Opposition Brief — Nucleononics, Inc. v. Benitec Australia, Ltd. (No. 07-1068)

FILED

MAR 2.0 2008

[REDACTED] |_SUPREME COURT OS

No. 07-1068

IN THE

Supreme Court of the Anited States

NUCLEONICS, INC.,

Petitioner,

Vv.

BENITEC AUSTRALIA, LTD.,

Respondent.

On Petition For A Writ Of Certiorari

To The United States Court of Appeals

For The Federal Circuit

BRIEF IN OPPOSITION

KEVIN M. BELL RICHARD J. OPARIL

Scott A.M. CHAMBERS, PH.D.* PATTON BoGccs LLP

PATTON BoGcs LLP 2550 M Street, NW

8484 Westpark Drive Washington, DC 20037

McLean, VA 22102 (202) 457-6000

(703) 744-8000 (202) 457-6315 (fax)

(703) 744-8001 (fax)

*Counsel of Record

Attorneys for Respondent

i

QUESTIONS PRESENTED

1. Whether the Federal Circuit correctly found,

based on the particular facts of this case, that

speculative future infringement that may never

materialize does not support declaratory judgment

jurisdiction?

2. Whether the Federal Circuit correctly found,

based on the particular facts of this case, that

jurisdiction over declaratory judgment claims ended

with patentee's covenant not to sue for infringement,

when the covenant was made before the District

Court had tried the case or issued any decision on

the merits?

ll

RULE 29.6 STATEMENT

Benitec Australia, Ltd. is 100% owned by Benitec

UK, Ltd., which is 100% owned by Benitec Limited,

a public company listed on the Australian Securities

Exchange.

iil

TABLE OF CONTENTS

QUESTIONS PRESENTED ......000.0...eeeeeeeeeeeeeeeeeeee i

BRULEE, 29.6 STATEMENT .........ccccccssccssssseccsesesnenses li

ARE TEE SRE EE tics reicwnscacsenvesnasiereinenccenninen iil

TE ST, SAAR REID deiitneeinciesesacisdncsnesdasancsonie v

CONSTITUTIONAL AND STATUTORY

RV Bee LON GY BD onncccccncnsssssssnsosecsasesenceseses 1

STATEMENT OF THE CASE .................cccccceeeeeeees 1

a, Bieta cdetictichatasiinnstaiihatinsicncndicenntes 1

B. The Parties, Patent, and Technology............ 2

Co... FI BIO eiithsesncieicsecentienciscsiexsnsdsnsncce 4

1. District Court Proceedings ...................... 4

2. Federal Circuit Affirmance.................... 13

3. USPTO Reexamination....................::006 14

REASONS FOR DENYING THE PETITION....... 15

A. The Decision Is Intricately Bound To

An Unusual, Complicated, And

Disputed Set Of Facts And Lacks Broad

PN iis Wibiiscoctsnnisincnicyictedaniatiches citi 15

B. Nucleonics' Petition Seeks To Broaden

Declaratory Judgment Jurisdiction To

iV

Obtain An Unconstitutional Advisory

C. The Federal Circuit's Decision Does Not

Conflict With Cardinal or Altvater. ............ 22

D. The Federal Circuit's Decision Does Not

Conflict With MedImmune..............c..ccc00000 27

1. Nucleonics' Activities Related To

Human Use Do Not Support

BN SES REE SN Opa MTC ee ORO 29

2. Nucleonics' Purported Wish To

Expand Its Efforts Does Not Support

REP SENS RY ra an a PO 30

3. Nucleonics' Alleged Agreement With

A "Pharmaceutical" Company Does

Not Support Jurisdiction. ..................06 35

SE A NINNIWOR sisetccictinanniccnaiucdipbionduandkastcssnnnannpieisnnsiieds 36

Vv

TABLE OF AUTHORITIES

CASES ,

Abbott Labs. v. Baxter Healthcare Corp.,

2007 U.S. Dist. Lexis 76449

CPG TD; TEL, TOU TFs css scsi cccscscciccscosasene 18

Adenta GmbH v. OrthoArm, Inc.,

501 F.3d 1364 (Fed. Cir. 2007)..................006. 19

Aetna Life Ins. Co. v. Haworth,

SE Es EE GED oi vndisdcsttndansoseianecensconenncina 21

Altvater v. Freeman,

ee is SI ROD es dccinncidnsnsnsconsecarassescencen 26

Arrowhead Indus. Water v. Ecolochem,

846 F.2d 731 (Fed. Cir. 1988), overruled

in part, 127 S. Ct. 764 (2007).............00008 21, 27

Baker Hughes Oilfield Operations, Inc. v.

Reedhycalog UK, Litd.,

228 Fed. Appx. 988 (Fed. Cir. 2007) ............. 19

Benitec Austl. Ltd. v. Nucleonics, Inc.,

495 F.3d 1340 (Fed. Cir. 2007)............... passim

Benitec Ausil. Ltd. v. Nucleonics, Inc.,

2005 U.S. Dist. Lexis 22008

CO Poss hechnnhans ciicchacscinwsinac 11

Boston Sct. Corp. v. Johnson & Johnson Inc.,

2008 U.S. Dist. Lexis 5510

Er: Re I ic NIUE sb chins danccansieisbcessndndwad 18

vi

Calderon v. Ashmus,

ee ec IID eibniccdcstunrsvsccsastdecccsceccienesne 21

Cardinal Chem. Co. v. Morton Int'l,

a A is esa scctncocssonenscncencnces passim

Cellco P'ship v. Broadcom Corp.,

227 Fed. Appx. 889 (Fed. Cir. 2007) ............. 19

Cordance Corp. v. Amazon.com, Inc.,

521 F. Supp. 2d 340 (D. Del. 2007)............... 18

Crossbow Tech., Inc. v. YH Tech.,

2007 U.S. Dist. Lexis 65646

Gre SA ER Dig MIUNED wicctcccrerscccecscvescorceses 18

FieldTurf USA, Inc.

v. Sports Constr. Group, LLC,

507 F. Supp. 2d 801 (N.D. Ohio 2007).......... 18

Furminator, Inc. v. Kim Laube & Co.,

2008 U.S. Dist. Lexis 1105

rs SING i SII cccecscondascéncssseccncccssonseas 17

Furminator, Inc. v. Ontel Prods. Corp.,

246 F.R.D. 579 (E.D. Mo. 2007) .................... 18

Honeywell Int'l Inc.

v. Universal Avionics Sys. Corp.,

488 F.3d 982 (Fed. Cir. 2007)..................0000.. 19

Independent Wireless Tel. Co.

