BUDD LARNER

A PROFESSIONAL CORPORATION 

 COUNSELLORS AT LAW 

150 JOHN F. KENNEDY PARKWAY 

SHORT HILLS, NJ 07078-2703 

973.379.4800 

FAX 973.379.7734 

www.buddlarner.com

942029v2 

NEW YORK CHERRY HILL SHORT HILLS PHILADELPHIA 

Direct Dial (973) 315-4439 

E-Mail: apollack@buddlarner.com 

 July 10, 2013 

Via ECF 

The Honorable Joel A. Pisano 

U.S. District Court for the District of New Jersey 

Clarkson S. Fisher Building & U.S. Courthouse 

402 East State Street 

Trenton, N.J. 08608 

 Re: AstraZeneca/Pozen v. DRL, Lupin & Anchen 

Civil Action No. 3:11-CV-2317-JAP-DEA 

Dear Judge Pisano: 

We represent the DRL defendants and write to explain the connection between two letters 

recently sent to Judge Arpert concerning contentions (D.E. 147 & D.E. 151) and plaintiffs’ 

motion for summary judgment filed June 28, 2013 (D.E. 152).1

 We ask that Your Honor 

schedule a telephone conference to address the matters discussed below and thereafter that Your 

Honor strike the summary judgment motion since there is no case or controversy or jurisdiction 

to hear it because it addresses a defense that DRL does not assert. A conference would be 

particularly helpful because the issues raised in the contention letters are now before Judge 

Arpert, but the summary judgment motion is before Your Honor. Nevertheless, because the 

contention letters and the summary judgment motion raise common issues, they should be 

assessed together. 

These contention letters and this summary judgment motion relate to a contention dispute 

that arose last year. See D.E. 98, 116, 125, 127 - 129 and 134. In that dispute, Plaintiffs 

AstraZeneca and Pozen Inc. (collectively, “Pozen”) sought leave to amend their responses to 

DRL’s invalidity contentions. Pozen argued that the Court should grant Pozen leave to amend its 

responses to DRL’s invalidity contentions because, inter alia, Lupin allowed Pozen to amend its 

 

1

 We attach these contention letters here. They are unrelated to two other letters sent to Judge Arpert recently that 

concern claim construction (D.E. 148 & D.E. 150). The claim construction letters were forwarded to Your Honor 

under cover of John E. Flaherty’s letter dated July 3, 2013 (D.E. 154). 

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Hon. Joel A. Pisano, U.S.D.J. 

July 10, 2013 

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NEW YORK CHERRY HILL SHORT HILLS PHILADELPHIA 

responses to Lupin’s invalidity contentions and Pozen wanted its contentions against DRL to be 

the same as its contentions against Lupin. 

The DRL and Lupin actions are consolidated for discovery purposes. However, citing 

Johnson v. Manhattan Ry. Co., 289 U.S. 479, 496-97 (1933), Judge Arpert denied Pozen’s 

request because “consolidation is permitted as a matter of convenience and economy in 

administration, but does not merge the suits into a single cause, or change the rights of the 

parties, or make those who are parties in one suit parties in another.” D.E. 134, p. 8. In short, 

Lupin’s consent to let Pozen amend its contentions offered no basis to impose those contentions 

on DRL. Judge Arpert also rejected Pozen’s other arguments for leave to amend its contentions. 

Id., pp. 6 - 7. 

After the parties briefed their contention dispute last year, but prior to the Court’s 

decision regarding Pozen’s contention amendment application (D.E. 134), Pozen sued DRL in a 

second Vimovo case (13-00091). Like the earlier Lupin (11-04275) and Anchen (11-06348) 

actions, the second DRL Vimovo case is also consolidated for discovery purposes with the first 

DRL Vimovo case (11-02317). However, DRL’s proposed ANDA product in the second DRL 

Vimovo case is different from its proposed ANDA product in the first DRL Vimovo case. DRL 

developed a different formulation for its second Vimovo ANDA specifically designed to avoid, 

and therefore not infringe, the claims of the ‘907 patent. 

Based upon that difference, Judge Arpert had DRL and Pozen exchange new contentions 

pursuant to the Local Patent Rules. See D.E. 145. Pursuant to that Order and the Local Patent 

Rules, Pozen identified the claims of the ‘907 patent it believed DRL’s second Vimovo ANDA 

infringed. DRL responded only with non-infringement contentions, because unlike in the first 

DRL Vimovo case, in the second DRL Vimovo case, DRL had no need to reach the issue of 

invalidity because non-infringement offers it a complete defense. Thus, DRL served no 

invalidity contentions in the second DRL Vimovo case. 

