# Opposition Brief — Apotex Corp. v. Astrazeneca AB (No. 08-867)

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## Record

- **Collection:** Supreme Court brief
- **Document type:** Opposition Brief
- **Published:** January 1, 2008

## Text

VI y FEB 6 - 2009
OFFICE OF THE CLERK

Supreme Court. US.

FILED

No. 08-867

In the Supreme Court of the Ginited States

APOTEX CorpP., ef al.,

Petitioners,

Le

ASTRAZENECA AB, ef al.,

Respondents.

On Petition for Writ of Certiorari to the United States
Court of Appeals for the Federal Circuit

BRIEF IN OPPOSITION

JAY I. ALEXANDER
MILBANK, TWEED,

HADLEY & MCCLoy LLP
1850 K Street, N.W.
Washington, D.C. 20006
(202) 835-7500

ERROL B. TAYLOR
Counsel of Record
FREDRICK M. ZULLOW
JOHN M. GRIEM, JR.
MILBANK, TWEED,

HADLEY & McCCLoy LLP
One Chase Manhattan Plaza
New York, NY 10005
(212) 530-5000

Counsel for Respondents

TABLE OF CONTENTS

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REASONS FOR DENYING THE WRIT...........c.scscsscssssersees 5

A. The Court of Appeals’ Precedent is Clear and
I a ciidiicssinns titigialicionstiapinnan emda ea tiaa aa 5

B. The Court of Appeals’ Rule is Consistent With
This Court’s Precedent And Long-Standing
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1. The Court of Appeals’ Rule Follows
Long-Standing Precedent and Policy. ...............00 9

2. Scott Paper Does Not Require a
CE Fis shstsia eastictacanacins Necetinnaaase nia 10

3. Petitioners’ Policy Arguments Are Also
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C. This Case Does Not Provide a Suitable Vehicle
For Decision in Any Event Because Petitioners
Evidence Was Rejected Below...............ssscccssesesssscsssssseee 16

’

D. The Second Question Presented in the Petition
Turns Solely on Fact-Bound Determinations
Involving No Important Legal Issue. .......0... ee 17

EAT hice ciicstch scinsccoucuevenvasonssstinrcntennepieeaeaaain 21

ll

RULE 29.6 STATEMENT

Pursuant to “ule 29.6, Respondents state that the parent
corporations or publicly held companies holding 10% or
more of the stock of AstraZeneca AB, Aktiebolaget Hassle or
AstraZeneca LP are AstraZeneca PLC and Zeneca
Wilmington, Inc. and that the parent corporation or publicly
held company holding 10% or more of the stock of KBI-E,
Inc. and KBI, Inc. is Merck & Co., Inc.

i]

TABLE OF AUTHORITIES

CASES

American Hoist & Derrick Co. v. Sowa & Sons,
Fa ae Be Oe, GE, TI ikki sided 14,15

Astra Aktiebolag v. Andrx Pharm., Inc.,
222 F.SUO. 20 425 C.D. Y.. 2008) occcssesecsissosassevessssccens 19

Avia Group Int'l, Inc. v. L.A. Gear Calif, Inc.,
BSS Fe ESF F OW Cie, FOB iicecicciccnsscccsssinrepirsriorecenias 15

Baxter Healthcare Corp. v. Spectramed, Inc.,
MD FSG US TS CER, Ci, UD vn vse vvccesvscssensscctesessccesecctsne 5,6

Beckson Marine, Inc. v. NFM, Inc.,
Ie Fe re. Gis HE Bs vis siigccsitsandscassacdioavsannevarsees 10

Belcher v. Stengel,
Ee ee eS iii ilies esha ards 17

Blonder-Tongue Labs., Inc. v. Univ. of lilinois Foundation,
Ae Sr, i dications eens 10

Board of License Comm'rs of Town of Tiverton v. Pastore,
BP i Be NE os Mi iG ere 17

Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc.,
ee Tt ee Cr AG PE ethics 10

Brown v. 3M,
Fe Pe Fe Or Gr. BE Btinvccececctsctsvsaceictesseaaes 10

iv

California v. San Pablo & Tulare R. Co.,
et sas istiti fickicaneacsivinrasieedsisooemascnen 17

Cardinal Chem. Co. v. Morton Int'l, Inc.,
ee eaicek reese ins ideorintcertatncdcioninnes 14

Dow Chem. Co. v. Astro-Valour, Inc.,
BE te 0 Ce. Gh BE vei cscs. cccnanseenecsccavdvcassveses 10

Fiskars, Inc. v. Hunt Mfg. Co.,
FF Pee EF 1 EE le BI sci nc ests gecsnsannshnresedennevancss 7,8

Harris Corp. v. IXYS Corp.,
EOF Bee UF TE. EAE, FOBT) ins esescnvcseoncsacsecersesneseresenpocs 7

In re Omeprazole Patent Litig.,
S6 Fad. Aas. FG CPO, Cit. FITS) 00. svccrnsccsscsscrsesssovesncene 19

Jones v. Hildebrandt,
EO «Ee kosher ei es Rne lan nerereE 17

Kim v. ConAgra Foods, Inc.,
BOS FS F388 Fr Cat Be inv incsieisesevesndsvscasctanesncesenacs 6