v. Radio Corp. of Am.,

te SE UIE wecttisvsoubinrccnntcensssasuccdosantinns 32

Vii

Integra Lifesciences I, Ltd. v. Merck KGaA,

331 F.3d 860 (Fed. Cir. 2003),

vacated, 545 U.S. 193 (20085)................. 8, 9, 10

Israel Bio-Engineering Project v. Amgen Inc.,

401 F.3d 1299 (Fed. Cir. 2005)...................... 34

Israel Bio-Engineering Project v. Amgen Inc.,

475 F.3d 1256 (Fed. Cir.),

cert. denied, 168 L. Ed. 2d 720 (2007)........... 34

Maryland Cas. Co. v. Pacific Coal & Oil Co.,

iiss sacestnsbinadeccscnateaton 21

Maxwell v. Stanley Works, Inc.,

2008 U.S. App. Lexis 323

I Sr, I ac sscecccnsesceesccecnssions 19

MedImmune, Inc. v. Genentech, Inc.,

BP Ps Ne IED eicthcspecinncncennsecccaccssce passim

MedImmune, Inc. v. Genentech, Inc.,

2008 U.S. Dist. Lexis 12198

ek ER ne 18

Merck & Co. v. Apotex, Inc.,

2007 U.S. Dist. Lexis 84426

RRA Is ie IED gicitnacstsennccaccieccscanecsannsns 17

Merck KGaA v. Integra Lifesciences I, Ltd.,

545 U.S. 193 (2005) .............cceceeee 10, 23, 29, 31

Micron Tech., Inc. v. Mosaid Techs., Inc.,

2008 U.S. App. Lexis 4387

Cc en, SN TIE I ccciebicentecstsccancntsnasssncsnn 19

Vili

MMUK, Inc. v. Ultimate Blackjack Tour LLC,

2007 U.S. Dist. Lexis 85502

COE TDs CARR: DO: Fy CIEE D wesnsisaiiccscescscsscosencenes 18

Monsanto Co. v. Syngenta Crop Prot., Inc.,

2008 U.S. Dist. Lexis 7236

CHE EE, BI RMS By Te ni ccs cccnscssccsccscnesesasces 17

Morton Int'l v. Cardinal Chem..,

967 F.2d 1571 (Fed. Cir. 1992)...............ccce00. 25

Pfizer Inc. v. Ranbaxy Labs.,

525 F. Supp. 2d 680 (D. Del. 2007)............... 17

Prima Tek II, L.L.C. v. A-Roo Co.,

222 F.3d 1372 (Fed. Cir. 2000).............cccccsees 32

Propat Int'l Corp. v. RPost, Inc.,

473 F.3d 1187 (Fed. Cir. 2007)...................00. 34

Rotec v. Mitsubishi,

215 F.3d 1246 (Fed. Cir. 2000)...................... 31

Sabert Corp. v. Waddington N. Am., Inc.,

2007 U.S. Dist. Lexis 68092

CED DE MR Wi PIED dithicbictcintcctscanexsstexasenecs 18

SanDisk Corp. v. STMicroelectronics, Inc.,

480 F.3d 1372 (Fed. Cir. 2007)........00..0...00... 19

Sierra Applied Sciences, Inc.

v. Advanced Energy Indus., Inc.,

363 F.3d 1361 (Fed. Cir. 2004)............... 12, 20

ix

Sony Elecs., Inc. v.

Guardian Media Techs., Ltd.,

497 F.3d 1271 (Fed. Cir. 2007)...................... 19

Steffel v. Thompson,

Re RE CRIP ESD cccccccccccccoccocccccscsosccccooecoses 23

Super Sack Mfg. Corp.

v. Chase Packaging Corp.,

57 F.3d 1054 (Fed. Cir. 1995), overruled

in part, 127 S. Ct. 764 (2007). ................. 25, 26

Teva Pharm. Indus. v. Reddy's Labs.,

2008 U.S. Dist. Lexis 16958

I I Mh III oc ccacccccccscecscccccccsccosscoses 18

Teva Pharm. USA, Inc. v.

Novartis Pharm. Corp.,

482 F.3d 1330 (Fed. Cir. 2007)...................... 19

Travelers Ins. Co. v. Obusek,

72 F.3d 1148 (3d Cir. 1995)............00000.... 20, 21

United States v. Munsingwear,

tL), 23

Valley Forge Christian College

v. Americans United for Separation

of Church and State, Inc.,

ET 20

Vantage Trailers, Inc. v. Beall Corp.,

2008 U.S. Dist. Lexis 7133

Ses Bit, EER. lhe SID ccccccccccccccocccccccccccceccs 17

Waterman v. Mackenzie,

Ey TED snktccnaisessscnnincsctanstoiséiniateél 33

STATUTES

ee Os BI, ainnnciecssccincenievesassiessandummiaaiial 21

EE Tt TID ai ncaa tinniicicnenintinenantininanealenniiniiial passim

RULES

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seaciniciindcecsansiaieibiapieiinnaasiitiapapaiiaiditialti 5,7

PR, Sip CG. Fo GD scttennccocsinntincntnnticasanciannintiobnshetn 10

T RY

PROVISIONS INVOLVED

It shall not be an act of infringement to

make, use, offer to sell, or sell within the

United States or import into the United

States a patented invention (other than a

new animal drug or veterinary biological

product (as those terms are used in the

Federal Food, Drug, and Cosmetic Act and

the Act of March 4, 1913) which is

primarily manufactured using

recombinant DNA, recombinant RNA,

hybridoma technology, or other processes

involving site specific genetic manipulation

techniques) solely for uses reasonably

related to the development and submission

of information under a Federal law which

regulates the manufacture, use, or sale of

drugs or veterinary biological products.

35 U.S.C. § 271(e)(1).

STATEMENT OF THE CASE

A. Introduction

This case presents a unique procedural and

factual posture that does not warrant granting

certiorari. The Federal Circuit has correctly applied

the precedents of this Court relating to declaratory

judgment jurisdiction to the facts of this case.

Simply put, there is no case or controversy currently

existing between the parties.

While the petition suggests that Benitec

Australia, Ltd. ("Benitec") brought suit for testing in

mice and rabbits (Pet. 5-6), it fails to admit that

2

these activities were asserted by Nucleonics, Inc.

("Nucleonics") to be animal testing for human

therapeutic use, as opposed to animal therapeutic

use or testing for animal therapeutic use. As

explained below, Benitec owns the rights to animal

testing for human use but a non-party to this lawsuit

owns the rights to animal testing for animal use.

B. The Parties, Patent, and Technology

The petition incorrectly characterizes the

respondent as a patent "troll." Pet. 8. In fact,

Benitec is a biotechnology company engaged in

developing technologies to treat serious diseases and

advancing medical research using gene silencing

technologies. Benitec Austl. Ltd. v. Nucleonics, Inc.,

495 F.3d 1340, 1342 (Fed. Cir. 2007) ("Benitec"), Pet.

App. 2a. See also J.A. 70-71 Jf 2, 9.' Benitec's work

involves human therapeutic use of double-stranded

RNA ("dsRNA" or "ddRNA"), often referred to as

interference RNA ("iRNA"). Human therapeutic use

of iRNA is covered by the claims of the patent-in-

suit, U.S. Patent No. 6,573,099 ("the '099 Patent").

The ‘099 Patent also covers use of iRNA in animals

other than humans. J.A. 68-69.

The ownership as well as the rights to practice

the ‘099 Patent are currently divided between

Benitec and Australian non-party Commonwealth

Scientific and Industrial Research Organization

("CSIRO"), with each holding a discrete bundle of

rights. J.A. 1528-52.

1 References to "J.A." are to the Confidential Joint

Appendix submitted to the Federal Circuit on June 13, 2006.

3

Specifically, Benitec has the exclusive right to

commercialize the '099 Patent in the "Human Field,"

which includes the use of the technology in humans

and any use of the technology in animal research for

testing the technology for human use. J.A. 1530 at

(B)(a); J.A. 1536 J 2.2; J.A. 1532(a-c). In contrast,

CSIRO has the exclusive right to commercialize the

‘099 Patent in non-human fields, including the

"Animal Field," which includes use of the technology

in animals and testing in animals for animal use.

J.A. 1530 at (B)(b); J.A. 1536 9 3; J.A. 1530-31(a-h).

Benitec also has the right to sublicense its human

therapeutic use and animal testing for human use,

but the right to sublicense the use of the technology

in the Animal Field belongs exclusively to CSIRO.

J.A. 1536437 9 4.3. Thus, Benitec has exclusive

patent rights relating to humans, while CSIRO has

exclusive rights in the animal field.

