IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE v. IPR ... · 2010. 12. 17. · IN...

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

AstraZeneca Pharmaceuticals LP, IPR Pharmaceuticals, Inc., AstraZeneca AB, and The Brigham and Women's Hospital, Inc.,

Plaintiffs,

v.

Apotex Corp.,

Defendant.

Civil Action No. 10-338-RBK-KW

PUBLIC VERSION D.I. 23


Plaintiffs,

v.

Aurobindo Pharma Limited,

Defendant.




Plaintiffs,

v.

Cobalt Pharmaceuticals Inc. and Cobalt Laboratories Inc.,

Defendants.



Case 1:10-cv-00338-RBK-KW Document 25 Filed 10/11/10 of 39 PageID #: 350


Plaintiffs,

v.

Glenmark Generics Inc., USA,

Defendant.




Plaintiffs,

v.

Mylan Pharmaceuticals Inc.,

Defendant.




Plaintiffs,

v.

Par Pharmaceutical, Inc.,

Defendant.





Plaintiffs,

v.

Sun Pharmaceutical Industries Ltd.,

Defendant.




Plaintiffs,

v.

Teva Pharmaceuticals USA, Inc.,

Defendant.




Plaintiffs,

v.

Torrent Pharmaceuticals Ltd. and Torrent Pharma Inc.,

Defendants.

Civ. Action No. 10-584-RBK-KW


PLAINTIFFS' ANSWERING BRIEF IN OPPOSITION TO DEFENDANTS' MOTIONS TO DISMISS


Ford F. Farabow FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER LLP 901 New York Avenue, N.W. Washington, DC 20001 Telephone: (571) 203-2700

Charles E. Lipsey Kenneth M. Frankel York M. Faulkner FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER LLP 11955 Freedom Drive, Suite 800 Reston, Virginia 20190 Telephone: (571) 203-2700

Mary K. Ferguson, Ph.D. Nathaniel S. Edwards, Ph.D. FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER LLP 55 Cambridge Parkway, Suite 700 Cambridge, MA 02142 Telephone: (617) 452-1600

Mary W. Bourke (#2356) Dana K. Severance (#4869) CONNOLLY BOVE LODGE & HUTZ LLP 1007 N. Orange Street Wilmington, DE 19899 Facsimile: (302) 658-5614 [email protected] [email protected]

Counsel for Plaintiffs

Bruce S. Manheim, Jr. ROPES & GRAY One Metro Center 700 12th Street, NW, Suite 900 Washington, DC 20005-3948 Telephone: (202) 508-4696

Henry J. Renk FITZPATRICK, CELLA, HARPER & SCINTO Avenue of the Americas New York, NY 10104-3800 Telephone: (212) 218-2100

Of Counsel for Plaintiffs AstraZeneca Pharmaceuticals LP, IPR Pharmaceuticals, Inc., and AstraZeneca AB

Dated: October 8, 2010

Of Counsel for Plaintiffs AstraZeneca Pharmaceuticals LP, IPR Pharmaceuticals, Inc., and AstraZeneca AB


TABLE OF CONTENTS

TABLE OF AUTHORITIES iii

I. NATURE AND STAGE OF THE PROCEEDINGS 1

II. SUMMARY OF THE ARGUMENT 3

III. STATEMENT OF FACTS 5

A. CRESTOR® and Plaintiffs' NDA 5

B. Defendants' ANDAs and Listing of the Patents-in-Suit 5

C. The First Set of CRESTOR® ANDA Actions 5

D. Indications for HeFH and Primary Prevention in the CRESTOR® Label 6

E. Plaintiffs' Complaints in the Current Set of Actions 8

IV. ARGUMENT 9

A. This Court Has Subject Matter Jurisdiction Over Plaintiffs' Claims for Patent Infringement 9

B. Plaintiffs' Complaints State a Claim of Infringement Under 35 U.S.C. § 271(e)(2) 11

1. 35 U.S.C. § 271(e)(2) Does Not Require that Defendants' ANDAs Include Paragraph IV Certifications 11

a. The plain language of 35 U.S.C. § 271(e)(2) does not require a Paragraph IV certification 12

b. Courts have recognized infringement under 35 U.S.C. § 271(e)(2) when there was no Paragraph IV certification 13

c. Neither the Supreme Court nor the Federal Circuit have required that a Paragraph IV certification be included in an ANDA to state a claim for infringement under § 271(e)(2) 15

2. Submission of a Section viii Statement Does Not Immunize Defendants from Suit 18

3. If the Court Were To Consider Extraneous Materials, then the Motions To Dismiss Must Be Converted to Motions for Summary Judgment and Plaintiffs Should Be Permitted Discovery 21

i


22

I 23

C. Plaintiffs' Infringement Claims Are Ripe for Adjudication

D.

E. Plaintiffs' Claim that Aurobindo Infringes the '618 Patent Is Not Barred by Claim Preclusion

25

V. CONCLUSION 26

ii


TABLE OF AUTHORITIES

Cases

Abbott Labs. v. Baxter Pharm. Prods., Inc., 471 F.3d 1363 (Fed. Cir. 2006) 16

Abraxis Bioscience, Inc. v. Navinta, LLC, 640 F. Supp. 2d 553 (D.N.J. 2009) 23

Acumed LLC v. Stryker Corp., 525 F.3d 1319 (Fed. Cir. 2008) 26

Allergan, Inc. v. Alcon Labs., Inc., 324 F.3d 1322 (Fed. Cir. 2003) passim

Apotex v. Thompson, 347 F.3d 1335 (Fed. Cir. 2003) 16

AstraZeneca Pharms., LP v. Aurobindo Pharma Limited, Civ. No. 08-md-1949, 2009 WL 483131 (D. Del. Feb. 25, 2009) 10

Bayer Healthcare, LLC v. Norbrook Labs., Ltd., 370 Fed. Appx. 103 (Fed. Cir. 2010) 20

Bayer Heathcare, LLC v. Norbrook Labs., Ltd, No. 08-C-0953, 2009 WL 637911 (E.D. Wisc. Sep. 24, 2009) 15, 20

Bayer Schera Pharma AG v. Sandoz, Inc., No. 08 Civ. 03710, 2010 WL 3768220 (S.D.N.Y. Sep. 28, 2010) 19

Bristol-Myers Squibb Co. v. Royce Labs., Inc., 69 F.3d 1130 (Fed. Cir. 1995) 16, 17

Bristol-Myers Squibb Co., v. Mylan Pharms., Inc., C.A. No. 09-651 (D. Del. Jan. 14, 2010) 14

Caraco Pharm. Labs., Ltd. v. Forest Labs., Ltd., 527 F.3d 1278 (Fed. Cir. 2008) 16

Conn. Nat'l Bank v. Germain, 503 U.S. 249 (1992) 12

CoreStates Bank, N.A. v. Huls America, Inc., 176 F.3d 187 (3d Cir. 1999) 25

Eisai Co., Ltd. v. Mutual Pharmaceuticals Co., No. 06-3613, 2007 WL 4556958 (D.N.J. Dec. 20, 2007) 11, 17, 21

iii


Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (1990) 16, 19

Glaxo Group Ltd. v. Apotex, Inc., 272 F. Supp. 2d 772 (N.D. Ill. 2003) 14, 16

Glaxo Group Ltd. v. Apotex, Inc., 376 F.3d 1339 (Fed. Cir. 2004) 15

Hughes Aircraft Co. v. Jacobson, 525 U.S. 432 (1999) 12

Impax Labs., Inc. v. Aventis Pharms., Inc., 235 F. Supp. 2d 390 (D. Del. 2002) 13, 14

Impax Labs., Inc. v. Aventis Pharms., Inc., 468 F.3d 1366 (Fed. Cir. 2006) 13, 14

In re Rosuvastatin Calcium Patent Lit., MDL No. 08-1949-JJF, 2010 U.S. Dist. LEXIS 64475 (D. Del. Jun. 29, 2010) 6

