IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF ILLINOIS ) ) ) ) ) ) ) ) ) ) ) )

GENZYME CORPORATION, Plaintiff v. COBREK PHARMACEUTICALS, INC., Defendant.

Civil Action No.

Plaintiffs Complaint For Patent Infringement Plaintiff Genzyme Corporation, by its undersigned attorneys, for its complaint against Defendant Cobrek Pharmaceuticals, Inc., hereby alleges as follows: Parties 1. Plaintiff Genzyme Corporation (Genzyme) is a corporation organized and

existing under the laws of the Commonwealth of Massachusetts, having its principal place of business at 500 Kendall Street, Cambridge, Massachusetts, 02142. 2. Upon information and belief, Defendant Cobrek Pharmaceuticals, Inc. (Cobrek)

is a corporation organized and existing under the laws of the state of Delaware, having a principal place of business at 3315 Algonquin Road, Rolling Meadows, Illinois 60008. Jurisdiction And Venue 3. This is an action for patent infringement arising under the patent laws of the

United States of America, Title 35, United States Code (U.S.C.). Jurisdiction is based on 28 U.S.C. 1331 and 1338(a).

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This Court has personal jurisdiction over Cobrek by virtue of the facts that, on

information and belief, Cobrek is registered in Illinois as a foreign corporation and has a principal place of business in the Northern District of Illinois. In addition, Cobrek has previously ceded personal jurisdiction in this Court, and has availed itself of the legal protections of the Northern District of Illinois by filing counterclaims seeking judicial relief from this Court in Bone Care International LLC et. al. v. Pentech Pharmaceuticals, Inc. et. al., U.S.D.C. Northern Illinois Civil Action No. 08-1083; Genzyme Corporation v. Cobrek Pharmaceuticals, Inc., et. al., U.S.D.C. Northern Illinois Civil Action No. 10-0112; and Connetics Corporation et. al. v. Pentech Pharmaceuticals, Inc. et al., U.S.D.C. Northern Illinois Civil Action No. 07-6297. 5. Venue is proper in this judicial district pursuant to 28 U.S.C. 1391(b) and (c),

and 28 U.S.C. 1400(b). Claim For Relief Patent Infringement 6. Genzyme holds approved New Drug Application (NDA) No. 21-027 for

Hectorol injection (2 g/mL), which product contains the active ingredient doxercalciferol. 7. The U.S. Food and Drug Administration (FDA) approved NDA No. 21-027 on

April 6, 2000 for Hectorol injection in an ampule presentation. 8. On or about April 18, 2008, Genzyme submitted to the FDA a supplement to

NDA No. 21-027 seeking FDAs approval to change the Hectorol injection dosing formulation and packaging configuration from an ampule presentation to a vial presentation (Supplemental NDA); and patent information for the United States Patent No. 5,602,116 (the 116 patent) pursuant to 21 C.F.R. 314.53. 9. NDA. On or about December 8, 2012, the FDA approved Genzymes Supplemental

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Hectorol is indicated for the treatment of secondary hyperparathyroidism in

patients with chronic kidney disease on dialysis. 11. On February 11, 1997 the 116 patent was lawfully issued. A copy of the 116

patent is attached hereto as Exhibit A. 12. The 116 patent claims, among other things, a method for lowering or maintaining

lowered serum parathyroid hormone in human patients suffering from hyperparathyroidism secondary to end stage renal disease by administering doxercalciferol. 13. 14. Genzyme is the owner of the 116 patent. In a letter dated March 7, 2012 (Notice Letter), Cobrek notified Genzyme that

Cobrek had submitted to the FDA Abbreviated New Drug Application (ANDA) No. 203982, seeking the FDAs approval to commercially manufacture, use and/or sell a generic version of the Hectorol injection product in a vial presentation (Cobreks ANDA Product) prior to the expiration of the 116 patent. 15. In its Notice Letter, Cobrek states that its ANDA contains a certification pursuant

to Section 505(j)(2)(A)(vii)(IV) of the Federal Food, Drug and Cosmetic Act that, in Cobreks opinion, the claims of the 116 patent are invalid, unenforceable and/or will not be infringed by the manufacture, use, or sale of Cobreks ANDA Product. 16. In its Notice Letter, Cobrek alleges that the 116 patent is invalid and

unenforceable for the reasons set forth in its November 24, 2009 notice letter to Genzyme (Cobreks Prior Notice Letter). 17. On receipt of Cobreks Prior Notice Letter, Genzyme sued Cobrek for

infringement of the 116 patent, the case is captioned Genzyme Corporation v. Cobrek Pharmaceuticals, Inc., et al., Civil Action No. 10-0112 (the 10-0112 Case).

