Amgen Inc. v. F. Hoffmann-LaRoche LTD et al

Filing 1006

MEMORANDUM in Support re #1005 MOTION in Limine to Preclude Amgen from Asserting that there Was a Restriction Requirement Separating the '008 Patent Claims From the Claims of the '868 and '698 Patents filed by F. Hoffmann-LaRoche LTD, Roche Diagnostics GmbH, Hoffmann LaRoche Inc.. (Attachments: #1 Exhibit A#2 Exhibit B#3 Exhibit C#4 Exhibit D (Part 1 of 3)#5 Exhibit D (Part 2 of 3)#6 Exhibit D (Part 3 of 3)#7 Exhibit E)(Seluga, Kimberly)

Amgen Inc. v. F. Hoffmann-LaRoche LTD et al

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Exhibit D, Part 3

R resentative Original Group.l Claims '933 Polype tide Claims
conditions, mammalian host cdls

transformed or iransfccted with an isolated
DNA sequence encoding the human

erythropoictin amino add sequence set out
in FIG. 6 or a fragment thereof; ,md

(b) isolating a gJycosylated erythropoietin polypeptide thcrdrom.
5. A non-naiiira!!y occurring human

eryihropoil'tin glycopl"teiii possessing the
in \'¡WI hiological prO¡K'ny o( causing. bone

m~irrnw (dls to incrcilsc productioii or
n.ticulo(ytes and red biood cdls which i:the product of

the process comprising the

StepS of:

(n) growing, under siiit1ible nutrient

conditions. mammalian host cells
iranslornicd or trmislcctcd with an isolated
DNA scqUl'llCe comprising a sequence

encoding the !c:ider sequence üf hum,iii

erythropoietin set out in FIG. 6; and

(b) isolating ii glycosylitcd erythropoietin
polypeptide therefrom.

6. ¡\ non-naiurally occurring glycoprotein

pwJlH.:i of iile cxpn.:úion iii :i non-!iuiiwii

ciicaryoilt IW~1 of an exo¡,enoiis DN:\
$eqocnçe comprising ,1 UN/\ sequence

i:ncüJing human erythropoietin. ~;iid
,

product possessing the in \'Í11! biologic,¡!

L__
85

property of causing human bone llE1rrow i

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,

Re rentative Od inal Grou 'I Claims '933 Polypeptide Claims

c.clls to inerc;ise produciion of reticulocytes

and red blood cdls llid having an average
c.irbohydr;uc composition which dini:s from ibni ofnUlmally occurring
erythropoietin, 7. The glycoprotein prodm:t

according to claim 3, 4, 5 or 6 wherein the
host cell is: 11 non-humaiimamniali,m celL.

7. The glycoprotein product according to
claim 3, 4. 5 or 6 whcreiiithc host ceil i~ ¡I

non-human m;illmali;in ctli,
8. The glycoprotdl1 product aci'u)'.Jing \ü

claim 7whcrciiiihl. non-human
1l,11llla!ìan cdl is a CILO celL.

178. i may use the following table in my tcsiimony in light olDr, Lodish's
expert report to e,\plain how claims 9-14 or Dr. !.rls '933 patent relate 10 the original claims in
Dr, tin's '298 ¡ipplícation that weri;~ assigned to rcslrictio!1 Group v;

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Original Group V Claim~ '933 Phannaceutical Com ition Claims
55. A pharmaceutical composition comprising

9. A pharmaccutical composition comprising
an clTcctive amoun! a gl;,'coproicin product

an dÌ\:etjvc amount of a polypeptide according
10

claims 1, 16, 39,40or4! aiid:,

eCfective for er;.'thropoiciin therapy according

r!i¡mllaccuiic:\¡ly ;¡çcepuibk diluent, adjuvant

to claim L 2, 3, 4, 5 or (¡ and a

orL:\rrwr.

pharmiiccuiicall:' acccpti:bk diluent. adjuvant
Or c,irner,

56, A method Cor providing erythropoietin
thcr:ipy to a mammal comprising administering
an cl1i:ctivc amount of a polypeptide according
I to claims I, 16,39, -10 or 41,
¡ !

JQ, A method for providing erytliropoktin therapy 10 a mílmmal comprising administering an effective amounl of a pharmaccuticul

,

composition afclaim 9,
i i. r\ mcthod for treming:i kidn('y dialysis
pmieii which comprises .,dministçring :1

¡ 57,1\ method according to claim 56 Whcrc¡ii

¡ the tlltr¡¡py comprises cnkmcing hemíltocrit

I kvcls,
I

pharniaccutical composition of claim 9 in an
amount dfectivc to incr\èasc ¡he hi.f1,llücrit

level of said piiicnL
12. 1\ pharmaceutical composition comprising
I an clTcciivc amount of a glycoproicin product

I elTectivc for erythropoietin therapy :!ccording ! to claim 7 and :i ph:inmiccu,îcally acceptable

i diltient, adjuvant or carrier.
i ,

I i 3. A method for providing erythropoietin I therapy to a imimmal comprising. administering

omposition or claim a I.can dli:ctivc amount of11.pliarmiicciiiical
! i

) ~.. .
Sï

i i 4, A method for trcatin!! a kidncv dialvsis

I pa¡jcii which comprises administering a
i phannrKeutie:i1 composition or daim i 2 in ¡m
i allOiiit ci'recti".. tu incr..:¡s" ¡he h"lll.lWcrÌl

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L_..

I level of said product.

¡ 79. 1 may liS'" the t()lIowing table În my testimony in light orDr. Ltldislls
expert repürt to explain how claims 1-3 and 7 of

Dr. Un's '080 paicni rdate to the origimi!

c!,iims in Dr. Lin's '298 application thaI were assigned to restriction Group J;

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,

Representative Ori inal Group I Claims '080 Pol e tide Claims
1, A purilied and isolated polypeptide having
part or ull of the primary structural

J, An isolated erythropoietin glycoprotein
having the in t'il'o biological activity of causing
bone marrow (,(;11, to incrc¡isc production of
rctlculocYh's and red biood r:~'lIs, wh;;rcìn said
erytlirop()ì~'¡¡n gl;.'r:oprotciii comprises ill;;

conformation and one or morc ofthc hiologieil
I prop::ni;: ol'l1~n\lr¡iily.()Lcllrr¡i1g erythropDietin

I. " .
í

i :ind diar¡ictcriz~'d bv b\;in'! ihe product of ii pro(,aryotk ur ctlcarv(;iic i;.\¡m:ssion oî an

i . ~, .

¡llilUrç (;l)'tlimpoi¡,in amino :iciJ sequenç(,' oj'
FIG. 6 and has glycosy!ation which dílìì:rs
from that of

! l..\:ogcnotls DNA scquence,
¡ 40, A glycoprotein product having a primary I structural conformation sunïciel1tly duplicativc

human uriniiry crythropoíç¡in.

2. An isolated erythropoietin glycoprotein

having the iii vi\' biological activiiy of causing
I OÎtliri of a nalu~lIy.(:ccurring ery1hr~poictin
I to ¡:J1ow possession 01 oiie or more o.f thc
I hiolügiç;:i propçnks ¡heicn!' mid lmvil1g an

bone marrow cells to ìncrcllsc- production of

¡ :ivl'ragi: orbühydr:He composiiion which

¡ di ili:rs jj,üll th;:l of natur;illy-occlJring
¡ crvihropoict¡ii.

