CELG v ACT - CELG Response Markman Brief

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Charles M. Lizza William C. Baton SAUL EWING LLP One Riverfront Plaza, Suite 1520 Newark, New Jersey 07102-5426 (973) 286-6700 [email protected]

Attorneys for Plaintiff Celgene Corporation

UNITED STATES DISTRICT COURT

DISTRICT OF NEW JERSEY

CELGENE CORPORATION,

Plaintiff,

v.

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

Defendants.

Civil Action No. 10-5197 (SDW)(MCA)

Hon. Susan D. Wigenton, U.S.D.J. Hon. Madeline C. Ar leo, U.S.M.J.

(Filed Electronically)

______________________________________________________________________________

CELGENE’S RESPONSIVE MARKMAN BRIEF ______________________________________________________________________________

Case 2:10-cv-05197-SDW-MCA Document 287 Filed 04/08/14 of 47 PageID: 8642

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TABLE OF CONTENTS

I.� INTRODUCTION ............................................................................................................. 1�II.� ARGUMENT ..................................................................................................................... 2�

A.� Crystal Forms of Lenalidomide ............................................................................. 2�1.� “3-(4-amino-l-oxo-l,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione” ........ 2�2.� “hemihydrate” ............................................................................................ 5�

(a)� The Claimed “hemihydrate” Does Not Require an Exact Ratio .................................................. 7�

(b)� “Hemihydrate” Is Not Limited to “Form B”................................ 10�3.� “Form A” ................................................................................................. 13�

(a)� Natco Improperly Seeks to Read Limitations From The Specification into “Form A” ....................................... 15�

(b)� Natco Misconstrues the File Histories of the ’357 and ’598 Patents ......................................... 19�

(c)� Celgene’s Construction Does Not Render the Claims Meaningless or Invalid .................................. 21�

(d)� Natco’s Attempt to Define Lengthy Phrases that Include “Form A” to Mean the Same Thing as “Form A” ....................... 24�

4.� Disputed Polymorph Claim Language That Does Not Contain the Term “Form A” ............................................ 24�(a)� Natco’s Construction Is Not Supported by the

Specification of the ’219 and ’598 Patents .................................. 26�(b)� Natco’s Construction Is Not Supported by the

Prosecution Histories of the ’219 and ’598 Patents ..................... 27�B.� Compounds, Pharmaceutical Compositions, and Related Methods of Use ......... 28�

1.� “said compound has the R-configuration” and “said compound has the S-configuration” ............................................... 28�(a)� Natco’s “Technical Principles”

Argument Is Legally Irrelevant .................................................... 28�(b)� Natco’s Construction Is Inconsistent

with the Intrinsic Evidence .......................................................... 29�(c)� Natco’s Case Law Is Inapposite ................................................... 31�(d)� Natco’s Proposed Constructions

Ignore the Language of the Claims .............................................. 32�2.� “Unit Dosage Form” ................................................................................ 33�3.� “administered cyclically” and “administered in a cycle” ........................ 35�


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TABLE OF CONTENTS (continued)

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4.� “cyclically administering” ....................................................................... 38�III.� CONCLUSION ................................................................................................................ 40�


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TABLE OF AUTHORITIES

Cases�Abbott Laboratories v. Sandoz, Inc.,

566 F.3d 1282 (Fed. Cir. 2009) .......................................................................................... 11, 12

AK Steel Corp. v. Sollac & Ugine, 344 F.3d 1234 (Fed. Cir. 2003) ................................................................................................ 30

ARS Techs., Inc. v. Pneumatic Fracturing, Inc., No. 09-4305, 2011 U.S. Dist. LEXIS 66050 (D.N.J. Jun. 20, 2011) ........................................ 35

Aspex Eyewear, Inc. v. Marchon Eyewear, Inc., 672 F.3d 1335 (Fed. Cir. 2012) ................................................................................................ 33

Baldwin Graphic Sys., Inc. v. Siebert, Inc., 512 F.3d 1338 (Fed. Cir. 2008) ................................................................................................ 17

Beachcombers v. Wildewood Creative Prods., 31 F.3d 1154 (Fed. Cir. 1994) .................................................................................................. 17

Bristol-Myers Squibb Co. v. Mylan Pharms., Inc., No. 09-651, 2012 U.S. Dist. LEXIS 68802 (D. Del. May 16, 2012) ....................................... 22

CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359 (Fed. Cir. 2002) .................................................................................................. 3

Chimie v. PPG Indus., 402 F.3d 1371 (Fed. Cir. 2005) ............................................................................................ 1, 37

CIAS, Inc. v. Alliance Gaming Corp., 504 F.3d 1356 (Fed. Cir. 2007) ................................................................................................ 32

Comark Commc’ns, Inc. v. Harris Corp., 156 F.3d 1182 (Fed. Cir. 1998) ................................................................................................ 17

Cordis Corp. v. Boston Scientific Corp., 561 F.3d 1319 (Fed. Cir. 2009) .......................................................................................... 18, 19

Genentech, Inc. v. Chiron Corp., 112 F.3d 495 (Fed. Cir. 1997) .................................................................................................. 32

Grober v. Mako Prods., 686 F.3d 1335 (Fed. Cir. 2012) .......................................................................................... 12, 21

Haemonetics Corp. v. Baxter Healthcare Corp., 607 F.3d 776 (Fed. Cir. 2010) .................................................................................................. 17

Home Diagnostics, Inc. v. LifeScan, Inc., 381 F.3d 1352 (Fed. Cir. 2004) .......................................................................................... 29, 36

In re Baxter, 656 F.2d 679 (C.C.P.A. 1981) .................................................................................................. 32


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In re Hunter, 288 F.2d 930 (C.C.P.A. 1961) .................................................................................................. 32

Invitrogen Corp. v. Clontech Labs., Inc., 429 F.3d 1052 (Fed. Cir. 2005) ................................................................................................ 23

Johns Hopkins Univ. v. Cellpro, Inc., 152 F.3d 1342 (Fed. Cir. 1998) ................................................................................................ 23

Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898 (Fed. Cir. 2004) ........................................................................................... passim

McCarty v. Lehigh Valley, R.R., 160 U.S. 110 (1895) .................................................................................................................. 40

Merck & Co., Inc. v. Teva Pharm. USA, Inc., 395 F.3d 1364 (Fed. Cir. 2005) ................................................................................................ 17

Omega Eng’g, Inc. v. Raytek Corp., 334 F.3d 1314 (Fed. Cir. 2003) .............................................................................. 12, 19, 21, 27

Orexo, AB v. Mylan Pharm, Inc., No. 11-3788, 2014 U.S. Dist. LEXIS 43257 (D.N.J. Mar. 31, 2014) ........................................ 5

Ortho-McNeil Pharms., Inc. v. Mylan Labs., 348 F. Supp. 2d 713 (N.D. W. Va. 2004) ................................................................................. 32

Pfizer Inc. v. Dr. Reddy’s Labs., Ltd., No. 09-943, 2011 U.S. Dist. LEXIS 19180 (D. Del. Feb. 28, 2011) ........................................ 22

Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc) ......................................................................... passim

Plantronics, Inc. v. Aliph, Inc., 724 F.3d 1343 (Fed. Cir. 2013) ................................................................................................ 13

Reckitt Benckiser, Inc. v. Tris Pharma, Inc., No. 09-3125, 2010 WL 4748648 (D.N.J. Nov. 16, 2010) ........................................................ 22

Sanofi-Aventis U.S. LLC v. Sandoz, Inc., 345 Fed. Appx. 594 (Fed. Cir. 2009) ...................................................................................... 2, 3

SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331 (Fed. Cir. 2005) .............................................................................................. 7, 8

SunRace Roots Enter. v. SRAM Corp., 336 F.3d 1298 (Fed. Cir. 2003) ................................................................................................ 18

Teva Neuroscience, Inc. v. Watson Labs., Inc., No. 2:10-cv-05078, 2013 WL 1595585 (D.N.J. Apr. 12, 2013) ............................................... 32

Tex. Instruments, Inc. v. U.S. Int’ l Trade Comm’n, 805 F.2d 1558 (Fed. Cir. 1986) ......................................................................................... passim


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Thorner v. Sony Computer Ent. Am. LLC, 669 F.3d 1362 (Fed. Cir. 2012) ............................................................................................ 3, 31

U.S. Surgical Corp. v. Ethicon, Inc., 103 F.3d 1554 (Fed. Cir. 1997) ................................................................................................ 24

Vanguard Prods. Corp. v. Parker Hannifin Corp., 234 F.3d 1370 (Fed. Cir. 2000) .................................................................................................. 5

Woods v. DeAngelo Marine Exhaust, Inc., 692 F.3d 1272 (Fed. Cir. 2012) .................................................................................................. 3

Wyeth, LLC v. Intervet, Inc., 771 F. Supp. 2d 334 (D. Del. 2011) .......................................................................................... 13


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Plaintiff Celgene Corporation (“Celgene”) submits this responsive brief in support of its

proposed constructions of the disputed language in U.S. Patent Nos. 6,281,230 (the “’230

patent”), 6,555,554 (the “’554 patent”), 7,189,740 (the “’740 patent”), 7,465,800 (the “’800

patent”), 7,968,569 (the “’569 patent”), 7,977,357 (the “’357 patent”), 8,193,219 (the “’219

patent”), 8,228,415 (the “’415 patent”), and 8,431,598 (the “’598 patent”) (Exs. 1-9).1

I. INTRODUCTION

The overarching principle of claim construction is that, absent an express definition in the

specification, a claim term should be given the full scope of its ordinary meaning. Phillips v.

AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc). This means that a proposed

construction that limits a term to embodiments from the specification is improper. Tex.

Instruments, Inc. v. U.S. Int’l Trade Comm’n, 805 F.2d 1558, 1563 (Fed. Cir. 1986) (“This court

has cautioned against limiting the claimed invention to preferred embodiments.”) The flip side

of this principle is that a proposed construction of a term that excludes embodiments from the

specification is similarly improper. See Chimie v. PPG Indus., 402 F.3d 1371, 1377 (Fed. Cir.

2005) (excluding embodiments is “rarely if ever . . . correct.”) Here, Natco’s proposed

constructions repeatedly ignore these bedrock principles of claim construction.

The first category of disputed terms appears in claims covering solid crystal forms, or

polymorphs, of lenalidomide. Here, Natco’s constructions violate governing Federal Circuit law

because they limit the disputed terms to specific embodiments from the patent specifications.

Natco’s improper attempt to limit claims to embodiments is a central theme of its opening brief,

and a pervasive legal error.

