s eri nfi me
y am
nd
he 720 t nt
am s

t Pa e ' onl i pe ntc am , nd pr des
he t nts y nde nde l i a
ovi :
Contole r e e or l phn m a e ial co postons c ani a a
r ld-elas a
r c utc
m ii
ont i ng s n
a i i edints- mi s iylc a i c
ctve ngr e
n no-alc i cd, omprsng'
ii .

a.

a i ne lpophii m arx conssi ofs t ss e t d fom t
n n ri
lc ti
itng ubsance elc e r he
g ou c itng of uns t a e a o hydr na e f ty acd,
r p onssi
aur t d nd/ r
oge t d a t i
s t,eser ora i t r ,f ty a i m o ,di orti l e i ,
als t s m des he eof a t c d no- - r gyc rds
waxe ,c n de ,a chol t olde i tveswih m etng poit
s er mi s nd
eser
rva i
t
li
ns

beo 9 OC(,ndwheentea tv i g e in i ds re bohi
lw 0 !a
r i h ci e n rd e t s ipes d t n
s d t lpo lcm arx and i t hydr lcm arx;
ai he i phii ti
n he
ophii ti
4

b.

a ou e hydr lc m arx whe en t lpophii ma rx i
n tr
ophii
ti
r i he i
lc ti s
dipe s d,a s i o e hydr lc marx c it ofcompounds
s r e nd ad ut r
ophii ti onsss
s lctd fom t gr p co itng ofpol r orco ym e s of
ee e r he ou nssi
yme s
pol r
a r i o m eha ylc a d, akyl nyl pol r , hydr
c ylc r t cr i ci l vi
yme s
oxyal
kyl
cel os s ca bo l
lul e , r xyakyl c lul es pol a chmi s de rns
e l os ,
ys c
de , xti ,
pec i , sa c s a derva i , agi c a i a na lr l or
tns t r he nd
i tves l ni c d, nd tza
s he i gums
ynt tc
;

C.

o i nal o he e pint ;
pto ly t r xci e s
whe e n t aci i r dinti pr e i an n ountof8 t 95%
r i he tve ng e e s es nt n
m
0o
by wei of t t a c
ght
he otl omposton, a whe en t a i
ii
nd
r i he ctve
i e e i dipe s d bot i t lpophii ma rx a i t
ngr di nt s s r e
h n he i
lc ti nd n he
hydr lcm arx.
ophii ti

( 2 2- a 4 Cli 3, c i de e d n o Cli 1 p o d s t mpo ii n a came i
DE 0 1 t ) am whih s p n e t n am , r vie :d
co sto s s li d n
.

( 1i 1 i t f r o tbes c ps ls mitb es' (#)4
C1am , n he o m f a lt, a ue , na lt, . ..
' /
Att r ques o t Pa tes a f l ng c am c t u ton bre i a a M ar man
he e t f he ri , nd olowi l i onsr c i
i fng nd
k
hea i on Dec m be 20,201 s e M ar man v.Fe l fw I tume s I . 5 F.d 967,979
rng
e r
2, e
k
l pe nsr nt, nc, 2 3

( d. r 1 9 ) t eCo r is e a Or e d tdJ n r 1 2 1 ( 1 ) c nsr ig c ran
Fe Ci. 9 5 , h u t su d n d r ae a uay 6, 0 3 DE 47 , o tun e ti
diput d c am soft ' Pae . TheCour' c am c t c i a e a f l
s e li
he 720 tnt
ts l i onsm tons r s olows:
Diput Cl m Te
s ed ai
rm

G arx'
t ti '
m
çi rlpophii m arx'
snne i
lc ti '

Cons r ton
t uc i

amacos ia l hom o e oussr t ei a1isvol e
r co c l
ne
tuc ur n l t um
ama rx i udi atl s onelpophii e pint wher t
ti ncl ng ea t
i
lc xci e ,
e he
ma rx i l td wihi one o m or ot s t nce
ti s ocae t n
r e her ubsa s

d e hydr phii m arx' am arx ofa las o hy o lce pi n , r t ma rx i
s r
out
o lc ti '
ti
t e t ne dr phii xci e t whe e he ti s
l a e out i t i lpophii m arx
oc t d sde he nner i
lc ti

ddipered'
çs s '

s fce l mi d t i or ae ones tnc wih a he
uf inty xe o nc por t
ubsa e t not r

4 ca eCl m 3 i de nde on Cli lstne s a i c ansal oft lm ia i of
B us ai
s pe nt
a m i ce s rl ont i l he i ttons
ï
Cli 1 e ,W a s n' ANDA Pr tca o y i rng Cll 3 i i i rnge Cl m 1. Sad
am . Thus t o s
oduc n nl nfi e a m f t nfi s ai
i
dif r nty,i De e nt ANDA Pr
fe e l f f nda s'
oductdoesnoti rngeCli 1 i c nno i rngeCl m 3.
nfi
am , t a t nf i
ai
5

' r i mes n i i
s en alm ne s
whe
i r r t d wiht
nco po a e t he
lpophii m arx a t
i
lc ti nd he
h dr hii m arx'
o lc ti '
çc itngofs t nc
donssi
ubsa es
s l ced fom t gr
e e t r he oup
c itng ofuns t a e
onssi
aur t d
al orhydr natd f ty
rd/
oge e a t
a i s ls e t r orn i
cd, at , se s m des
t r of f ty a i monohe e , a t c d
,
di,orti yc rds wa ,
- rgl e i , xes
c a de ,a c e t r
er mi s nd hol se ol
de i tve wih meli
rvai s t
tng
Po n sbe o 90O '
it lw
C'
' ee t d fom t gr
t lc e r he oup
s
c itng of'
onssi

whe en mes lm i i s fcen l m i t i om or t i wihi
ri
an ne s ufi i ty xed o nc
ae t t n
bot t lpo lcmarx a t hydr phii m arx
h he i phii ti nd he
o lc ti

S etng poi s'
d li
m
nt'

t r ngeoft mpe am esatwhi h a s i begi t c ngefom
he a
e rt
c old
ns o ha
r
a s i t lqui
old o i d

c t i ng oneormor oft f l ng s t nce ,e ch ha ng
on a ni
e he olowi ubsa s a
vi
m etng poi sbelw 900 uns t a e f ty acd,s tofa
li
nt o
C: a ur t d a t i al n
uns t aed fty a d, se ofa uns t a e f ty a i a deof
a urt a t ci e t r n aur t d a t c d, mi
a uns t a e f ty a i hyd oge t d f t a i s tofa
n aur t d a t c d, r na e aty cd, al
hyd oge t f ty a d,e t rofahydr na e f ty a d,n de
r naed a t ci se
oge t d a t ci mi
ofahydr nae f ty acd,f ty a i m onogl e i f t a i
oge t d at i at c d
yc rd, aty c d
di l e i f ty acd ti yc i wa ce n i c ese ol
g yc rd, at i rgl erd, x, r m de, hol t r
de i tve
rva i

a e l i r tr s c f ng t ta elm e c ansonl
n xc usona y e m pe iyi ha n e nt ont i
y
wha i e e sy s tf t i a r ct d ls butdoe note l e
t s xpr s l e orh n e ie it
s
xcud
s bsa e l r l t t orouti oft contxtofs i elm e
u t nc s m e aed o,
sde he
e
ad e nt

(e DE 1 7 . F rhe ,h Pate a r e t t ef lo n cam tr c n tu to :
Se
4 ) u t r te ris g e d o h o lwig li e m o sr cins
Agr e Upon Cl m Te
ed
ai
rm

Cons r ton
t uc i

t dr hii '
t op lc'
hy

ha ng a a fniy t waer
vi n f t o t

ç i phii'
t po lc'
l

ha ngapoo a fniy t wa dsaque fui
vi
r fi t o r
ous l ds

S ontoledr l s or lphn mac utc
ç r l eea e a
c
r e ial
c
omposton'
ii '

a or lpha mac utc composton whe e
n a
r e ial
ii
r by
t dis uton ofaci i r e i not
he s ol i
tve ng edint s
i e ae
mm di t

( e DE 6 a 3 .
Se
8 t)
The Co r hed a no -u y tilfo Ap i 8 tr u h Ap i 2 2 3,wih cosn
ut l
nj r ra r m rl h o g
rl1 , 01 t l ig
ri se
tti r
e i ngs a t nd
a gume sc
r
nt onductd on Aprl26,201 The Pa testl dpos-ralp opos d fndi off c a
e
i
3.

i ri
he e di , ral nd
co l i of 1 on Aprl 19 201 Aferca e u consde aton of t pla ngs ti a
ncusons aw
i , 3. t r f l
de ii n t si o e bis a ot rs isons t Cour fndsasf l .
posto e tm ny, xhi t , nd he ubm s i , he
tl
olows
6

I.
I

THE LAW OF I
NFRI
NGEM ENT

P ru n t 35U. C. 2 ()2 ,ti a a to ifig me t
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s n n s lc lca i a dme aa i . (# a % 3 )
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s n un e u rs h t rl a lt o muains v g os g s n

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23 6 1 ( n oCr sl.
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t tl o sto ( 2 2 1a ! 3 40 . Ac odigy,h Co r' a l i wil o a d e s
oa c mpo iin. DE 0 - t ! 4, ) c r n l t e u ts nayss ln t d rs
t elmia i .
hes i t tons

1 Asa r e t b t ePa t sa du e so dbyt eCo r,h a j ci efio h lc' a s
3 g e d o y h ri n nd rt o
e
h u tte de tv çp p ii'me n
l

Eha ngapoorafi t t r a
4 vi
fniy owa ds queoustui .'
l ds'
1
2

beow 900C. Cl m 1a s r quiesan S e hy ophii mati ' nssi ofoneoft lse
l
ai
lo e r
t r dr lc rx'co itng
out
he itd
hydr lc1 s bsa s Fi ly,Cli 1r quiest tmes n i be dipe s d i e c oft
ophii 4 u tnce . na l a m e r ha
alm ne
s r e n a h he
m a rc .
ties

i
.