Lear Siegler, Inc. v. Aeroquip Corp.,
FFF et Ce, Fi ive vcccesicsnsiseincpsavnecivaticeenseens 15

Lewmar Marine, Inc. v. Barient, Inc.,
B27 F2eb TOGO, Ci, VIG bicesccccvcccccssnescsecscstnicscccrnasines 10

Lisle Corp. v. AJ Mfg. Co.,
BIS © Bd FIG CG, Cie, FS) nevi nsseccvesesicessassvsascesencsens 10

Markman y. Westview Instruments, Inc.,
BEF RF, Bee OE Bi iiettceioniiswasiin 1 & 7, Ft

Vv

Mycogen Plant Science, Inc. v. Monsanto Co.,
243 F.3d 1316 (Fed. Cir. 2001).......... nceeguteetecaeamaune 10

Nazomi Comms., Inc. v. ARM Holdings, Plc.,
EI te FRO POE, Car, FOG Pv cncsiccsnscccccevcccsccssernsetescosses 7

O’Reilly v. Morse,
Se i iniaccsusshackadanadenaes ctcimaniolaianiaaiaaee: 18

Peters v. Active Mfg. Co.,
ti CS WN riick ineiksieanssicseineiieciavsesnanpbees 1,9, 10, 12

Polaroid Corp. v. Eastman Kodak Co.,
FOE Be VASO LPOG. TP. TIGG) onivcsscnccssisscsvesenercecessscseoseses 10

Pope Manufacturing Co. v. Gormully,
A te MR IN ica seri ineatkos sus sissivarpsasevonesanepbopacsipbanés 9

Precision Instrument Mfg. Co. v. Automotive
Maintenance Machinery Co.,
sss s\ ca vaiiics aise ssaoussondicinarsoecdeioeenl 9

Rhine v. Casio, Inc.,
PO Oe CBOE CPOE. CW. TOGG) oii neces ccc csccsccccscncesecsesencs 7

Scott Paper Co. v. Marcalus Mfg. Co.,
Pe I EO aac stan ptececitncisnntesenisvasisignaioved passim

Sinclair & Carroll Co. v. Interchemical Corp.,
MT GN oases csssccccstsacecsisssnesesseinrcscasiarcocecee 14

SmithKline Beecham Corp. v. Apotex Corp.,
Oe Fe CO, SE, BP svinscsninecivicesecasscbnicsbesssesenees 6

Tate Access Floors, Inc. v. Interface
Architectural Res., Inc.,
BOO Pde ESOT POE. CW. 2OOZ) -inciiccnsccsiscctiavsensens 3,6, 7,33

V1

The Monrosa v. Carbon Black Export, Inc.,

Be te) WN as ties sctkncsesskccetesdasccecesesoassnonssonvenanssvcses 17
Warner-Jenkinson Co., Inc. v. Hilton-Davis Chem. Co.,

I gic cnucnabescersenbbierdetshanvasieacchsentcnins err
Westinghouse Co. v. Formica Co.,

PE IIE D ossiasnensenaccacevavaciintesssscenvésvacosvaseasscanevive 1]
STATUTES
i ia ain cin cecliapioanabdadantadenanbenkpeoain’ 10, 14
RULES

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INTRODUCTION

This case is not appropriate for review on either of the
questions presented. On the first question, the petition fails
to meet the criteria for review for at least three reasons:

First, the Court of Appeals has consistently applied a
methodical and rigorous comparison of the patent claim
against the prior art (to determine validity) and the accused
product (to determine infringement). Where the evidence
indeed shows that the accused product and the prior art are
the same, and the patent claims read on the prior art, then the
patent is invalid. In such a case, the accused infringer has a
complete defense to the action for infringement. The Court
of Appeals’ precedent traces back more than a century to the
rule that: “‘[t]hat which infringes, if later, would anticipate, i
earlier.” Peters v. Active Mfg. Co., 129 U.S. 530, 537 (1889).
The decision below follows this long line of precedent, which
necessarily and logically rejects the short-hand “practicing
the prior art” defense in favor of a claim-based analysis of
patent infringement and validity, an approach required not
only by Peters; but also by this Court’s more recent
precedent in Markman v. Westview Instruments, Inc., 517
U.S. 370 (1996).

Second, Petitioners’ assertion that the Court of Appeals’
rejection of a “practicing the prior art” defense is out of step
with this Court’s precedent is wrong. Petitioners’ reliance on
Scott Paper Co. v. Marcalus Mfg. Co., 326 U.S. 249 (1945)
is misplaced. The Court’s statement there that “[t}he
assignor has a complete defense to an action for infringement
where the alleged infringing device is that of an expired
patent,” id. at 258 (emphasis added), is no way inconsistent
with the Court of Appeals’ approach because invalidation of
a patent is just as “complete” a defense to an action for
infringement as is a judgment of non-infringement. Scott
Paper additionally does not bear the weight placed upon it by

2

Petitioners because it was a narrow decision addressing the
breadth of the doctrine of assignor estoppel. The case did not
purport to establish the broad rule that Petitioners now seek
to attribute to it.