1 Exs. 1-12 refer to the exhibits to the Declaration of Andrew S. Chalson submitted in support of Celgene’s Opening Markman Brief. See D.I. 249-1 through 249-4. Exs. 13-23 refer to the exhibits to the Declaration of Andrew S. Chalson submitted herewith.


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The second category of disputed terms appears in claims concerning compounds,

pharmaceutical compositions, and related methods of use. Here, Natco’s constructions violate

Federal Circuit law by seeking to inappropriately limit the claims by both reading limitations into

the disputed terms while excluding embodiments of the claimed inventions.

I I . ARGUMENT

Celgene addresses the disputed terms below in the order set forth in Natco’s opening

claim construction brief.2

A. Crystal Forms of Lenalidomide

These disputes affect ten claim terms appearing in the ’800, ’357, ’219, and ’598 patents.

1. “ 3-(4-amino-l-oxo-l,3 dihydro-isoindol-2-yl)-piper idine-2,6-dione”

The parties agree that this term refers to lenalidomide itself. See D.I. 252 at 4. This

should be the end of the inquiry for construction of this term. Natco, however, erroneously

argues that a method of making lenalidomide should be read into the claim as a process

limitation. See id. at 4-6. This violates Federal Circuit principles of claim construction. See

Sanofi-Aventis U.S. LLC v. Sandoz, Inc., 345 Fed. Appx. 594, 598-99 (Fed. Cir. 2009) (vacating

construction reading illustrative and optional language in the specification into the claims as

process limitations). Accordingly, Natco’s construction should be rejected.

2 Celgene’s opening brief (D.I. 249) generally tracked the order set forth in the Joint Claim Construction and Prehearing Statement (D.I. 248). Natco’s opening brief (D.I. 252), on the other hand, reordered the terms for reasons unknown to Celgene. Celgene believes that the terms should be presented during the Markman hearing in the order set forth in the Joint Claim Construction and Prehearing Statement but, for the Court’s convenience, has reordered them here to more closely track Natco’s opening brief.


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The parties’ propose the following:

“ 3-(4-amino-l-oxo-l,3 dihydro-isoindol-2-yl)-piper idine-2,6-dione”

Celgene’s construction Natco’s construction

No construction required lenalidomide, prepared according to the methods described in U.S. Patent Nos. 6,281,230 and 5,635,517

Nothing that Natco cites in support of its construction constitutes lexicography that would

support reading process limitations into the claim. Instead, the best support that Natco can

muster is a description of how the claimed compound “can” (not must) be made. D.I. 252 at 4-5.

The use of the permissive word “can” is dispositive here—it proves that the described process is

not mandatory for making the compound. See Sanofi, 345 Fed. Appx. at 598-99.

Despite the use of the word “can,” Natco argues that this permissive disclosure is “the

unequivocal limiting definition” of the term. D.I. 252 at 6. That is neither true, nor is it the law.

Rather, “[t]o act as its own lexicographer, a patentee must ‘clearly set forth a definition of the

disputed claim term’ other than its plain and ordinary meaning.” Thorner v. Sony Computer Ent.

Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012) (quoting CCS Fitness, Inc. v. Brunswick Corp.,

288 F.3d 1359, 1366 (Fed. Cir. 2002) (same)); Woods v. DeAngelo Marine Exhaust, Inc., 692

F.3d 1272, 1283 (Fed. Cir. 2012) (same). Indeed, “[i]t is not enough for a patentee to simply

disclose a single embodiment or use a word in the same manner in all embodiments, the patentee

must ‘clearly express an intent’ to redefine the term.” Thorner, 669 F.3d at 1365 (citation

omitted). Here, there is no clear definition or intent to redefine the chemical name of

lenalidomide. Natco’s own expert, Dr. Mark Hollingsworth, who reviewed the ’800 patent,

testified that the “name listed in the patent is the chemical name of lenalidomide,” and agreed

that the chemical name says nothing about how the compound is prepared. (See Ex. 13, 9/29/11


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Hollingsworth Tr. at 68:20-69:11.) Thus, the language in the specification falls far short of

“lexicography.”

Natco also argues that the claims must be limited to a single manufacturing process

because the patent does not disclose an “alternative process for making lenalidomide . . . .” D.I.

252 at 6. This is a central theme of Natco’s Opening Markman Brief—it alleges that its

proposed constructions must be correct because the patents-in-suit contain only a single

embodiment that is allegedly consistent with its proposed constructions. Unfortunately for

Natco, this is not the law. Rather, the Federal Circuit has repeatedly held that specific

embodiments are not definitions, and has “expressly rejected the contention that if a patent

describes only a single embodiment, the claims of the patent must be construed as being limited

to that embodiment.” Phillips, 415 F.3d at 1323; Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d

898, 906 (Fed. Cir. 2004) (same); see also Tex. Instruments, 805 F.2d at 1563 (“This court has

cautioned against limiting the claimed invention to preferred embodiments . . . .”).

Tellingly, despite seeking to read “product-by-process”3 limitations into the claims,

Natco never uses that phrase in its brief, nor cites to a single case addressing such claims. See

D.I. 252 at 4-6. This is because the law is decidedly against Natco. Virtually every patent that

claims a compound discloses a method of making the compound, but by including such standard

information, compound claims are not converted to product-by-process claims. For example, the

Federal Circuit has held that “[t]he method of manufacture, even when cited as advantageous,

does not of itself convert product claims into claims limited to a particular process. . . . A novel

product that meets the criteria of patentability is not limited to the process by which it was

made.” Vanguard Prods. Corp. v. Parker Hannifin Corp., 234 F.3d 1370, 1372-73 (Fed. Cir.

3 A product-by-process claim “is a product claim that defines the claimed product in terms of the process by which it is made.” MPEP § 2173.05(p) (8th ed. Rev. 9, August 2012).


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2000); see also Phillips, 415 F.3d at 1323 (warning against “the danger of reading limitations

from the specification into the claim”); Orexo, AB v. Mylan Pharm, Inc., No. 11-3788, 2014 U.S.

Dist. LEXIS 43257, at *18-19 (D.N.J. Mar. 31, 2014) (following Vanguard and declining to read

a process limitation into a product claim).

Natco’s position is also directly contrary to its prior representation to this Court that “the

’800 patent contains no claims directed to any manufacturing processes.” (Ex. 14, Natco’s

June 10, 2011 Letter to Judge Arleo at 4 (emphasis added).) Natco’s new position is also

contrary to Natco’s August 30, 2010 Notice Letter to Celgene, which formed the basis for the

original complaint in this action. That Notice Letter states that the “plain meaning of this term

limits the construction of the claims to the compound known as lenalidomide. The patent

specification confirms that the plain meaning should be applied and the prosecution history

does not suggest that construction should deviate from the plain meaning.” (Ex. 15 at 33

(emphasis added).) In other words, Natco began this case by agreeing with Celgene that this

term refers to lenalidomide, without limitation as to how the compound is prepared. Thus,

Natco’s attempt to now force a process limitation into the claims should be disregarded.

Accordingly, “3-(4-amino-l-oxo-l,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione” is

“lenalidomide,” without limitation as to how the compound is prepared.

2. “ hemihydrate”

For this term, Natco’s proposed construction ignores the explicit disclosures of the

intrinsic record and improperly excludes embodiments from the scope of the claims. Natco also

disregards governing Federal Circuit law by improperly seeking to limit the claims to examples

from the specification. The parties’ proposed constructions are as follows:


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“ hemihydrate”


“A hydrate containing approximately half a mole of water to one mole of the compound forming the hydrate”

“a solid crystalline form of lenalidomide containing one water molecule for every two molecules of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione, formally associated with one another within the unit cell in the solid crystalline structure, and which crystal form is specifically identified in the ‘800 patent as the Form B polymorphic form, and demonstrated in TGA, Karl Fischer analysis, powder X-ray diffraction patterns, IR spectra, and/or DSC analysis, as distinguishable from other polymorphs, such as the anhydrous form”

Natco’s proposed construction differs from Celgene’s in two ways. First, Natco ignores the

intrinsic record in seeking to limit “hemihydrate” to an “exact” 1:2 ratio of water to the

compound forming the hydrate. In other words, Natco’s proposed construction requires exactly

0.5 molecules of water per molecule of lenalidomide. See D.I. 252 at 7-9. Second, Natco

ignores governing Federal Circuit case law in proposing, through various convoluted clauses that

each import nonexistent limitations into the claims, that the term “hemihydrate” limits the claims

to the exemplary “Form B” disclosed in the specification. Id. at 9-13.

As an initial matter, Natco’s proposed construction is internally inconsistent (and

therefore unsupportable) because “hemihydrate” cannot mean an exact 1:2 ratio (in other words,

exactly 0.5 molecules of water per molecule of lenalidomide), and simultaneously limit the

claims to exemplary Form B. Indeed, the specification explicitly describes exemplary Form B as

a hemihydrate that contains a ratio of water to lenalidomide that is not an exact 1:2 ratio. (Ex. 4

at 6:64-7:6, 22:40-43, figs 9, 37-39 (describing hemihydrates containing anywhere from 0.46 to

0.59 molecules of water per molecule of lenalidomide).) As such, Natco cannot have it both

ways. Its proposed construction lacks merit for this reason alone.


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(a) The Claimed “ hemihydrate” Does Not Require an Exact Ratio

Natco’s lead argument mistakenly asserts that “hemihydrate is not a term of

approximation.” D.I. 252 at 7. In support of this position, Natco falsely represents that “[t]his

issue has already been decided by the Federal Circuit, which defined hemihydrate just as Natco

proposed.” Id. at 7 (citing SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1339

(Fed. Cir. 2005)). In reality, SmithKline is inapposite and, if anything, supports Celgene’s

proposed construction. Specifically, in SmithKline, the court was asked to consider if the district

court erred in construing the term “crystalline paroxetine hydrochloride hemihydrate”—a four-

word phrase that is not at issue here—to require “commercially significant amounts” of the

claimed compound. 403 F.3d at 1335, 1338-41. Because there was nothing in the intrinsic

record to support reading that limitation into the claims, the Federal Circuit reversed. Id. at

1338-40. The Federal Circuit was not asked to, and in fact did not, consider or address the issues

raised here, including whether the “hemihydrate” in the disputed claim term was “exact” or

“approximate.” See generally id.

