celg v act - act response markman brief

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UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY

x CELGENE CORPORATION, Plaintiff,

v.

NATCO PHARMA LIMITED, ARROW INTERNATIONAL LIMITED, and WATSON LABORATORIES, INC. Defendants.

: : : : : : : : : :

Honorable Susan D. Wigenton, U.S.D.J. Civil Action No. 10 CV 5197 (SDW) (MCA) Electronically Filed

x NATCO PHARMA LIMITED, ARROW INTERNATIONAL LIMITED, and WATSON LABORATORIES, INC.

Counterclaim Plaintiffs,

v. CELGENE CORPORATION,

Counterclaim Defendant.

: : : : : : : : : : : :

x

DEFENDANTS RESPONSIVE CLAIM CONSTRUCTION BRIEF OF COUNSEL George C. Lombardi Michael K. Nutter Maureen L. Rurka Kevin E. Warner WINSTON & STRAWN LLP 35 West Wacker Drive Chicago, Illinois 60601 (312) 558-5600

WINSTON & STRAWN LLP The Legal Center One Riverfront Plaza, Suite 730 Newark, NJ 07102 (973) 848-7676 James S. Richter Melissa Steedle Bogad Attorneys for Defendants Natco Pharma Ltd., Arrow International Ltd. and Watson Laboratories, Inc.

Case 2:10-cv-05197-SDW-MCA Document 290 Filed 04/08/14 Page 1 of 40 PageID: 8867

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TABLE OF CONTENTS

Page

TABLE OF AUTHORITIES ......................................................................................................... iii

I. INTRODUCTION .............................................................................................................. 1

II. DISPUTED TERMS OF THE POLYMORPH PATENTS ................................................ 2

a. Form A and Form A Terms ..............................................................................2

i. Form A .....................................................................................................3

1. Celgenes Construction Is Internally Inconsistent And Violates Established Canons Of Claim Construction ......................5

2. The BMS Case Does Not Support Celgenes Construction .............7

3. Celgenes Construction Improperly Seeks Coverage of More Than The Subject Matter Disclosed .....................................10

4. Celgenes Construction Also Renders Claim Terms Duplicative And/Or Superfluous ...................................................12

ii. Remaining Form A Terms ......................................................................13

b. Unsolvated Crystalline [Lenalidomide] Terms ..................................................15

c. Hemihydrate .......................................................................................................17

i. Hemihydrate Is Not A Term Of Approximation ....................................17

1. The 800 Patent Does Not Redefine Hemihydrate And The Plain Meaning Should Control ...............................................17

2. Dr. Byrns Prior Works Are Consistent With Natcos Construction And Directly Contradict His Declaration .................19

3. Celgenes Construction Is Unsupported By The Intrinsic Record ............................................................................................20

ii. Hemihydrate Refers To The Form B Polymorph ...................................21

d. 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione ..................22

III. DISPUTED TERMS OF THE PHARMACEUTICAL PATENTS.................................. 24


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ii

a. Said Compound has the R-Configuration and Said Compound has the S-Configuration ....................................................................................................24

i. Natcos Constructions Are Consistent With The Intrinsic Record ............25

ii. Celgenes Constructions Violate Established Principles Of Claim Construction ...............................................................................................26

iii. Celgenes Constructions Are Inconsistent With The Understanding Of A Person Of Ordinary Skill In The Art ................................................28

b. Unit Dosage Form ..............................................................................................29

IV. THE REMAINING DISPUTED TERMS ........................................................................ 30

a. Administered in a Cycle/ Administered Cyclically ........................................30

b. Cyclically Administering ...................................................................................32

V. CONCLUSION ................................................................................................................. 34


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TABLE OF AUTHORITIES

Page(s) CASES

AstraZeneca AB v. Mutual Pharma Co. Inc., 384 F.3d 1333 (Fed. Cir. 2004)....................................................................................13, 16, 23

Baran v. Med. Device Techs., Inc., 616 F.3d 1309 (Fed. Cir. 2010)................................................................................................25

Bristol-Myers Squibb Co. v. Mylan Pharms., Inc., No. 09-651-LPS, 2012 WL 1753670 (D. Del. May 16, 2012) ..............................................7, 8

Dow Chem. Co. v. United States, 226 F.3d 1334 (Fed. Cir. 2000)................................................................................................27

Gen. Am. Transp. Corp. v. Cryo-Trans, Inc., 93 F.3d 766 (Fed. Cir. 1996)....................................................................................................22

Glaxo Group Ltd. v. Ranbaxy Pharm. Inc., 262 F.3d 1333 (Fed. Cir. 2001)................................................................................................25

Markman v. Westview Instruments, Inc., 52 F.3d 967 (Fed. Cir. 1995) (en banc), affd, 517 U.S. 370 (1996) .......................................30

Modine Mfg. Co. v. U.S. Intl Trade Commn, 75 F.3d 1545 (Fed. Cir. 1996)..................................................................................................16

Multiform Desiccants, Inc. v. Medzam, Ltd., 133 F.3d 1473 (Fed. Cir. 1998)....................................................................................29, 31, 32

Novozymes A/S v. DuPont Nutrition BioSciences APS, 723 F.3d 1336 (Fed. Cir. 2013)................................................................................................12

O2 Micro Intl Ltd. v. Beyond Innovation Tech. Co., 521 F.3d 1351 (Fed. Cir. 2008)................................................................................................31

Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005)....................................................................................17, 30, 32

Rhine v. Casio, Inc., 183 F.3d 1342 (Fed.Cir. 1999).................................................................................................12

Telcordia Techs., Inc. v. Cisco Sys. Inc., 612 F.3d 1365 (Fed. Cir. 2010)................................................................................................22

Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313 (Fed. Cir. 2002)..........................................................................................18, 22


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Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295 (Fed. Cir. 1999)................................................................................................22

Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576 (Fed. Cir. 1996)................................................................................17, 18, 28, 30

STATUTES

35 U.S.C. 112 ..................................................................................................................11, 25, 27

OTHER AUTHORITIES

A Dictionary of Chemistry 275 (4th ed. 2000) .............................................................................18

McGraw-Hill Dictionary of Scientific and Technical Terms 977 (6th ed. 2003) .........................18

The Penguin Dictionary of Science 200 (7th ed. 1993) ................................................................18


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I. INTRODUCTION

Celgenes approach to claim construction for each of the four patent families at issue is at

odds with established Federal Circuit precedent and contravenes long-accepted scientific

principles.

