Case 1:22-cv-02229-MKV Document 55 Filed 11/16/22 Page 1 of 14
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`U NI T E D S T A T E S DI S T RI C T C O U R T
`S O U T H E R N DI S T RI C T O F N E
`W Y O R K
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`A C UI T A S T H E R A P E U TI C S I N C.,
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`Pl ai ntiff ,
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`C as e N o. 1: 2 2 -c v -0 2 2 2 9 -M K V
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`vs.
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`G E N E V A N T S CI E N C E S G M B H, a n d
`A R B U T U S BI O P H A R M A C O R P.,
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`D ef e n d a nts .
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`R E P L Y I N F U R T H E R S U P P O R T O F D E F E N D A N T S’
`M O TI O N T O DI S
`MI S S
` T H E FI R S T A
`M E N D E D C O
`M P L AI N T
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`D ar al y n J. D uri e (pr o h a c vi c e gr a nt e d)
`Eri c C.
`Wi e n er (pr o h a c vi c e gr a nt e d)
`D U RI E T A N G RI L L P
`2 1 7 L ei d es d orff Str e et
`S a n Fr a n cis c o, C A 9 4 1 1 1
`T: 4 1 5 -3 6 2 -6 6 6 6
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`Kir a A. D a vis
`D U RI E T A N G RI L L P
`9 5 3 E. 3 r d Str e et
`L os A n g el es, C A 9 0 0 1 3
`T: 2 1 3 -9 9 2 -4 4 9 9
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`R a y m o n d N. Ni mr o d
`Is a a c N ess er
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`M att h e w D. R o bs o n
`Q UI N N E M A N U E L U R Q U H A R T &
`S U L LI V A N, L L P
`5 1 M a dis o n A v e n u e, 2 2 n d Fl o or
`N e w Y or k, N Y 1 0 0 1 0
`T: 2 1 2 -8 4 9 -7 0 0 0
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`K e vi n P. B. J o h ns o n
`Q UI N N, E M A N U E L, U R Q U H A R T &
`S U L LI V A N, L L P
`5 5 5 T wi n D ol p hi n Dri v e, 5t h Fl o or
`R e d w o o d S h or es, C A 9 4 0 6 5
`T: 6 5 0 -8 0 1 -5 0 0 0
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`S a n dr a H a b er n y ( pr o h a c vi c e gr a nt e d)
`Q UI N N, E M A N U E L, U R Q U H A R T &
`S U L LI V A N, L L P
`8 6 5 S. Fi g u er o a Str e et, 1 0t h Fl o or
`L os A n g el es, C A 9 0 0 1 7
`T: 2 1 3 -4 4 3 -3 0 0 0
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`Att or n e ys f or D ef e n d a nt G e n e v a nt S ci e n c es
`G m b H
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`Att or n e ys f or D ef e n d a nt Ar b ut us Bi o p h ar m a C or p.
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`Case 1:22-cv-02229-MKV Document 55 Filed 11/16/22 Page 2 of 14
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`T A B L E O F C O N T E N T S
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`P a g e
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`I.
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`A C UI T A S’ S I N D E M NI T Y T H E O R Y F AI L S ....................................................................1
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`A.
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`B.
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`A c uit as H as N ot S h o w n A C o ntr o v ers y B et w e e n D ef e n d a nts A n d
`Pfi z er/ B N T ...............................................................................................................1
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`A c uit as H as N ot S h o w n A R e as o n a bl e P ot e nti al Of I n d e m nifi c ati o n
`Li a bilit y ....................................................................................................................4
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`1.
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`2.
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`3.
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`T h e A m e n d e d C o m pl ai nt F ails O n Its F a c e T o All e g e A
`R e as o n a bl e P ot e nti al O f I n d e m nifi c ati o n Li a bilit y ( F a ci al Att a c k) ............5
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`E v e n If C o nsi d er e d, T h e I n d e m nit y Pr o visi o n S h o ws T h er e Is N o
`R e as o n a bl e P ot e nti al Of I n d e m nifi c ati o n Li a bilit y ( F a ct u al Att a c k) ..........6
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`Alt er n ati v el y, J uris di cti o n al Dis c o v er y Is
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`W arr a nt e d ..................................7
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`II.
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`A C UI T A S’ S I N DI R E C T I N F RI N G E M E N T T H E O R Y F AI L S .........................................8
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`III.
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`I N T H E A L T E R N A TI V E, T H E C O U R T S H O U L D D E C LI N E J U RI S DI C TI O N ............9
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`I V.
