UNITED STATES DISTRICT COURT 

DISTRICT OF NEW JERSEY 

SHIRE LLC, et al., 

 Plaintiffs, 

 v. 

AMNEAL PHARMACEUTICALS LLC et al., 

 Defendants. 

 C.A. No. 2:11-cv-03781-SRC-CLW 

(CONSOLIDATED) 

SHIRE LLC, et al., 

 Plaintiffs, 

 v. 

WATSON LABORATORIES, INC. et al., 

 Defendants. 

 C.A. No. 2:12-cv-00083-SRC-CLW 

DOCUMENT FILED 

ELECTRONICALLY

REPLY MEMORANDUM OF LAW IN SUPPORT OF DEFENDANTS’ MOTION FOR 

PARTIAL SUMMARY JUDGMENT OF NO WILLFUL INFRINGEMENT

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TABLE OF CONTENTS 

Page 

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

II. ARGUMENT .......................................................................................................................1

A. Shire’s Argument That The ANDA Defendants Induce JM Fails ...........................1

B. Shire’s Allegations Against JM Are Equally Flawed ..............................................4

1. Shire Has Not Alleged Actual Past Infringement Against JM, Let 

Alone Willful Past Infringement ..................................................................4

2. The Evidence Shire Cites Is Protected Safe Harbor Activity ......................6

3. Shire’s Focus on JM’s Patent Analyses Is A Mere Distraction ..................7

C. Shire Cannot Meet The Objective Prong Of Willfulness ........................................8

D. The Alleged Future Infringement By Defendants Is Still Speculative ..................10

E. Shire’s Exceptional Case Claims Are Of No Moment ..........................................11

III. CONCLUSION ..................................................................................................................12

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TABLE OF AUTHORITIES 

Page(s) 

CASES 

Bard Peripheral Vascular, Inc. v. W.L. Gore & Assocs., Inc., 682 F.3d 1003 

(Fed. Cir. 2012), cert. denied, 133 S. Ct. 932 (2013) ................................................................9

Black & Decker, Inc. v. Robert Bosch Tool Corp., 260 F. App’x 284 

(Fed. Cir. 2008) ..........................................................................................................................9

Celgene Corp. v. Teva Pharmaceuticals USA, Inc., 412 F. Supp. 2d 439 

(D.N.J. 2006)..................................................................................................................2, 10, 11 

Computer Accelerations Corp. v. Microsoft Corp., 503 F. Supp. 2d 819 

(E.D. Tex. 2007) ........................................................................................................................4 

DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314 

(Fed. Cir. 2009) ......................................................................................................................8, 9

Forest Laboratories, Inc. v. Ivax Pharmaceuticals, Inc., 501 F.3d 1263 (Fed. 

Cir. 2007). ..............................................................................................................................2, 3

Giffney Perret, Inc. v. Matthews, No. 07 C 0869, 2009 U.S. Dist. LEXIS 23531 

(N.D. Ill. Mar. 24, 2009) ..........................................................................................................11

King Pharms., Inc. v. Sandoz, Inc., No. 08-5974 (GEB), 2010 U.S. Dist. LEXIS 

127647 (D.N.J. Sept. 7, 2010) ...................................................................................................4

Masimo Corp. v. Philips Elecs. N. Am. Corp., No. 09-80-LPS-MPT, 2013 U.S. 

Dist. LEXIS 83704 (D. Del. June 14, 2013) ..............................................................................9

Medicines Co. v. Mylan, Inc., 

No. 11-cv-1285, 2013 U.S. Dist. LEXIS 176269 (N.D. Ill. Dec. 16, 2013) ............................11 

Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005) ..................................................7

O2 Micro Int’l Ltd. v. Monolithic Power Sys., 467 F.3d 1355 (Fed. Cir. 2006)..............................4

Primos, Inc. v. Hunter’s Specialties, Inc., No. C01-0004, 2004 U.S. Dist. LEXIS 

31226 (N.D. Iowa Sept. 7, 2004), aff’d 451 F.3d 841 (Fed. Cir. 2006) ....................................3

Safeclick, LLC v. Visa Intern. Service Ass’n, 208 Fed. App’x 829 

(Fed. Cir. 2006) ..........................................................................................................................4

In re Seagate Technology, LLC, 497 F.3d 1360 (Fed. Cir. 2007) .........................................8, 9, 10 

