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Case 2:10-cv-05197-SDW-MCA Document 287 Filed 04/08/14 Page 1 of 47 PageID: 8642

Charles M. Lizza
William C. Baton
SAUL EWING LLP
One Riverfront Plaza, Suite 1520
Newark, New Jersey 07102-5426
(973) 286-6700
clizza@saul.com
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.,

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


Hon. Susan D. Wigenton, U.S.D.J.
Hon. Madeline C. Arleo, U.S.M.J.
(Filed Electronically)

Defendants.
______________________________________________________________________________
CELGENES RESPONSIVE MARKMAN BRIEF
______________________________________________________________________________

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TABLE OF CONTENTS
INTRODUCTION ............................................................................................................. 1

II.

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I.

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)
(b)

3.

The Claimed hemihydrate


Does Not Require an Exact Ratio .................................................. 7
Hemihydrate Is Not Limited to Form B................................ 10

Form A ................................................................................................. 13
(a)
(b)

Natco Misconstrues the File


Histories of the 357 and 598 Patents ......................................... 19

(c)

Celgenes Construction Does Not


Render the Claims Meaningless or Invalid .................................. 21

(d)
4.

Natco Improperly Seeks to Read Limitations


From The Specification into Form A ....................................... 15

Natcos Attempt to Define Lengthy Phrases that Include


Form A to Mean the Same Thing as Form A ....................... 24

Disputed Polymorph Claim Language


That Does Not Contain the Term Form A ............................................ 24
(a)
(b)

B.

Natcos Construction Is Not Supported by the


Specification of the 219 and 598 Patents .................................. 26
Natcos Construction Is Not Supported by the
Prosecution Histories of the 219 and 598 Patents ..................... 27

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)

Natcos Technical Principles


Argument Is Legally Irrelevant .................................................... 28

(b)

Natcos Construction Is Inconsistent


with the Intrinsic Evidence .......................................................... 29

(c)

Natcos Case Law Is Inapposite................................................... 31

(d)

Natcos 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)
Page

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4.
III.

cyclically administering ....................................................................... 38

CONCLUSION ................................................................................................................ 40

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TABLE OF AUTHORITIES

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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 Commcns, 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 Engg, 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. Reddys 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. Intl Trade Commn,
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

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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. Intl Trade Commn, 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, Natcos 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, Natcos constructions violate governing Federal Circuit law
because they limit the disputed terms to specific embodiments from the patent specifications.
Natcos improper attempt to limit claims to embodiments is a central theme of its opening brief,
and a pervasive legal error.

Exs. 1-12 refer to the exhibits to the Declaration of Andrew S. Chalson submitted in support of
Celgenes 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,

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pharmaceutical compositions, and related methods of use. Here, Natcos 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.
II.

ARGUMENT
Celgene addresses the disputed terms below in the order set forth in Natcos 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)-piperidine-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, Natcos construction should be rejected.

Celgenes opening brief (D.I. 249) generally tracked the order set forth in the Joint Claim
Construction and Prehearing Statement (D.I. 248). Natcos 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 Courts convenience, has reordered them here
to more closely track Natcos opening brief.

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The parties propose the following:


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

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Celgenes construction
No construction required

Natcos construction
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 hereit 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. Natcos 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

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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 Natcos Opening Markman Briefit 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-process3 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

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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).
Natcos 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, Natcos
June 10, 2011 Letter to Judge Arleo at 4 (emphasis added).) Natcos new position is also
contrary to Natcos 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,
Natcos 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, Natcos 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

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Celgenes construction

A hydrate containing approximately half a


mole of water to one mole of the compound
forming the hydrate

Natcos construction
a solid crystalline form of lenalidomide
containing one water molecule for every two
molecules of 3-(4-amino-1-oxo-1,3 dihydroisoindol-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

Natcos proposed construction differs from Celgenes 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, Natcos 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, Natcos 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

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Natcos 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 Celgenes
proposed construction. Specifically, in SmithKline, the court was asked to consider if the district
court erred in construing the term crystalline paroxetine hydrochloride hemihydratea fourword phrase that is not at issue hereto 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
SmithKlines 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, Natcos reliance on SmithKline is misplaced because, even in that case,

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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 Natcos 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 Natcos expert Dr. Hollingsworth recognizes that Natcos construction is
inconsistent with the intrinsic evidence. Indeed, he could not reconcile the patents clear
disclosures with Natcos 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 patents science weighs against Dr. Hollingsworths 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

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([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
its hemihydrate, its 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 Natcos construction. Under Federal Circuit case law, however,
the patentees use governs. See Phillips, 415 F.3d at 1316. Here, the patents explicit use of the
term hemihydrate to refer to a non-exact ratio of water to lenalidomide is controlling, and
Natcos proposed construction, which contradicts the explicit disclosures of the intrinsic
evidence, is unsupportable.
Natcos 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
integerslike Celgenes construction allowsthere 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 Celgenes 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