For the Polymorph Patents,1 Natco proposes constructions for Form A, hemihydrate,

and terms directed to unsolvated crystalline [lenalidomide] that are consistent with how these

terms are defined in the specification and understood by a person of skill in the art. By contrast,

Celgene offers broad, litigation-driven constructions that ignore the undisputed scientific

definitions of hemihydrate and Form A, as well as the inventors unambiguous

characterization of these terms in the intrinsic record. In doing so, Celgene seeks to improperly

broaden the claim scope to cover more than the subject matter that is disclosed and properly

supported by the specification. For example, the testimony of Celgenes own expert, Dr. Jerry

Atwood, clearly shows that its proposed constructions are internally inconsistent, read out

express claim limitations, and lead to absurd resultsincluding the proposition that a claim

expressly limited to the Form A crystal also includes the undisputedly distinct Form F

crystal. There is no authority supporting that type of proposal.

Natcos proposed constructions for the Pharmaceutical Patents2 likewise consistently

adhere to established scientific principles and to the intrinsic evidence. By contrast, Celgenes

constructions are contrary to general scientific concepts and violate established concepts of claim

construction, including the doctrine of claim differentiation. For example, under Celgenes 1 As defined in Defendants Opening Markman Brief (D.I. 250), Natco refers to U.S. Pat. Nos. 7,465,800 (the 800 patent), 7,977,357 (the 357 patent), 8,193,219 (the 219 patent), and 8,431,598 (the 598 patent) collectively as the Polymorph Patents. 2 As defined in Defendants Opening Markman Brief, Natco refers to U.S. Pat. Nos. 6,281,230 (the 230 patent), 6,555,554 (the 554 patent), and 8,228,415 (the 415 patent) collectively as the Pharmaceutical Patents.


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construction, all claims cover all disclosed embodiments and additional limitations in certain

dependent claims are given no independent meaning. For at least these reasons, Celgenes

proposed constructions of the disputed terms of the Pharmaceutical Patents are incorrect.

The third and fourth patent families each cover one patent (the Multiple Myeloma

Patent3 and the MDS Patent4) and relate to methods of treating multiple myeloma and

myelodysplastic syndrome, respectively. The disputed terms in both patents relate to dosing

lenalidomide pursuant to a cyclical dosing regimen, which has established technical meanings

in the pharmaceutical art. Consistent with Federal Circuit mandate that construction of disputed

technical terms is required, Natcos proposed construction aligns with statements in the

specification and the file history, as well as scientific understanding. Celgene, by contrast,

proposes no construction at all, despite the fact that these disputed technical terms do not have a

plain and ordinary meaning. For at least this reason, Natcos proposals should be adopted over

Celgenes non-construction.

II. DISPUTED TERMS OF THE POLYMORPH PATENTS

a. Form A and Form A Terms

The first dispute concerning the Polymorph Patents relates to certain terms in the 357

and 598 patents that expressly require the distinct crystal form of lenalidomide that the

specification describes and characterizes as Form A. The disputed terms and the parties

constructions are set forth below.

3 As defined in Defendants Opening Markman Brief, Natco refers to U.S. Pat. No. 7,968,569 as the Multiple Myeloma Patent or the MM Patent. 4 As defined in Defendants Opening Markman Brief, Natco refers to U.S. Pat. No. 7,189,740 as the Myelodysplastic Syndrome Patent or the MDS Patent.


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chemical characteristics. (Ex. A,5 357 patent, 6:13-54, 2:16-25, 3:37-42, Figs. 1-5, 51, and 53-

54.) For example, the specification defines Form A in the following way:

One embodiment of the invention encompasses Form A of 3-( 4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione. Form A is an unsolvated, crystalline material that can be obtained from non-aqueous solvent systems. . . . 5.2.1 Form A

The data described herein for Form A, as well as for Forms B-H, were obtained using the experimental methods described in Examples 6.3-6.7, provided below.

Form A can be obtained from various solvents, including, but not limited to 1-butanol, butyl acetate, ethanol, ethyl acetate, methanol, methyl ethyl ketone, and THF. FIG. 1 shows a representative XRPD pattern of Form A. The pattern is characterized by peaks, preferably significant peaks, at approximately 8, 14.5, 16, 17.5, 20.5, 24, and 26 degrees 2. Representative IR and Raman spectra data are provided in FIGS. 2 and 3.

Representative thermal characteristics of Form A are shown in FIG. 4. TGA data show a small weight increase up to about 150 C., indicating an unsolvated material. Weight loss above 150 C. is attributed to decomposition. The DSC curve of Form A exhibits an endotherm at about 270 C.

Representative moisture sorption and desorption data are plotted in FIG. 5. Form A does not exhibit a significant weight gain from 5 to 95% relative humidity. Equilibrium can be obtained at each relative humidity step. As the form dries from 95% back down to 5% relative humidity, it tends to maintain its weight such that at 5% relative humidity it has typically lost only about 0.003% by weight from start to finish. Form A is capable of remaining a crystalline solid for about 11 days when stored at about 22, 45, 58, and 84% relative humidity.

Interconversion studies show that Form A can convert to

Form B in aqueous solvent systems and can convert to Form C in acetone solvent systems. Form A tends to be stable in anhydrous

5 All references herein to Ex. __ refer to exhibits attached to the accompanying Declaration of Melissa Steedle Bogad (Bogad Declaration), submitted herewith.


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solvent systems. In water systems and in the presence of Form E, Form A tends to convert to Form E.

When stored for a period of about 85 days under two different temperature/relative humidity stress conditions (room temperature/0% relative humidity (RH) and 40 C./93% RH), Form A typically does not convert to a different form.

In sum, Form A is a crystalline, unsolvated solid that melts at approximately 270 C. Form A is weakly or not hygroscopic and appears to be the most thermodynamically stable anhydrous polymorph of 3-(4amino-1-oxo-1,3 dihydroisoindol-2-yl)-piperidine-2,6-dione discovered thus far.