Janssen Pharmaceutica, NV. v. Apotex, Inc., 540 F.3d 1353 (Fed. Cir. 2008) 16

Kearns v. General Motors Corp., 94 F.3d 1553 (Fed. Cir. 1996) 25, 26

Merck & Co. v. Apotex, Inc., 292 Fed. App'x 38 (Fed. Cir. 2008) 16

Merck & Co., Inc. v. Teva Pharm USA, Inc., 347 F.3d 1367 (Fed. Cir. 2003) 23

Nordisk A/S v. Caraco Pharm. Labs., Ltd., 601 F.3d 1359 (Fed. Cir. 2010) 16

Novo Nordisk Inc. v. Mylan Pharms. Inc., No. 09-2445, 2010 WL 1372437 (D.N.J. Mar. 31, 2010) 11, 17, 21

Purepac Pharm. Co. v. Thompson, 238 F. Supp. 2d 191 (D.D.C. 2002) 20

Purepac Pharm. Co. v. Thompson, 354 F.3d 877 (D.C. Cir. 2004) 20

Revolution Eyewear, Inc. v. Aspex Eyewear, Inc., 556 F.3d 1294 (Fed. Cir. 2009) 24

iv


Roche Palo Alto LLC v. Apotex, Inc., 25 531 F.3d 1372 (2008)

Stratos Lightwave, Inc. v. Picolight, Inc, No. 03-917, 2005 WL 681308 (D. Del. Mar. 23, 2005) 25

Takeda Pharmaceuticals Co. v. Sandoz, Inc., No. 07-3844, 2007 WL 2936208 (S.D.N.Y. Oct. 9, 2007) 22

Teva Pharm. USA v. Abbott Labs., 301 F. Supp. 2d 819 (N.D. Ill. 2003) 13, 15

Warner Lambert Co. v. Apotex Corp., 316 F.3d 1348 (Fed. Cir. 2003) 13, 16, 18, 19

Statutes

21 U.S.C. § 355 17

21 U.S.C. § 355(j) 14

6, 9, 15 21 U.S.C. § 355(j)(2)(A)(vii)(IV)

9 21 U.S.C. § 355(j)(2)(A)(viii)

6 21 U.S.C. § 355(j)(5)(B)(iii)

6 21 U.S.C. § 355(j)(5)(F)(2)

21 U.S.C. § 355A(1)(b)(1)(A)(i)(I)

28 U.S.C. § 1331

28 U.S.C. § 1338(a)

35 U.S.C. § 271(e)(2)

Rules

Fed. R. Civ. P. 12(b)(1) 3

4, 10, 11 Fed. R. Civ. P. 12(b)(6)

4, 21 Fed. R. Civ. P. 12(d)

6

3, 8, 10

3, 8, 10

passim


I. NATURE AND STAGE OF THE PROCEEDINGS

This memorandum responds collectively to the individual motions to dismiss filed by

Defendants in the above-referenced actions. 1 These actions concern two method of treatment

patents covering indications for AstraZeneca's highly successful cholesterol-lowering drug,

CRESTOR® (rosuvastatin calcium). Plaintiffs AstraZeneca Pharmaceuticals LP ("AZPLP"),

IPR Pharmaceuticals, Inc. ("IPR"), and AstraZeneca AB ("AZAB") hold all substantial rights in

U.S. Patent No. 6,858,618 ("the '618 patent"), which does not expire until December 17, 2021.2

(Mylan Am. Compl. at ¶ 17.) The '618 patent claims methods of treating heterozygous familial

hypercholesterolemia ("HeFH") in a patient by administering rosuvastatin. (Id. at Ex. A ('618

pat.) at 9:45-10:45.) Plaintiff The Brigham and Women's Hospital, Inc. ("BWH") is the owner

of U.S. Patent No. 7,030,152 ("the '152 patent"), which does not expire until April 2, 2018. (Id.

at ¶ 31.) Plaintiff IPR licensed the '152 patent from BWH and holds all relevant and substantial

rights in '152 patent. (Id.) The '152 patent claims methods of treating a human with normal

cholesterol levels but with an elevated level of C-reactive protein ("CRP") by administering a

statin (including rosuvastatin) to reduce the risk of developing a future cardiovascular disorder.

(Id. at Ex. C ('152 pat.) at 32:7-26.)

Ten sets of generic drug companies have filed abbreviated new drug applications

("ANDA") with the U.S. Food and Drug Administration ("FDA") seeking to market generic

versions of rosuvastatin calcium: Apotex Corp. ("Apotex"); Aurobindo Pharma Limited and

'Plaintiffs' Amended Complaints against all Defendants allege corresponding similar facts. Therefore, for simplicity in this brief, Plaintiffs cite to paragraphs of the core facts in their Amended Complaint against Defendant Mylan Pharmaceuticals Inc. (C.A. No. 10-342, D.I. 5) (hereinafter, "Mylan Am. Compl."), in lieu of citing all the corresponding paragraphs in the Amended Complaints against each of the other Defendants.

2 There is a six month pediatric exclusivity for the '618 patent until June 17, 2022.


Aurobindo Pharma USA Inc.; Cobalt Pharmaceuticals Inc. and Cobalt Laboratories Inc.

(collectively, "Cobalt"); Glenmark Generics Inc., USA ("Glenmark"); Mylan Pharmaceuticals

Inc. ("Mylan"); Par Pharmaceutical Inc. ("Par"); Sandoz Inc. ("Sandoz"); Sun Pharmaceuticals

Industries Ltd. ("Sun"); Teva Pharmaceuticals USA, Inc. ("Teva"); and Torrent Pharmaceuticals

Ltd. and Torrent Pharma Inc. (collectively, "Torrent").

On April 30, 2010, Plaintiffs AZPLP, IPR, AZAB, and BWH (collectively, "Plaintiffs")

filed Amended Complaints ("Complaints") against Defendants Apotex, Aurobindo, 3 Cobalt,

Glenmark, Mylan, Par, Sandoz, Sun, and Teva alleging infringement of the '618 and '152

patents under 35 U.S.C. § 271(e)(2)(A). On July 8, 2010, Plaintiffs filed their Complaint against

Torrent raising similar allegations. (C.A. No. 10-584, D.I. 1.) That statute provides:

It shall be an act of infringement to submit an [ANDA] for a drug claimed in a patent or the use of which is claimed in a patent . . . if the purpose of such submission is to obtain approval . . . to engage in the commercial manufacture, use, or sale of a drug . . . product claimed in a patent or the use of which is claimed in a patent before the expiration of such patent.

35 U.S.C. § 271(e)(2)(A).

This is the second set of patent infringement actions based on CRESTOR ® ANDA filings

by all but two of those Defendants (Glenmark and Torrent). The first set of actions, initiated in

December 2007,4 addressed infringement of the basic compound patent covering rosuvastatin

3 Aurobindo Pharma USA, Inc. originally was a defendant but has since been dismissed from this action by stipulated order. (C.A. No. 10-339, D.I. 7 (so ordered Aug. 5, 2010).) In this brief, "Aurobindo" refers to Aurobindo Pharma Limited.

4 The first set of patent infringement actions was a multi-district litigation combining suits filed by AZPLP, AstraZeneca UK Limited ("AZUK"), IPR, and Shionogi Seiyaku Kabushiki Kaisha ("Shionogi") against eights sets of Defendants: Mylan; Sun; Sandoz; Par; Apotex Inc. and Apotex Corp.; Aurobindo Phanna Limited and Aurobindo Pharma USA; Cobalt; and Teva. The actions against all defendants but Teva were filed in 2007. The action against Teva was filed in July 2008. Glenmark and Torrent were not parties to the first set of ANDA actions.

2


calcium, U.S. Patent No. RE 37,314 ("the '314 patent"). The Honorable Judge Joseph J. Farnan

tried the first set of actions in the District of Delaware in early 2010. On June 29, 2010, the court

held that the '314 patent is valid, enforceable, and infringed by all defendants in the '314 action.5

All of those defendants except Sandoz appealed the court's decision on or about August 9, 2010,

and Sandoz agreed to be bound by the outcome of that appellate review.

On July 23, 2010, Apotex, Aurobindo, Cobalt, Glenmark, Mylan, Par, Sun, and Teva

filed individual motions to dismiss the Complaints for lack of subject matter jurisdiction and

failure to state a claim. On August 27, 2010, Torrent filed a similar motion to dismiss. 6 The

arguments they raised largely overlap. To simplify matters for the Court, Plaintiffs address all

arguments raised by all those defendants (hereinafter, collectively, "Defendants") in this

omnibus answering brief.