Had the Federal Circuit been asked to address that issue, it would have found examples in

SmithKline’s patent specification that referred to the hemihydrate as containing 2.5% and 2.6%

water. (See Ex. 16, U.S. Patent No. 4,721,723 at 6:51-7:23.) Those percentages correspond to

0.52 and 0.54 moles of water per mole of paroxetine hydrochloride, respectively. In other words,

the ratio is approximately 1:2, but it is not exact. Nevertheless, the patent (and the Federal

Circuit) appropriately refers to the invention as a “hemihydrate,” just as the ’800 patent does


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here.4 Thus, Natco’s reliance on SmithKline is misplaced because, even in that case,

“hemihydrate” is clearly a term of approximation.

Natco also incorrectly asserts that its “construction is consistent with the intrinsic

record.” D.I. 252 at 7. This is simply not true. Indeed, Natco relies solely on irrelevant

extrinsic evidence in support of this position, rather than the intrinsic record. Specifically, Natco

relies solely on cites to several extrinsic dictionaries that do not even mention Natco’s “exact 1:2

ratio” (id. at 7-8), despite conceding that “extrinsic evidence is less relevant than the intrinsic

record” (id. at 3). Natco resorts to such irrelevant evidence because its construction is explicitly

inconsistent with the intrinsic record of the ’800 patent, including the claims. For example,

Claim 10 recites a “hemihydrate . . . having between approximately 0.46 and approximately 0.59

moles of water per mole of [lenalidomide].” (Ex. 4 at 22:40-43.) The specification explicitly

describes a hemihydrate with at least that same ratio. (Ex. 4 at 6:67-7:6 & Figs. 9, 37-39.)

Even Natco’s expert Dr. Hollingsworth recognizes that Natco’s construction is

inconsistent with the intrinsic evidence. Indeed, he could not reconcile the patent’s clear

disclosures with Natco’s “exact 1:2 ratio.” Out of desperation, he instead attacked the patent as

“arbitrary” and “sloppy.” (Ex. 13, 9/29/11 Hollingsworth Tr. at 80:7-11; 80:21-81:2.) This

newly minted5 attack on the patent’s science weighs against Dr. Hollingsworth’s credibility. In

any event, his testimony cannot alter that the ’800 patent explicitly discloses and claims a

hemihydrate having an approximate ratio of 0.46 to 0.59 moles of water per mole of

4 This makes sense, considering that the Federal Circuit “normally do[es] not interpret claim terms in a way that excludes disclosed examples in the specification. Verizon Servs. v. Vonage Holdings, 503 F.3d 1295, 1305 (Fed. Cir. 2007); see also Chimie, 402 F.3d at 1377 (excluding embodiments is “rarely if ever . . . correct”); Gilead Scis., Inc. v. Sigmapharm Labs., LLC, No. 10-4931, D.I. 80 at 11 (D.N.J. May 31, 2012) (excluding embodiments is “illogical”). 5 Dr. Hollingsworth failed to raise any such attacks in either of his declarations. See generally D.I. 85-5 & D.I. 251-2. (See also Ex. 13, 9/29/11 Hollingsworth Tr. at 87:7-88:7.)


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lenalidomide. The Court should therefore discount his opinions. Phillips, 415 F.3d at 1318

(“[A] court should discount any expert testimony ‘that is clearly at odds with the claim

construction mandated by . . . the written record of the patent.’”) (citation omitted).

Moreover, Dr. Hollingsworth testified that “even if [the applicants of the ’800 patent] say

it’s hemihydrate, it’s not clear that it is hemihydrate.” (Ex. 13, 9/29/11 Hollingsworth Tr. at

85:17-19.) In other words, Dr. Hollingsworth agrees that the ’800 patent explicitly describes a

“hemihydrate” having a non-exact ratio of 0.46 to 0.59 moles of water per mole of lenalidomide,

but still urges the Court to adopt Natco’s construction. Under Federal Circuit case law, however,

the patentee’s use governs. See Phillips, 415 F.3d at 1316. Here, the patent’s explicit use of the

term “hemihydrate” to refer to a non-exact ratio of water to lenalidomide is controlling, and

Natco’s proposed construction, which contradicts the explicit disclosures of the intrinsic

evidence, is unsupportable.

Natco’s proposal is also inconsistent with the understanding of those of ordinary skill in

the art. Natco insists that “when the ratios cannot be expressed as common fractions or

integers—like Celgene’s construction allows—there is no common hydration label for the

crystal. It is simply referred to by the ratio itself, e.g., a crystal with a hydration ratio of .46:1 or

.59:1.” D.I. 252 at 8. Of course, this is directly contradicted by the fact that claim 10 and the

specification of the ’800 patent explicitly refer to “a crystal with a hydration ratio of .46:1 or

.59:1” as a “hemihydrate.” (See Ex. 4 at 22:40-43, 6:67-7:6, & Figs. 9, 37-39.) It also ignores

that Celgene’s experts, Dr. Byrn and Dr. Atwood, explained that “hemihydrate” means “a

hydrate containing approximately half a mole of water to one mole of the compound forming the

hydrate,” and that “‘hemihydrate’ has an approximate, rather than an exact or rigid molar ratio

between water molecules and molecules of the compound forming the hydrate.” D.I. 249-6 at


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¶¶ 25-26; see also D.I. 249-5 at ¶ 20. (See also Ex. 16 at 6:51-7:23 (setting forth examples of

hemihydrates with 0.52 and 0.54 moles of water per mole of paroxetine hydrochloride).)

There are several reasons why the ratio is approximate rather than exact, including

“limitations and imperfections in the ability to accurately measure an exact molar ratio.” See

D.I. 249-6 at ¶ 28; see also D.I. 249-5 at ¶ 20. Natco’s expert Dr. Hollingsworth agrees; he

admitted no fewer than six times during his deposition that such limitations and imperfections

affect every measurement. (See, e.g., Ex. 13, 9/29/11 Hollingsworth Tr. at 97:13-17; 100:16-17;

101:6-7; 101:15; 102:3-4; 103:3-5; 107:4-5; 109:5-7.)6 In fact, Dr. Hollingsworth admitted that,

under certain circumstances, he might call a compound a hemihydrate even if tests did not

produce results evidencing an exact 1:2 ratio. (Id. at 105:6-12.)

In light of the foregoing, Natco’s proposed construction lacks merit. “Hemihydrate” does

not require an exact ratio of water to the compound forming the hydrate. Rather, “hemihydrate”

means “a hydrate containing approximately half a mole of water to one mole of the compound

forming the hydrate.” This is consistent with the intrinsic record and the ordinary meaning to

one of skill in the art. Accordingly, the Court should adopt Celgene’s construction.

(b) “ Hemihydrate” Is Not L imited to “ Form B”

Natco spends nearly five pages of its opening brief arguing that “hemihydrate” is also

limited to exemplary “Form B” and all of the data associated with that exemplary form in the

6 Natco attempts to negate this by citing to a textbook that Dr. Byrn co-wrote that defines a different term—“monohydrate”—as a “crystal form containing one mole of water per mole of compound.” D.I. 252 at 8-9. Of course, the text book, which is irrelevant extrinsic evidence, does not define “hemihydrate,” the term at issue here, and says nothing about any “exact” ratio. Thus, Natco’s conclusion that Dr. Byrn has admitted that “it is possible to obtain a hemihydrate with an exact 1:2 ratio of water to compound,” does not follow. Id. at 9. It is also untrue. See id. (citing D.I. 253 at Ex. H at 160:8-161:12, 165:24-167:9). Dr. Byrn testified that one could obtain something “close” to 1:2, but never testified that one could obtain an “exact” ratio. Dr. Atwood agrees. (See Ex. 17, 1/17/14 Atwood Tr. at 161:5-24.)


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’800 patent’s specification. See D.I. 252 at 9-13. Despite its length, Natco’s argument lacks

substance.

First, Natco improperly argues that “hemihydrate” must be limited to exemplary Form B

because it is the only hemihydrate identified in the specification. See D.I. 252 at 9-10. This is

contrary to law. Indeed, “although the specification often describes very specific embodiments

of the invention, [the Federal Circuit] ha[s] repeatedly warned against confining the claims to

those embodiments.” Phillips, 415 F.3d at 1323; see also Tex. Instruments, 805 F.2d at 1563

(same). The Federal Circuit has also “expressly rejected the contention that if a patent describes

only a single embodiment, the claims of the patent must be construed as being limited to that

embodiment.” Phillips, 415 F.3d at 1323; Liebel-Flarsheim, 358 F.3d at 906 (same). Thus,

Natco’s arguments lack merit.

In attempting to avoid this governing authority, Natco cites to Abbott Laboratories v.

Sandoz, Inc., 566 F.3d 1282 (Fed. Cir. 2009), in which the Federal Circuit construed the term

“crystalline” as limited to only one crystal known as “Crystal A.” D.I. 252 at 10. Natco ignores,

however, that the Federal Circuit acknowledged in Abbott that “[w]hen the specification

describes a single embodiment to enable the invention, this court will not limit broader claim

language to that single application unless the patentee has demonstrated a clear intention to limit

the claim scope using words or expressions of manifest exclusion.” Abbott, 566 F.3d at 1288

(quotations and citations omitted). There, based on facts that do not exist here, the Federal

Circuit found such a “clear intention,” as well as a “clear and intentional disavowal of claim

scope.” Id. at 1288-90. For example, the Japanese priority application in that case disclosed

both “Crystal A” and “Crystal B,” but when Abbott filed the U.S. application, it chose to remove

all references to “Crystal B.” Id. at 1290 (finding that this choice “establishes unequivocally that


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Abbott knew and could describe both Crystal A and Crystal B,” and that “Abbott could have

retained the disclosure of Crystal B to support the broader claims of the [patent-in-suit], but

instead disclosed and claimed A alone”). The Federal Circuit also found a “clear and intentional

disavowal of claim scope beyond Crystal A” in Abbott’s prosecution history based on specific

declarations submitted during prosecution. Id.

None of those facts are present here. Nevertheless, Natco disingenuously argues that the

“evidence in this case is even more compelling” simply because “the specification offers no

suggestion that the hemihydrate can exist as any polymorph other than Form B.” D.I. 252 at 10.

In other words, Natco’s only argument in support of its position is that exemplary Form B is the

only embodiment in the specification that reads on the “hemihydrate” claims. But as set forth

above (and agreed upon by Natco’s own cited case law), the Federal Circuit requires much more

than disclosure of a single embodiment to limit claim terms. See Abbott, 566 F.3d at 1288.