(Ex. A, 5:35-38; 6:13-54.) In short, the patent uses Form A as a label that refers to a particular

polymorph called Form A that has all the analytical characteristics by which it is described in the

specification, in order to distinguish it from the other crystalline Forms B-H. Because Celgenes

construction attempts to read out the term Form A from the claim, it is incorrect.

1. Celgenes Construction Is Internally Inconsistent And Violates Established Canons Of Claim Construction

Celgenes proposed construction is internally inconsistent and violates established

principles of claim construction at least because it renders the term Form A superfluous and

violates the plain meaning of this term. For example, Celgenes proposed construction of Form

A requires only that it can be distinguished from other forms. (Celgenes Opening Markman

Brief at 23.) Celgene then argues that the term Form A is a term of reference that means

any crystal form of lenalidomide that has the particular characteristic value specified in the

claim. (Id. at 28.) But Celgenes own expert, Dr. Jerry Atwood, admits that a single analytical

characteristic such as DSC or XRPD as recited in claims 1 and 2, respectively, is not always

sufficient, when taken in isolation, to distinguish one polymorphic form of a compound from

another. (Ex. B, Deposition of Dr. Jerry L. Atwood, Ph.D., Jan. 17, 2014 (Atwood Dep. Tr.),

35:16-36:11; 41:21-43:12.) For lenalidomide specifically, multiple techniques would be required


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to differentiate Forms A-H in instances where the XRPD pattern is not, by itself, sufficient. (Id.

at 44:3-45:7; 46:7-47:11.) By Dr. Atwoods own admission, therefore, the claimed characteristic

of XRPD or DSC included in the claims is not sufficient to distinguish one crystal form from

other forms, as Celgene now argues is required by its construction.

Dr. Atwoods testimony also reveals a plethora of additional inconsistencies in Celgenes

proposed construction that illustrate why it does not make sense and violates established canons

of claim construction. First, Dr. Atwoods interpretation of the 357 patent claims allows for

things that are not Form A, such as Form F lenalidomide, to be covered by certain claims of the

357 patent, notwithstanding that all of the asserted claims specifically require Form A. (Id. at

72:6-15; 73:8-74:6; 74:9-19; 75:4-14; 103:2-13.) Dr. Atwood readily admits that Form A and

Form F as disclosed by the 357 patent are not the same crystal form, and can be differentiated

from each other on the basis of their properties. (Id. at 123:8-124:12.) But he still says a claim

that says Form A can cover Form F. That construction is inconsistent with the plain

meaning of Form A, which does not include or equate to Form F, an entirely different

crystalline form having distinct physical and chemical properties.

Second, Dr. Atwood testified that unsolvated crystalline lenalidomide that has none of

the XRPD associated with Form A can still fall within the scope of Form A in claim 1 of the

357 patent. (Id. at 70:15-22; 69:2-12.) This is also inconsistent with the express disclosure in

the specification requiring that Form A alone is characterized by certain XRPD peaks that are

expressly linked to Form A. (Ex. A, 6:22.)

Third, Dr. Atwood admits that Celgenes construction, which effectively ignores the term

Form A and focuses solely on the additional analytical limitation in the claims, entirely reads

out the claim requirement for Form A. (Ex. B, 88:13-16 (Whether the A is there or not, if


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form is construed as I have construed Form A, then the claim has the same scope in my

opinion.); id. at 72:22-74:6; 89:15-20; 91:2-18; 92:11-23; 93:12-25.) In other words, Dr.

Atwood testified that Form A lenalidomide has the same construction as Form B, Form C,

or Form D. (Id. at 77:7-12; 78:20-79:17, 80:16-81:8.) This proposed constructionwhich

entirely reads out the express claim limitation requiring Form Acannot be correct.

Finally, Celgenes proposed construction leads to absurd results. Under Celgenes

construction, a hypothetical product can infringe claim 1 directed to the Form A crystal if it

meets the subsequent DSC limitation in the claim, while not infringing claim 2 that is also

directed to Form A, if it does not meet the particular XRPD limitation in that claim. For

example, Dr. Atwood admits that an unsolvated crystalline form of lenalidomide that has none of

the characteristic XRPD peaks attributed to Form A in the specification and in Figure 1 would

not be considered Form A for purposes of claim 2, but would be considered Form A for

purposes of claim 1, if it met the DSC limitations recited in claim 1. (Id. at 103:2-13.) This

result makes no sense because the patentee invented only one crystalline Form A and described

this crystalline Form A, not by its individual analytical characteristics such as DSC in isolation,

but by a combination of its analytical characteristics exactly as described in the specification.

2. The BMS Case Does Not Support Celgenes Construction

Celgenes reliance on Bristol-Myers Squibb Co. v. Mylan Pharms., Inc. (BMS), which

is not controlling authority, is entirely misplaced. No. 09-651-LPS, 2012 WL 1753670 (D. Del.

May 16, 2012). The patents involved in that case were directed to various polymorphs of a drug

called efavirenz, which were described and claimed using numerical designations (e.g., Form I,

Form II, etc.). Id. at *1. The parties disputed whether the Form terms incorporated the XRPD

and DSC patterns in the Figures (defendants proposal), or whether the terms were intended only


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as shorthand references for the defining characteristics recited in the remainder of the claim

(plaintiffs proposal). Id. at *3.

In adopting plaintiffs construction, the BMS decision hinged on particular aspects of the

patent specification that have no counterpart to the specification at issue here. Specifically, the

BMS court found that the inventors description of these embodiments with varying levels of

detail demonstrates a clear intent to claim crystal forms of efavirenz that required less than the

full [XRPD] diffractograms and [DSC] thermograms as depicted in the Figures. Id. at *4

(emphasis added). For example, the specification stated:

In a first embodiment, the present invention provides Form 1 of crystalline Efavirenz.

In a preferred embodiment, Form 1 crystalline Efavirenz is

in substantially crystalline form. In another preferred embodiment, the Form 1 crystalline

Efavirenz is characterized by an x-ray powder diffraction pattern comprising four or more 2 values selected from the group consisting of 6.0 0.2, 6.3 0.2, 10.3 0.2, 10.8 0.2, 14.1 0.2, 16.8 0.2, 20.0 0.2, 20.5 0.2, 21.1 0.2, and 24.8 0.2.