II. SUMMARY OF THE ARGUMENT

1. As a matter of law, Defendants cannot succeed on their motions to dismiss under

Rule 12(b)(1) for lack of subject matter jurisdiction on the asserted grounds that: (1) a Paragraph

IV certification is required for an infringement claim under 35 U.S.C. § 271(e)(2); and (2) a

Section viii statement filed by some Defendants precludes an infringement claim against them

under § 271(e)(2). Those arguments fail, because § 271(e)(2) is not a jurisdictional statute but

instead defines an act of infringement. This Court has jurisdiction under 28 U.S.C. §§ 1331 and

1338(a), because Plaintiffs filed a cause of action under the United States patent laws.

5 The case against Apotex Inc. had been transferred by that time, but Apotex Corp. remained a defendant.

6 Sandoz filed an Answer and Affirmative Defenses. (C.A. No. 10-344, D.I. 11.)

3


2. Defendants' motions to dismiss for alleged failure to state a claim under Rule

12(b)(6), based on the same legal theories, also fail as a matter of law. A Paragraph IV

certification is not required to state a claim under § 271(e)(2) under the plain language of the

statute, and relevant precedent has recognized claims for infringement under § 271(e)(2) where

the ANDA applicant did not submit a Paragraph IV certification.

3. Likewise, the plain language of § 271(e)(2) and relevant precedent establishes that

a Section viii statement does not immunize an ANDA applicant from infringement. Defendants'

arguments to limit an act of infringement under § 271(e)(2) solely to those instances where a

generic company decides to file a Paragraph IV certification, and to allow a Section viii

statement to act as a shield against an infringement suit, are flatly inconsistent with the statute.

Such an interpretation would improperly allow a generic drug company to unilaterally dictate

when the filing of ANDA constitutes an act of infringement. Plaintiffs' infringement allegations

meet the requirements set forth in § 271(e)(2), stating a claim for infringement.

4. If the Court considers for the Rule 12(b)(6) motions, materials submitted by

Defendants that are outside of the pleadings, Fed. R. Civ. P. 12(d) requires that the motions to

dismiss be converted to motions for summary judgment and that Plaintiffs be given a reasonable

opportunity to conduct discovery and present evidence relevant to the motion.

5. Contrary to Defendants' arguments, Plaintiffs' § 271(e)(2) claims were ripe for

review upon Defendants' ANDA filings, allowing subject matter jurisdiction over those claims.

6.

M111n11nEM

4


7. Contrary to Defendant Aurobindo's arguments, Plaintiffs' claim that Aurobindo

infringes the '618 patent is not barred by the doctrine of claim preclusion, because Plaintiffs did

not previously sue Aurobindo for infringement of that patent.

III. STATEMENT OF FACTS

A. CRESTOR® and Plaintiffs' NDA

CRESTOR® (rosuvastatin calcium) is a member of the "statin" class of drugs. (Mylan

Am. Compl. at 8.) Statins lower cholesterol levels and are used to treat individuals suffering

from elevated serum cholesterol levels. (Id.) Plaintiffs AZPLP, IPR, and AZAB manufacture,

market, and sell CRESTOR® tablets in the United States. (Id. at ¶ 9.) IPR holds New Drug

Application ("NDA") No. 021366 for CRESTOR ® tablets in 5 mg, 10 mg, 20 mg, and 40 mg

dosage forms. (Id. at ¶ 7.)

B. Defendants' ANDAs and Listing of the Patents-in-Suit

In August 2007, all Defendants (except for Torrent) submitted ANDAs to the FDA

seeking approval to market their generic copies of CRESTOR ®; they subsequently notified

Plaintiffs AZPLP, IPR, and AZAB that they had filed ANDAs with the FDA seeking approval to

market rosuvastatin calcium tablets. (Id. at TT 10, 11.) In 2010, Torrent notified Plaintiffs that it

had filed with the FDA its rosuvastatin ANDA. (C.A. No. 10-584, D.I. 1, ¶ 12.) By 2007, IPR

had listed with the FDA for publication in the Orange Book patents covering CRESTOR®,

including the '618 patent. (Mylan Am. Compl. ¶ 18.) The '152 patent was not listed until

March 8, 2010. (Id. at If 32.)

C. The First Set of CRESTOR® ANDA Actions

Beginning in December 2007, AZPLP, IPR, AZUK, and Shionogi brought suit against

eight of the defendant groups (all but Glenmark and Torrent), asserting infringement of the '314

patent under 35 U.S.C. § 271(e)(2). All eight sets of defendants had challenged the '314 patent

5


under 21 U.S.C. § 355(j)(2)(A)(vii)(IV). As a result of those lawsuits, FDA approval of the

defendants' ANDAs, by statute, was automatically stayed until August 13, 2011. See 21 U.S.C.

§§ 355(j)(5)(B)(iii), 355(j)(5)(F)(2); see also 21 U.S.C. § 355A(1)(b)(1)(A)(i)(I). On June 29,

2010, the district court held that the '314 patent is valid, enforceable, and infringed. See In re

Rosuvastatin Calcium Patent Lit., MDL No. 08-1949-JJF, 2010 U.S. Dist. LEXIS 64475 (D. Del.

Jun. 29, 2010). Seven of the defendant groups (all except Sandoz) filed Notices of Appeal on or

about August 9, 2010.

The district court also ordered that the effective date of FDA approval of those

defendants' ANDAs cannot occur until the expiration of the '314 patent (which is January 8,

2016, with an extension to July 8, 2016 due to pediatric exclusivity). See MDL No. 08-1949-JJF

(D. Del.), D.I. 563 (Jul. 15, 2010) (Amended Final Judgment Order). However, if any of those

defendants' appeals succeed, then the FDA may approve those ANDAs immediately.

D. Indications for HeFH and Primary Prevention in the CRESTOR ® Label

Certain Defendants raise arguments based on , to which the

following facts are relevant. The HeFH indication covered by the '618 patent was part of the

CRESTOR® label in effect in August 2007 when the first eight sets of defendants filed their

ANDAs. (Severance Decl.7 at ¶ 2; Ex. 1 at 11 (07/2007 CRESTOR® Label).) In November

2007, however, specific mention of HeFH within the indications and usage section of the

CRESTOR® label was removed. (Id. at ¶ 3; Ex. 2 at 1-2 (11/2007 CRESTOR ® Label).) That

latter version of the CRESTOR® label was in effect when the first set of ANDA actions was filed

on the '314 patent in December 2007. Thus, there was no separate HeFH indication in the

CRESTOR® label at that time.

7 The Declaration of Dana K. Severance is submitted herewith.

6


On October 15, 2009, the FDA approved and added to the label a separate, standalone

indication for the use of CRESTOR ® to treat pediatric patients 10 to 17 years of age having

HeFH, as well as further material information supporting the use, safety, and efficacy of

CRESTOR® for that use. (Mylan Am. Compl. at ¶ 21; see also id. at Ex. B (10/2009

CRESTOR® Label).)

The primary care indication covered by the '152 patent was also not part of the

CRESTOR® label in effect when the first set of ANDA actions was filed in December 2007.

(Severance Decl. at 3; Ex. 2 (11/2007 CRESTOR Label).) On February 8, 2010, the FDA

7


approved for the first time an indication for the use of CRESTOR ® for the primary prevention of

cardiovascular disease in patients with normal cholesterol levels but elevated CRP. (Mylan Am.

Compl. at ¶ 35; see also id. at Ex. D (02/2010 CRESTOR® Label).) Further additional material

information supporting the use, safety, and efficacy of CRESTOR ® for that use was also added

to the label at that time. (Id.)

E. Plaintiffs' Complaints in the Current Set of Actions

After the FDA approved the indications for HeFH and primary prevention in the

CRESTOR® labels, Plaintiffs filed the present actions under 35 U.S.C. § 271(e)(2)(A), alleging

that Defendants' filing of their ANDAs, which seek approval to sell Defendants' respective

generic rosuvastatin calcium tablets before the expiration of the '618 and '152 patents, which

would induce infringement, infringed one or more claims of those patents. For example, the

Complaint against Mylan alleges (and corresponding Complaints against the other Defendants

allege), inter alia:

• Subject matter jurisdiction is proper under 28 U.S.C. §§ 1331 and 1338(a). (Mylan Am. Compl. at 12.)

