Amgen, Inc. v. Hoechst Marion Roussel, Inc.

Decision Date15 October 2004
Docket NumberNo. CIV.A. 97-10814-WGY.,CIV.A. 97-10814-WGY.
Citation339 F.Supp.2d 202
PartiesAMGEN, INC., Plaintiff, v. HOECHST MARION ROUSSEL, INC. and Transkaryotic Therapies, Inc., Defendants.
CourtU.S. District Court — District of Massachusetts

D. Dennis Allegretti, Duane Morris LLP, Boston, MA, for Amgen, Inc., Plaintiff.

Linda A. Baxley, Day Casebeer Madrid Winters & Batchelder LLP, Cupertino, CA, for Amgen, Inc., Plaintiff.

Michael F. Borun, Marshall, O'Toole, Gerstein, Murray & Borun, Chicago, IL, for Amgen, Inc., Plaintiff.

Craig H. Casebeer, Day Casebeer Madrid Winters & Batchelder LLP, Cupertino, CA, for Amgen, Inc., Plaintiff.

Padmaja Chinta, Fish & Neave, New York, NY, for Hoechst Marion Roussel, Inc., Transkaryotic Therapies, Inc., Defendants.

Jane J. Choi, Marshall, O'Toole, Gerstein, Murray & Borun, Chicago, IL, for Amgen, Inc., Plaintiff.

Lloyd R. Day, Jr., Day Casebeer Madrid Winters & Batchelder LLP, Cupertino, CA, for Amgen, Inc., Plaintiff.

Edward DiLello, Darby & Darby, New York, NY, for Lonza Biologic, Movant.

Bindu Donovan, Fish & Neave, New York, NY, for Hoechst Marion Roussel, Inc., Transkaryotic Therapies, Inc., Defendants.

Jennifer R. Dupre, Carr & Ferrell, Palo Alto, CA, for Amgen, Inc., Plaintiff.

Russell W. Faegenburg, Fish & Neave, New York, NY, for Hoechst Marion Roussel, Inc., Transkaryotic Therapies, Inc., Defendants.

Deborah E. Fishman, Day Casebeer Madrid Winters & Batchelder LLP, Cupertino, CA, for Amgen, Inc., Plaintiff.

Gerald J. Flattmann, Fish & Neave, New York, NY, for Hoechst Marion Roussel, Inc., Transkaryotic Therapies, Inc., Defendants.

Kevin M. Flowers, Marshall, O'Toole, Gerstein, Murray & Borun, Chicago, IL, for Amgen, Inc., Plaintiff.

Robert S. Frank, Jr., Choate, Hall & Stewart, Boston, MA, for Hoechst Marion Roussel, Inc., Transkaryotic Therapies, Inc., Defendants.

Mark S. Freeman, Choate, Hall & Stewart, Boston, MA, for Hoechst Marion Roussel, Inc., Transkaryotic Therapies, Inc., Defendants.

Robert M. Galvin, Day Casebeer Madrid Winters & Batchelder LLP, Cupertino, CA, for Amgen, Inc., Plaintiff.

Douglas J. Gilbert, Fish & Neave, New York, NY, for Hoechst Marion Roussel, Inc., Transkaryotic Therapies, Inc., Defendants.

Michael R. Gottfried, Duane Morris LLP, Boston, MA, for Amgen, Inc., Plaintiff.

James F. Haley, Jr., Fish & Neave, New York, NY, for Hoechst Marion Roussel, Inc., Transkaryotic Therapies, Inc., Defendants.

Kenneth B. Herman, Fish & Neave, New York, NY, for Hoechst Marion Roussel, Inc., Transkaryotic Therapies, Inc., Defendants.

Douglass C. Hochstetler, Marshall, O'Toole, Gerstein, Murray & Borun, Chicago, IL, for Amgen, Inc., Plaintiff.

Derek M. Kato, Fish & Neave, New York, NY, for Hoechst Marion Roussel, Inc., Transkaryotic Therapies, Inc., Defendants.

Ryan M. Kent, Keker & VanNest LLP, San Francisco, CA, for Amgen, Inc., Plaintiff.

Peter J. Knudsen, Fish & Neave, New York, NY, for Hoechst Marion Roussel, Inc., Transkaryotic Therapies, Inc., Defendants.