Shire LLC v. Amneal Pharms., LLC, No. 2:11-cv-03781, 2013 U.S. Dist. LEXIS 

180920 (D.N.J. Dec. 23, 2013) ..............................................................................................3, 4

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Spine Solutions, Inc. v. Medtronic Sofamor Danek USA, Inc., 620 F.3d 1305 

(Fed. Cir. 2010) ..........................................................................................................................9

Tarkus Imaging, Inc. v. Adobe Sys., Inc., 867 F. Supp. 2d 534 (D. Del. 2010) ...............................8 

TGIP, Inc. v. AT&T Corp., 527 F.Supp. 2d 561 (E.D. Tex. 2007) ................................................10

United States v. Hook, 471 F.3d 766, 775 (7th Cir. 2006) .............................................................11

STATUTES 

35 U.S.C. § 271(a) ...........................................................................................................................5 

35 U.S.C. § 271(b) ...........................................................................................................................5 

35 U.S.C. § 271(c) ...........................................................................................................................5 

35 U.S.C. § 271(e)(1) ...................................................................................................................7, 9 

35 U.S.C. § 271(e)(2) .......................................................................................................................5 

35 U.S.C. § 271(e)(2)(A) .................................................................................................................4 

35 U.S.C. § 285 ........................................................................................................................11, 12 

RULES 

Fed. R. Civ. P. 26(b)(5)(B) ..............................................................................................................8 

D.N.J. L. Pat. R. 3.1(h) ................................................................................................................3, 5 

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I. INTRODUCTION 

In its opposition to Defendants’ motion for partial summary judgment of no willful 

infringement, Shire now advocates willfulness claims not previously pled or disclosed, and 

presents a storyline intended to create the appearance of factual disputes. Indeed, Shire 

continues to use misdirection and sleight of hand to overly complicate and conflate issues, in the 

hopes of drawing the Court’s attention away from the governing law and the narrow scope of the 

willfulness claims Shire has repeatedly and consistently disclosed—even after the filing of this 

motion. Shire’s futile attempt to preserve its willfulness claims by presenting new arguments in 

its opposition brief is impermissible. 

While the “facts” presented by Shire are certainly disputed, those disputes do not 

preclude summary judgment because even Shire stops short of calling the identified activity 

“infringing”—and where there has not been infringement, there cannot be willful infringement. 

Instead, the activity Shire identifies is all of the sort that Congress envisioned, encouraged, and 

fully blessed in the form of the Hatch-Waxman Act’s “safe harbor” provisions. Because Shire 

cannot support a claim for willful infringement, Defendants’ motion should be granted. 

II. ARGUMENT 

A. Shire’s Argument That The ANDA Defendants Induce JM Fails 

Shire devotes the bulk of its opposition brief to a revisionist history of “facts” regarding 

JM’s development of lisdexamfetamine dimesylate API and JM’s consideration of the patents-insuit. The irrelevance of this evidence is discussed below in Section II.B and the inaccuracies in 

Shire’s portrayal are addressed in the accompanying Responses to Shire's Supplemental Facts.1

 

 

1

 Aspects of Shire’s recitation draw from inadvertently produced privileged documents that are 

the subject of JM’s pending Appeal (D.I. 552). To the extent the Court finds that Shire’s 

(cont’d)

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But even if accepted as true, Shire’s narrative does not present any serious challenge to 

Defendants’ assertion that the sole act of past infringement alleged against the ANDA 

Defendants—and the sole predicate basis for a finding of willfulness—is the filing of the 

ANDAs.2 In fact, Shire never denies that the filing of an ANDA is a legally insufficient basis on 

which to find willful infringement, even when the ANDA is allegedly baseless.3 See, e.g., 

Celgene Corp. v. Teva Pharm. USA, Inc., 412 F. Supp. 2d 439, 445 (D.N.J. 2006). Shire has 

thus failed to raise any genuine issue of material fact regarding the willfulness claim it pled in its 

Amended Complaints and identified in its infringement contentions to the ANDA Defendants. 