Despite the absence of invalidity contentions in the second DRL Vimovo case, Pozen 

submitted “validity contentions.” When asked why it submitted validity contentions when DRL 

served no invalidity contentions, Pozen said that its validity contentions responded to DRL’s 

invalidity contentions in the first DRL Vimovo action and DRL’s three-line affirmative defense 

of invalidity in its second DRL Vimovo case answer. The parties discussed this issue with Judge 

Arpert during a June 21, 2013 status conference. He directed the parties to write letters 

explaining this issue further. That request led to the letters attached here (D.E. 147, D.E. 151) as 

well as Pozen’s summary judgment motion. Since the letters and motion both concern the 

absence of DRL invalidity contentions, both should be addressed together and by the same judge. 

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Hon. Joel A. Pisano, U.S.D.J. 

July 10, 2013 

Page 3 

942029v2 

NEW YORK CHERRY HILL SHORT HILLS PHILADELPHIA 

 Pozen’s contention letter to Judge Arpert (D.E. 151, p. 2) explains that it seeks summary 

judgment of validity in the second DRL Vimovo case to preclude DRL from litigating invalidity 

in the first DRL Vimovo case. Recognizing that it would need to prove that “invalidity” was 

“actually litigated” in the second DRL Vimovo case in order to achieve the preclusive effect it 

seeks,2

 Pozen cites the Restatement (Second) of Judgments § 27 (1980), and specifically 

comment (d). Specifically, Pozen argues: 

Summary judgment on the issue of validity in this case will preclude DRL from 

litigating the same issue in DRL I. “When an issue of fact or law is actually 

litigated1 and determined by a valid and final judgment, and the determination is 

essential to the judgment, the determination is conclusive in a subsequent action 

between the parties,2

 whether on the same or a different claim.” Nat’l R.R. 

Passenger Corp. v. Pa. Pub. Util. Comm’n, 288 F.3d 519, 525 (3rd Cir. 2002) 

(quoting Restatement (Second) of Judgments § 27 (1980)). 

1

”When an issue is properly raised, by the pleadings or otherwise, and is submitted for 

determination, and is determined, the issue is actually litigated within the meaning of this Section. 

An issue may be submitted and determined on . . . a motion for summary judgment. . . . A 

determination may be based on a failure of . . . proof.” Restatement (Second) of Judgments § 27 

cmt. D (1980). 

2

”If two actions which involve the same issue are pending between the same parties, it is the first 

final judgment rendered in one of the actions which becomes conclusive in the other action, 

regardless of which action was brought first.” Restatement (Second) of Judgments § 27 cmt. l 

(1980)); see also id. § 14 (“For purposes of res judicata, the effective date of a final judgment is 

the date of its rendition, without regard to the date of commencement of the action in which it is 

rendered or the action in which it is to be given effect.”) 

 However, this same Restatement, in the very next comment, clearly explains why Pozen’s 

3-page summary judgment motion cannot yield an “actually litigated” result. 

 Comment (e) of this Restatement, entitled “Issues not actually litigated,” explains that: 

• “There are many reasons why a party may choose not to raise an issue, or to contest an 

assertion, in a particular action.” (Here, for example, DRL has no need to argue 

invalidity in its second case and, in fact, if it succeeds in its non-infringement argument 

will benefit from not invalidating the patent.)

 

2 As the party contending that an issue has been conclusively litigated and determined in a prior action, Pozen has 

the burden of proving this contention. See Restatement (Second) of Judgments § 27 (1980), cmt. (f). 

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Hon. Joel A. Pisano, U.S.D.J. 

July 10, 2013 

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NEW YORK CHERRY HILL SHORT HILLS PHILADELPHIA 

• “[I]f preclusive effect were given to issues not litigated, the result might serve to 

discourage compromise, to decrease the likelihood that the issues in an action would be 

narrowed by stipulation and thus intensify litigation.” (Here, for example, DRL would 

not choose to narrow the issues in the second DRL Vimovo case by dropping a validity 

challenge if the effect of that required DRL to concede validity in the first DRL Vimovo 

case.) 