Third, even if there were cause to consider the first
question presented, this case is an exceptionally poor vehicle
for doing so. The trial record is devoid of any evidence that
would support Petitioners’ “practicing the prior art” defense.
Thus, the outcome of this case can not be determined by the
Court’s answer to the first question. The district court
expressly rejected Petitioners’ proffered scientific evidence
_ purportedly demonstrating the structure of Petitioners’
accused product and the prior art as not based on proper,
representative samples. (Pet App. at 264a-265a). The Court
of Appeals did not disturb these fact-bound determinations
on appeal. (Pet. App. at 32a-35a). The question presented is
therefore moot in the context of this case.

Perhaps this last point explains why Petitioners did not
see fit to raise the issue in their petition for rehearing or
rehearing en banc at the Court of Appeals. Petitioners’
ambivalence, coupled with the unanimity of the Court of
Appeals in a long line of decisions on this point,
demonstrates further why the question presented is not
appropriate for this Court’s review.

As to the second question presented by Petitioners—i.e.,
whether Petitioners’ product suffered from a chemical
reaction that the patented invention was designed to
prevent—certiorari should be denied because this fact-bound
question was decided on the specific evidence in this case
and affirmed by the Court of Appeals. It presents no legal
question of general significance.

3

COUNTERSTATEMENT

Respondents’ claims of infringement of its '505 and '230
patents against Petitioners (Apotex) and other defendants
(Mylan/Esteve, Lek and Impax) were heard in a bench trial
over 42 days of extensive testimony by scientific experts and
fact witnesses. The district court’s opinion comprises
hundreds of pages of detailed analysis of the scientific
evidence. (Pet. App. at 45a-401a).

The trial court conducted a thorough claim construction
analysis, taking into account the prior art as well as the other
relevant evidence in accordance with well-established
practice. (Pet. App. at 110a-126a). The trial court then
carefully compared each element of the asserted patent
claims against the structure of Petitioners’ product, and
determined that Petitioners’ product literally infringed a
number of asserted claims. (Pet App. 108a-126a; 244a-
280a). The court similarly analyzed each of the other
defendants’ accused products, finding some to infringe and
some not to infringe, depending on whether or not they met
all of the claim elements. (Pet App. at 131la-244a; 280a-
312a).

The trial court further engaged in a detailed analysis of
the validity of the two patents. The court compared each
prior art reference asserted as anticipatcry by Petitioners and
the other defendants against the patent claims, and also
engaged in a detailed review of the prior art asserted tv make
the patent claims obvious.: (Pat App. at 338a-400a). The
court concluded that the defendants had not shown by clear
and convincing evidence that any of Respondents’ asserted
patent claims was invalid. (Pet. App. at 400a).

Petitioners did not raise a “practicing the prior art”
defense as a legal theory separate and apart frem the

4

conventional literal infringement and invalidity theones
adjudicated by the trial court, and the trial court did not
decide any such question. However, Petitioners did attempt
to adduce evidence, through the testimony of their experts
Dr. Signorino and Dr. Cima, consisting of test samples made
specifically for the litigation. Petitioners proffered these
samples to show the characteristics of Petitioners’ accused
product as well as of a product allegedly made according to
one of the prior art references (the EP '495 patent). The trial
court rejected both pieces of evidence. As to the samples
allegedly showing Petitioners’ product, the court found:
“This evidence is of little value, however, because Apotex
did not demonstrate that Dr. Signorino’s Reproduction
Pellets were representative of Apotex’s product.” (Pet App.
at 264a). As to the samples allegedly showing the prior art
product, the court found: “Furthermore, Plaintiffs presented
evidence that Dr. Signorino did not follow the teachings of
the ‘495 Patent, but instead modified certain ingredients and
procedures in creating his reproductions.” (Pet. App. at
265a). The Court of Appeals did not disturb either fact-
bound determination. (Pet. App. at 32a-3Sa).

In its brief on appeal, Petitioners did make mention of
their contention that their accused product “practiced the
prior art,” albeit each time without citation to specific
evidence in the record. However, Petitioners in urging
reversal dedicated the vast majority of their briefing to the
traditional argument that their product did not infringe
because it did not meet all of the elements of the patent
claims as properly construed. Insofar as the Court of
Appeals considered the Petitioners to have raised “‘practicing
the prior art” as a separate legal theory for reversal, the court
stated in two sentences:

Apotex also argues that its manufacturing process
merely practices the prior art, citing European

5

Patent Application No. EP 124,495 A2 (“the '495
European application”). It is well established,
however, that “practicing the prior art” is not a
defense to infringement. Tate Access Floors, Inc. v.
Interface Architectural Res., Inc., 279 F.3d 1357,
1365-69 (Fed. Cir. 2002); Baxter Healthcare Corp.
v. Spectramed, Inc., 49 F.3d 1575, 1583 (Fed. Cir.
1995). (Pe. App. at 32a).

This is the entire extent of the Court of Appeals’
pronouncement on the “practicing the prior art” issue.

”

Petitioners did not raise a “practicing the prior art
argument in their petition for rehearing or rehearing en banc
before the Court of Appeals. The question is squarely
presented, only for the first time now, in the current petition
for certiorari.