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`DI S MI S S A L S H O U L D B E
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`WI T H O U T L E A V E T O A M E N D .......................................1 0
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`i
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`Case 1:22-cv-02229-MKV Document 55 Filed 11/16/22 Page 3 of 14
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`T A B L E O F A U T H O RI TI E S
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`C as es
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`P a g e
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`A mi d a x Tr a di n g Gr p. v. S. W.I. F. T. S C R L ,
` 6 7 1 F. 3 d 1 4 0 ( 2 d Cir. 2 0 1 1) ..................................................................................................... 1 0
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`Arris Gr p., I n c. v. Britis h. T el e c o m ms. P L C ,
` 6 3 9 F. 3 d 1 3 6 8 ( F e d. Cir. 2 0 1 1) .............................................................................................. 8, 9
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`3 M C o. v. A v er y D e n nis o n C or p. ,
` 6 7 3 F. 3 d 1 3 7 2 ( F e d. Cir. 2 0 1 2) .............................................................................................. 2, 3
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`E M C C or p. v. N or a n d C or p. ,
` 8 9 F. 3 d 8 0 7 ( F e d. Cir. 1 9 9 6) .................................................................................................... 1 0
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`H art y v. W. P oi nt R e alt y, I n c. ,
` 2 8 F. 4t h 4 3 5 ( 2 d Cir. 2 0 2 2) ............................................................................................... 5, 6, 7
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`H e wl ett -P a c k ar d C o. v. A c c el er o n L L C ,
` 5 8 7 F. 3 d 1 3 5 8 ( F e d. Cir. 2 0 0 9) .......................................................................................... 2, 3, 4
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`Mi cr os oft C o r p. v. D at a T er n, I n c. ,
` 7 5 5 F. 3 d 8 9 9 ( F e d. Cir. 2 0 1 4) ........................................................................................ 5, 6, 8, 9
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`Mit e k S ys., I n c. v. U nit e d S er vs. A ut o. Ass’ n ,
` 3 4 F. 4t h 1 3 3 4 ( F e d. Cir. 2 0 2 2) ......................................................................................... p assi m
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`S RI I nt’l, I n c. v. A d v a n c e d T e c h. L a b’ ys, I n c. ,
` 1 2 7 F. 3 d 1 4 6 2 ( F e d. Cir. 1 9 9 7) .................................................................................................. 4
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`T a n d o n v. C a pt ai n’s C o v e M ari n a of Bri d g e p ort, I n c. ,
` 7 5 2 F. 3 d 2 3 9 ( 2 d Cir. 2 0 1 4) ....................................................................................................... 6
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`ii
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`Case 1:22-cv-02229-MKV Document 55 Filed 11/16/22 Page 4 of 14
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`T h e C o urt s h o ul d dis miss t his c as e b e c a us e A c uit as h as n ot m et its b ur d e n t o s h o w s u bj e ct
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`m att er j uris di cti o n . Alt er n ati v el y, t h e C o urt s h o ul d e x er cis e its dis cr eti o n t o d e cli n e j uris di cti o n.
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`I.
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`A C UI T A S’ S I N D E
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`M NI T Y T H E O R Y F AI L S
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`A c uit as ’s i n d e m nit y t h e or y r e q uir es t h at it s h o w b ot h ( a) a n “ a ct u al i nfri n g e m e nt
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`c o ntr o v ers y ” b et w e e n D ef e n d a nts a n d Pfi z er/ B N T a n d ( b) a r e as o n a bl e p ot e nti al of i n d e m nit y
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`li a bilit y, “ b e y o n d b ar e i n d e m nit y d e m a n ds or r e q u ests .” Mit e k S ys., I n c. v. U nit e d S er vs. A ut o.
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`Ass’ n , 3 4 F. 4t h 1 3 3 4, 1 3 4 5 -4 6 ( F e d. Cir. 2 0 2 2). A c uit as h as n ot m et eit h er r e q uir e m e nt. T h at t h e
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`F e d er al Cir c uit i n Mit e k r e c e ntl y r eli e v e d
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`A c uit as of t h e n e e d t o als o s h o w a c o n c essi o n of
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`i n d e m nifi c ati o n d o es n ot c h a n g e t his r es ult.1 Mit e k o nl y c o nfir m s t h at dis miss al is a p pr o pri at e.
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`A.
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`A c uit as H as N ot S h o w n A C o nt r o v e rs y B et w e e n D ef e n d a nts A n d Pfi z e r /B N T
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`A c uit as a d mits ( at 1 2) t h at it m ust s h o w a n a ct u al c o ntr o v ers y b et w e e n D ef e n d a nts a n d
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`Pfi z er/ B N T . F a cts t h at A c uit as c o n c e d e s d e m o nstr at e t h at it f ail e d t o m e et its b ur d e n. S p e cifi c all y ,
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`A c uit as d o es n ot dis p ut e t h at: (i) D ef e n d a nts’ l ett ers t o Pfi z er/B N T l a c k a n y i nfri n g e m e nt a n al ysis
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`or cl ai m c h arts ; (ii) t h e l ett ers off er e d a c oll a b or ati o n as w ell as dis c ussi o n of a li c e ns e; a n d (iii)
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`G e n e v a nt a n d B N T ( Pfi z er’s C o vi d -1 9 v a c ci n e p art n er ) h a v e a hist or y of c oll a b or ati o n a n d pri or
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`li c e nsi n g wit h o ut liti g ati o n. M or e o v er , A c uit as a d mits ( at 2 0) t h at it is n ot pri v y t o a n d d o es n ot
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`k n o w t h e st at us of dis c ussi o ns b et w e e n G e n e v a nt a n d Pfi z er/ B N T —
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`m a k i n g it i m p ossi bl e f or
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`A c uit as t o s h o w a pr es e nt c o ntr o v ers y b et w e e n D ef e n d a nts a n d Pfi z er/ B N T.
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`B e c a us e it c a n n ot dis p ut e t h es e f a cts , A c uit as r es orts t o mis dir e cti o n. F or e x a m pl e, A c uit as
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`ar g u es t h at b e c a us e D ef e n d a nts s u e d n o n -p art y M o d er n a aft er
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`h a vi n g pr e vi o usl y s e nt M o d er n a
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`l ett ers, a n a ct u al c o ntr o v ers y b et w e e n D ef e n d a nts a n d Pfi z er/ B N T m ust e xist as w ell . B ut M o d er n a
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`is sit u at e d v er y diff er e ntl y vis -à -vis D ef e n d a nts t h a n is Pfi z er/ B N T.