• “An issue is not actually litigated if the defendant might have interposed it as an 

affirmative defense but failed to do so; nor is it actually litigated if it is raised by a 

material allegation of a party’s pleading but is admitted (explicitly or by virtue of a 

failure to deny) in a responsive pleading.” (Here, the issue would not be litigated 

because DRL’s failure to raise it in contentions would be an admission of or a failure to 

deny validity.) 

• “In the case of a judgment entered by confession, consent, or default, none of the issues is 

actually litigated. Therefore, the rule of this Section does not apply with respect to any 

issue in a subsequent action.” (Here, because Pozen’s summary judgment motion would 

be equivalent to a default judgment, it cannot be “actually litigated.”) 

 Courts in the Third Circuit and elsewhere have held that matters were not “actually 

litigated” in situations like this one. See Power Integrations, Inc. v. Fairchild Semiconductor 

Int’l, Inc., 763 F. Supp. 2d 671, 680 (D. Del. 2010) (Where the same parties in a prior trial 

litigated patent obviousness (after the accused infringer generally pled patent invalidity in its 

answer), issue preclusion did not apply to anticipation in a second trial regarding the same patent 

and the same parties because anticipation was not “actually litigated” though obviousness was). 

If the assertion of invalidity in general in an answer,3

 plus subsequent litigation through trial of 

obviousness cannot preclude later litigation of anticipation of the same patent, DRL’s dropping 

its affirmative defense of all invalidity issues cannot preclude all invalidity contentions in a 

separate case. Moreover, where an issue is not argued by a party and thus receives insufficient 

analysis by the Court, that issue is not “actually litigated” and cannot have preclusive effect in a 

later case. See Chicago Truckers Drivers Pension Fund v. Century Motor Freight, Inc., 125 F.3d 

526, 530 (7th Cir. 1997).4

 

 

3 The Power decision does not describe the affirmative defenses to the complaint at issue. However, that answer 

included a general invalidity defense. See Power, No. 08-309, D.E. 49, ¶ 30 (D. Del. filed Nov. 7, 2008), “Second 

Defense: Invalidity of the Asserted Patents” (“The ‘851 Patent, the ‘876 Patent, and the ‘270 Patent are invalid for 

failing to comply with the provisions of the Patent Laws, Title 35 U.S.C, including without limitation 35 U.S.C §§ 

102, 103, 112, 121 and/or under the doctrine of obviousness-type double patenting”). 

4

 Courts have also held that an issue is not “actually litigated” if a party drops its defense relevant to it. See Amadeo 

v. Principal Mutual Life Ins. Co., 290 F.3d 1152, 1159 (9th Cir. 2002) (“A voluntary dismissal of a claim prior any 

adjudication and without any stipulated findings of fact does not actually litigate any issue”); Adolph Coors Co. v. 

Case 3:11-cv-02317-JAP-DEA Document 158 Filed 07/10/13 Page 4 of 14 PageID: 5634
Hon. Joel A. Pisano, U.S.D.J. 

July 10, 2013 

Page 5 

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NEW YORK CHERRY HILL SHORT HILLS PHILADELPHIA 

 Both this Court’s Local Patent Rules and the law regarding issue preclusion work to 

streamline litigation and focus the parties on the core issues and resolve others. See D.E. 134, p. 

4. (“The rules are designed specifically to ‘require parties to crystallize their theories of the case 

early in litigation and to adhere to those theories once they have been disclosed.’” citing Atmel Corp. 

v. Info. Storage Devices, Inc., 1998 WL 775115, at *2 (N.D. Cal. Nov. 5, 1998). Restatement 

(Second) of Judgments § 27 (1980), comment (e) (“[I]f preclusive effect were given to issues not 

litigated, the result might serve to discourage compromise, to decrease the likelihood that the issues 

in an action would be narrowed by stipulation and thus intensify litigation”). 

The Local Patent Rules narrow cases by requiring an identification of asserted claims. 

The point of doing that before disclosure of non-infringement and/or invalidity contentions is so 

that those contentions address only the asserted claims. See Allyn Lite, New Jersey Federal 

Practice Rules (2013 ed.), Comment to Local Civil Rule 9.3, at 151. Similarly, responsive

contentions properly address only those already raised. By attempting to conflate the contentions 

in the two DRL Vimovo cases, Pozen upends a primary purpose of the Local Patent Rules: to 

streamline cases and remove issues. Rather than focusing on DRL’s existing non-infringement 

contentions in the second DRL Vimovo case, Pozen proposes to add in new “validity 

contentions” to a case with no invalidity contentions. In doing so, Pozen seeks to broaden what 

should be a relatively straightforward non-infringement case by forcing DRL to assert invalidity 

in the second case or to risk preclusion in the first case based on a procedurally defective 

summary judgment motion. We ask Your Honor to strike Pozen’s motion for lack of subject 

matter jurisdiction. 