Nucleonics, Inc. ("Nucleonics")

REDACTED

a

REDACTED

On

April 1, 2004, long after the issuance of the '099

Patent, Nucleonics announced that it had raised

$49.2 million in venture capital financing to pursue

therapeutic use of iRNA. J.A. 2748-49. See also J.A.

1410 § 11.

C. Proceedings Below

1. District Court Proceedings

On March 22, 2004, Benitec sued Nucleonics for

infringement of the '099 Patent. Benitec had filed

suit against Nucleonics as its competitor for human

therapeutic use of iRNA and had argued that animal

testing for human use was infringing activity.

5

Nucleonics' April 30, 2004 answer to the complaint

did not include any counterclaims. J.A. 75-78.

On July 13, 2004, Nucleonics moved to dismiss

the action for lack of jurisdiction based on 35 U.S.C.

§ 271(e)(1), asserting that all of its activities,

including animal-related activities, would fall within

the safe harbor. Benitec, 495 F.3d at 1342, Pet. App.

2a-3a. Nucleonics unambiguously represented to the

District Court and Benitec that "Benitec has shot

before there is even a target" because "Nucleonics'

accused activities are directed to developing and

submitting information to the [FDA] and are

therefore exempt from infringement under [§

271(e)(1)]." Id. at 1842, Pet App. 2a-3a. See also

J.A. 2656. Nucleonics further asserted that "Benitec

lacks a statutory basis to sue for infringement at this

time, and it is premature for this Court even to

entertain such a claim.

REDACTED

* The FDA must approve an IND before clinical trials (i.e.,

human testing) can be conducted.

REDACTED

ie

REDACTED

In support of its motion, Nucleonics submitted

declarations by Dr. Satishchandran, Nucleonics' co-

founder and Vice President for Research and

Development. J.A. 2666-76, J.A. 2798-801. Dr.

Satishchandran averred that:

(@)

REDACTED

eve

ie

: ae

é

REDACTED

Thus, Nucleonics repeatedly represented to the

District Court and Benitec that all of its work fell

within the scope of the §271(e) safe harbor.

Throughout discovery, Nucleonics maintained this

position and never sought to supplement its

discovery responses with the position it now

embraces in an attempt to defeat dismissal in the

District Court. Neither the Federal Circuit dissent

nor Nucleonics' petition to this Court mention

Nucleonics' motion or declaration.

Benitec's opposition to Nucleonics' motion to

dismiss relied primarily upon the Federal Circuit's

decision in Integra Lifesciences I, Ltd. v. Merck

KGaA, 331 F.3d 860 (Fed. Cir. 2003) ("Integra"),

vacated, 545 U.S. 193 (2005). J.A. 2696-702. The

Federal Circuit had held that pre-clinical

9

experiments to screen and identify potential new

drug candidates did not qualify for safe harbor

protection under § 271(e)({1). In deciding that pre-

clinical research is not exempt from infringement,

the Federal Circuit held that "[t]he safe harbor does

not reach any exploratory research that may

rationally form a predicate for future FDA clinical

tests." Integra, 331 F.3d at 867. Thus, the Federal

Circuit held that the safe harbor exemption did not

reach back down the research chain to protect the

earliest stages of screening and research for

potential drug candidates. Id. at 867.

Based on the Federal Circuit's subsequently-

overruled Integra decision, Benitec had argued that

Nucleonics' research activities extended beyond the

scope of the § 271(e)(1), and thus were not protected

by the safe harbor exemption. The District Court

agreed and denied Nucleonics' motion to dismiss on

February 7, 2005. J.A. 2850. The District Court

noted, however, that "the Supreme Court may

possibly reverse the Federal Circuit's holding in

Integra". Id. Accordingly, the court denied

Nucleonics' motion "with leave to renew in the event

the Integra case is reversed." Id. See also Benitec,

495 F.3d at 1342, Pet. App. 3a.

On February 16, 2005, Nucleonics sought leave to

file an amended answer, which for the first time

included a_ counterclaim seeking declaratory

judgment that the '099 Patent was invalid and

unenforceable. J.A. 252-65. The District Court

granted Nucleonics leave on September 14, 2005.

J.A. 23.

On June 13, 2005, this Court decided Merck

KGaA v. Integra Lifesciences I, Litd., which vacated

10

the Federal Circuit's Integra ruling and clarified the

broad range of activities that § 271(e)(1) exempts

from infringement. 545 U.S. 193, 207 (2005)

("Merck"). In view of Merck and the District Court's

prior ruling, on August 1, 2005, Benitec moved to

dismiss the case without prejudice pursuant to Fed.

R. Civ. P. 41(a)(2). J.A. 1373-74. Benitec explained

that, in light of this Court's decision and Nucleonics'

previous representations to the District Court,

Benitec could only bring new claims if

Nucleonics is ultimately successful in

obtaining FDA approval for its infringing

products or otherwise engages in

infringing activities not otherwise

permitted under the § 271(e) exemption.

Nucleonics' original motion, which the

[District] Court indicated it would

reconsider if the law were changed by [this

Court's decision in the] Integra case, is

essentially a motion for dismissal for lack

of jurisdiction because there can be no case

or controversy if the § 271(e)({1) exemption

applies. There is no basis for this Court to

dismiss with prejudice infringement claims

that do not yet exist. Accordingly, Benitec

respectfully requests that the Court

dismiss this case without prejudice.

J.A. 1379. Benitec's reply reiterated that it "has no

basis to continue to assert its claims." J.A. 1508

(emphasis added).

Despite the unambiguous nature of _ the

statements Nucleonics made to the District Court in

its own motion to dismiss on the same § 271(e)(1)

grounds, Nucleonics opposed Benitec's motion for

11

dismissal and made self-contradictory statements.

In support of its opposition, Nucleonics filed a

declaration of its President and CEO, Robert

Towarnicki ("“Towarnicki"). J.A.1408-13. Towarnicki

asserted that Nucleonics "wishes" to expand its

business to include animal husbandry and

veterinary products, and that Nucleonics has had

"discussions" with an unknown breeding stock

supplier. Benitec, 495 F.3d at 1348, Pet. App. 18a.

See also J.A. 1412 § 20. There is, however, no other

evidence in the record regarding Nucleonics'

"wishes" or the nature and scope of any such

discussions.

Towarnicki also asserted that Nucleonics had

"signed an agreement" with a "pharmaceutical"

company to work on an “exploratory collaboration".

Nucleonics' "Petition For Rehearing And Rehearing

En Banc", filed August 3, 2007, available at 2007 WL

2434249, ("Pet. for Reh'g") at 4. See also J.A. 1410-

11. As with Nucleonics' vague "discussions", there is

no other evidence in the record regarding the nature,

scope, or progress of any such "exploratory

collaboration", nor is there any explanation of how

such work with a "pharmaceutical" company could

possibly fall outside of the protection of the 35 U.S.C.

§ 271(e)(1) safe harbor.

The District Court granted Benitec's motion on

September 29, 2005. Benitec Austl. Ltd. v.

Nucleonics, Inc., 2005 U.S. Dist. Lexis 22008 (D. Del.

Sept. 29, 2005), Pet. App. 36a-45a. Nucleonics

appealed.

Benitec represented to the Federal Circuit that

"[tlo the extent that there is any ambiguity in the

record, Benitec's motion [to dismiss] included — and

12

was intended to include — a promise not to sue

Nucleonics for patent infringement arising from

activities and/or products occurring on or before the

District Court's September 29, 2005 dismissal

order...." Non-Confidential Brief Of Plaintiff-

Appellee Benitec Australia, Ltd., filed April 27, 2006,

available at 2006 WL 1433923, at 12 (citation

omitted). See also Benitec, 495 F.3d at 1343, Pet.

