Schering Corp. v. Amgen, Inc., No. CIV.A. 96-587 MMS.

CourtUnited States District Courts. 3th Circuit. United States District Court (Delaware)
Writing for the CourtMurray M. Schwartz
Citation18 F.Supp.2d 372
Decision Date30 July 1998
Docket NumberNo. CIV.A. 96-587 MMS.
PartiesSCHERING CORPORATION and Biogen, Inc., Plaintiffs, v. AMGEN INC., Defendant.
18 F.Supp.2d 372
SCHERING CORPORATION and Biogen, Inc., Plaintiffs,
v.
AMGEN INC., Defendant.
No. CIV.A. 96-587 MMS.
United States District Court, D. Delaware.
Argued June 23, 1998.
Decided July 30, 1998.

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Steven J. Balick, and Steven T. Margolin of Ashby & Geddes, Wilmington, Delaware; Of Counsel: Gerald Sobel, Aaron Stiefel, and Daniel DiNapoli of Kaye, Scholer, Fierman, Hays & Handler, LLP, New York, New York; John F. Hoffman, and Richard Grochala of Schering-Plough Corporation, Kenilworth, New Jersey; Michael J. Astrue of Biogen, Inc., Cambridge, Massachusetts; James F. Haley of Fish & Neave, New York, New York, for plaintiffs.

Richard K. Herrmann of Stradley, Ronon, Stevens & Young, LLP, Wilmington, Delaware; Of Counsel: John J. McDonnell, Daniel A. Boehnen, and Grantland G. Drutchas of McDonnell Boehnen Hulbert & Berghoff, Chicago, Illinois; Lloyd R. Day, Jr. of Cooley Godward LLP, Palo Alto, California; D. Dennis Allegritti of Burns & Levinson LLP, Boston, Massachusetts; Steven M. Odre, Stuart L. Watt, and Robert R. Cook of Amgen Inc., Thousand Oaks, California, for defendant.

OPINION

MURRAY M. SCHWARTZ, Senior District Judge.


I. Introduction

Schering Corporation ("Schering") and Biogen, Inc. ("Biogen") (collectively "Schering") filed a patent infringement suit against Amgen, Inc. ("Amgen"), alleging Amgen infringed Biogen's U.S. Patent No. 4,530,901 ("the '901 Patent"), entitled "Recombinant DNA Molecules and Their Use in Producing Human Interferon-Like Polypeptides."1 Amgen answered the Complaint alleging various affirmative defenses and counterclaimed seeking a declaratory judgment that the '901 Patent is unenforceable, invalid, not infringed, and has been misused. Jurisdiction is proper under 28 U.S.C. § 1338(a).

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Pursuant to Markman v. Westview Instruments, Inc., 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996), the Court now construes the scope and meaning of disputed claim language in the '901 Patent.

II. Factual Background
A. History of Interferon

The '901 Patent relates generally to the synthesis of human alpha2 interferon (also referred to as "IFN-α"), a naturally occurring human protein that functions as an antiviral and anti-tumor agent in human beings.3 The importance of interferon was first appreciated in the 1950s, and because of its ameliorative properties, became of interest as a pharmaceutical. Interferon may be produced by leukocyte cells (a type of white blood cell), fibroblast cells, or lymphoblastoid cells in the human body. The '901 Patent, however, addresses primarily leukocyte interferon which is produced in the human body when these cells are exposed to viruses or other foreign invaders. Only minute amounts of interferon, however, can be extracted from the human cells which produce it. As a result, researchers explored alternative ways interferon could be produced in mass quantities.

The '901 Patent describes an alternative method by which to harvest alpha interferon: recombinant DNA4 technology.5 Briefly, the recombinant DNA technology at issue operates by: 1) identifying and isolating the DNA that contains the genetic code for manufacturing interferon in the human body; 2) inserting the isolated DNA into a bacterium which did not otherwise produce interferon; 3) growing the bacterium into enormous quantities, with each new bacterium containing the inserted interferon DNA; 4) utilizing the protein-making capacity of the bacteria cells to produce interferon; and 5) collecting the interferon from the bacteria to be used for pharmaceutical purposes.