In another preferred embodiment, the Form 1 crystalline

Efavirenz is characterized by an x-ray powder diffraction pattern substantially in accordance with that shown in in FIG. 1.

In another preferred embodiment, the Form 1 crystalline

Efavirenz is characterized by a differential scanning calorimetry thermogram having a peak at about 138 C to about 140 C

(Ex. C, U.S. Pat. No. 6,673,372 at 3:13-30 (emphasis added).) In other words, the patent

specifications described the claimed crystalline form of efavirenz in several separate

embodiments, with each embodiment reciting a different analytical characteristic of the crystal

form such as XPRD or DSC characteristics. On this basis, the court concluded that there was no


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basis to strictly limit[ing] the various Form terms to the complete XRPD and/or DSC patterns

illustrated in the Figures. 2012 WL 1753670 at *4.

That is not the case here because the Polymorph Patent specifications do not repeatedly

describe different Form embodiments using less than the full set of [analytical] data shown in the

Figures. Id. Here, each polymorph is disclosed in a single embodiment that describes and

characterizes the polymorph in terms of several analytical characteristics including XRPD, DSC,

IR, Raman, and TGA, among others. For example, the intrinsic record does not even suggest

that the inventors intended to claim crystalline Form A lenalidomide having less than the full set

of analytical attributes expressly associated with Form A. Celgene does not, and cannot, argue

otherwise. Instead, the specification here explicitly states, and Celgene acknowledges, that just

[o]ne embodiment of the invention encompasses Form A. (Atwood Decl. 23; Celgene

Opening Markman Brief at 28; Ex. A, 357 patent, 5:35 (emphasis added).) This single

embodiment describes Form A exactly as Natco proposes, i.e., by describing all its attributes,

including by reference to each figure that describes the Form A crystal. Unlike the patents

involved in the BMS case, other disclosed embodiments in the 357 patent specification are

directed not to Form A having a subset of its characteristics, but instead to Forms B-H, which are

entirely different crystal forms. (Ex. A, 5:38-67.)

The facts in the BMS case are also distinguishable on the basis of differences in the

prosecution history. In that case, the Examiner rejected pending claims reciting Form terms as

not enabled. The patentee amended the claims to recite additional XRPD and/or DSC

characteristics in response to the enablement rejection. The court agree[d] with Plaintiffs that

such changes would have been unnecessary if the meaning of the various Form terms were

properly understood already to incorporate the Figures. 2012 WL 1753670 at *4.


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In the present case, the facts are exactly the opposite. As explained in Natcos opening

brief, the then-pending 357 patent claims were initially directed generally to unsolvated

crystalline lenalidomide having specific XRPD characteristics and did not recite any Form

terms. (Defendants Opening Markman Brief at 16-17.) The examiner rejected these claims,

stating that the specification, while being enabling for [lenalidomide] Form A with a[sic] X-ray

diffraction pattern of fig. 1; does not reasonably provide enablement for the claimed scope of

unsolvated [lenalidomide] with the claimed XRPD peaks. In response, Celgene narrowed

these claims by adding the Form A limitation, and the objection was withdrawn. (Defendants

Opening Markman Brief at 16-17.) Based on this file history, it is clear that the patentee

intended Form A to have a clearly defined meaning as described in the specification, as

opposed to being a shorthand reference to a particular crystalline form having the characteristics

set forth in the remainder of the claim.

3. Celgenes Construction Improperly Seeks Coverage of More Than The Subject Matter Disclosed

Celgene argues that Natcos construction improperly reads limitations into the claims and

therefore cannot be correct. Contrary to what Celgene suggests, Natcos proposed construction

simply gives meaning to the otherwise meaningless Form A term (Atwood Decl., 26) by

clarifying the inherent characteristics of the claimed Form A crystal that are necessarily and

inevitably present in the crystal form recited in the 357 patent claims. Under Celgenes

construction, however, Form A is required to have only the characteristic recited in the

particular claim, and does not require the additional characteristics that define Form A in the

specification.

As discussed above, Celgene does not, and cannot, argue that the Polymorph Patent

specification discloses a version of Form A crystal having the DSC characteristics recited in


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claim 1, but not also having the XRPD, IR, Raman, TGA, and other analytical characteristics that

the specification associates with the Form A crystal. Similarly, Celgene does not, and cannot,

argue that the specification discloses a version of the Form A crystal having the XRPD

characteristics recited in claim 2, but not also having all the other analytical characteristics

recited in the other claims, and attributed by the specification to the Form A crystal. (See

Atwood Decl. 23.) Indeed, Celgene conveniently ignores that Form A is described in the

specification in a single embodiment, as having all the analytical characteristics disclosed.

Thus, Natcos proposed construction does not narrow the scope of the claims to cover less than

what is disclosed and claimed as Form A in the 357 patent.

To the contrary, Celgenes litigation-driven construction seeks coverage of more than

what is supported by the specification (i.e. Form A having one or some but not all the

characteristics attributed to it by the specification). Dr. Atwoods testimony on this issue is

particularly telling. For instance, Dr. Atwood testified that under Celgenes construction,

undiscovered forms [] would similarly be covered by claim 1 of the 357 patent. (Ex. B,

139:22-140:14 (emphasis added).) A proposed construction that results in the claim covering

more than what the specification teaches a person of ordinary skill how to make lacks

enablement as required by 35 U.S.C. 112. See ALZA Corp. v. Andrx Pharma, LLC, 603 F.3d

935, 940 (Fed. Cir. 2010) (To be enabling, the specification of a patent must teach those skilled

in the art how to make and use the full scope of the claimed invention without undue

experimentation.) (internal citations omitted). By Dr. Atwoods own admission, that is

precisely the case here because the specification does not teach how to make and use any Form

A crystal that does not have all the characteristics attributed to Form A by the specification.