• The FDA approved for CRESTORe's label indicated uses to treat pediatric patients 10 to 17 years of age having HeFH and for the primary prevention of cardiovascular disease. (Id. at TT 21, 35.)

• Mylan filed ANDA No. 79-161 to obtain approval to market the Mylan Rosuvastatin Calcium Tablets in the United States before the expiration of the '618 and '152 patents. (Id. at '111{ 19, 33.)

• If the FDA approves ANDA No. 79-161, Mylan intends to market, offer for sale, and sell the Mylan Rosuvastatin Calcium Tablets in the United States before the expiration of the '618 and '152 patents. (Id. at In 20, 34.)

• The labeling associated with the Mylan Rosuvastatin Calcium Tablets causes ANDA No. 79-161 to be an application for a drug the uses of which are claimed in the '618 and '152 patents in violation of 35 U.S.C. § 271(e)(2)(A). (Id. at TT 25, 39.)

8


® If the FDA approves ANDA No. 79-161, the sale of the Mylan Rosuvastatin Calcium Tablets with their associated labeling before the expiration of the '618 and '152 patents will cause infringement of one or more claims of the '618 and '152 patents, respectively. (Id. at ,ffif 26, 40.)

• The Mylan Rosuvastatin Calcium Tablets, if approved by the FDA, will be prescribed and administered to human patients to treat HeFH and for the primary prevention of cardiovascular disease, which uses will constitute direct infringement of the '618 and '152 patent, respectively. These uses will occur with Mylan's specific intent and encouragement, and will be uses that Mylan knows or should know will occur. Mylan will actively induce, encourage, aid and abet this prescription and administration, with knowledge and specific intent that these uses will be in contravention of Plaintiffs' rights under the '618 and '152 patents. (Id. at IN 27, 41.)

® Under 35 U.S.C. § 271(e)(2)(A), the submission by Mylan to the FDA of amended ANDA No. 79-161 to obtain approval for the commercial manufacture, use, or sale of the Mylan Rosuvastatin Calcium Tablets before the expiration date of the '618 and '152 patents, which claim uses of those Tablets, constitutes infringement of one or more claims of the '618 and '152 patents, either literally or under the doctrine of equivalents. (Id. at TT 28, 42.)

For the Defendants who were in the first set of actions, FDA approvals of their ANDAs

are stayed by the Order in those actions until July 8, 2016, unless the holdings are reversed after

appeal. By filing Complaints against Glenmark and Torrent, FDA approvals of Glenmark and

Torrent's ANDAs are also temporarily stayed.9

IV. ARGUMENT

A. This Court Has Subject Matter Jurisdiction Over Plaintiffs' Claims for Patent Infringement

Defendants

moved to dismiss the Complaints against them under Fed. R. Civ. P. 12(b)(1) for lack of

subject matter jurisdiction on the following asserted grounds: (1) a Paragraph IV certification

(under 21 U.S.C. § 355(j)(2)(A)(vii)(IV)) is required for an infringement claim under 35 U.S.C.

§ 271(e)(2); and (2) a Section viii statement (under 21 U.S.C. § 355(j)(2)(A)(viii)) precludes an

9 Suit was filed against Glenmark for infringement of the '314 patent in June, 2010.

9


infringement claim against them under § 271(e)(2). Those arguments fail as a matter of law,

because § 271(e)(2) is not a jurisdictional statute but rather defines the act of infringement, under

controlling Federal Circuit authority.

This Court has subject matter jurisdiction over Plaintiffs' § 271(e)(2) patent infringement

claims pursuant to 28 U.S.C. §§ 1331 and 1338(a). Section 1338(a) provides: "The district

courts shall have original jurisdiction of any civil action arising under any Act of Congress

relating to patents . . . ." 35 U.S.C. § 271(e)(2), part of the Patent Code, is an Act of Congress

relating to patents. Section 1331 provides: "The district courts shall have original jurisdiction of

all civil actions arising under the Constitution, laws, or treaties of the United States."

Accordingly, this Court has subject matter jurisdiction over these patent infringement claims.

The Federal Circuit and Judge Farnan in this District have clearly held that § 271(e)(2) is

an infringement statute, not a jurisdictional statute. See Allergan, Inc. v. Alcon Labs., Inc., 324

F.3d 1322, 1330 (Fed. Cir. 2003); AstraZeneca Pharms., LP v. Aurobindo Pharma Limited, Civ.

No. 08-md-1949, 2009 WL 483131, at *2 (D. Del. Feb. 25, 2009). In Allergan, the Federal

Circuit explained:

Section 271(e)(2) is not a jurisdictional statute in the strict sense of the word.

* * *

Once Congress creates an act of infringement, jurisdiction in the district court is proper under 28 U.S.C. § 1338(a) . . . . Section 271(e)(2) is an Act of Congress relating to patents. In short, section 271(e)(2) makes it possible for the district court to exercise its section 1338(a) jurisdiction in the situation in which an ANDA has been filed.

324 F.3d at 1330. In the first set of CRESTOR ® ANDA actions, Judge Farnan relied on the

holding in Allergan in determining that the limitations set forth in § 271(e)(2) are not

jurisdictional. See AstraZeneca, 2009 WL 483131, at *2.

10


These Defendants inappositely rely primarily upon cases that pertain to infringement, not

jurisdiction, and are discussed below regarding their motion under Rule 12(b)(6). The only cases

these Defendants cite that address this issue in terms of jurisdiction are two district court cases,

which are inconsistent with the controlling Federal Circuit authority and precedent in this

District on § 271(e)(2) discussed above, and thus should not be followed. See Eisai Co., Ltd. v.

Mutual Pharmaceuticals Co., No. 06-3613, 2007 WL 4556958, at *12 (D.N.J. Dec. 20, 2007);

Novo Nordisk Inc. v. Mylan Pharms. Inc., No. 09-2445, 2010 WL 1372437, at *9 (D.N.J. Mar.

31, 2010).

B. Plaintiffs' Complaints State a Claim of Infringement Under 35 U.S.C. § 271(e)(2)

These Defendants' same arguments also fail under Rule 12(b)(6). They present two

purely legal issues. First, whether a ANDA applicant's Paragraph IV certification is necessary

for infringement § 271(e)(2)—it is not. Second, whether an ANDA applicant's submission of a

Section viii statement precludes infringement under § 271(e)(2)—it does not. Moreover,

Plaintiffs' infringement allegations meet the requirements set forth in § 271(e)(2), thus properly

stating a claim for relief. Contrary to these Defendants' arguments, nothing in the statute or case

law precedent authorizes a generic drug company to unilaterally decide whether its ANDA

submission constitutes infringement.

1. 35 U.S.C. § 271(e)(2) Does Not Require that Defendants' ANDAs Include Paragraph IV Certifications

The crux of these Defendants' attack is that a Paragraph IV certification is an element of

an infringement action under 35 U.S.C. § 271(e)(2) and, because Plaintiffs do not allege that

these Defendants submitted Paragraph IV certifications for the patents in suit, the Complaints fail

to state a cause of action. To the contrary, as a matter of law, § 271(e)(2) does not require a

Paragraph IV certification to convert the submission of an ANDA into an "act of infringement."

11


Plaintiffs' Complaints allege that these Defendants have infringed the '618 and '152 patents

under § 271(e)(2) through the submission of their ANDAs seeking approval to market

rosuvastatin products prior to expiration of these patents, which claim FDA-approved uses of

rosuvastatin products, and will induce infringement. (See Section III.E, supra.) Plaintiffs'

Complaints clearly meet the statutory requirements.

a. The plain language of 35 U.S. C. 271(e)(2) does not require a Paragraph IV certification

The starting point in construing the statutory provision is the language of the statute

itself. See Hughes Aircraft Co. v. Jacobson, 525 U.S. 432, 438 (1999) ("As in any case of

statutory construction, our analysis begins with 'the language of the statute.' And where the

statutory language provides a clear answer, it ends there as well.") (citation omitted). The

Supreme Court has "stated time and again that courts must presume that a legislature says in a

statute what it means and means in a statute what it says there. When the words of a statute are

unambiguous, then, this first canon is also the last: 'judicial inquiry is complete.'" Conn. Nat'l

Bank v. Germain, 503 U.S. 249, 253-54 (1992) (citation omitted).