App. 5a. Thus, Benitec has unconditionally —

covenanted not to sue Nucleonics for patent

infringement arising from activities and/or products

occurring on or before the date dismissal was

entered in this action — September 29, 2005.’ See

Sierra Applied Sciences, Inc. v. Advanced Energy

Indus., Inc., 363 F.3d 1361, 1375-76 (Fed. Cir. 2004)

(statements by attorney in colloquy with the District

Court, in Federal Circuit brief, and at oral argument

constituted a promise to forebear from suing).

After this Court issued MedImmune, Inc. uv.

Genentech, Inc., 127 S.Ct. 764 (2007), both parties

To the extent that Nucleonics complains that Benitec's

covenant does not include a covenant not to sue for the

REDACTED

Nucleonics has

never withdrawn these sworn declarations and it is most

reasonable to presume they are still correct. Moreover, Benitec

could not include the rights for animal use in animal

therapeutics in its covenant not to sue because it neither owns

nor controls these rights, which are owned by CSIRO. J.A.

1528-52; A1530 at (B)(b); J.A. 1530-31(a-h); J.A. 1536-37 4 4.3.

See, e.g., Pope Mfg. Co. v. Gormully & Jeffery Mfg. Co., 144 US.

248, 250 (1892).

13

filed supplemental briefs on that decision with the

Federal Circuit.

2. Federal Circuit Affirmance

The Federal Circuit affirmed the District Court's

dismissal in an opinion that followed this Court's

precedent, despite Nucleonics' attempts to

mischaracterize it.

The Federal Circuit recognized that if "a party

has actually been charged with infringement of the

patent, there is, necessarily, a case or controversy

adequate to support jurisdiction’ at that time."

Benitec, 495 F.3d at 1344; Pet. App. 9a, (quoting

Cardinal Chem. Co. v. Morton Int'l, 508 U.S. 83, 96

(1993)). Nucleonics' assertion that "the majority

gave no further credence to Cardinal Chemical"

regarding jurisdiction (Pet. 13) is incorrect. The

Federal Circuit recognized that "once that burden [of

establishing jurisdiction] has been met, absent

further information, that jurisdiction continues."

Benitec, 495 F.3d at 1344-45; Pet. App. 9a-10a (citing

Cardinal, 508 U.S. at 98).

The Federal Circuit further noted that “fi]f a

party to an appeal suggests that the controversy has,

since the rendering of the judgment below, become

moot, that party bears the burden of coming forward

with subsequent events that have produced that

alleged result." Benitec, 495 F.3d at 1345, Pet. App.

10a (quoting Cardinal, 508 U.S. at 98; emphasis

added by Federal Circuit). The Federal Circuit then

addressed the fact-intensive events subsequent to

the filing of this litigation that have divested

jurisdiction. Benitec, 495 F.3d at 1345-49, Pet. App.

lla-22a.

14

Nucleonics also incorrectly alleges that the

Federal Circuit's analysis of whether any of

Nucleonics' asserted activities supported jurisdiction

was “except in name, a clear return to the

disapproved ‘reasonable apprehension of imminent

lawsuit’ test.” Pet. 28. Nucleonics ignores the fact

that in MedImmune, this Court held that for

declaratory judgment jurisdiction to exist, the

dispute must be “definite and concrete"; "real and

substantial"; and of "sufficient immediacy and reality

to warrant the issuance of a declaratory judgment."

MedImmune, 127 S. Ct. at 771 (emphasis added). In

accordance with MedImmune, the Federal Circuit

assessed whether Nucleonics’ asserted activities had

"sufficient immediacy and reality" to present a case

or controversy. See, e.g., Benitec, 495 F.3d at 1346,

1348-49, Pet. App. 14a, 19a-20a, 22a-23a.

Nucleonics' petition for rehearing and petition for

rehearing en banc was denied.

8. USPTO Reexamination

On October 4, 2004, Nucleonics initiated a third

party reexamination of the ‘099 Patent at the U.S.

Patent and Trademark Office ("USPTO"). Benitec,

495 F.3d at 1342, n.1, Pet. App. 3a-4a, n.1. On May

18, 2006, Nucleonics requested a second

reexamination of the ‘099 Patent. Id. On October

26, 2006, the USPTO merged these’ two

reexaminations, and they are still pending. Jd.; U.S.

Reexamination Nos. 90/007,247 and 90/008,096 (see

http: / /portal.uspto.gou/external/portal/pair).

In its first reexamination request, Nucleonics

claimed that the ‘099 Patent was invalid for alleged

indefiniteness and lack of written description and

15

provided the USPTO with art that Nucleonics

asserted invalidated the '099 Patent. J.A. 1616-17.

Nucleonics' second request added more art that it

asserted invalidated the patent. U.S. Reexamination

No. 90/008,096.

Although the USPTO issued rejections of the

claims over art provided by Nucleonics, the USPTO

did not base any rejections on Nucleonics' claims of

indefiniteness or lack of written description. U.S.

Reexamination Nos. 90/007,247 and 90/008,096.

Benitec has responded to all rejections and has

cancelled claims. Jd. The merged reexamination

proceeding is still pending. Id.

REASONS FOR DENYING THE PETITION

This case presents no issue meriting the Court's

attention. First, the Federal Circuit's decision in

this case is intricately bound to an unusual,

complicated, and disputed set of facts. Thus, the

decision lacks the broad import attributed to it by

Nucleonics. Second, the decision does not conflict

with any decisions of this Court. Third, the Federal

Circuit's decision correctly applied the law to the

unusual posture of this case.

A. The Decision Is Intricately Bound To An

Unusual, Complicated, And Disputed Set

Of Facts And Lacks Broad Applicability.

Nucleonics' assertions of the importance of the

opinion in this case "to defendants in every patent

infringement suit" is absurd in view of the fact-

dependant nature of the opinion. The Federal

Circuit's opinion did not set forth any broad or

original pronouncements of law, even in dicta.

16

Rather, the opinion consists of (a) a detailed

exploration of the facts, including the existence of

relevant factual issues that are not resolved because

the facts were not provided to the District Court or

are not yet in existence and (b) application of

existing law of this Court and the Federal Circuit to

the specific facts. The Federal Circuit based its

jurisdictional decision on the following specific

factors:

e Benitec moved to dismiss its claims before

any trial or decision on iniringement

(Benitec, 495 F.3d at 1343, 1347-48, Pet.

App. 4a-5a, 16a-17a);

e Benitec covenanted not to sue Nucleonics

based on activities that had already occurred

(Benitec, 495 F.3d at 1343, 1347-48, Pet.

App. 5a, 17a);

e Nucleonics was not presently engaging in

any potentially infringing activity, and its

plans for future potentially infringing

activity were not definite or concrete

(Benitec, 495 F.3d at 1346-47, 1348-50, Pet.

App. 13a-15a, 17a-21a);

e after Benitec filed suit, this Court clarified

the § 271(e)(1) safe harbor such that it

became evident that Nucleonics' only

current or imminent activities of any

commercial interest to Benitec are shielded

from claims of infringement (Benitec, 495

F.3d at 1342, 1349, Pet. App. 4a, 20a-22a);

e before Benitec moved to dismiss the case for

lack of jurisdiction, Nucleonics had moved to

dismiss on the same grounds (Benitec, 495

F.3d at 1342, Pet. App. 2a-3a); and

17

e the patent-at-issue is currently being

reexamined (see, e.g., Benitec, 495 F.3d at

1342, n.1, Pet. App. 3a-4a, n.1) and may

emerge with different claims.