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Celgenes construction that covers undiscovered forms also makes the claim invalid for

lack of a supporting written description. To satisfy the written description requirement [of

112], the applicant must convey with reasonable clarity to those skilled in the art that, as of the

filing date sought, he or she was in possession of the invention, and demonstrate that by

disclosure in the specification of the patent. Novozymes A/S v. DuPont Nutrition BioSciences

APS, 723 F.3d 1336, 1344 (Fed. Cir. 2013) (internal citations omitted). And the patent

specification here does not disclose any undiscovered crystal forms that fall within the claim

scope of Form A, let alone convey with reasonable clarity that the inventors were in

possession of these undiscovered crystal forms.

The Federal Circuit has previously explained that claims should be so construed, if

possible, as to sustain their validity. Rhine v. Casio, Inc., 183 F.3d 1342, 1345 (Fed. Cir. 1999).

That maxim requires rejecting Celgenes constructions, which render the claims invalid as

lacking written description and/or enablement.

4. Celgenes Construction Also Renders Claim Terms Duplicative And/Or Superfluous

To the extent Celgene argues that Natcos proposed construction is incorrect because it

renders limitations to specific analytical characteristics in claims 1-14 of the 357 patent

duplicative and/or superfluous, the argument has no merit in view of Celgenes own proposed

construction that suffers from the same alleged deficiencies. As Dr. Atwood admits, Celgenes

construction of Form A includes the chemical name of lenalidomide and therefore renders

duplicative and superfluous the express recitation of the chemical name of lenalidomide

elsewhere in the claim. (Ex. B, 101:13-22.) The fact is that it is poor claim drafting that results

in alleged redundancies, not Natcos proposed construction.


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For at least the foregoing reasons, Celgenes construction of Form A lacks merit and

the Court should adopt Natcos proposed construction of this term.

ii. Remaining Form A Terms

Natco proposes that the other three disputed terms that recite Form A as part of a larger

phrase be given the same construction as Form A, because the additional characteristics recited

in these terms whose meanings are not in dispute simply describe characteristics that the

specification attributes to the Form A crystal. Celgene agrees that Form A requires

construction when taken alone, but incredibly asserts that larger phrases containing the term

Form A do not require construction. In support, Celgene argues that there is no lexicography

in the specification, for these longer phrases containing Form A, and therefore that the plain

and ordinary meaning should apply. (Celgenes Opening Markman Brief at 30.)

This makes little sense. The specification clearly describes Form A as a crystal having

certain identified characteristics. It is thus illogical to say that the specification provides

lexicography for the phrase Form A, but then drops that lexicography when Form A is used

followed by certain of those associated characteristics. Additionally, the Federal Circuit long

ago rejected the rigid formalism requiring lexicography to take the form of a statement that I

define ___ to mean ___. AstraZeneca AB v. Mutual Pharm. Co., Inc., 384 F.3d 1333, 1339

(Fed. Cir. 2004). Celgene has already agreed that the phrase Form A does not have a plain and

ordinary meaning, but rather that it requires construction. Therefore, larger terms containing this

phrase necessarily also require construction. For this reason alone, the Court should adopt

Natcos proposed construction of these terms. (See also Defendants Opening Markman Brief at

14-20.)

Celgene also contends that Natcos proposal is incorrect because (1) it allegedly reads out

the agreed-upon definitions of the claim terms crystalline and endotherm; and (2) it results in


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that has characteristics assigned to Form A in the specification, and the characteristics assigned

to Form A in the specification equal the crystal form called Form A.

Not only is this construction entirely consistent with the specification and file history, it

avoids the enablement and written description issues that result from adopting Celgenes

construction. See Modine Mfg. Co. v. U.S. Intl Trade Commn, 75 F.3d 1545, 1557 (Fed. Cir.

1996) (When claims are amenable to more than one construction, they should when reasonably

possible be interpreted so as to preserve their validity.) (internal citations omitted), abrogated

on other grounds by Festo Corp. v. Shoketsu Kizoku Kogyo Kabushiki Co., Ltd., 234 F.3d 558

(Fed. Cir. 2000).

Celgene, on the other hand, argues that these terms do not require construction. It

suggests that there is no lexicography in the specification for these terms and therefore that the

plain and ordinary meaning should apply. (Celgenes Opening Markman Brief at 33.) This

makes no sense because Celgenes bald assertion that there is no lexicography for these terms

begs the question of whether a person of ordinary skill would understand these phrases to have a

special meaning based on the specification disclosure. Additionally, the Federal Circuit long ago

rejected the rigid formalism requiring lexicography to take the form of a statement that I define

___ to mean ___. AstraZeneca AB, 384 F.3d at 1339. The specification clearly defines Form A

as the crystal form having the characteristics assigned to Form A. For this reason alone, the

Court should adopt Natcos proposed construction of these claims for the reasons discussed in

Natcos opening brief. (Defendants Opening Markman Brief at 20-25.)

Celgene also contends that Natcos proposal is incorrect because it reads out the agreed-

upon definitions of crystalline and endotherm, terms that are nested within these larger


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by numerous extrinsic sources, and that should end the inquiry. (See, e.g., Ex. D, McGraw-Hill

Dictionary of Scientific and Technical Terms 977 (6th ed. 2003) (defining hemihydrate as [a]

hydrate with a 2:1 molecular ratio of anhydrous compound to water); Ex. E, A Dictionary of

Chemistry 275 (4th ed. 2000) (defining hemihydrate as [a] crystalline hydrate containing two

molecules of compound per molecule of water); Ex. F, The Penguin Dictionary of Science 200

(7th ed. 1993) (defining hemihydrate as [a] compound that has one molecule of water of

crystallization for every two molecules of the compound). See also D.I. 251, Attachment #2,

Second Declaration of Mark D. Hollingsworth, Ph.D., (Hollingsworth Decl.) 21-22.) The

intrinsic evidence changes nothing about this understanding. Accordingly, the term should be

construed as it is used in the art, as reflected by every dictionary definition in evidence, and not

solely by reference to the patent disclosure. This is what Natco proposes when recognizing the

heavy presumption in favor of the terms ordinary meaning. Teleflex, Inc. v. Ficosa N. Am.

Corp., 299 F.3d 1313, 1325 (Fed. Cir. 2002).