The language of 35 U.S.C. § 271(e)(2) is "plain and unambiguous." See Allergan, 324

F.3d at 1335 (Schall, J., concurring); see also id. at 1345 (Linn, J., concurring) ("35 U.S.C.

§ 271(e)(2) is itself not grammatically complex."). Section 271(e)(2) provides in relevant part:

It shall be an act of infringement to submit —

(A) an application under section 505(j) of the Federal Food, Drug, and Cosmetic Act . . . for a drug claimed in a patent or the use of which is claimed in a patent, * * *

If the purpose of such submission is to obtain approval under such Act to engage in the commercial manufacture, use, or sale of a drug or veterinary biological product claimed in a patent or the use of which is claimed in a patent before the expiration of such patent.

12


35 U.S.C. § 271(e)(2) (emphasis added). If Congress intended to make a Paragraph IV

certification to be an element of infringement under § 271(e)(2), it could have easily drafted the

statute accordingly. See Teva Pharm. USA v. Abbott Labs., 301 F. Supp. 2d 819, 829-30 (N.D.

Ill. 2004. It did not.

Therefore, the requirements of § 271(e)(2) are met for a method of use patent if: (1) the

defendant submits an ANDA for a drug; (2) a patent claims a use of that drug approved by the

FDA; 1 ° (3) the ANDA applicant seeks approval to commercially manufacture, use, or sell the

drug before the expiration of that patent; and (4) the ANDA applicant will thereby induce

infringement of the method of use patent. Plaintiffs pleaded these facts. (See Section III.E,

supra.)

b. Courts have recognized infringement under 35 U.S.C. 271(e)(2) when there was no Paragraph IV certification

Courts in the District of Delaware and other districts, have recognized claims for

infringement under § 271(e)(2) where the ANDA applicant did not submit a Paragraph IV

certification, and the Federal Circuit has allowed such infringement claims without Paragraph IV

certifications. Indeed, some of the present Defendants previously have raised and lost on this

very issue.

In Impax Labs., Inc. v. Aventis Pharms., Inc., 235 F. Supp. 2d 390, 397 (D. Del. 2002),

Impax filed an ANDA to market a generic version of riluzole. At that time, there were no

patents listed in the Orange Book for that drug. See Impax Labs., Inc. v. Aventis Pharms., Inc.,

468 F.3d 1366, 1372-73 (Fed. Cir. 2006). Nevertheless, Impax brought a claim under

§ 271(e)(2) in this District for a declaratory judgment of invalidity and unenforceability of an

10 The Federal Circuit has held that for infringement of a method of use patent under § 271(e)(2), the infringing use must be approved by the FDA. See Warner Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1355 (Fed. Cir. 2003); Allergan, 324 F.3d at 1334.

13


Aventis patent. Impax, 235 F. Supp. 2d at 391. On appeal, the Federal Circuit explained that,

"[u]nder 35 U.S.C. § 271(e)(2), it is an act of infringement to submit an ANDA under 21 U.S.C.

§ 355(j) for a drug claimed in a patent before the patent's expiration." Impax, 468 F.3d at 1372.

The Federal Circuit then addressed the validity and unenforceability of the patent, even though

"[a]t the time that Impax filed its ANDA, there was no patent listed with respect to riluzole in the

FDA's [Orange Book]," and thus no paragraph IV certification regarding that patent. Id. at

1372-73.

Relying on the Federal Circuit decision in Impax, Judge Farnan in this District denied

Mylan's motion to dismiss in Bristol-Myers Squibb Co. v. Mylan Pharms., Inc., C.A. No. 09-651

(D. Del. Jan. 14, 2010). (Severance Decl. ¶ 4; Ex. 3 (C.A. No. 09-651-JJF, D.I. 31 (01/14/2010

Order).) Mylan moved to dismiss Bristol-Myers's patent infringement complaint under

§ 271(e)(2) on the ground that Mylan's ANDA did not include a Paragraph IV certification,

because the patent-in-suit was not listed in the FDA's Orange Book. See id. at 1. Relying on

Impax, the court rejected that argument: "[M]y view is that you don't need an [O]range [B]ook

listing to bring a 271 action." (Severance Decl. ¶ 5; Ex. 4 (C.A. No. 09-651, 01/14/2010 Hearing

Tr.) at 4:20-22; see id. at 11:5-6.)

In Glaxo Group Ltd. v. Apotex, Inc., 272 F. Supp. 2d 772, 779 (N.D. Ill. 2003), the

district court likewise relied on the plain language of § 271(e)(2) to reject the argument that the

filing of its ANDA could not be an act of infringement because it did not include a Paragraph IV

certification:

That brings the court full circle, back to the plain wording of § 271(e)(2), which provide[s] that the submission of an application under § 355 of the FDCA is an act of infringement if the purpose is to obtain approval to engage in the commercial manufacture, use or sale of a drug claimed in a patent before the expiration of that patent.

14


On appeal, the Federal Circuit affirmed the finding of infringement, holding that "Apotex

infringed the patents pursuant to 35 U.S.C. § 271(e)(2) by the filing of its ANDA application,"

even though "Apotex's ANDA filing is atypical in that it did not contain a [Paragraph IV]

certification." Glaxo Group Ltd. v. Apotex, Inc., 376 F.3d 1339, 1344, 1351 (Fed. Cir. 2004).

Similarly, after observing that "the plain language of § 271(e)(2)" does not require a

Paragraph IV certification, the court in Teva, 301 F. Supp. 2d at 829-30, rejected the same

argument:

[If] Congress [had] intended to limit the artificial act of infringement created by § 271(e)(2) to ANDAs containing Paragraph IV certifications . . . it could have easily done so. The provision might have read, for example, "It shall be an act of infringement to submit an application containing a certification described in § 355(j)(2)(a)(vii)(IV)."

See also Bayer Healthcare, LLC v. Norbrook Labs., Ltd., No. 08-C-0953, 2009 WL 6337911

(E.D. Wis. Sep. 24, 2009) (holding that a Paragraph IV certification is not required for a

§ 271(e)(2) infringement claim).

c. Neither the Supreme Court nor the Federal Circuit have required that a Paragraph IV certification be included in an ANDA to state a claim for infringement under 11271(e)(2)

Undeterred by the plain statutory language and precedent, these Defendants erroneously

assert that the Supreme Court and Federal Circuit have interpreted § 271(e)(2) to require a

Paragraph IV certification for an act of infringement. These Defendants incorrectly try to

expand the uncontroversial principle for which those cases stand, namely that submitting an

ANDA with a Paragraph IV certification is sufficient to constitute a statutory act of infringement

under § 271(e)(2). The question that those cases do not address—but which the cases discussed

above specifically address and answer "no"—is whether a Paragraph IV certification is necessary

to a state a claim for infringement under § 271(e)(2).

15


For example, in Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (1990), the Supreme

Court construed a different provision (§ 271(e)(1)), see id. at 663, and stated in dicta:

That is what is achieved by § 271(e)(2)—the creation of a highly artificial act of infringement that consists of submitting an ANDA or a paper NDA containing the fourth type of certification that is in error as to whether commercial manufacture, use, or sale of the new drug (none of which, of course, has actually occurred) violates the relevant patent.

Id. at 678. These Defendants rely upon this language to argue that a Paragraph IV certification is

required for infringement under § 271(e)(2). However, this dicta merely reflects the principle

that an ANDA submission with a Paragraph IV certification is sufficient to trigger a claim under

§ 271(e)(2). Eli Lilly does not address whether an ANDA submission without a Paragraph IV

certification for approval prior to the expiration of the patent can also trigger an infringement

claim under § 271(e)(2). As the Glaxo district court explained: "It is clear from the Court's

discussion [in Eli Lilly] that the only issue before it was whether § 271(e)(1) covered medical

devices . . . . What constitutes infringement under § 271(e)(2), and whether a paragraph IV

certification is necessary before § 271(e)(2) can apply, were not before the court." 272 F. Supp.