I rcticulocyics and rcd blood i:dìs, wherein said I crytlimpoictìn glycoproiein comprises ili: i m:illre erythropoi::tin ,-imino acid scqw:ncc oÎ
I FIG, 6 :ind is not isolated ¡rom human urine.
, , ,

I.
i I

i 3. A non-naiiinilly occurring erythropoietin j glycoprotein having the- in vim biological

,. . ,
í¡..I
ì

¡ activity o(causiiig bone marrow cl.ls to
I increase production of H.'iiculocvics and red i blood cells, whi.n:in s:iid cnihmpoíetin

! g ycoproti.ll cÜI1¡mses lli: m:lurc
i erythropoietin amino acid sequc-n('c ofFle;, 6,

7, An isolated polypeptidc produci

,~
i characterìzed by being the product of , i exprcssion by a prokaryotìc host cell of . '""~--"~"-- ,,--'---_.,---,,-,,--,-.-,--iSO. i m:i)- lls~~ ii\(,' íÒiJiw,:ing t,ibh: iii c.\:pcri report to çxplain ho\I,' claims -1.6 of

the
an

¡ exogenous DNA sequence cncodîn~ tlie- mature

I erythropoietin amino acid scqiicncc ofFiCi. 6,

11)' li.slil1hJny in lighi o(Dr. L.oJisÏ1's

Dr. Lin's '080 patent rd,l!c to thc origin,d dain): in

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Dr. Lin's "298 applic,HÎon 11ml were assigiicd to restriction Group V:
Ori inal Grou V Claims '080 Pharmaceutical Compoition Claims
, I i

55, :\ pharmaceutical composition
comprising an effective amouiit ûf a
polypeptide according 10 claims I, i 6, 39. 40 or 4 I and ,i ph¡irmacciiilcaily acci.pi¡ibk

I 4. A phannaceiitic.al composition
i comprising a therapeutically cflCciivc
I ¡¡mount an erythropoietin glycoprotein

I produci according to claim i, 2 () 3.
I 5. A nwiÌ\od f\ir providing erythropoietin

diiuem, adjuviint orCilrricr.
56. r\ method for providing crythmpoíctin

i ihempy to ,ilmHllm::i comprising

tli.:r:py 10 a mammal comrrisirig
: administering an clìccti\'c amount or ü

i administering an erl\ctiv.. amount or a i pharmaeclltie.i1 composition of daini ,L ,
!

j polypeptide according 10 claims I, 16, 39,
¡ 40 or41.
I I

I 6. A method for treating a kidney dialysis
i

! patic!H which comprises administering a

157,:\ method :lccordinD: to claim 56
i

! phanl1ac..uti~~i.1 composition of claim ,1 in
i an amount erfective lü incn,,'~ise the

i wh"rcin tlw thcr:ipy comprises enh:memg
! hemillocrit levels.
¡

I hematocrii kvcl or said pilicnt.
!

2, Under 35 U.S.C. § 121, Dr. Un's '008 P:itcnt Claims Caniiot Be
Used :IS a Reference to Invalidate Dr. Lin's '933 11ntl '080

Patent Claims
18 i. I-laving reviewed the lìk histüry for Dr. Lill's '933 and '080 pateiits, 1!nd

based on my wiJcrstiinJing of the subject matter of

the claims assigned to the various restriction

groups as inroril1:J by Dr. I.odish's ¡;xpcri repori (Lodish ~~) 524.530). it is my opinion tliatlli;;
¡ippJk:iiions. giving rise!i Dr. Un's '93:; :md 'oSO palcnb wcrc likd :dta the Lx:miil1ers' .lu!:1986 restriction requiremellt in the '298 nppli¡;,iiion and conwineò claims drawn to the non.

eJected inventions --- specifically, the inventions of restriction Groups I and V - and nOi to the
Group II inveiiiion elecLcd and prosecuted to issuance in Dr. Un's '008 patent. There/ore, it is

my opinion that the applications giving rise to Dr, Un's '933 and '080 p,ucnis satisl)-.the "lied

90

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as ¡i n:sult or' rcquiri;'llc111 Iiir § i 2 i protection, i nolC ¡hat !\k Sofüc!i'luS docs not contesiihis

point in his rq)orl.
i 82. 1';1r. Süf¡xkol1s docs, however, comesl that

the consonance n:quircnient

for § 121 rroteciion is satisfied lor Dr, Un's '933 and '080 patents. ivlr. Sorocleous opines that
the claims oltlie '933 and '080 patents are not consonant with ihe July 1986 restriction
requirement for two separate rc.1sons (discussed below), and that, "(a)$ a result, the safe harbor
provisions of 35 U.S.C. § 12 i do noi apply, and ¡he '008 patent claims are avaiJ:iblc for doublepat(,llting purpf!SCS against ¡he '933 and '080 p:ltent$." Sofoc!coiis ';l; 465, 468. This orinion is
Hawed beca\isi. .\k Soj();,kÜ\lS does not apply ¡he proper kgal analysis in his ¡¡ss(,ssnii~nl nf

cmisonancc.
! 83. The lÌrst consommee vìolation alleged by Mr. SoîoclcollS n~g~irding Dr.

Un's '933 ,liJ '080 patents is.

that, when certain '933 mid '080 clriims "were amended such ihm

they coufd not be made from natural sources, and only from recol1biliani DNA and host ecJJs,
i\pplìc:1J1 vitiated ¡he Patent OfTcc's raiiol1iilc for Üs restriction requirement and broki: the
consonance requirement ol * 12 i:' Sofocleoiis ~ 464. This argument is Oawcd bcc,wse ¡\ilr.
Sofoclcotls altel1plS to set the line oldcmarC¡¡lîon surrounding restriction Group II Oil ii basis

other than by looking to the actual restriction groupings (i.e.. the substance oltlie claims in each
restriction groiip), as the Federal Circuit has iiislriicted. See Texas hisrrimienrs, 988 F.2d al
i 179,
184, Spcciíìcally, Mr. Süj(lclcoliS focuses on ihe kiilowing st¡JWmcnt made by

,he Examini:r and specubtcs ¡h;it "¡he Examiner scp:irai.:d the polypeptidç cl:iims tin Group ¡¡
¡¡"(1m ¡he recombinani DN..\ and hiist cell duíms ¡in (¡roup HI, bccausl,' shi: condudcd thaI ¡he

¡Group 1.1 polypc-piidi. ¡;iaims could be made trom an alienwtive SO,lfce, such as natural tissilC"

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(Sofockous i¡ 464):

Inventions i and ii arc related as process of nmking and product made.
The invciiioiiS arc distinct ilciiher (I) ihc prev,:css iis diiimed

can b;,' used 10 m;ikc anoiher and maierìally different PWdlH;t. m

(2) the produc; n$ d;iimcd can be made by another and
imlterlally dìfj(.r~'nl pmctss. \'lPL~P 806.05i-t),
In..h¡:- C;lSC. the rwiduct,J!S daimc"9_il;!\' be mij).£t:~;¡ m.s.tcri:iIJï different Rmdiiet. 8.l1fJUìsjjO!;liio!) (fOlll..:\.liluniJty.

