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

• Decision Date: 30 October 2003
• Docket Number: No. CIV.A. 97-10814-WGY.,CIV.A. 97-10814-WGY.
• Citation: 287 F.Supp.2d 126
• Parties: AMGEN, INC., Plaintiff, v. HOECHST MARION ROUSSEL, INC. and Transkaryotic Therapies, Inc., Defendants.
• Court: U.S. District Court — District of Massachusetts

287 F.Supp.2d 126

AMGEN, INC., Plaintiff, v. HOECHST MARION ROUSSEL, INC. and Transkaryotic Therapies, Inc., Defendants.

No. CIV.A. 97-10814-WGY.

United States District Court, D. Massachusetts.

October 30, 2003.

D. Dennis Allegretti, Duane Morris LLP, Boston, MA, Linda A. Baxley, Day Casebeer Madrid Winters & Batchelder LLP, Cupertino, CA, Michael F. Borun, Marshall, O'Toole, Gerstein, Murray & Borun, Chicago, IL, Craig H. Casebeer, Day Casebeer Madrid Winters & Batchelder LLP, Cupertino, CA, Jane J. Choi, Marshall, O'Toole, Gerstein, Murray & Borun, Chicago, IL, Lloyd R. Day, Jr., Day Casebeer Madrid Winters & Batchelder LLP, Cupertino, CA, Jennifer R. Dupre, Carr & Ferrell, Palo Alto, CA, Deborah E. Fishman, Day Casebeer Madrid Winters &amp Batchelder LLP, Cupertino, CA, Kevin M. Flowers, Marshall, O'Toole, Gerstein, Murray & Borun, Chicago, IL, Robert M. Galvin, Day Casebeer Madrid Winters & Batchelder LLP, Cupertino, CA, Michael R. Gottfried, Duane Morris LLP, Boston, MA, Douglass C. Hochstetler, Marshall, O'Toole, Gerstein, Murray & Borun, Chicago, IL, Ryan M. Kent, Day Casebeer Madrid Batchelder, Cupertino, CA, Patricia L. Leden, Jonathan D.J. Loeb, Day Casebeer Madrid & Batchelder, LLP, Cupertino, CA, David M. Madrid, Day Casebeer Madrid Winters & Batchelder LLP, Cupertino, CA, Mario Moore, Day Casebeer Madrid & Batchelder, Cupertino, CA, Jackie N. Nakamura, Day Casebeer Madrid Winters & Batchelder LLP, Cupertino, CA, Edward M. O'Toole, Sandip H. Patel, Marshall, O'Toole, Gerstein, Murray & Bourn, Chicago, IL, Elaine Stracker, Christopher E. Stretch, Day Casebeer Madrid Winters & Batchelder LLP, Cupertino, CA, Terry L. Tang, Courtney Towle, Day, Casebeer Madrid & Batchelder, Cupertino, CA, Richard M. Wong, Scansoft, Inc., Peabody, MA, for Amgen, Inc., Plaintiff.

Padmaja Chinta, Bindu Donovan, Russell W. Faegenburg, Gerald J. Flattmann, Fish & Neave, New York, NY, Robert S. Frank, Jr., Mark S. Freeman, Choate, Hall & Stewart, Boston, MA, Douglas J. Gilbert, James F. Haley, Jr., Kenneth B. Herman, Derek M. Kato, Peter J. Knudsen, Anna A. Kobilansky, Denise L. Loring, Fish & Neave, New York, NY, Peter C. McCabe, III, Winston & Strawn, Chicago, IL, Mark A. Michelson, Choate, Hall & Stewart, Boston, MA, Steven F. Molo, Winston & Strawn, Chicago, IL, Raymond C. Perkins, Abbott Laboratories, Abbott Park, IL, Melanie R. Rupert, Barbara A. Ruskin, Krista M. Rycroft, Herbert F. Schwartz, Ellen A. Scordino, Robert B. Wilson, Keith A. Zullow, Fish & Neave, New York, NY, for Hoechst Marion Roussel, Inc., Transkaryotic Therapies, Inc.

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

MEMORANDUM AND ORDER

YOUNG, Chief Judge.

INTRODUCTORY NOTE: On September 18, 2003, this Court held that Amgen had successfully rebutted the presumption of prosecution history estoppel but noted that it might have to revisit the issue if the Federal Circuit's Festo opinion was published before this Court's opinion was finished. 9/18/03 Pretrial Conference Tr. at 7, ll. 17-25, and 8, ll. 1-5. This Court had scheduled release of this opinion for early October, 2003, pending final proofreading. The Federal Circuit released its opinion in Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., Ltd., 344 F.3d 1359 (Fed. Cir.2003) ("Festo III") on September 26, 2003. Because Festo III authoritatively interprets the Supreme Court's decision in Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., Ltd., 535 U.S. 722, 122 S.Ct. 1831, 152 L.Ed.2d 944 (2002) ("Festo II"), the recent Federal Circuit decision governs here under familiar stare decisis principles.

As this Court's interpretation of the Supreme Court decision had proceeded along a somewhat different tack, and since the growth of the law in this area "moves at a lightning pace," Festo III, 344 F.3d at 1375-76 (Rader, J., concurring), it seems appropriate to set forth this Court's original analysis of Festo II, noting its confirmation or remediation on a section-by-section basis by the Federal Circuit in Festo III, and identifying and setting forth the revised analysis required by that decision.