Second, Natco misrepresents the prosecution history of the ’800 patent and alleges that

Celgene disavowed claim scope covering anything other than exemplary Form B. See D.I. 252

at 11-13. Natco ignores that “for prosecution disclaimer to attach, [Federal Circuit] precedent

requires that the alleged disavowing actions or statements made during prosecution be both clear

and unmistakable.” Omega Eng’g, Inc. v. Raytek Corp., 334 F.3d 1314, 1325-26 (Fed. Cir.

2003); see also Grober v. Mako Prods., 686 F.3d 1335, 1341 (Fed. Cir. 2012) (“[T]he doctrine of

prosecution disclaimer only applies to unambiguous disavowals.”). Here, at no point during

prosecution did Celgene limit the claims of the ’800 patent to exemplary Form B. In fact,

Natco’s cited portions of the prosecution history, including the Examiner’s “Reasons for

Allowance” (and the “chemical abstract” cited therein) specifically refer only to a

“hemihydrate,” not to “Form B.” D.I. 255-7, Ex. N at PageID 7780.


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Natco also improperly relies on an election following a restriction requirement7 to imply

that the applicants disavowed claim scope. See D.I. 252 at 11-13. The law does not support this

argument. In fact, the Federal Circuit and courts in this Circuit have held the exact opposite.

See, e.g., Plantronics, Inc. v. Aliph, Inc., 724 F.3d 1343, 1349-51 (Fed. Cir. 2013) (reversing

construction because election “does not amount to anything clear or unambiguous to disclaim

claim scope otherwise encompassed by the broadly drafted claims”); Wyeth, LLC v. Intervet,

Inc., 771 F. Supp. 2d 334, 345-46 (D. Del. 2011) (election following restriction is not a

disavowal). In any event, Celgene never elected claims limited to “Form B.” Rather, it elected

claims pertaining to “hemihydrate.” Natco’s position lacks merit for this additional reason.

Finally, Natco alleges that “Celgene’s attempts to broaden the scope of ‘hemihydrate’

beyond Form B must fail because the specification discloses only one embodiment, the Form B

polymorph, in connection with the hemihydrate.” D.I. 252 at 13. As discussed above, however,

this is not the law. Absent a clear disavowal, which does not exist here, claims are not limited to

a single embodiment. Phillips, 415 F.3d at 1323; Liebel-Flarsheim, 358 F.3d at 906.

In short, because Natco’s attempt to read exemplary “Form B” into the claims is contrary

to governing law and unsupported by the intrinsic record, it must fail.

3. “Form A”

The term “Form A” appears in each asserted claim of the ’357 patent and asserted claims

1-4 and 14 of the ’598 patent. The disputed terms and the parties’ constructions are as follows:

7 When the USPTO determines that claims in a patent application are directed to subject matter defining two or more distinct inventions, it will sometimes issue what is known as a “restriction requirement.” See MPEP § 802.02 & 803; 37 C.F.R. § 1.142(a). The applicant may then choose to “elect” one of those inventions for the current application, and pursue the other inventions in one or more separate but related applications. See MPEP § 818 & 201.06.


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Term Celgene’s construction Natco’s construction

“ Form A”

“A polymorphic form of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione that can be distinguished from other forms”

“The lenalidomide crystal form described in the specification as Form A, having all of the characteristics assigned to Form A in the specification”

“ unsolvated crystalline Form A of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piper idine-2,6-dione, which has a differential scanning calor imetry thermogram having an endotherm at approximately 270° C”

No construction required


“ unsolvated crystalline Form A of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piper idine-2,6-dione”



“ an unsolvated crystalline Form A of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piper idine-2,6-dione having a differential scanning calor imetry thermogram endotherm at approximately 270º C”



As set forth in Celgene’s opening brief, “Form A” is simply a term of convenience that one of

ordinary skill in the art would understand as being capable of distinguishing forms, as opposed

to, for example, mixtures of forms. See D.I. 249 at 26-32; D.I. 249-5 at ¶¶ 25-27. (See also Ex.

17, 1/17/14 Atwood Tr. at 81:25-83:22; 108:13-20.)

The parties agree that “Form A” is not explicitly defined in the intrinsic record of any of

the patents-in-suit. Natco nevertheless argues that “Form A” must be defined by “all the

characteristics attributed to the Form A polymorph by the specification”—in other words, Natco


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seeks to read dozens of unsupported limitations into the claims. See D.I. 252 at 14-20. As

discussed below, Natco’s arguments lack merit.

(a) Natco Improperly Seeks to Read Limitations From The Specification into “Form A”

Despite conceding that “Form A” “has no established meaning,” Natco asserts that one of

ordinary skill in the art “would understand ‘Form A’ in these patents to mean the particular

polymorph that has the various characteristics attributed to it by the specification.” D.I. 252 at

16.8 Natco ignores, however, that the “various characteristics” in the specification are merely

exemplary. Indeed, the specification explicitly refers to “Form A” as “[o]ne embodiment.” (Ex.

8 at 5:35.)

Moreover, the only evidence Natco supplies regarding the understanding of one of

ordinary skill in the art comes from its expert, Dr. Hollingsworth, who admitted that he ignored

the language of the claims in forming his opinion regarding the meaning of “Form A”:

Q. Does the language specifically recited in the claims inform your opinion of the meaning of Form A?

A. Not particularly, no, because the Form – Form A has already been defined essentially in the specification of the patent.

(Ex. 18, 11/26/13 Hollingsworth Tr. at 195:1-6 (emphasis added).)9 In other words, Dr.

Hollingsworth ignored the bedrock principle of claim construction that “the claims themselves

provide substantial guidance as to the meaning of particular claim terms.” Phillips, 415 F.3d at

8 Natco also argues that form terms “act[] as a unique identifier.” D.I. 252 at 15. Natco is mistaken. Indeed, Natco’s expert Dr. Hollingsworth admitted the same polymorphic form can and actually has been assigned different names by different labs. (See Ex. 18, 11/26/13 Hollingsworth Tr. at 190:10-191:16.) Natco’s “unique identifier” theory therefore lacks merit. 9 Of course, as noted above, “Form A” is not “defined” in the specification of any patent-in-suit, and Natco does not argue that it is. Rather, as explained herein, Natco simply seeks to read an embodiment into the claims.


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1314. As such, his opinions regarding the understanding of one of ordinary skill in the art are at

best irrelevant to the construction of “Form A.”

Natco (and Dr. Hollingsworth) also ignore that each claim of the ’357 patent explicitly

sets forth specific limitations, such as a DSC endotherms or XRPD peaks.10 Natco seeks to

improperly ignore the explicit words of the claims in reading all of the characteristics of

exemplary Form A from the specification into the claims. See Phillips, 415 F.3d at 1314. For

example, in the context of claim 1 of the ’357 patent, “Form A” simply means any unsolvated

crystalline form of lenalidomide having the particular characteristic value specified in the

claim—in this case a DSC endotherm at approximately 270° C. (Ex. 6 at 22:29-24:14) Under

Natco’s construction, all of the details pertaining to exemplary Form A from the specification are

read into the term “Form A,” including the DSC endotherm. Thus, the specific limitations

explicitly set forth in each claim would be rendered duplicative and/or superfluous by Natco’s

incorporation of the specification into “Form A.” Natco’s construction thus improperly fails to

encompass the full scope of the claim term and attempts to read myriad nonexistent limitations

into the claims. See D.I. 249 at 27-29.

Additionally, Natco’s attempt to read every detail pertaining to exemplary Form A from

the specification into the claims is also improper because it would result in at least claims 1-14 of

the ’357 patent having the exact same scope. Dr. Hollingsworth agreed that his opinion would

result in claims with identical scope. (See Ex. 18, 11/26/13 Hollingsworth Tr. at 210:1-7 10 Natco recognizes this, but falsely alleges that, in addition to “Form A,” the claims “optionally recite an additional identifying characteristic that the specification associates exclusively with ‘Form A.’” D.I. 252 at 14. First, the “additional identifying characteristics” are not “optional.” They are mandatory, and they define the scope of the claims. See Phillips, 415 F.3d at 1314. Second, the additional limitations of each claim are not associated “exclusively” with exemplary Form A. For example, despite Natco’s assertion to the contrary, claim 1 of the ’357 patent can and does cover more than just exemplary Form A; it also covers exemplary Form F, which, like exemplary Form A, is unsolvated and has a DSC endotherm at approximately 270° C. (See Ex. 6 at 9:49-61; Ex. 17, 1/17/14 Atwood Tr. at 72:2-15.)


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(“[T]hey’re all claiming the same thing.”). This is improper for several reasons. First, it

improperly renders claim language redundant and/or superfluous. See, e.g., ARS Techs., 2011

U.S. Dist. LEXIS 66050, at *17-18 (declining to construe a term so as to render subsequent

claim language redundant).

Second, as Natco admits, “a claim construction that gives meaning to all terms of the

claim is favored over one that does not.” D.I. 252 at 18 (citing Merck & Co., Inc. v. Teva Pharm.

USA, Inc., 395 F.3d 1364 (Fed. Cir. 2005); Haemonetics Corp. v. Baxter Healthcare Corp., 607

F.3d 776 (Fed. Cir. 2010)). Nevertheless, Natco and its expert admittedly seek to ignore all of

the language in each claim of the ’357 patent, as well as claims 1-4 and 14 of the ’598 patent,

except for the term “Form A.” (See, e.g., Ex. 18, 11/26/13 Hollingsworth Tr. at 195:1-6.)

Third, Natco’s proposed construction violates the doctrine of claim differentiation.

Specifically, “the presence of a dependent claim that adds a particular limitation gives rise to a

presumption that the limitation in question is not present in the independent claim.” Phillips,

415 F.3d at 1315; see also Baldwin Graphic Sys., Inc. v. Siebert, Inc., 512 F.3d 1338, 1345 (Fed.

Cir. 2008) (independent claims “are naturally broader than their dependent counterparts.”);

Comark Commc’ns, Inc. v. Harris Corp., 156 F.3d 1182, 1187 (Fed. Cir. 1998) (holding district

court’s construction improper because it rendered a dependent claim “completely superfluous

and redundant of” an independent claim); Beachcombers v. Wildewood Creative Prods., 31 F.3d

1154, 1162 (Fed. Cir. 1994) (holding an interpretation that caused one claim to have the same

scope as another claim to be presumptively unreasonable). Natco has failed to rebut this

presumption—indeed, it has ignored it entirely.