çcon r ld- e e'
d tole Relas '

The Pa tes ha a e d t t t me ng of ç ntoled-e e e or pha m a u i a
ri
ve gr e ha he ani
d r l r l as al r ce tc l
co
c
ompostons'sta or lphar ce ia c
ii 'i çn a
ma utc l omposton wher byt di s utonofa tvei ed e
ii
e he s ol i
c i ngr i nt

i no i d ae' ( 6 a 3 . Th d snto o Smme it r la e' lg ty v re bewe n
s t mme it. DE 8 t ) e e i n f t dae ee s 'sih l ais t e
'
i
i
t e rs Fo e m pl ,Pl ntfs e r,Dr Si
he xpe t. r xn e ai if ' xpe t . nko,de i a i e ae r e e pr ta
fnes n mm di t elas oduc s

o eta rlae a la t7 % o a tv i rd e ti 45miu e . ( il . y3 a 1 3:8 2
n h t ee s s t e s 5 f cie nge in n
n ts Tra Tr Da t 9 1 - 1

t ik Die t) Ont eo h rh n W as nf r ao Dr J s i e c ie a i d aerlae
sn o rcl.
h t e a d, to o multr . o h d srb s n mme it ee s
pod c a o eta rla e 8 % o a tv i g e in i 3 miue . ( ilTr Da 2a 7 (os i
r u t s n h t ee s s 5 f cie n rde tn 0 n t s Tra . y t 3 J h
De .)
p).
De e n s a g t t Cl i 1 r quie a c r ld- eea e cor a t r ANDA
f nda t r ue ha am
e rs
ontole r l s
e, nd hei

Pr ts cor i i e ae r l a e.
oduc '
e s mm dit e e s

For t i fn s d pr ts c r l d-e e s
her i ihe
oduc ' ontole r l a e

c r t rsi , f nda sbl met t e ' en e i c tng.
ha ace itcs De e nt a he ablts t rc oa i
W hie t e e i c tng d ha t efe t o de a ng r e e,Pl i if ofe ed
l he nt rc oai oes ve he f c f l yi elas
antfs f r
e de e t t t W as c e is l i contole r l as , wih t i
vi nc ha he
ton or te f s
r ld-e e e t he nner a o e m arc
nd ut r ti es

wor ng t e he t de a t r l s ofmes lm i Pli tf spr ded t W a s n Pr t
ki og t r o l y he eea e
aa ne. a n if ovi
he t o oduc

De eo me tRe o t(h t as n PDR',wh c idc tst a t e c r ofW as n' tbe
v lp n p r t e ç to
W
' ih n iae h t h o e
)
to s a lt
r la e 3 % o me aa n a ro eh u o r sd n ei p l7. p o p aeb fe . ( 0 a
ee s s 6 f s lmie he n o r f e ie c n l 2 h s h t u fr PTX 23 t

1 Asa r e t byt ePa t sa du d rt o b t eCo r tea j ci et y r p lc' a
4 g e d o h ri n n e so d y h u q h de tv l d o hii'me ns
e
h
S nga afi t t waer'
é
havi n fniy o t .'
1
3

81.5 Plitfs e p r Dr Sik c n ime a til h tte W as n PDR ce ryi dc tst a
)1 an if' x e t . n o o fr d t ra t a h
to
lal n iae h t
t W aton ANDA Pr tsc e i noti e a er e e The W as PDR a s r porst t
he
s
oduc ' or s
mm dit elas .
t on
lo e t ha

t co et bltr quie s nt ni hour ofr i nc i PH 7. Kr b' bi r t bufe be or
he r a e e r s eve o ne
s esde e n
4 e s ca bona e f r f e

rla i 75 me an ne ( TX 0 3 a 8 s eas Tra Tr Da 3a 1 89 1 t ik Die t
ee sng % s lmi . P 2 t 2; e lo il . y t 9 :- 4 sn o r c)
(I y ulo a t efrtwoh u s t a' g igt b t dea e c mpo n . Afe t a, uc n
$ f o o k t h is t o r,h ts on o e he ly d o ne t tr h tyo a
f
s e t te n hou s ve whih i r ly hourfve you a e silnothitng eve m y c e vai
e ha ve
r e n, c s ea l
i ,
r tl
ti
n
ons r tve

tleh df ri daer la e I i ce ryac nr le r laef nn lto .l.
l s ol o mme it ee s . t s lal o to ld ee s o u ai n')
r
'
Pli if alo i r
antfs s ntoduce Dr St ve Lite anex r i c r l d r e ef multon a
d . e n tl,
pe t n ontole elas or a i nd
tsi who c
e tng,
onduc e e e i coa dis uton- m pr s sudi s of t W as ANDA
t d nt rc
t s ol i co omie t e
he
ton
Pr ct Dr Lite c
odu . . tl ondu e e rme st obs r e t dis uton and r m ova oft e erc
ctd xpe i nt o e v he s ol i
e
l he nt i
c tng f t W a s ANDA Pr ti a 1 Lier PH 7. phos t bufe ves el wih sirng
oa i or he ton
oduc n
t,
2
pha e f r s , t tri
c mpmubl t a USP Paddl 2 a r t .6 A c r ng t Dr Lite hi goa wa t obs r
o
eo
e ppa a us 1
co di o . tl , s l s o e ve
whehert e e i c i on t W as AN DA Pr twoul be r ponsbl f t sow,
t he nt rc oatng
he ton
oduc
d
es
i e or he l
s t i d r las s
usane ee e hown i t W as PDR. l hi e rm e s Dr Lite obs r e t tt
n he ton
n s xpe i nt, . tl
e v d ha he
W a s ANDA Pr tse e i coai i r pt e wihi m i e a i s ve e y c
ton
oduc ' ntrc tng s u ur d t n nut s nd s e r l ompr m ie
o sd
wihi 30mi ut safe benge
t n
n e tr i xpos dt pl 7.2 phos t bufe .7 Dr Lite' i a s t t
e o '
l
phae f r1
. tl s m ges how ha

t e ercco i on t W a s t e wa cea l c
he nt i atng he ton ablt s l ry ompr m ie a trtn m i e i pl 7. At
o s d fe e nut s n ' 2.
l

1 Alhought W as ANDA Pr tsdis utonpr iet sst fna pr t a o
5 t
he ton
oduc ' s ol i
ofl e t he i l oduc , s ppos t
ed o

j t h c r o t etbe , anif' x r Dr S n otsi e t a t ee trcc ai gwo dn t
us t e o e f h a lt Plitfs e pet . i k e tf d h t h n e i o tn ul o
i
c eof un i hourt eeoft dis uton t si
om
f tl
hr
he s ol i e tng. Thus hourf i t di s uton pr ie i
,
our n he s ol i
ofl s

r al h u o ewh nd tr nn t ed sou ino me an n . ( eTra Tr Da 3a 1 6:3
e ly o r n e eemi ig h is lto f s lmie Se il . y t 9 2
t 1 7 1 ( g yDie t)
o 9 :2 Bu a rcl.
1 O neOfDr Lite' g si hi sudy wa t a oxi t t c tonst twe e us d i t
6
tl s oal n s t
s o ppr ma e he ondii ha r e n he
.

W as nPDR f rt eW as nANDA. ( il . y2a 2 :- 5t tl Die t)
to
o h to
Tra Tr Da t 78 2 Li e r cl.
l

1 Dr Liter or d phot a ci a soft t e eve y t mi esusng ahi h r ol i
7
tl ec de
ogr phi m ge
he ablt r wo nut
i
g es uton
c me a. The ephot r
n r
s
og aphswer dipl ye durngt ti l
e s a d i he ra .
1
4

30 mi e ,t c tng wase r l c
nut s he oai
xteme y ompr ie a bewe n 30 a 32 mi t t c tng
om s d, nd t e
nd
nu es he oa i
hadco eof t t oft tblt Dr Litea s obs r e t ta tr32m i e ,whe t e e i
m
f he op he a e . . tl l o e v d ha fe
nut s
n he nt rc
coai wasc
tng
ompl t y c
eel ompr m ie - a t m e alm i wa e
o s d nd he s a ne s xpos d t t btfe s u i n on
e o he kf r ol to
a 1sde - t m es l mi gr nuls fo t W as ANDA Pr tw e e notdi s vi Dr
1 i s he
a a ne a e r m he t on
oduc r
s ol ng. .
Litepr vi d i eso t tblta tr68 m i es whi s
tl o de mag f he a e fe
nut , ch how wha Dr Litedes rbe a ç
t . tl
ci d s i
a

pi o . .md sov d me aa n g a ue . ( ilTr Da 2 a 3 25t 3 3t tl Die t;
l f . t is le s lmie rn ls' Tra . y t 6: o 7: Li e rc)
e
'
l
s ea s PTX 22 ) Afe 8 mi ue , n twadtee d o tee p rme , . tl' i g s
e lo
2 . tr 6 n t s a d o r h n f h x e i ntDr Lit s ma e
e
de
monsr t t tt r i silapie- abei a s al rpie- ofme a n i g a esr si a t
ta e ha he e s tl
l l t m le l
s l m ne r nul e tng t he

31 . s d n h ey i h ou ii f slmi e n i
t
bo t m oft ve s l (e PTX 2 ) Ba e o t ev r h g s lb l yo me an n a dh s
to
he s e . S e
own t tng o t W a s ANDA Pr t Dr Litec ude t ti wa nott e erccoai
esi f he t on
oduc , . tl oncl d ha t s
he nt i
tng
oft W a s ANDA Pr
he ton
oduc t tdea t r l s o mes lm i Rahe ,Dr Lite f md
t ha lyed he eea e f
aa ne. t r . tl ot
t tdhe emus be s ehi elead i t s tm t twoul r ul i t sowe r e et t
ha ç r
t
t om t ng s ded n he yse ha
d es t n he l r elas ha

i s e - ( il . y 2a 3 2 t 4 2( t eDie t)
s e n' Tra Tr Da t 9:2 o 0: Lit r cl.
'
l
Ha ng viwe t e de a lse t t t si ony,Ifnd t tPli if ha me
vi
e d he vi nce nd itned o he e tm
i ha antf s ve t
t i bur n t pr by a pr po r nc of t e d e t t t W a s AN DA Pr ucti
he r de o ove
e nde a e
he vi enc ha he ton
od
s
$ ontoled-e e s -''
$ r l r l a e'l
c
i.
i

'l rLi phii M ati '
tnne po lc
rx'

The Cour ha c tue çmarx't m e n ç m a r c c ly homog oussr t e i
t s onsr d d ti ' o a ç c os opi a l
a
ene
tucur n
a lisvol e'a Si rlpo lc ma rx' t m e n ç m arx i udi a las o lpo lc
1 t um ' nd tnne i phii ti ' o a $ ti ncl ng t e t ne i phii
a

e cp e twh r t emarx i lc tdwi i o eo moeoh rs bsa e . ( 1 7a 6 9 .
x iin , ee h ti s o ae t n n r r te u tnc s' DE 4 t - )
h
'

