Amgen Inc. v. Hoechst Marion Roussel, Inc.

Decision Date03 August 2006
Docket NumberNo. 05-1157.,05-1157.
Citation457 F.3d 1293
PartiesAMGEN INC., Plaintiff-Appellee, v. HOECHST MARION ROUSSEL, INC. (now known as Aventis Pharmaceuticals Inc.) and Transkaryotic Therapies, Inc., Defendants-Appellants.
CourtU.S. Court of Appeals — Federal Circuit

Lloyd R. Day, Jr., Day Casebeer Madrid & Batchelder LLP, of Cupertino, California, argued for plaintiff-appellee. With him on the brief were Edward M. O'Toole, Howrey LLP, of Chicago, Illinois; Michael F. Borun, Marshall, Gerstein & Borun LLP, of Chicago, Illinois; and Stuart L. Watt, Amgen Inc., of Thousand Oaks, California. Of counsel were Renee M. DuBord Brown, Robert M. Galvin, Jonathan Loeb, David M. Madrid, Linda A. Sasaki-Baxley, Krista M. Carter, Courtney Towle, and Patricia L. Peden, Day Casebeer Madrid & Batchelder LLP, of Cupertino, California; Kevin M. Flowers, Marshall, Gerstein & Borun LLP, of Chicago Illinois; Robert R. Cook, Monique L. Cordray, Steven M. Odre, and Wendy A. Whiteford, Amgen Inc., of Thousand Oaks, California; and Michael R. Gottfried and D. Dennis Allegretti, Duane Morris, LLP, of Boston, Massachusetts.

Carter G. Phillips, Sidley Austin Brown & Wood LLP, of Washington, DC, argued for defendants-appellants. With him on the brief was Joseph R. Guerra.

Before MICHEL, Chief Judge, CLEVENGER, Senior Circuit Judge, and SCHALL, Circuit Judge.

Opinion for the court filed by Circuit Judge SCHALL.

Dissenting-in-part opinion filed by Chief Judge MICHEL.

SCHALL, Circuit Judge.

This is a patent case. Amgen, Inc. ("Amgen") is the owner of U.S. Patent Nos. 5,547,933 ("the '933 patent"), 5,618,698 ("the '698 patent"), 5,621,080 ("the '080 patent"), 5,756,349 ("the '349 patent"), and 5,955,422 ("the '422 patent"). The patents are directed to recombinant deoxyribonucleic acid ("DNA") technology relating to the production of the hormone erythropoietin ("EPO"). All five patents share a common specification and descend from Application No. 06/561,024 ("the '024 application"), filed on December 13, 1983.

In April of 1997, Amgen brought a declaratory judgment action against Hoechst Marion Roussel, Inc. (now known as Aventis Pharmaceuticals Inc.) ("HMR") and Transkaryotic Therapies, Inc. ("TKT") (collectively, "HMR/TKT") in the United States District Court for the District of Massachusetts, alleging that HMR/TKT's Investigational New Drug Application ("INDA") for an EPO product infringed the five patents. In January of 2001, following a Markman hearing, summary judgment proceedings, and a bench trial, the district court issued an opinion in which it: (i) construed the disputed claims; (ii) held the patents not unenforceable; (iii) held the asserted claims of the '080, '349, and '422 patents not invalid and infringed with the exception of claim 7 of the '349 patent, which it found not infringed; (iv) held the asserted claims of the '698 patent not infringed; and (v) held the asserted claims of the '933 patent not infringed or, in the alternative, invalid for failure to satisfy 35 U.S.C. § 112. Amgen, Inc. v. Hoechst Marion Roussel, Inc., 126 F.Supp.2d 69, 165-66 (D.Mass.2001) ("Amgen I").

In Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313 (Fed.Cir.2003) ("Amgen II"), we affirmed in toto the district court's claim construction. We also affirmed (i) the court's determination that none of the patents at issue is unenforceable by reason of inequitable conduct; (ii) its contingent determination that the asserted claims of the '933 patent are invalid under section 112; (iii) its grant of summary judgment that claim 1 of the '422 patent is infringed; (iv) its determination that the '933, '698, '080, and '349 patents are not anticipated by U.S. Patent No. 4,377,513 ("the Sugimoto patent"); and (iv) its determination that claims 1, 3, 4, and 6 of the '349 patent are infringed. Id. at 1320.

However, we vacated (i) the district court's determination that the asserted claims of the '933 patent are not infringed; (ii) its determination that Dr. Eugene Goldwasser's clinical study, described in Dr. Goldwasser's grant application entitled "Erythropoietin: Purification, Properties, Biogenesis" ("the Goldwasser reference"), and the Sugimoto patent do not anticipate claim 1 of the '422 patent; (iii) its determination that the Sugimoto patent does not render claim 1 of the '422 patent obvious; (iv) its determination that claims 2-4 of the '080 patent are not invalid and are infringed under the doctrine of equivalents; (v) its determination that the asserted method claims of the '698 patent are not rendered obvious by the Sugimoto patent and are not infringed; and (vi) its determination that the Sugimoto patent does not render claims 1, 3, 4, 6, and 7 of the '349 patent invalid and that claim 7 of the '349 patent is not infringed. Id.