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`Whil e D ef e n d a nts’ l ett ers t o
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`1 Gi v e n
`D ef e n d a nts n o l o n g er c o nt e n d t h at a c o m pl ai nt r e q uir es a
`Mit e k’s i nstr u cti on ,
`c o n c essi o n of a n i n d e m nit y o bli g ati o n, as h a d b e e n pr e vi o usl y st at e d i n ot h er c as es.
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`Case 1:22-cv-02229-MKV Document 55 Filed 11/16/22 Page 5 of 14
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`Pfi z er/ B N T w er e s e nt wit h t h e hist ori c al b a c k dr o p of pri or c oll a b or ati o n , D ef e n d a nts’ l ett ers t o
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`M o d er n a w er e s e nt d uri n g a n o n g oi n g y e ars -l o n g liti g ati o n b attl e i n w hi c h M o d er n a is s e e ki n g t o
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`i n v ali d at e s e v er al of D ef e n d a nts’ P at e nts . A c uit as f urt h er i g n or es t h at (i) D ef e n d a nts h a v e n ot s u e d
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`Pfi z er/ B N T d es pit e h a vi n g s u e d M o d er n a m or e t h a n ei g ht m o nt hs a g o a n d (ii) dis c ussi o ns b et w e e n
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`Pfi z er/ B N T a n d G e n e v a nt h a v e n ot b e e n t er mi n at e d. D kt. 4 4 at 2 4 n .9 . A c uit as als o err o n e o usl y
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`r eli es ( at 9) o n D ef e n d a nts ’ m e nti o n of A c uit as i n t h eir c o m pl ai nt a g ai nst M o d er n a as s u p p os e dl y
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`“s h o w i n g t h at D ef e n d a nts d o all e g e t h at A c uit as’s t e c h n ol o g y vi ol at es t h eir p at e nts.” T his is f als e.
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`M o d er n a is n ot a n A c uit as c ust o m er, a n d
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`th e c o m pl ai nt o nl y m e nti o ns A c uit as t o pr o vi d e t h e f ull
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`f a ct u al c o nt e xt of M o d er n a’s li c e nsi n g hist or y, n ot as a n a c c us e d i nfri n g er.
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`A c uit as als o att a c ks D ef e n d a nts’ c oll a b or ati o n off er t o Pfi z er/ B N T as s o m e h o w n ot si n c er e
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`b e c a us e it w as s e nt aft er “t h e v a c ci n e ” h a d alr e a d y b e e n us e d i n cli ni c al tri als. B ut, it w as w ell-
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`k n o w n t h at Pfi z er/ B N T w er e f a ci n g c h all e n g es r el at e d t o f or m ul ati o n, s u c h as st a bilit y a n d st or a g e
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`iss u es, a n d t h er e w as t h e p ossi bilit y f or n e xt -g e n er ati o n v a c ci n es ( e. g. , b o ost er s h ots). T h e l ett ers
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`off er e d a c c ess t o “ G e n e v a nt s ci e ntists’ e xt e nsi v e e x p eri e n c e a n d e x p ertis e wit h t h e f or m ul ati o n
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`a n d
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`m a n uf a ct ur e of L N P d el i v er y s yst e ms. ” D kt. 4 5 -2 .2 A c uit as’s c o nt e nti o n t h at D ef e n d a nts’
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`P at e nts d o n ot r el at e t o st or a g e, tr a ns p ort, or m a n uf a ct uri n g o nl y hi g hli g hts t h at D ef e n d a nts off er e d
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`a g e n ui n e c oll a b or ati o n i n w hi c h Pfi z er/ B N T c o ul d g ai n a c c ess t o G e n e v a nt s ci e ntists ’ e x p ertis e
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`r e g ar di n g f or m ul ati o n m att ers b e y o n d t h os e all e g e dl y a d dr ess e d i n t h e pat e nts.
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`A c uit as’s r es ort t o mis dir e cti o n e xt e n ds e v e n f urt h er t o t h e t hr e e c as es it cit es o n t his iss u e:
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`Mit e k ; 3 M C o. v. A v er y D e n nis o n C or p. , 6 7 3 F. 3 d 1 3 7 2 ( F e d. Cir. 2 0 1 2); a n d H e wl ett -P a c k ar d
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`2 C o ntr ar y t o A c uit as’s s u g g esti o n ( at 5) t h at D ef e n d a nts h a v e n ot c o m m er ci ali z e d r el e v a nt
`L N P t e c h n ol o g y, D ef e n d a nts’ t e c h n ol o g y is us e d i n t h e o nl y c o m m er ci al si R N A -L N P pr o d u ct
`( O N P A T T R O® ), a n d
`m ulti pl e c o m p a ni es h a v e li c e ns e d t h e t e c h n ol o g y f or us e wit h
`m R N A,
`i n cl u di ng v a c ci n es. S e e , e. g. , w w w. g e n e v a nt. c o m/ o ur -t e c h n ol o g y; w w w. g e n e v a nt. c o m/ gritst o n e -
`a n d -g e n e v a nt -s ci e n c es -a n n o u n c e -li c e ns e-a gr e e m e nt -f or-c o vi d -1 9 -v a c ci n e/ .
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`Case 1:22-cv-02229-MKV Document 55 Filed 11/16/22 Page 6 of 14
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`C o. v. A c c el er o n L L C , 5 8 7 F. 3 d 1 3 5 8 ( F e d. Cir. 2 0 0 9).