The impact of the Federal Circuit opinion has

likewise been limited. In cases citing Benitec in

which the intellectual property owner sued for

infringement or could otherwise have been

characterized as asserting its intellectual property at

the time of filing of the suit in question, then

successfully sought to have counterclaims

challenging its intellectual property dismissed for

lack of jurisdiction, either the intellectual property

owner provided a covenant not to sue that satisfied

the court that there was no longer any case or

controversy, the intellectual property owner had

filed a formal statutory disclaimer with the USPTO

(thereby, prohibiting any suit for infringement of the

disclaimed patent), or the court found that the party

seeking a declaratory judgment had not shown

current, or concretely-planned future, possibly

infringing activity. See Monsanto Co. v. Syngenta

Crop Prot., Inc., 2008 U.S. Dist. Lexis 7236 (E.D. Mo.

Jan. 31, 2008) (finding both that patent owner's

conduct did not show willingness and preparedness

to enforce its patent and that declaratory plaintiff

did not show current or planned infringing activity);

Vantage Trailers, Inc. v. Beall Corp., 2008 U.S. Dist.

Lexis 7133 (S.D. Tex. Jan. 31, 2008); Furminator,

Inc. v. Kim Laube & Co., 2008 U.S. Dist. Lexis 1105

(E.D. Mo. Jan. 7, 2008); Pfizer Inc. v. Ranbaxy Labs.,

525 F. Supp. 2d 680 (D. Del. 2007); Merck & Co. v.

Apotex, Inc., 2007 U.S. Dist. Lexis 84426 (D.NWJ.

Nov. 15, 2007); MMUJK, Inc. v. Ultimate Blackjack

18

Tour LLC, 2007 U.S. Dist. Lexis 85502 (N.D. Cal.

Nov. 7, 2007); Furminator, Inc. v. Ontel Prods. Corp.,

246 F.R.D. 579 (E.D. Mo. 2007); Abbott Labs. v.

Baxter Healthcare Corp., 2007 U.S. Dist. Lexis 76449

(N.D. Ill. Sept. 28, 2007); Crossbow Tech., Inc. v. YH

Tech., 2007 U.S. Dist. Lexis 65646 (N.D. Cal. Aug.

21, 2007).

In cases citing Benitec in which the intellectual

property owner sued for infringement or could

otherwise have been characterized as asserting its

intellectual property at the time of filing of the suit

in question, and did not provide a satisfactory

covenant or disclaimer, the District Courts retained

jurisdiction. Boston Sci. Corp. v. Johnson & Johnson

Inc., 2008 U.S. Dist. Lexis 5510 (D. Del. Jan. 24,

2008); Cordance Corp. v. Amazon.com, Inc., 521 F.

Supp. 2d 340 (D. Del. 2007); Sabert Corp. v.

Waddington N. Am., Inc., 2007 U.S. Dist. Lexis

68092 (D.N.J. Sept. 14, 2007); FieldTurf USA, Inc. v.

Sports Constr. Group, LLC, 507 F. Supp. 2d 801

(N.D. Ohio 2007). See also Teva Pharm. Indus. v.

Reddy's Labs., 2008 U.S. Dist. Lexis 16958 (D.N.J.

Mar. 4, 2008) (denying summary judgment motion

for lack of case or controversy as to claim for which

patentee provided covenant not to sue, but denying

summary judgment motion on the merits without

prejudice to refile as to claim for which no covenant

was provided); MedImmune, Inc. v. Genentech, Inc.,

2008 U.S. Dist. Lexis 12198 (C.D. Cal. Feb. 7, 2008)

(granting motion to dismiss claims for declaratory

judgment of invalidity and unenforceability of patent

claims as to which patentee provided covenant not to

sue, but retaining jurisdiction over claims for

19

declaratory judgment on patent claim as to which no

covenant was provided).

The Federal Circuit's other decisions applying

MedImmune illustrate that it is correctly applying

this Court's precedent and also that jurisdiction is

found to exist in the majority of cases. In the nine

cases other than Benitec in which the Federal Circuit

applied MedImmune to determine whether

jurisdiction existed, it found that jurisdiction was

lacking in only one. Maxwell v. Stanley Works, Inc.,

2008 U.S. App. Lexis 323 (Fed. Cir. Jan. 8, 2008). In

seven cases, the Federal Circuit found that

jurisdiction did exist, although it found that

discretionary dismissal had been proper in one of

these (Cellco) and might be proper on remand in

another (Sony). Micron Tech., Inc. v. Mosaid Techs.,

Inc., 2008 U.S. App. Lexis 4387 (Fed. Cir. Feb. 29,

2008); Adenta GmbH v. OrthoArm, Inc., 501 F.3d

1364 (Fed. Cir. 2007); Honeywell Int'l Inc. v.

Universal Avionics Sys. Corp., 488 F.3d 982 (Fed.

Cir. 2007); Teva Pharm. USA, Inc. v. Novartis

Pharm. Corp., 482 F.3d 13380 (Fed. Cir. 2007);

SanDisk Corp. v. STMicroelectronics, Inc., 480 F.3d

1372 (Fed. Cir. 2007); Cellco P'ship v. Broadcom

Corp., 227 Fed. Appx. 889 (Fed. Cir. 2007); Sony

Elecs., Inc. v. Guardian Media Techs., Lid., 497 F.3d

1271 (Fed. Cir. 2007). In one case, the court did not

determine whether jurisdiction existed, but vacated

and remanded for consideration in light of

MedImmune. Baker Hughes Oilfield Operations, Inc.

v. Reedhycalog UK, Ltd., 228 Fed. Appx. 988 (Fed.

Cir. 2007).

Indeed, a finding of jurisdiction in this case would

improperly open all patent holders, whether

20

licensing the patent or not, to expansive threats of

declaratory judgment action for mere patent

ownership. Nucleonics essentially argues that

present activities that do not infringe and undefined,

hypothetical future activities can support

jurisdiction under the Declaratory Judgment Act.

Adopting Nucleonics' standard would confer

jurisdiction to nearly anyone abstaining from any

contemplated action, no matter how theoretical or

remote in time, because they feared they might

someday be sued for infringement. Thus, it is the

result desired by Nucleonics that would result in

grave and widespread harm — to every patent

owner.

B. Nucleonics' Petition Seeks To Broaden

Declaratory Judgment Jurisdiction To

Obtain An Unconstitutional Advisory

Opinion.

Article III jurisdiction is limited to the resolution

of cases and controversies. Valley Forge Christian

College v. Americans United for Separation of

Church and State, Inc., 454 U.S. 464, 471 (1982);

Sierra Applied Sciences, 363 F.3d at 1372; Travelers

Ins. Co. v. Obusek, 72 F.3d 1148, 1153-54 (3d Cir.

1995). The requirement for the existence of a case or

controversy is not relaxed in cases under the

Declaratory Judgment Act. See Obusek, 72 F.3d at

1153.

A controversy "must be a real and substantial

controversy admitting of specific relief through a

decree of a conclusive character, as distinguished

from an opinion advising what the law would be

upon a hypothetical state of facts." Aetna Life Ins.

21

Co. v. Haworth, 300 U.S. 227, 241 (1937). "Basically,

the question in each case is whether the facts

alleged, under all the circumstances, show that there

is a substantial controversy, between parties having

adverse legal interests, of sufficient immediacy and

reality to warrant the issuance of a declaratory

judgment." Maryland Cas. Co. v. Pacific Coal & Oil

Co., 312 U.S. 270, 273 (1941). Here, the degree of

immediacy and reality required to create jurisdiction

is not present. This fact-specific finding does not

convert this case into one of Constitutional

importance.

