Free COMPLAINT - District Court of Delaware - Delaware

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE GLAXO GROUP LTD. and SMITHKLINE BEECHAM CORPORATION d/b/a GLAXOSMITHKLINE, Plaintiffs, v. LUPIN LTD. and LUPIN PHARMACEUTICALS, INC., Defendants. ) ) ) ) ) ) ) ) ) ) ) )

C.A. No.

COMPLAINT Plaintiffs Glaxo Group Ltd. and SmithKline Beecham Corporation, d/b/a GlaxoSmithKline, for their Complaint against Defendants Lupin Ltd. and Lupin

Pharmaceuticals, Inc., hereby allege as follows. THE PARTIES 1. Plaintiff Glaxo Group Ltd. is a company organized and existing under the

laws of England and having an office and place of business at Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB60NN, United Kingdom. 2. Plaintiff SmithKline Beecham Corporation, d/b/a GlaxoSmithKline, is a

Pennsylvania corporation having an office and place of business at 1 Franklin Plaza, Philadelphia, Pennsylvania 19102. Plaintiffs Glaxo Group Ltd. and SmithKline Beecham

Corporation, d/b/a GlaxoSmithKline, are hereinafter referred to as "GSK." 3. On information and belief, Defendant Lupin Ltd. is a corporation

organized and existing under the laws of India and having an office and place of business at Laxmi Towers, B Wing, Bandra Kurla Complex, Bandra (East), Mumbai, Maharashtra 400 051, India.

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4.

On information and belief, Defendant Lupin Ltd. manufactures numerous

generic drugs, including, inter alia, cefprozil, lisinopril, and meloxicam, for sale and use throughout the United States, including in the State of Delaware. 5. On information and belief, Defendant Lupin Pharmaceuticals, Inc. is a

Virginia corporation having an office and place of business at Harborplace Tower, 111 S. Calvert Street, 21st Floor, Baltimore, Maryland 21202. 6. On information and belief, Defendant Lupin Pharmaceuticals, Inc. is the

United States agent for Lupin Ltd. for purposes including, but not limited to, making regulatory submissions to the United States Food and Drug Administration ("FDA"). 7. On information and belief, Lupin Pharmaceuticals, Inc. also is the United

States marketing and sales agent for Lupin Ltd. wherein, following FDA approval of an Abbreviated New Drug Application ("ANDA"), Lupin Ltd. manufactures and supplies the approved generic drug product to Lupin Pharmaceuticals, Inc., which then markets and sells the product throughout the United States, including in the State of Delaware. 8. On information and belief, and consistent with its practice with respect to

other generic products, following any FDA approval of the ANDA at issue in this action, Lupin Ltd. will sell the generic product accused of infringement in this action through Lupin Pharmaceuticals, Inc. throughout the United States, including in the State of Delaware. 9. On information and belief, Lupin Pharmaceuticals, Inc. is a wholly owned

subsidiary and alter ego of Lupin Ltd. On information and belief, for all purposes relevant to this action, Lupin Ltd. and Lupin Pharmaceuticals, Inc. are effectively the same entity and are referred to collectively hereinafter as "Lupin."

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THE NATURE OF THE ACTION 10. This is a civil action for infringement of United States Patent No.

5,859,021 ("the `021 patent"). This action is based upon the Patent Laws of the United States, 35 U.S.C. §§ 1 et seq. JURISDICTION AND VENUE 11. This Court has jurisdiction over the subject matter of this action under 28

U.S.C. §§ 1331 and 1338(a). 12. This Court has personal jurisdiction over Lupin by virtue of the fact that,

inter alia, Lupin has consented to personal jurisdiction in this Court for this action. 13. 1400(b). THE PATENT 14. On January 12, 1999, the `021 patent, titled "Antiviral Combinations," Venue is proper in this judicial district under 28 U.S.C. §§ 1391 and

was duly and legally issued to Glaxo Group Ltd. as assignee. Since that time, Glaxo has been, and continues to be, the sole owner of the `021 patent and the sole owner of the right to sue and to recover for any infringement of that patent. A copy of the `021 patent is attached hereto as Exhibit A. ACTS GIVING RISE TO THIS ACTION 15. The FDA granted approval of New Drug Application ("NDA") 20-857 to

GSK in September 1997 to sell an oral tablet dosage form containing 150 mg of lamivudine and 300 mg of zidovudine for use in treating Human Immunodeficiency Virus ("HIV") infection in humans. The tablets approved under GSK's NDA are prescribed and sold in the United States under the tradename COMBIVIR®.

