Case 1:15-cv-10698-MLW Document 53 Filed 04/29/15 Page 1 of 3 UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS —————————————————— X : JANSSEN BIOTECH, INC. and NEW : YORK UNIVERSITY, : Civil Action No. 1:15-cv-10698-MLW : Plaintiffs, : : v. : : CELLTRION HEALTHCARE CO., LTD., : CELLTRION, INC., and HOSPIRA, INC., : : Defendants. : : —————————————————— X DECLARATION OF DAN H. HOANG IN SUPPORT OF DEFENDANTS’ OPPOSITION TO PLAINTIFFS’ MOTION FOR PARTIAL SUMMARY JUDGMENT AND A PRELIMINARY AND PERMANENT INJUNCTION; AND IN SUPPORT DEFENDANTS’ CROSS-MOTION FOR PARTIAL SUMMARY JUDGMENT ON COUNT 2 OF THE COMPLAINT I, Dan H. Hoang, declare as follows: 1. I am an attorney at the Chicago office of Winston & Strawn representing Defendants Celltrion Healthcare Co., Ltd., Celltrion, Inc., and Hospira, Inc. in the above- captioned case. I am a member in good standing of the Bar of the State of Illinois and have been admitted to practice pro hac vice by Order of this Court dated April 8, 2015, Dkt. 33. 2. I offer this declaration in support of Defendants’ Opposition to Plaintiffs’ Motion for Partial Summary Judgment and a Preliminary and Permanent Injunction; and Defendants’ Cross-Motion for Partial Summary Judgment on Count 2 of the Complaint, filed concurrently herewith. Case 1:15-cv-10698-MLW Document 53 Filed 04/29/15 Page 2 of 3 3. Attached hereto as Exhibit 1 is a true and correct copy of the Filing Notification Letter from the Food and Drug Administration regarding Celltrion, Inc.’s Biologics License Application, dated October 7, 2014. 4. Attached hereto as Exhibit 2 is a copy of Janssen Biotech, Inc.’s Patent List Pursuant to 42 U.S.C. § 262(l)(3)(A), dated December 26, 2014. 5. Attached hereto as Exhibit 3 is a true and correct copy of Celltrion, Inc.’s Detailed Statement Pursuant to 42 U.S.C. § 262(l)(3)(B), dated February 5, 2015. 6. Attached hereto as Exhibit 4 is a true and correct copy of Hospira, Inc. and Celltrion, Inc.’s Notice of Commercial Marketing Pursuant to 42 U.S.C. § 262(l)(8)(A), dated February 5, 2015. 7. Attached hereto as Exhibit 5 is a true and correct copy of Biologics and Biosimilars: Balancing Incentives for Innovation, Hearing Before the Subcomm. on Courts and Competition Policy of the H. Comm. on the Judiciary, 111th Cong. (2009). Executed in Chicago, Illinois on April 29, 2015. /s/ Dan H. Hoang Dan H. Hoang WINSTON & STRAWN LLP 35 West Wacker Drive Chicago, Illinois 60601-9703 Phone: (312) 558-5600 [email protected] Case 1:15-cv-10698-MLW Document 53 Filed 04/29/15 Page 3 of 3 CERTIFICATE OF SERVICE I, Andrea L. Martin, hereby certify that this document filed through the ECF system will be sent electronically to the registered participants as identified on the Notice of Electronic Filing (NEF) and paper copies will be sent to those indicated as non-registered participants on April 29, 2015. /s/Andrea L. Martin, Esq. Andrea L. Martin, Esq. 4837-8089-2963.1 Case 1:15-cv-10698-MLW Document 53-1 Filed 04/29/15 Page 1 of 1 Case 1:15-cv-10698-MLW Document 53-2 Filed 04/29/15 Page 1 of 1 Case 1:15-cv-10698-MLW Document 53-3 Filed 04/29/15 Page 1 of 1 Case 1:15-cv-10698-MLW Document 53-4 Filed 04/29/15 Page 1 of 1 Case 1:15-cv-10698-MLW Document 53-5 Filed 04/29/15 Page 1 of 257 Exhibit 5 Case 1:15-cv-10698-MLW Document 53-5 Filed 04/29/15 Page 2 of 257 BIOLOGICS AND BIOSIMILARS: BALANCING INCENTIVES FOR INNOVATION HEARING BEFORE THE SUBCOMMITTEE ON COURTS AND COMPETITION POLICY OF THE COMMITTEE ON THE JUDICIARY HOUSE OF REPRESENTATIVES ONE HUNDRED ELEVENTH CONGRESS FIRST SESSION JULY 14, 2009 Serial No. 111–73 Printed for the use of the Committee on the Judiciary ( Available via the World Wide Web: http://judiciary.house.gov U.S. GOVERNMENT PRINTING OFFICE 51–014 PDF WASHINGTON : 2010 For sale by the Superintendent of Documents, U.S. Government Printing Office Internet: bookstore.gpo.gov Phone: toll free (866) 512–1800; DC area (202) 512–1800 Fax: (202) 512–2104 Mail: Stop IDCC, Washington, DC 20402–0001 VerDate Aug 31 2005 14:53 Apr 27, 2010 Jkt 000000 PO 00000 Frm 00001 Fmt 5011 Sfmt 5011 H:\WORK\COURTS\071409\51014.000 HJUD1 PsN: 51014 Case 1:15-cv-10698-MLW Document 53-5 Filed 04/29/15 Page 3 of 257 COMMITTEE ON THE JUDICIARY JOHN CONYERS, JR., Michigan, Chairman HOWARD L. BERMAN, California LAMAR SMITH, Texas RICK BOUCHER, Virginia F. JAMES SENSENBRENNER, JR., JERROLD NADLER, New York Wisconsin ROBERT C. ‘‘BOBBY’’ SCOTT, Virginia HOWARD COBLE, North Carolina MELVIN L. WATT, North Carolina ELTON GALLEGLY, California ZOE LOFGREN, California BOB GOODLATTE, Virginia SHEILA JACKSON LEE, Texas DANIEL E. LUNGREN, California MAXINE WATERS, California DARRELL E. ISSA, California WILLIAM D. DELAHUNT, Massachusetts J. RANDY FORBES, Virginia ROBERT WEXLER, Florida STEVE KING, Iowa STEVE COHEN, Tennessee