An action or counterclaim brought under the

Declaratory Judgment Act, 28 U.S.C. § 2201, et seq.,

may not be used to obtain an advisory opinion on a

hypothetical state of facts. Calderon v. Ashmus, 523

U.S. 740, 746 (1998); Obusek, 72 F.3d at 1153-54

("The existence of a ‘case or controversy’ is a

condition precedent to the proper exercise of judicial

power by a federal court and the Declaratory

Judgment Act can not relax that constitutional

requirement."); Arrowhead Indus. Water v.

Ecolochem, 846 F.2d 731, 736 (Fed. Cir. 1988) (A

declaratory plaintiff is not entitled to "an advisory

opinion on whether it would be liable for patent

infringement if it were to initiate some merely

contemplated activity."), overruled in part by

MedImmune, 127 S. Ct. at 774 n.11 (rejecting

Federal Circuit's use of "reasonable-apprehension-of-

suit test"). Nucleonics' attempt to obtain an advisory

opinion when there is insufficient immediacy and

reality to support a declaratory judgment action

should be rejected, and the petition for certiorari

should be denied.

Ba tir 2

22

Additionally, a party wishing to challenge the

validity of a patent is not without recourse if it

cannot establish declaratory judgment jurisdiction:

it may file a reexamination of the patent in the

USPTO and even participate in it. In fact, that is

precisely what Nucleonics has done here. On

October 4, 2004, Nucleonics initiated a third party

Reexamination challenging the validity of the '099

Patent. On May 18, 2006, Nucleonics requested yet

another reexamination of the '099 Patent. Benitec,

495 F.3d at 1342, n.1, Pet. App. 3a-4a, n.l. On

October 26, 2006, the USPTO merged these two

reexaminations, and they are still pending. Id.; U.S.

Reexamination Nos. 90/007,247 and 90/008,096 (see

http: / /portal.uspto.gou/external/portal/pair).

Thus, the claims with which the '099 Patent will

emerge from reexamination are not known.

C. The Federal Circuit's Decision Does Not

Conflict With Cardinal or Altvater.

The Federal Circuit's analysis recognized that if

"a party has actually been charged with

infringement of the patent, there is, necessarily, a

case or controversy adequate to support jurisdiction'

at that time." Benitec, 495 F.3d at 1344, Pet. App.

9a (quoting Cardinal, 508 U.S. at 96). It further

recognized that "once that burden [fof establishing

jurisdiction] has been met, absent further

information, that jurisdiction continues." Benitec,

495 F.3d at 1344-45, Pet. App. 9a-10a (citing

Cardinal, 508 U.S. at 98). The Federal Circuit also

noted that "[iJf a party to an appeal suggests that

the controversy has, since the rendering of the

judgment below, become moot, that party bears the

23

burden of coming forward with subsequent events

that have produced that alleged result." Benitec,

495 F.3dat 1345, Pet. App. 10a (quoting Cardinal,

508 U.S. at 98; emphasis added by Federal Circuit).

Cardinal recognized that a change in

circumstances can divest jurisdiction: "fiJf, before

the court had decided the case, either party had

advised it of a material change in circumstances that

entirely terminated the party's controversy, it would

have been proper either to dismiss the appeal or to

vacate the entire judgment of the District Court."

508 U.S. at 98. See also id. at 97 (If "[the Federal

Circuit] had jurisdiction while the case was pending

before it, the case remains alive (barring other

changes) when it comes to us.") (emphasis added);

United States v. Munsingwear, 340 U.S. 36, 39

(1950) (a case that becomes moot should be reversed

or vacated and remanded for dismissal); Steffel v.

Thompson, 415 U.S. 452, 459 n.10 (1974) (an “actual

controversy must be extant at all stages of review,

not merely at the time the complaint is filed.").

In the instant case, there were material changes

in circumstances that entirely terminated the

controversy. Specifically, (1) this Court's holding in

Merck, in’ combination with (2)

REDACTED ia

it did not plan to seek FDA approval to manufacture

and market a prospective drug product until at least

2012, if ever (3) as a result, Nucleonics' activities

could not be found to be infringing, and (4) Benitec

covenanted not to sue Nucleonics for any activities

before the date that District Court dismissed the

sult.

24

Further, the Federal Circuit's determination that

Cardinal “did not hold that the ultimate burden of

proof in the trial court was on other than the party

seeking to invoke declaratory judgment jurisdiction"

(Benitec, 495 F.3d at 1345, Pet. App. 10a-11a) is fully

in accord with this Court's decision in Cardinal. By

its own terms, Cardinal is limited to circumstances

where a party is seeking to vacate a judgment. See,

e.g., Cardinal, 508 U.S. at 100 ("the burden of

demonstrating that changed circumstances provide a

basis for vacating the judgment of patent invalidity

rests on the party that seeks such action") (emphasis

added); id. at 95 (The “issue before [this Court in

Cardinal concerned] the jurisdiction of an

intermediate appellate court — not the jurisdiction

of either a trial court or this Court. In the trial court,

of course, a party seeking a declaratory judgment has

the burden of establishing the existence of an actual

case or controversy.") (emphasis added).

As the Federal Circuit had previously recognized:

The question actually before the Supreme

Court in Cardinal was “whether the

affirmance by the Court of Appeals for the

Federal Circuit of a finding that a patent

has not been infringed is a _ sufficient

reason," by itself, "for vacating a

declaratory judgment holding the patent

invalid." [Cardinal, 508 U.S. at 85]. The

Court answered in the negative, but noted

"that factors in an unusual case might

justify [the Federal Circuit's] refusal to

reach the merits of a_ validity

determination," id. at [102], making the

decision a relatively narrow one. In other

25

words, according to Cardinal, a claim for a

declaratory judgment of invalidity is

independent of the patentee's charge of

infringement in the following — and only

the following — way: an affirmed finding of

noninfringement does not, without more,

justify a reviewing court's refusal to reach

the trial court's conclusion on invalidity.

Super Sack Mfg. Corp. v. Chase Packaging Corp., 57

F.3d 1054, 1060 (Fed. Cir. 1995), overruled in part by

MedImmune, 127 S. Ct. at 774 n.11 (rejecting

Federal Circuit's use of "reasonable-apprehension-of-

suit test”).*

Thus, Cardinal did not hold or even suggest that

"the ultimate burden of proof in the trial court was

on other than the party seeking to invoke

declaratory judgment jurisdiction." Benitec, 495

F.3d at 1345, Pet. App. 10a-lla. Cardinal did not

even make any such statement in dicta.

The Federal Circuit properly found that Cardinal

does not apply to District Court jurisdiction,

particularly where that Court has not rendered any

judgment on the merits. Cardinal states that the

consideration perhaps "most important is the

interest of the successful litigant in preserving the

value of a declaratory judgment that... ‘it obtained on

a valid counterclaim at great effort and expense."

508 U.S. at 99 (quoting Morton Int'l v. Cardinal

Chem., 967 F.2d 1571, 1577 (Fed. Cir. 1992) (Nies, C

* Although MedImmune rejected the "reasonable-

apprehension-of-suit test" (127 S. Ct. at 774 n.11), the rejected

test was not used to support Super Sack's finding regarding the

applicability of Cardinal.

26

J., dissenting from denial of rehearing en banc).

Cardinal also decried "the wasteful consequences of

relitigating the validity of a patent after it has once

been held invalid in a fair trial" occasioned by

routinely vacating judgments of invalidity. Jd. at

100-01. See also Super Sack, 57 F.3d at 1060

(where, as in the instant case, "the trial court

neither made a finding on infringement nor reached

a conclusion on validity[,] Cardinal, addressed to the

propriety of appellate jurisdiction over final

judgments respecting infringement and va! lity,

simply does not apply.") This particular rationaie for

the Cardinal decision has no relevance to cases, such

as the instant case, in which there is no successful

litigant, there is no judgment on the merits, and

there has been no trial.