ücetJrrint!~,

Soíocleous \ 459 (quoting '298 File History, Paper 8, 7/3/86 ütlicc Action) (emphasis ;iddcd by
Mr, Sofoc!eoiis) (Ar-'1~ITC 00952500),
i 85, Having reviewed the substance oCthe claims assigned to n:striciion

Groups I and II. and Dr. L.ndislls annly:;::; of them, I believe thai !\-1 Sofo;:eous is readiiig toii
nniçÎ1 ¡¡¡iO iilt. Ex:un¡n~~rs' rcii;irks. qlJoled above. f\S. Dr, J.oJish explains, while "Sülnt. ofihe

original Group i claims (c.g" c!iim 40) could be made by a mnierialty diilcrenl process than ihe
process encompassed within restriction Group IJ," Mr, SofocJeou::'s interpretation olthc
Examiner's remarks "is inconsistent wiih ihe facl th:11 Group I included claims that could 1101

el1i.ompass products isoliicd from a niltiira!!y occurring source." Lodish ~c; 526.527. For
ex,implc. Dr. Lodish (;xplains in his n:porl thaI origin;,l claiii I, which was assigned to Gwup i.

w;is limited tl) polyp¡;p¡idcs m:,dc (rom non-n;ltiiri! sourct.s:

¡,:\ puritìcd and isolated polypep¡idc having part or all oftlic the biological propcnics olnaturJlly-occurring el)'thropoiciin and
primary Slriiclural conlorl1aliolì and one or more of

characterized by being the product of procar)'otìc or eucaryotic

expression or ¡m exogenous DNA sequence,
Lodish ~ì 526. For ihese rC11sons,I disagree with NIL SofoclcoiiS'S premise thai. in order to
m¡¡ini,¡in çon~onaiice. the '933 and '080 çJaim:; must not be Jiniit('d!O polypcpiides made from

nüii-o:llur;:l sourçcs. SÜi(KJcO\lS ~ 464.

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186, Dr. Lodish lia.s explained thatihe local point ol¡lie Group II claims is
DNA;

Th;, E.\:llli!wì" Jescríbeo Group II ,::- "dr,iwn to Dx:\." B,iSd
on the subjet'l m¡l1~r of

the claims ¡bsignL:d 10 Group I i. J ;igree

with this chnnic!crizaiio!1, The claims assigned to Group ii ineludi.d both process and non~proccss c1i:ims. The common feature of c!¡iiins 14, i 5, i 7~36, 58, and 6 I -72 is that c¿lch claim requires a specifk, purilìcd, and isolated DNA sequence, encoding either human or immkcy erythropoietin or an analog
polypeptide related to eryihropoietin in both structure ilnd
fuiiction, While some of these claims arc directed to host cells coniaining or processes using such purified and isolated DNAs, none arc directed to erythropoietin polypeptides or

~~rylhrúpoie-tin phann;ceutical wmpo;;iiions. Nor do any of these claims rdate to hosl cells or processes fÖr use- ddith::c by

structures oihcr th:mihc iiiroductioii oïpurified and isolated DN:\ encoding ihe desired poly¡xptîdc. Addítîonally,ihese claims dû not relate to cells or processi;s di;lìned by a required
production level for any polypeptide. 'l1icrelore, based on ¡he

slil:Üect matter ofille claims assigned io Group!l, ii is my opinion that ihe tocal point ofGrotlp 11 was the recited DNA,
Lodisli ~15:?A. Bascd on Dr. I.odislls opinion ihut the rocal point oltlle Group Ii claims is DNA,
;\ld not isolmion fnim ll()!1-naiura! ,.mirCes.. it is my i.pil1ion ihm ihe mere f:icti1w! Si.Hlll' '933 and
'080 claims \I.'~~r~~ mnenJcJ to recite "l1HHli\lilmlly occurring" ~¡yc()protdlÌ prOll\lcts í:o irrdev:iit

to ddcrmining \Vhc¡h~~r those claims ar.. consonant with the Ex:imin;,rs' n.:strkiioii rcquireiii:nt.
IS7. Dr, Lodish examined the substance ofihe '933 and '080 claims from a

technic.,11 perspective and concluded that none ofihcse claims "fall within the scope ol'rcsiriction

Croup II, 'drawn to DNA,'" Lodish ~.i 533, 539, Dr, Lodish explained why his opinion was not
inconsisten! wiih the Üict that some ofihc '933 and '080 claims reciic the Ii.nn "DNA ":
Some of the original cl:'1iino: assigned to Group 1 (e.g. original

claims) ;iS weil as '933 daills I~S makt: reìcrence w us;. of;ll exogeiious DNA seauenci: to produce EPO erythropoktìn polypepiides. ßutlikc ihe origil1ai chiims assigned to GrOllp i.
none 0('933 cJiiims 1-8 is directed 10 DNA or a liosl cell iraiisfccicd with DNA. Thus, it is my opinion tlini aii ordiii;¡rìly

skilled ,llisan would recognize ;:nd undcrswnd tlwt there arc no
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material diiTercnces betweeii original eluims I~13 ofihc '298 application and '933 claims 1.8 which thus would full within
the scope olilic Group I category of within the scope of

claims and would not fall

the Group If category of claims.

Unlike ¡he claims of

the '933 patent, each oï ¡he '080 claims is

limiiid by ¡he Fig, 6 polypepiÙle scqtlCIKe, Whik ¡hcr~~ \\cre
no original claims reciting ihe Fig. Ú cl),thropokiin ;miino ¡H.:id

seqHenCi., this narrowing 1ímÍ!aliOl\ in no way crosses the line oï

dcmarcatiùn drawn around ihe DNA cell subject llaw.:r of restriction Group II. l'vloreovcr, as described above, is dear that
the Examiner made no distinction in the restriction r~'qtlin:m~~nt
",
,

between an EPO "polypeptide" and an ËPO ;'glyeoproii.in,"
given the inclusion or original claim 40 direcicd to "a glycoprotein product" in restriction Group 1. Like the original claims :issigncd to Group 1, none of'()80 claims 1-3 Of 7 is

directed to DNA or a host ccl1tran5Jcctcd with DNA. In (bc!,
¡ike origìnal claim 40, nOl1eüf'OSO claims 1.3 or Î makcs any rr.!cn.:ncc tü EPO DNA sq\lCIlCCS \\'haisocvcr. Thus, it is my

opinion that an ordinarily skilled artiS;ll1 would recognized and
underswnd that '080 claims i -3 and 7 fall within thi: SCOpè of restriction Group I, and do not íillJ wi!hiii the scope of
restriction Group 11.

Lodish ~.i 535, 541. For the reasons explained in rk Lodish's report, it is my opinion ihai none

ortlle claims orDr, Un's '933 and '080 pillents cross the !ine ofdemareaiion drawn around the
invcntion deekd by i\nigcn following ihe i:;x¡lniincrs' restriction requirement in th¡; '298

application.