We remanded the case to the district court to do the following: (i) construe the term "therapeutically effective amount" in claim 1 of the '422 patent and then determine whether either the Goldwasser reference or the Sugimoto patent anticipates claim 1 or whether the Sugimoto patent renders claim 1 obvious, id. at 1354, 1356, 1358; (ii) determine whether the Sugimoto patent renders claims 2-4 of the '080 patent obvious and whether, as far as claims 2-4 are concerned, Amgen can rebut the presumption of the surrender of equivalents and thus assert infringement of those claims under the doctrine of equivalents, id. at 1345, 1358; (iii) determine whether the Sugimoto patent renders claims 4-9 of the '698 patent obvious and whether claims 4-9 are infringed, id. at 1357, 1358; and (iv) determine whether the Sugimoto patent renders claims 1, 3, 4, 6, and 7 of the '349 patent obvious and whether claim 7 of the '349 patent is infringed, id. at 1357, 1358.

The case is now back before us following proceedings on remand in which the district court construed the term "therapeutically effective amount" in claim 1 of the '422 patent and conducted a further bench trial. See Amgen, Inc. v. Hoechst Marion Roussel, Inc., 339 F.Supp.2d 202 (D.Mass.2004) ("Amgen III Validity & Literal Infringement Judgment"); Amgen, Inc. v. Hoechst Marion Roussel, Inc., 287 F.Supp.2d 126 (D.Mass.2003) ("Amgen III Doctrine of Equivalents Judgment"). Based upon various findings and rulings, the court entered judgment in favor of Amgen as follows: (i) claim 1 of the '422 patent is not invalid, Amgen III Validity & Literal Infringement Judgment, 339 F.Supp.2d at 334, 336; (ii) claims 2-4 of the '080 patent are not invalid, id. at 336, and Amgen is not estopped from asserting infringement of claims 2-4 under the doctrine of equivalents because it rebutted the presumption of surrender of equivalents, Amgen III Doctrine of Equivalents Judgment, 287 F.Supp.2d at 160; (iii) claims 4-9 of the '698 patent are not invalid and are literally infringed, Amgen III Validity & Literal Infringement Judgment, 339 F.Supp.2d at 336; (iv) claims 1, 3, 4, 6, and 7 of the '349 patent are not rendered obvious by the Sugimoto patent, id. at 325, 336, and claim 7 of the '349 patent is literally infringed, Amgen III Validity & Literal Infringement Judgment, 339 F.Supp.2d at 336.

On appeal, HMR/TKT challenges all of the above rulings. Our disposition of the appeal is as follows:

(i) Because we hold that the district court erred in its construction of the term "therapeutically effective amount" in claim 1 of the '422 patent, we vacate the judgment of the district court that claim 1 is not invalid. We remand the case to the district court for a determination as to whether the Goldwasser reference anticipates claim 1 under a revised claim construction. (ii) We reverse the judgment of the district court that HMR/TKT's accused product infringes claims 2-4 of the '080 patent under the doctrine of equivalents. We do so because we hold that the district court erred in ruling that Amgen rebutted the presumption that, during prosecution, it surrendered coverage to EPO with a 165-amino acid sequence, which is the sequence of HMR/TKT's product. Because claims 2-4 of the '080 patent are not infringed, it is unnecessary for us to address HMR/TKT's alternative argument by way of an affirmative defense that claims 2-4 are anticipated by the Goldwasser reference. (iii) We affirm the judgment of the district court that claims 4-9 of the '698 patent are not invalid and are literally infringed. (iv) We affirm the judgment of the district court that claim 7 of the '349 patent is not invalid and is literally infringed. Thus, we affirm-in-part, reverse-in-part, vacate-in-part, and remand.1

BACKGROUND
I.

As noted, the patents at issue relate to recombinant DNA technology for the production of EPO. EPO, which is a naturally occurring hormone, stimulates the production of red blood cells in the bone marrow through a process called erythropoiesis. Thus, the production of EPO is useful in treating blood disorders characterized by low hematocrit, which is a low ratio of red blood cells to total blood cells. The production of EPO in usable amounts was made possible by Amgen's team led by Dr. Fu-Kuen Lin, who first successfully identified the EPO DNA sequence. See '422 patent, col. 20, ll. 28-33. Amgen markets and sells its EPO product under the brand name "Epogen."

DNA is the genetic material of all living things.2 Id. col. 1, ll. 28-29. DNA is composed of a series of subunits, called nucleotides, that are linked together to form a linear polymeric form—a strand. Id. col. 1, ll. 33-35. Each nucleotide contains one of four nitrogen-containing ring compounds, called bases. The bases fall into two categories: pyrimidines, which include cytosine ("C") and thymine ("T"), and purines, which include adenine ("A") and guanine ("G"). Id. col. 1, ll. 35-46; James D. Watson et al., Molecular Biology of the Gene 98 (5th ed.2004); Bruce Alberts et al., Molecular Biology of the Cell 63, 120 (4th ed.2002). The sequence of A, T, G, and Cs on a strand of DNA forms what is known as a "DNA sequence." DNA is...

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