1 The Cou tno est t sc l i n sa e n ast t cor oft W a s ANDA Pr
8
r t hat hi oncuso t nds ve
o he e he t on
odud.
15

Pl i if co e t t i r lpo lc m arx i t W aton ANDA Pr ti t
antfs nt nd hat he nne i phii
ti n he
s
oduc s he
ma os pialy homogene
cr co c l
ous diti i o mag sum se a e1 is l wihi t vol
srbuton f
ne i
tar t 9 te f t n he ume
r, aitfs f r d he
de i d by t pe i e oft Pr tsm e a a i gr e l s
fne
he rmetr he oduc ' s l m ne anuls. n uppo t Pl n if ofe e t
r ulsofs ve al e t c
es t
e r t ss onduc e by Dr Da d Buga t i a l ialc m itwih o 25 ye r
td
. vi
y, her naytc he s t ver
as

ofexpe inc i a l i lc m ity.
re e n naytca he sr

Fis, Dr Bug y c n u td Sc n i Elcr n M ir c p (ssM , 2 a d En r y
rt . a o d ce n nng e to
ç ,0 n
)
eg
cos o y ç

Dip rie x- dain (' '2 a ay i o t eu o td ( rc r)tb esusd t ma et
s esv Ra ito t
EDx' ' n l ss n h nc ae o o e a lt e o k he
)
fna W a s ANDA Pr t I s t t SEM i l ton
oduc . n hor, he
EDX t tng c r l t s t t pog a ca
esi ore a e he o r phi l
f t esofat bltc os s c i n wih t i ntt a l a i ofm ag i se r t i t s
eaur
a e r s e to t he de iy nd oc ton
nesum t a a e n he nme
fe d ofviw .2 The i a fom t t tng s
il
e 2
m ges r he esi how mag i se r t t be e nl diti e
nesum t a ae o
ve y srbut d
t oug utt c e oft W as tbl t- i l ng wihi t t blts mes n i g a eshr ho he or
he ton a e ncudi
t n he a e '
alm ne r nul
t e f r ng am a r c c l ho oge oussr c ur i a1 oft vol oft m e an i
herby o mi
c os opialy m ne
tu t e n 1 he ume he s lm ne
g an e . Thus t lpo lc marx i l t wihi one or m or ot r s t nc - t
r uls
, he i phii
ti s ocaed t n
e he ubsa es he

l i undiput t tt
ts
s ed ha heW a s ANDA Pr uc con a nsm a i sea a e a t t
t on
od t t i
gnesum t r t , nd ha
fom bot sde t tfedt tmag sum
r
h i s esii ha
ne i
mag sum sea ae i lpophii Furhe ,e t
ne i t r t s i
lc.
t r xpers
sea ae i t s l ofahyd oge t f ty a d- oneoft c t goresofs t nc lse i t
t r t s he a t
r naed a t ci
he a e i
ubsa es itd n he
1
9

'20Pae tsCli 1a . L e Tra Tr Da 3a 1 8:2t 1 9: t n oDie t; il . y5
7 tn ' am () s e il . y t 6 1 o 6 5 sik r c) Tra Tr Da
a 6 1 - ( b Cr sl. W h t e ma n su se rt h sametngp n beo 9 0C i a
t 4:220 Kibe o s)
eh r g e im taae a
li oit lw 0 s

l it fsnmiincopy t ntePrit,n abenm adlse itealnlw.ageofasampl s
on o c atn r bt echni at sa dwi b ofeesons dobtb an i
o etos ewe hquet e us l e d r t d no tiieo m
o
e
l
sEM i
c
ha es
ecr
a
e'
t
opogr phy,s h ast outi ofco es e g anul i at bl c os -ec i
a
uc
he lne
mpr s d r es n a et r s s ton. W hent be m
he a
ofelc r nsi ng on t s m pl s co r e e to a ee itd a deeced t f m a
e to mpi es he s e, e nda y l cr ns r m te nd t t o or n

i g . ( ilTr Da 1a 7 3t 7 : ( g yDie t) Ac o dngt Plitfs e eqEth s
ma e Tra . y t 7: o 84 Bu a r cl. c r i o anif ' xp r s l i
l
n e h iue tl d n h h r c u ia i usr . Tra Tr Da t 83 4
z
'
i ave. c mmo tc n q uiie i t ep n ma e tc lnd ty' ( il . y 1a 7 :s l o
y
( EDX Dieeci que conduct d i t snme apparausasSEM ,buti t ad ofm oniorng
Bu a i rcl.
g y sat )
t mi
2
1
e n he
t
ns e
t i
s co r eecr ,EDX monior X-a e itd fom elm e a nucliofa s mpl The
e nda y l tons
t s r ys m te r
e nt l e
a e.

e te X-a aeu iu t e c pat u a ee n . ( il . y 1a 7 5 21( a Die t)
mitd rys r nq e o a h ri lr lme t Tra Tr Da t 8:- Bug y r cl.
c
S c u ldwihEDX alwsfrt ed tcino a ee n a alc t n i tesmpe ( il
EM o p e t
l
o o h ee to f n lme t t o ai n h n l. Tra
o
Tr Da 1a 7 :2t 8 1( g yDie t)
. y t 82 o 0: Bu a rcl.
2 Thi wa as donet i tf and l a es lm sa c gl ol t a dic s d be ow.
2 s s lo
o den iy
oc t odil t r h yc ae, s s us e l
1
6

m e anmi gr uls- i a or nce wih t Cour' c tu ton ofE nne lpo lcm arx.'
s l ne an e n cc da
t he
ts onsr c i
s r i phii ti '
i
W hieDe e
l f ndan sa tmpt d t ca tdoubton t r la lt oft SEM t te e o s
he e ibiiy he
EDX t si done
e tng
by Dr Buga e n i yi t thi r ulsa e f tf t ' ofi m e rng' fo t mi r om i
.
y, ve mpl ng ha s es t r l iacs' l a i ' r m he c ot ng
ar
s
pr s ,2 D ef nda t ofe ed no e r t tm o t tDr Buga s r uls e bi çsra i ,
oce s 3 e n s f r
xpe t esi ny ha .
y' es t xhi t stitons'
'

l r t rngs or G l ng' - a 1of whi a e c a sc i c a of çs e rng' a a e wi l
t aei '
c
' é dozi ' 1
bul
ch r l s i ndii
lm a i ' nd r dey
r c ze bya ytc lche it a s h. Addii ly, .
e ogni d
nal i a
m ss s uc
tonal Dr Buga e m i d sxcr ss c i
y xn ne i os - e toned

s ra e wi S EDX (h e s ra e fo t tbes, t e c s ra ep o dng smi r
u f c s t EMh
tr e u fc s r m wo a lt) wih a h u f c r vii i l
a
i a s. Thi de o ta e t co it y oft me hods
m ge
s m nsr t s he nssenc
he t .
De enda sas ar d t tDr Buga si age s
f nt lo gue ha .
y' m s howi m a sum se ae wihi t
ng gne i t ar t t n he
me a n neg mm l i i onsse wiht W a s m a a t ng pr s t taddsmagne il
s l mi r es s nc it nt t he ton nuf c mi
oce s ha
slm

se rt t te ga ulsa trte ga u e a ef r d. Ho v r a e pli e b Dr S n o t
taae o h rn e je h rn ls r ome
we e , s x an d y . i k ,he
m e a a negr lsha po es a t m a sum sea ae i a e t i itat t por oft
s l mi
mm e ve r , nd he gne i t r t s bl o nflr e he es he

g a ue u o tb e c mp e so ( il . y3a 1 3:6t 1 5:8t n oDie t; il .
r n ls p n a lt o r sin. Tra Tr Da t 7 1 o 7 1 sik rc) Tra Tr
Da 1a 2 :- 2( a De )(1 W o l ib fi t s yt tny u e p re c a1 rn lswil
y t 015 1 Tin p. f
Q: ud t e ar o a ha i o r x e in e 1g a ue l
h v s mep r si t e A: s')
a e o o e n h m? Ye .).
'
Anot ra gument Def nda si t tt 9 Paen r quie a i
he r
by e nt s ha he 720 t t e r s n nnerlpophii m arx
i
lc ti
t ti s i l ts r t a ditnc ' fom t out rhydr lc ma rx. De e
ha s pataly tepa a e nd si t' r he e
ophii ti
f ndant c e
s ont nd
t t t pr s nc of s um sa c g yc a e i i t m e aami gr nul a mag i
ha he e e e
odi
t r h l olt nsde he s l ne a es nd
nesum

se r t outi t m e a n negr nul me t tt W a s AN DA Pr tc ansf i d
t a a e sde he s l mi a es ans ha he ton
oduc ont i l xe
m
2 M ir om yi us d f t c eai ofta , os - e tone s f e . Dr Buga us d
3 c ot
s e or he r ton l t cr s s c i d urac s
.
y e
mi r t
c o omy t pr par t t bl ts mpl sf SEM o e e he a e a e or
EDX a l i. l d ng s Dr Buga e e
nays s n oi o, .
y poxi d
e ch tbl to o aT- ountand posto d asai es se bl e a apr t r ne a l The
a a e nt
m
ii ne t nl s tel ad t ede e mi d ng e.
t blti t nbr htdownwa d a r st bl dei a rpeii f s on. Fort fnal epa a i
a e s he oug
r c os he a n e ttve a hi
he i pr r ton
ofea h s mpl ,Dr Buga e pl
c n e .
y m oyed a e r mel s r di
n xte y ha p, amond-i
tppedbldet e
a o xpos t
e he
fa ts pos i e s f cef anayss.
l te t sbl ura or l i
1
7

ma rc r whi h i outi t s ope oft 5 Pa e . I s
ties' c s sde he c
'
he 720 t nt n uppor oft sa g e ,Def nda s
t hi r um nt e nt
r l on t pr e uton hit y oft 9 Pae a Dr Ki st si ony t tt ' Pa e
ey
he os c i
sor
he 720 tnt nd . bbe' e tm
ha he 720 t nt

r q r Ss pa ae a ditnc' ma rc .
e uies se r t nd si t' ties
As a es e durng c am consr to a de onsr t d a til t Pae doe not
ddr s d i l i
tuci n, nd m ta e t ra , he tnt s
r quie a pa tc a physc lor s ta sr t e wih marc s pa a e a ditnc fom e h
e r
ri ul r
ia
pai l tucur t
ti es e r t nd si t r
ac
o he .4 Ra he , ha m at r i t r ltons pbet e t e pi nt i dif r ntl tons As
t r2
t r w t te s s he ea i hi we n he xci e s n f e e oca i .
t tfe t by Dr Si
esi d o
. nko,t t r çi r'a S e ' s t i ty de c i t rghtplce i
he e ms dnne ' nd t r' ufk en l s rbe he i
out
a n
whi hea h ma rxm us bei or rt pe f m isf ton a c r t r e eofm es a i z
c c
ti
t n de o r or t unc i nd ontol he elas
alm ne.s
Furhe , aitfsha s
t r Pl n if ve hownt tt W as ANDA Pr uc ' i
ha he t on
od ts nnerlpo lcm arx i
i phii ti s
t ma i sea a e is l t ti dipe s wih t me a a ne i t g a e . Onl t
he gnesum t r t t e f ha s s r ed t he s l mi n he r nul s
y he
m a sum sea ae m a up t i rlpo lc ma rx. Pl i if ha a s s
gne i t rt
kes he nne i phii ti
antfs ve lo hown t tot r
ha he
c mi a s t nce c n bepr e wihi t s m er gi a t lpophii e i e s a t tt
he c l ubsa s a
es nt t n he a e on s he i
lc xc pint , nd ha he
s um sa c gl l t f und wihi t g a es f wihi t ç i ly ot r e i e s'
odi t r h yco a e o
t n he r nul ks t n he s ona l he xc pint'
opt

l tto o Cli 1c.
i ain f am ()
mi
Afe c i rng t e de epr s nt a t t si ony fom bot Pa tes Ifnd t t
tr onsde i he vi nc e e ed nd he e tm
r
h ri , i ha
Pl n if ha pr n by a pr pond a e of t e de e t t t W aton ANDA Pr t
aitfs ve ove
e
er nc
he vi nc ha he
s
oduc