REASONS FOR DENYING THE WRIT

The Court of Appeals’ precedent is uniform and
consistent, and comports completely with this Court’s
precedent and the broad policy goals of the Patent Statute.
No confusion or lack of clarity exists as to the legal and
evidentiary requirements for a showing of patent
infringement. Because the petition points to no important,
unsettled legal issue, certiorari should be denied.

A. The Court of Appeals’ Precedent is Clear and
Uniform.

The Court of Appeals has consistently resisted calls by
litigants to create the same short-hand “practicing the pnor
art” defense to literal patent infringement urged by
Petitioners here. The Court of Appeals’ precedent is clear
and consistent and soundly grounded in precedent and policy.

6

The court first addressed the issue expressly in Baxter
Healthcare Corp. v. Spectramed, Inc., 49 ¥.3d 1575, 1583
(Fed. Cir. 1995). In rejecting a “practicing the prior art”
defense, the Court of Appeals explained that “{[}}itera)
infringement exists if each of the limitations of the asserted
claim(s) read on, that is, are found in the accused device.
Questions of obviousness in light of the prior art go to
validity of the claims, not to whether the accused device
infringes.”

In Tate Access Floors, Inc. v. Interface Arch. Res., Inc.,
279 F.3d 1357, 1365-69 (Fed. Cir. 2002), the court
elaborated on its Baxter decision and the rubric for
determining patent infringement under a “literal
infringement” theory——-which is ordinarily the primary theory
on which infringement is determined in patent actions. First,
the claims of the patent are construed and then the claims, as
construed, are compared to the accused device. /d. at 1366.
This is precisely the long-standing approach that this Court
re-affirmed most recently in Markman, 517 U.S. at 374
(“Victory in an infringement suit requires a finding that the
patent claim covers the alleged infringer’s product or
process, which in turn necessitates a determination of what
the words in the claim mean.”’) (internal quotations omitted).
Indeed, claim construction is the first step in the
determination of both infringement and validity and the
Court of Appeals has been careful to warm that the same
claim construction must be used for both purposes. See, e.g.,
Kim v. ConAgra Foods, Inc., 465 F.3d 1312, 1324 (Fed. Cir.
2006) (‘The same claim construction governs for validity
determinations as for infringement determinations.’’);
SmithKline Beecham Corp. v. Apotex Corp., 439 F.3d 1312,
1316 (Fed. Cir. 2006) (“claims must be construed the same
way for validity and for infringement’’).

7

Evidence of the prior art is sometimes useful in the claim
construction analysis because where the claim language is
ambiguous, the court should generally adopt a more narrow
construction that preserves the validity of the claim over the
prior art. /d. at 1367; see, e.g., Harris Corp. v. IXYS Corp.,
114 F.3d 1149, 1153 (Fed. Cir. 1997) (“claims should be
read in a way that avoids ensnaring the prior art if it is
possible to do so”). However, where no genuine ambiguity
exists, and the claim language clearly reads on the prior art,
the claim is invalid. /d. at 1367; Rhine v. Casio, Inc., 183
F.3d 1342, 1345 (Fed. Cir. 1999) (“if the only claim
construction that is consistent with the claim’s language and
the written description renders the claim invalid, then the
axiom {that claims should be construed ‘if possible’ to
sustain their validity] does not apply and the claim is simply
invalid”); Nazomi Comms., Inc. v. ARM Holdings, Ple., 403
F.3d 1364, 1368 (Fed. Cir. 2005) (same). As the Court of
Appeals summarized it in Tate Access: ‘Fairness and the
public notice function of the patent law require the courts to
afford patentees the full breadth of clear claim language, and
bind them to it as well.” 279 F.3d at 1367; Cf Markman,
517 U.S. at 390 (describing the importance to the public of
“certainty” and “uniformity” in the constrection of patent
claims).

Contrary to what is stated in the petition (Pet. at 14-15),
the Court of Appeals did not deviate from this approach in
Fiskars, Inc. v. Hunt Mfg. Co., 221 F.3d 1318 (Fed. Cir.
2000). Fiskars—like the precedent on which it relied-—was
an infringement case decided under the doctrine of
equivalents, rather than under a literal infringement theory.
See Warner-Jenkinson Co., Inc. v. Hilton-Davis Chem. Co.,
520 U.S. 17 (1997) (explaining nature and application of the
patent law doctrine of equivalents). The Court of Appeals in
Tate Access explained why Fiskars is inapposite in a literal
infringement case:

8

With respect to literal infringement, these cases
[including Fiskars] are inapposite. The doctrine of
equivalents expands the reach of claims beyond
their literal language. That this expansion is guided
and constrained by the prior art is no surprise, for
the doctrine of equivalents is an equitable doctrine
and it would not be equitable to allow a patentee to
claim a scope of equivalents encompassing material
that had been previously disclosed by someone else,
or that would have been obvious in light of others’
earlier disclosures. But this limit on the equitable
extension of literal language provides no warrant for
constricting literal language when it is clearly
claimed.