For example, dependent claim 3 of the ’357 patent is presumed to be narrower in scope

than independent claim 1, from which it depends. Claim 3 recites three specific XRPD peaks, in


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addition to claim 1’s DSC endotherm at approximately 270° C. Federal Circuit precedent creates

a presumption that the XRPD peaks of claim 3 are not required by claim 1. Under Natco’s

construction, however, “Form A” already includes both the DSC of claim 1 and the XRPD peaks

of claim 3. Natco’s construction thus violates the presumption that claim 3 is narrower in scope

than claim 1. Moreover, the presumption is “especially strong” in this case because the only

difference between those two claims is the XRPD limitation that Natco and its expert contend are

already included in claim 1. See SunRace Roots Enter. v. SRAM Corp., 336 F.3d 1298, 1302-03

(Fed. Cir. 2003); see also Phillips, 415 F.3d at 1314-1315. This is but one example, but it is true

for each of claims 1-14 of the ’357 patent (each dependent claim adds a single additional

limitation).

Finally, Natco’s reliance on the specifications of the ’357 and ’598 patents is misplaced

to the extent that Natco seeks to read an embodiment into the claims absent clear and

unmistakable disavowal of claim scope. See Cordis Corp. v. Boston Scientific Corp., 561 F.3d

1319, 1329 (Fed. Cir. 2009) (holding that a narrowing construction requires a clear and

unmistakable disclaimer of claim scope); Liebel-Flarsheim, 358 F.3d at 906 (“[The Federal

Circuit] has expressly rejected the contention that if a patent describes only a single embodiment,

the claims of the patent must be construed as being limited to that embodiment . . . [T]he claims

of the patent will not be read restrictively unless the patentee has demonstrated a clear intention

to limit the claim scope using ‘words or expressions of manifest exclusion or restriction.’”). The

patent specifications in this case neither support Natco’s proposed construction nor contain any

words of manifest exclusion or restriction from which a person of ordinary skill in the art might

conclude that the patentees failed to claim anything more broadly than exemplary Form A.

Rather, the specification explicitly states that “Form A” is “[o]ne embodiment of the invention,”


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and that the “entire scope of this invention is not limited by the specific examples described

herein, but is more readily understood with reference to the appended claims.” (Ex. 6 at 5:35-37,

22:24-26.)

For at least these reasons, the Court should reject Natco’s construction of “Form A.”

(b) Natco Misconstrues the File Histories of the ’357 and ’598 Patents

Natco next mischaracterizes the prosecution histories to justify its attempt to improperly

read dozens of limitations from the specification into the claims. D.I. 252 at 16-18. “[F]or

prosecution disclaimer to attach [Federal Circuit] precedent requires that the alleged disavowing

actions or statement made during prosecution be both clear and unmistakable.” Omega, 334

F.3d at 1325-26; see also Cordis, 561 F.3d at 1329. There is no such disclaimer here.

First, Natco argues that Celgene “expressly narrowed the claims to recite ‘Form A’

lenalidomide” in response to an enablement rejection in the ’357 file history. D.I. 252 at 17

(citing a 3/7/11 Interview Summary and 3/10/11 Supplemental Amendment and Response).

Natco is mistaken. As an initial matter, Natco ignores that in responding to the enablement

rejection upon which it relies, the patentee did not narrow the claims; in fact, the patentee did

not amend any of the asserted claims at issue to include the term “ Form A.” (See Ex. 19,

9/3/2010 Amendment and Response to Office Action at 2-7.) Instead, the patentee argued that

the claims were enabled because a person “of ordinary skill in the art would understand that a

crystalline form may be characterized by fewer than all of the peaks in an XRPD pattern.” (Id. at

10.) Next, Natco ignores that the Interview Summary upon which it relies does not discuss or

even mention any enablement rejection. Rather, the summary explicitly indicates that the

interview pertained to a “restriction” request—in other words, a request from the examiner to


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move certain of the claims into a separate patent to simplify review of the application. See D.I.

257-4; see also D.I. 257-5 at 9-10.

Finally, Natco relies upon the patentee’s Supplemental Amendment and Response, but

ignores that there is no mention of any enablement rejection in that amendment, and certainly

nothing that could be construed as a clear and unmistakable disavowal of claim scope. See

generally D.I. 257-5. In fact, this amendment (and the prosecution history of the ’357 patent as a

whole) is silent as to the purpose of the amendment to recite “Form A” in the claims. Indeed, the

patentee had previously disagreed with the examiner’s enablement rejection, and had declined to

amend any claims in response thereto. Notably, Natco cites no authority in support of its

position with respect to the ’357 patent’s prosecution history, and has not even alleged, let alone

proven, that the portions of the file history upon which it relies rise to the level of “clear and

unmistakable” disavowal of scope required by the Federal Circuit.

Moreover, the patent examiner’s “Reasons for Allowance” demonstrate that Natco is

mistaken. Those “Reasons” were based on the fact that the claims “are drawn to the specific

crystalline form A of unsolvated [lenalidomide] having the characteristic of an X-ray diffraction

patter [sic] of figure 1 or a DSC thermogram having an endotherm at approximately

270°C . . . which are neither anticipated nor rendered obvious by the art of record.” (Ex. 20,

3/23/11 Notice of Allowability, Detailed Action at 2 (emphasis added).) It is notable that the

examiner distinguished between XRPD and DSC, as those are the two different, specific test

methods explicitly recited in the different independent claims. But Natco’s proposed

construction would read XRPD and DSC limitations into all of the asserted claims, including

both independent claims. In other words, Natco’s reliance on the ’357 patent file history is

misplaced because the claims were allowed based on the different, specific limitations set forth


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in the independent claims of the ’357 patent, and not on “all of the characteristics assigned to

Form A in the specification,” as Natco asserts.

Second, Natco argues that the prosecution history of the ’598 patent similarly limits the

scope of “Form A” to Natco’s proposed definition. D.I. 252 at 17 (citing D.I. 257-6 and 257-7).

Once again, however, Natco mischaracterizes the prosecution history. Here, the cited portions of

the file history do not relate specifically to the term “Form A.” Rather, the patentee merely

pointed out that the specification provided descriptions “of the solid forms and methods of

preparing the solid forms of the instant claims.” See D.I. 257-7 at 8 (citing, “for example,”

portions of the specification describing exemplary Form A). Contrary to Natco’s assertion, this

vague reference to the specification does not “reflect Celgene’s clear intent to define Form A by

the combination of its analytical attributes as described in the specification.” D.I. 252 at 17.

This is not the clear and unmistakable disavowal of claim scope that Natco needs to support its

construction. See Omega, 334 F.3d at 1325-26; Grober, 686 at 1341.

Accordingly, the prosecution histories of the ’357 and ’598 patents do not contain

anything to suggest Celgene intended to limit the term “Form A” to any single embodiment

described in the specification, and certainly do not rise to the level of disavowal required by the

Federal Circuit. Natco’s proposed constructions must fail for this additional reason.

(c) Celgene’s Construction Does Not Render the Claims Meaningless or Invalid

Natco next asserts that “any construction that allows ‘Form A’ to cover crystalline forms

that do not have all the characteristics assigned to Form A by the specification would render the

‘Form A’ limitation meaningless.” D.I. 252 at 18. As explained above and in Celgene’s opening

brief, this is not true for several reasons. Most notably, when faced with nearly identical

disputes, courts in this Circuit have construed polymorphic “Form” terms exactly as Celgene has


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proposed here, refusing to read limitations from the specification into the claims. See, e.g.,

Bristol-Myers Squibb Co. v. Mylan Pharms., Inc., No. 09-651, 2012 U.S. Dist. LEXIS 68802, at

*7-13 (D. Del. May 16, 2012) (relying on Dr. Atwood’s expertise and construing “Form” terms

to mean “a polymorphic crystal form of [the drug in question] that can be distinguished from

other forms”); Pfizer Inc. v. Dr. Reddy’s Labs., Ltd., No. 09-943, 2011 U.S. Dist. LEXIS 19180,

at *18 (D. Del. Feb. 28, 2011) (construing “Form” terms as “terms of convenience”).

Despite this precedent, Natco alleges that Celgene’s construction is not only

“meaningless,” but also renders the claims invalid as “insolubly ambiguous and therefore

indefinite,” and for “lack of written description and/or enablement.” D.I. 252 at 18-19. Natco is

again mistaken. As an initial matter, validity is not properly addressed in Markman proceedings.

See, e.g., Reckitt Benckiser, Inc. v. Tris Pharma, Inc., No. 09-3125, 2010 WL 4748648, at *16

(D.N.J. Nov. 16, 2010) (agreeing that “resolution of invalidity will require findings of fact on

issues that have not been fully presented and have no place in the claim construction process”).

Thus, Natco’s invalidity arguments are improper and should not be given any weight. In any

event, those arguments lack merit.

First, Natco argues that the claims are “insolubly ambiguous and therefore indefinite”

because three arbitrary questions are allegedly unanswerable by one of ordinary skill in the art.

See D.I. 252 at 18. As an initial matter, Natco’s questions are irrelevant to claim construction.

See Reckitt, No. 09-3125, 2010 WL 4748648, at *16. In any event, as set forth below, Natco is

incorrect—each of Natco’s questions is answered by the claims themselves. See, e.g., D.I. 249-5

at ¶¶ 24-26, 29.


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Q1. “ How must the lenalidomide be distinguishable from other forms in order to qualify as Form A?” D.I. 252 at 18.

A1. Each claim recites specific limitations that define its scope. For example, claim 1 requires unsolvated lenalidomide with a DSC endotherm at approximately 270° C. See, e.g., D.I. 249-6 at ¶¶ 24-26, 29.

Q2. “ What analytical method(s) should be used to determine whether the crystal form is Form A?” D.I. 252 at 18.

A3: Each asserted claim clearly sets forth the analytical methods that one of skill in the art could use to determine if a crystal form contained the claimed limitations. See, e.g., D.I. 249-6 at ¶¶ 24-26, 29. Natco’s expert, Dr. Hollingsworth, agrees. (See Ex. 18, 11/26/13 Hollingsworth Tr. at 216:18-221:6.)

Q3. “ Which analytical attributes of Form A, as disclosed by the specification, should be satisfied in order for the crystal to qualify as Form A?” D.I. 252 at 18.

A3: Natco erroneously focuses on “the specification.” The claims define the invention, and each claim sets forth the specific analytic attribute(s) that are necessary to meet the claim.

Second, Natco argues that the claims are invalid for “lack of written description and/or

enablement” because the specification does not disclose or teach a person of skill how to make

any other unsolvated form of lenalidomide—other than exemplary Form A—that meets all of the

attributes specified in the claims. See D.I. 252 at 19. Again, this is irrelevant to claim

construction. Even assuming that Natco is correct—it is not (see, e.g., the above discussion of

Form F)—a single embodiment is sufficient to disclose and enable claims with a broader scope.