 The case law in this jurisdiction holds that such motion practice is forbidden. Based on a 

lack of the requisite “case and controversy,” Judge Garrett Brown procedurally denied summary 

judgment of invalidity of a claim in a patent case because of a patent holder’s statement that it 

would not assert that claim against the accused infringer in that or any other case. See Teva 

Pharm. Ind., Ltd. v. Dr. Reddy’s Lab., Ltd., 2008 U.S. Dist. LEXIS 16958 at *11 (D.N.J. Mar. 4, 

2008) (“The case and controversy requirement must be evaluated claim by claim. . . and Teva 

has conceded that it is not pursuing an infringement claim as to claim 1 of the ‘008 patent”). 

 IRS, 519 F.2d 1280, 1283 (10th Cir. 1975) (“To obtain the protection afforded by the doctrine of collateral estoppel 

an issue must have been raised, litigated and actually adjudged on the merits in the first proceeding. Here, the 

overhead issue was raised but, because it was abandoned by the IRS, was not judicially determined”); U.S. v. Young, 

804 F.2d 116, 118 (8th Cir. 1986) (“A fact established in prior litigation not by judicial resolution but by stipulation 

has not been ‘actually litigated’ and thus is the proper subject of proof in subsequent proceedings”); Serby v. First 

Alert, Inc., 2013 U.S. Dist. LEXIS 45942, at *15 (E.D.N.Y. Mar. 27, 2013), citing Restatement (Second) of 

Judgments § 27, comment (e) (earlier settlement and Rule 41 dismissal with prejudice had no preclusive effect in 

later patent case concerning same patent because “[w]here a judgment between parties is entered by consent prior to 

trial on any issue, no issue may by be said to have been fully, fairly or actually litigated”). 

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Hon. Joel A. Pisano, U.S.D.J. 

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NEW YORK CHERRY HILL SHORT HILLS PHILADELPHIA 

Moreover, when pursuant to this Court’s Local Patent Rules, a party narrows its asserted claims 

in contentions, the Court loses subject matter jurisdiction over those not asserted in the 

contentions, even if they had been asserted in the complaint. See Hoffman-La Roche Inc. v. 

Mylan Pharm. Inc., 2009 U.S. Dist. LEXIS 114784 at *20–21 (D.N.J. Dec. 9, 2009) (accused 

infringer failed to demonstrate a live case or controversy with respect to claims whose assertion 

patent holder did not carry forward in local rule contentions). 

 Here, like the patentees in the case above who dropped their assertion of particular patent 

claims, DRL has dropped the affirmative defense of invalidity through its contentions. Thus, 

there is no case and controversy regarding invalidity in the second DRL Vimovo case and the 

Court should strike Pozen’s summary judgment motion without requiring a DRL response. That 

would properly keep the issues narrowly focused on the only dispute, i.e., non-infringement. 

The alternative (which Pozen hopes to provoke) is for DRL to seek amendment of its contentions 

to raise invalidity in the second case or to litigate in the first case whether the grant of summary 

judgment in case two has preclusive effect in case one. 

 Since we believe Pozen's motion is improper, and hope to avoid unnecessary motion 

practice, we ask for a conference on this issue and, after such submissions and consideration as 

Your Honor deems appropriate, that Your Honor strike the motion. 

 

 Respectfully submitted, 

___________________ 

Alan H. Pollack 

cc: Counsel of Record (by email) 

Case 3:11-cv-02317-JAP-DEA Document 158 Filed 07/10/13 Page 6 of 14 PageID: 5636
BUDD LARNER