279 F.3d at 1367 (emphasis in original).

The case at bar was decided under a literal infringement
theory and not under the doctrine of equivalents. Thus,
Petitioners’ claim that the Court of Appeals in the case at bar
has “repudiated” a defense it had previously “affirmed” in
Fiskars is simply incorrect. (Pet at 15). The Court of
Appeals has never endorsed a “practicing the prior art”
defense in a literal infringement case. Rather, the court
requires a methodical analysis in which the claims are first
construed and then compared separately to the accused
device (to determine infringement) and the prior art (to
determine validity). That was the approach employed by the
lower courts in this case.

9

B. The Court of Appeals’ Rule is Consistent With
This Court’s Precedent And Long-Standing
Policy Determinations.

1. The Court of Appeals’ Rule Follows
Long-Standing Precedent and
Policy.

The Court of Appeals’ approach has roots that go back at
least to the 1889 Peters decision, a case ignored in the
petition. In Peters, the Court endorsed the view that:

Had the complainant’s invention been first in time
and patented, the Binghamton sheath would have
been an infringement; and, conversely, had the
Binghamton sheath been patented, the com-
plainant’s would have been an infringement. That
which infringes, if later, would anticipate, if earlier.

Peters, 129 U.S. at 537. It has thus long been clear that
where there is unity among what is patented (i.e., the
invention defined by the patent claims as_ properly
coinstrued), the accused infringing device and the prior art,
the result is that the patent is invalid. This result well serves
long-standing policies that encourage elimination of patents
that block the use of public domain technology See, e.g.,
Pope Manufacturing Co. v. Gormully, 144 U.S. 224, 234
(1892) (“It is as important to the public that competition
should not be repressed by worthless patents, as that the
patentee of a really valuable invention should be protected in
his monopoly ... .”) (internal quotations omitted); Precision
Instrument Mfg. Co. v. Automotive Maintenance Machinery
Co., 324 U.S. 806, 816 (1945) (“A patent by its very nature is
affected with a public interest. ... [It] is an exception to the
general rule against imonopolies and to the nght to access to a
free and open market.”); Blonder-Tongue Labs., Inc. v. Univ.

10

of Illinois Foundation, 402 U.S. 313, 342-346 (1971)
(examining the detrimental impact on the public from
multiple patent infringement suits if the patentee is allowed
to re-litigate validity of a patent once declared invalid).'

The Court of Appeals has consistently recognized the
applicability of the Peters rule in cases of asserted
similarities between the accused device and a prior art
device, but in each case has applied a rigorous and
methodical analysis in which the patent claims are first
construed and then compared separately to both the accused
infringement and the prior art. See, e.g., Polaroid Corp. v.
Eastman Kodak Co., 789 F.2d 1556, 1573 (Fed. Cir. 1986);

ewmar Marine, Inc. v. Barient, Inc., 827 F.2d 744, 747
(Fed. Cir. 1987); Mycogen Plant Science, Inc. v. Monsanto
Co., 243 F.3d 1316, 1324 (Fed. Cir. 2001); Bristol-Myers
Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1378
(Fed. Cir. 2001); Brown v. 3M, 265 F.3d 1349, 1352-53 (Fed.
Cir. 2001); Dow Chem. Co. v. Astro-Valour, Inc., 267 F.3d
1334, 1339-40 (Fed. Cir. 2001); Beckson Marine, Inc. vy.
NFM, Inc., 292 F.3d 718, 726 (Fed. Cir. 2002); Lisle Corp. v.
AJ Mfg. Co., 398 F.3d 1306, 1315 (Fed. Cir. 2005). These
cases, in addition to those mentioned ante, uniformly
recognize the principle that if the patent claims cover the
prior art, they are invalid because one cannot claim patent
protection for what was already in the prior art.

2 Scott Paper Does Not Require a
Contrary Result.

Petitioners’ argue that this Court’s 1945 decision in Scott
Paper requires that the Court now establish a new defense to
literal patent infringement separate and apart from the

' Of course, a challenge to patent validity must be undertaken and
decided in light of the statutory presumption of validity in 35
U.S.C. §282, as discussed infra.

1]

traditional claim-based analysis. As mentioned, that
traditional analysis, which requires construction of the patent
claims as its first step, was most recently sanctioned in
Markman in 1996, a case that dealt extensively with the
proper methodology for construing patent claims.

In Scott Paper, the patentee acquired by assignment a
patent from the respondent and later asserted that the
respondent infringed the patent. The respondent defended on
the ground that its machine was a copy of what was
described in a different, expired, prior art patent. 326 US. at
251. The narrow question presented was whether the
assignor of the patent (the respondent) was “estopped by
virtue of his assignment to defend a suit for infringement of
the assigned patent on the ground that the alleged infringing
device is that of a prior art, expired patent.” /d. at 250. The
reference to estoppel was a reference to the rule established
in Westinghouse Co. v. Formica Co., 266 U.S. 342, 349
(1924) that ‘“‘an assignor of a patent rent is estopped to attack
the utility, novelty or validity of a patented invention which
he has assigned or granted as against any one claiming the
right under his assignment or grant. As to the rest of the
world, the patent may have no efficacy and create no right of
monopoly; but the assignor can not be heard to question the
right of his assignee to exclude him from its use.” (internal
citations omitted).