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16.

On information and belief, on or before July 16, 2008, Lupin submitted

ANDA 90-246 to the FDA under § 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355(j)). 17. ANDA 90-246 seeks the FDA approval necessary to engage in the

commercial manufacture, use, offer for sale and sale of a generic oral tablet dosage form containing 150 mg of lamivudine and 300 mg of zidovudine for use in treating HIV infection in humans ("the Generic Product"), prior to the expiration of the `021 patent. 18. ANDA 90-246 contains an allegation under § 505(j)(2)(A)(vii)(IV) of the

Federal Food, Drug, and Cosmetic Act that the claims of the `021 patent are either invalid, unenforceable and/or not infringed by the manufacture, use or sale of the Generic Product. GSK received written notification of ANDA 90-246 and its § 505(j)(2)(A)(vii)(IV) allegations on July 17, 2008. 19. On information and belief, and consistent with its practice with respect to

other generic products, Lupin Ltd. has designated Lupin Pharmaceuticals, Inc. as its agent in the United States for purposes of filing ANDA 90-246 and for marketing and selling the Generic Product in the United States, including in the State of Delaware, upon any approval of ANDA 90-246. 20. Lupin Ltd.'s submission of ANDA 90-246 with its § 505(j)(2)(A)(vii)(IV)

allegations to the FDA through its subsidiary and agent Lupin Pharmaceuticals, Inc. constitutes infringement of the `021 patent under 35 U.S.C. § 271(e)(2)(A). Moreover, if Lupin Ltd.

commercially makes, uses, offers to sell or sells the Generic Product within the United States, or imports the Generic Product into the United States, or induces or contributes to any such conduct

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during the term of the `021 patent, it would further infringe that patent under 35 U.S.C. § 271(a), (b) and/or (c). 21. Lupin Pharmaceuticals, Inc. is jointly and severally liable for the

infringement of the `021 patent. On information and belief, Lupin Pharmaceuticals, Inc. actually filed ANDA 90-246 with the FDA and otherwise participated in, contributed to, aided, abetted and/or induced the submission of ANDA 90-246 and its § 505(j)(2)(A)(vii)(IV) allegations to the FDA. 22. Lupin Pharmaceuticals, Inc.'s filing of ANDA 90-246 and other

participation in, contribution to, aiding, abetting and/or inducement of the submission of ANDA 90-246 and its § 505(j)(2)(A)(vii)(IV) allegations to the FDA constitute infringement of the `021 patent under 35 U.S.C. § 271(e)(2)(A). Moreover, if Lupin Pharmaceuticals, Inc. commercially manufactures, uses, offers to sell or sells the Generic Product within the United States, or imports the Generic Product into the United States, or induces or contributes to any such conduct during the term of the `021 patent, it would further infringe the `021 patent under 35 U.S.C. § 271(a), (b) and/or (c). 23. Lupin had actual and constructive notice of the `021 patent prior to filing

ANDA 90-246 and, on information and belief, was aware that the filing of ANDA 90-246 with its § 505(j)(2)(A)(vii)(IV) allegations with the FDA constituted an act of infringement of the `021 patent. 24. GSK will be irreparably harmed by Lupin's infringing activities unless

those activities are enjoined by this Court. GSK does not have an adequate remedy at law. PRAYER FOR RELIEF WHEREFORE, Plaintiffs pray for judgment as follows: A. That Lupin has infringed the `021 patent; -5-

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B.

That, pursuant to 35 U.S.C. § 271(e)(4)(A), the effective date of any

approval of ANDA 90-246 under § 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355(j)) shall not be earlier than the expiration date of the `021 patent, including any extensions and additional periods of exclusivity; C. That, pursuant to 35 U.S.C. § 271(e)(4)(B) and otherwise, Lupin, its

officers, agents, servants and employees, and those persons in active concert or participation with any of them, are preliminarily and permanently enjoined from making, using, offering to sell or selling the Generic Product within the United States, or importing the Generic Product into the United States, prior to the expiration of the `021 patent, including any extensions and additional periods of exclusivity; D. That GSK be awarded monetary relief if Lupin commercially makes, uses,

offers to sell or sells the Generic Product within the United States, or imports the Generic Product into the United States, prior to the expiration of the `021 patent, including any extensions and additional periods of exclusivity, and that any such monetary relief be awarded to GSK with prejudgment interest; and E. That GSK be awarded such other and further relief as this Court deems

just and proper, including any appropriate relief under 35 U.S.C. § 285.