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`First , f ar fr o m d e m o nstr ati n g t h at s u bj e ct m att er j uris di cti o n e xists h er e , Mit e k a ct u all y
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`d e m o nstr at es h o w f ar t h e f a cts of t his c as e ar e fr o m t h e r e q uir e d mi ni m u m . I n Mit e k , t h e p at e nt e e
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`h a d s e nt o v er 1, 0 0 0 d e m a n d l ett ers t o b a n ks a cr oss t h e c o u ntr y,
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`m ost of w hi c h w er e
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`Mit e k ’s
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`c ust o m ers, i n cl u di n g d et ail e d i nfri n g e m e nt cl ai m c h arts. 3 4 F. 4t h at 1 3 3 8, 1 3 4 5. A n d t h e n t h e
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`p at e nt e e w e nt f urt h er , a ct u all y s u e d o n e of Mit e k ’s c ust o m er s, a n d w as i n t h e mi dst of tri al i n t h at
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`m att er w h e n
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`Mit e k fil e d its d e cl ar at or y j u d g m e nt s uit. I d. at 1 3 4 5. T h e F e d er al Cir c uit f o u n d all
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`of t h at t o b e “j ust e n o u g h” t o s h o w a n a ct u al c o ntr o v ers y. I d.3 If m or e t h a n 1, 0 0 0 d e m a n d l ett ers,
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`cl ai m c h arts, a n d bri n gi n g s uit a g ai nst a c ust o m er ar e “j ust e n o u g h ” t o cr e at e a c o ntr o v ers y, t h e n
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`D ef e n d a nts’ a cts h er e —
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`t w o l ett ers, n o cl ai m c h arts, a n d n o c ust o m er liti g ati o n, all i n t h e c o nt e xt
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`of a y e ars -l o n g hist or y of c oll a b or ati o n—
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`c o m e n o w h er e cl os e .
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`S e c o n d , A c uit as ( at 1 2) cit es 3 M f or t h e pr o p ositi o n t h at a c o m m u ni c ati o n st ati n g t h at a
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`pr o d u ct “ m a y i nfri n g e ” c o u pl e d wit h a li c e nsi n g off er s uffi c e s t o cr e at e a n a ct u al c o ntr o v ers y . N ot
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`s o. A c uit as i g n or es k e y f a cts of 3 M , c e ntr al t o its h ol di n g , s h o wi n g t h at t h e p at e nt e e “ es c al at e[ d]
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`t h e dis p ut e ” aft er its i niti al c o m m u ni c ati o n. 6 7 3 F. 3 d at 1 3 8 0. S p e cifi c all y, aft er t he i niti al
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`c o m m u ni c ati o n, t h e all e g e d i nfri n g er r ej e cte d t h e li c e ns e off er. I d. at 1 3 7 9. In r es p o ns e , t h e
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`p at e nt e e st at e d t h at it w o ul d b e s e n di n g cl ai m c h arts r efl e cti n g its a n al ysis of t h e a c c us e d pr o d u ct.
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`I d. T h e F e d er al Cir c uit n ot e d t h at “ b y st ati n g t h at it h a d a n al y z e d t h e [ a c c us e d pr o d u ct] a n d w o ul d
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`s e n d [ all e g e d i nfri n g er] cl ai m c h arts, [ p at e nt e e] p er h a ps si g n al e d its i nt e nt t o es c al at e t h e dis p ut e.”
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`I d. at 1 3 8 0. I n dis p ut a bl y, th er e h as b e e n n o “ es c al ati o n ” h er e.
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`T hir d , A c uit as ( at 1 3) cit es H e w l ett-P a c k ar d as h ol di n g t h at “[ a] p at e nt o w n er s e n di n g t h e
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`pl ai ntiff t w o l ett ers s e e ki n g t o ‘dis c uss ’ a p at e nt ” c a n cr e at e a j usti ci a bl e c o ntr o v ers y. B ut H e wl ett -
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`3 All e m p h as es i n t his bri ef ar e a d d e d u nl ess ot h er wis e s p e cifi e d.
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`3
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`Case 1:22-cv-02229-MKV Document 55 Filed 11/16/22 Page 7 of 14
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`P a c k ar d i n f a ct s a ys t h e o p p osit e: “ [ A] c o m m u ni c ati o n fr o m a p at e nt o w n er t o a n ot h er p art y,
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`m er el y i d e ntif yi n g its p at e nt a n d t h e ot h er p art y’s pr o d u ct li n e, wit h o ut m or e,
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`c a n n ot est a blis h
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`a d v ers e l e g al i nt er ests b et w e e n t h e p arti es, l et al o n e t h e e xist e n c e of a ‘d efi nit e a n d c o n cr et e ’
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`dis p ut e. ” 5 8 7 F. 3 d at 1 3 6 2. I n d e e d, t h e c o urt i n H e wl ett -P a c k ar d f o u n d a n a ct u al c o ntr o v ers y
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`b as e d o n f a cts t h at A c uit as o mits fr o m its dis c ussi o n —
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`s p e cifi c all y, t h at t h e p at e nt e e (i) w as a n o n -
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`pr a cti ci n g e ntit y , (ii) i m p os e d i n its l ett ers ti g ht, t w o-w e e k d e a dli n es f or r es p o ns e s, (iii) d e m a n d e d
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`t h at t h e r e ci pi e nt n ot i niti at e a l a ws uit, a n d (i v) i nsist e d t h at if t h e r e ci pi e nt di d n ot
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`m e et its
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`d e a dli n es it w o ul d ass u m e t h e r e ci pi e nt h a d n ot hi n g t o s a y a b o ut t h e m erits . I d. at 1 3 6 2 -6 3. N ot hi n g
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`of t h e s ort is pr es e nt h er e. I n d e e d, D ef e n d a nts’ l ett ers s et n o d e a dli n es f or r es p o ns es.