2d at 778.11

In Bristol-Myers Squibb Co. v. Royce Labs., Inc., 69 F.3d 1130 (Fed. Cir. 1995), upon

which these Defendants also rely, the court recognized that the statutory act of infringement is

"The other Federal Circuit cases that these Defendants contend similarly construe § 271(e)(2) to require a Paragraph IV certification likewise simply reflect that filing an ANDA with a Paragraph IV certification is sufficient to state a claim under § 271(e)(2), not that it is necessary. See Nordisk A/S v. Caraco Pharm. Labs., Ltd., 601 F.3d 1359, 1362 (Fed. Cir. 2010); Warner Lambert, 316 F.3d at 1358; Janssen Pharmaceutica, N.V. v. Apotex, Inc., 540 F.3d 1353, 1356 (Fed. Cir. 2008); Abbott Labs. v. Baxter Pharm. Prods., Inc., 471 F.3d 1363, 1365 (Fed. Cir. 2006); Apotex v. Thompson, 347 F.3d 1335, 1339 (Fed. Cir. 2003); Caraco Pharm. Labs., Ltd. v. Forest Labs., Ltd., 527 F.3d 1278, 1283 (Fed. Cir. 2008); Merck & Co. v. Apotex, Inc., 292 Fed. App'x 38, 40 (Fed. Cir. 2008).

16


predicated solely upon the applicant seeking approval before patent expiry. That such a request

often takes the form of a Paragraph IV certification, however, does not these give these

Defendants license to rewrite the statute to make the certification a requirement. As the Federal

Circuit explained in Bristol-Myers, "once it is clear that a party seeking approval of an ANDA

wants to market a patented drug prior to the expiration of the patent, the patent owner can seek to

prevent approval of the ANDA by bringing a patent infringement suit." Id. at 1132. In the

present case, Plaintiffs have clearly pleaded that these Defendants seek such pre-expiry approval

of a drug whose FDA-approved use is claimed in the '618 and '152 patents, and will induce

infringement, which is sufficient to state a § 271(e)(2) claim.

The two cases cited by these Defendants that actually address whether a Paragraph IV

certification is required to a state a claim for infringement are decisions from the District of New

Jersey: Eisai, 2007 WL 4556958, at *12, and Novo v. Mylan, 2010 WL 1372437, at *9.

However, they are inconsistent with the plain language of § 271(e)(2), the Federal Circuit's

decisions, and the precedent from this District and others discussed above, and neither case is

controlling for these actions in the District of Delaware.12

12 In Eisai, the court inserted a Paragraph IV certification requirement into § 271(e)(2), despite (i) conceding that the plain text of § 271(e)(2) did not require such a certification, 2007 WL 4556985, at *9; (ii) acknowledging that the certification and listing provisions of § 355 did not change the statutory language of § 271(e)(2), id. at * 10; and (iii) recognizing that Congress could have, but did not, include such a requirement, id. ("If Congress had intended to limit the artificial act of infringement by § 271(e)(2) to ANDAs containing Paragraph IV certifications it could have easily done so . . . [b]ut Congress did not do so."). The court, instead, relied on erroneous interpretations of Supreme Court and Federal Circuit decisions, holding that these cases required a Paragraph IV certification as an essential element for an infringement action under § 271(e)(2). Id. at *11. However, as more fully explained in Section IV.B.1.c. above, these cases merely hold that a Paragraph IV certification is sufficient for § 271(e)(2) infringement, not that it is necessary.

17


2. Submission of a Section viii Statement Does Not Immunize Defendants from Suit

Defendants

further argue that the submission of a Section viii statement—that the method of use

patent does not claim a use for which the ANDA applicant is seeking FDA approval—precludes

a § 271(e)(2) infringement action. These Defendants thus contend that a Section viii statement is

a per se non-infringing alternative, and that the mere submission of the statement in an ANDA

precludes infringement under § 271(e)(2). Just as the plain language of § 271(e)(2) does not

require the submission of a Paragraph IV statement for infringement based on an ANDA

submission, the plain language of the statue similarly does not preclude infringement if an

ANDA applicant submits a Section viii statement.

These Defendants ignore the plain language of § 271(e)(2) and take the incorrect position

that the Federal Circuit in Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348 (Fed. Cir. 2003)

and Allergan held that no cause of action exists under § 271(e)(2) when a Section viii statement

is filed. Neither case addressed the issue of whether a plaintiff is precluded from bringing an

infringement action under § 271(e)(2) when the generic drug applicant submits a Section viii

statement on a patent that covers a use the FDA approved under the relevant NDA. Indeed, the

Federal Circuit has yet to address this very question.

In Warner Lambert, the Federal Circuit held: "it is not an act of infringement to submit

an ANDA for approval to market a drug for a use when neither the drug nor that use is covered

by an existing patent, and the patent at issue is for a use not approved under the NDA." 316 F.3d

at 1355 (emphasis added). In Allergan, the Federal Circuit likewise held that a method of use

patent holder does not have an infringement action against an ANDA applicant when the use

claimed in the patent is not FDA-approved and the ANDA applicant is not seeking approval for

18


that use. 324 F.3d at 1334. Unlike the facts in Warner Lambert and Allergan, Plaintiffs have

pleaded in these present actions that their patents at issue are for uses that are approved under the

NDA. (See Mylan Am. Compl. at in 21, 35.) Thus, the holdings in Warner Lambert and

Allergan do not prohibit infringement suits here.13

A careful application of the holdings in Allergan and Warner-Lambert is particularly

warranted given the disagreement expressed by members of the Federal Circuit. See Allergan,

324 F. 3d at 1343 (Shall, J. and Clevenger, J. concurring). In Allergan, Judges Shall and

Clevenger rejected outright the generic company's argument that a Section viii

statement precluded a patent holder from bringing suit under § 271(e)(2). Judge Shall reasoned

that:

[T]he conclusion is at odds with the plain language of 35 U.S.C. § 271(e)(2). In addition, as the Supreme Court stated in Eli Lilly, "[the ANDA] scheme will not work, of course, if the holder of the patent pertaining to the pioneer drug is disabled from establishing in court that there has been an act of infringement."

Allergan, 324 F. 3d at 1343, (quoting Eli Lilly, 496 U.S. at 678). The concerns raised by the

Supreme Court and members of the Federal Circuit for plaintiffs to have recourse to a cause of

action are directly implicated by these Defendants' attempt here to turn Section viii statements

into a per se immunization against an infringement action under § 271(e)(2). Such an approach

would improperly and unfairly allow generic companies to define and dictate the circumstances

under which the filing of an ANDA would constitute infringement under § 271(e)(2).

13 Similarly, Bayer Schera Pharma AG v. Sandoz, Inc., No. 08 Civ. 03710, 2010 WL 3768220, at *7 (S.D.N.Y. Sep. 28, 2010), cited by Mylan in its October 1, 2010 letter to the Court (Civ. No. 10-342, D.I. 14), involved a patent covering unapproved uses of the drug, and thus is not pertinent to the facts at hand.

19


Plaintiffs submit that the Court took the correct approach in Bayer Healthcare v.

Norbrook. In Bayer, Norbrook initially filed a Paragraph IV certification with its Abbreviated

New Animal Drug Application, but later withdrew and replaced it with a Section I statement

under the Generic Animal Drug and Patent Term Restoration Act, which is equivalent to a

Section viii statement for drugs for humans. 2009 WL 6337911, at *5. Norbrook then moved to

dismiss Bayer's complaint for failure to state a claim and lack of subject matter jurisdiction. The

district court denied the motion, determining that, despite the statement corresponding to a

Section viii statement, Bayer could maintain its infringement action. "Bayer's complaint set out a

plausible claim for infringement because a Paragraph IV certification is not necessary to state a

cause of action under 35 U.S.C. § 271(e)(2) as long as the purpose of the submission to the FDA

is to obtain approval to engage in the manufacturer or sale of a product, 'the use of which is

claimed in a patent.'" Id. at *9. 14

Finally, these Defendants rely on dicta from the opinions in Purepac Pharm. Co. v.

Thompson, 238 F. Supp. 2d 191 (D.C. Cir. 2002) ("Purepac 1") and Purepac Pharm. Co. v.