A PROFESSIONAL CORPORATION 

 COUNSELLORS AT LAW 

150 JOHN F. KENNEDY PARKWAY 

SHORT HILLS, NJ 07078-2703 

973.379.4800 

FAX 973.379.7734 

www.buddlarner.com

00940788 

NEW YORK CHERRY HILL SHORT HILLS PHILADELPHIA 

Direct Dial (973) 315-4439 

E-Mail: apollack@buddlarner.com 

 June 26, 2013 

Via ECF 

The Honorable Douglas E. Arpert 

U.S. District Court for the District of New Jersey 

Clarkson S. Fisher Building & U.S. Courthouse 

402 East State Street 

Trenton, N.J. 08608 

 Re: AstraZeneca/Pozen v. DRL, Lupin & Anchen 

Civil Action No. 3:11-CV-2317-JAP-DEA 

Dear Judge Arpert: 

As per Your Honor’s instructions during the June 21, 2013 scheduling conference, DRL 

writes to explain why the “validity contentions” sent by Pozen on June 13, 2013 are improper 

and contravene this Court’s Local Patent Rules. The Local Patent Rules permit a “response to 

invalidity contentions” when the accused infringer serves invalidity contentions. In the case at 

issue, DRL served no invalidity contentions. Pozen’s “response” is therefore improper and 

should be stricken. 

 At the May 9, 2013 status conference, Pozen argued that its second vimovo case against 

DRL needed a new and discrete round of contentions under the Local Patent Rules. 

Accordingly, the Court entered a Scheduling Order (D.E. 145) specific to the second of the two 

DRL vimovo cases that required “DRL [to] disclose its invalidity and non-infringement 

contentions to Plaintiffs by May 23, 2013.” DRL disclosed only non-infringement contentions 

and disclosed no invalidity contentions. As a result, unless DRL were to seek leave to amend its 

contentions, it cannot in this case argue invalidity – even if its Notice Letter raised that 

possibility. But unlike the ANDA product at issue in the first DRL vimovo case, DRL designed 

the ANDA product at issue here specifically to avoid infringement, and therefore this case does 

not need to reach the issue of invalidity. Accordingly, DRL did not serve invalidity contentions. 

Pozen nevertheless interposed validity contentions despite DRL's decision to forgo any invalidity 

contentions. 

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Hon. Douglas E. Arpert, U.S.M.J. 

June 26, 2013 

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NEW YORK CHERRY HILL SHORT HILLS PHILADELPHIA 

 During the June 21st telephone conference, Stephen Hash, on behalf of Pozen, argued that 

Pozen had a “duty and obligation” to submit “validity contentions” because DRL’s answer and 

Notice Letter referenced invalidity defenses. That is the only argument Pozen offers. That 

argument must fail because it renders L. Pat. R. 3.6(c) meaningless and undermines the main 

point of the contention process of the Local Patent Rules: to winnow the issues down and focus 

the case on fewer disputes. Surely Pozen does not contend that DRL, who failed to serve 

invalidity contentions, can nevertheless argue invalidity because its Notice Letter discussed 

invalidity. To the contrary, DRL would be required to seek leave of court to add invalidity 

contentions belatedly. If the Court were to permit belated invalidity contentions, the Court 

would then permit the patent holder to put in a “Response to Invalidity Contentions.” See L. Pat. 

R. 3.6(i). But an amendment to add invalidity contentions is not a matter of right. As Your 

Honor has held in several cases including this one, “the Local Patent Rules require parties to 

crystallize their theories of the case early in litigation and to adhere to those theories once they 

have been disclosed,” King Pharms., Inc. v. Sandoz Inc., 2010 WL 2015258, at *4 (D.N.J. May 

20, 2010). D.E. 134, p. 9. 

 Pozen’s stated excuse – “needing” to respond to DRL’s answer and Notice Letter – is 

therefore plainly untrue. What Pozen is apparently trying to do is to use the contention process 

of the second DRL vimovo case as a hook to refer to and use in the first DRL vimovo case the 

very contentions this Court refused Pozen leave to add into the first DRL vimovo case. See D.E. 

134. But slipping those contentions into the second DRL vimovo case is inappropriate.1

 As this 

Court noted just three months ago in denying Pozen leave to amend contentions in the first DRL 

vimovo case, consolidation for discovery does not merge the various cases. D.E. 134. p 8 

(“Plaintiffs, therefore, may not amend their responses simply to promote uniformity among the 

consolidated actions.”). 

If Pozen thinks the existence of the second DRL vimovo case justifies an amendment to 

its contentions in the first DRL vimovo case, it should be forthright and say so. Then the proper 

path for Pozen would be to seek leave to amend its contentions in the first DRL vimovo case and 

not to pretend that assertions made in the Notice Letter or a three-line affirmative defense in an 

answer, but that DRL never carried forward in any contentions, somehow warrant Pozen’s 60-

page “validity contention” response. If Pozen were to make such a motion, DRL could then 

respond to whatever arguments Pozen may make and the Court would have the merits of the 

issue presented. 