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`Fi n all y, A c uit as d o es n ot cit e a n y c as e t o s u p p ort its ar g u m e nt ( at 1 2) t h at D ef e n d a nts’
`
`pr es er v ati o n of ri g hts u n d er § 2 8 7( a) s h o ws a n a ct u al c o ntr o v ers y. T h at is u ns ur prisi n g b e c a us e
`
`“ [t]h e crit eri a f or a ct u al n oti c e u n d er § 2 8 7( a) ar e n ot c o e xt e nsi v e wit h t h e crit eri a f or fili n g a
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`d e cl ar at or y j u d g m e nt a cti o n .” S RI I nt ’l, I n c. v. A d v a n c e d T e c h. L a b’ ys, I n c., 1 2 7 F. 3 d 1 4 6 2, 1 4 7 0
`
`( F e d. Cir. 1 9 9 7).4 T h e “ st at ut or y p ur p os es ar e disti n ct, s er v e diff er e nt p oli ci es, a n d ar e g o v er n e d
`
`b y diff er e nt l a ws. ” I d. T his m a k es g o o d s e ns e. Ot h er wis e , a p at e nt e e c o ul d n ot pr es er v e a cl ai m
`
`f or pr e-s uit d a m a g es vi a a ct u al n oti c e wit h o ut cr e ati n g a ris k of a d e cl ar at or y j u d g m e nt a cti o n —
`
`a n o ut c o m e t h at w o ul d dis c o ur a g e pr e -s uit s ettl e m e nts a n d i n c e nti vi z e pr e m at ur e l a ws uits.
`
`B.
`
`A c uit a s H as N ot S h o w n A R e as o n a bl e P ot e nti al Of I n d e m nifi c ati o n Li a bilit y
`
`As dis c uss e d b el o w: ( 1) A c uit as’s A m e n d e d C o m pl ai nt f ails o n its f a c e b e c a us e it d o es n ot
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`all e g e a n y r e as o n a bl e p ot e nti al of i n d e m nit y li a bilit y —
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`r e q uir e d u n d er Mit e k —
`
`a n d t h e C o urt
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`s h o ul d n ot c o nsi d er A c uit as’s e xtri nsi c e vi d e n c e t o r e b ut D ef e n d a nts’ f a ci al att a c k; ( 2) e v e n if t h e
`
`
`4 A c uit as att e m pts t o disti n g uis h S RI b e c a us e it w as d e ci d e d pr e -M e dI m m u n e , b ut M e dI m m u n e
`d o es n ot u n d er mi n e or e v e n c o m m e nt o n t h e F e d er al Cir c uit’s i nstr u cti o n t h at th e crit eri a f or n oti c e
`u n d er § 2 8 7( a) ar e diff er e nt fr o m t h os e f or s h o wi n g a n a ct u al c o ntr o v ers y.
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`4
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`Case 1:22-cv-02229-MKV Document 55 Filed 11/16/22 Page 8 of 14
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`
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`C o urt di d c o nsi d er e xtri nsi c e vi d e n c e, it o nl y f urt h er d e m o nstr at es t h at A c uit as c a n n ot m e et its
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`b ur d e n; a n d ( 3) alt er n ati v el y, j uris di cti o n al dis c o v er y is w arr a nt e d.
`
`1.
`
`T h e A m e n d e d C o m pl ai nt F ails O n Its F a c e T o All e g e A R e as o n a bl e
`P ot e nti al Of I n d e m ni fi c ati o n Li a bil it y ( F a ci al Att a c k)
`
`B e c a us e D ef e n d a nts’ m oti o n pr es e nts a f a ci al att a c k , as A c uit as a d mits ( at 9) , t h e C o urt
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`“ m ust cl os el y a n al y z e t h e r el e v a nt i n d e m nit y all e g ati o ns t o d et er mi n e
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`w h et h er t h e y s uffi c e . ”
`
`Mit e k , 3 4 F. 4t h at 1 3 4 6 ; s e e als o H art y v. W. P oi nt R e alt y, I n c. , 2 8 F. 4t h 4 3 5, 4 4 1 ( 2 d Cir. 2 0 2 2)
`
`(f a ci al att a c k is “ b as e d s ol el y o n t h e all e g ati o ns of t h e c o m pl ai nt a n d e x hi bits att a c h e d t o it ”) . H er e ,
`
`o n t h eir f a c e , A c uit as’s all e g ati o ns ar e i ns uffi ci e nt u n d er Mit e k . A c uit as d o es n ot all e g e t h at t her e
`
`is a r e as o n a bl e p ot e nti al f or i n d e m nit y li a bilit y u n d er t h e a gr e e m e nt or a n y f a cts fr o m w hi c h t h e
`
`C o urt c o ul d i nf er s u c h a “r e as o n a bl e p ot e nti al. ”
`
`Mit e k di d n ot alt er t h e w ell -est a blis h e d r ul e t h at a b ar e c ust o m er d e m a n d f or i n d e m nit y is
`
`i ns uffi ci e nt t o s h o w j uris di cti o n. T o t h e c o ntr ar y, Mit e k r e q uir es a s h o wi n g t h at, “b e y o n d b ar e
`
`i n d e m nit y d e m a n ds or r e q u ests, t h er e
`
`w as a ct u all y a ‘r e as o n a bl e p ot e nti al ’ of [ pl ai ntiff’s]
`
`i n d e m nifi c ati o n li a bilit y. ” 3 4 F. 4t h at 1 3 4 6. I m p ort a ntl y, Mit e k cit e d wit h a p pr o v al t h e i nstr u cti o n
`
`i n Mi cr os oft C or p. v. D at a T er n, I n c. , 7 5 5 F. 3 d 8 9 9 ( F e d. Cir. 2 0 1 4), t h at t h e “m erit of t h e c ust o m er
`
`r e q u est ” is r el e v a nt t o d et er mi ni n g w h et h er a pl ai ntiff h as s uffi ci e ntl y pl e d a n i n d e m nit y -b as e d
`
`a ct u al c o ntr o v ers y . 3 4 F. 4t h at 1 3 4 6 (q u oti n g 7 5 5 F. 3 d at 9 0 4). Y et A c uit as’s A m e n d e d C o m pl ai nt
`
`is e ntir el y d e v oi d of a n y all e g ati o n r e g ar di n g t h e m erits of B N T’s r e q u est. D kt. 4 2, ¶ 2 6.