Thompson, 354 F.3d 877 (D.C. Cir. 2004) ("Purepac II") (affirming Purepac 1). These decisions

are inapposite. Neither Purepac decision involved the question of whether a Section viii

statement precludes an infringement allegation under § 271(e)(2). They were not even patent

infringement cases. Instead, the Purepac cases involved a dispute between a generic drug

manufacturer and the FDA over the rejection of an ANDA application based on a finding that

Purepac's Section viii statement was inappropriate and the refusal to grant final ANDA approval

until Purepac filed a Paragraph IV certification. See Purepac I, 238 F. Supp. 2d at 192. The

14 The Federal Circuit rejected Norbrook's Petition for Permission to Appeal, holding that granting the petition was not warranted. See Bayer Healthcare, LLC v. Norbrook Labs., Ltd., 370 Fed. Appx. 103 (Fed. Cir. 2010).

20


Purepac decisions do not address the question of whether filing a Section viii statement

precludes a court from exerting subject matter jurisdiction or prevents a patent owner from

asserting an infringement claim. As a result, these Defendants' reliance on the Purepac

decisions also is misplaced.'5

3. If the Court Were To Consider Extraneous Materials, then the Motions To Dismiss Must Be Converted to Motions for Summary Judgment and Plaintiffs Should Be Permitted Discovery

Defendants

filed materials outside the Complaints,

. These extraneous materials were not

available to Plaintiffs when they filed suit, and therefore did not form the basis of the

Complaints. Moreover, Plaintiffs submit, for all the reasons set forth above in Sections II.B.1

and II.B.2 supra, that these materials are irrelevant to the disposition of Defendants' Motions to

Dismiss. However, if the Court were to decide to consider these extraneous materials, then Fed.

R. Civ. P. 12(d) requires that the motions to dismiss be converted to motions for summary

judgment and that Plaintiffs be given a reasonable opportunity to conduct discovery and present

evidence relevant to the motion.16

15 Nor does the district court decision in Novo v. Mylan support these Defendants' interpretation of Section viii. The decision was based on the erroneous view that a § 271(e)(2) action could only be predicated on a Paragraph IV certification and the lack of such a certification (i.e., filing a Section viii statement instead) precludes jurisdiction. The court reached its decision by relying heavily on the flawed analysis in Eisai, which, as discussed in Section IV.B.1.c., supra, ignores the plain language of § 271(e)(2) and relevant precedent, and is not controlling here. 2010 WL 1372437, at *10.

16 Given the preliminary stage of these proceedings where absolutely no discovery has been conducted, Plaintiffs propose that, if the Court were to deny the motions to dismiss, the proper way to proceed is with discovery on a normal schedule. However, if the Court were to decide to convert these preliminary motions to dismiss into motions for summary judgment, Plaintiffs request the right to file a Rule 56(f) affidavit at that time.

21


Defendants _1=0111111=n11MIN

. .111111111111 i,'

Defendants' reliance on these extraneous materials

essentially asks the Court to weigh evidence and inferences to summarily decide Plaintiffs'

§ 271(e)(2) infringement claims that Defendants will cause infringing uses of their rosuvastatin

drugs and induce infringement on a motion to dismiss, without giving Plaintiffs the benefit of

discovery to factually challenge Defendants' statements. Plaintiffs have had no discovery

regarding Defendants' proposed (not final) labels, or correspondence between Defendants and

the FDA regarding their labels, whether and when the labels have changed, and the effect of

those labels in inducing infringement. The language contained in Defendants' labels and

whether that language is sufficient to induce infringement goes to the very heart of Plaintiffs'

allegations. Such language should not be considered by this Court until after discovery at the

summary judgment or trial phase of this litigation. See Takeda Pharmaceuticals Co. v. Sandoz,

Inc., No. 07-3844, 2007 WL 2936208, at *5, n.4 (S.D.N.Y. Oct. 9, 2007). It would be premature

and improper for the Court to decide whether Defendants' labels will cause infringement of

patents covering FDA-approved uses without giving Plaintiffs the opportunity to obtain

discovery on these issues.

C. Plaintiffs' Infringement Claims Are Ripe for Adjudication

raise an additional jurisdictional argument that Plaintiffs' claims are not ripe for review

because they are based on speculative activity that the FDA will require the labels for these

Defendants' rosuvastatin calcium products to include information relating to the methods of

treatments claimed in the '618 and '152 patents. However, an infringement claim under

§271(e)(2) is ripe for review upon the filing of an ANDA, which typically is years ahead of

22


patent expiration. See e.g., Merck & Co., Inc. v. Teva Pharm USA, Inc., 347 F.3d 1367 (Fed. Cir.

2003) (affirming district court ruling that defendant infringed plaintiff's method patent five years

before its expiration); Abraxis Bioscience, Inc. v. Navinta, LLC, 640 F. Supp. 2d 553 (D.N.J.

2009) (finding patent infringement in an ANDA litigation where method-of-use patent expired in

2014, almost eight years after the ANDA was filed). Plaintiffs' claims are premised on these

Defendants' ANDA filings—each submitted an ANDA seeking approval to market a drug

product, the FDA-approved uses of which are claimed in the '618 and '152 patents, prior to the

expiration of those patents. Whether these Defendants' labels will cause direct infringement, as

alleged, is a matter for proof, not summary disposition without discovery. Moreover, while

Plaintiffs are confident that the Federal Circuit will uphold the '314 patent, as in any litigation, a

risk exists that it will not, and these Defendants could launch their rosuvastatin drug products

before expiration of the patent in 2016. Therefore, Plaintiffs' infringement claims are ripe for

review at this time.

23


24


E. Plaintiffs' Claim that Aurobindo Infringes the '618 Patent Is Not Barred by Claim Preclusion

Defendant Aurobindo incorrectly argues that Plaintiffs' claim that Aurobindo infringes

the '618 patent is barred by claim preclu •sion based on the earlier action against Aurobindo on the

'314 patent. (See C.A. No. 10-339, D.I. 14 (Aurobindo Br.) at 16.) To the contrary, claim

preclusion does not bar Plaintiffs' current suit against Aurobindo because, prior to the current

action, Plaintiffs did not sue Aurobindo for infringement of the '618 patent.

Claim preclusion requires: (1) a final judgment on the merits in a prior suit involving;

(2) the same parties or their privities; and (3) a subsequent suit based on the same cause of

action. CoreStates Bank, N.A. v. Huls America, Inc., 176 F.3d 187, 194 (3d Cir. 1999).

"Whether two claims for infringement constitute the 'same claim' is an issue particular to patent

law and thus Federal Circuit law applies." Roche Palo Alto LLC v. Apotex, Inc., 531 F.3d 1372,

1379 (2008).

Aurobindo's argument fails the third prong of the CoreStates test. In Kearns v. General

Motors Corp., 94 F.3d 1553, 1555 (Fed. Cir. 1996), the Federal Circuit explained that, "[b]y

statutory and common law, each patent establishes an independent and distinct property right . . .

Each patent asserted raises an independent and distinct cause of action." The court then rejected

the defendants' claim preclusion argument for patents not previously asserted. The Federal

Circuit held that while claim preclusion ("res judicata") would bar a second action for

infringement of the same five patents at issue in the first action, it did not bar claims of

infringement of sixteen additional patents in the second action where those patents were not

asserted in the first action, even though those additional patents could have been asserted in the

first action. See id. at 1555-57. Likewise, in Stratos Lightwave, Inc. v. Picolight, Inc., No. 03-

917, 2005 WL 681308 (D. Del. Mar. 23, 2005), Judge Farnan relied on Kearns to hold that claim

25


preclusion does not prevent a subsequent suit on a different patent. "Stratos is asserting different

patents in Stratos II than in Stratos I, not different claims of the same patents. 'Each patent

asserted raises an independent and distinct cause of action.'" Id. at *2 (quoting Kearns, 94 F.3d

at 1555).

Aurobindo does not provide any legal support for its proposition that a subsequent suit on

a different patent is precluded by not asserting that patent in a prior suit. Instead, the cases cited

by Aurobindo are inapposite, because they addressed whether a prior suit for infringement of a

patent precluded a second suit for infringement of that same patent. See Acumed LLC v. Stryker

Corp., 525 F.3d 1319, 1322 (Fed. Cir. 2008); Roche, 531 F.3d at 1379-80. Accordingly, claim

preclusion does not bar Plaintiffs' claim against Aurobindo for infringement of the '618 patent.

V. CONCLUSION

For the foregoing reasons, Plaintiffs respectfully request that the Court deny Defendants'

motions to dismiss.