Shire’s new theory, based on an alleged cooperative venture between the ANDA 

Defendants and JM, is both improper and insufficient to defeat summary judgment. Under this 

circular theory, Shire suggests that willfulness claims are available against the ANDA 

Defendants because they “have induced and contributed to JM’s willful infringement.” (Shire’s 

Opp. Br. (D.I. 571) at 16.) Shire merely presupposes that JM and the ANDA Defendants are in a 

cooperative venture, citing to Forest Laboratories, Inc. v. Ivax Pharmaceuticals, Inc., 501 F.3d 

1263 (Fed. Cir. 2007). (Shire’s Opp. Br. at 3, 6, 7, 16-18.) In fact, Forest does not hold that any 

situation in which a third party supplies API to an ANDA filer amounts to a cooperative venture. 

________________________ 

(cont’d from previous page)

assertions based on such documents raise fact disputes and defeat summary judgment, JM 

reserves the right to renew its request for summary judgment if the Appeal is granted. 

2 See, e.g., Responses to Shire's Supplemental Facts at Facts 59, 66. 

3

 Shire’s brief seems to suggest that it need not respond to Defendants’ legal argument because 

JM’s status as an API supplier rather than an ANDA filer somehow obviates the effect of the 

ANDA-related case law cited in Defendants’ brief. (Shire’s Opp. Br. at 6.) This effort rings 

hollow. The fact remains that the only two acts of infringement alleged by Shire (the generics’ 

inclusion of paragraph IV certifications in their ANDAs, and JM’s written authorization 

allowing each ANDA to reference its DMF 22442) relate exclusively to the ANDA filings. 

Thus, the ANDA-related case law is plainly applicable. 

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Rather, the court found that a cooperative venture existed based on the facts of record in that 

case. By contrast, Shire has not established the existence of a cooperative venture, or any 

relationship between the ANDA Defendants and JM that amounts to anything more than an 

ordinary business relationship resulting from arms-length transactions. In any event, the 

cooperative venture addressed in Forest bore on the question of induced infringement, not 

willfulness. Forest, 501 F.3d at 1272. Finally, even if a “cooperative venture” did exist and 

even if JM were held to be a willful infringer, that finding does not automatically extend to any 

indirect infringers. See, e.g., Primos, Inc. v. Hunter’s Specialties, Inc., No. C01-0004, 2004 U.S. 

Dist. LEXIS 31226, at *55-60 (N.D. Iowa Sept. 7, 2004) (“[D]amages owed by [defendants] for 

inducing direct infringement cannot be multiplied due to [the direct infringer’s] willfulness.”), 

aff’d 451 F.3d 841 (Fed. Cir. 2006). 

However, the Court need not grapple with Shire’s effort to extend its flawed reading of 

Forest because Shire never identified inducement and contribution to JM’s willful infringement 

in its L. Pat. R. 3.1(h) disclosures to the ANDA Defendants. As addressed in Defendants’ 

opening brief (D.I. 519) at Sec. II.B and confirmed in Shire’s L.R. 56.1 Responses (D.I. 572 at 

Fact 13), Shire’s L. Pat. R. 3.1(h) willful infringement disclosures provide very limited 

allegations against the ANDA Defendants and do not mention JM: “Upon information and belief, 

[the ANDA Defendants] filed [their] ANDA[s] despite an objectively high likelihood that the 

Asserted Claims are valid and that [the ANDA Defendants’] product[s] infringe[] the patents-insuit.” The contentions contain no further allegation of willful infringement by the ANDA 

Defendants, and make no mention of Shire’s new theory of willfulness by inducing or 

contributing to JM’s acts. This late-added theory flies in the face of the Local Rules and denies 

Defendants “adequate notice and information with which to litigate their case.” Shire LLC v. 

Amneal Pharms., LLC, No. 2:11-cv-03781, 2013 U.S. Dist. LEXIS 180920, at *5 (D.N.J. Dec. 

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23, 2013) (quoting Computer Accelerations Corp. v. Microsoft Corp., 503 F. Supp. 2d 819, 822 

(E.D. Tex. 2007)). 

Notably, Shire’s characterizations of the willfulness claims against the ANDA 

Defendants in the Pre-Trial Order—filed after this motion was filed—are even narrower and 

speak only to future claims of willful infringement in the event there is a commercial launch. 

(D.I. 546, at 17, 20, 23, 26, 29, 32-33.) The Court should reject Shire’s desperate attempt to 

keep its willfulness claim in play by introducing legally defective and factually unsupported new 

claims in its opposition brief. See, e.g., Safeclick, LLC v. Visa Intern. Service Ass’n, 208 Fed. 