2 Asn tdi teCo r' cam c n t to Or e ,t wh r ) nt p o e ui nhit r , li ,
4 oe n h u ts li o smcin d r çno ee i he r s c to so y cams
g
o s e i ai ndo st etr Se aaea ddsic ' p e r' ( 1 7a 8 .
r p ct to e h em sp rt n it t a p a . DE 4 t )
k
n
'
2 A e ane by Dr Si on c os e m i ton,e pi sf
5
xpl i d
. nko
r s xn na i xci ent ound i dif r ntl tonswihi
n fe e ocai
tn
s
t t bltwilply dif r ntr es Fore mpl t m a slm se r t l t d i t g a e
he a e l a f e e ol .
xn e, he gne il t a a e ocae n he r nul s
wilha a efe tont r l s oft m es l mi ,whe e smag sum se r t i t
l ve n f c
he eea e he
a a ne
ra
ne i t a ae n he
e r gr nul rs c wils r asal brc nt Si ia l s um sa c gl a ei t
xta a a pa e l e ve
u i a . m l ry, odi tr h ycolt n he
e r gr a s ewilaf c t r e eofmes l mi , l s um sa c gl a ewihi t
xta mml r pac l fe t he elas
a a ne whie odi t r h ycolt t n he

ganuls-a or ngt Dr Siko- wilbeirlva . ( Tra Tr Da 3a 232- . Thus
r e cc di o . n
l ree nt See il . y t 233)
,
at ug t s s bsa sa et ma rx-or ng s bsa si t t bl , c hasd fe en
lho h he e u t nce r he ti f mi u t nce n he a et ea h
if r t
fmci de ndi o isr lto t t g a es Thi a s doesno vi aet S onssi of'
t tons pe ng n t e ai n o he r nul .
s lo
t ol t he û itng
c
lmia i a t s u sa c g yc ae wihi t gr nul sdoesnotf m t i rlpophii
i tton, s he odi m t r h l ol t t n he a e
or he nne i
lc
m arx a i unr l t t t see e o t Cl i .
ti nd s e aed o hi lm nt f he am
1
8

c ansan S nn rlpophii m arx' t ti doc t d wihi one orm or ot rs t nc y'snc
ont i
f e i
i
lc ti ' ha s i a e t n
l
e he ubsa es' i e
t lpophii m arx c a ne by t g a es i l a e wihi a l s t s um sa c
he i
lc ti onti d
he r nul s oc t d t n t ea t he odi
tr h
gycolt pa tc e ou sdet gr nuls Thus t sa pe tofCli 1hasbee m e .
l a e ril s t i he a e .
,hi s c
am
n t
ii
i.

çM eli Poi sBeow 900C'
d tng nt l
'

I o d rf rma n su se rt t fl wi i Cli 1a ' ram ofs b tn e ,i mu t
n r e o g e i m ta ae o al t n am ()s e l
h
u sa c s t s
ha m etngpoi sbel 9 C. Esa ihi t m etng poi sofa s t nc m i hts m lke
ve li
nt ow 00
tbls ng he li
nt
ubsa e g ee i

a e s c n e tho v r i t i c s ,h metn p it ( rter n eof e rt e a whiha
n a y o c p ; we e,n hs a e te lig on s o h a g tmpeaurs t c
s ldb gn t tr fo as ldt lq i )o ma nei m se rt ha b c mehol c ntse .
oi e is o u n r m oi o iu d f g su taae s e o
ty o e td
To pr t tmagnesum se r t ha me tng poi t beow 900C,Pl i if 'e r Dr
ove ha
i t a a e s li
ns l
antfs xpe t .
Buga t t d t m a i sea ae f
y ese he gnesum t r t ound i t W as ANDA Pr t2 Dr Buga us d
n he ton
oduc . 6 .
y e

i r r s c r co t deer i t tt m a i sea a epr de by W a s n i ahydr t of
nf aed pe tos py o t m ne ha he gnesum t r t ovi d
to s
ae

ma n su se rt (lo k o a $ g su se rt dh d ael.; Plitfsas p o i e
g ei m taae as n wn s : nei m ta ae iy rt' z an if lo r v d d
ma
t tsi onyofDr Ro f Pi l a e r on t is ofm eli poi s Dr Pi l who Ifnd
he e tm
. dolo na , n xpe t he s ue
tng nt . . na ,
i
t bec e bl ,r le onDr Buga stsi r s t a s r lpas-a pr s ntda r f r est
o r di e ei d
.
y' e tng e uls nd eve a t nd e e - y e e enc o

2
6Spe t al , Dr Bug ys j ce teW as nma n sl se r t smp et dfee ta
cik ly . a ube td h
to g e il ta ae a l o ifrn il
m

s a nn c lrmer (DSC' a dte mo rvmerca ay i ($ ', o ho whc aef r
c n ig ao i ty $ ' n h r g a i ti n lss G
t )
TGA' b t f ih r o ms
)
o t ema a ay i. DS me s rsh a to o as mp ea i i s be t dt ahe tn pr fl
f h r l n lss C m u e e tl w f n l s t s u j ce o ai g o ie
nut t n e
aue
( . , ni r% ei tmp r t a ac nsa t ae s as 100C perm i e,wihi at mper t r
eg.a nce n e e ame t o tn rt , uch
tng ) l asmpeun eg e at ema ta sto wihnt te e au ern e he tma to
a e. f a l d r o s h r lr n iin t i ha tmp rtr a g , a y l w
i t oroutoft t t d s mpl . A ta ii whe e he tfowsi o t s mpl i kno asa
no
he ese a e
r nston
r a l
nt he a e s wn n
e he mi e nt A ta ii whe e he tfowsoutoft s m pl i known a a exot nni
ndot r c ve . r nston
r a l
he a e s
sn
he c
e . An e t r i eve i rpr s nt by adownwa d pe k on aDSC t r ogr m . Bot
vent
ndo he m c nt s e e e ed
r a
he m n
h
m etng a de
li nd hydr ton a e e do he mi eve s
ai r n t r c nt .

TGA me s rsweg tls o g i fo asmpl a i i s be tdt h ai . A weg t
a u e ih o s r an r m n e s t s u j ce o e t
ng
ih

l sma i i a et tt ma e i ha s m er i ua s ve o ise e i t ti gi of, ,n
os y nd c t ha he t ral d o esd l ol nt n t xtror ha s ven f or i
t ca eofahydr t ,awei l sma as i c t t e uton oft waerofc ysalz ton
he s
ae
ght os y lo ndi a e he vol i
he t - - r t lia i
f om a s m pl
r
a e.
2 M a sum sea a eca e s i dif r f m s s h astdi a e'a t nbydr t ,'
7 gne i t r t n xit n fe ent or , uc
û hydr t ' nd t
n
a e'
i c tng t pr enc ofwae m olc es
ndia i he es e
tr e ul .

co ude t tt m a i m sea a e us i t W a s ANDA Pr
ncl
ha he gnesu t r t ed n he t on
oductha a m etng poi t
s
li
n
beow 900C. Dr Pi la s r i on t webst of W a s n' m a i se r t s i r
l
. na lo eled
he
ie
t o s gnesum t a a e upple ,
Covi e ali kr , c r po t m a il se r t t ha am etng poi beow 900C.
di nN lnc odt whih e rs gneslm t a a e o ve
li
nt l
De e n spr de isown e r i t se d,Dr Ha r Brtan,
f nda t ovi d t
xpe t n he l
. ry iti who r le on hi own
ei d
s
r f r nce ,as wela Dr Buga s t s r s t t s
eee s
l s .
y' e t e uls, o uppor W a s s a g e t mag i
t t on' r um nt hat
nesum

sea aedoesno m etuntla tm pe a ur i exc s o 10 C.
t rt
t l i e r t e n e s f 00
Dr Buga s t tng de onsr t s t e t r i eve s o a o
.
y' esi
m ta e wo ndo he m c nt : ne r und 800 C,a her
not

aomd 1 5 C. Th r i n d s u eta t es c n e d t emi p a ( on fo lw t hih
rt 2 0
ee s o ip t h t h e o d n oh r c e k g ig r m o o g
m
i t a z
tmp rt r)i ameto te n hy ousfor ofmagnesum searte.B H owever i i t efrt
e eau e s
l f h n dr
, t s h is
pea beg l i bel 900C,o whih t e rsbut he . Pli if 'expe tcli st tt
k, im ng ow
n
c he xpe t t ads a ntf s
r am ha he
frt pea i t smula ous de a i and m et of mag sum se r t di a e. Thus
is
k s he i t ne
hydr ton
l
ne i
t a a e hydr t
,

a c ri gt Dr Pia ,h ma ne i se rt u e i t W as nANDA P o u t(h d h d ae
c o dn o . n lte g sum taae s d n he to
r d c t e i y rt