26


Respectfully submitted,

Is! Mary W. Bourke Ford F. Farabow

Mary W. Bourke (#2356) FINNEGAN, HENDERSON, FARABOW, Dana K. Severance (#4869) GARRETT & DUNNER LLP

CONNOLLY BOVE LODGE & HUTZ LLP

901 New York Avenue, N.W. 1007 N. Orange Street Washington, DC 20001

Wilmington, DE 19899 Telephone: (571) 203-2700

Facsimile: (302) 658-5614 [email protected]

Charles E. Lipsey

[email protected] Kenneth M. Frankel York M. Faulkner

Attorneys for Plaintiffs FINNEGAN, HENDERSON, FARABOW, AstraZeneca Pharmaceuticals LP, GARRETT & DUNNER LLP

IPR Pharmaceuticals, Inc.,

11955 Freedom Drive, Suite 800

AstraZeneca AB, and Reston, Virginia 20190

The Brigham and Women's Hospital, Inc. Telephone: (571) 203-2700

Mary K. Ferguson, Ph.D. Bruce S. Manheim, Jr. Nathaniel S. Edwards, Ph.D. ROPES & GRAY FINNEGAN, HENDERSON, FARABOW, One Metro Center GARRETT & DUNNER LLP

700 12th Street, NW, Suite 900

55 Cambridge Parkway, Suite 700

Washington, DC 20005-3948 Cambridge, MA 02142

Telephone: (202) 508-4696 Telephone: (617) 452-1600

Henry J. Renk Of Counsel for Plaintiffs

FITZPATRICK, CELLA, HARPER & SCINTO AstraZeneca Pharmaceuticals LP, Avenue of the Americas IPR Pharmaceuticals, Inc., New York, NY 10104-3800 and AstraZeneca AB

Telephone: (212) 218-2100


Of Counsel for Plaintiffs AstraZeneca Pharmaceuticals LP,

854602v1 IPR Pharmaceuticals, Inc., and AstraZeneca AB

27


CERTIFICATE OF SERVICE

The undersigned hereby certifies that on this 8th day of October, 2010, true and correct redacted copies of PLAINTIFFS' ANSWERING BRIEF IN OPPOSITION TO DEFENDANTS' MOTIONS TO DISMISS were served on counsel listed below in the manner indicated:

Via Electronic Mail and Federal Express Via Electronic Mail and Hand Delivery

Apotex Corp. Lead Counsel Apotex Corp. Local Counsel Robert B. Briesblatt Jeremy C. Daniel Craig M. Kuchii KATTEN MUCHIN ROSENMAN LLP 525 W. Monroe Street Chicago, Illinois 60661 [email protected] [email protected] [email protected]

Richard L. Horwitz (#2246) David E. Moore (#3983) POTTER ANDERSON & CORROON LLP Hercules Plaza 1313 N. Market St., 6th Floor Wilmington, DE 19801 [email protected] [email protected]

Aurobindo Pharma Limited Lead Counsel Aurobindo Pharma Limited Local Counsel Edward J. Pardon Jeffrey S. Ward Thomas P. Heneghan Shane A. Brunner MERCHANT & GOULD 10 East Doty Street , Suite 600 Madison, Wisconsin 53703-3376 [email protected] [email protected] [email protected] [email protected]

Richard D. Kirk (rk0922) Stephen B. Brauerman (sb4952) BAYARD, P.A. 222 Delaware Avenue, Suite 900 Wilmington, DE 19899-5130 [email protected] [email protected]

Cobalt Pharmaceuticals, Inc., et al Lead Counsel Cobalt Pharmaceuticals, Inc., et al Local Steve A. Maddox William R. Zimmerman KNOBBE MARTENS OLSON & BEAR LLP 1717 Pennsylvania Avenue, Suite 900 Washington, D.C. 20006 [email protected] [email protected]

Payson LeMeilleur KNOBBE MARTENS OLSON & BEAR LLP 2040 Main Street, 14 th Floor Irvine, CA 92614 [email protected]

Counsel Richard L. Horwitz (#2246) David E. Moore (#3983) POTTER ANDERSON & CORROON LLP Hercules Plaza 1313 N. Market St., 6 th Floor Wilmington, DE 19899 [email protected] [email protected]

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Glenmark Generics Inc., USA Lead Counsel Daniel E. Yonan H. Keeto Sabharwal STERNE KESSLER GOLDSTEIN & FOX 1100 New York Avenue Washington, DC 20005 [email protected] [email protected]

Glenmark Generics Inc., USA Local Counsel William J. Wade (#704) Anne Shea Gaza (#4093) Sarah R. Stafford (#5234) RICHARDS LAYTON & FINGER, P.A. One Rodney Square 920 N. King Street Wilmington, DE 19801 [email protected] [email protected] stafford@rlf. corn

Mylan Pharmaceuticals Inc. Local Counsel John C. Phillips, Jr. (#110) PHILLIPS, GOLDMAN & SPENCE P.A. 1200 North Broom Street Wilmington, DE 19806 [email protected]

Mylan Pharmaceuticals Inc. Lead Counsel William A. Rakoczy Deanne M. Mazzochi Joseph T. Jaros Eric R. Hunt RAKOCZY MOLINO MAZZOCHI SIWIK LLP 6 West Hubbard Street, Suite 500 Chicago, IL 60610 [email protected] [email protected] [email protected] [email protected]

Arnold B. Calmann Jane Juhn SAIBER LLC One Gateway Center, te Floor Newark, NJ 07102-5311 [email protected] [email protected]

Par Pharmaceutical, Inc. Lead Counsel Daniel G. Brown WILSON, SONSINI, GOODRICH & ROSATI 1301 Avenue of the Americas, 40 th Floor New York, NY 10019 [email protected]

Dutch D. Chung WILSON, SONSINI, GOODRICH & ROSATI 1700 K Street, 5 th Floor Washington, DC 20006 [email protected]

Par Pharmaceutical, Inc. Local Counsel Frederick L. Cottrell, III (#2555) Steven J. Fineman (#4025) Stephen M. Ferguson (#5167) RICHARDS, LAYTON & FINGER P.A. One Rodney Square 920 N. King Street Wilmington, DE 19801 [email protected] [email protected] [email protected]

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Sun Pharmaceutical Industries Ltd. Lead Counsel Charles B. Klein John K. Hsu WINSTON & STRAWN LLP 1700 K Street, N.W. Washington, D.C. 20006-3817 [email protected] [email protected]

Sun Pharmaceutical Industries Ltd. Local Counsel Kevin G. Abrams (#2375) John M. Seaman (#3868) ABRAMS & BAYLISS LLP 20 Montchanin Road, Suite 200 Wilmington, DE 19807 [email protected] [email protected]

Teva Pharmaceuticals USA, Inc. Lead Counsel Richard A. Kaplan Ralph J. Gabric Jeffry M. Nichols Jason W. Schigelone BRINKS HOFER GILSON & LIONE NBC Tower, Suite 3600 455 North Cityfront Plaza Dr. Chicago, Iii 60611 [email protected] [email protected] [email protected] [email protected]

Teva Pharmaceuticals USA, Inc. Local Counsel Joseph H. Huston, Jr. (#4035) STEVENS & LEE P.C. 1105 North Market Street, 7 th Floor Wilmington, DE 19801 [email protected]

Torrent Pharmaceuticals Ltd., et al. Lead Counsel Dennis A. Bennett GLOBAL PATENT GROUP, LLC 1005 N. Warson Road, Suite 201 St. Louis, Missouri 63132 [email protected]

Torrent Pharmaceuticals Ltd., et al. Lead Counsel Francis J. Murphy (#223) MURPHY & LANDON 1011 Centre Road, #210 Wilmington, DE 19805 [email protected]

Respectfully submitted,


/s/ Mary W. Bourke Mary W. Bourke (#2356) CONNOLLY BOVE LODGE & HUTZ LLP 1007 N. Orange Street ilmington, DE 19899 Telephone: (302) 658-9141 Facsimile: (302) 658-5614 [email protected]

Attorneys for Plaintiffs

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE v. IPR ... · 2010. 12. 17. · IN...

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Transcript of IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE v. IPR ... · 2010. 12. 17. · IN...