The Court held in Scott Paper that the doctrine of
assignor estoppel established in Westinghouse did not apply
“So as to penalize the use of the invention of an expired
patent.” 326 U.S. at 254. The Court concluded that “the
patent laws preclude the patentee of an expired patent and all
others including petitioner from recapturing any part of the
former patent munopoly; for those laws dedicate to all the
public the ideas and inventions embodied in an expired
patent.” /d. at 256. The Court went on: “It follows that the

12

patent laws preclude the petitioner assignee from invoking
the doctrine of estoppel, as a means of continuing as against
respondent, his assignor, the benefit of an expired monopoly,
and they preclude the assignor from estopping himself from
enjoying rights which it is the policy of the patent laws to
free from all restrictions.” Jd.

It is clear from the Court’s reasoning that it viewed the
patent laws as preventing one from validly patenting subject
matter that had been dedicated to the public in an expired
prior art patent, and that this rule trumped the assignor
estoppel! doctrine. This holding is in no way inconsistent
with the Court of Appeals decision below. The result of such
an attempt to claim prior art subject matter—under Peters,
Scott Paper or the Court of Appeals’ precedent—is that the
patent claim, if it is indeed correctly construed to encompass
prior art, is invalid. In this way, “[{t]he assignor has a
complete defense to an action for infringement where the
alleged infringing device is that of an expired patent.” Jd. at
258 (emphasis added).

Petitioners place heavy reliance on this last quotation (see
Pet. at 3, 13) and attempt to interpret the words as if the
Court had made a refinement to how a court must evaluate a
theory of infringement. This ignores the emphasized words
‘an action for infringement.” Read in context, it is clear
from this sentence that the Court was simply speaking of the
end result of the action, i.e., that the patentee cannot prevail.
Logically, of course, it is just as much a “complete defense to
an action for infringement” if the patent claims are invalid
than if the claims are not infringed. The rest of the opinion,
as explained above, makes clear that the reason the patentee
does not prevail is that his patent, if claiming prior art, is
invalid.

13

The Court of Appeals was presented with the same
argument based on Scott Paper in Tate Acces: and came to
the same conclusion. 279 F.3d at 1368-69. There, the Court
of Appeals recognized that “the Scott Paper rationale was
based on the premise that the assigned patent would be
invalid due to anticipation were it coextensive with the
expired prior art patent.” /d. at 1369. The Court of Appeals
went on to note that “(t]he statement [in Scott Paper] that, in
such circumstances, the assignor has a ‘complete defense to
an action for infringement’ must be understood in context.”
Id. (emphasis in original). It is telling that the court went on
to analyze infringement and validity the traditional way, by
construing the claims and comparing them to the accused
infringing device and the prior art. /d. at 1370-72. The
lower courts did no differently in the case at bar.

a Petitioners’ Policy Arguments Are
Also Flawed.

Petitioners’ argument ior the creation of a new patent law
“practicing the prior art” defense is thus ungrounded in
precedent. Petitioners’ policy-based arguments are equally
baseless. Petitioners urge that creating such a defense would
make it “unnecessary” for an accused infringer to prove
invalidity of the patent. According to Petitioners, this would
make for a more “balanced and fair’ process in which the
accused infringer can avoid having to carry its burden of
proof of invalidity by clear and convincing evidence, despite
the contrary requirement of the Patent Statute and precedent,
and also allow the patent owner to avoid an invalidity
challenge. (Pet. at 18-23). Petitioners’ argument suffers
from a number of flaws.’

* Petitioners even go so far as to state that “(t]he Federal Circuit
has effectively eliminated an accused infringer’s ability to prove
non-infringement of a valid patent.” (Pet. at 19). This is clearly

14

As discussed above, important policy considerations
dictate that the validity of patent rights should be adjudicated,
when called into question. See pp. 9-10, ante. Indeed, this
Court has stated that “‘of the two questions [validity and
infringement], validity has the greater public importance.’”
Cardinal Chem. Co. v. Morton Int'l, Inc., 508 U.S. 83, 100
(1993) (quoting Sinclair & Carroll Co. v. Interchemical
Corp., 325 U.S. 327, 330 (1945)) and has “emphasized the
importance to the public at large of resolving questions of
patent validity.” /d. However, in making this determination,
the Patent Statute requires that:

‘‘A patent shall be presumed valid. Each claim of a
patent ... shall be presumed valid independently of
the validity of other claims .... The burden of
establishing invalidity of a patent or any claim
thereof shall rest on the party asserting such
validity.

35 U.S.C. §282. The Court of Appeals has explained that the
presumption arises in part due to the deference owed to
patent examiners, who are employees of an administrative
agency (the U.S. Patent & Trademark Office) presumed to
have some expertise in the pertinent art and presumed to have
properly done their job in examining the patent. American
Hoist & Derrick Co. v. Sowa & Sons, 725 F.2d 1350, 1359
(Fed. Cir. 1984).

The court has further explained that the presumption
opcratcs only as a “procedural device”’ that “‘placcs on a party
asserting invalidity the initial burden of going forward to

wrong, as indicated by the plethora of Court of Appeals’ decisions
cited ante, all of which carefully evaluate validity and
infringement separately according to established norms under
which the patent claims are first cunstrued and then compared
separately to the accused and prior art devices.