fr h sametn pon b l w 9 0 Dr Brtan, nt eoh rh n camst th frt e ki
o m) a
lig it eo 0 C. . iti o h t e a d, li ha te is p a s
onl t dehy ai n ofmagne i sea ae,a t mag sum se a e S t' a t s c
y he
dr to
sum t r t nd hus
ne i t ar t t s' t he e ond
mel
0
gnesum t r t s hydr t z
aed.g
en t r ce nt when t t m pe am e i a
dohe mi ve ,
he e r t s bove 90 C andm a i sea a ei de
Consde i t dif r n e r opi onsa t e de epr s nt lfnd t tPli if
i rng he fe e t xpe t ni
nd he vi nc e e ed, i ha a ntf s
ha pr ve by apr ponde anc oft e de et tmag i se r t di a e- t s tnc
ve o n
e
r e he vi nc ha
nesum t a a e hydr t he ubsa e
us d i t W a s ANDA Pr t- m et beow 9 C. I m a ng t sde e mi ton,lf d
e n he t on
oduc
ls l 00
n ki hi t r nai
oun
Dr Pi lsa l ssve y c edi e. Spec fc l Dr Pi e aned t tt s co e he mi
. na ' na y i r r bl
ii aly, . nal xpl i ha he e nd ndot r c
2 Thehydrt f m ofm a i sea a ei ac ysa lnesr ctr whe ewa e f
8
aed or
gnesum t r t s r t li t u tte r t r onnspar oft
t he
c ysa ltie sr t e Thede dr t f m ofmagne i sea a ei alo ac ys alne
r t l a tc tucur .
hy aed or
sum t r t s s r t li
sr t e;howe r i doesnotha waermol c e .
tuc ur
ve , t
ve t
e ul s
2 D ï Brtan o ne t thydr t c d no smula o l de a ean mel. Howeve ,Dr
9 . it i pi d ha
a es oul t i t ne usy hydr t d t
r .
Brtai di notr e t any lt r t ei a vi a t so ni a Pli if we ea et poi t
it n d
ef r o
ie aur n ni ng t hi pi on, nd a ntfs r bl o nt o
ar f r et tco r di t t sa ol topi on.
e e enc ha nta ced hi bs ut ni
20

pe i Dr Buga s t tng s
ak n .
y' esi howsa ve y s r pe t ti t mel fom a pur hi h quaiy
r ha p ak ha s he t r
e, g
lt
cr t l Thi i i pora be a ei de o ta eswha ha
ysa .
s s m tnt c us t m nsr t
t ppene du i t fr tpe
d rng he is ak. Dr Pi l
. na
opi t ts h ahi q lt cr t lnee t be pr uce fo a lq d,a sncet tlqui
ned ha uc
gh uaiy ysa
ds o
od d r m i ui nd i ha i d

woul ha t be c e t d durng t fr te he mi pea t c ysali m a i se r t
d ve o
rae
i he is ndot r c k, he r t lne gnesum t a ae

di r t mus tun fo s i t lqui durng t fr tpea Dr Pi lalo r i on t
hyd ae
t t ' r m old o i d i he is
k. . na s eled
wo
lt r t er e e st tr pore al sofa s r 3 a c
ie aur ef r nce ha e td os
niotopy 0 c ompanyi t fr te he m oft
ng he is ndot r
he
DSC f magne i sea a e. Thi bolt e hi opi on t tt d hydr ton of m a i
or
sum t r t
s ser d s ni ha he e
ai
gnesum
sea ae a t fr tendo he m i pe k wa a compa e by am et
t r t t he is
t r c a
sc
ni d
l.
Ialo a knowldget tm a pr e - y r f r nc i c t t tm a i se r t has
s c
e
ha ny es ntda e e e es ndi a e ha gnesum t a ae
a m etng poi f r a
li
nt a bove 90 C. Ho ve ,i wa c e r fom t t tmony t tt e meli
O
we r t s l a r he esi
ha hes
tng

poit a e t e oft a
n s r hos
he nhydr f m ofmag sum se r e,whi i notus d i t W a s
ous or
ne i t a at
ch s
e n he ton
ANDA Pr uct W hie t e rswer i onc usve a t why s e r f e s- nn ey, he
od .
l he xpe t
e nc l i s o
om e er nce
m l t
Ha
ndbook ofPha m a u i a Excpi nt - cha d t m etng poi ofm a sum se r t t t
r ce tc l i e s
nge he li
nt
gne i t a a e o he

hi r n
ghe , nhydr f m m etngpoi si r e e tons t si ofltl c e
ous or
li
nt n ec nt dii , hi s ite ons quenc t t Cour
e o he
q
a Pl i if ha s
s antfs ve hown bya pr ponde a eoft e de et tt hydr t d f m ofmagne i
e
r nc
he vi nc ha he
a e or
sum
se aef md i t W a s ANDA Pr uc beg nst t nt lqui a t fr te t r i pea
tar t ot n he t on
od t i o ur o i d t he i s ndo he m c k.

a Do tieo uv lns
. crn fEq ia e t
Eve i t meli poi ofmagne i se r t we ef
n f he tng nt
sum t a ae r oundt be a
o
bove900C,hedoc rne
t
ti

of e ui l nt woul ne rhe e s r quie a fndi ofi rnge e . Spe tca l m a i m
q va e s
d ve t l s e r i ng nfi m nt
cil ly, gnesu
se r t i eq va e t se rc a i whih i lpophii and a hydr enaed f ty acd t thasa
t a a e s ui l nt o t a i cd, c s i
lc
og t a t i ha

3 Anio r i apr pe t ofc ysal whe sudid underpol rz d lg . Thel sofa s r py
0
s topy s o ry r t s n t e
a i e i ht
os
nioto
i as oc ae wiht l sofc ysalniy. Thel sofc ysa lniy i alo c itntwih am et
s s it d t he os
r t li t
os
r t li t s s onsse
t
l,
o t f ma i ofa lqui
r he or ton
i d.
21

me tng poi bel 900 C. Pl i if expe t tsii d notonl t m ag sum sea a e and
li
nt ow
antfs'
rs e tfe
y hat
ne i
t rt
se rcacd a e t e ae compounds'butas t tt y bo h a ekno t pe f m t f ton of
ta i i r i lt d
r
,
'
lo ha he t r
wn o ror he unc i

sowi d ug r l a e by vit oft i lpophii naur l f c ,Dr Si t tfe t tusng
l ng r e e s
rue her i
lc t e. n a t . nko esii d ha i
se ca i i t ' Pa e a usngm a i m sea a ei t W aton ANDA Pr tha t
t mi c d n he 720 t nt nd i
gnesu t r t n he
s
oduc s he

smer s l:two d c n r lt rla e o me an ne ( ilTr Da 3 a 20 1 - 9 t ik
a e ut i ul o to he ee s f s lmi . Tra . y t 5:3 1 sn o

Die t)3 I essence, P an if h v s o t tt u e o ma n su se rt i t W as n
r cl 1 n
litfs a e h wn ha he s f g e im taae n he to
.

ANDA Pr
oductperor s t i ly t s m e f i i s t nta l t s m e wa wih
f ms ubsanta l he n
uncton n ubsa ily he n
y t
s tnta l t s me r ul as t us of sea i a i wih a m etng poi be ow 900C. Se
ubsa ily he n
es t he e
t rc c d t
li
nt l
e
Cr Pac agig,559 F.d a 1 2.
own k n
3 t 31
Ac or ngl Ifndt tPl i if 'ha m e t i bur nt s t t unde t doc rneof
c di y, i ha antfs ve t her de o how ha ,
r he ti

e va e s t W a s ANDA Pr t m e t Cli 1 s r quie e of a lse lpophii
qui l nt , he ton
oduc
e s am ' e r m nt
itd i
lc
e i e wih am etng poi be ow 900C.2
xc pint t
li
nt l
3
tout rHvdr lcM arx'
ç e
ophii ti '
The Cour ha c tue t tr E erhydr lcm arx't m e n <amati ofa l s
t s onsr d he e m %
out
ophii ti ' o a <
rx
t ea t
onehydr lc e i e ,whe et ma rx i l a e outi t i rlpophii m arx.
ophii xcpint
r he ti s oc t d sde he nne i
lc ti '
d3

od t e a ds he
3 DT si sc ncuson t tt m a sum sea a ei t W a s ANDA Pr uc r t r t
1 . nko' o l i ha he gne i t r t n he t on
r l eofm e an i sba e on t t si a t si o
eeas
s lm nei s d he e tng nd e tm nyofShie' e r , Lite t
r s xpe t Dr. tl , he
de ii ofDr J hi aW a s f mul t , t t si a opi on ofDr Le Tr vi a
. e e no, n
ton or aor and he e tng nd ni
poston
. os ,
expe tf De e n swho t t d t di s uton pr ri ofW as smil mes a i
r or f nda t
ese he s ol i
ope tes
ton' led
alm ne

1aue. (e Til rDa 3a 2 52 t 2 61 tik Di cl.
rn ls S e r T . y t 0 :0 o 0 :8 sn o r t
a
e)

2 Dek d nsag eta a pyn ted crneo e uiae t wi viaea e iecam
fn a t ru h t g lig h o ti f q v lns l t t n nt li
l i
r

lmia i - t tt lpophil e i e shavemeli po nt be ow 90 C. Howe r unde t
i t ton ha he i
lc xc pint
tng i s l
0
ve ,
r he
t a iy oft cr lmsa e lfnd t tt t llmia i nze'doesnotpr e a i to of
otlt
he icl tnc s, i ha he l i t tons l'
al
e mpt pplcai n
t doc rne. N o a y,se rcacd a m a i se r t woul ha t s m ef nc i i t
he ti
t bl t a i i nd gnesum t a ae
d ve he n
u ton n he
p od t a m a sum se aeunde goesac ngebel 900C. W hehe t si ca ld am et
r uc , nd gne i t art
r
ha
ow
t r hi s le
l

o ad h d ain( rb t , wa p n tet c e c l i tef r lto wo db a
r e y rto o oh) s p i g h wo h mias n h o mu ai n ul e n
i s b tn il h n e S eP e, n . .T v Ph r . US I c, 9F.d 1 6 ,1 7 - 0( d.
n u sa ta c a g . e hz r I c v e a a ms, A, n .42 3 3 4 3 9 8 Fe
Ci. 0 5 (iainso te )
r 2 0 ) ctto mi d .
t
22

I i t s e t tt W a s n ANDA Pr tc ai s um sa ch gl ol t a t t
t s mdiputd ha he t o
oduc ont ns odi tr
yc ae, nd ha

s du sac gy oaei asac d rv tv t a ft wi nt es b tnc slse i Cli 1b .
o im tr h lc lt s tr h ei ai e h t is t h u sa e itd n am ( )
hi