Dr. Charles Weissmann, the named inventor of the '901 Patent, was the first person able to identify and isolate DNA bearing the genetic code for human alpha interferon using recombinant DNA technology. Human leukocyte cells were induced to make interferon by exposing them to a virus. A RNA (ribonucleic acid)6 mixture was collected from the induced cells, which contained among its constituents RNA encoding for alpha interferon. Double-stranded DNA fragments (cDNA or copy DNA) corresponding to the RNA segments in this mixture were then made according to methods known in the art. These cDNA segments were spliced into plasmids (circular loops of DNA found only in bacteria) which were in turn inserted into E. coli bacteria. Thousands of these transformed bacteria were then grown into colonies of billions of bacteria, each of which contained a copy of the plasmid that transformed the bacteria.

Individual alpha interferon DNA was identified and isolated by systematically exposing the cDNA in the bacterial plasmid to the original RNA mixture. In this way, RNA complementary to the cDNA hybridized to

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the cDNA.7 The RNA, which hybridized to the cDNA, was then injected into frog oocytes (eggs) to determine if the RNA in question, when translated into protein, coded for interferon. Oocytes which contained the RNA coding for leukocyte interferon were effectively able to fight off viruses to which they were exposed, while the oocytes not coding for interferon died when exposed to the virus.

In this general manner, the '901 Patent identifies a number of DNA sequences that code for alpha interferon ("the DNA inserts") which were each physically isolated by Dr. Weissmann. Each of these isolated DNA inserts, contained in a plasmid within a host cell, were then physically deposited with an official depository in Germany on January 7, 1980.8 The application for the '901 Patent was subsequently filed on February 4, 1980.9

Later, Dr. Weissmann made further discoveries, including the fact that there are a number of different genes that code for different subtypes of alpha interferon. As a result, Biogen, three months later, filed a continuation-in-part application to cover this newly discovered subject matter. However, a patent never issued on this continuation-in-part application.

B. The '901 Patent

The '901 Patent issued to Biogen on July 23, 1985, after being assigned to it by the inventor, Weissmann. Schering was subsequently granted an exclusive license to practice the '901 Patent.

The independent claims of the '901 Patent, Claims 1, 5, 8, 9, and 12, are directed to: a substantially pure DNA sequence containing the DNA coding on expression for a polypeptide10 of the IFN-α type (Claim 8); a recombinant DNA molecule that may be used to express an IFN-α type polypeptide in a host cell (Claim 1); a host cell transformed with a recombinant DNA molecule containing DNA coding on expression for a polypeptide of the IFN-α type (Claim 5); and methods for producing these polypeptides involving: 1) the preparation of a recombinant DNA molecule containing an IFN-α type DNA sequence, 2) transformation of a host cell with the DNA molecule, 3) culturing of the host, and 4) collection of the IFN-α type protein product (Claims 9 and 12). Schering contends Amgen's consensus interferon product infringes all of these independent claims.11 Specifically, the following claim language is in dispute:

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1. "A recombinant DNA molecule consisting of segments of DNA from different genomes" (Claims 1, 5, 9 and 12);

2. "which have been joined end-to-end outside of living cells" (Claims 1, 5, 9 and 12);

3. "which have the capacity to infect some host and to be maintained therein, and the progeny thereof" (Claims 1, 5, 9 and 12);

4. "DNA sequences which hybridize to any of the foregoing DNA inserts," (Claims 1, 5, 8, 9, 12);

5. "A polypeptide of the IFN-α type," (Claims 1, 5, 8, 9, 12);

6. "(b) DNA sequences ... which code on expression for a polypeptide of the IFN-α type, and (c) DNA sequences which code on expression for a polypeptide of the IFN-α type coded for on expression by any of the foregoing DNA sequences ...." (Claims 1, 5, 8, 9, 12); and

7. "A substantially pure DNA sequence ... said DNA sequences coding on expression for only a single polypeptide chain," (Claim 8).

The Court, however, need only consider Claims 1 and 8, as they are representative of the claim disputes existing in the other independent claims.12 The disputed claim language will be construed according to the claim construction principles which are set out below.

III. Applicable Law for Claim Construction

Patent infringement actions consist of two discreet and separate phases. In the first phase, the Court construes the scope and meaning of a patent, while in the second phase, the claim, as properly construed, is compared to the accused product. See Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473, 1476 (Fed.Cir.1998). The first phase is known as claim construction and is exclusively a matter of law to be determined by the Court. See Cybor Corp. v. FAS Technologies, Inc., 138 F.3d 1448, 1455 (Fed.Cir.1998) (in banc). The Court only addresses the claim construction phase in this opinion.13

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Proper claim construction requires an examination of the claim language, the specification, and, if introduced, the prosecution history.14 See Phonometrics, Inc. v. Northern Telecom Inc., 133 F.3d 1459, 1464 (Fed. Cir.1998) (citing Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed.Cir. 1996)). Foremost in importance is the asserted claim itself and, therefore, the claim language constitutes the appropriate starting point for the claim construction analysis. See id. (citations omitted); see also Vitronics, 90 F.3d at 1582 (a court "must look to the words of the claims themselves, both asserted and nonasserted, to define the scope of the patented invention.").