 

1

 Incorporating the disputed validity contentions into the second DRL vimovo case is also 

pointless since DRL does not in the second DRL vimovo case claim the patent is invalid. 

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Hon. Douglas E. Arpert, U.S.M.J. 

June 26, 2013 

Page 3 

940788 

NEW YORK CHERRY HILL SHORT HILLS PHILADELPHIA 

 There are seven prior versions of Pozen “validity contentions.”2 This would be the 

eighth, and the fourth directed to DRL. Pozen’s effort to introduce yet another set of “validity 

contentions” through the back door must be rejected. 

 For all the reasons set forth here and in the D.E. 116, 129 and 134, the Court should strike 

Pozen’s June 14, 2013 “validity contentions” in their entirety. DRL encloses a Proposed Order 

for the convenience of the Court consistent with this request. 

 

 Respectfully submitted, 

___________________ 

Alan H. Pollack 

cc: Counsel of Record (by email) 

attachment 

 

2

 (1) Pozen’s original validity contentions to DRL; (2) Pozen’s original validity contentions to 

Lupin; (3) Pozen’s Proposed Amended validity contentions to Lupin; (4) Pozen’s Proposed 

Amended validity contentions to DRL; (5) Pozen’s “Compromise” validity contentions to Lupin; 

(6) Pozen’s proposed “Compromise” validity contentions to DRL; and (7) Pozen’s validity 

contentions to Anchen. 

Case 3:11-cv-02317-JAP-DEA Document 158 Filed 07/10/13 Page 9 of 14 PageID: 5639
940894 

UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF NEW JERSEY 

 

ASTRAZENECA AB, ASTRAZENECA : Civil Action No. 11-2317 (JAP-DEA) 

LP, and POZEN INC., : 

 Plaintiffs, : 

 v, : 

DR. REDDY’S LABORATORIES INC. and: 

DR. REDDY’S LABORATORIES LTD., : 

 Defendants. : 

ASTRAZENECA AB, ASTRAZENECA : Civil Action No. 11-04275 (JAP-DEA) 

LP, KBI-E INC., and POZEN INC., : 

 Plaintiffs, : 

 v. : 

LUPIN LTD. and LUPIN : 

PHARMACEUTICALS INC., : 

 Defendants. : 

ASTRAZENECA AB, ASTRAZENECA : Civil Action No. 11-06348 (JAP-DEA) 

LP, KBI-E INC., and POZEN INC., : 

 Plaintiffs, : 

 v. : 

ANCHEN PHARMACEUTICALS, INC., : 

 Defendants. : 

ASTRAZENECA AB, ASTRAZENECA : Civil Action No. 13-00091 (JAP)(DEA) 

LP, and POZEN INC., : 

 Plaintiffs, : 

 v, : 

DR. REDDY’S LABORATORIES INC. and: 

DR. REDDY’S LABORATORIES LTD., : 

 Defendants. : 

[PROPOSED] ORDER STRIKING CONTENTIONS

WHEREAS, Defendants Dr. Reddy’s Laboratories Inc. and Dr. Reddy’s 

Laboratories Ltd. (“DRL”) has, by letter dated June 26, 2013, moved to strike the 

contentions of Plaintiffs AstraZeneca AB, AstraZeneca LP, and Pozen Inc. (“Pozen”), 

entitled “ASTRAZENECA AB’S, ASTRAZENECA LP’S, KBI-E INC.’S, AND POZEN 

INC.’S RESPONSES TO DR. REDDY’S LABORATORIES, INC. AND DR. REDDY’S 

LABORATORIES, LTD.’S INVALIDITY CONTENTIONS PURSUANT TO L. PAT. 

R. 3.6(i)” and the associated chart entitled “PLAINTIFFS’ RESPONSIVE 

Case 3:11-cv-02317-JAP-DEA Document 158 Filed 07/10/13 Page 10 of 14 PageID: 5640
940894

CONTENTIONS PURSUANT TO L. PAT. R. 3.4A(c) and 3.6(i),” both dated June 13, 

2013; 

WHEREAS, by letter dated June 28, 2013, Pozen opposed DRL’s motion to 

strike the Pozen contentions described above; 

THEREFORE, these matters, having come before the Court in the status 

conference conducted on June 21, 2013, and all parties having had a full opportunity to 

be heard through the letters described above: 

IT IS on this ___th day of July, 2013, 

ORDERED that the motion to strike the invalidity contentions described above is 

GRANTED. 