( e DE 2 2 1a ! 3 - 9 . Plitfsc n e dt a s du sa c gy oaei t W as nANDA
Se
0 - t ! 7 3 ) an if o tn h t o im trh l c lt n he to
Pr tf m sa hydr lc m a rx i t e r gr a s c outi t m es a i gr nul s
oduc or
ophii ti n he xta mml r pa e sde he
alm ne a e ,

wh c c nant el o hlcmarx. ToPlitfs t sstsist r q ie n o Cli 1b t a
ih o t i h i p ii ti
p
anif,hi aife he e ur me t f am ( ) h t
t hydr lc ma rx beousi t i rlpophii m arx.
he
ophii ti
t de he nne i
lc ti
Pl ntfs hav s id ampl e de
ai if
e upple
e vi nce a t si ony t s
nd e tm
o uppor t i poston.
t her
ii
Specfca l Dr Buga s SEM ii ly, .
y'
EDX t si r ve l t m a r c c l ho oge ous
e tng e a s he
c os opialy m ne

diti i n o s um sar h gl l t i i and ou sde t mes l mi gr esi W a s s
srbuto f odi t c yco a e nsde
t i he a n ne anul n ton'
ANDA Pr duct M or r t SEM o .
eove , he
EDX ove l y i a s s
ra m ge how cuse s of s um sa c
l tr
odi
trh
gl l t i t extag a a s c oft W a s t bl t Dr .Buga a Si t sii d t t
yco a e n he r r nulr pa e he ton a e . s
y nd nko e tfe ha
t s aggr ga e of s um s a c gl olt f m t out hyd ophii mati s i t
he e
e ts
odi
tr h yc a e or he
er
r lc
rce n he
e r g a a s e.
xt a r nul r pac

De e n s a gum e r ga di t hydr phii m arx i smia t t i a gume
f nda t ' r
nt e r ng he
o lc ti s i lr o her r
nt
r ga di t lpophii mati bec us mag sum se r t - t lpophii m arx-or ng
e r ng he i
lc
rx: a e
ne i
t a a e he i
lc ti f mi

s bsa e- i pr s nti t e r gr l rs ewih t s um sa c gl a e,hem arc a e
u t nc s e e n he xta mm a pac t he odi t r h ycolt t
ties r

mie a d s c d a p e e ev oae te ç o ssi g o 'l ttonofCli 1b . The as
x d, n u h u l r snc ilts h s n itn f i ai
c
mi
am ( )
y lo
cai t s r nde s t Snne ' a d er' ma rx r quie e s m e ni es . Howe r a
l m hi e r he ç r' nd t
i
out ' ti e r m nt
a ngl s
ve , s
di c s d a
s us e bove t sa gum e i t va lng, t ma rc ne d notbe%s pa a e a ditnc '
, hi r
nt s ma ii as he ties e
te r t nd si t'
a t mag i sea a eouti t gr nul sdoe notf r t lpophii m arx underCl i
nd he
nesum t r t
sde he a e
s
o m he i
lc ti
am

1a . Rahe ,t ma i se r t i t e r r nulrs ema ha a he f ton( g.
() t r he gnesum ta ae n he xtag a a pac y ve not r unci e. ,
3 Asno eda ve t t r S arx'i c t u d t me f ma r c c l homoge
3
t bo , he e m t ti 's onsr e o an t c os opialy
m
a
neous
sr t e i a 1isvol '
tucur n 1 t ume.
'

l b ia t a d i t eae t t e f r to o t e marc s S mial i i te e ta rn a
u rc n ) n s mr ltd o h o main f h tie . i lry, t s h x rg a ulr
s lm sar h gl l t is l t tm a sup t outrhydr phii m arx. Thi t e ' mati i
odil t c yco a e t ef ha ke
he e
o lc ti
s G r' rx s
out

not i ngwiht i rlpo lcm arx, c i onet mag sum sea a el a e wihi t
m xi
t he nne i phii ti whih s
he
ne i t r t oc t d t n he
gr nu e .
a ls
He vi consde e t evi nce and t a gu nt m a by bot sde ,I fnd t
a ng
i r d he de
he r me s de
h i s i hat

Plitfsh v s o b aprp n ea e o t e e ie c ta Cli 1b i i rn e b t e
an if a e h wn y e o d rnc f h vd n e h t am ( ) s nfig d y h
W a s n ANDA Pr t Spe f l Pli if haves
to
oduc .
cikaly, antf s
hownt ti i mor lkey t nnott tt
ha t s e i l ha
ha he
s um sa c gl l t i t W a s AN DA Pr tf m sahydr phii ma rx t ti ou sdeof
odi t r h yco a e n he ton
oduc or
o lc ti ha s t i
t me aami gr nuls t t c ai t lpophii ma rx. Thus t hydr lc m arx i
he s l ne a e ha ont n he i
lc ti
, he
ophii
ti s
S e 'wih r pec t t lpophii m arx.
t r' t es t o he i
out
lc ti

tW he ei t Ac i I e e ti Dipe s d Bo h i t Li phii M arx
< r n he tve ngr di n s s r e t n he po lc ti
a i t Hvd ophii M arx'
nd n he
r lc ti '
The fna lmia i ofCli 1 i t tmes n i mus be dipe s d3 i bot lpophii
lc
i l i t ton
am s ha
alm ne
t
s re 4 n h i
a hydr lc ma rc . To de
nd
ophii
ties
monsr t t diti i of me a n i wihi t W as
ta e he srbuton
s l m ne t n he t on
AN DA Pr t Dr Buga anayze t oft s ac he a l d by SEM a EDX wih
oduc , .
y l d wo
he mf es
nayze
nd
t
Ra a i i .3 Each s f ceDr Buga a l d s
m n mag ng 5
ura
.
y nayze howe m e aami consse l postone
d s l ne
it nty ii d
t oug tt e ie t di e i la e oft c os - e tone s f e. l s ,t Ra a
hr hou he ntr wo- m nsona r a he r s s c i d urac n um he m n
i a ng s
m gi howsm e aa i dipe s d t oug
s lm ne s r e hr houtt en iet bl t
he tr a e .
3 v s r e 'wa c tuedt mea tufi i n l mi d t i om or t one s t ewih
4 t pe s d' s onsr
Di
o
nçs fc e ty xe o nc
ae
ubsanc t

a oh r' ç W l eenme aa n i i o p rtdwi t elp phlcmarxa dt eh d o hlc
n te . s h r i s lmie s nc r o ae t h i o ii ti n h y r p ii
' g
h
ma rx'wa consr dt mea t r i m e a n n i s t intym i dt i m o aei wihi
ti ' s
tue o
n i e n s l mi e s ufk e l xe o nco r t t t n
whe
bo h t lpophii mati a t hydr lcm arx.'
t he i
lc rx nd he
ophii ti '
3 Rn a i i i af m ofs cr c t ta l f i ntfc ton ofc mi lc
5 m n mag ng s or
pe tos opy ha lows or de ii a i
he ca ompounds
.
Ra a s tos opy me ur svi ai na fe ncesbewee dif r ta oms andt fe ncy
m n pecr c
as e br to l r que i t n fe en t ,
he r que
oft vi a i de ndson t sr t eoft c m ialc
he br tons pe
he tuc ur
he he c ompou
nd. CouplngRa
i
man
s tos opywih am ir c ci a ngt hni a l f t de e m i ton oft l cai of
pecr c
t
c os opi m gi ec que lows or he t r na i
he o ton
ac
ompound ofi e es - i otrca e,mes a i
nt r t n t s
alm ne.
24

As pr vi l dic s d,t macos opi aly hom oge ous diti i ofm a slm
e ousy s us e he
r c c l
ne
srbuton
gne il
sea ae i t W a s ANDA Pr uc ' gr nulsg ve rs t a i rlpophii m arx. Furhe ,
t r t n he ton
od ts a e i s ie o n nne i
lc ti
t r
i ha bee s wn t tmes n i i s t i nty mi dwihi t gr nul s3 Thus wih r ga d
t s n ho ha
alm ne s ufk e l xe t n he a e .6
, t e r
t t i rlpophii marx, antfsha de o tae byapr ponder nceoft e de t t
o he nne i
lc ti Pl i if ve m nsr t d
e
a
he vi nce ha
m e an i i dipe s i t i rlpophii m arx.
s lm ne s s red n he nne i
lc ti
Pl i if 'e t Dr Si
antfs xper, . nko,r le on W a s sma acurng pr s ,t t si ony o
ei d
ton' nuf t i
oce s he e tm
f

W a s f mult r ,M es r .Gupt a Ti n,a we la t Ra
t on or a o s
ss
a nd a s l s he man i agi t c ude t t
m ng o oncl ha

me anmi i dipes d i t hydr lc marx. ( e TralTr Day 3 a 1 6 1 t nko
s l ne s s re n he
ophii ti Se i .
t 89:- 5 si

Die t) Dr Sik e pli d t a d ig t e ma u a trng p o e s o t W as n ANDA
rcl. . n o x ane h t urn h n fcu i r c s f he to
Pr d c,fi e '( rs l pat ls o me an nea ec e td dlig t g a uain p o e s
o u t ç n s' o mal ri e ) f slmi r rae t n he r n lto r c s.
f
c
r
Thes û i ' ca alo be c e t d durng t milng se ofm a acurng. The mes a i
e t nes' n s
f
rae
i he li t p
nuf t i
alm ne

g a esa fnesa e mi d wih o he i r dint , ncudi s um sa ch gl ol t ,durngt
r nul nd i r xe t t r ng e e s i l ng odi t r yc a e i he
ma acurng p oc s . Pl i if c e t tt e fnesa e s alpm il sofm e a n ne a
nuf t i r e s
antfs ontnd ha hes i
r m l
ce
s l mi nd
a e ou sde of t gr nul s i t e r gr nulr s e. One of t W a s ANDA Pr t
r ti
he a e n he xta a a pac
he ton
oduc

f r ult s Rag v a Gu a,t tûe by vi ot d de ii t tbot gr nul a tnes
o m a or , ha endr pt esi d
de ape poston ha h a es nd s
lo e tfe ha
a e f med d i t gr nulton se oft m mm f curng pr es .1 He a s t sii d t t
r or
urng he a a i t p
he
at i
oc s3

l so im sac gy oae wh nmie wi t eg a uain,two dbemi ig wi t sn s
d q d u trh lc lt , e x d t h rn lto i ul
l
h
xn t he e
h
a s s i wilbego ngi o t whol ma rx, c woul bet gr nulsa t fnesobt ne
lo, o t l
i nt he
e ti whih
d he a e nd he i
ai d

fo t g a uain. ( il . y3a 1 0:- 0( pa3 +- De ).
r m he rn lto ' Tra Tr Da t 4 7 1 Gu t 0 6 p.)
'