I B8. Equally imponanl. Dr. Lodish cC\~lmin(;J ih!; $iibslanc" (lthc '933 ,inò
'080 ciaims as conipa,,'d 10 thai o(¡he origÎn:i! claims in Dr. tin's '298 application and

concluded thai allthi: '933 imd '080 claims fall wiihin the scope of cither Group I or Cìrüup V .,

IwO ürthe restriction groups nol elected for examinaiion in the '298 appliclltion. Lüdish ~~ 533,
539. S¡x:eincally, Dr. Lodish opincd thaI ;933 eliims 1-8 and '080 claims 1-3, and 7 Call wiihin
¡h~' scopi: of

Group 1. and ¡hat '933 claims 9.14 ::id '080 claims 4-6 iàii within ihe scope of

Group V, LoJish ~~ 534, 536, 540, 542, ¡note that Mr. Sofoçlcotls agrees ¡hat '933 claims 9.14

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and '080 claims 4-5 "fåll wiihin resll"cied Group V" (and, therefore, do not cross

the line of

demarcation Jr;l\.' ;:lound rcsirietion Group II), Soli)ckotls i: -166, For ihe reasons explained in
Dr. Lodîsh"s report, it 1s my opinion IhM all the claims of

Dr. Lin's "933 :ind '080 patcnbare

eonsonani wiih the claims in Dr. Un's '298 :ipplkation ¡hil ihe E:-;:iniiiers ilssiglh:d ,0 restrictioii
Groups J and V.

189. The second consonance violation all0gcd by 1'v1r. So!()clcous reg:irJing the

'933 and '080 patents is that these patents broke consonance "by issuing with claims from
muliiple r.:stricid Groups," specilìcally Groups J and V. Sofoclcotl": Cl:~! 466, 46S. This

argument is flawed bi.causc ii h¡is no basis in ihe law.

190. !\-1r SofoclcOllS f:iib to identify ;:my legal siippori for his theory that
conson¡mce is violated when a patent issues with claims drawn to inventioiis assigned 10 IWO

dinerenl restriction groups, ni:ther otwhich was clccicd for cxaminniion III

the parcnt

application. Nor am t aware of

aiiy legal support for 1\r. SOtOCIcOllS'S theory. In my opinion.
the double

the nik proposed by i\k Sofocleous moves away n,Oll the fundamental purpMe of

pati,.'nting doctrine, because u !mer P¡w:nl thm wntaìns claims drawn only 10 the- non-dee-ted
inventions, and nollO tÎ1ç subject matter thaI \\-¡iS elected ftir examination in the c:irlicl" p:itcnt,

dues 1l00eXlcnd the h.'nll ofiliat earlier palen!.

191. As the Federal Circuit has made clear, the consonance requirement is
siitisJied as long as the claims in the issued patent "do no! cross the line- of d~~mi.rcaiion drawn
¡irmind the Ùii'ettirm elected ¡It ,he res'ric,irm r/!t¡uire/lett." .\)'1Ibol Tl!chs.. 93-5 ¡:,2d at 1579

(empii:sis :¡ddcd). To my knowledge. (he Federal Circuii has never held that an npplíc:itìon Jikd
as a n:suli ora restrkiion requirement (or a patent issuing thcrcthim) c,innO! contain claims

drawn to iiivçntiol1~ (rom multiple n:-sirlctíon groups not dected jor txamiiiatioii in the parent

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,lppJìcation, ¡fanything, the language in Gerber Gan/wll, one orthe Fedeml Circuit's key cases
regarding cons-nunce, suggests JUS! the opposit(:, See Gerber, 9 i 6 F.2d ut 688 ('To gain the

bcneíìts of Section i 2 i , , , Gerber niust have brought its case within the purview ülthe SlJtule,

i.;:" it musl have limited the claims in iis divisional application to the non-elected invention or
im'I!Jltio1l,,"') (crnpliasis addd),
in, Addiiionally, Mr, SOfOCIeOlIS'S theory that ihe '933 and 'OSO pah:iits arc

not consonant heCnllSe they include claims from Groups i and V ignores ¡hat restriction practice

is discretionary, see 35 U,$,C. § 121; MPEP § 803, and that the Examiners in this case exercised
their discreiion 10 allow Amgen 's counsel to proSeCll\c claims lrom Groups I iind V !()gcthcr in

¡he' in, '87.1. '774. and '556 aprlication~ leading io Dr, Lin's '933 ¡ind '080 patellls. For ¡ill
thcs~' ro:asons, ii is my upinion Ih:11 Dr, Un's '933 and '080 palcils do ¡WI viol,Hç ih~~ .;onsun~U1cç

n:quirçnil'l1! by including claims from boih Croup r ;ind Group V.

193. In my view, the rckv,Hll consider:iion in assessing conSOl1¡¡nct,' for Dr.

Lin's '933 and 'ú80 patents is whethcr the claims in ihose patents arc cmisonant wiih the Group i
and Ciroup V claims pending in Dr. Un's '298 ::pplication at the time of

the 1986 restriction

n:quirenicni - claims which the Exnmincrs deemed pmeniably distinct lroii thc Group II claims
¡h:\1 were e!ccltd ilnd prostcuted to issuance in 1); Lin's '008 paten!. As iiowd ;ibovC", Dr,

Lodis1i has c.',lniintd Ü¡~. ciaims from a lechnical p::rspçctívc ¡md opined thm '933 claims ¡-S

and '080 cl:iims i -3, and 7 nil! within ¡he scope olGroup I, and ihal '933 c!:i¡ms 9-)4 and 'OlW
claims 4-6 fall within the scope of

Group v, Lodish \11 534, 536, 540, 5.12. Therefore, it is my

opinion that Dr. Lin's '933 and '080 patents satisfy ¡he consonance requirement for ~ 121
proteciion,
194. For ¡hI. rC,i.ons discusscd :ibov¡;, it is my opiniDlì ¡hat the sak harbor

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rrovisiwb 0(35 U,S.c. ~ i 2.1 trpply w Dr. Lirls '933 :iiid 'OÖO pall,ll!S, and !ha! Dr. Lin\: 'OOS

¡mtcllt d;:ims cannot b~ used l~)r double-pateniing purposes 10 invalid;i¡!, Dr. Liils "933 and '080
patent claims. In connection with my testimony regarding this opinion, I may Ilse cerlain

grnphics or demonstmtivcs, siich as tliose included in Exhibit 4 to my report.
3, Dr, Un's '933 :ind '080 P:Hent Claims Arc Patentably Dísiiiict

from Dr, Lin's '008 Pateni Chiims .