App’x 829, 835-36 (Fed. Cir. 2006) (affirming summary judgment of non-infringement where 

district court refused to consider patentee’s new infringement theory raised in opposition brief); 

O2 Micro Int’l Ltd. v. Monolithic Power Sys., 467 F.3d 1355, 1369 (Fed. Cir. 2006) (same); King 

Pharms., Inc. v. Sandoz, Inc., No. 08-5974 (GEB), 2010 U.S. Dist. LEXIS 127647 (D.N.J. Sept. 

7, 2010) (granting motion in limine to preclude theories not identified in contentions). 

B. Shire’s Allegations Against JM Are Equally Flawed 

1. Shire Has Not Alleged Actual Past Infringement By JM, Let Alone 

Willful Past Infringement 

JM’s Opening Brief asserted that, with regard to JM, the single alleged act of past

infringement is JM’s written authorization allowing each ANDA to reference its DMF. Shire 

alleged this one act of past infringement in each of its five amended complaints: 

Upon information and belief, the inclusion of Johnson Matthey’s written 

authorization in the [] ANDA[s] for the purpose of supporting the [] ANDA[s] is an 

act of infringement of one or more claims of the [] patent[s-in-suit] under 35 U.S.C. 

§ 271(e)(2)(A) directly and/or indirectly in a cooperative venture, including by 

inducement and/or contributory infringement. 

(See, e.g., D.I. 219, ¶¶ 59, 85, 98, 124.) Though Shire refuses to admit this fact outright, its 

carefully worded objections verify the accuracy of JM’s statement. 

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In response to Defendants’ Fact Statement No. 10, Shire disputes that the written 

authorization “is the only act of infringement by Johnson Matthey that is alleged by Shire,” and 

insists that it has put forth other allegations under §§ 271(a), (b), and (c).4

 (D.I. 572, at Fact 10.) 

However, Shire only points to its allegations of future infringement—confirming that JM’s 

written authorization is the single accused act of past infringement. Specifically, Shire is forced 

to cite to identical paragraphs in its five amended complaints against the Defendants: 

Upon information and belief, Johnson Matthey’s commercial manufacture, use, 

sale, offer for sale and/or importation into the United States of the 

lisdexamfetamine dimesylate API that will be used as the main component in the 

[ANDA Defendant’s] Proposed Product that is the subject of [its] ANDA [] will 

infringe one or more claims of the [] patent directly under 35 U.S.C. § 271(a) 

and/or indirectly in a cooperative venture under 35 U.S.C. § 271(b) and/or (c). 

(See D.I. 572, at Fact 10 (citing to D.I. 219 ¶¶ 87, 100, 126; D.I. 220 ¶¶ 84, 97, 125; D.I. 129 ¶¶ 

85, 100, 164; D.I. 221 ¶¶ 84, 97, 123; D.I. 222 ¶¶ 85, 97, 123) (emphasis added).)5

Shire also cites to its Disclosure of Infringement Contention to Johnson Matthey (i.e.

Sawchuck Decl. Ex. 173 D.I. 594-13), and in particular to pages 4-6, which purport to satisfy the 

requirements of Local Patent Rule 3.1(a). (D.I. 572, at Fact 10.) Again, other than the ANDArelated activity, the Infringement Contentions identify only future infringement by JM that might

occur only if the ANDA Defendants market their proposed ANDA products. (Response to Shire 

Fact 77.) It is not disputed that Defendants have not to date marketed their ANDA products. 

Shire’s L. Pat. R. 3.1(h) disclosure of the basis for its willfulness allegations against JM 

is similarly limited to potential future conduct: “JM makes, uses, sells, offers for sale, and/or 

 

4

 Shire also includes § 271(e)(2) in this list, though the relevant allegations cited are those 

already quoted above on written authorization. (See D.I. 219, ¶ 59, 85, 98, 124.) 

5

 Shire also cites back to the many identical “written authorization” paragraphs. (See D.I. 572 at 

Fact 10, citing to D.I. 219 ¶¶ 85, 98, 124; D.I. 220 ¶¶ 82, 95, 123; D.I. 129 ¶¶ 85, 98, 124; D.I. 