3 The Rn n i i s w st gr nul st ha t hi he tc entai ofmes l m i
6
ma mag ng ho he a e o ve he g s onc r ton
a n ne.

3 At n pon i t etsi n , . pae pan ta t d n tg t(ne h n rdp re t
7 o e itn h e t y Mr Gu t x lis h t t o o e o l u d e e c n
mo
we
ga ue . W eg t 1to sn sa we1' ( ilTr Da 3a 1 9 1 - 8( p a3 +- De .)
r n ls
e a o f e s l. Tra . y t 3 :5 1 Gu t 0 6 p).
'
25

De enda sar t tt e Sfnes'a em e e y s lrgr nul s a t t r ca be no
f nt gue ha hes ti ' r
r l male a e , nd hat he e n

d ie 'i t ee ta r n lrs c b c us te aete ev sg a ue . ( e Tra Tr Da 5 a
t n s'n h xr g a ua pa e e a e h y r h ms le r n ls S e il . y t
f
1 20- 2 ( bb Cr sl.8 I t ti s'a egr nuls t n mes a i c nnotbe dipe s d i
01: 5 Ki e o s)3 f he G ne ' r a e , he
t
alm ne a
s re n
t e r gr a outrh o lcma rx.
he xta mml r e ydr phii ti
Not t t ndi t s m a i ga e of Si vs g a e, ltnd t tPl ntfsha t
wihsa ng he e ntc m
i ne . r nul ' l ha ai if ve he
f
'
sr r a glme a have pr n by a pr ponde anc of t e denc t t m e alm i i
tonge r l nt nd
ove
e
r e
he vi e ha
s a ne s
dipe s i t o e hydr phii ma rx. Pl i if ha me t i btr n by de
s red n he ut r
o lc ti
antf s ve t he r lde
monsr tngt t
ta i ha

s l pa tc e ofm e aami a e i t e r r nul s c dipe s d wih t s um sa c
mal ril s
s l ne r n he xtag a ar pa e, s r e t he odi t r h
gl a e. M or ove ,a t tse t by Dr . a a Si t sc l i i s
ycolt
e r s esi d o
s Bug y nd nko, hi onc uson s upporedby t
t
he
R

i i e rme t ts
magng xpe i nt ha howsm es a neunior l diti e tuoughoutt t bl .9
almi
f m y srbutd l
he a et3

am an

I
V.

I
NVALI TY
DI

As dic s d a
s us e bove,De e ntW aton Fl rda a ks t Cour t de a e t tt '
f nda
s
o i s he
t o clr ha he 720

Pae i i ldt 35U. C.j11 f lc ofwrte desrptona orlc ofe e nt
tnt s nvai mder
S.
2 or a k
itn ci i nd/ a k nablme .
W a s Fl i a guest ti t W a s n AN DA Pr uc i f
ton orda r
ha f he t o
od t s ound t i rnget ' Pa e ,he
o nfi he 720 t nt t n

t Pae i i ld f l k ofwrte des i i a e blmen be us t W a s ANDA
he tnt s nva i or ac
itn crpton nd na e t ca e he t on
Pr
oduc i notade t l de crbe i ore bl d by t ' Pa e . Furhe ,W as Fl i
ts
qua ey s i d n
na e
he 720 t nt
t r t on orda
a gue t ti t c am sar c tue br d enoug t e ompa st W a s ANDA pr t
r s ha f he l i
e onsr d oa
h o nc
s he t on
oduc ,
t n t ' Paen ' wrte des rp i i i dequa ebec us i do nott a aç xe ma rx'
he he 720 t ts itn c i ton s na
t
a e t es
e ch d d ti '
mi
c
omposton.
ii

3 An t rW a s e pl
8
he
ton m oyee, r Tin,esii d by vi o de ii t tt e ç
M . a t tfe
de poston ha hes %nes'a ei d
' r ndee
o

g a u e . ( ilTr Da 2 4:- 9( a De ). Heas tsiidt a t e eçs e 'c nan
r n ls Tra . y 0 7 1 Tin p.
)
lo e tfe h t h s i n s' o ti
t
me an n i te ( il . y2 4:02 ( a De . .
s lmie n h m. Tra Tr Da 0 2 -2 Tin p)
)

3 Addii ly,De e n sdi not si o t i own t s t tt Si ' a ei e s al
9
tonal
f nda t d
e tng f her
o how ha he ç nes' r nde d m l
f
gr nul s
a e.

26

W. fe St r
gal anda d
E pa t as e tng i i t mus pr en cla and c nci e de t ove eo e a
d ry s ri nvaldiy
A
t es t e r
onvi ng vi nce o r m

pae tsp e u to o v l iy. Po e I . . rPh r , n .6 6F.d 1 51 11 9 6 ( d.
tn ' r s mp in f ai t ' z n nc v Pa a m.I c, 9 3 1 , 5 - 0 Fe
d '
Ci. 01 )(iig 3 U. C.j 2 2 M ir s . Cop.v 4iLt.P'//,1 S.Ct 2 3 2 45
r 2 2 ctn 5 S.
8 ; c o ot r .i d Jl 31
j
1
. 2 8, 2

( 01 ) 4 cla a d c n i ig e ie c mu tplc t n a ii c n ito (nt efc fn r
2 1) 0 e r n o vncn vd n e s a e s bdng o v cin i h a t ide)
a
.

t a tetuh o ( e f cu lc n e to aeh g y p o a l. Pr co d Ga l Co v T v
h t h rt f t ) a t a o tnins r ihl r b be' o tr r mbe . . e a
h
'
Ph r .US l c,5 6 F.d 9 9 9 4 ( d Ci.2 0 ) (i to o te ) Th b r e o
a ms A, n . 6 3 8 , 9 Fe . r 0 9 ct ins mitd . e u d n f
a
esa ihi i ldiy r i wih t pa t a s ri i i t a e ssa eve y sa oft
t bls ng nva i t ema ns t he ry s e tng nvaldiy nd xit t r t ge he

l iai n. Ki e l- ar Wo lwie I c v Fis Qu lt Bab Pr d . L C,6 0 F.d 1 93
i g to
t
mb ry cl k rd d , n . . r t a i
y y o s, L 6 3 2 ,
1 9 ( d. r 2 1 (e o atrto i o i ia)(iainso te )
2 5 Fe Ci. 01 ) s c nd leain n rgn l ctto mitd .
B. TheWrtenDe cr i Enabl ntRe r nt
it s èton/
eme quieme

3 U. C.j 1 2 r q r st tapae ts ct to c nan awrte d srp in o te
5 S.
1 e uie ha
tn pe i in o ti
ka
itn e c ito f h
ca me i nton.l Thi r uie e t( e v t e ur t tt i nt rha pos es i a of
li d nve i 4
s eq r m n t r es o ns e ha he nve o d s son, s
s

4 35u sc j28 ()p o ie :
0
2 a r vd s
A p tn s al ep e l dv l Ea h cam o ap tn ( te i ide e d n,
ae t h l b r sl
me ai c li f ae t wheh r n n p n e t
d.
de nde t ormuli ede nde f m)s lbepr umedvai i pe ntyof
pe n ,
tpl pe nt or hal es
ld nde nde l
t vai t ofohe cli s de nde tormuli ede nde cai ss l be
he ldiy
t r am ; pe n
tpl pe nt l m ha l
pr umed va i e nt
es
ld ve hough de nde upon a i ld cli .Thebur n of
pe nt
n nva i am
de
esa ihi i ldiy ofapa e ora c am t r s lr tont pa t
t bls ng nva i t
t nt ny l i he eof hal es
he ry
a s ri s h i vai t
s e tng uc n ldiy.
4 35 U .S. j 1 2 a p o i s
1
C. 1 () r vde :

Thes c fc i s lcont n awrte des rptonoft i nton,a oft
pe iiaton hal
ai
itn c i i
he nve i nd he
mn
nnera pr s ofm a ng an usng i,n s 1 1,ce ,c s ,and e ct
nd oce s
ki
d i t i uch 1 lar oncie
xa
tnnsast e bl anyper on s ledi t a to whi i pe ti , wih whih i
e
o na e
s kil n he r t
ch t rans or t
c t
i m os ne ryconne e t makea us t s me,a s ls f t t be t
s t al
ctd, o
nd e he a
nd hal et orh he s

mo ec n e ae b teiv n o o j itiv n o o c n n o t h i v n in,
d o tmpltd y h n e tr r on n e t r f a yig u t e n e to

t fl d t o t ea p iainrle o o tes cscs j c matrltrcame b hm ; o
he ii ae f h p lc to eid n, f h pe i ube t te ae li d y i h w
ng
t es e i ain a c mp ih st i i n tmae il ' I r Alo ,7 F.d 11 ,l 7 ( d Ci.
h p cfc to c o ls e hs s o tra. n e tn 6 3 68 1 2 Fe . r
'
1 9 )( u tn f r We t i 5 F.d 25 2 2 ( C. A.1 7 ) (n en lq o ai n maks
9 6 q o ig n e rhem, 41 2 7, 6 C. P. 9 6) itr a u tto r

o te ) l o d rt stsyt ewrte d s rp inrq r me t th ( tnt a plc n d sno
mitd . n r e o aif h itn e cito e uie n,ç e pae ) p ia t oe t
t
ha et uiie a y p riulrf r ofds l u et d s rb te s b e tma trcame ,b tt e
v o tlz n a t a o m
c
icos r o e cie h u j c te li d u h
de c i i mus clrl al pe s of or nm' s l i t a tt r c ze t t he or s
s rpton
t e y low r ons
di y kil n he r o e ogni ha
he

iv n e wh ti came . 1 ( u tto o te )
n e td a s li d' à q o ains mitd .
'
TheFe a Cic tha sae t sa d f dee mi ngwhehe t wrte des rpton
der l r ui s t td he t ndm' or t r ni
t r he itn c i i
r uie e hasbee me a f l ws:
eq r m nt
n t s olo

Alh u h (h a pia t do s n tha e t d s rb e a ty t s b e t matr
to g te p lc nq e o v o e cie x cl he u j c te
c am e ...hedes rpton mus cea l al pe s ofor na ys l i t a t o
l i d, t
ci i
t l ry low r ons
di r kil n he r t

r c g i et a (eo s qiv n e wh ti came . . et s f rs f e c o
e o nz h t h r he n e td a s li d. . Th e t o ufkin y f
s
uppor i apa e a i a i i whe he t dic os e oft a i ton r le
tn
r nt pplc ton s t r he s l ur
he pplcai ei d
upon l ea o bl c
l s na y onve t t a ts t tt i nt ha pos es i a t t
r
ys o he rian ha he nve or d s son t ha

tmeo teltrcame s be t te.
i f h ae li d u jc ma tr'
'
I r Ha s Mir c mpue Pr d . I c Pae tLig ,9 2 F.d 1 2 ,1 3 ( d Ci.1 2
n e ye c o o tr o s, n . tn t . 8 2 5 7 5 3 Fe . r 99 )
i