Particularly significant in this case is the principle that claim language is interpreted to ascertain the meaning that a person of ordinary skill in the art would give to the claims in dispute. See Wiener v. NEC Electronics, Inc., 102 F.3d 534, 539 (Fed.Cir. 1996). The operative time for determining what meaning the disputed language of the claim has in the art...

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7 practice notes
  • Lacks Industries v. McKechnie Vehicle Components, No. 96-CV-75692.
    • United States
    • United States District Courts. 6th Circuit. United States District Court (Eastern District of Michigan)
    • July 1, 1999
    ...to ascertain the meaning that a person of ordinary skill in the art would give to the claims in dispute." Schering Corp. v. Amgen, Inc., 18 F.Supp.2d 372, 380 (D.Del.1998) (citing Wiener, 102 F.3d at 539). Although words in a claim generally have their ordinary meaning, "a patentee may choo......
  • Relume Corp. v. Dialight Corp., No. 98-CV-72360.
    • United States
    • United States District Courts. 6th Circuit. United States District Court (Eastern District of Michigan)
    • August 26, 1999
    ...to ascertain the meaning that a person of ordinary skill in the art would give to the claims in dispute." Schering Corp. v. Amgen, Inc., 18 F.Supp.2d 372, 380 (D.Del.1998) (citing Wiener, 102 F.3d at 539). Although words in a claim generally have their ordinary meaning, "a patentee may choo......
  • Schering Corp. v. Amgen, Inc., No. CIV.A.96-587 MMS.
    • United States
    • United States District Courts. 3th Circuit. United States District Court (Delaware)
    • October 9, 1998
    ...116 S.Ct. 1384, 134 L.Ed.2d 577 (1996), was held June 23, 1998 ("Markman hearing"). An Opinion and Order which issued on July 30, 1998, 18 F.Supp.2d 372 ("Markman Opinion"), construed seven separate aspects of language found in the claims of the '901 Patent. Schering has moved for reargumen......
  • Schering Corp v. Amgen Inc.
    • United States
    • United States Courts of Appeals. United States Court of Appeals for the Federal Circuit
    • August 1, 2000
    ...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 n......
  • Request a trial to view additional results
7 cases
  • Lacks Industries v. McKechnie Vehicle Components, No. 96-CV-75692.
    • United States
    • United States District Courts. 6th Circuit. United States District Court (Eastern District of Michigan)
    • July 1, 1999
    ...to ascertain the meaning that a person of ordinary skill in the art would give to the claims in dispute." Schering Corp. v. Amgen, Inc., 18 F.Supp.2d 372, 380 (D.Del.1998) (citing Wiener, 102 F.3d at 539). Although words in a claim generally have their ordinary meaning, "a patentee may choo......
  • Relume Corp. v. Dialight Corp., No. 98-CV-72360.
    • United States
    • United States District Courts. 6th Circuit. United States District Court (Eastern District of Michigan)
    • August 26, 1999
    ...to ascertain the meaning that a person of ordinary skill in the art would give to the claims in dispute." Schering Corp. v. Amgen, Inc., 18 F.Supp.2d 372, 380 (D.Del.1998) (citing Wiener, 102 F.3d at 539). Although words in a claim generally have their ordinary meaning, "a patentee may choo......
  • Schering Corp. v. Amgen, Inc., No. CIV.A.96-587 MMS.
    • United States
    • United States District Courts. 3th Circuit. United States District Court (Delaware)
    • October 9, 1998
    ...116 S.Ct. 1384, 134 L.Ed.2d 577 (1996), was held June 23, 1998 ("Markman hearing"). An Opinion and Order which issued on July 30, 1998, 18 F.Supp.2d 372 ("Markman Opinion"), construed seven separate aspects of language found in the claims of the '901 Patent. Schering has moved for reargumen......
  • Schering Corp v. Amgen Inc.
    • United States
    • United States Courts of Appeals. United States Court of Appeals for the Federal Circuit
    • August 1, 2000
    ...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 n......
  • Request a trial to view additional results

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