221 ¶¶ 82, 95, 121; D.I. 222 ¶¶ 82, 95, 121). 

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imports the lisdexamfetamine dimesylate API in the Defendants’ products despite an objectively 

high likelihood that the Asserted Claims are valid and that Defendants’ products infringe the 

patents-in-suit.” (D.I. 594-13 at 340 (emphasis added).) Though drafted in the present tense, the 

allegation is inherently prospective because the “Defendants’ products” remain hypothetical. 

Perhaps most telling, in the Pre-Trial Order submitted after this motion was filed, Shire 

described its willfulness claims against JM strictly in terms of potential future acts: 

Shire seeks a further judgment declaring that infringement of the patents-insuit is willful if Johnson Matthey commercially manufactures, uses, sells, 

offers to sell, and/or imports any product that is the subject of any of the 

Defendants’ ANDAs and/or DMF No. 22442 that infringes the patents-in-suit. 

(D.I. 546 at 32 (emphasis added).) This request is virtually identical to the Prayer for Relief 

included each of Shire’s Amended Complaints: 

A judgment declaring that infringement of the ‘735 patent is willful if

Defendants commercially manufacture, use, sell, offer to sell and/or 

import any product that is the subject of ANDA No. 202802 and/or DMF 

No. 22442 that infringes the ‘735 patent. 

(See, e.g., D.I. 219, at p. 52, Sec. xiv.) In sum, Shire plead this case in the first instance as a 

traditional ANDA case. To defeat JM’s motion to dismiss, Shire argued vigorously that JM 

should be treated as if it were an ANDA filer. Shire served contentions narrowly describing both 

the infringement and willfulness claims against JM, and never amended those contentions to 

expand its claims. And most recently, in a Pre-Trial Order that Shire had reason to believe 

would strictly constrain its proofs at trial, Shire described its willfulness claim against JM as 

strictly prospective. As a result, Shire should not now be permitted to belatedly expand the 

willfulness claim to address illusory acts of past direct infringement. 

2. The Evidence Shire Cites Is Protected Safe Harbor Activity 

Even if Shire could expand its pleadings to encompass past acts, the purported “evidence 

in the record supporting Shire’s assertion that Johnson Matthey has manufactured, used, offered 

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to sell, and sold lisdexamfetamine API” also does not raise a genuine fact dispute because even 

Shire does not go so far as to assert that such acts constitute “patent infringement.” (See D.I. 572 

at Fact 17.) Nor could Shire credibly contend that such acts constitute infringement in view of 

the safe harbor provision of § 271(e)(1), which provides that: 

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 . . . 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. 

(emphasis added). JM’s activities described in Shire's Responses to Facts 17 and 19, (D.I. 572), 

fall squarely within the safe harbor and thus cannot be infringing acts under the statute. See 

Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 206 (2005) (Congress “exempted 

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.” (citation omitted) (emphasis in original)). By not claiming the past 

activity as infringing and not seeking related damages relief,6

 Shire effectively concedes that 

such activity is protected by the safe harbor. Indeed, that conclusion is compelled by the 

evidence, which demonstrates that each action listed was taken with regard to parties either filing 

or contemplating NDA or ANDA submissions. (See Response to Fact 66.) 

3. Shire’s Focus on JM’s Patent Analyses Is A Mere Distraction 

Shire devotes much of its brief to an examination of JM’s employees’ communications 

about and analyses of the Shire patents. (Opp. Br. at 7-14.) Even viewed in the light most 

 

6

 (See, e.g., D.I. 219, at pp. 50-73 (including no present claim for damages); Proposed Pretrial 

Order (D.I. 546) at 17, 20, 23, 26, 29, 32, 46, 76 (indicating that a) Shire will not call witnesses 

for damages; b) Shire will not offer evidence for damages; and c) Shire does not seek damages 

for past infringement from any Defendant).) 