( u tng V scah I c v Ma r a ,9 5 F.d 1 5 , 1 6 ( d.Ci. 1 91) (leain i
q oi a - t n . . hu k r 3 2 5 5 5 3 Fe r 9 ) atrto s n
o ii a) tl us a ive tri n tr q ie t d s rb e ey dealo h si v n in. f a
rg n l. t- , n n no s o e urd o e c ie v r t i f i n e to ' #. t
-h
'
1 4. Addii ly, fe m pl a e not ne s a y t s
53
tona l lxa es r
ce s r o uppor t ade
t he
quac of a wrte
y
itn

d srp in. Falo- ne Fak e v I gl , 4 F.d 1 5 ,1 6 ( d. r20 6 .
e cito '
' k Gu tr ln r . n i 4 8 3 3 7 3 6 Fe Ci. 0 )
s
35U. C. 1 2as rq ie t tapae t p cfc to e a l ap ro s ildi t ea to
S. j 1 lo e ur s ha tn s e i ain n be es n k l n h r t
e
m a andus t cai i n i n. ll i t f rl kofe blm e i aconcuso of1w a
ke
e he l med nve to fnvaldiy o ac
na e nt s
l i n a nd
m us bes
t uppore byf c spr d by c e ra c ncnge de e,f rt gr ntoft pa e by
td
a t ove
l a nd onvi i vi nc o he a
he t nt

te PTO c n e wih i t prs mpi n o v ldt i ldng c mpla c wih j
h
a i s t t he eu to f aiiy ncu i o in e t
T lc m, l c v DatpontCop. 9 8 F.d 9 ,9 ( d.Ci.1 9 ) t e e a lme t
ee o n . . a i
r , 0 2 31 41 Fe
r 9 0 . Th n b e n
28

r quie nti s tsi d whe o s le i t a t a trr di t s cii a i c d pr c ie
e r me s ai fe
n ne kild n he r, fe ea ng he pe fc ton, oul a tc
t c am e i ve i wihou undue e rme ai ' AK StelCor v Solac drUgi 344
he l i d n nton t t
xpe i ntton.
'
e
p. . l
nes

F.d 1 4,1 4 ( d. r 2 0 )(uoi I r Wa d , 5 F.d 7 , 3 - 7( d. r 1 8 )
3 23 2 4 Fe Ci. 0 3 q tng n e n s 8 8 2 31 7 6 3 Fe Ci. 99 ) .
The f c or f de e m i ngwhe he unduee rm e a i i r r d i l
a t s or t r ni
t r
xpe i ntton s equie nc ude:

() t q a t y o e p rme tto n c s ay ( )t n t o drci n o
1 he u ni f x ei nain e e s r , 2 he momt f ie to r
t
g ia e p e e td,() te p e e c o a e e o wokig e a e ,()t e
ud nc r s ne 3 h rs n e r bsnc f r n x mpls 4 h
n t r o t eiv n in, 5 t saeof h p ira t( ) h rltv s il ft s i
al e f h n e to () he tt t e ro r,6 t e eaie kl o ho e n
z
t a t( ) h p e itbit o u p e it bl yo t ea ta d( ) h b e dho te
he r,7 t e rd ca l y r n rd ca ii f h r, n 8 t e r a t f h
i
t
cam s.
li

I r Wands 858F. a 737.
ne
,
2d t
Furhe ,t que to of e blmentdoe no tu on whehe t ac us pr t i
t r he
si n
na e
s t tm
t r he c ed oduc s

e a e I se d,t l b e b ig t es e i ai no t ep tn mu t e c tos s ildi te
n bld. n ta çto e na ln ,h p ct to f h ae t s ta h h e k l n h
l
k
e

at o t ma a dus te z/ cpeo t came i v ni nwi u t u e p rme tto '
r h w o ke n e h /l s o f he li d n e to t t md e x ei n ain.
/
ho
'
Du e Cop.v Os a S v ni I c, 5 F.d 1 98 1 0 ( d Ci. 01 (uoi Ge ne h
r l r . r m yla a n .2 6 3 2 , 3 6 Fe . r 20 ) q tng ne t c ,
I c v No oNo ds A/ ,1 F.d 1 61 1 6 ( e . r 1 9 )(leain i o ii a)(mp a i
n . . v r ik S 08 3 3 , 3 5 F d Ci. 9 7 atrto n rgn l e h ss
i o ii a) Th ,ti t ea sre camsrt e t a tea c sdde iewhc mu t ee a ld
n rgn l. us i s h se td li ah r h n h c u e vc ih s b n be
by t pa e -n-ui.
he t nti s t

I aldi Anal i
nv i t
y
yss
As a i ta ma t ,l5nd t tW a s Fl i i ope l i kes t W a s ANDA
n niil ter
ha
ton orda mpr ry nvo
he ton
yng he a e ie ove t s
he ton
Pr
oductwhe a gui i ldiy. Appl i t 1 w r c td ab ,i i nott W a s ANDA
n r ng nva i t

Pr d c t a mu tb e a ldt e j 1 2 rt r i i Cli 1a d3o te'20Pae t h tmu t
o u t h t s e n be md r 1 ; ahe,t s ams n f h 7
tn t a s
bee bld.
na e
Not t t ndi t Co t fnds t t W as Fl i ha no pr n b cla a
wihs a ng, he ur i
ha
t on orda s t ove y e r nd
c nci e denc t tt , Pae s i a i f ist c
onvi ng vi e ha he 720 t nt pecsc ton a l o onveyt ape s s le i t a t
o
r on kild n he r

29

t t t na e i nt s i ve ed t phn mac utca c
ha he m d nve or n nt he r e i l omposto a pr es es c r d by
ii ns nd oc s ove e
Cli 1a 3. Addii ly, a s Fl i hasnotp o n by cea a convi ng e de
a ms nd
tona l W ton orda
r ve
l r nd
nci vi nce
t tt 5 20 Pa e s cii ton f ist ena e a pe s s le i t a tt m a a us t
ha he 7
t nt pe fcai al o bl
r on kil d n he r o ke nd e he
pha ma u i a co postons a pr e s sco r by Cl i s 1 a 3. Thus W a s Fl i
r ce tc l m ii
nd oc s e ve ed
am
nd
, ton orda

ha n t r ve b ce ra dc n i cnge ie c t tCli 1a d3aei v ldun e 3 U. C.
s o p o n y la n o v n i vd n e ha ams n r n ai d r 5 S. j
11
2.

W orh notng a r l va t t Cou tsa l i i t t tm ony ofDe e nt 'e r
t
i nd e e nt o he
r' nayss s he esi
f nda s xpe t

DrKibe S e i al , . b eu q io al tsiidta tth e mpl o t ' 2 Pae t
. b . p ct ly Dr Kib ne uv c l etfe h t û l e xn e f he 7 0 tn
k
y
l
a dtes e i c to swil l w y ut ma ap o u tta wo dft( am 1 . ( il . y
n h p cf ai n l al o o ke r d c h t ul i Cli 1' Tra Tr Da
i
o
'
5a 1 3 1 - 3 ( b eCr sl. Dr Ki b as t si e a s c wi r g r t Cli 3. I fd,
t 1 :2 1 Kib o s) . b e lo e tf d s u h t e ad o am
i
h
na
du i c os e
rng r s xnmi ton,Pl i if 'c
na i
antfs ouns lwaked Dr Ki t oug e h a pe tofCl m 1
e l
. bbe hr h ac s c
ai
a co pa ed i t Exa pl 1fom t 9 Pa e . Dr Ki a e d t tea h pa tofCl m 1
nd m r t o
m e r he 720 t nt
. bbe gr e ha c r
ai

wa p o ie fra dtug ti Ex mp e1 ( ilTr Da 5a 1 9: t 1 11 ( b eCr sl.
s r vd d o n a h n a l . Tra . y t 0 9 o 1 :6 Ki b o s)
V.

CO NCLUSI
ON
ts i ngs e orh bove, Pl ntfs ha esabls
ai if ve t ihed by a
Ba e upon t Cour' fndi s t f t a
sd
he

nd
he 72
pr ponde a e oft e de t tt De e
e
r nc
he vi nce ha he f ndan s 2 ha i rnge Cl i s la 3 oft ' 0
t 4 ve nfi d am

Pa e t Addii l Def nt ha f iedt pr by cl ra c ncng e de et tt
tn .
tonaly, enda s ve al o ove
ea nd onvi i vi nc ha he
Pa e i i ld f l k ofwrte de c i i a ore bl men . Fort s r a ons Pl ntfs
t nt s nva i or ac
itn s rpton nd/ na e t
he e e s , ai if

aee tt dt terq e td ijmcierle . Ho ve, h Co r d cie t ma eafn i o
r n ie o h e u se nt tv eif we r t e u t e ln s o k i dng f
l

4 w hiei wasonl W aton Fl i t tfld t ANDA, he Cour deci st ditnguih t
2
l t
y
s
orda ha ie he
t
t lne o si s he
c
onduc ofe c W as e tt ase h De e da ti duc dorc rbut t t c t ci oft
t a h t on n iy, ac f n n n e
onti ed o he onsnzton he
W a s AN DA Pr duc a t flngoft W a s n ANDA .
t on
o t nd he ii
he t o
30

wilul i rnge nt f pur e of awa di a t ney' f s N o i t s ot r s a
lf nfi me or pos s
r ng tor s ee .
r s hi he wie n

ç x e to a c s 'u e 3 U. C. 28 .
$ c p in l a e' nd r 5 S. j 54
e
3

Fna j g n s al su b s p r t o d r
i lud me t h lis e y e a ae r e ,
z
z
4

DO NE AND ORDERED i Chn r a W e tPa m Bea h,Fl i t s ./ da of
n
mbe s t s l
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l ai if fr d vi nc ha fndans

r r e e i e edShie' Li da pr t ldonoti t s a i nsr m a kabl i t c extof
eve s - ngne r
tnd he e cto e r e n he ont
r s al * oduc ,
at mptng t de l abi ui l tge i dnz Ther wa as e de ofse t ke by
te i o veop oeq vaen nerc g.
e s lo vi nce tps a n
Def nda st a d i rnge e . It r f edeci t m a a fndi ofwilul s
e nt o voi nfi m nt he e or
lne o ke i ng
lf nes .
31