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MORRIS, NICHOLS, ARSHT & TUNNELL LLP

/s/ Karen Jacobs Louden (#2881)
Jack B. Blumenfeld (#1014) Karen Jacobs Louden (#2881) James W. Parrett, Jr. (#4292) 1201 N. Market Street P.O. Box 1347 Wilmington, DE 19899-1347 (302) 658-9200 [email protected] [email protected] [email protected] Attorneys for Glaxo Group Ltd. and SmithKline Beecham Corporation d/b/a GlaxoSmithKline

OF COUNSEL: John M. Desmarais Peter J. Armenio KIRKLAND & ELLIS LLP Citigroup Center 153 East 53rd Street New York, NY 10022 (212) 446-4800 F. Christopher Mizzo KIRKLAND & ELLIS LLP 655 15th Street, N.W. Washington, DC 20005 (202)879-5000 August 29, 2008
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EXHIBIT A

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JS 44 (Rev. 11/04)

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CIVIL COVER SHEET

The JS 44 civil cover sheet and the information contained herein neither replace nor supplement the filing and service of pleadings or other papers as required by law, except as provided by local rules of court. This form, approved by the Judicial Conference of the United States in September 1974, is required for the use of the Clerk of Court for the purpose of initiating the civil docket sheet. (SEE INSTRUCTIONS ON THE REVERSE OF THE FORM.)

I. (a)

PLAINTIFFS
Glaxo Group Ltd. and SmithKline Beecham Corporation d/b/a GlaxoSmithKline

DEFENDANTS
Lupin Ltd. and Lupin Pharmaceuticals, Inc.

(b) County of Residence of First Listed Plaintiff
(EXCEPT IN U.S. PLAINTIFF CASES)

County of Residence of First Listed Defendant
(IN U.S. PLAINTIFF CASES ONLY) NOTE: IN LAND CONDEMNATION CASES, USE THE LOCATION OF THE LAND INVOLVED.

(c) Attorney's (Firm Name, Address, and Telephone Number)
Jack B. Blumenfeld and Karen Jacobs Louden, Morris, Nichols, Arsht & Tunnell LLP, 1201 North Market Street, P.O. Box 1347, Wilmington, DE 19899-1347, (302) 658-9200

Attorneys (If Known)

II. BASIS OF JURISDICTION
1 U.S. Government Plaintiff

(Place an "X" in One Box Only)

III. CITIZENSHIP OF PRINCIPAL PARTIES(Place an "X" in One Box for Plaintiff
(For Diversity Cases Only) PTF Citizen of This State 1 DEF 1 and One Box for Defendant) PTF DEF Incorporated or Principal Place 4 4 of Business In This State Incorporated and Principal Place of Business In Another State Foreign Nation 5 5

X3

Federal Question (U.S. Government Not a Party)

2

U.S. Government Defendant

4 Diversity (Indicate Citizenship of Parties in Item III)

Citizen of Another State

2

2

Citizen or Subject of a Foreign Country

3

3

6

6

IV. NATURE OF SUIT
CONTRACT 110 Insurance 120 Marine 130 Miller Act 140 Negotiable Instrument 150 Recovery of Overpayment & Enforcement of Judgment 151 Medicare Act 152 Recovery of Defaulted Student Loans (Excl. Veterans) 153 Recovery of Overpayment of Veteran's Benefits 160 Stockholders' Suits 190 Other Contract 195 Contract Product Liability 196 Franchise REAL PROPERTY 210 Land Condemnation 220 Foreclosure 230 Rent Lease & Ejectment 240 Torts to Land 245 Tort Product Liability 290 All Other Real Property

(Place an "X" in One Box Only) TORTS PERSONAL INJURY 310 Airplane 315 Airplane Product Liability 320 Assault, Libel & Slander 330 Federal Employers' Liability 340 Marine 345 Marine Product Liability 350 Motor Vehicle 355 Motor Vehicle Product Liability 360 Other Personal Injury CIVIL RIGHTS 441 Voting 442 Employment 443 Housing/ Accommodations 444 Welfare 445 Amer. w/Disabilities Employment 446 Amer. w/Disabilities Other 440 Other Civil Rights PERSONAL INJURY 362 Personal Injury Med. Malpractice 365 Personal Injury Product Liability 368 Asbestos Personal Injury Product Liability PERSONAL PROPERTY 370 Other Fraud 371 Truth in Lending 380 Other Personal Property Damage 385 Property Damage Product Liability PRISONER PETITIONS 510 Motions to Vacate Sentence Habeas Corpus: 530 General 535 Death Penalty 540 Mandamus & Other 550 Civil Rights 555 Prison Condition