Anna A. Kobilansky, Fish & Neave, New York, NY, for Hoechst Marion Roussel, Inc., Transkaryotic Therapies, Inc., Defendants.

Patricia L. Leden, Day Casebeer Madrid & Batchelder, LLD, Cupertino, CA, for Amgen, Inc., Plaintiff.

Jonathan D.J. Loeb, Day Casebeer Madrid & Batchelder, LLP, Cupertino, CA, for Amgen, Inc., Plaintiff.

Denise L. Loring, Fish & Neave, New York, NY, for Hoechst Marion Roussel, Inc., Transkaryotic Therapies, Inc., Defendants.

David M. Madrid, Day Casebeer Madrid Winters & Batchelder LLP, Cupertino, CA, for Amgen, Inc., Plaintiff.

Peter C. McCabe, III, Winston & Strawn, Chicago, IL, for Hoechst Marion Roussel, Inc., Transkaryotic Therapies, Inc., Defendants.

Mark A. Michelson, Choate, Hall & Stewart, Boston, MA, for Hoechst Marion Roussel, Inc., Transkaryotic Therapies, Inc., Defendants.

Steven F. Molo, Winston & Strawn, Chicago, IL, for Hoechst Marion Roussel, Inc., Transkaryotic Therapies, Inc., Defendants.

Mario Moore, Day Casebeer Madrid & Batchelder, Cupertino, CA, for Amgen, Inc., Plaintiff.

Jackie N. Nakamura, Day Casebeer Madrid Winters & Batchelder LLP, Cupertino, CA, for Amgen, Inc., Plaintiff.

Edward M. O'Toole, Marshall, O'Toole, Gerstein, Murray & Borun, Chicago, IL, for Amgen, Inc., Plaintiff.

Sandip H. Patel, Marshall, O'Toole, Gerstein, Murray & Bourn, Chicago, IL, for Amgen, Inc., Plaintiff.

Raymond C. Perkins, Abbott Laboratories, Abbott Park, IL, for Hoechst Marion Roussel, Inc., Transkaryotic Therapies, Inc., Defendants.

Melanie R. Rupert, Fish & Neave, New York, NY, for Hoechst Marion Roussel, Inc., Transkaryotic Therapies, Inc., Defendants.

Barbara A. Ruskin, Fish & Neave, New York, NY, for Hoechst Marion Roussel, Inc., Transkaryotic Therapies, Inc., Defendants.

Krista M. Rycroft, Fish & Neave, New York, NY, for Hoechst Marion Roussel, Inc., Transkaryotic Therapies, Inc., Defendants.

Herbert F. Schwartz, Fish & Neave, New York, NY, for Hoechst Marion Roussel, Inc., Transkaryotic Therapies, Inc., Defendants.

Ellen A. Scordino, Fish & Neave, New York, NY, for Hoechst Marion Roussel, Inc., Transkaryotic Therapies, Inc., Defendants.

Elaine Stracker, Day Casebeer Madrid Winters & Batchelder LLP, Cupertino, CA, for Amgen, Inc., Plaintiff.

Christopher E. Stretch, Day Casebeer Madrid Winters & Batchelder LLP, Cupertino, CA, for Amgen, Inc., Plaintiff.

Terry L. Tang, Day Casebeer Madrid Winters & Batchelder LLP, Cupertino, CA, for Amgen, Inc., Plaintiff.

Courtney Towle, Day, Casebeer Madrid & Batchelder, Cupertino, CA, for Amgen, Inc., Plaintiff.

Robert B. Wilson, Fish & Neave, New York, NY, for Hoechst Marion Roussel, Inc., Transkaryotic Therapies, Inc., Defendants.

Richard M. Wong, Scansoft, Inc., Peabody, MA, for Amgen, Inc., Plaintiff.

Keith A. Zullow, Fish & Neave, New York, NY, for Hoechst Marion Roussel, Inc., Transkaryotic Therapies, Inc., Defendants.

MEMORANDUM AND ORDER

YOUNG, Chief Judge.