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favorable to Shire for purposes of summary judgment, Shire’s allegations do not raise a material 

fact issue since Shire has not properly presented claims of actual past infringement, and has not 

advanced a willfulness claim on the basis of such past acts. The reason why Shire is struggling 

to keep its willfulness claim in play is plain. Shire is desperate to preserve some legal basis to 

put before the Court at every possible opportunity JM’s privileged internal analyses reflected in 

documents that Shire should not be permitted to even have or use for any purpose. Although 

Magistrate Judge Waldor held that JM waived its attorney-client privilege and work-product 

protection, JM has appealed that decision (D.I. 552), and Shire should not be permitted to use 

these documents while its appeal is pending. See Fed. R. Civ. P. 26(b)(5)(B) (requiring party to 

not use documents subject to a claim of privilege). Moreover, Shire’s brief and facts also 

improperly use documents to which Roxane has asserted a claim of attorney-client privilege, 

which is also improper under Rule 26(b)(5)(B). 

Shire’s references to these documents in multiple submissions in relation to virtually 

every issue in the case leaves little doubt that Shire’s goal is to prejudice the mind of the fact 

finder against the Defendants and cast doubt on the viability of their arguments. Defendants 

respectfully submit that the Court should not facilitate Shire’s efforts and should instead grant 

summary judgment of no willfulness based on the lack of a material factual dispute. 

C. Shire Cannot Meet The Objective Prong Of Willfulness 

Even if the facts adduced by Shire in its opposition were both accepted as true and 

considered relevant to the “subjective prong” of the willfulness inquiry,7

 Shire fails to point to 

 

7

 Evidence regarding the subjective prong of Seagate is irrelevant to the willfulness inquiry if 

plaintiff cannot first satisfy the objective prong. See DePuy Spine, 567 F.3d at 1337 (declining 

to address subjective prong where plaintiff did not meet objective prong); Tarkus Imaging, Inc. 

v. Adobe Sys., Inc., 867 F. Supp. 2d 534, 538 n.4 (D. Del. 2010) (“[T]he Court may only 

proceed to the subjective second-prong inquiry if the objective prong is first satisfied.”). 

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any evidence in support of the “objective prong” of willfulness as required by the In re Seagate

willful infringement standard. 497 F.3d 1360 (Fed. Cir. 2007) (en banc). 

The objective prong of the Seagate analysis evaluates the reasonableness of the accused 

infringers’ defenses. Bard Peripheral Vascular, Inc. v. W.L. Gore & Assocs., Inc., 682 F.3d 

1003, 1006 (Fed. Cir. 2012), cert. denied, 133 S. Ct. 932 (2013). Under Seagate, the patentee 

must prove “by clear and convincing evidence that the infringer acted despite an objectively high 

likelihood that its actions constituted infringement of a valid patent.” Id. It is well established 

that “both legitimate defenses to infringement claims and credible invalidity arguments 

demonstrate the lack of an objectively high likelihood that a party took actions constituting 

infringement of a valid patent.” Black & Decker, Inc. v. Robert Bosch Tool Corp., 260 F. App’x 

284, 291 (Fed. Cir. 2008). A defense need not be ultimately successful to rebut the first prong. 

See DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1335-37 (Fed. Cir. 

2009). Moreover, of particular relevance here, “[t]he state of mind of the accused infringer is not 

relevant to this objective inquiry.” Seagate, 497 F.3d at 1371; Masimo Corp. v. Philips Elecs. N. 

Am. Corp., No. 09-80-LPS-MPT, 2013 U.S. Dist. LEXIS 83704, at *5-21 (D. Del. June 14, 

2013) (refusing to consider evidence relevant to subjective prong including the “parties’ state of 

mind” where patentee could not meet objective prong). 

In this case, Defendants have put forth, inter alia, defenses of patent invalidity and of 

non-infringement under the §271(e)(1) safe harbor. In its opposition Shire does not even address 

these defenses, let alone put forward evidence that such defenses are objectively unreasonable. 

Indeed, Defendants have moved for summary judgment on certain of these invalidity defenses 

(D.I. 499)—resulting in Shire’s immediate voluntary withdrawal of the claims addressed. (D.I. 