 

 ___________________________________ 

 DOUGLAS E. ARPERT 

 United States Magistrate Judge 

Case 3:11-cv-02317-JAP-DEA Document 158 Filed 07/10/13 Page 11 of 14 PageID: 5641
John E. Flaherty

Partner 

T. 973.639.7903 

F. 973.297.3971 

jflaherty@mccarter.com

McCarter & English, LLP 

Four Gateway Center 

100 Mulberry Street 

Newark, NJ 07102-4056 

T. 973.622.4444 

F. 973.624.7070 

www.mccarter.com 

BOSTON

HARTFORD 

NEW YORK 

NEWARK 

PHILADELPHIA 

STAMFORD 

WILMINGTON 

June 28, 2013 

VIA ECF 

Hon. Douglas E. Arpert, U.S.M.J. 

U.S. District Court for the District of New Jersey 

Clarkson S. Fisher Building & U.S. Courthouse 

402 East State Street 

Trenton, New Jersey 08608 

RE: AstraZeneca AB, et al. v. Dr. Reddy’s Laboratories, Ltd., et al., 

 Civ. Action No. 3:11-cv-02317 (consolidated for discovery) 

Dear Judge Arpert: 

 We, along with Covington & Burling and Vinson & Elkins represent 

Plaintiffs AstraZeneca AB, AstraZeneca LP, KBI-E Inc., and Pozen Inc. 

(collectively, “Plaintiffs”) in this Hatch-Waxman litigation involving the patents 

related to the product Vimovo®. DRL has filed two separate ANDAs relating to 

those patents. Those filings came nearly two years apart and have resulted in two 

separate Hatch-Waxman cases. Civil Case No. 3:11-cv-2317 (“DRL I”) was filed on 

April 21, 2011. Civil Case No. 3:13-cv-91 (“DRL II”) is more recent, filed on 

January 4, 2013. 

 This letter responds to DRL’s June 26, 2013, letter in which DRL challenged 

Plaintiffs’ service of Responses to Invalidity Contentions in DRL II under L. Pat. R. 

3.4A and 3.6(i) (the “Responses”). In their letter, DRL suggests entry of an order 

striking Plaintiffs’ Responses. In this letter, we suggest the entry of an order 

granting summary judgment against DRL on its affirmative defense of patent 

invalidity. 

 Plaintiffs served their Responses to rebut DRL’s allegations that the claims of 

U.S. Pat. No. 6,929,907 (“the ’907 Patent”) are invalid. DRL certified to the FDA 

that the claims of the ’907 Patent were, inter alia, invalid in connection with its 

second ANDA, and detailed its invalidity allegations in its November 20, 2012, 

Notice Letter to Plaintiffs. Plaintiffs, in their Complaint, requested that the Court 

resolve that dispute by entering judgment that the claims of the patents-in-suit, 

including the ’907 Patent, are valid. See Dkt. 1. DRL, in turn, pleaded invalidity of 

the ’907 Patent as an affirmative defense in its Answer. 

Despite the dispute over the validity of the ’907 Patent, DRL did not serve 

invalidity contentions to support its defense or to rebut Plaintiffs’ request for 

judgment. DRL provided no explanation at the time for its failure to do so. 

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Hon. Douglas E. Arpert, U.S.M.J. 

June 28, 2013 

Page 2

Plaintiffs served their Responses to rebut DRL’s allegations of invalidity “to the 

extent DRL intends to rely on or incorporate by reference its Invalidity Contentions 

served in DRL I in this case.” Responses at 1. Shortly after Plaintiffs served their 

responses, DRL informed Plaintiffs that DRL had decided not to serve invalidity 

contentions in this case, and DRL’s letter to the Court likewise states that it has made 

a “decision to forgo any invalidity contentions” in this case. 

 If DRL’s adamant representation that it has decided not to put forward 

evidence of invalidity in this case can be taken at face value, the Court should enter 

summary judgment in Plaintiffs’ favor on DRL’s affirmative defense of invalidity. 