I. INTRODUCTION

This patent infringement action concerns patents held by Amgen, Inc. ("Amgen"), relating to the manufacture of a recombinant (genetically engineered) DNA1 product, known as epoietin alfa,2 that is similar to natural erythropoietin ("EPO"), a hormone that stimulates production of red blood cells, and is useful in, among other things, treating patients who need blood transfusions and suffer from blood composition disorders such as hemophilia, anemia, and sickle cell disease. This product and this case are not new to the public or to this Court. The case began brewing in 1997, when Amgen filed a declaratory judgment in the United States District Court for the District of Massachusetts against Defendants Hoechst Marion Roussel, Inc.3 and Transkaryotic Therapies, Inc. (collectively "HMR/TKT") claiming that three of its patents were infringed by HMR/TKT's human EPO product, "HMR 4396," produced from the R223 cell line grown in culture. See Amgen, Inc. v. Hoechst Marion Roussel, Inc., 3 F.Supp.2d 104, 106 (D.Mass.1998). In 1999, Amgen amended the complaint to include two other patents. Amgen, Inc. v. Hoechst Marion Roussel, Inc., 126 F.Supp.2d 69, 96-98 (D.Mass.2001) ("Amgen I"). A lengthy jury-waived trial ensued. It commenced in May 2000 and lasted twenty-three days over the course of four months. Id. at 78. Not surprisingly, HMR/TKT appealed this Court's decision, Amgen I, 126 F.Supp.2d 69. In Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313 (Fed.Cir.2003) ("Amgen II"), the Federal Circuit affirmed a majority of this Court's findings and rulings but vacated and remanded a few issues to this Court. Id. at 1358. This memorandum and order addresses those issues on remand, some of which have already been decided by the Court and announced to the parties, thus requiring only a brief review.

II. BACKGROUND: PROCEDURAL AND SUBSTANTIVE HISTORY
A. The Patents at Issue

There were originally five patents at issue in this case. Only four, however, remain on remand. The patents and claims now at issue are: Claim 1 of U.S. Patent No. 5,955,422 (issued Sept. 21, 1999) ("'422 patent"); Claims 2-4 of U.S. Patent No. 5,621,080 (issued Apr. 15, 1997) ("'080 patent"); Claims 4-9 of U.S. Patent No. 5,618,698 (issued Apr. 8, 1997) ("'698 patent"); and Claims 1, 3, 4, 6, and 7 of U.S. Patent No. 5,756,349 (issued May 26, 1998) ("'349 patent"). Amgen I, 126 F.Supp.2d at 79; Amgen II, 314 F.3d at 1320.4

Although the patents vary, they all share a common disclosure and identical specifications. Amgen I, 126 F.Supp.2d at 79. For ease of reference, the Court cites to the specification found in the '933 patent, which is identical to the specification of the patents in dispute on remand. '933 Patent, Ex. 1.5

B. The Technology

As Amgen I set out the basics of the underlying technology in detail, only a brief summary is provided here. EPO is a naturally occurring hormone that controls erythropoiesis, the production of red blood cells in bone marrow. '933 Patent, Ex. 1, col. 5: 39-67. Erythropoiesis occurs continuously to offset cell destruction. Id. It enables a sufficient (but not excessive) amount of red blood cells to be available in the blood to provide tissue oxygenation. Id. Hemoglobin is the protein in the red blood cells that actually transports the oxygen. Amgen I, 126 F.Supp.2d at 98. The amount of hemoglobin correlates to the amount of oxygen. Id. Hematocrit, which indicates the relative proportion of red blood cells to the total volume of blood, measures the ability of the blood to supply oxygen to the body. Id. Thus, generally an increase or decrease in hematocrit equates with an increase or decrease in the ability to supply oxygen to the body. Id. Under normal conditions, a person has a hematocrit of about forty-five to fifty, which means forty-five to fifty percent of the blood is made up of red blood cells. Id.

EPO...

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    ...or at least creates a heavy "presumption that each ensuing step is [not] in step-plus function form." Amgen, Inc. v. Hoechst Marion Roussel, Inc., 339 F.Supp.2d 202, 255 (D.Mass.2004); see also Cardiac Pacemakers, Inc., 381 F.3d at 1382; Epcon Gas Sys., Inc. v. Bauer Compressors, Inc., 279 ......
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1 books & journal articles
  • Amgen v. HMR: a case for deference in claim construction.
    • United States
    • Harvard Journal of Law & Technology Vol. 20 No. 2, March 2007
    • March 22, 2007
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