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On April 4, 2012, final judgment was entered in the 10-0112 Case, holding that

the 116 patent is valid and enforceable. 19. In its Notice Letter, Cobrek alleges that the 116 patent is invalid and

unenforceable for the reasons set for in Defendants Proposed Findings of Fact and Conclusions of Law, dated January 8, 2011 in the case captioned Bone Care International LLC et. al. v. Pentech Pharmaceuticals, Inc. et. al., U.S.D.C. Northern Illinois Civil Action No. 08-1083 (the 08-1083 Case), (Dkt. ID No. 610). 20. On April 4, 2012, final judgment was entered in the 08-1083 Case, holding that

the 116 patent is valid and enforceable. Count I Infringement Of The 116 Patent 21. Genzyme repeats and realleges the allegations of paragraphs 1-20 as though fully

set forth herein. 22. Cobrek infringed the 116 patent under 35 U.S.C. 271(e)(2) by filing its ANDA

seeking approval from the FDA to engage in the commercial manufacture, use, and/or sale of Cobreks ANDA Product before the expiration of the 116 patent. Further, the commercial manufacture, use, offer for sale, sale and/or importation of Cobreks ANDA Product will infringe one or more claims of the 116 patent. 23. Cobreks ANDA Product, if approved, will be administered to patients with end

stage renal disease and secondary hyperparathyroidism in amounts sufficient to lower and maintain lowered parathyroid hormone (PTH) levels with a lower incidence of hypercalcamia than would result from using calcitriol or alfacalcidol to achieve the same level of PTH suppression.. 24. On information and belief, this administration will occur at Cobreks active behest

and with their intent, knowledge and encouragement and Cobrek will actively encourage, aid and -4-

abet this administration with knowledge that it is in contravention of Genzymes rights under the 116 patent. 25. On information and belief, the offer for sale or sale of Cobreks ANDA Product,

if approved by the FDA, would induce infringement of, and/or be contributory infringement of the 116 patent under 35 U.S.C. 271. 26. 27. Cobrek had notice of the 116 patent prior to undertaking its acts of infringement. Genzyme is entitled to the relief provided by 35 U.S.C. 271(e)(4), including an

order of this Court that the effective date of any approval of ANDA No. 203982 be a date which is not earlier than the expiration of the 116 patent, and any other exclusivity to which Genzyme is or becomes entitled. Prayer For Relief WHEREFORE, Genzyme respectfully requests the following relief: 28. Judgment that Cobreks filing of ANDA No. 203982 is an act of infringement

under 35 U.S.C. 271(e)(2)(A); 29. Judgment declaring that the offer for sale or sale of Cobreks ANDA Product, if

approved by the FDA, would induce infringement of, and/or be contributory infringement of the 116 patent under 35 U.S.C. 271; 30. An Order that the effective date of any FDA approval of ANDA No. 203982

relating to Cobreks ANDA Product be no earlier than the expiration date of the 116 patent, and any other exclusivity to which Genzyme is or becomes entitled; 31. Preliminary and permanent injunctions enjoining Cobrek and their officers,

agents, attorneys and employees, and those acting in privity or concert with them, from engaging in the commercial manufacture, use, offer to sell, or sale within the United State or importation

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into the United States of Cobreks ANDA Product until no earlier than the expiration date of the 116 patent, and any other exclusivity to which Genzyme is or becomes entitled; 32. If Cobrek engages in the commercial manufacture, use, offer to sell or sale within

the United States or importation into the United States of Cobreks ANDA Product prior to the expiration date of the 116 patent, and any other exclusivity to which Genzyme is or becomes entitled, a Judgment awarding damages to Genzyme resulting from such infringement; 33. 34. The costs and reasonable attorney fees of Genzyme in this action; and Such further and other relief as this Court may deem just and proper.

Respectfully submitted,

Date: April 19, 2012

/s/ Oscar L. Alcantara Oscar Alcantara GOLDBERG KOHN, LTD. 55 East Monroe, Suite 3300 Chicago, Illinois 60603 Telephone: (312) 201-4000 Facsimile: (312) 332-2196 Of Counsel Scott K. Reed Filko Prugo FITZPATRICK CELLA HARPER & SCINTO 1290 Avenue of the Americas New York, New York 10104-3800 Telephone: (212) 218-2100 Facsimile: (212) 218-2200 Attorneys for Plaintiff Genzyme Corporation

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