195. 1\k Soloçkous does nol stati: in his reporl that ¡he '933 and '080 piltef1i
claims :ire JWI palentably disiinct from the '008 l"'lIenl daims. Nor Jocs1'I-Îr, Sofocleous sl¡lc

that Amgeils counsel has improperly extended ihe icrm orDr, Lin's '00& patent by Üiiling to
tenninally disclaim Dr. Un's '933 and '080 patents, However, Exhibit C úrMr. Sorodeous's

reporl includes an unnumbered demOl1Slruiivc, titled "Tcrm or Amgen EPO Patents," which

graphically derkis ihill Dr. Un's '933 Jnd '080 pateii!s rcpn:sent an "impf(p~~r e.\tiris¡,ln o(
inü)\ofloly:' ben i( ~ i 21 did n"t prohibit us.. üÎ Dr. 1'111':- 'OOg eiaims feil' double pat:!liing

piirpost.'s against DL ¡,in's '933 ¡ind '080 claims (which It dü~s, for the n:asons c:\plaind ab()v~),

it is my opinion ihm the eoiiclusion cxpresscd in Mr. Sofocleous' demol1slrative is unsuppürl\d
because it depends ol1lhc unstutcd rissumpiion Iliatthe claims of

the '933 and '080 paIcnis (lrc

not paleillably distinct from the claims in the 'ODS patent - an issue that 1'r. Sofocleotls did not

address anywhere in his report.
196. Ivloreüver, based on !he C:\pCft repon orDr, Lodish, it is my opinion ilim,

in addiiiol1to being unsupported, Mr, Sofocküus's demonsirative is wrong. i have b..cn
informed thai '933 claims 3, 7-9, and 11-14 arc the only claims ollk Lin's '933 palCl1 asserted

in ¡his case, and the only '933 claims whidi Rochc contends arc invalid for double paleniing
over the '008 patent claims. As Dr. Ladish cxplriins in dci,iil in his eXpCl1 report, '933 claims 3,
7.9, and 11-1.:;Ie paieni:blydisiinct (rom th\. claims Milie '008 pat¡:rlr. Lodish \'1 417-42.0.

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On;; of th;; distiiictions Dr. Lodish discusses in his eX¡;t:n report is th:it "each ofihe ;issçrted
daiim: n:çilt: "jJOsitive ll'ljliirL'l1ell îor the products' ¡II l'i\' biologiç;'¡ activity (or ihi.rapçuiie
cllictj, as compared to ihç 'OOS claims., which do not." Lodisli~. 418. Oiher Jistìni:tions

between the '933 and '008 patent claims also are explained in Dr. Lodislls expert report, Lodish
Ex, C;,
i 97. i have been ìnfonncd th~l! '080 claims 3, 4, and 6 arc the only claims ùr

Dr. Lin's '080 pak'nt asscrlcJ ¡nthis case, and the only '080 daims '.\hicli Rntiic contends an:
invalìd fÖr doiible p"tcniing over th~' 'OOR palCnl claims. As Dr. Lodisli ,";.plains in Ji:wil in his

report. '080 claims 3, 4, :ind 6 ilrc paicnwbly distinct froiiihe claims oî Dr. UIl'S '008 patent.
Lodish 'rl 4 17-420, Onc of

tile dis1inctions Dr, Lodish discusses in his report ís that, "each ofthc

asserted claims recite a positiw! requirement for ihe products' in vivo biological activity (or

therapeutic ellect), as compared to the '008 claiins, which do no!." Lodish ~ 4 i 8, Other
disiintiioiis between the 'OBO and 'OOB palen! claims ;ilso arc t.\plnincd in Dr. Lodii'¡ls expert
repOi1, Lodish b. (ì,

l 98. As noted carlia, ¡he obvimisness.typc double patenting. doctrine is

designed to prevent improper tiniewise extension of

the pilCIH ríght by prohibiting claims in a

later patent which :irc not p:itentabiy distinct from cJrims in a commonly-owned earlier p:ient
from enjoying a longer patent Icrm. Because.

lor the rCilsons discussed in Dr. L.odblls L'xpert

r~Ton. the d:iinis in Dr, Un's '933 and '080 patents are pmcntably distinct from the claims in
Dr. !.n's 'om; patcni, the -933 and '080 pati,n! claims do nol c.\tind the Icrii of fl;il(~n¡ protection
¡or the '008 palent,

D, DR. LIN'S '422 P.-\ENT CL.AIMS ARE NOT lr;v"J.D FOR OB\-'IOVSNESS-

lYrE DOlJBU: PATENTING OVEn DR, LIN'S '008 p" TENT CLAIMS
1. Examination history of

Dr. Un's '422 Paten1

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199, My discussion of

Or. Un's '422 patent begins whh the' J79 application.

A:- mentioned iihove, Dr. Un's '179 application was iicd on October 23, 1987, alier ihe
rc:;iriction n::quin::mcilihat was cn\ercd during C\amimHion or

Dr, L.in's '1% iipplication, Dr.

Un's' 179 applkaiiol\ was l¡kd undi.r 3i C.LR. ~ i .60, which ¡x:rmiH¡,d Aingeils i.Olll1Sc! to
me the; i 79 appllcaiion by submitting u irue copy oliht. prior ;298 application, including ~1 copy

olthc oaih or dcchimtion originally tiled in Dr, Lin's '298 application. In keeping with the
earlier resiriction requirement. Aingen's counsi:1 cancelled atl claims that belonged to restriciion

Group ii (which w~~n; being i:x:imind in Dr. Llils '298 :ippl¡caiion), and sdcctcd original claim
! -,. \\hidi belonged io n;striction Group I ,)rth~' '298 :ipplkaiion - l(irc.\¡miin¡¡¡io;1 in ili~" 179

,ippi¡ciiiiofl.
200, On November 6, 1990, with examination of

Dr. Lin's' 179 ¡ipplicatÎon

dcluyed pending the outcome oCthe '097 interlèrcnce proceeding. discussed above, Amgcn's

eounsd advanced ihe examination lending 10 the '422 patent by fiing U,S, Patent Appliemion

No, 07/609,74 i ('lil. '74 I appiil.aiion'l Like the' 179 ripplicaiion. Dr. !.n's '74 i applicuiion
was tild UiKkr 37 C.F.R. ~ 1.ÚO, which pcnniiicd Amg:c:1's counsd t(¡ tile ihe '7.; 1 :ipplicatio!l

by slIbmiiiing ¡i true wpy otthe prior' i 79 application, including a copy ort!i\: tl;iih ()r
d¡;çl:niion originally tikd in Dr, Un's '179 applii.ation, And. us it ii~id d01W whl.n filing ¡hI.

'li9 application, Amgcn's eotJlscl, consistent with the Examiners' i 986 lcstriciion requiremellt
in the '298 applícaiion, canceled all claims thai belonged to restriction Group II, and selected a

claim from the other, non-elected groups forcxamilltltioii in the '74 ¡ application. Aingen's
counsel

then added three new claims, numbered 61-63, to the' 74 I application. The' ¡ 79

applic:iiioii provided çoniinuity for Dr. Liils '74 I application to p-erm¡t the '74 1 ,ipplication to

claim ¡he bcne!ìt oftlic lì1îng dale of

Dr, Liii'S '298 applíçation under 35 USe. § 120,

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201. On :\pril 6,1992, Examiner Nolan issued a rölriction requirement ¡'or Dr,
Lin'~ "741 application. The rcsiriction requin:ment identified scven separate invention groups
and rcquired thai Amgcn"s counsel sekct claims from only one of

these seven groups for furilier

examination in the '74 i applic.ation. "741 File lIistory, Tab 4, 4/6J92 Ofice Action (At\'l.ITC

0094313 i). In n:sponsc to this restriction requirement, Amgcn's counscl sclected pending
claims 61-63, which thc Examiner had assigned w Group ViI, lÌ.i fUrlher examination inthc
'74 I application.