544.) Credible defenses of invalidity militate against a finding of willfulness. See, e.g., Spine 

Solutions, Inc. v. Medtronic Sofamor Danek USA, Inc., 620 F.3d 1305, 1319-20 (Fed. Cir. 2010) 

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(upholding jury’s verdict of nonobviousness while reversing denial of JMOL of no willfulness 

because defendant “was not objectively reckless” in relying on obviousness defense); TGIP, Inc. 

v. AT&T Corp., 527 F.Supp. 2d 561, 579 (E.D. Tex. 2007) (granting JMOL of no willfulness 

“[e]ven though [defendant] ultimately did not prove its invalidity defense by clear and 

convincing evidence” because “its position was hardly objectively unreasonable”). The evidence 

in support of Defendants’ invalidity arguments—and Shire’s reaction to Defendants’ summary 

judgment motion—is at least sufficient to establish that these defense are not “objectively 

unreasonable” as a matter of law. Because Shire cannot meet the objective prong of the Seagate 

analysis, the willfulness inquiry should end there. 

D. The Alleged Future Infringement By Defendants Is Still Speculative 

 As explained in Section III.C. of Defendants’ Opening Brief and in this Court’s holding 

in Celgene Corp. v. Teva Pharmaceuticals USA, Inc., 412 F. Supp. 2d 439, 445 (D.N.J. 2006), 

willfulness claims are not permissible for future conduct, like the contemplated future 

commercial activity alleged here. Though Shire repeatedly uses the word “commercial” in its 

opposition brief to imply that actionable commercial activity has taken place, Shire nevertheless 

concedes that this activity has not yet occurred: 

Moreover, the potential commercial sales by the ANDA Defendants is right 

around the corner. The “30-month stay” is nearly complete, and the ANDA 

Defendants could commercially launch their products unless the Court precludes 

them prior to that time, i.e., by granting Shire’s case-dispositive motion for 

summary judgment (ECF No. 496), a preliminary injunction, or some other decision 

on the merits. Thus, Defendants’ request that Shire’s willful infringement claims be 

dismissed with prejudice because “there has been no commercial launch of the 

generic products at issue” is specious. (Defs. Br. at 6 n.3; Defs. Motion.) 

(Shire’s Opp. Br. at 6-7 (emphasis added).) 

Shire’s urging that its willfulness claims on the future conduct are sustainable because 

“the potential commercial sales by the ANDA Defendant is [sic] right around the corner” is 

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insufficient. (Shire’s Opp. Br. at 6; see also id. at 18, 19.) This argument was tried and rejected 

in Medicines Co. v. Mylan, Inc., No. 11-cv-1285, 2013 U.S. Dist. LEXIS 176269 (N.D. Ill. Dec. 

16, 2013). In that ANDA case, Shire’s own counsel sought to avoid summary judgment of no 

willfulness against its brand name client by arguing “that [the ANDA filer Defendant] will 

willfully infringe the patents-in-suit ‘if [Defendant] commercially manufactures, uses, sells, 

offers to sell, or imports its generic [] product in the future.’” Id. at *76. The Court rejected this 

argument, admonishing Shire’s counsel as follows: 

TMC, however, does not cite any authority suggesting that this type of declaratory 

relief is appropriate. Nor does TMC cite any facts to warrant this type of 

declaratory relief. “Perfunctory and undeveloped arguments, and arguments that 

are unsupported by pertinent authority, are waived.” United States v. Hook, 471 

F.3d 766, 775 (7th Cir. 2006). The Court, therefore, grants Mylan’s motion for 

summary judgment with respect to TMC’s willful infringement claim. See Giffney 

Perret, Inc. v. Matthews, No. 07 C 0869, 2009 U.S. Dist. LEXIS 23531, 2009 WL 

792484, at *16 (N.D. Ill. Mar. 24, 2009) (granting partial summary judgment to 

the defendant because the plaintiffs “undeveloped arguments amounted] to a 

waiver of Plaintiff s opposition to Defendants’ motion for summary judgment”). 

2013 U.S. Dist. LEXIS 176269, at *77-78. Likewise, this Court should reject Shire’s attempt to 

preserve a speculative claim for future willful infringement in this case. 

E. Shire’s Exceptional Case Claims Are Of No Moment 

Throughout its opposition brief, Shire references its 35 U.S.C. § 285 “exceptional case” 

claim as a basis for denying summary judgment. Specifically, Shire presents the backwards and 

misleading argument that, because a finding of willfulness may be relevant to a subsequent 

exceptional case analysis, willfulness claims should automatically survive summary judgment 

where the plaintiff intends to seek an exceptional case ruling. While willful infringement can be 

a predicate for an exceptional case, it is illogical to accept that the existence of an exceptional 

case claim compels denial of summary judgment on the predicate claim. See Celgene, 412 F. 