As will be discussed in further detail below, this Court reasserts its prior holding—in light of Festo III—that Amgen has successfully rebutted the presumption of prosecution history estoppel. Therefore, its earlier finding that HMR/TKT infringes claims 2 through 4 of U.S. Patent No. 5,621,080 (issued April 15, 1997) (the "`080 patent") is reaffirmed.

I. INTRODUCTION

In light of the recent Supreme Court decision in Festo II, 535 U.S. 722, 122 S.Ct. 1831, 152 L.Ed.2d 944, the Federal Circuit remanded to this Court its ruling in Amgen, Inc. v. Hoechst Marion Roussel, Inc., 126 F.Supp.2d 69 (D.Mass.2001) ("Amgen I"), that Amgen, Inc. ("Amgen") was not estopped by the prosecution history from claiming equivalent infringement by the human erythropoietin ("EPO") product ("HMR 4396") produced by Hoechst Marion Roussel, Inc.¹ and Transkaryotic Therapies, Inc. (collectively "HMR/TKT"). Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1345 (Fed.Cir.2003) ("Amgen II"). Based upon Festo II, the Federal Circuit ruled that a presumption of prosecution history estoppel applied here. Therefore, it vacated this Court's finding of equivalent infringement and remanded "for an analysis under the narrow ways of rebutting the Supreme Court's presumption of estoppel" as laid out in Festo II. Amgen II, 314 F.3d at 1345. This opinion addresses the discrete issue of whether Amgen has successfully rebutted the Festo II presumption of prosecution history estoppel held to be present in Amgen II. Id.

II. DISCUSSION

A. Background and Procedural History

In Amgen I, this Court construed the amendment "mature erythropoietin amino acid sequence of FIG. 6" in claims 2-4 of U.S. Patent No. 5,621,080 (issued April 15, 1997) (the "'080 patent") as requiring an EPO glycoprotein "comprising the fully realized erythropoietin amino acid sequence of Figure 6, which depicts 166 amino acids." Amgen I, 126 F.Supp.2d at 100. Pursuant to this construction, the Court found that HMR 4396 did not literally infringe claims 2, 3, and 4 of the '080 patent because HMR 4396 comprised only 165 amino acids. Id. at 101.

This Court then turned to the doctrine of equivalents and found that HMR 4396 performed substantially the same function in substantially the same way to obtain substantially the same result as the EPO glycoprotein of claims 2 and 3 of the '080 patent. Id. at 133. Therefore, it ruled that Amgen's '080 patent was equivalently infringed by TKT/HMR's product. Id.

In response to TKT/HMR's argument that Amgen should be estopped from arguing equivalent infringement, this Court ruled that prosecution history estoppel did not apply because Amgen did not add the "mature amino acid sequence of Figure 6" limitation "in an attempt to overcome a rejection, to avoid prior art," but, instead, to "demonstrate that `same invention' type double patenting did not apply," that is, to distinguish the '080 patent from U.S. Patent No. 5,547,933 (the "'933 patent"). Id. at 134-35.

The Federal Circuit agreed that the amendment was made for this purpose but made clear that under Festo II, "a narrowing amendment to satisfy any requirement of the Patent Act may give rise to an estoppel." Amgen II, 314 F.3d at 1345 (emphasis added). Therefore, it held that the presumption of prosecution history estoppel applied here. The Federal Circuit then vacated this Court's finding of equivalent infringement and remanded for an analysis based on the "narrow ways of rebutting the Supreme Court's presumption of estoppel" outlined in Festo II. Id. at 1345. Because the Court's factual findings (that TKT/HMR's product performed substantially the same function in substantially the same way to obtain substantially the same result) were not disturbed—or even challenged—on appeal, the Court need only analyze whether Amgen can rebut the presumption of prosecution history estoppel and pursue an infringement claim based on the doctrine of equivalents. If Amgen can, the Court's ruling that Amgen's '080 patent was equivalently infringed shall be reaffirmed.

On May 16, 2003, Amgen moved for judgment under the Federal Rule of Civil Procedure 52(c) that claims 2-4 of the '080 patent are equivalently infringed [Document No. 659]. TKT/HMR opposed Amgen's motion and moved for judgment that Amgen is estopped from asserting infringement under the doctrine of equivalents [Document No. 678].² Both parties, however, have agreed that the Court summarily can decide this motion based on the current record without further evidentiary presentation. TKT/HMR's Mem. in Opp'n at 1; Amgen's Mem. in Support at 5-6.

B. Overview Of Festo II As Interpreted By This Court And The Federal Circuit

The doctrine of equivalents was created because language is not always sufficiently precise to capture the essence, nuances, and range of an invention in light of unexpected technological advances. Festo II, 535 U.S. at 731, 122 S.Ct. 1831 ("Things are not made for the sake of words, but words for things." (quoting Autogiro Co. of America v. United States, 181 Ct.Cl. 55, 384 F.2d 391, 397 (1967))). The doctrine of equivalents was designed to provide patent applicants the wiggle room that claim language alone cannot, thus protecting patentees from copyists who make insubstantial changes. Festo II, 535 U.S. at 732-33, 122 S.Ct. 1831; Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 607, 70 S.Ct. 854, 94 L.Ed. 1097 (1950). In other words, it was designed to protect the intended invention, even if not adequately or ably described.

Prosecution history estoppel, on the other hand, arises when an amendment, by its language, discernibly limits the scope of the invention before the Patent and Trademark Office (the "Patent Office"). The purpose of prosecution history estoppel is to "hold the inventor to the representations made during the application process and the inferences that...