102. On October 6, 1992, Amgcn advanced the cxamiiiut¡on le;iding to the '422

patent by liliiig U.S. Palent Applic.ation No. 07i957,073 ("ihe '073 applicmioii"), Dr. Lin's '073
appJic;ition utilized the "file wrapper continuation" procedure under 3ï C.F.R. ~ i .62, which is
discussed above. .'\s a result. the prior '74 i applkaiion was abandoned, and ib spe;;íri,atiùl1,
ckii!1S and drawings. including all amendments, \\~~ri; i.arricd t~)ni.'¡lrd ¡ind "eolilÌml¡;" (1,(;.,

physìc;iJ!y inçludcd) in Dr. ¡.in's '073 applicaiion. The 'ì4 I ¡ind . i 79 iipplîc;itions providd

continuity lor Dr. Un's ;073 application to permit the '073 ;ipplicatÎon to daim ¡he bciidìi olilic
rìliiigdute of

Dr, Un's '298 application under 35 U.S.c. § 120,
203, On AUgU$12, 1993, Amgerls cOlinscl advanced the examination lc~iding 10

the '422 patent by Hling U,S. Patent Applie1.ltion No, 08/100,197 C'tlic; 197 applkatiün"). Like
the- '073 :ipplica¡ìon hd¡:Jre- it, Dr, ¡,in's' 197 appliciii¡on utilized the "nil wrapper cüntinuation"
proccdiiri; under 37 c.r,R. ~ 1.62. As a re-sul!. the prior '073 application was abandoned. ilid ilS

specilkation, claims and dr:iwings, including all amendments, were carried lonvard and
"continued" (i,e., physically included) in Dr. Un's' 197 application. The '073, '741, iliid '179

¡ipplications provided continuity It)r Dr, Lin's '197 applicatioii to permit the' 197 application 10
;.laim tilt: bCl1dit ()(:l1e jJjj¡¡g J;lle u(Dr. Un"s '298 :ippikat¡oii unJ('r 35 u.se. ~ 120,

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204, As oneil happens during the cours of examination or a paIC'nt applicution,

all April 28, 1999, ;\ingcn's counsel chose to cancel pending claims 61-63 aiid to replace ¡hem
with new ciaims to advance ihe l'x;:mination orthe '19ï application. These new claims,
numbered 64 :l1d 65, were iiltimatdy allowl.d by thl. ExiHliiner on ~-1y 28, 1999, and tliey issuC'
:IS claims i and 2 of

Dr. Lin's '422 pawnt on Septcmber 21, 1999,

205. Bccmisc the' 197 application contained claims dr:iwii 10 ihc inveniioiis of
Group V of

the i 986 rcstríciíoii requirement iii the '298 application, Amgen's counsel iilcd
10 ensure ihri the end of the term of

terminal disclaimers

the '422 palent coincided with the end

of

tho: term orille '933 and '080 patents, which, as explained above. :ilso contained claims that
I within ¡llti scope of i 986 rcstrìciìon Group V. (See '422 File History, Tabs 37 ilnd 39,

rei

4i26i99 Tcmiiniil Disclaimers (AM-lTC 00943727; At'v1~llC 00943736)),
206, I may use the following table in my icstimony in light of

Dr, Lodísh's

expert report to explain huw the claims ofO!" Un's '422 patent relate to the original duims in
Dr, Lirls '298 application th.il were assigned to resiriction Group V;

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OriginalOrou V ClaimS . . "422 Pharlceutical Com 'sition Claims

55, A pharmaceutical composition comprising
an effective amoum of ¡¡ polypeptide according

1, A pharmaceutical cüinposition comprising a

therapeutically eflictive amount ülhum:ii
erythropoietin and a plmrmaccutically

to claims I, 16,39,4001'41 and a
pharmaceutically acceptable diluenl, adjuvant
or

acceptable diluent, adjuvant or carrier, wherein i
said erythropoietin is purilìcd from mammalian I

carrier.

eells grown in culture. i
56. ¡\ method ìor providing erythropoìetin

therapy to a mamma! comprising aJniinis¡i:ring

2. ¡\ p!iarmaccullcalIY-:li.ccpiahk pn,'par:ltion

an elkelÌvt' amount of ,l polypeptide ilccordiiig

conwining a th;:r;petliic:illy effetlivc amount
of erythropoietin wherein human serum
albumin is mixed wiih s:iid cryihropoietiii,

to claims I, 16,39,4001'41,
57, A method according to claim 56 wherein
the iherapy comprises enhancing hemaiocrit

!evds.

2.

Under 35l!S,C, S 121, Dr_ Liils 'OilS Patent Claims Caiinoilk
l!si'd liS ¡¡ Referencc to Invalidate 01', Un's '422 P~itent Claims

207.
my undc:rsi:ndiiig of

Having rcviev,;ed the file history for Or. !.n':: '422 patent, ;.I1Ù b,ised on
the subject matter of

the claims assigned to the various restriction groups as

informed by Dr. Lodislls expert report (Lodish~' 524-530), it is my opinion that the
applications giving ri:-c to Dr.l.in\; '422 patent were filed alter the Examiners' July 1986
r;:;;!fic¡iCin requirein;::it in th;: '298 :ipplÎl:iiinll ;ind con¡¡incd claims drawn!o thc Ilon-cìcctid
¡iivcntions,iid not

to ih;: Group II invention ckct:: and proscnlteJ in issuilnce in Dr, l.¡n's '008

p,iicnt. Then:l()re, it is my opinion ihat the applicaiions giving rise to Dr. !.n's '422 palent
s¡¡tisiY the "Jì1cd ¡i:- a result or' rcquireiicnI for § i:2 i prOlcction, i note thai Ivlr, Sofüclcous docs

not cOnt~'st this point in his report,

208. 1\-1 Solt:ideous doi:s, however. contest tli,H ¡lie consonance reqiiin.:men!

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!(,;r ~ 121 pmlt:ciion b satÎSiied for Dr. Liils '..n palCnL Spt;ci!i(;jllY. ivlr. Sofockous cunllnds
thui tht: '41:2 patent broke cúnS()naflC~ by issuing wii!i claims from both Group V and Group VII

of ih~ i 992 resiriction requirement. Soroclcous ~~ .17 i ~Î4, This opinion is íliiwd b~cause Mr.
Sof¡xlcOU$ docs nol .ipply the proper legiil an.ilysis in his assessment uf consonance.
209, Mr. Solocleous's consonance opinion relics on the premise ihat the 1992

restriction requirement sel forth in ihc '74 I application always :;supersedes ihe earlier July i 986
n::stríciion requirement set iìlrth in the ':298 applicatioii for the applications leading to the '.'122

patent" ,,-- cven for pmposcs ol assessing whether ~ i 2 i prohibits us~ ofthL' 'OOS pU1tlll claims

for Joubie patenting purposes against the '422 patent claims. Soloclcous c¡ 4ìO. Mr. Sofûcleous

Üi.ils to ideiii¡fy any legal support for this assertion. This is nol surprising, bec1iusc Mr,
Sofoclcous's ihcory is inconsis!Ciit with both the purpose 3.nd the text of

the ~ 1:1 s;ife harbor.