FORFEITURE/PENALTY 610 Agriculture 620 Other Food & Drug 625 Drug Related Seizure of Property 21 USC 881 630 Liquor Laws 640 R.R. & Truck 650 Airline Regs. 660 Occupational Safety/Health 690 Other LABOR 710 Fair Labor Standards Act 720 Labor/Mgmt. Relations 730 Labor/Mgmt.Reporting & Disclosure Act 740 Railway Labor Act 790 Other Labor Litigation 791 Empl. Ret. Inc. Security Act

BANKRUPTCY 422 Appeal 28 USC 158 423 Withdrawal 28 USC 157 PROPERTY RIGHTS 820 Copyrights 830 Patent 840 Trademark

OTHER STATUTES 400 State Reapportionment 410 Antitrust 430 Banks and Banking 450 Commerce 460 Deportation 470 Racketeer Influenced and Corrupt Organizations 480 Consumer Credit 490 Cable/Sat TV 810 Selective Service 850 Securities/Commodities/ Exchange 875 Customer Challenge 12 USC 3410 890 Other Statutory Actions 891 Agricultural Acts 892 Economic Stabilization Act 893 Environmental Matters 894 Energy Allocation Act 895 Freedom of Information Act 900Appeal of Fee Determination Under Equal Access to Justice 950 Constitutionality of State Statutes

X

SOCIAL SECURITY 861 HIA (1395ff) 862 Black Lung (923) 863 DIWC/DIWW (405(g)) 864 SSID Title XVI 865 RSI (405(g)) FEDERAL TAX SUITS 870 Taxes (U.S. Plaintiff or Defendant) 871 IRS--Third Party 26 USC 7609

V. ORIGIN

(Place an "X" in One Box Only)

X1

Original Proceeding

2 Removed from

(specify) State Court Appellate Court Reopened Litigation Cite the U.S. Civil Statute under which you are filing (Do not cite jurisdictional statutes unless diversity):

3 Remanded from

4 Reinstated or

5 Transferred from another district

6 Multidistrict

7 Judge from Magistrate
Judgment

Appeal to District

VI. CAUSE OF ACTION VII. REQUESTED IN COMPLAINT: VIII. RELATED CASE(S) IF ANY
DATE

35 U.S.C. Section 271

Brief description of cause:

patent infringement
DEMAND $ CHECK YES only if demanded in complaint: X No Yes JURY DEMAND: DOCKET NUMBER

CHECK IF THIS IS A CLASS ACTION UNDER F.R.C.P. 23
(See instructions):

JUDGE

Joseph J. Farnan, Jr.

07-713 (JJF)

SIGNATURE OF ATTORNEY OF RECORD

8/29/08
FOR OFFICE USE ONLY RECEIPT # AMOUNT

/s/ Karen Jacobs Louden (#2881)
APPLYING IFP JUDGE MAG. JUDGE

JS 44 Reverse (Rev. 11/04)