Yet, despite the unanimity of dictionary definitions and the fact that the patentees

expressly chose not to redefine hemihydrate, Celgene attempts to rely on the intrinsic record to

justify redefining the term in a manner that is inconsistent with how it is used in the art and that

was clearly not intended by the patentees. (See Celgenes Opening Markman Brief at 20-23; see

Such

reliance on the intrinsic record is improper and inconsistent with Celgenes own prior statements

that hemihydrate is not redefined in the patent, but rather is used in its ordinary capacity.


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3. Celgenes Construction Is Unsupported By The Intrinsic Record

Celgene also improperly relies on data reported in the specification that it incorrectly

contends redefines hemihydrate as a term of approximation. For instance, Celgene argues that

data concerning the Form B polymorph suggests it is a hemihydrate that can have differing water

contents ranging from approximately 0.46 moles to approximately 0.59 moles of water per mole

of lenalidomide. (Celgenes Opening Markman Brief at 21 (citing Ex. 4 (800 patent), 6:67 7:5

& Figs. 9, 37-39).) Not only is this inconsistent with Celgenes prior statements that the patent

does not redefine hemihydrate (Celgenes Opening Markman Brief at 20-21), but such

language is fully consistent with Natcos proposed construction of hemihydrate.

The reality is that specification data showing a range of water contents in the tested

samples reflects the practical limitations inherent in measuring water contents associated with

samples of hemihydrate. As Celgene admits, the patent does not redefine hemihydrate, but

rather reports the water content of measured samples of the claimed hemihydrate. A person of

ordinary skill in the art (POSA) would not read this disclosure as redefining the claimed

hemihydrate, but rather as reporting the measured water content of the claimed hemihydrate.

Simply


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because the method of measuring the hemihydrate sample does not provide a water content in an

exact 1:2 ratio does not mean that the sample itself is not in reality a hemihydrate. Thus, the

specification language that Celgene points to as allegedly supporting its construction is, in fact,

fully consistent with Natcos proposed construction.

ii. Hemihydrate Refers To The Form B Polymorph

Based on the unambiguous disclosure in the intrinsic record and the patentees clear

disavowal of claim scope directed to polymorphs other than Form B, hemihydrate must also be

limited in this instance to the Form B polymorph.

As Natco pointed out in its opening brief, the 800 patent specification is littered with

numerous references to the Form B polymorph being the hemihydrate, and to the lenalidomide

hemihydrate being in the form of polymorph Form B. (See Defendants Opening Markman Brief

at 9-10); Ex. I, 800 patent, 17:37-40, 5:35-51, 7:31, 6:677:6, 12:31-32).) There is no

disclosure in the specification or file history of the hemihydrate being any polymorph other than

Form B, and conversely, there is no disclosure of the Form B polymorph having, or being

capable of having, any hydration state other than as the hemihydrate. Additionally, the

patentees conduct during prosecution clearly identifies the claimed hemihydrate as referring

to the Form B polymorph and disavows claim scope directed to any other disclosed polymorph

or mixtures, or unidentified hemihydrates. (See Defendants Opening Markman Brief at 11-13.)

Celgenes argument that Natcos construction improperly limits the claim scope to a

specific embodiment is unavailing and misleading for at least two reasons. First, and as

explained above, the 800 patent specification discloses only one embodiment, the Form B

polymorph, in connection with the hemihydrate. Thus, Natcos construction does not randomly

select one of several disclosed embodiments in limiting the claims scope, but rather construes

hemihydrate in the context of the intrinsic record, which repeatedly refers to hemihydrate as


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the methods described in U.S. Pat. Nos. 6,281,230 and 5,635,517, the entireties of which are

incorporated herein by reference. (Ex. I, 800 patent at 4:665:1.) The specification then

proceeds to detail how, from the lenalidomide prepared by the processes denoted in the 230 and

517 patents, various forms of lenalidomide may be obtained, as disclosed in the 800 patent.

(Id. at 5:13-32.) The specification, file history, and extrinsic evidence in the record provide no

further information about how to synthesize the claimed compounds. Consistent with this

disclosure, Natco proposes that lenalidomide is made by the methods described in the 517 and

230 patents. A broader construction would lead to a compound that a person of ordinary skill in

the art did not know how to make at the time of the invention, and which would therefore be

invalid for reasons discussed above.

Celgene suggests this construction is incorrect because it changes the standard meaning

of the phrase, and further that lexicography requires a statement in the form I define ___ to

mean ___. But the Federal Circuit has repeatedly held that such rigid formalism is not

required for an inventor to change the otherwise ordinary meaning of a term. AstraZeneca AB,

384 F.3d at 1339 (Fed. Cir. 2004). Rather, a claim may be clearly redefined without an explicit

statement of redefinition . . . [T]he specification may define claim terms by implication such

that the meaning may be found in or ascertained by a reading of the patent documents. Id. at

1339-40 (internal citation omitted).) That is what the inventors did here. Nowhere does the

specification or the file history disclose or suggest alternate methods of making lenalidomide that

is used to produce the claimed crystalline polymorphs.

Moreover, all lenalidomide used to make the crystal forms disclosed in the specification

and used in the working examples presumably was made by the processes of the 517 and 230

patents, further suggesting implicit disavowal of other processes. AstraZeneca AB, 384 F.3d at


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specification that it argues compel a conclusion that all claims cover racemates and therefore that

Natcos construction is an attempt to read out preferred embodiments absent a disavowal of

claim scope. (Id. at 7.) This is clearly inconsistent and violates established Federal Circuit

precedent that not all claims need cover all embodiments disclosed in a patent. Baran v. Med.