See, e.g., Johns Hopkins Univ. v. Cellpro, Inc., 152 F.3d 1342 (Fed. Cir. 1998) (genus of

antibodies is enabled by disclosure of method of making one antibody within the genus); see also

Invitrogen Corp. v. Clontech Labs., Inc., 429 F.3d 1052 (Fed. Cir. 2005) (claims are not limited

to the specification’s lone disclosure of how to make and use the invention). In light of the

foregoing, the Court should disregard Natco’s invalidity arguments and adopt Celgene’s

construction of the “Form A” terms.


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(d) Natco’s Attempt to Define Lengthy Phrases that Include “Form A” to Mean the Same Thing as “Form A”

Natco proposes to define three lengthy phrases that contain the term “Form A” to mean

the same thing as “Form A.” D.I. 252 at 20. Here, Natco again improperly seeks to read all of

the characteristics of exemplary Form A from the specification into the claims. Natco’s

proposed constructions for those phrases lack merit for the same reasons as its proposed

construction for the term “Form A,” as well as for the additional reasons discussed in Celgene’s

opening brief. See D.I. 249 at 29-32.

Natco concedes that other than “Form A,” the “additional limitations in these disputed

terms are not in dispute.” D.I. 252 at 20. Nevertheless, Natco insists that these lengthy phrases

be construed to mean the same thing as “Form A.” This makes no sense, especially considering

that by construing the lengthy phrases to mean the same thing as “Form A,” Natco seeks to read

the meanings of other disputed terms (e.g., the chemical name of lenalidomide) and undisputed

terms (e.g., “crystalline” and “endotherm”) out of the claims. This is nonsensical, and a waste of

the Court’s and parties’ resources. Indeed, claim construction “is not an obligatory exercise in

redundancy.” U.S. Surgical Corp. v. Ethicon, Inc., 103 F.3d 1554, 1568 (Fed. Cir. 1997).

For at least these reasons, the Court should decline Natco’s invitation to construe these

phrases to mean the same thing as “Form A.”

4. Disputed Polymorph Claim Language That Does Not Contain the Term “Form A”

Even where the claims do not recite the term “Form A,” Natco again improperly limits

the terms to embodiments from the specification. This time, Natco seeks to construe four

lengthy phrases in the ’219 and ’598 patents that do not contain the term “Form A” to mean the

same thing as “Form A.” D.I. 252 at 20-21. This is improper. The Federal Circuit has

repeatedly held that specific embodiments are not definitions. See, e.g., Phillips, 415 F.3d at


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1323 (“[A]lthough the specification often describes very specific embodiments of the invention,

[the Federal Circuit] ha[s] repeatedly warned against confining the claims to those

embodiments.”); Liebel-Flarsheim, 358 F.3d at 906 (same); Tex. Instruments, 805 F.2d at 1563

(“This court has cautioned against limiting the claimed invention to preferred

embodiments . . . .”). Celgene submits that none of these phrases require construction, as

follows:


“ unsolvated crystalline 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piper idine-2,6-dione having an X-ray powder diffraction pattern comprising peaks at approximately 8, 14.5, 16, 17 .5, 20.5, 24, and 26 degrees 2

�”

(’219 patent, claim 1)



“ an unsolvated crystalline form of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piper idine-2,6-dione having a differential scanning calor imetry thermogram endotherm at approximately 270º C and an X-ray powder diffraction pattern compr ising peaks at approximately 8, 14.5, and 16 degrees 2

�

and a thermogravimetr ic analysis curve indicative of an unsolvated mater ial” (’598 patent, claim 5)



“ an unsolvated crystalline form of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piper idine-2,6-dione having an X-ray powder diffraction pattern comprising peaks at approximately 8, 14.5, 16, 17.5, 20.5, 24, and 26 degrees 2

�”

(’598 patent, claim 10)



“ an unsolvated crystalline form of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piper idine-2,6-dione, which has a differential scanning calor imetry thermogram having an endotherm at approximately 270° C” (’598 patent, claims 1, 17)




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Natco’s proposed constructions lack merit for the same reasons as its proposed construction of

the “Form A” terms, as well as for the additional reasons discussed in Celgene’s opening brief.

See D.I. 249 at 32-36. Nevertheless, Natco argues that its constructions are supported by the

specification as well as the prosecution histories of the ’219 and ’598 patents.11 Natco is wrong.

(a) Natco’s Construction Is Not Supported by the Specification of the ’219 and ’598 Patents

Natco’s discussion of these terms is based entirely on its position that the claims must be

limited to a single embodiment. Specifically, Natco argues that its constructions are consistent

with the specification of the ’219 and ’598 patents because exemplary Form A is allegedly the

only unsolvated crystalline lenalidomide described in the specification as having the

characteristics recited in the claims. See D.I. 252 at 22-25. Natco’s only argument is contrary to

established law.12 As explained herein and in Celgene’s opening brief, the Federal Circuit has

repeatedly held that specific embodiments are not definitions, and has “expressly rejected the

contention that if a patent describes only a single embodiment, the claims of the patent must be

construed as being limited to that embodiment.” Phillips, 415 F.3d at 1323; Liebel-Flarsheim,

358 F.3d at 906; see also Tex. Instruments, 805 F.2d at 1563. As such, the Court should not

adopt Natco’s proposed construction of these phrases.13

11 Natco also states that its construction would “avoid[] enablement and written description issues that would arise if Celgene’s construction is favored.” D.I. 252 at 22. This contention is baseless, and as discussed above, validity is not properly addressed during claim construction. As such, the Court should disregard it. 12 Natco’s argument is also factually wrong. For example, Natco alleges that “the specification does not teach or even suggest the possibility that other unsolvated crystalline polymorphs of lenalidomide exist . . . .” D.I. 252 at 22-23. Natco ignores that the specifications explicitly recite that both Forms F and G are “unsolvated material.” (See Exs. 7 & 9 at 9:59-10:16.) 13 Natco again seeks to avoid this governing case law by relying on Abbott, but as explained above, Abbott does not apply to the facts of this case.


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(b) Natco’s Construction Is Not Supported by the Prosecution Histories of the ’219 and ’598 Patents

Natco also improperly seeks to limit the claims by mischaracterizing the prosecution

histories, but nothing in the intrinsic record supports limiting the claims to cover only “Form A.”

Once again, Natco ignores that “for prosecution disclaimer to attach, [Federal Circuit] precedent

requires that the alleged disavowing actions or statements made during prosecution be both clear

and unmistakable.” Omega, 334 F.3d at 1325-26. Natco cannot point to any such disavowal here

because none exists.

At no point during prosecution did Celgene limit the claims to exemplary Form A. Natco

relies on the applicants’ amendment of the claims to recite “unsolvated” crystalline lenalidomide,

but it cannot be disputed that this amendment does not limit the claims to exemplary Form A.

There is no “clear and unmistakable” disavowal of claim scope in that amendment or anywhere

else in the prosecution history. In fact, Natco points to nothing more than the applicants’

illustrative citations to portions of the specification relating to exemplary Form A as support for

the fact that claims to “unsolvated” lenalidomide were enabled and sufficiently described. D.I.

252 at 24. These citations do not constitute a disclaimer of all claim scope besides exemplary

Form A.14 Indeed, this is not the law. Without clear, unambiguous disavowal, a broader claim is

not limited to a single embodiment, even one used to enable the invention. See Phillips, 415

F.3d at 1323; Liebel-Flarsheim, 358 F.3d at 906; see also Tex. Instruments, 805 F.2d at 1563.

Because there is no “clear and unmistakable” disavowal of claim scope anywhere in the ’219 or

’598 patent file histories, Natco’s proposed constructions must fail.

14 Natco’s reference to Form H (D.I. 252 at 23) is similarly unavailing, as Celgene correctly told the Patent Office that skilled artisans would understand that Form H is not covered by the claims because Form H is not unsolvated, as required by all claims of ’219 and ’598 patent. See D.I. 257-11 at 8-9. (See also Ex. 7 at 10:17-40 & 22:25-24:6; Ex. 9 at 10:17-40 & 22:36-24:39.)


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B. Compounds, Pharmaceutical Compositions, and Related Methods of Use

These disputes affect six claim terms in the ’230, ’554, ’415, ’740, and ’569 patents.

1. “said compound has the R-configuration” and “said compound has the S-configuration”

For these terms, Natco has proposed constructions that ignore the intrinsic evidence and

the principles of claim differentiation.


“Said compound has the R-configuration”

“Said compound has the R-isomer”

“the stereochemical configuration of the compound is all or substantially all the R-isomer, thus excluding a compound that is a racemic mixture”

“Said compound has the S-configuration”

“Said compound has the S-isomer”

“the stereochemical configuration of the compound is all or substantially all the S-isomer, thus excluding a compound that is a racemic mixture”

As Celgene explained in its opening brief, the parties’ dispute centers on the fact that Celgene’s

constructions mean that the compound contains at least some of the specified isomer, while

Natco’s constructions mean that the compound contains only, or substantially all, the specified

isomer. D.I. 249 at 4-8. Celgene’s constructions are consistent with the intrinsic record, while

Natco’s improperly exclude embodiments and deny the claims their full scope.

(a) Natco’s “Technical Principles” Argument Is Legally Irrelevant

Natco argues that a person of skill in the art would understand the phrase “has the R-

configuration” to mean that “the compound is comprised of all or substantially all the R-

enantiomer.” D.I. 252 at 27. Natco’s argument, however, is irrelevant under the canons of claim

construction. To read the phrase “all or substantially all” into these claim terms, there must be a

clear and unmistakable disavowal of claim scope in the patent specification or prosecution

history. See, e.g., Home Diagnostics, Inc. v. LifeScan, Inc., 381 F.3d 1352, 1358 (Fed. Cir.


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2004) (patentee is entitled to full scope of claims absent “a clear disavowal or contrary

definition”). Here, there has been no such disavowal. (See Ex. 1 at 8:1-8.) Without such a

disavowal, Natco’s expert’s testimony is entirely irrelevant. See Phillips, 415 F.3d at 1318 (“[A]

court should discount any expert testimony ‘that is clearly at odds with the claim construction

mandated by the claims themselves, the written description, and the prosecution history, in other

words, with the written record of the patent.’”) (citation omitted).15

Moreover, other patents issued to both Celgene and Natco’s expert Dr. Boeckman set

forth how to claim one isomer as “substantially free” of another. First, when Celgene wanted to

claim an isomer of lenalidomide to the exclusion of others, it did so explicitly. (See Ex. 21, U.S.