Patent claims are presumed valid and may only be proven invalid by clear and 

convincing evidence. Robotic Visions Sys., v. View Eng’g., Inc., 189 F.3d 1370, 

1377 (Fed. Cir. 1999). Without any evidence to support its affirmative defense of 

invalidity, DRL cannot prevail on that defense, and Plaintiffs are entitled to summary 

judgment. Celotex Corp. v. Catrett, 477 U.S. 317, 477-78 (1986) (“One of the 

principal purposes of the summary judgment rule is to isolate and dispose of 

factually unsupported claims or defenses.”). Accordingly, Plaintiffs are filing today 

and providing with this letter a motion for summary judgment that the claims of the 

’907 Patent are not invalid. 

 Summary judgment on the issue of validity in this case will preclude DRL 

from litigating the same issue in DRL I. “When an issue of fact or law is actually 

litigated1 and determined by a valid and final judgment, and the determination is 

essential to the judgment, the determination is conclusive in a subsequent action 

between the parties,2 whether on the same or a different claim.” Nat’l R.R. 

Passenger Corp. v. Pa. Pub. Util. Comm’n, 288 F.3d 519, 525 (3rd Cir. 2002) 

(quoting Restatement (Second) of Judgments § 27 (1980)). 

 It may be that DRL wants to be taken at its word that it does not contest the 

validity of the patent and, presumably, is prepared to have judgment entered. That 

judgment may moot the entire issue in both cases. 

 

1

 “When an issue is properly raised, by the pleadings or otherwise, and is submitted for 

determination, and is determined, the issue is actually litigated within the meaning of this 

Section. An issue may be submitted and determined on . . . a motion for summary judgment . 

. . . A determination may be based on a failure of . . . proof.” Restatement (Second) of 

Judgments § 27 cmt. D (1980). 

2

 “If two actions which involve the same issue are pending between the same parties, it is the 

first final judgment rendered in one of the actions which becomes conclusive in the other 

action, regardless of which action was brought first.” Restatement (Second) of Judgments § 

27 cmt. l (1980)); see also id. § 14 (“For purposes of res judicata, the effective date of a final 

judgment is the date of its rendition, without regard to the date of commencement of the 

action in which it is rendered or the action in which it is to be given effect.”) 

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Hon. Douglas E. Arpert, U.S.M.J. 

June 28, 2013 

Page 3

 Now, it may be that DRL decided to try for some strategic or tactical 

advantage in the DRL II case by not raising invalidity contentions. Rather, mindful 

that Your Honor had denied Plaintiffs’ request to amend its Responses to DRL’s 

invalidity contentions in the earlier DRL I case, the defendant may have hoped to 

prevent Plaintiffs from presenting the full response in DRL II: a case that came about 

because DRL elected to file a second ANDA challenging the same patents. It was 

DRL’s decision that resulted in the second case (DRL II). If DRL is not willing to 

consent to judgment on validity it should not be allowed to preclude a full defense of 

the validity of the patents in both cases. 

 If DRL is seeking some strategic advantage by, in effect, relying on its 

DRL I invalidity contentions and invalidity defense for the DRL II case without 

giving Plaintiffs an opportunity to provide the responses to those contentions—as 

required under the Court’s Local Rules—then Plaintiffs should have an opportunity 

to provide their Responses. DRL chose to file a second ANDA and chose to raise 

the issue of validity in the ensuing case, aware that these choices would lead to an 

opportunity, not only for itself to raise new invalidity contentions or rely on those 

served in DRL I, but also for Plaintiffs to respond. 

 Perhaps recognizing this issue, on page 2 of its letter, DRL recognizes that 

the second action represents changed conditions and arguably would warrant 

application of the Responses to both cases. We agree. The filing of the second case 

following from DRL’s decision to file a second ANDA is a changed circumstance 

that provides good cause for amending the Responses in DRL I. Plaintiffs have 

timely provided their Responses, and DRL cannot now argue that it will be 

prejudiced by alleged delay in Plaintiffs’ Responses as it did in its opposition to 

Plaintiff’s earlier motion for leave to amend in DRL I. The new case is just getting 

underway, and the parties have now largely agreed to a schedule to start and finish 

fact and expert discovery. The Responses in DRL II should stand and Amendment 

in DRL I is appropriate under all the present circumstances. 

Respectfully submitted, 

s/John E. Flaherty 

John E. Flaherty 

cc: Counsel of Record (via email) 

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