? 1 Ü. As ,:xpbin(-d above, ~ i? I is dcsigni: to proti:cl ;ipplic;iflls jÌ\:i1l
:dlegations or doubk p:ih:nlÍng iii íns!:inci:s ','.Î1\.rè the I !SPTO has dc!crmin::d ¡!Hit an :ìrrlieniíon

wntail1$ ckiiins to lìuliipk inderçndciii nnd distinct iii\'cllioIiS, unJ has issui:d a restrictiol1 requirement ¡orcing the applicant to divide out and prosecute c!nims 10 these inventions in
separate applications. Section 12 J provides in pertinent part:
A patent issuing on an applic1ition with respect

to which a requirement for rcsirictíon under this section has been made, or
be used :is:i rctcrence ¡;iiher in

an 1ipplicatiün tìkd ;is a result of such a requirement, shall no!

the Paienl and Tmdeniark Otlce

or iii ¡be courts :igaiiist a division;1I applic;liioH ür ag:iinsi the

origin:d npplicai¡on or any palcn! ¡ssud on diller ofihi:ii, if ilic divisional application ìs tiled bcfÖre ¡b:: issuance ulthe p;l!efl
on the other applicmion,

Therelúre, when obviousncsHypc düuble p:iienting is raised in the litigniion coii~xt O,c., when

a claim ol ii commonly-owned, earlier patent is asscl1cd for double patenting purpose;; iigainsi a
claim o(:. p;itcii-in-suli), the relevant restriction requirement is the one that lìrsl forced ihe

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Applicant 10 prosectHc the claims otihe patent-in-suit in a separate application from the claims
that wen: pros;;ciiicd to issuance in the patent hèing as.serted t()r double pateming purposes. In

other words, the rdevunl rcstriciion requirement is the on:; ihat :.¡¡\lscd ih~~ il1iiial"fÒr!\ in ¡he
road" leading 10 two scparnte pjtcms.

2 i I, In this ìiisianec, since :\mgcn's counsel is invoking the § 12 i safC harbor

to prevent using the '008 patent claims lor double-patenting purposes against the ;'122 claims,
the rdcvaiit restriction requiremcni is the one that caused the initial

"lork in the road" k:ióing to

the 'OOR pnti:nt in one din:ction and the '422 pati:nl in the other. T!ius, the relevant point of

rc!~n:nce is ihe /9B6 rcstrÎCiion requirement in ihe '298 application, iii which the Examiners

forced Amgen to prosecute iL" non-elected claims separately from its Group II claims that were
prosecuted to issuance in Dr, Un's 'ODS patent.

:2 12. Mr. Sotoclcous's nsscriion ¡hm the 1992 restriction requirement set forth

in the '741 applic,ition "supersedes the earlier July 1986 restriction requirement setlorth in the
'298 ,ipplk;iiion k)r thc applications !eiiding 10 the '422 patent" is l1awed bi'Ca\l:'''~ it is ov~~rbroad

and incorrect wh;:n applkd to thç isstlc ofwhcthcr § 121 precludl.s use (lethe '(j(),' pawii' d(fÙm
tor double pah.'nting pmpüst' against ¡he '4:: paICI111.!:iins. Thc 1992 restriction n:quin:meiit

sel IOl1h in th~~ '74 i appJicut¡otl might be rdevafl if Amg¡;ii were invoking § 121to prev('m

Roche from using another patent thai issiied from the '74 i application, or another pnknt that
issued from a difl(,rent applicaiioii filed ns a result olthe 1992 rcsiriction requirement, for

doublc~pateni¡ng piirposeS" agiiinst ihe '422 palen!. Bili no such argumcl1 Clln be made in this

case, bccmisc Dr. Lirls '422 p¡¡ent is the only patent that issued from the '74 i ::pplication and

subsequent rclawd applications.
2 i 3. Applying the correel lcgn! 3lwlysis, Dr. Lodish examined ihc claims olthe

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'422 palen! a:; compared to the oríginal diiÎms subjectlo the i 986 restrictioii requirement in tlK~
'298 application. iind opined that the '422 p:ient claims fall wiihin the scüpç: of

Group V orihe

i 986 reslriciioii requirement '- one olthe restriciion groups nol elected for examination iiithc
earlkr '298 applic:'iiion - and do not (¡ill wiihin ¡he scope of

Group II. !.odi:;h Vi 548-552. Dr.

Ludish providcJ illL' following cxplamilÌon in !lis exp('rl report:

Consis\cnt wiih the orìgiii:! claims assigned io rcslrìciion Group V ("drawn to pharmaccutical composition"), '422 claim I is drawn to ¡i pharmaceutical comfXsition comprising human EPO. '422 claim i does not include any liinit,iiion concerning or invoking the purified or isolated EPO DNA olrestriction Group 11. This is confirmed by ihe Federal Circuit's holding that '422 claim 1 is infringed by u pharmaceutical composition comprised orhuniaii EPO produced by a process using "gene activated" EPO DNA, wherein the EIlO DNA was never
purified or isolated, A/lgen I/iC. 1'. J-o('cJist MarìOf/ ROII.I',I,:!,

!iw, 314 F3d, 1313, 134g.49 (Fed. (if. 20(3). Tli;: limilatìon "puriiìcd lrom malll)lllian cells grown in cult,irl." wa~ not prcsenl in the original ckiims ¡iss¡gned 10 restriction Group V in tlie '293 application, This :iubjeci maller. how;:vcr, be:irs nü relaiionship to iht EPO DNA and transftCied host cell Stloj;:ct maHcr ofrestrìctioii Group II,

'422 claim 2 ìs also drawn to a phann:.H;eiiikal composition
comprising human EPO coiisistenl with ¡he original claims

assigned to restriction Group V, "drawn to pharmacemical composition." The lil1it¡iion "wherein human :icniin albumin is mixed with said erythropoiciin" was not present in the original claims assigned to restriction Group V in the '298 application, 'l1ìls subject malter, however, bears no relationship to the EPO DN/\ and trmislected host cell subjec.t maHer or
restriction Group II,

Thus, it is my opinion tliat an ordinarily ::killed artisan in 1984 would have recognized and understood thai the '422 claims fall
within the SCOpe of restriction GroiiI' V and do not làll within

the scope of restriction Group il.

Lodish ~~ 550-552. For the reasons explained in Dr, L.odislls expert report, it is my opinion that

Dr. Un's '422 palent satbíkstlie consonance requirement for § 121 protection,
214. For ilil. rl.,bnnS discussl.d ¡ibuve, it is my opinion ¡hat tht: safç harbor

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provisionsol35 U.S.C. § IZI applyio Dr. Lin's '422 patent, and thai thc '008 patcnt claims
cannot bc iised j~)r doiiblc~pai\.nting purposes to invalidate ihe ;422 patent cbims, In connection

with my !:.stiniony n:g¡irding this opinion, I llay use certain graphic:; ür demonstratives, such as

tho"e included in Exhibit 4 to my report.
3.

Dr, Un's '422 Patent Claims Arc Paiciitably Distinct from Dr, Lin's '008 Paiciii Cluims
t-k Sofõ:clcous does not staic in his report that the ;422 patent claims an:

215,

IIl) paicninbly distinct ¡rom the '008 P¡~lent cbims, Nor doc:' :\-11'. Sof(x:bi\JS SIMe ibM :\Ilg~'n

h;i~ ìinpn,p;,'dy c\¡~'!1kd ihe !i:nn úi" DL Liils '008 p;iicni by Edling 10 tl.nl1in:dly disdaìni Dr.