TRENT FRANKS, Arizona HENRY C. ‘‘HANK’’ JOHNSON, JR., LOUIE GOHMERT, Texas Georgia JIM JORDAN, Ohio PEDRO PIERLUISI, Puerto Rico TED POE, Texas MIKE QUIGLEY, Illinois JASON CHAFFETZ, Utah LUIS V. GUTIERREZ, Illinois TOM ROONEY, Florida BRAD SHERMAN, California GREGG HARPER, Mississippi TAMMY BALDWIN, Wisconsin CHARLES A. GONZALEZ, Texas ANTHONY D. WEINER, New York ADAM B. SCHIFF, California LINDA T. SA´ NCHEZ, California DEBBIE WASSERMAN SCHULTZ, Florida DANIEL MAFFEI, New York PERRY APELBAUM, Majority Staff Director and Chief Counsel SEAN MCLAUGHLIN, Minority Chief of Staff and General Counsel SUBCOMMITTEE ON COURTS AND COMPETITION POLICY HENRY C. ‘‘HANK’’ JOHNSON, JR., Georgia, Chairman JOHN CONYERS, JR., Michigan HOWARD COBLE, North Carolina RICK BOUCHER, Virginia JASON CHAFFETZ, Utah ROBERT WEXLER, Florida BOB GOODLATTE, Virginia CHARLES A. GONZALEZ, Texas F. JAMES SENSENBRENNER, JR., SHEILA JACKSON LEE, Texas Wisconsin MELVIN L. WATT, North Carolina DARRELL ISSA, California BRAD SHERMAN, California GREGG HARPER, Mississippi MIKE QUIGLEY, Illinois CHRISTAL SHEPPARD, Chief Counsel BLAINE MERRITT, Minority Counsel (II) VerDate Aug 31 2005 14:53 Apr 27, 2010 Jkt 000000 PO 00000 Frm 00002 Fmt 5904 Sfmt 0486 H:\WORK\COURTS\071409\51014.000 HJUD1 PsN: 51014 Case 1:15-cv-10698-MLW Document 53-5 Filed 04/29/15 Page 4 of 257 C O N T E N T S JULY 14, 2009 Page OPENING STATEMENTS The Honorable Henry C. ‘‘Hank’’ Johnson, Jr., a Representative in Congress from the State of Georgia, and Chairman, Subcommittee on Courts and Competition Policy ............................................................................................... 1 The Honorable Howard Coble, a Representative in Congress from the State of North Carolina, and Ranking Member, Subcommittee on Courts and Competition Policy ............................................................................................... 2 WITNESSES The Honorable Anna G. Eshoo, a Representative in Congress from the State of California Oral Testimony ..................................................................................................... 7 Prepared Statement ............................................................................................. 10 Mr. Bruce A. Leicher, Senior Vice President and General Counsel, Momenta Pharmaceuticals, Inc., Cambridge, MA Oral Testimony ..................................................................................................... 14 Prepared Statement ............................................................................................. 16 Mr. Jeffrey P. Kushan, on behalf of the Biotechnology Industry Organization (BIO), Woodrow Wilson School of Public and International Affairs, Prince- ton, NJ Oral Testimony ..................................................................................................... 38 Prepared Statement ............................................................................................. 40 Mr. Alex M. Brill, Research Fellow, American Enterprise Institute (AEI), Washington, DC Oral Testimony ..................................................................................................... 173 Prepared Statement ............................................................................................. 175 Mr. Jack W. Lasersohn, General Partner, Verticle Group, on behalf of Na- tional Venture Capital Association (NVCA), Arlington, VA Oral Testimony ..................................................................................................... 181 Prepared Statement ............................................................................................. 184 Mr. Larry McNeely, Healthcare Reform Advocate, U.S. Public Interest Re- search Groups (USPIRG), Washington, DC Oral Testimony ..................................................................................................... 189 Prepared Statement ............................................................................................. 191 Ms. Teresa Stanek Rea, President, American Intellectual Property Law Asso- ciation (AIPLA), Washington, DC Oral Testimony ..................................................................................................... 196 Prepared Statement ............................................................................................. 198 LETTERS, STATEMENTS, ETC., SUBMITTED FOR THE HEARING Prepared Statement of the Honorable Howard Coble, a Representative in Congress from the State of North Carolina, and Ranking Member, Sub- committee on Courts and Competition Policy .................................................... 4 Prepared Statement of the California Healthcare Institute (CHI) submitted by the Honorable Darrell Issa, a Representative in Congress