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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. Natcos 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, Natcos 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 Celgenes construction.
(b)

Hemihydrate Is Not Limited 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

Natco attempts to negate this by citing to a textbook that Dr. Byrn co-wrote that defines a
different termmonohydrateas 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, Natcos 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 patents specification. See D.I. 252 at 9-13. Despite its length, Natcos argument lacks

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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,
Natcos 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

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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 Abbotts 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, Natcos 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 Natcos 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 Engg, 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,
Natcos cited portions of the prosecution history, including the Examiners 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

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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. Natcos position lacks merit for this additional reason.
Finally, Natco alleges that Celgenes 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 Natcos 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:

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

Celgenes construction

Natcos construction

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

No construction required

The lenalidomide crystal


form described in the
specification as Form A,
having all of the
characteristics assigned to
Form A in the
specification

No construction required

The lenalidomide crystal


form described in the
specification as Form A,
having all of the
characteristics assigned to
Form A in the
specification

an unsolvated crystalline Form A of 3-(4amino-1-oxo-1,3 dihydro-isoindol-2-yl)No construction required


piperidine-2,6-dione having a differential
scanning calorimetry thermogram endotherm
at approximately 270 C

The lenalidomide crystal


form described in the
specification as Form A,
having all of the
characteristics assigned to
Form A in the
specification

Form A

unsolvated crystalline Form A of 3-(4amino-1-oxo-1,3 dihydro-isoindol-2-yl)piperidine-2,6-dione, which has a differential


scanning calorimetry thermogram having an
endotherm at approximately 270 C

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

As set forth in Celgenes 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 specificationin 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

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discussed below, Natcos 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

Natco also argues that form terms act[] as a unique identifier. D.I. 252 at 15. Natco is
mistaken. Indeed, Natcos 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.) Natcos unique identifier theory therefore lacks merit.

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

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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
claimin this case a DSC endotherm at approximately 270 C. (Ex. 6 at 22:29-24:14) Under
Natcos 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 Natcos
incorporation of the specification into Form A. Natcos 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, Natcos 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 Natcos 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]heyre all claiming the same thing.). This is improper for several reasons. First, it

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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, Natcos 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 Commcns, Inc. v. Harris Corp., 156 F.3d 1182, 1187 (Fed. Cir. 1998) (holding district
courts 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
presumptionindeed, 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 1s DSC endotherm at approximately 270 C. Federal Circuit precedent creates

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a presumption that the XRPD peaks of claim 3 are not required by claim 1. Under Natcos
construction, however, Form A already includes both the DSC of claim 1 and the XRPD peaks
of claim 3. Natcos 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, Natcos 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 Natcos 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

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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 Natcos 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 requestin 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.

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


Finally, Natco relies upon the patentees 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 examiners 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 patents 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 examiners 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
270C . . . 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 Natcos proposed
construction would read XRPD and DSC limitations into all of the asserted claims, including
both independent claims. In other words, Natcos 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

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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 Natcos 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 Natcos assertion, this
vague reference to the specification does not reflect Celgenes 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. Natcos proposed constructions must fail for this additional reason.
(c)

Celgenes 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 Celgenes 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.,

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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. Atwoods 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. Reddys 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 Celgenes 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, Natcos 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, Natcos 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
incorrecteach of Natcos 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. Natcos 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 lenalidomideother than exemplary Form Athat 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 correctit 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 specifications lone disclosure of how to make and use the invention). In light of the
foregoing, the Court should disregard Natcos invalidity arguments and adopt Celgenes
construction of the Form A terms.

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(d)

Natcos Attempt to Define Lengthy Phrases that Include


Form A to Mean the Same Thing as Form A

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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. Natcos
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 Celgenes
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 Courts 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 Natcos 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,

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:
Term

Celgenes construction

Natcos construction

(219 patent, claim 1)

The lenalidomide crystal


form described in the
specification as Form A,
having all of the
characteristics assigned to
Form A in the
specification

an unsolvated crystalline form of 3-(4amino-1-oxo-1,3 dihydro-isoindol-2-yl)piperidine-2,6-dione having a differential


scanning calorimetry thermogram endotherm
at approximately 270 C and an X-ray
powder diffraction pattern comprising peaks No construction required
at approximately 8, 14.5, and 16 degrees 2
and a thermogravimetric analysis curve
indicative of an unsolvated material

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 3-(4-amino-1-oxo-1,3


dihydro-isoindol-2-yl)-piperidine-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

No construction required

(598 patent, claim 5)


an unsolvated crystalline form of 3-(4amino-1-oxo-1,3 dihydro-isoindol-2-yl)piperidine-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

No construction required

The lenalidomide crystal


form described in the
specification as Form A,
having all of the
characteristics assigned to
Form A in the
specification

No construction required

The lenalidomide crystal


form described in the
specification as Form A,
having all of the
characteristics assigned to
Form A in the
specification