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INSTRUCTIONS FOR ATTORNEYS COMPLETING CIVIL COVER SHEET FORM JS 44
Authority For Civil Cover Sheet
The JS 44 civil cover sheet and the information contained herein neither replaces nor supplements the filings and service of pleading or other papers as required by law, except as provided by local rules of court. This form, approved by the Judicial Conference of the United States in September 1974, is required for the use of the Clerk of Court for the purpose of initiating the civil docket sheet. Consequently, a civil cover sheet is submitted to the Clerk of Court for each civil complaint filed. The attorney filing a case should complete the form as follows: I. (a) Plaintiffs-Defendants. Enter names (last, first, middle initial) of plaintiff and defendant. If the plaintiff or defendant is a government agency, use only the full name or standard abbreviations. If the plaintiff or defendant is an official within a government agency, identify first the agency and then the official, giving both name and title. (b) County of Residence. For each civil case filed, except U.S. plaintiff cases, enter the name of the county where the first listed plaintiff resides at the time of filing. In U.S. plaintiff cases, enter the name of the county in which the first listed defendant resides at the time of filing. (NOTE: In land condemnation cases, the county of residence of the "defendant" is the location of the tract of land involved.) (c) Attorneys. Enter the firm name, address, telephone number, and attorney of record. If there are several attorneys, list them on an attachment, noting in this section "(see attachment)". II. Jurisdiction. The basis of jurisdiction is set forth under Rule 8(a), F.R.C.P., which requires that jurisdictions be shown in pleadings. Place an "X" in one of the boxes. If there is more than one basis of jurisdiction, precedence is given in the order shown below. United States plaintiff. (1) Jurisdiction based on 28 U.S.C. 1345 and 1348. Suits by agencies and officers of the United States are included here. United States defendant. (2) When the plaintiff is suing the United States, its officers or agencies, place an "X" in this box. Federal question. (3) This refers to suits under 28 U.S.C. 1331, where jurisdiction arises under the Constitution of the United States, an amendment to the Constitution, an act of Congress or a treaty of the United States. In cases where the U.S. is a party, the U.S. plaintiff or defendant code takes precedence, and box 1 or 2 should be marked. Diversity of citizenship. (4) This refers to suits under 28 U.S.C. 1332, where parties are citizens of different states. When Box 4 is checked, the citizenship of the different parties must be checked. (See Section III below; federal question actions take precedence over diversity cases.) III. Residence (citizenship) of Principal Parties. This section of the JS 44 is to be completed if diversity of citizenship was indicated above. Mark this section for each principal party. IV. Nature of Suit. Place an "X" in the appropriate box. If the nature of suit cannot be determined, be sure the cause of action, in Section VI below, is sufficient to enable the deputy clerk or the statistical clerks in the Administrative Office to determine the nature of suit. If the cause fits more than one nature of suit, select the most definitive. V. Origin. Place an "X" in one of the seven boxes. Original Proceedings. (1) Cases which originate in the United States district courts. Removed from State Court. (2) Proceedings initiated in state courts may be removed to the district courts under Title 28 U.S.C., Section 1441. When the petition for removal is granted, check this box. Remanded from Appellate Court. (3) Check this box for cases remanded to the district court for further action. Use the date of remand as the filing date. Reinstated or Reopened. (4) Check this box for cases reinstated or reopened in the district court. Use the reopening date as the filing date. Transferred from Another District. (5) For cases transferred under Title 28 U.S.C. Section 1404(a). Do not use this for within district transfers or multidistrict litigation transfers. Multidistrict Litigation. (6) Check this box when a multidistrict case is transferred into the district under authority of Title 28 U.S.C. Section 1407. When this box is checked, do not check (5) above. Appeal to District Judge from Magistrate Judgment. (7) Check this box for an appeal from a magistrate judge's decision. VI. Cause of Action. Report the civil statute directly related to the cause of action and give a brief description of the cause. Do not cite jurisdictional statutes unless diversity. Example: U.S. Civil Statute: 47 USC 553 Brief Description: Unauthorized reception of cable service VII. Requested in Complaint. Class Action. Place an "X" in this box if you are filing a class action under Rule 23, F.R.Cv.P. Demand. In this space enter the dollar amount (in thousands of dollars) being demanded or indicate other demand such as a preliminary injunction. Jury Demand. Check the appropriate box to indicate whether or not a jury is being demanded. VIII. Related Cases. This section of the JS 44 is used to reference related pending cases if any. If there are related pending cases, insert the docket numbers and the corresponding judge names for such cases. Date and Attorney Signature. Date and sign the civil cover sheet.

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2 AO 440 (Rev. 03/08) Civil Summons

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UNITED STATES DISTRICT COURT
for the

__________ District of __________
Glaxo Group Ltd. and SmithKline Beecham Corporation d/b/a GlaxoSmithKline, ) Plaintiff ) Lupin Ltd. and v. ) Lupin Pharmaceuticals, Inc., ) Defendant )

Civil Action No.

Summons in a Civil Action To: (Defendant's name and address) Lupin Ltd. Laxmi Towers, B Wing Bandra Kurla Complex Bandra (East) Mumbai, Maharashtra 400 051 India A lawsuit has been filed against you. Within 20 days after service of this summons on you (not counting the day you received it), you must serve on the plaintiff an answer to the attached complaint or a motion under Rule 12 of the Federal Rules of Civil Procedure. The answer or motion must be served on the plaintiff's attorney, whose name and address are:
Jack B. Blumenfeld and Karen Jacobs Louden Morris, Nichols, Arsht & Tunnell LLP 1201 N. Market Street P.O. Box 1347 Wilmington, DE 19899

If you fail to do so, judgment by default will be entered against you for the relief demanded in the complaint. You also must file your answer or motion with the court.