15

establish a prima facie case” and “establishes that the burden
of persuasion on the issue of invalidity also rests throughout
the litigation on the party asserting invalidity.” Lear Siegler,
Inc. v. Aeroquip Corp., 733 F.2d 881, 885 (Fed. Cir. 1984).
“The presumption is one of law, not fact, and does not
constitute ‘evidence’ to be weighed against a challenger’s
evidence.” Avia Group Int'l, Inc. v. L.A. Gear Calif., Inc.,
853 F.2d 1557, 1562 (Fed. Cir. 1988). “In the end, the
question is whether a// of the evidence establishes that the
validity challenger so carried his burden as to have persuaded
the decisionmaker that the patent can no longer be accepted
as valid.” Lear Siegler, 733 F.2d at 885 (emr::csis in
original). As the Court of Appeals summarized it in
American Hoist:

To summarize on this point, §282 creates a
presumption that a patent is valid and imposes the
burden of proving invalidity on the attacker. That
burden is constant and never changes and is to
convince the court of invalidity by clear evidence.
Deference is due the Patent and Trademark Office
decision to issue the patent with respect to evidence
bearing on validity which it considered but no such
deference is due with respect to evidence it did not
consider. All evidence bearing on the validity issue,
whether considered by the PTO or not, is to be taken
into account by the tribunal in which validity is
attacked.

725 F.2d at 1360.

Petitioners offer no cogent argument for deviating from
established law and policy under which questions regarding a
patent’s validity should not be avoided, but adjudication of
validity should occur against the backdrop of the statutory
presumption of validity. Nothing is ‘unfair’ or “unbalanced”’

16

in requiring the courts and litigants to be mindful of the
procedural burdens imposed by the Patent Statute in the
course of adjudicating patent validity. But this procedural
device creates no difficulties that would justify a wholesale
abandonment of the Court of Appeals’ approach in favor of a
short-hand “practicing the prior art” defense. That approach
would, contrary to this Court’s precedent, avoid important
determinations of patent validity in cases where an accused
infringer asserts that the patentee is claiming prior art subject
matter that should be free for public use.

C. This Case Does Not Provide a Suitable Vehicle
For Decision in Any Event Because Petitioners’
Evidence Was Rejected Below.

Even if it were inclined to announce a new “practicing
the prior art” defense to infringement, the Court should not
do so in this case because a decision favorable to Petitioners
on that legal question cannot affect the outcome. The record
is devoid of any evidence, accepted by the courts below, that
would demonstrate that Petitioners actually were practicing a
process, or manufacturing a product, identical to the prior art.
It is telling that Petitioners never attempt to cite any finding
by the lower courts that would support their legal contention,
and indeed, no such finding exists.

In fact, the district court flatly rejected the Petitioners’
proffered evidence purportedly showing the physical
characteristics of its accused product and a product allegedly
made according to the prior art. Specifically, the district
court found that test samples allegedly showing Petitioners’
product had “little value” because Petitioners did not
demonstrate that the samples were representative of
Petitioners’ product. (Pet App. at 264a). The district court
also found that test samples allegedly representing the prior
art did not actually follow the teachings of the prior art. (Pet.

17

App. at 265a). The Court of Appeals did not disturb either
fact-bound determination. (Pet. App. at 32a-35a).

“The court is not empowered to decide moot questions or
abstract propositions, or to declare ... principles or rules of
law which cannot affect the result as to the thing in issue in
the case before it.” California v. San Pablo & Tulare R. Co.,
149 U.S. 308, 314 (1893). Where it is apparent from the
factual record that a decision on the question presented could
not affect concrete rights of the litigants before the Court, the
Court has routinely declined to exercise its certiorari
jurisdiction. See, e.g., Board of License Comm'rs of Town of
Tiverton v. Pastore, 469 U.S. 238, 239-40 (1985); Jones v.
Hildebrandt, 432 U.S. 183, 187 (1977); Belcher v. Stengel,
429 U.S. 118, 119-20 (1976); The Monrosa v. Carbon Black
Export, Inc., 359 U.S. 180, 183-84 (1959),

Given the state of this record, even were the Court to
grant the petition and announce a new defense to patent
infringement based on “practicing the prior art” as Petitioners
have requested, it could not possibly benefit Petitioners,
whose evidence on this point has already been found fatally
deficient. No ruling by this Court could remedy this defect.
The Court should not therefore use this case as a vehicle to
take up the moot question as to whether to create a new
defense to patent infringement.

D. The Second Question Presented in the Petition
Turns Solely on Fact-Bound Determinations
Involving No Important Legal Issue.

Petitioners’ second question—“[w]jhether an accused
infringer can be liable if the invention involves a feature
designed to prevent a naturally occurring chemical reaction
when the accused product contains that feature only as a
result of the natural chemical reaction the invention is

18

designed to prevent”—1s so highly dependent on the specific
facts of a given case as to present no important legal question
of general consequence. Resolution of the issue in a given
case would require factual findings as to the intended
purpose of the invention, the scope of the patent disclosure,
and the physical and chemical processes occurring in
connection with the accused product, among other fact-bound
questions. To those facts as found, a court would have to
apply the legal construction of the claims of the particular
patent-in-suit to determine infringement and validity. It is
not apparent how any legal rule of general application could
be fashioned that would both advance the patent system and
lead to a just result in all cases.