Patent No. 7,709,502 at 28:34-64 (claiming “substantially chirally pure” isomers).) Such

language, however, does not appear in any claims of the ’230 or ’554 patents. Second, in his

own patent, Dr. Boeckman explicitly claimed one isomer as “substantially free” of another

because he knew that was the only way to limit the scope of the claim. (See Ex. 22, U.S. Patent

No. 7,781,418 at 13:65-14:9.) Accordingly, the asserted claims of the ’230 and ’554 patents are

not limited as Natco’s suggests.

(b) Natco’s Construction Is Inconsistent with the Intrinsic Evidence

Natco argues that Celgene’s construction “violates established rules of claim

construction” because it would allegedly make claims 2, 15, and 16 of the ’230 patent identical

in scope. D.I. 252 at 28-29. Natco is mistaken—claims 15 and 16 are unambiguously narrower

than claim 2. As an initial matter, “under the doctrine of claim differentiation, dependent claims

are presumed to be of narrower scope than the independent claims from which they depend.” AK 15 In any event, Natco’s expert Dr. Boeckman concedes that even compounds that in his opinion “have the R-configuration” could contain up to ten percent of molecules having the S-configuration, and vice versa. (See Ex. 23, 10/6/11 Boeckman Tr. at 38:1-12; 41:2-7; 41:18-20.) See also D.I. 251 at ¶ 22.


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Steel Corp. v. Sollac & Ugine, 344 F.3d 1234, 1242 (Fed. Cir. 2003).16 That presumption applies

here, and Natco has failed to address, let alone rebut it.

In any event, claims 15 and 16 of the ’230 patent are narrower than independent claim

2.17 The below diagram shows the relationship between claim 2 and claims 15 & 16:

Claim 2 of the ’230 patent (large, purple circle above), which, as Natco concedes, “says nothing

about which isomers the compound contains,” broadly covers all isomers and mixtures of

isomers. See D.I. 252 at 28. Claim 15 (blue circle on the left) requires that the compound “has 16 See also Enzo Biochem, Inc. v. Applera Corp., 599 F.3d 1325, 1334 (Fed. Cir. 2010) (same); 35 U.S.C. § 112(d) (“[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); MPEP § 608.01(n) (6th Ed. Rev. 2, July 1996) (“The test for a proper dependent claim . . . is whether the dependent claim includes every limitation of the claim from which it depends. The test is not one of whether the claims differ in scope.”) (emphasis added). 17 The same is true of (1) claims 24-25 of the ’230 patent, which depend from claim 19; (2) claims 2-3 of the ’554 patent, which depend from claim 1; and (3) claims 14-15 of the ’554 patent, as they depend from claim 11. Natco’s expert agrees. (Ex. 23, 10/6/11 Boeckman Tr. at 50:7-13; 51:19-52:10.)

Compound, including all mixtures (Claim 2)

R- and S- (Claims 15 & 16)

S-configuration (Claim 16)

R-configuration (Claim 15)


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the R-configuration,” meaning that it excludes compositions that contain only the S-isomer. (Ex.

1 at 28:15-18.) Claim 16 (red circle on the right) requires that the compound “has the S-

configuration,” meaning that it excludes compositions that contain only the R-isomer. (Id.)

Claims 15 and 16 thus overlap in that both cover mixtures where the compound “has” both the

R- and the S-isomers. Those claims diverge in that Claim 15 does not cover a compound that

“has” only the S-isomer, and vice versa. The relationship of the claims is clear, and does not run

afoul of the doctrine of claim differentiation.

Natco also incorrectly argues that the specification and prosecution history support its

construction. First, the portion of the specification that Natco relies upon states that “individual

isomers themselves . . . are within the scope of the present invention.” D.I. 252 at 29 (citing Ex.

1 at 8:2-7.) This statement is not lexicography of the term “has the R-configuration” or “has the

S-configuration.” Thus, it does not limit the scope of the claims. See, e.g., Thorner, 669 F.3d at

1365 (“To act as its own lexicographer, a patentee must ‘clearly set forth a definition of the

disputed claim term’ other than its plain and ordinary meaning.”). Second, the portion of the

prosecution history that Natco relies upon describes the claims as being directed to the “use of

the R-isomer” and the “use of the S-isomer.” D.I. 252 at 29. This citation, however, is

consistent with Celgene’s construction because it does not exclude mixtures of R and S isomers.

Thus, it is not the clear and unambiguous disavowal of claim scope that is required to support

Natco’s construction. Accordingly, the intrinsic evidence does not support Natco’s construction.

(c) Natco’s Case Law Is Inapposite

Natco cites two decisions in support of its misguided and incorrect assertion that “case

law on this issue also favors Natco’s construction.” D.I. 252 at 30. In fact, both decisions are


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factually inapposite because in both cases, the racemate18 was prior art to the specifically

claimed isomers. See Ortho-McNeil Pharms., Inc. v. Mylan Labs., 348 F. Supp. 2d 713, 724

(N.D. W. Va. 2004); Teva Neuroscience, Inc. v. Watson Labs., Inc., No. 2:10-cv-05078, 2013

WL 1595585, at *7 (D.N.J. Apr. 12, 2013). It therefore makes sense that the patentees in those

cases were not permitted to claim the prior-art racemates. See, e.g., Teva, 2013 WL 1595585, at

*5 (acknowledging that including the prior-art racemate would “negate the stated objective of the

invention, which was to prepare and use a ‘novel’ compound, R(+)-PAL”). Of course, that is not

the case here, where “[b]oth the racemates of [lenalidomide] isomers and the individual isomers

themselves . . . are within the scope of the present invention.” (See Ex. 1 at 8:1-8 (emphasis

added).) Moreover, neither of Natco’s cases involved any claims that include the word “has,”

which is central to the parties’ dispute here.19 Thus, Natco’s case law does not favor its

construction.

(d) Natco’s Proposed Constructions Ignore the Language of the Claims

Natco’s proposed constructions also lack merit for a fourth reason: Natco has ignored the

“open” transitional phrases “comprises” and “comprising” that appear in each of the disputed

claims. “‘Comprising’ is a term of art used in claim language which means that the named

elements are essential, but other elements may be added and still form a construct within the

scope of the claim.” Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed. Cir. 1997) (citing

In re Baxter, 656 F.2d 679, 686 (C.C.P.A. 1981)); see also CIAS, Inc. v. Alliance Gaming Corp.,

504 F.3d 1356, 1360-61 (Fed. Cir. 2007) (citing In re Hunter, 288 F.2d 930 (C.C.P.A. 1961), and 18 A racemate, or racemic mixture, is a mixture containing both the R- and S- isomers. 19 Notably, one of the same defendants in this case, Watson Laboratories, Inc. (“Watson”), was a Defendant in the Teva case. There, Watson opposed a “substantially pure” limitation, the exact opposite of the argument that it is making here. It is telling that Watson has chosen not to disclose those facts, or the distinguishing factors identified above, to this Court.


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explaining that “our predecessor court explained that this usage of ‘comprising’ also embraces

‘comprises’ and ‘which comprises.’”). In other words, claims that use the transitional language

“comprising” or “comprises” mean the claims necessarily can include other elements.

Here, for example, the term “said compound has the R-configuration” first appears in

asserted dependent claim 15 of the ’230 patent, which depends from claims 1 and 2. (See Ex. 1

at 28:15-16.) Rewritten as a single claim, claim 15 recites as follows:

15. A method of treating inflammation, inflammatory disease or autoimmune disease in a mammal which comprises administering thereto an effective amount of a compound of the formula:

in which said compound has the R-configuration.

(Id.) As such, claim 15 explicitly requires lenalidomide having the R-configuration, but it also

explicitly allows for the presence of the S-configuration through its use of the word “comprises.”

This same reasoning applies to each of the relevant asserted claims. Natco seeks to read the

“comprises” transitional phrase out of the claims. This is improper. See Aspex Eyewear, Inc. v.

Marchon Eyewear, Inc., 672 F.3d 1335, 1348 (Fed. Cir. 2012) (reversing claim construction

reading language out of claim). Natco’s proposed claim constructions must fail for this

additional reason.

2. “Unit Dosage Form”

Here, Natco seeks to arbitrarily cherry pick certain language in the specification to limit

the definition of “unit dosage form.” As explained in Celgene’s opening brief (D.I. 249 at 8-10),

the parties agree that the specification of the ’415 patent provides a definition of “unit dosage


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form,” but disagree on the portion of the specification that the Court should consider as that

definition:

“unit dosage form”


“Physically discrete units suitable as a unitary dosage”

“Physically discrete units suitable as a unitary dosage containing a predetermined quantity of active material calculated to produce the desired therapeutic effect”

Natco alleges that its construction “includes the full definition of ‘unit dosage form’” from the

specification. D.I. 252 at 31. This is not true. The specification of the ’415 patent recites:

The compositions preferably are formulated in unit dosage form, meaning physically discrete units suitable as a unitary dosage, or a predetermined fraction of a unitary dose to be administered in a single or multiple dosage regimen to human subjects and other mammals, each unit containing a predetermined quantity of active material calculated to produce the desired therapeutic effect in association with a suitable pharmaceutical excipient.

(Ex. 8 at 9:18-25 (emphasis added).) Natco clearly has not proposed the “full definition” of this

term as set forth in the specification. Instead, Natco’s construction takes the first clause in the

specification, ignores the second clause, takes the third clause, and ignores the fourth clause.

Natco’s piecemeal approach is not how claim construction works. Natco cannot simply pick the

parts of the specification that it likes and ignore the parts it does not.

Celgene’s construction, on the other hand, properly focuses on the portion of the

specification containing the “meaning” of “unit dosage form,” which is set off from the rest of

the passage with commas as a separate clause. The remainder of the specification quoted by

Natco merely refers back to the “compositions preferably are formulated” language, and is not

lexicography.

Natco accuses Celgene of “clip[ping] off the language ‘containing a predetermined

quantity of active material calculated to produce the desired therapeutic effect.’” D.I. 252 at 31.


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That is incorrect. The first portion of this language, “a predetermined quantity of active

material,” is redundant because claim 1, from which all of the relevant claims depend, already

specifies that the quantity of active material is “from 1 mg to 100 mg” of lenalidomide. This

redundancy is improper. See ARS Techs., Inc. v. Pneumatic Fracturing, Inc., No. 09-4305, 2011

U.S. Dist. LEXIS 66050, at *17-18 (D.N.J. Jun. 20, 2011) (declining to construe a term so as to

render subsequent claim language redundant). And (as explained in Celgene’s opening brief) the

’415 patent prosecution history precludes the inclusion of a “therapeutic effect” limitation in the

term “unit dosage form.” See D.I. 249 at 9-10.