Name of clerk of court

Date:
Deputy clerk's signature

(Use 60 days if the defendant is the United States or a United States agency, or is an officer or employee of the United States allowed 60 days by Rule 12(a)(3).)

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Proof of Service

I declare under penalty of perjury that I served the summons and complaint in this case on by: (1) personally delivering a copy of each to the individual at this place, ; or (2) leaving a copy of each at the individual's dwelling or usual place of abode with who resides there and is of suitable age and discretion; or (3) delivering a copy of each to an agent authorized by appointment or by law to receive it whose name is ; or (4) returning the summons unexecuted to the court clerk on My fees are $ for travel and $ . for services, for a total of $
0.00 0.00

,

.

Date:
Server's signature

Printed name and title

Server's address

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UNITED STATES DISTRICT COURT
for the

__________ District of __________
Glaxo Group Ltd. and SmithKline Beecham Corporation d/b/a GlaxoSmithKline, ) Plaintiff ) Lupin Ltd. and v. ) Lupin Pharmaceuticals, Inc., ) Defendant )

Civil Action No.

Summons in a Civil Action To: (Defendant's name and address)
Lupin Pharmaceuticals, Inc. Harborplace Tower 111 S. Calvert Street, 21st Floor Baltimore, MD 21202

A lawsuit has been filed against you. Within 20 days after service of this summons on you (not counting the day you received it), you must serve on the plaintiff an answer to the attached complaint or a motion under Rule 12 of the Federal Rules of Civil Procedure. The answer or motion must be served on the plaintiff's attorney, whose name and address are:
Jack B. Blumenfeld and Karen Jacobs Louden Morris, Nichols, Arsht & Tunnell LLP 1201 N. Market Street P.O. Box 1347 Wilmington, DE 19899

If you fail to do so, judgment by default will be entered against you for the relief demanded in the complaint. You also must file your answer or motion with the court.

Name of clerk of court

Date:
Deputy clerk's signature

(Use 60 days if the defendant is the United States or a United States agency, or is an officer or employee of the United States allowed 60 days by Rule 12(a)(3).)

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Proof of Service

I declare under penalty of perjury that I served the summons and complaint in this case on by: (1) personally delivering a copy of each to the individual at this place, ; or (2) leaving a copy of each at the individual's dwelling or usual place of abode with who resides there and is of suitable age and discretion; or (3) delivering a copy of each to an agent authorized by appointment or by law to receive it whose name is ; or (4) returning the summons unexecuted to the court clerk on My fees are $ for travel and $ . for services, for a total of $
0.00 0.00

,

.

Date:
Server's signature

Printed name and title

Server's address

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE GLAXO GROUP LTD. and SMITHKLINE BEECHAM CORPORATION d/b/a GLAXOSMITHKLINE, Plaintiffs, v. LUPIN LTD. and LUPIN PHARMACEUTICALS, INC., Defendants. ) ) ) ) ) ) ) ) ) ) ) )

C.A. No.

PLAINTIFFS' RULE 7.1 STATEMENT Pursuant to Fed. R. Civ. P. 7.1(a), the undersigned counsel for Glaxo Group Ltd. and SmithKline Beecham Corporation, d/b/a GlaxoSmithKline, which is a non-governmental corporate party, certifies that: (i) GlaxoSmithKline plc, is a publicly held company that does not have a parent corporation and there is no publicly held corporation that owns 10% or more of its stock; and (ii) Glaxo Group Ltd. and SmithKline Beecham Corporation are ultimately whollyowned subsidiaries of GlaxoSmithKline plc. MORRIS, NICHOLS, ARSHT & TUNNELL LLP OF COUNSEL: John M. Desmarais Peter J. Armenio KIRKLAND & ELLIS LLP 153 East 53rd Street New York, NY 10022 (212) 446-4800 Christopher Mizzo KIRKLAND & ELLIS LLP 655 15th Street, N.W. Washington, DC 20005 (202) 879-5000 August 29, 2008
2458332

/s/ Karen Jacobs Louden (#2881)
Jack B. Blumenfeld (#1014) Karen Jacobs Louden (#2881) James W. Parrett, Jr. (#4292) 1201 North Market Street P.O. Box 1347 Wilmington, DE 19899-1347 (302) 658-9200 [email protected] [email protected] [email protected] Attorneys for Plaintiffs Glaxo Group Ltd. and SmithKline Beecham Corporation d/b/a GlaxoSmithKline