The legal application of construed patent claims to facts
involving the patented invention and accused product by the
lower courts in the case sub judice is in no way inconsistent
with the holding of O'Reilly v. Morse, 56 U.S. 62 (1853), the
authority on which Petitioners rely. In O'Reilly, the Court
rejected as invalid the attempt to claim “the use of the motive
power of the electric or galvanic current, which | call electro-
magnetism, however developed, for making or printing
intelligible characters, letters, or signs, at any distances”
because to sustain such a claim would foreclose al! possible
improvements in telecommunications technology and thus
the claim was deemed “too broad, and not warranted by law.”
Id. at 113. However, the Court allowed the patentee to
validly claim his invention tn more concrete terms in seven
other claims. /d. at 85-86, 112. As is readily apparent in this
case, Respondent’s claims are to a concrete and specific
pharmaceutical product having certain coating layers and
specific ingredients. These claims are not so broadly drawn
that it can plausibly be argued that they encompass a law of
nature or natural phenomenon. (See -Pet. App. at 4a-Sa
(quoting claims of '505 and '230 patents)). No inconsistency

19

therefore exists between this case and the precedent on which
Petitioners rely.

Petitioners’ real quarrel is with the district court’s
construction of the specific claim element “inert subcoating
... disposed on said core region” which the district court
identified as the issue on which Petitioners’ infringement
depended. (Pet. App. at 250a). In making this
determination, the district court adopted its previous
construction of this claim element (which appears in both the
'505 and '230 patents) that did not require that the inert
subcoating be formed in any particular manner. (Pet. App.
at 25la). The district court had first made this claim
construction during litigation involving the First Wave
defendants. Astra Aktiebolag v. Andrx Pharm., Inc., 222
F.Supp.2d 423, 464, 468-75 (S.D.N.Y. 2002). The Court of
Appeals had affirmed. /mn re Omeprazole Patent Litig., 84
Fed.Appx. 76 (Fed. Cir. 2003). After construing this claim
element, the district court conducted a detailed review of the
scientific evidence to determine whether Petitioners’ accused
product contained an inert subcoating and whether such a
coating met the claim element. (Pet. App. at 251a-275a).

Whether or not a discrepancy exists between what
Petitioners allege was the “purpose” of the invention as
stated in the written description of the patents-in-suit and the
district court’s construction of the “inert subcoating” claim
element was fully explored at the Court of Appeals. That
court explained:

We rejected that argument in the appeal from the
district court’s first wave trial based on our
conclusion that the phrase ‘“‘|djisposed on’ does not
specify any method or structure involved in
application of the subcoating.”” 84 Fed. Appx. 76,

20

80 (Fed. Cir. 2003). We reject that argument in this
appeal for the same reason.

(Pet App. at 31a).

Put simply, both the district court and the Court of
Appeals have construed the specific patent claims at issue in
this case in light of all the relevant evidence and concluded
that the factual question as to how the subcoating is formed ts
legally irrelevant to the question of whether the claim
element is met for purposes of infringement. Whether or not
the accused product contains a naturally occurring
subcoating, as urged by Petitioners, is not germane to the
infringement of these two particular patents.

The issue raised in the second question is thus
inextricably intertwined with the particular claim language
and disclosure of the '505 and '230 patents-in-suit in this
case. The Court of Appeals’ decision establishes no general
rule of law that would govern the interpretation or
application of patent claims in any other case not involving
these patents. The court’s decision in no way establishes any
rule of law that allows patenting of “a law of nature or a
natural phenomenon” as alleged in the petition. (Pet. at 11).
The Court of Appeals, like the district court, did nothing
more than analyze the written description and claim language
of these two patents and reached the conclusion that the
claim language does not limit the invention to the method by
which the subcoating is formed.

Rule 10 states: “A petition for a writ of certiorari is
rarcly granted when the asserted error consists of erroneous
factual findings or the misapplication of a properly stated
rule of law.” Sup. Ct. R. 10. Petitioners’ second question
presents nothing more than an assertion that the claim
construction reached by the district court and the Court of

21

Appeals was wrong, as was the application of that claim
construction to the particular products in issue in this case.
This is not the type of question that the rules contemplate as
suitable for review on certiorari.

CONCLUSION
For the foregoing reasons, the petition should be denied.
Respectfully submitted,

ERROL B. TAYLOR
Counsel of Record
FREDRICK M. ZULLOW
JOHN M. GRIEM, JR.
MILBANK, TWEED,

HADLEY & MCCLoy LLP
One Chase Manhattan Plaza
New York, NY 10005
(212) 530-5000

JAY I. ALEXANDER
MILBANK, TWEED,

HADLEY & McCCLoy LLP
1850 K Street, N.W.
Washington, D.C. 20006
(202) 835-7500

Counsel for Respondents

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386017_0024%3A2. Public record. Not legal advice.