`
`I nst e ad, A c uit as h a s pl e d o nl y t h at “A c uit as’s li c e ns e a gr e e m e nt wit h Bi o N T e c h c o nt ai ns
`
`i n d e m nifi c ati o n pr o visi o ns ” an d t h at B N T h as
`
`m a d e a d e m a n d. I d. T h at is it. T h er e ar e n o
`
`“i n d e m nit y all e g ati o ns ” i n t h e pl e a di n g fr o m w hi c h t h e C o urt c a n dr a w a c o n cl usi o n a b o ut w h et h er
`
`t h er e is a r e as o n a bl e p ot e nti al of i n d e m nit y li a bilit y. I n f a ct, A c uit as ass erts err o n e o usl y t h at t h e
`
`m erits of t h e c ust o m er d e m a n d ar e irr el e v a nt . I d. ( “
`
`Wh et h er or n ot A c uit as ulti m at el y w o ul d h a v e
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`5
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`Case 1:22-cv-02229-MKV Document 55 Filed 11/16/22 Page 9 of 14
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`
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`i n d e m nifi c ati o n o bli g ati o ns, Bi o N T e c h’s ass erti o n t h at it h as i n d e m nifi c ati o n ri g hts is s uffi ci e nt
`
`t o cr e at e d e cl ar at or y-j u d g m e nt j uris di cti o n . . . . ”). S u c h all e g ati o ns ar e i ns uffi ci e nt u n d er Mit e k ,
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`j ust as t h e y ar e u n d er Mi cr os oft . T h us , t h e A m e n d e d C o m pl ai nt f ails o n its f a c e.
`
`A p p ar e ntl y r e c o g ni zi n g its pl e a di n g f ail ur e , A c uit as r eli es o n t h e e xtri nsi c e vi d e n c e of a
`
`r e d a ct e d v ersi o n of a n a gr e e m e nt wit h B N T, p ur p ort e dl y i n cl u di n g t h e r el e v a nt i n d e m nit y t er ms
`
`( e v e n t h e s e al e d v ersi o n r e d a ct e d m a n y p orti o ns of t h e a gr e e m e nt ). B e c a us e D ef e n d a nts m o u nt e d
`
`a f a ci al att a c k , h o w e v er, t h e C o urt h as dis cr eti o n t o d e cli n e t o c o nsi d er t his e xtri nsi c e vi d e n c e a n d
`
`s h o ul d d o s o h er e . H art y , 2 8 F. 4t h at 4 4 1 ( f or a f a ci al att a c k u n d er R ul e 1 2( b)( 1) , “it is n ot err or
`
`f or t h e distri ct c o urt t o b as e its r uli n g s ol el y o n t h e all e g ati o ns of t h e c o m pl ai nt ” a n d d e cli n e t o
`
`c o nsi d er e xtri nsi c e vi d e n c e ).
`
`T h is C o urt g a v e A c uit as a f ull a n d f air o p p ort u nit y t o a m e n d its c o m pl ai nt a n d f urt h er
`
`i nstr u cte d t h at “[t]his will b e Pl ai ntiff’s l ast o p p ort u nit y t o a m e n d t h e c o m pl ai nt i n r es p o ns e t o
`
`ar g u m e nts r ais e d i n t h e p arti es’ l ett ers . ”
`
`D kt. 3 7.
`
`D ef e n d a nts’ l ett er r ef er e n c e d b y t h e C o urt
`
`s p e cifi c all y i d e ntifi e d t h e i ns uffi ci e n c y of A c uit as’ s i n d e m nit y c o nt e nti o ns. D kt. 3 6 -1 . Y et, d es pit e
`
`o pti n g t o a m e n d, A c uit as di d n ot all e g e t h er e w as a r e as o n a bl e p ot e nti al of i n d e m nit y li a bilit y, n or
`
`di d it att a c h t h e a gr e e m e nt t o its A m e n d e d C o m pl ai nt or e v e n r e cit e t h e i n d e m nit y pr o visi o n o n
`
`w hi c h it n o w s e e ks t o r el y. Gi v e n t h e C o urt’s a d m o niti o n, t h e C o urt s h o ul d n ot p er mit A c uit as t o
`
`r e b ut a f a ci al att a c k o n t h e s uffi ci e n c y of its pl e a di n g b y r el yi n g o n a d o c u m e nt it t a cti c all y
`
`wit h h el d .
`
`2.
`
`T h e r e I s N o
`S h o ws
`T h e I n d e m nit y P r o visi o n
`C o nsi d e r e d,
`E v e n If
`R e as o n a bl e P ot e nti al Of I n d e m ni fi c ati o n Li a bilit y ( F a ct u al Att a c k)
`
`A c uit as ’s i n d e m nit y t h e or y w o ul d f ail e v e n if t h e C o urt w er e t o c o nsi d er t h e A c uit as -B N T
`
`a gr e e m e nt. I n a f a ct u al c h all e n g e , A c uit as b e ars t h e b ur d e n of pr o vi n g j uris di cti o n . T a n d o n v.