Supp. 2d at 445 (“This holding [striking willfulness claims] does not prohibit plaintiffs from 

Case 2:11-cv-03781-SRC-CLW Document 622 Filed 03/31/14 Page 15 of 17 PageID: 156208
12 

applying for attorney’s fees under the ‘exceptional cases’ provision of Section 285 if they 

prevail.”). 

III. CONCLUSION 

For the reasons set forth above and in Defendants’ opening brief, the Court should grant 

summary judgment of no willful infringement.

Case 2:11-cv-03781-SRC-CLW Document 622 Filed 03/31/14 Page 16 of 17 PageID: 156209
13 

Dated: March 31, 2014 Respectfully submitted, 

 

By: s/Stuart D. Sender 

Stuart D. Sender 

Ellen T. Lowenthal 

Kenneth E. Crowell 

BUDD LARNER, PC 

150 John F. Kennedy 

Parkway 

Short Hills, NJ 

07078-2703 

H. Keeto Sabharwal 

Daniel E. Yonan 

Marsha R. Gillentine 

Jeremiah B. Frueauf 

STERNE, 

KESSLER, 

GOLDSTEIN & 

FOX P.L.L.C. 

1100 New York 

Avenue, NW 

Washington, DC 

20005 

Attorneys for 

Defendant 

Amneal 

Pharmaceuticals LLC

By: s/Diane Ragosa 

Diane Ragosa 

Saira B. Haider 

AXINN, VELTROP & 

HARKRIDER LLP 

114 West 47th Street 

New York, NY 

10036 

Jonathan A. Harris 

AXINN, VELTROP & 

HARKRIDER LLP 

900 State House Square 

Hartford, CT 

06103 

Attorneys for Defendants 

Actavis Elizabeth LLC 

and Actavis LLC

By: s/Gregory R. Haworth 

Gregory R. Haworth 

DUANE MORRIS LLP 

1037 Raymond 

Boulevard, Suite 1800 

Newark, NJ 07102-5429 

Douglas R. Nemec 

Stacey L. Cohen 

Rachel Blitzer 

SKADDEN, ARPS, 

SLATE, MEAGHER & 

FLOM LLP 

Four Times Square 

New York, NY 10036- 

6522 

Attorneys for Defendants 

Johnson Matthey Inc. and 

Johnson Matthey

Pharmaceutical

Materials.

By: s/Eric I. Abraham 

Eric I. Abraham 

Christina L. Saveriano 

HILL WALLACK LLP 

202 Carnegie Center 

Princeton, NJ 08540 

M. Andrew Woodmansee 

Matthew M. D’Amore 

Eric C. Pai 

MORRISON & 

FOERSTER LLP 

12531 High Bluff Drive 

Suite 100 

San Diego, CA 92130-2040 

Attorneys for Defendant 

Sandoz Inc. 

By: s/Arnold B. Calmann 

Arnold B. Calmann 

Jeffrey Soos 

Geri L. Albin 

SAIBER LLC 

One Gateway Center 

10th Floor, Suite 1000 

Newark, NJ 07102 

Matthew R. Reed 

Katherine Hasper 

WILSON SONSINI 

GOODRICH 

& ROSATI 

650 Page Mill Road 

Palo Alto, CA 94304 

Wendy L. Devine 

WILSON SONSINI 

GOODRICH 

& ROSATI 

12235 El Camino Real 

San Diego, CA 92130 

Attorneys for Defendants 

Mylan Pharmaceuticals 

Inc. and Mylan Inc.

By: s/Mark S. Olinsky 

Mark S. Olinsky 

Theodora McCormick 

SILLS CUMMIS & 

GROSS P.C. 

The Legal Center 

One Riverfront Plaza 

Newark, NJ 

07102 

Alan B. Clement 

Peter Fallon 

LOCKE LORD LLP 

3 World Financial Center 

New York, NY 

10281 

Scott B. Feder 

Myoka Kim Goodin 

Amanda K. Kelly 

LOCKE LORD LLP 

111 South Wacker Drive 

Chicago, IL 60606 

Attorneys for Defendant 

Roxane Laboratories, Inc.

Case 2:11-cv-03781-SRC-CLW Document 622 Filed 03/31/14 Page 17 of 17 PageID: 156210