Schering Corp v. Amgen Inc.

• Decision Date: 01 August 2000
• Citation: 55 USPQ2d 1650,222 F.3d 1347
• Parties: (Fed. Cir. 2000) SCHERING CORPORATION and BIOGEN, INC., Plaintiffs-Appellants, v. AMGEN INC., Defendant-Appellee. 99-1251 DECIDED:
• Court: U.S. Court of Appeals — Federal Circuit

Page 1347

222 F.3d 1347 (Fed. Cir. 2000)

SCHERING CORPORATION and BIOGEN, INC., Plaintiffs-Appellants, v. AMGEN INC., Defendant-Appellee.

99-1251

United States Court of Appeals for the Federal Circuit

DECIDED: August 1, 2000

Appealed from: United States District Court for the District of Delaware.

Gerald Sobel, Kaye, Scholer, Fierman, Hays & Handler, LLP, argued for plaintiffs-appellants. With him on the brief were Aaron Stiefel, and Daniel P. DiNapoli. Of counsel on the brief were Michael J. Astrue, Biogen, Inc., of Cambridge, Massachusetts; and James F. Haley, Jr., Fish & Neave, of New York, New York.

Daniel A. Boehnen, McDonnell Boehnen Hulbert & Berghoff, of Chicago, Illinois, argued for defendant-appellee. With him on the brief were John J. McDonnell, andGrantland G. Drutchas. Of counsel on the brief were Steven M. Odre, Stuart L. Watt,Robert R. Cook, Monique Cordray, and Craig Crandall, Amgen Inc., of Thousand Oaks, California. Also of counsel on the brief was D. Dennis Allegretti, Duane, Morris & Heckscher, LLP, of Boston, Massachusetts.

Senior Judge Murray M. Schwartz

Before RADER, Circuit Judge, ARCHER, Senior Circuit Judge, and GAJARSA, Circuit Judge.

RADER, Circuit Judge.

Schering Corporation and Biogen, Inc. (collectively, Schering) sued Amgen Inc. in the United States District Court for the District of Delaware for infringing U.S. Patent No. 4,530,901 (the '901 patent). The '901 patent claims recombinant DNA molecules encoding specific types of human interferon, microorganisms genetically engineered to produce that interferon, and methods of producing interferon with recombinant technology. The district court conducted a pre-trial Markman hearing to construe the patent's claims. After the district court announced its claim construction decision, seeSchering Corp. v. Amgen, Inc., 18 F. Supp. 2d 372 (D. Del. 1998) (Schering I), Schering moved for entry of summary judgment of noninfringement in Amgen's favor, explaining that it could not prevail at trial under the district court's interpretation of the claims. The district court granted Schering's motion, and dismissed without prejudice Amgen's motions for summary judgment of patent invalidity and misuse, concluding that those motions are moot in light of the district court's noninfringement judgment. See Schering Corp. v. Amgen, Inc., 35 F. Supp. 2d 375, 50 USPQ2d 1051 (D. Del. 1999) (Schering II). Schering appeals only the district court's claim construction. Because this court concludes that the district court correctly construed the claims, and because Schering conceded noninfringement under that claim construction, this court affirms the district court's judgment of noninfringement.

I.

Biogen, Inc. is the assignee of the '901 patent; Schering Corp. is Biogen's exclusive licensee under the patent. The '901 patent resulted from the pioneering work of Dr. Charles Weissmann in the fields of immunology and molecular biology in the late 1970s. Dr. Weissmann's work focused on certain human polypeptides, known as interferons. Since the late 1950's, immunologists knew that interferons have important anti-viral and anti-tumor properties. They studied interferons by extracting and purifying blood samples from human subjects. Scientists now appreciate that different cells of the human immune system produce many interferon subtypes. However, at the time of Dr. Weissmann's work, scientists had conclusive evidence of only two varieties: interferon produced by cells known as fibroblasts, and interferon produced by cells known as leukocytes. No one had successfully characterized the specific genes that code for interferon polypeptides, nor had anyone developed a means for producing substantial quantities of interferon. Dr. Weissmann, through a series of elegant experiments, isolated pieces of DNA that code for one of the leukocyte interferon polypeptides, the interferon now referred to in the scientific community as "IFN--1."

The '901 patent claims the recombinant DNA molecules containing the structural genes isolated by Dr. Weissmann. As originally filed, the claims referred to leukocyte interferon, instead of IFN-. The patent also claimes genetically engineered micro-organisms containing these recombinant DNA molecules. Finally, the '901 patent claims a method for producing interferon polypeptides by transforming microorganisms with Dr. Weissmann's recombinant DNA molecules, culturing the transformed microorganisms, and then collecting the interferon produced by the cells. Examples of each type of claim, claims 1, 5, and 9, state:

1. A recombinant DNA molecule consisting of segments of DNA from different genomes which have been joined end-to-end outside of living cells and which have the capacity to infect some host and to be maintained therein, and the progeny thereof, comprising a DNA sequence selected from the group consisting of:

(a) the DNA inserts of Z-pBR322(Pst)/HcIF-2h (DSM 1700), Z-pBR322(Pst)/HcIF-SN35 (DSM 1701), Z-pBR322(Pst)/HcIF-SN42 (DSM 1702) and Z-pKT287(Pst)/HcIF-2h-AH6 (DSM 1703),

(b) DNA sequences which hybridize to any of the foregoing DNA inserts and which code on expression for a polypeptide of the IFN- type, and

(c) DNA sequences which code on expression for a polypeptide of the IFN- type coded for on expression by any of the foregoing DNA sequences and inserts,

said DNA sequences and inserts being operatively linked to an expression control sequence in said recombinant DNA molecule.