`
`C a pt ai n ’s C o v e
`
`M ari n a of Bri d g e p ort, I n c. , 7 5 2 F. 3 d 2 3 9, 2 4 3 ( 2 d Cir. 2 0 1 4). A s e x pl ai n e d i n
`
`
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`6
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`Case 1:22-cv-02229-MKV Document 55 Filed 11/16/22 Page 10 of 14
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`
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`Mit e k , t h e c o urt m ust e v al u at e b ot h ( 1) “[t] h e c h ar a ct er of t h e i n d e m nit y d e m a n ds r e c ei v e d ” a n d
`
`( 2) “t h e pr e cis e s c o p e of t h e c orr es p o n di n g i n d e m nit y a gr e e m e nts.” 3 4 F. 4t h at 1 3 4 6.
`
`As t o t h e first f a ct or, A c uit as h as n ot s u b mitt e d B N T’s all e g e d i n d e m nit y d e m a n d or a n y
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`ot h er e vi d e n c e of t h e c h ar a ct er of t h e i n d e m nit y d e m a n d . S e e Mit e k , 3 4 F. 4t h at 1 3 3 8 ( n oti n g
`
`pl ai ntiff’s f ail ur e t o “ att a c h a n y d o c u m e nts e m b o d yi n g
`
`… a d e m a n d f or i n d e m nifi c ati o n ”). A s t o
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`t h e s e c o n d fa ct or, A c uit as d o es n ot s h o w a r e as o n a bl e p ot e nti al t h at t h e pr e cis e s c o p e of t h e
`
`i n d e m nit y a gr e e m e nts a p pli es h er e. N or c o ul d it b e c a us e t h e i n d e m nit y pr o visi o n o nl y c o v ers
`
`i nfri n g e m e nt
`
` D kt.
`
`5 0 at 1 1 .
`
`D ef e n d a nts’ p at e nt cl ai ms r e q uir e a n u cl ei c a ci d s u c h as m R N A a n d at l e ast t hr e e s e p ar at e li pi d
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`t y p es, t y pi c all y i n s p e cifi e d r ati os. Infri n g e m e nt of
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`D ef e n d a nts’ P at e nts w o ul d
`
`n ot b e
`
`
`
` b e c a us e A c uit as a d mitt e dl y d o es n ot s u p pl y m R N A
`
`a n d o nl y s u p pli es t w o li pi ds. S e e id . at 5; i d. at 1 1 ( a d mitti n g D ef e n d a nts’ P at e nts “ all …
`
`r e q uir e
`
`m R N A -L N P c o m p o n e nts , a n d “ A c uit as pr o vi d e d li pi d c o m p o n e nts”) ; i d. at 1 4 .5 T h es e iss u es ar e
`
`dis p ositi v e, y et t h e O p p ositi o n d o es n ot e v e n m e nti o n t h e m.
`
`3.
`
`Alt e r n ati v el y, J u ris di cti o n al Dis c o v e r y Is
`
`W a r r a nt e d
`
`I n t h e alt er n ati v e, if t h e C o urt is i n cli n e d t o d e n y t his m oti o n b as e d o n t h e e xtri nsi c
`
`e vi d e n c e , D ef e n d a nts r e q u est j uris di cti o n al dis c o v er y of t h e u nr e d a ct e d v ersi o n of t h e A c uit as-
`
`B N T
`
`a gr e e m e nt as
`
`w ell
`
`as
`
`dis c o v er y
`
`c o n c er ni n g : (i) t h e a gr e e m e nt’s
`
`n e g oti ati o n , (ii)
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`i n d e m nifi c ati o n of B N T b y A c uit as, (iii) D ef e n d a nts’ l ett ers, a n d (i v) B N T’s all e g e d i n d e m nit y
`
`d e m a n d . S e e H art y , 2 8 F. 4t h at 4 4 2 ( c o urts h a v e “ ‘br o a d dis cr eti o n w h et h er t o all o w dis c o v er y as
`
`t o f a cts b e ari n g o n j uris di cti o n’”). Dis c o v er y is p arti c ul arl y w arr a nt e d i n vi e w of A c uit as’s t a cti c al
`
`
`5 B y c o ntr ast, t h e ass ert e d p at e nt cl ai ms i n Al n yl a m P h ar ms., I n c. v. Pfiz er , I n c., et al ., N o.
`2 2 -3 3 6 ( D. D el.) ar e dir e ct e d
`, wit h o ut r e q uiri n g a n u cl ei c a ci d or a n y ot h er
`li pi ds. T h us, Pfi z er/ B N T’s all e g e d i nfri n g e m e nt b as e d o n t h eir us e of t h e A c uit as li pi d w o ul d
`e x e m plif y i nfri n g e m e nt u n d er t h e i n d e m nit y pr o visi o n
`.
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`7
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`Case 1:22-cv-02229-MKV Document 55 Filed 11/16/22 Page 11 of 14
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`
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`d e cisi o n t o pl a c e t h e r e d a ct e d B N T
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`a gr e e m e nt b ef or e t h e
`
`C o urt
`
`w hil e
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`wit h h ol di n g B N T ’s
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`i n d e m nit y d e m a n ds, A c uit as’s r es p o ns es, a n d r el at e d c o m m u ni c ati o ns —
`
`i nf or m ati o n t h at w o ul d
`
`b e es p e ci all y si g nifi c a nt gi v e n t h e c o ns pi c u o us 1 4 -m o nt h d el a y b et w e e n D ef e n d a nts’ first l ett er
`
`a n d B N T’s all e g e d first d e m a n d ( d es pit e t h e a gr e e m e nt’s r e q uir e m e nt of a “ pr o m pt[] ” d e m a n d).