Nor is the Federal Circuit's decision in conflict

with Alivater v. Freeman. 319 U.S. 359 (1943). In

Altvater, the District Court decided the case on the

merits, finding non-infringement and invalidity, but

the Eighth Circuit vacated the invalidity decision on

the basis that the non-infringement ruling had

mooted the counterclaims. Id. at 362-63. This Court

reversed and remanded. Id. at 365-66. Unlike in

the instant case, the Altvater declaratory plaintiff's

claims were not moot because there was no

intervening event between filing and judgment on

the merits — such as a covenant not to sue — that

divested the court of jurisdiction. Here, there were

intervening events.

27

D. The Federal Circuit's Decision Does Not

Conflict With MedImmune

Nucleonics alleges that the Federal Circuit's

analysis of whether any of Nucleonics' asserted

activities supported jurisdiction was “except in

name, a clear return to the disapproved ‘reasonable

apprehension of imminent lawsuit' test." Pet. 28.

Nucleonics ignores the fact that in MedIlmmune, this

Court held that for declaratory judgment jurisdiction

to exist, the dispute must be "definite and concrete";

"real and substantial"; and of "sufficient immediacy

and reality to warrant the issuance of a declaratory

judgment." MedImmune, 127 S. Ct. at 771

(emphasis added). In accordance with MedJmmune,

the Federal Circuit properly assessed whether

Nucleonics’' asserted activities had “sufficient

immediacy and reality" to present a case or

controversy. See, e.g., Benitec, 495 F.3d at 1346,

1348-49, Pet. App. 14a, 19a-20a, 22a-23a.

Nucleonics, in alleging that its asserted vague

“wishes” and potential future activities support

jurisdiction to challenge the validity of claims of a

patent that may emerge from reexamination with

substantially different claims, would remove the

long-standing requirements for immediacy and

reality from the case or controversy requirement.

See, e.g., Haworth, 300 U.S. at 241 (a controversy

"must be a real and substantial controversy

admitting of specific relief through a decree of a

conclusive character, as distinguished from an

opinion advising what the law would be upon a

hypothetical state of facts."); Arrowhead Indus., 846

F.2d at 736 (declaratory plaintiff not entitled to "an

28

advisory opinion on whether it would be liable for

patent infringement if it were to initiate some

merely contemplated activity."). Even the Federal

Circuit dissent agreed that: "[i]Jf this declaratory

judgment action were filed today... the required case

or controversy had not been established" and "the

future controversy would not satisfy the sufficient

immediacy and reality test for the filing of a new suit

today...." Benitec, 495 F.3d at 1350, 1354, Pet. App.

23a, 33a.

Significantly, in MedIJmmune itself, the threat of

harm avoided by petitioner's continuing royalty

payments would otherwise have been "imminent".

127 S. Ct. at 772 (emphasis added). Thus, the

teaching of MedImmune is that declaratory

judgment jurisdiction exists when “Petitioner's own

acts... eliminate the imminent threat of harm." Id.

(emphasis added). In the instant case, Nucleonics is

simply not faced with “imminent' injury in fact

fairly... trace[able] to" any concrete action by

Benitec. Id. at 772 n.8 (citation omitted).

For Nucleonics' activities prior to the District

Court's dismissal of the suit, Benitec's covenant not

to sue destroyed any “substantial controversy"

between the parties. Based on the facts of this case,

including the scant and hypothetical information

provided to the Court by Nucleonics, Nucleonics'

later activities are not “definite and concrete" or

"real and substantial" enough and are not of

“sufficient immediacy and reality to warrant the

issuance of a declaratory judgment." MedImmune,

127 S. Ct. at 771; Benitec, 495 F.3d at 1346, 1348-49,

Pet. App. 14a, 19a-20a, 22a-23a.

29

1. Nucleonics' Activities Related To

Human Use Do Not Support

Jurisdiction.

In its motion to dismiss, Nucleonics itself

represented that

REDACTED

J.A. 2662. See also J.A. 2659, J.A. 2661-

63.

After Merck was decided by this Court, Benitec

recognized that Nucleonics was exempt from

infringement under 35 U.S.C. § 271(e)(1). See, e.g.,

J.A. 1379. As the Federal Circuit stated, Benitec

and Nucleonics "have now both taken the position

that Nucleonics' present activities related to the

human medical application of RNAi are, in light of §

271 and the Supreme Court's decision in Merck, not

infringing and cannot become infringing until after

Nucleonics files a new drug application ('NDA’)...."

Benitec, 495 F.3d at 1347, Pet. App. 14a. See alse

id., 495 F.3d at 1342, Pet. App. 3a (Nucleonics

30

asserted that an NDA will not be filed until at least

2010-12); J.A. 2663. Thus, Nucleonics' activities

reasonably related to human use of RNAi, including

animal testing, are exempt from current

infringement liability and will be exempt for many

years.

The record does not support any showing that a

controversy of sufficient immediacy and reality

exists between Benitec and Nucleonics. Nucleonics

may never file an NDA, and any product or

technique approved by the FDA may not come

within the scope of the claims of the '099 Patent.

This is particularly true since a reexamination of the

'099 Patent is pending. See, e.g., Benitec, 495 F.3d at

1342, n.1, Pet. App. 3a-4a, n.1. It is therefore not

known what, if any, claims may exist by the time

Nucleonics may file an NDA. Indeed, even

Nucleonics admits that it may be many years until it

files an NDA. Accordingly, any controversy

regarding Nucleonics' human applications of RNAi

lacks the requisite reality and immediacy to support

declaratory judgment jurisdiction.

2. Nucleonics' Purported Wish To

Expand Its Efforts Does Not Support

Jurisdiction.

After Benitec moved to dismiss, Nucleonics

asserted for the first time that it "wishes to expand

its efforts beyond human health to animal

husbandry[,]"and had "executed a confidentiality

agreement” as a "prerequisite to detailed technical

discussions" for possible work. Benttec, 495 F.3d at

1348, Pet. App. 18a. See also J.A. 1412 | 20. This

vague wish does not create jurisdiction. The

31

described activity is largely speculative, describing

generally what might someday happen. Further, as

properly found by the Federal Circuit, the concrete

acts that Nucleonics did describe do not constitute

infringement under 35 U.S.C. § 271(a). Benitec, 495

F.3d at 1848-49, Pet. App. 17a-2la. See, e.g., Rotec

v. Mitsubishi, 215 F.3d 1246, 1254-55 (Fed. Cir.

2000). |

Even if Nucleonics does eventually engage in

activity within the scope of current or reexamined

claims, § 271(e)(1) would likely exempt them, in view

of

REDACTED

and (2) the wide

breadth of activities that are protected: § 271(e)(1)

"“exempt[s] from infringement all uses of patented

compounds ‘reasonably related' to the process of

developing information for submission under any

federal law regulating the manufacture, use, or

distribution of drugs." Merck, 545 U.S. at 206. See

also id. at 208 ("We thus agree with the Government

that the use of [patented technology] in preclinical

studies is protected under §271(e)(1) as long as there

is a reasonable basis for believing that the

experiments will produce ‘the types of information

that are relevant to an IND or NDA." (emphasis

added)). Thus, infringing activity may never occur.