Device Techs., Inc., 616 F.3d 1309, 1316 (Fed. Cir. 2010). In reality, this portion of the

specification fully supports Natcos construction, which recognizes that certain claims cover

racemates and isomers, and certain narrowed, dependent claims cover only isomers.

i. Natcos Constructions Are Consistent With The Intrinsic Record

Claims 1 and 18 of the 230 patent, and claims 1 and 10 of the 554 patentthe broadest,

independent claimssay nothing about R-configuration or S-configuration, and Natco makes no

attempt here to limit the scope of those claims in that respect. (See Defendants Opening

Markman Brief 25-26; Ex. J, 230 patent; Ex. K, 554 patent.) By stark contrast, dependent

claims 15, 16, 24, and 25 of the 230 patent, and claims 2, 3, 14, and 15 of the 554 patent,

contain additional, narrowing limitations expressly limiting those claims to the R-configuration

or the S-configuration, not the racemate. (See Defendants Opening Markman Brief at 25-26,

Ex. J, 230 patent at 28:1518; 28:5861; Ex. K, 554 patent at 27:6228:2, 28:5054); see also

35 U.S.C. 112 ([A] claim in dependent form shall contain a reference to a claim previously set

forth and then specify a further limitation of the subject matter claimed.); Glaxo Group Ltd. v.

Ranbaxy Pharm. Inc., 262 F.3d 1333, 1336 (Fed. Cir. 2001) (Dependent claims are generally

narrower in scope than the claims from which they depend.). Accordingly, Natcos

constructions of ha[ving] the R-configuration and ha[ving] the S-configuration are entirely

consistent with certain embodiments of the invention as disclosed in the specification, and limit

the scope of only of those dependent claims.


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Celgene recognizes the patents express statement that [t]he racemates can be used as

such or can be separated into their individual isomers for use in the claimed invention.

(Celgenes Opening Markman Brief at 6-7, citing Ex. 1 (230 patent), 8:6-7 (emphasis added).)

In fact, the patents describe two distinct methods to obtain either or both [isomer] substantially

free of the other; i.e., in a form having an optical purity of >95%:

The racemates can be used [on their own] or can be separated into their individual isomers mechanically as by chromatography using a chiral adsorbent. Alternatively, the individual isomers can be prepared in chiral form or separated chemically from a mixture by forming salts with a chiral acid, such as the individual enantiomers of 10-camphorsulphonic acid, camphoric acid, -bromocamphoric acid, methoxyacetic acid, tartaric acid, diacetyltartaric acid, malic acid, pyrrolidone-5-carboxylic acid, and the like, and then freeing one or both of the resolved bases, optionally repeating the process, so as to obtain either or both substantially free of the other; i.e., in a form having an optical purity of >95%.

(Defendants Opening Markman Brief, citing 230 patent at 8:6-17 (emphasis added); accord id.,

citing 554 patent at 7:43-54 (emphasis added).) The specification therefore clearly teaches that

certain embodiments can use only the individual R- or S-isomer. The dependent claims

containing this restrictive language should be construed consistently with that understanding.

ii. Celgenes Constructions Violate Established Principles Of Claim Construction

Claim 2 of the 230 patent recites a method of treating certain conditions through the use

of a chemical compound. (See Defendants Opening Markman Brief at 28-29; Ex. J, 27:44-45.)

It contains no language about racemic forms of the compound, or that compound containing

the R-isomer or S-isomer in any amounts. Claims 15 and 16, on the other hand, depend from

claim 2 and contain the additional limitation that the compound have the R-configuration or the

S-configuration, respectively. (See Ex. J, 28:15-18.) This narrowing language is consistent with

the specification disclosure that the lenalidomide can be used as the racemate or as an individual


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isomer. (Id. at 8:6-17 (emphasis added); Ex. K, 554 patent, 7:43-54 (emphasis added).) Where

the specification expressly discloses embodiments that are narrower than others, and these

embodiments are recited as additional limitations in certain dependent claims, these limitations

must have some narrowing effect. See 35 U.S.C. 112 ([A] claim in dependent form shall

contain a reference to a claim previously set forth and then specify a further limitation of the

subject matter claimed.) (emphasis added). Under Celgenes construction, however, claims 15

and 16 would cover racemic mixtures. The R-isomer and the S-isomer and would add no

further limitation over claim 2.

Celgenes construction is also inconsistent with the specification that clearly

contemplates the use of lenalidomide as a racemic mixture and also, alternatively, as an isomer

in the R-configuration or in the S-configuration. In other words, the Pharmaceutical Patent

disclosure does disclose different embodiments that are directed to use of the racemic mixture or

to use of the individual isomers. But the fact that there is no difference between these claims

under Celgenes construction, even though the specification unequivocally discloses narrower

embodiments directed to the individual isomers, is the clearest evidence that Celgenes

construction is incorrect. See Dow Chem. Co. v. United States, 226 F.3d 1334, 1341-42 (Fed.

Cir. 2000) (applying the doctrine of claim differentiation and concluding that an independent

claim should be given broader scope than a dependent claim to avoid rendering the dependent

claim redundant).7 Essentially, Celgenes proposal ignores the additional claim limitations

completely and cannot be what the patentees intended or what Federal Circuit precedent permits.

7 In the Polymorph Patent specification, Form A is never disclosed as having less than the full set of characteristics described and attributed to the Form A crystal. See supra Section II.a.i.3.


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iii. Celgenes Constructions Are Inconsistent With The Understanding Of A Person Of Ordinary Skill In The Art

Celgenes proposed constructions are also at odds with the meaning of the claim terms as

would be understood by a person having ordinary skill in the art. Celgene admits that the 230

and 554 specifications do not redefine the meaning of the disputed claim terms. (Celgenes

Opening Markman Brief at 6.) Their meaning to a person of skill in the art thus controls the

inquiry. See Vitronics, 90 F.3d at 1582.