L.i¡i':- ''-22 patcm, I 10\\I.\'cl', C\hibii C of1\k Sof()C!cous's rcr)(jrl includes an llllHmib;,rd

dellmistrativc, Ütled "Term of /\mgeii EPO P,itcnI5," which gr:pliícal!y depicb ihat!lic '422

paient reprcscnts an "improper extension of monopoly." Even if § 121 did no! prohibit usc or
Dr, !.n's '008 claims tor double patenting purposes against Dr, Un's '422 claíms (which it docs,
for the reasons explained above), it is Ily Opiiiiol1that ¡he conclusion e."\presscd in ¡vIr.
SOI(K!lOHS'S i.k:l1onstrativç is uiisupP0i1cd because i¡ depends Oil tll;: wistalcd ¡iSSiirnption thil¡

thc c1aiinsülDr. L.in's '422 patent :ire not patentably dis¡inct from the claims iii Dr, UllS '008
patent - ;m issue that 1'v1r. Sofoc!eoiis did not address anywherc in his report.

216. l\'10rco\'cr, based on ihe expert report of Dr, Lodish, it is my opinion that,
in ¡)ldition 10 b;:ing unsupporicd, Mr, Sofì.!Cleoiis's demonstrative is wrong, I havc been

informed that '422 daim I is ¡he only claim ùlDc Un's '-122 p;itcnt assi,rtcd in this c;ise, imd the
only '422 çbim which RCidiC conh:nds is invalid ïor düulik patl'iiiìng over Dr. I.in's '00:- p~lten!

d:iims. As Dr. LoJish explains iii detail in his expert report, '422 cbill I is p¡lIeni-bly distinct
fhi!H the claims of

the '008 palen!. Lodish i;~; 417-420. On!. ofihc distinctions Dr, Lodish
the asserted claims recites a positiw ri~qliirel/e11

Jiscuss~S in his experi report is ihal "each of

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lor the products' in i'ivo biological activity (or ihernpclltic effect), as compared to the '008

àiims, whieh do not" Lodish ~ 4 i S. Other disiinct¡ons between the '422 and '008 P¡¡kiit
claims also iite explained in Dr. Lodish's expcri report, Lodisli Ex, G,

217. As noted earlier, ihe obviousness-type double pateiiing doctrine ¡s

designed to prevent improper timew¡se exwnsion oltlie patent right by prohibiting claims in a
later patellt which are not p:itentably distinct from claims in a commonly-owned earlier patent

from enjoying:i longer patent lenn. Because, for the reasons disc\lssed in Dr. L.odislls expert
rcport the d1ini~ in Dr. Un's '422 palenl are pateniably distinct from the claims in Dr. L.in's
'om; p:I!Cl1t, ihi: '~21. p;!\cn¡ ,l;ims do not cX!1:I"l¡hc term Orpalcllt pmiectiill1 iii!" ih" 'OOX
palC"n!.

E. DR. LiN'S '868 AND '698 PATENTCUli\S ARE NOT INV1\L1D FOR

OBVIOUSNESS. Tn'E DOUBLE PATENTING OVER DR. LtN'S '008 PATENT CLAIMS
2 i 8, In his report, Mr. Solocleous concludes that, "by failing to properly

Jise!aim the '868 patentli.n1ì, Amgcn extended its pllcnl protcctioii for nearly g years beyond
¡he 2004 t'xpiratiù!l orihe 'OOS paten!." SotocicOllS -I 447, Similarly, with resp1.ct to ¡he '(¡98

patt'nt, 1\.1r. SoltlCkoiiS conclude$th;ii, "¡b)y ¡¡¡¡ling 10 properly disclaim ¡hi. '698 pawnt term,

Amgen extended its patent protection tor nearly 8 years beyond the 2004 cxpir:t¡oii ofihe 'OOS

patent." Sofí:dco\ls 'ii 451. tvlr. Sofoc1cou$ also includes in Exhibit C oí'his rcport two

unnumhered demonstratives, bOih tiiled "Term of Amgeii EllO Patents." which graphieaJ!y
depict hi~ wIKlu~¡()ns ¡hal the '86X and '698 p;itcrHs improrcrly exlend iiit' term nfp;l!t'ni
pr(ìcçiion ft)r ihç .OOS ¡XHeli\. In my opinion, these çonci\lsiöns :mJ ¡he n:bied JCll011S1r;itives

arc unsupported bCC,llJse ihey depend on the uiistated assumption iliill the claims of Dr, Un's
'868 ;;id '698 patents ¿¡n: not pateiitably' distinct from the claims in Dr, Un's 'OOg patent - an

issue ¡hat Mr. Sofoc.!cous did not address ¡Il)'whcrc in his report,

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219, r..1orcovcr, based onihe cxpi:ri report of Dr. Lodish, ii is my opinion that,
in addition 10 being unsupported, Mr, So!òcleous's conclusions in ~~ 447 and 45 I and n:I;ltcd

ùemonstniiives an: \vrong, I have been informed that '868 claims 1-2 and '698 claiiis 4-9 J:rc
tli: only claims orik '868 ;md '698 palenis ;isscrled in ihis case, .mJ ¡hi: only '86B and '698

,!aims which Roche contends arc invalid fÒr dütihk: p-iicniing over th~' '008 p;iienl d:iims. !\s
Dr. Lodish i:xplaiiis iii detail in his expert report, '868 claims I ~2 and '698 claims 4-9 arc
patentably distinct from the claims of the '008 patent. Lodish.~ 42 I ~424, One of

the

distinctions Dr, Lodish discusses in his expert report is thai "each oftlic ¡isscrted '868 ¡iid '698

claims recites ¡¡ positii't' requiremem for the prüdiici orihc c1aímed process to IU1It the in vil'o

bìologk.ii activity iit causing boii~ mamm cdls 10 ¡ricre:is:: production oi'ro:¡çukcyit.S and red
blood cd

Is:' where:is "i!ie '(JOS daíl1s i.ick this critici\! ri:quircilent:' Lodish l:: .122. OihL'r

distinciions bçtween ihe '868 and '698 paicnt claims :lId the '003 patent claims ¡¡Iso Me

explained in Dr. Lodislls expert report. Lodish Ex. O.
220. As noted earlier, the obvioiisness-type double pateniing doctrine is
designd to prevent improper timewise extension of

the palent right by prohibiiing claims iii a

¡¿iler palent which arc no! paieniibly distinct ¡rom claims iii a cominonly-üwned cartier paicllt
lrom \.njoying a longi.r patL~nt kflL Because, for the reasons discussed in Dr. L.oJislls expert

re¡Xil1. ihe claims in Dr. Lin's '868 and '698 patents art! patentably distinct froiitliC cl;iiiis in

Dr, Un's '008 patel1,thi: '868 and '698 patent claims do not extend the ienn ofpa¡ent protection
lor the 'OOg patent.

F, TilE CLAIMS OF DR. LiN'S PATENTS.IN~SUll Aiu: NOT INVALID FOR ûßvIOUSNt:ss-TYI'l: DOUBLE PATF.t'~nNG OVER CLAIM 10 OFTIIE LAI

'016 PATENT

1. The USI'TO \Va:; Corll~ello Apply ihe "Two-WõlY" DOiihli'P:llcnting Te~t

108