3. “administered cyclically” and “administered in a cycle”

These terms appear in the claims of the ’740 patent. Here, Natco ignores the plain and

ordinary meanings of “administer” and “cycle” and instead seeks to limit the terms to

embodiments from the specification. Natco does so despite starting its argument by admitting

that “each word of the disputed phrases is a simple English word whose meaning would be clear

to the reader.” D.I. 252 at 32. Natco then argues that combining these “simple English words”

somehow transforms the phrases into obscure “term[s] of art” that are inscrutable without

construction. Id. at 32-33. Natco, however, has failed to establish that these phrases are

technical terms of art that require construction. Accordingly, Natco’s proposed constructions

lack merit and the plain and ordinary meaning controls.

The parties’ proposed constructions are as follows:20

20 Natco also argues that the terms “administered cyclically” and “administered in a cycle” from the ’740 patent should be “construed similarly” to “cyclical administration” from the unrelated ’569 patent. D.I. 252 at 32. Celgene agrees with this argument to the extent it means that the words have their plain and ordinary English meanings and need no further construction, as Celgene has proposed. But Natco apparently means something much different. Instead, despite Natco’s argument that the terms should be “construed similarly,” it has not proposed similar constructions for the terms. Instead, Natco asks the Court to improperly read certain embodiments from the specification into the terms, while excluding other embodiments.


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“administered cyclically”


“Administered according to a pre-determined dosing regimen that includes administering lenalidomide for an initial period, followed by a pre-determined treatment-free interval, and repeating this sequential administration”

“administered in a cycle”


“Administered according to a pre-determined dosing regimen that includes administering lenalidomide for an initial period, followed by a pre-determined treatment-free interval, and repeating this sequential administration”

Natco’s proposed construction focuses on an alleged need for a “treatment-free interval,”

arguing that “all cyclical dosing regimens disclosed in the specification teach a treatment-free

(rest) period.” D.I. 252 at 33-34. As an initial matter, even if Natco were correct that all of the

examples in the specification required a rest period, it would remain legal error to read such a

“rest period” into the claims absent a clear disavowal of claim scope under governing Federal

Circuit law. See Phillips, 415 F.3d at 1323; Tex. Instruments, 805 F.2d at 1563 (“This court has

cautioned against limiting the claimed invention to preferred embodiments or specific examples

in the specification.”); see also Home Diagnostics, 381 F.3d at 1358 (patentee is entitled to full

scope of claims “[a]bsent a clear disavowal or contrary definition”).

In any event, Natco is incorrect. The ’740 patent specification explicitly recites

embodiments that do not require “treatment-free” or “rest” periods. Specifically, the

specification states that:

In certain embodiments, the prophylactic or therapeutic agents of the invention are cyclically administered to a patient. Cycling therapy involves the administration of a first agent for a period of time, followed by the administration of the agent and/or the


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second agent for a period of time and repeating this sequential administration.

(Ex. 3 at 19:5-10 (emphasis added).) By ignoring this language, Natco improperly reads

embodiments out of the claims.21 Indeed, the above-quoted portion of the specification explicitly

contemplates, as within the scope of the claims, “cycling therapy” that includes the

administration of agent “A” for a period of time, followed by administration of agents “A” and

“B” for a period of time, and repeating this “sequential administration.” (Id.) In this

embodiment, agent “A” would be administered throughout the “cycling therapy” with no “rest

period.” Natco’s proposal would improperly read this embodiment out of the claims. See

Chimie, 402 F.3d at 1377 (“[A] construction that would not read on the preferred

embodiment . . . would rarely if ever [be] correct and would require highly persuasive

evidentiary support.”) (quotations omitted); see also Gilead, No. 10-4931, D.I. 80 at 11 (“A

claim construction that would result in claims that do not cover the preferred embodiments of the

patent is illogical.”).

Moreover, the “pre-determined dosing regimen” and “pre-determined treatment-free

interval” language that Natco seeks to read into the claims does not appear anywhere in the

intrinsic record. Nevertheless, Natco argues that its construction is supported by “the plain

language of the claims requiring cyclical administration.” D.I. 252 at 34. Once again, Natco’s

argument cherry picks only certain portions of the intrinsic record—in this case dependent

claims 20, 22, and 30—and ignores the rest of the intrinsic evidence, including claims 18 and 29.

Natco’s chosen claims (20, 22, and 30) explicitly recite certain rest periods, but claims 18 and 29

do not. (Compare Ex. 3 at 31:1-3, 31:6-9, & 31:27-28 with id. at 30:62-63 & 31:24-26.) As

21 Indeed, Natco ignores this language and misleadingly quotes the very next paragraph in the specification in support of its proposed “treatment-free interval.” See D.I. 252 at 34 (quoting Ex. 3 at 19:16-21).


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such, contrary to Natco’s assertion, the plain language of the claims does not support its

construction. If anything, the plain language of the claims supports the fact that “administered

cyclically” and “administered in a cycle” do not require construction, and certainly not the

construction proposed by Natco. When the patentees sought to limit the claims to include

periods of rest, they explicitly claimed those periods, in addition to reciting the disputed terms.

Natco’s construction should be rejected for this additional reason.

Finally, with respect to extrinsic evidence, Natco alleges that the dictionaries cited by

Celgene “are entirely consistent with Natco’s proffered construction.” D.I. 252 at 35. Once

again, this is false. None of the definitions of “cyclically” and “cycle” contained in those

dictionaries supports, or even hints at, Natco’s proposed “treatment-free interval” limitation. See

D.I. 249 at 13 (citing Exs. 11 and 12). For each of the foregoing reasons, and those discussed in

Celgene’s opening brief, the Court need not construe these plain and ordinary words.

4. “cyclically administering”

Despite Natco’s assertion that all of the “cyclic” terms “should be construed similarly”

(D.I. 252 at 32), Natco has proposed a definition for “cyclically administering” in claim 1 of the

’569 patent that differs substantially from its proposed constructions for the two preceding terms:

“cyclically administering”


No construction required “Administering lenalidomide and dexamethasone in combination for 21 consecutive days”


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As with the similar terms in the ’740 patent, this term is not defined in the specification,22

and is composed of plain and ordinary words. It therefore does not require construction.

Nevertheless, Natco seeks to read nonexistent limitations into the claims based on two

arguments. First, Natco alleges that its construction is consistent with the specification. Second,

Natco alleges that Celgene “unequivocally” disclaimed any construction besides Natco’s during

prosecution. Both arguments lack merit for the following reasons.

First, Natco’s construction is not consistent with the intrinsic record. Indeed, nothing in

the intrinsic record supports reading Natco’s narrowing limitation—“[a]dministering

lenalidomide and dexamethasone in combination for 21 consecutive days”—into claim 1 of the

’569 patent. Natco’s alleged support for this limitation is, yet again, several embodiments from

the specification that Natco seeks to read into the claims. See D.I. 252 at 36. But as discussed

above and in Celgene’s opening brief, it is improper to read embodiments and examples into the

claims. See Phillips, 415 F.3d at 1323; Tex. Instruments, 805 F.2d at 1563.

Natco also concedes that when the patentee wanted to specify the days on which

dexamethasone was to be administered, it knew how to do so. See D.I. 252 at 37

(acknowledging that claim 13 specifies days for dexamethasone administration, while claim 1

and its dependent claims do not). From that admission, Natco seeks to draw the conclusion that

if the days for dexamethasone administration are not explicitly set forth in the claims, then

dexamethasone must be administered every day “for 21 consecutive days.” See id. Natco’s

conclusion does not follow from its admission. On the contrary, the only appropriate conclusion

22 To the extent that Natco alleges that the patentee acted as his own lexicographer for this term (D.I. 252 at 39-40), this is not true. Rather, “[t]o act as its own lexicographer, a patentee must ‘clearly set forth a definition of the disputed claim term’ other than its plain and ordinary meaning.” Thorner, 669 F.3d at 1365; see also id. at 1368 (lexicography “require[s] a clear and explicit statement by the patentee”); CCS Fitness, 288 F.3d at 1366 (same); Woods, 692 F.3d at 1283 (same).


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to draw from Natco’s admission is that claim 1 is broader than claim 13 to the extent that it does

not specify the days on which dexamethasone must be administered. Because Natco’s

construction is inconsistent with the intrinsic record, it must fail.

Second, Natco misinterprets the prosecution history. Specifically, Natco asserts that one

of ordinary skill in the art “would understand Celgene’s cancellation of language imposing a

requirement for dexamethasone administration on specific days of the cycle to mean that

dexamethasone can be administered in combination with lenalidomide for 21 consecutive days.”

Id. at 39 (emphasis added). Natco’s use of the phrase “can be” illustrates that the limitation it

seeks to read into the claims is not mandatory—there is no disavowal of claim scope. In other

words, claim 1 of the ’569 patent is broad enough to cover Natco’s “in combination for 21

consecutive days” limitation, but it is not so limited. Natco’s proposal must fail for this

additional reason. See McCarty v. Lehigh Valley, R.R., 160 U.S. 110, 116 (1895) (“[W]e know

of no principle of law which would authorize us to read into a claim an element which is not

present.”). For each of the foregoing reasons, and those discussed in Celgene’s opening brief,

the Court need not construe these plain and ordinary words.

III. CONCLUSION

For the foregoing reasons, as well as those set forth in its Opening Markman Brief,

Celgene respectfully requests that the Court adopt its proposed constructions for the disputed

claim language.


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Dated: April 8, 2014 Respectfully submitted, By: s/ Charles M. Lizza

Charles M. Lizza William C. Baton SAUL EWING LLP One Riverfront Plaza, Suite 1520 Newark, New Jersey 07102-5426 (973) 286-6700 [email protected] OF COUNSEL: F. Dominic Cerrito Eric C. Stops Andrew S. Chalson QUINN EMANUEL URQUHART & SULLIVAN LLP 51 Madison Avenue New York, New York 10010 (212) 849-7000 Anthony M. Insogna JONES DAY 12265 El Camino Real Suite 200 San Diego, California 92130-4096 (858) 314-1200 Richard G. Greco RICHARD G. GRECO PC 90 State Street, Suite 700 Albany, New York 12207 (212) 203-7625 Attorneys for Plaintiff Celgene Corporation


CELG v ACT - CELG Response Markman Brief

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