Furthermore, given the broad scope of the

§ 271(e)(1) safe harbor, any non-safe harbor

activities performed or products produced by

Nucleonics would necessarily be in the area of

animal therapy or research for animal therapy, with

no application to human therapy. As Benitec

explained before the Federal Circuit, it would have

32

no interest in suing Nucleonics in this area, in which

it does not have commercialization rights and does

not compete: the expense of a lawsuit to assert

another party's rights does not make good business

sense. Plaintiff-Appellee Benitec Australia, Ltd.'s

Response to Defendant-Appellant Nucleonics'

Supplemental Brief, filed March 5, 2007, at 6-8. See

also J.A. 1528-52; J.A. 1530 at (B)(b); J.A. 1530-31(a-

h); J.A. 1536-37 9 4.3; Benitec, 495 F.3d at 1349, Pet.

App. 2la ("Benitec has never challenged use of the

technology in testing in animals for animal use and

claims another company owns any right to do so.").

Additionally, Benitec would be precluded from

suing Nucleonics over any activities or products in

the animal arena without joining CSIRO, which

owns the rights to the '099 Patent in the animal

field. It has long been the law that, in order for

patent infringement plaintiffs to have standing, the

patent owner must be joined.’ See, e.g., Independent

Wireless Tel. Co. v. Radio Corp. of Am., 269 U.S. 459,

468 (1926). In the context of licensing, this Court

has explained:

[t]he patentee or his assigns may, by

instrument in writing, assign, grant and

convey, either, lst, the whole patent,

comprising the exclusive right to make,

>Since the 1966 amendment of Federal Rule of Civil

Procedure 19, "{a]s a general rule, [the Federal Circuit]

continues to adhere to the principle set forth in Independent

Wireless that a patentee should be joined, either voluntarily or

involuntarily, in any infringement suit brought by an exclusive

licensee." Prima Tek II, L.L.C. v. A-Roo Co., 222 F.3d 1372,

1377 (Fed. Cir. 2000).

33

use and vend the invention throughout the

United States; or, 2d, an undivided part or

share of that exclusive right; or, 3d, the

exclusive right under the patent within

and throughout a specified part of the

United States.... A transfer of either of

these three kinds of interests is an

assignment, properly speaking, and vests

in the assignee a title in so much of the

patent itself, with a right to sue infringers;

in the second case, jointly with the

assignor; in the first and third cases, in the

name of the assignee alone."

Waterman v. Mackenzie, 138 U.S. 252, 255 (1891)

(citation omitted; emphasis added).

The division of rights to the ‘099 Patent

corresponds to the second situation in Waterman:

each of Benitec and CSIRO have an undivided part

of the patent — the right to practice in humans or

animals, respectively — each having their part of the

patent right throughout the United States. See also

Pope Mfg. Co., 144 U.S. at 250 (addressing the

question "whether a patentee can split up his patent

into as many different parts as there are claims, and

vest the legal title to those claims in as many

different persons" and recognizing the rule that the

patent monopoly "is for one entire thing, and that in

order to enable the assignee to sue, the assignment

must convey to him the entire and unqualified

monopoly which the patentee held, in the territory

specified, and that any assignment short of that is a

mere license.").

The Federal Circuit has explicitly set forth the

application of this rule to the co-owner relationship,

Jon PS

34

stating "[e]ven an ownership interest, however,

would not be sufficient to give [putative patent co-

owner] IBEP prudential standing to sue for

infringement, as IBEP would have to join all the

other co-owners in order to establish such standing."

Israel Bio-Engineering Project v. Amgen Inc., 401

F.3d 1299, 1304-05 (Fed. Cir. 2005) (emphasis

added)). “Absent the voluntary joinder of all co-

owners of a patent, a co-owner acting alone will lack

standing." Israel Bio-Engineering Project v. Amgen

Inc., 475 F.3d 1256, 1264-65 (Fed. Cir.), cert. denied,

168 L. Ed. 2d 720 (2007).

Thus, CSIRO, an _ Australian research

organization, would be a necessary party to

resolution of any claim regarding animal rights.

Because Benitec simply does not hold any of the

bundle of rights to animal therapy or animal

research for animal therapy, CSIRO is a necessary

party even though a contract between CSIRO and

Benitec, which was effective at the time that Benitec

filed suit and at the time it filed its motion to

dismiss, suggests that Benitec has the ability to file

suit. See, e.g., Propat Int'l Corp. v. RPost, Inc., 473

F.3d 1187, 1192 (Fed. Cir. 2007) (a right to sue

clause did not confer the exclusive licensee with

standing to sue since the plaintiff did not hold

enough of the bundle of rights).

Nucleonics' vague wish to enter the animal field

does not provide a basis for jurisdiction here.

35

3. Nucleonics' Alleged Agreement With A

"Pharmaceutical" Company Does Not

Support Jurisdiction.

After Benitec filed for dismissal, Nucleonics

asserted that it had signed an agreement to work

with a "pharmaceutical" company on an “exploratory

collaboration" but that it did not perform due to

vague "concerns about this litigation". Pet. for Reh'g

at 4. See also J.A. 1410-11. Nucleonics asserts that

its choice to stop this unspecified pre-dismissal work

supports jurisdiction over its declaratory judgment

claims because "MedImmune specifically holds that

declaratory judgment jurisdiction is not defeated

where a putative infringer — by virtue of coercion

resulting from the patentee's threats — abstains

from allegedly infringing activity that, if otherwise

engaged in, would have supported jurisdiction" and

complains that the Federal Circuit "departe[d] from

MedImmune" in not considering “the fact that

Nucleonics was coerced to end a collaboration,

involving allegedly infringing activity...." Pet. 30-31.

The Federal Circuit did not, however, need to decide

whether MedImmune set such a low standard, as

Nucleonics' asserted activity does not meet even this

standard.

Nucleonics first raised this vague collaboration

after Benitec moved to dismiss the litigation. Thus,

Benitec never considered, much less alleged, that

this collaboration was infringing. Indeed, despite

pertinent discovery requests by Benitec, Nucleonics

never provided Benitec enough information to even

consider the question. Thus, referring to the

collaboration as "allegedly infringing" is

36

disingenuous, especially in view of Nucleonics'

statements that all of its research findings would

become part of an IND submission to the FDA.

In its petition for rehearing by the Court of

Appeals, Nucleonics asserted that this collaboration

would “not [be] within the safe harbor fof

§ 271(e)(1)]". Pet. for Reh'g at 4. This unsworn

attorney assertion is belied by (1)

REDACTED

(see

section III].A, supra); (2) the only information

provided in Nucleonics' sworn declaration describing

this work suggests that it would fall within the safe

harbor (Pet. for Reh'g at 4 (describing the work as

"exploratory collaboration" with a "pharmaceutical"

company)); and (3) the breadth of the safe harbor,

which makes it likely that any work in any way

relevant to the use of the technology in humans

would be exempt from infringement. Thus, on the

factual record, the alleged corroboration does not

support the exercise of jurisdiction.

CONCLUSION

For the foregoing reasons, the petition for a writ

of certiorari should be denied.

37

Dated March 20, 2008

Of Counsel:

JENNIFER L. KING

Respectfully submitted,

Pe Zw

KEVIN M. BELL

Scott A.M. CHAMBERS, PH.D.

PATTON Bocas LLP

8484 Westpark Drive

McLean, VA 22102

(7038) 744-8000

(703) 744-8001 (fax)

RICHARD J. OPARIL

PATTON BoGGs LLP

2550 M Street, NW

Washington, DC 20037

(202) 457-6000

(202) 457-6315 (fax)

Attorneys for Respondent

PATTON BoGGs LLP

2550 M Street, NW

Washington, DC 20037

(202) 457-6000

(202) 457-6315 (fax)