`
`II.
`
`A C UI T A S’ S IN DI R E C T IN F RI N G E
`
`M E N T T H E O R Y F AI L S
`
`A c uit as
`
`als o h as n ot
`
`m et its b ur d e n t o est a blis h j uris di cti o n o n t h e or i es of i ndir e ct
`
`i nfri n g e m e nt. First , A c uit as is wr o n g i n ar g ui n g ( at 2) t h at “[t] h e f a cts of Mit e k dis pr o v e ” a n
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`o bli g ati o n t o s h o w “ a n affir m ati v e a ct dir e ct e d at
`
`A c uit as .” I n Mit e k , t h e p at e nt e e e x pli citl y
`
`m e nti o n e d
`
`Mit e k (t h e d e cl ar at or y j u d g m e nt pl ai ntiff) i n
`
`a n e arli er c o m pl ai nt a g ai nst a
`
`Mit e k
`
`c ust o m er , s u b p o e n a e d
`
`Mit e k i n t h e s uit t o o bt ai n d o c u m e nts a n d t esti m o n y r e g ar di n g
`
`Mit e k ’s
`
`pr o d u ct , a n d “ Mit e k a n d its pr o d u ct
`
`w er e fr e q u e ntl y
`
`m e nti o n e d i n t h e lit i g ati o n” a g ai nst t h e
`
`c ust o m er . 3 4 F. 4t h at 1 3 3 8. T h os e w er e affir m ati v e a cts b y t h e p at e nt e e s q u ar el y dir e ct e d at t h e
`
`d e cl ar at or y j u d g m e nt pl ai ntiff . I d. at 1 3 4 3 -4 4. T h er e is n ot hi n g si mil ar h er e.
`
`S e c o n d, A c uit as h as n ot pl e d a n a ct u al c o ntr o v ers y as t o c o ntri b ut or y i nfri n g e m e nt b e c a us e
`
`D ef e n d a nts’ l ett ers di d n ot ass ert t h at (i) t h e t w o li pi ds A c uit as all e g e dl y s u p pli es ar e u ns uit a bl e
`
`f or s u bst a nti al n o n-i nfri n gi n g us es, or (ii) A c uit as k n e w t h e li pi ds w er e es p e ci all y m a d e or a da pt e d
`
`f or us e i n i nfri n gi n g D ef e n d a nts’ P at e nts. T h es e f a cts ar e dis p ositi v e u n d er a p pli c a bl e c as el a w,
`
`w hi c h f o c us es o n t h e p at e nt e e’s c o m m u ni c ati o ns pri or t o t h e fili n g of t h e d e cl ar at or y j u d g m e nt
`
`a cti o n . S e e Mi cr os oft , 7 5 5 F. 3 d at 9 0 6; Arris Gr p., I n c. v . Britis h. T el e c o m ms. P L C, 6 3 9 F. 3 d 1 3 6 8,
`
`1 3 7 7 ( F e d. Cir. 2 0 1 1). F or e x a m pl e , i n Mi cr os oft , t h e c o urt f o u n d n o a ct u al c o ntr o v ers y as t o
`
`c o ntri b ut or y i nfri n g e m e nt w h er e t h e p at e nt e e’s pr e -s uit c o m m u ni c ati o ns t o t h e c ust o m er ( cl ai m
`
`c h arts) “ d[i d] n ot i m pl y or s u g g est t h at [s u p pli er’s pr o d u ct] is n ot
`
`… s uit a bl e f or s u bst a nti al n o n -
`
`i nfri n gi n g us e.” 7 5 5 F. 3 d at 9 0 6. T h e s a m e is tr u e h er e —
`
`A c uit as d o es n ot all e g e t h at D e f e n d a nts’
`
`pr e -s uit c o m m u ni c ati o ns m e nti o n A c uit as or t h e s uit a bilit y of its li pi ds f or n o n -i nfri n gi n g us es.
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`8
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`Case 1:22-cv-02229-MKV Document 55 Filed 11/16/22 Page 12 of 14
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`
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`T hir d , A c uit as h as n ot pl e d a n a ct u al c o ntr o v ers y as t o i n d u c e m e nt b e c a us e D ef e n d a nts’
`
`l ett ers d o n ot all e g e t h at
`
`A c uit as is e n c o ur a gi n g i nfri n g e m e nt b y Pfi z er/ B N T. T h us, u n d er
`
`Mi cr os oft , t h e l ett ers d o n ot cr e at e a n a ct u al c o ntr o v ers y r e g ar di n g i n d u c e m e nt. Id. at 9 0 5
`
`( p at e nt e e’s c o m m u ni c ati o n t o c ust o m er di d n ot m e nti o n t h e s u p pli er a n d t h us “[ w] hil e t h es e cl ai m
`
`c h arts all e g e t h e c ust o m ers ’ dir e ct i nfri n g e m e nt of t h e ’4 0 2 p at e nt b as e d o n its us e of Mi cr os oft’s
`
`[pr o d u ct], t h e y d o n ot i m pli e dl y ass ert t h at Mi cr os o ft i n d u c e d t h at i nfri n g e m e nt ”).
`
`F o urt h , A c uit as ar g u es ( at 1 5) t h at it c a n est a blis h a n a ct u al c o ntr o v ers y u n d e