'901 patent, col. 36, ll. 4-23.

5. A unicellular host transformed with at least one recombinant DNA molecule, said molecule, consisting of segments of DNA from different genomes which have been joined end-to-end outside of living cells and which have the capacity to infect some host and to be maintained therein, and the progeny thereof, comprising a DNA sequence selected from the group consisting of:

(a) the DNA inserts of Z-pBR322(Pst)/HcIF-4c (DMS 1699), Z-pBR322(Pst)/HcIF-2h (DSM 1700), Z-pBR322(Pst)/HcIF-SN35 (DSM 1701), Z-pBR322(Pst)/HcIF-SN42 (DSM 1702) and Z-pKT287(Pst)/HcIF-2h-AH6 (DSM 1703),

(b) DNA sequences which hybridize to any of the foregoing DNA inserts and which code on expression for a polypeptide of the IFN- type, and

(c) DNA sequences which code on expression for a polypeptide of the IFN- type coded for on expression by any of the foregoing DNA sequences and inserts.

Id. at col. 36, ll. 39-59

9. A method for producing a polypeptide comprising the steps of preparing a recombinant DNA molecule, consisting of segments of DNA from different genomes which have been joined end-to-end outside of living cells and which have the capacity to infect some host and to be maintained therein, and the progeny thereof, comprising a DNA sequence selected from the group consisting of:

(a) the DNA inserts of Z-pBR322(Pst)/HcIF-2h (DSM 1700), Z-pBR322(Pst)/HcIF-SN35 (DSM 1701), Z-pBR322(Pst)/HcIF-SN42 (DSM 1702) and Z-pKT287(Pst)/HcIF-2h-AH6 (DSM 1703),

(b) DNA sequences which hybridize to any of the foregoing DNA inserts and which code on expression for a polypeptide of the IFN- type, and

(c) DNA sequences which code on expression for a polypeptide of the IFN- type coded for on expression by any of the foregoing DNA sequences or inserts, and having operatively linked thereto an expression control sequence; transforming an appropriate host with said recombinant DNA molecule; culturing said host; and collecting said polypeptide.

Id. at col. 37, ll. 18-40. Even a cursory review of the claims reveals that they recite the specific recombinant DNA inserts isolated by Dr. Weissmann, and their use. Many years later, scientists sequenced Dr. Weissmann's DNA inserts and discovered that they code for a subtype of leukocyte interferon known as IFN--1.

Schering sued Amgen, alleging that Amgen's consensus interferon product infringes the '901 patent. Amgen's product is a synthetic polypeptide that does not correspond to any naturally occurring interferon subtype. Instead, Amgen reviewed the amino acid sequence of each known IFN- subtype (interferon, like all peptides, is a string of amino acids, each of which is coded for by one of several DNA sequences). Based on this review, Amgen produced a recombinant DNA sequence that codes for an amino acid sequence that is a consensus, or average, of the sequences found in the natural IFN- subtypes. Thus, Amgen produces an amino acid sequence, which at each position contains an amino acid present in one or more known IFN- subtype, but does not duplicate the amino acid sequence of any single IFN- subtype.

II.

This court reviews the district court's grant of Schering's summary judgment motion without deference, applying the same standard as the trial court. SeeNobelpharma AB v. Implant Innovations, Inc., 141 F.3d 1059, 1064, 46 USPQ2d 1097, 1103 (Fed. Cir. 1998). In applying a de novo standard, this court examines the record in the light most favorable to the non-movant, Amgen. See id.

Following its pre-trial Markman hearing, the district court construed the claims of the '901 patent. Schering contends that the district court erred in its interpretation of the term "polypeptide of the IFN- type." This court reviews the central question of claim interpretation without deference. See Key Pharm. v. Hercon Lab. Corp., 161 F.3d 709, 713, 48 USPQ2d 1911, 1914 (Fed. Cir. 1998). Therefore, notwithstanding the district court's exhaustive and well-reasoned fifty-five page opinion, this court undertakes an independent examination of the claim limitations.

The district court limited the '901 patent claims to DNA sequences for the naturally occurring IFN--1 subtype, instead of construing the claims to cover sequences that code generally for all IFN- polypeptides. The district court also concluded that the claim language covers only sequences for an immature interferon polypeptide. An immature polypeptide includes extraneous sequences such as leader and/or targeting sequences that normal human cells cleave...