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

(598 patent, claim 10)


an unsolvated crystalline form of 3-(4amino-1-oxo-1,3 dihydro-isoindol-2-yl)piperidine-2,6-dione, which has a differential
scanning calorimetry thermogram having an
endotherm at approximately 270 C
(598 patent, claims 1, 17)

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Natcos proposed constructions lack merit for the same reasons as its proposed construction of

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the Form A terms, as well as for the additional reasons discussed in Celgenes 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)

Natcos Construction Is Not Supported by the


Specification of the 219 and 598 Patents

Natcos 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. Natcos only argument is contrary to
established law.12 As explained herein and in Celgenes 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 Natcos proposed construction of these phrases.13

11

Natco also states that its construction would avoid[] enablement and written description
issues that would arise if Celgenes 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

Natcos 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)

Natcos Construction Is Not Supported by the


Prosecution Histories of the 219 and 598 Patents

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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, Natcos proposed constructions must fail.

14

Natcos 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

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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.
Term

Celgenes construction

Natcos construction

Said compound has


Said compound has the R-isomer
the R-configuration

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


Said compound has the S-isomer
the S-configuration

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 Celgenes
constructions mean that the compound contains at least some of the specified isomer, while
Natcos constructions mean that the compound contains only, or substantially all, the specified
isomer. D.I. 249 at 4-8. Celgenes constructions are consistent with the intrinsic record, while
Natcos improperly exclude embodiments and deny the claims their full scope.
(a)

Natcos Technical Principles Argument Is Legally Irrelevant

Natco argues that a person of skill in the art would understand the phrase has the Rconfiguration to mean that the compound is comprised of all or substantially all the Renantiomer. D.I. 252 at 27. Natcos 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

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

Natcos Construction Is Inconsistent


with the Intrinsic Evidence

Natco argues that Celgenes 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 mistakenclaims 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, Natcos 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 Sconfiguration, 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

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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:
Compound, including
all mixtures (Claim 2)

R-configuration
(Claim 15)

R- and S(Claims 15 & 16)

S-configuration
(Claim 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. Natcos expert agrees. (Ex. 23, 10/6/11 Boeckman Tr. at
50:7-13; 51:19-52:10.)

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

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1 at 28:15-18.) Claim 16 (red circle on the right) requires that the compound has the Sconfiguration, 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 Celgenes 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
Natcos construction. Accordingly, the intrinsic evidence does not support Natcos construction.
(c)

Natcos Case Law Is Inapposite

Natco cites two decisions in support of its misguided and incorrect assertion that case
law on this issue also favors Natcos 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

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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 Natcos cases involved any claims that include the word has,
which is central to the parties dispute here.19 Thus, Natcos case law does not favor its
construction.
(d)

Natcos Proposed Constructions


Ignore the Language of the Claims

Natcos 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

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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). Natcos 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 Celgenes 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

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definition:
unit dosage form
Celgenes construction
Physically discrete units suitable as a unitary
dosage

Natcos construction
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, Natcos construction takes the first clause in the
specification, ignores the second clause, takes the third clause, and ignores the fourth clause.
Natcos 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.
Celgenes 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

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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 Celgenes 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, Natcos 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
Natcos 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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Term

Celgenes construction

administered
cyclically

administered
in a cycle

Natcos construction

No construction required

Administered according to a predetermined dosing regimen that


includes administering lenalidomide
for an initial period, followed by a
pre-determined treatment-free
interval, and repeating this sequential
administration

No construction required

Administered according to a predetermined dosing regimen that


includes administering lenalidomide
for an initial period, followed by a
pre-determined treatment-free
interval, and repeating this sequential
administration

Natcos 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.

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(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. Natcos 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, Natcos
argument cherry picks only certain portions of the intrinsic recordin this case dependent
claims 20, 22, and 30and ignores the rest of the intrinsic evidence, including claims 18 and 29.
Natcos 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 Natcos assertion, the plain language of the claims does not support its

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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.
Natcos 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 Natcos 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, Natcos 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
Celgenes opening brief, the Court need not construe these plain and ordinary words.
4.

cyclically administering

Despite Natcos 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
Celgenes construction
No construction required

Natcos construction
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

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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 Natcos during
prosecution. Both arguments lack merit for the following reasons.
First, Natcos construction is not consistent with the intrinsic record. Indeed, nothing in
the intrinsic record supports reading Natcos narrowing limitation[a]dministering
lenalidomide and dexamethasone in combination for 21 consecutive daysinto claim 1 of the
569 patent. Natcos 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 Celgenes 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. Natcos
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 Natcos admission is that claim 1 is broader than claim 13 to the extent that it does

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not specify the days on which dexamethasone must be administered. Because Natcos
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 Celgenes 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). Natcos use of the phrase can be illustrates that the limitation it
seeks to read into the claims is not mandatorythere is no disavowal of claim scope. In other
words, claim 1 of the 569 patent is broad enough to cover Natcos in combination for 21
consecutive days limitation, but it is not so limited. Natcos 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 Celgenes 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
clizza@saul.com
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