Expressly denoting the compounds stereochemical R- or S-configuration as the patentees

chose to do in the dependent claims at issue indicates to the skilled artisan that the compound is

present as the single enantiomer having that particular stereochemical configuration, and not as

the racemic mixture. (D.I. 251, Second Decl. of Robert K. Boeckman, Jr., Ph.D., (Boeckman

Decl.) 20; Defendants Opening Markman Brief at 27.)8 As Natcos expert explained, the

racemic mixture would never be described as having the R-configuration or as having the S-

configuration. (Boeckman Decl., 18, 20.) By contrast, omitting any express reference to

either the R- or S-isomer, as the patentees chose to do in claim 2 indicates to the skilled artisan

that the racemic mixture is covered by that claim. (Id. 18, 20.) Celgenes proposal is thus

inconsistent with the manner in which the skilled artisan would understand the claim terms. One

cannot have at the same time a compound that is both the racemate and also exists in the R-

configuration or the S-configuration. Celgenes proposal is therefore incorrect. 8 Dr. Boeckmans own prior work reflects the common understanding in the art that a reference to either the R- or S-isomer implies a degree of optical purity that excludes the racemic mixture. Specifically, in a patent claiming a different novel enantiomeric compound, Dr. Boeckman defines the level of purity for that compound as above 95% or, alternatively, as above 98%. Accordingly, the racemic mixture (50/50) is clearly excluded, and any presence of the other enantiomer is due only to an impurity. See Ex. L, U.S. Patent No. 7,781,418, 3:60-65 (defining substantially enantiomerically pure in the context a different enantiomeric compound as having a purity of at least 95% of a referenced enantiomer and at most 5% of the other enantiomer, and in other embodiments, defining it as a purity of at least 98% of a reference enantiomer and at most 2% of the other enantiomer).


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Westview Instruments, Inc., 52 F.3d 967, 973 (Fed. Cir. 1995) (en banc) (interpreting inventory

as used in the patent claim to mean articles of clothing rather than cash or inventory receipts),

affd, 517 U.S. 370 (1996). This case is no different. Cyclical administration has an established

technical meaning in the pharmaceutical field and is distinguishable from other types of dosing

regimens, for example, continuous administration. The patent specification further evidences the

technical nature of the cyclic dosing concept by devoting an entire section, titled Cycling

Therapy, to defining and explaining this dosing regimen, as well as describing specific

embodiments contemplated under the cyclical administration regimen. (Ex. N, 740 patent, 19:4-

21.) If these were ordinary English words whose meanings were apparent, there would have

been no need for specific discussion of the concept in the specification.

When the meaning of a technical term is in dispute, the Federal Circuit has made clear

that it must be construed. Multiform Dessicants, 133 F.3d at 1476; O2 Micro Intl Ltd. v. Beyond

Innovation Tech. Co., 521 F.3d 1351, 1362 (Fed. Cir. 2008) (holding that failure to construe the

term only if was error where parties engaged in technical dispute over its scope). In

compliance with this mandate, Natco has provided constructions for these claim terms that are

faithful to the intrinsic record. Celgene has offered no construction at all. For this reason alone,

Natcos proposed construction should be adopted.

Additionally, because Celgenes underlying premise that the disputed terms have well-

understood meanings is incorrect, its reliance on general-purpose dictionaries is also misplaced.

As Celgene points out, the Federal Circuit explained that the ordinary meaning of claim

language as understood by a person of skill in the art may be readily apparent even to lay judges,

and claim construction in such cases involves little more than application of the widely accepted

meaning of commonly understood words. . . .In such circumstances, general purpose dictionaries


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may be helpful. Phillips, 415 F.3d at 1314 (emphasis added). As explained above, however,

this is not such a circumstance because the disputed terms are technical in nature and do not have

a readily apparent meaning. For such technical terms, the proper construction results, not from

examining general-purpose dictionaries, but the intrinsic record which reveals how those closest

to the patenting process. . .viewed the subject matter. Multiform Dessicants, Inc., 133 F.3d at

1478. Indeed, the Federal Circuit has cautioned that [c]ourts must exercise caution lest

dictionary definitions, usually the least controversial source of extrinsic evidence, be converted

into technical terms of art having legal, not linguistic, significance. The best source for

understanding a technical term is the specification from which it arose, informed, as needed, by

the prosecution history. Id. Based on the correct analytical framework, Natcos construction of

these terms is consistent with the intrinsic record and in keeping with established scientific

principles.9 (Defendants Opening Markman Brief, p. 32-35.)

For at least the foregoing reasons, the Court should reject Celgenes non-construction of

these disputed terms and adopt Natcos construction instead.

b. Cyclically Administering

Certain asserted claims of the 569 patent require cyclically administering lenalidomide

and dexamethasone in treating multiple myeloma. (Ex. O, 569 patent.) The parties

construction of these terms is as follows.

9 To the extent extrinsic evidence is relevant it is not both dictionaries that Celgene cites are entirely consistent with Natcos proffered construction in that they both require repeated, sequential administration at regular intervals. (Defendants Opening Markman Brief, p. 35.) Likewise, Natcos construction also requires repeated, sequential administration over a pre-determined period. (Id.)


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V. CONCLUSION

For all of the reasons set forth above, Natco requests that the Court to adopt its proposals

for the disputed claims terms of the patents-in-suit.

WINSTON & STRAWN LLP Attorneys for Natco Pharma Ltd., Arrow International Ltd., and Watson Laboratories, Inc.

By: s/ Melissa Steedle Bogad

James S. Richer [email protected] Melissa Steedle Bogad [email protected]

Dated: April 8, 2014

OF COUNSEL:

George C. Lombardi Michael K. Nutter Maureen L. Rurka Kevin E. Warner WINSTON & STRAWN LLP 35 West Wacker Drive Chicago, Illinois 60601-9703 (312) 558-5600


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35

CERTIFICATION OF SERVICE

I hereby certify that on April 8, 2014, copies of the foregoing Defendants

Responsive Claim Construction Brief and supporting documents were electronically filed and

served by electronic mail upon the following:

Charles M. Lizza William C. Baton SAUL EWING One Riverfront Plaza, Suite 1520 Newark, New Jersey 07102-5426 F. Dominic Cerrito Eric Stops Andrew Chalson QUINN EMANUEL URQUHART & SULLIVAN, LLP 51 Madison Avenue, 22nd Floor New York, New York 10010 Anthony M. Insogna JONES DAY 12265 El Camino Real Suite 200 San Diego, California 92130-4096 Jason G. Winchester JONES DAY 77 West Wacker Drive Chicago, Illinois 60601-1692 Richard G. Greco RICHARD G. GRECO PC 90 State Street, Suite 700 Albany, New York 12207

I certify that the foregoing statements made by me are true. I am aware that if any of the

foregoing statements are willfully false, I am subject to punishment.

s/ Melissa Steedle Bogad Melissa Steedle Bogad

Dated: April 8, 2014


celg v act - act response markman brief

Documents

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disputed terms

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defendants natco pharma

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