927 F.2d 1200 (Fed. Cir. 1991), 90-1273, Amgen, Inc. v. Chugai Pharmaceutical Co., Ltd.

Docket Nº:90-1273, 90-1275.
Citation:927 F.2d 1200
Party Name:18 U.S.P.Q.2d 1016 AMGEN, INC., Plaintiff/Cross-Appellant, v. CHUGAI PHARMACEUTICAL CO., LTD., and Genetics Institute, Inc., Defendants-Appellants.
Case Date:March 05, 1991
Court:United States Courts of Appeals, Court of Appeals for the Federal Circuit
 
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Page 1200

927 F.2d 1200 (Fed. Cir. 1991)

18 U.S.P.Q.2d 1016

AMGEN, INC., Plaintiff/Cross-Appellant,

v.

CHUGAI PHARMACEUTICAL CO., LTD., and Genetics Institute,

Inc., Defendants-Appellants.

Nos. 90-1273, 90-1275.

United States Court of Appeals, Federal Circuit

March 5, 1991

Suggestion for Rehearing In Banc

Declined May 20, 1991.

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[Copyrighted Material Omitted]

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Edward M. O'Toole, Marshall, O'Toole, Gerstein, Murray & Bicknall, Chicago, Ill., argued, for plaintiff/cross-appellant. With him on the brief were Michael F. Borun, Richard A. Schnurr and Christine A. Dudzik. Also on the brief were Steven M. Odre and Robert D. Weist, Amgen, Inc., Thousand Oaks, Cal., of counsel.

Kurt E. Richter, Morgan & Finnegan, New York City, and William F. Lee, Hale & Dorr, Boston, Mass., argued for defendants-appellants. Of counsel were Eugene Moroz, Michael P. Dougherty and William S. Feiler, Morgan & Finnegan, New York City.

Before MARKEY, LOURIE and CLEVENGER, Circuit Judges.

LOURIE, Circuit Judge.

This appeal and cross appeal are from the March 4, 1990, judgment of the United States District Court for the District of Massachusetts, Amgen, Inc. v. Chugai Pharmaceutical Co., 13 USPQ2d 1737, 1989 WL 169006 (1990), and involve issues of patent validity, infringement, and inequitable conduct with respect to two patents: U.S. Patent 4,703,008 ('008), owned by Kirin-Amgen Inc. (Amgen), and U.S. Patent 4,677,195 ('195), owned by Genetics Institute, Inc. (GI).

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Chugai Pharmaceutical Co., Ltd. (Chugai) and Genetics Institute, Inc. (collectively defendants) assert on appeal that the district court erred in holding that: 1) Amgen's '008 patent is not invalid under 35 U.S.C. Secs. 102(g) and 103; 2) the '008 patent is enforceable; 3) the failure of Amgen to deposit the best mode host cells was not a violation of the best mode requirement under 35 U.S.C. Sec. 112; and 4) claims 4 and 6 of GI's '195 patent are invalid for indefiniteness under 35 U.S.C. Sec. 112.

On cross appeal, Amgen challenges the district court's holdings that: 1) claims 1 and 3 of the '195 patent are enabled; 2) the '195 patent is enforceable; 3) this is not an exceptional case warranting an award of attorney fees to Amgen; and 4) claims 7, 8, 23-27 and 29 of the '008 patent are not enabled by the specification.

We affirm the district court's holdings in all respects, except that we reverse the court's ruling that claims 1 and 3 of the '195 patent are enabled. We also vacate that part of the district court's judgment relating to infringement of those claims.

BACKGROUND 1

Erythropoietin (EPO) is a protein consisting of 165 amino acids which stimulates the production of red blood cells. It is therefore a useful therapeutic agent in the treatment of anemias or blood disorders characterized by low or defective bone marrow production of red blood cells.

The preparation of EPO products generally has been accomplished through the concentration and purification of urine from both healthy individuals and those exhibiting high EPO levels. A new technique for producing EPO is recombinant DNA technology in which EPO is produced from cell cultures into which genetically-engineered vectors containing the EPO gene have been introduced. The production of EPO by recombinant technology involves expressing an EPO gene through the same processes that occur in a natural cell.

THE PATENTS

On June 30, 1987, the United States Patent and Trademark Office (PTO) issued to Dr. Rodney Hewick U.S. Patent 4,677,195, entitled "Method for the Purification of Erythropoietin and Erythropoietin Compositions" (the '195 patent). The patent claims both homogeneous EPO and compositions thereof and a method for purifying human EPO using reverse phase high performance liquid chromatography. The method claims are not before us. The relevant claims of the '195 patent are:

  1. Homogeneous erythropoietin characterized by a molecular weight of about 34,000 daltons on SDS PAGE, movement as a single peak on reverse phase high performance liquid chromatography and a specific activity of at least 160,000 IU per absorbance unit at 280 nanometers.

    * * * * * *

  2. A pharmaceutical composition for the treatment of anemia comprising a therapeutically effective amount of the homogeneous erythropoietin of claim 1 in a pharmaceutically acceptable vehicle.

  3. Homogeneous erythropoietin characterized by a molecular weight of about 34,000 daltons on SDS PAGE, movement as a single peak on reverse phase high performance liquid chromatography and a specific activity of at least about 160,000 IU per absorbance unit at 280 nanometers.

    * * * * * *

  4. A pharmaceutical composition for the treatment of anemia comprising a therapeutically effective amount of the homogeneous erythropoietin of claim 4 in a pharmaceutically acceptable vehicle.

    Dr. Hewick assigned the patent to GI.

    The other patent in this litigation is U.S. Patent 4,703,008, entitled "DNA Sequences Encoding Erythropoietin" (the '008 patent), issued on October 27, 1987, to Dr. Fu-Kuen Lin, an employee of Amgen. The claims of

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    the '008 patent cover purified and isolated DNA sequences encoding erythropoietin and host cells transformed or transfected with a DNA sequence. The relevant claims are as follows:

  5. A purified and isolated DNA sequence consisting essentially of a DNA sequence encoding human erythropoietin.

    * * * * * *

  6. A procaryotic or eucaryotic host cell transformed or transfected with a DNA sequence according to claim 1, 2 or 3 in a manner allowing the host cell to express erythropoietin.

    * * * * * *

  7. A procaryotic or eucaryotic host cell stably transformed or transfected with a DNA vector according to claim 5.

  8. A purified and isolated DNA sequence consisting essentially of a DNA sequence encoding a polypeptide having an amino acid sequence sufficiently duplicative of that of erythropoietin to allow possession of the biological property of causing bone marrow cells to increase production of reticulocytes and red blood cells, and to increase hemoglobin synthesis or iron uptake.

  9. A cDNA sequence according to claim 7.

    * * * * * *

  10. A procaryotic or eucaryotic host cell transformed or transfected with a DNA sequence according to claim 7, 8, or 11 in a manner allowing the host cell to express said polypeptide.

  11. A transformed or transfected host cell according to claim 23 which host cell is capable of glycosylating said polypeptide.

  12. A transformed or transfected mammalian host cell according to claim 24.

  13. A transformed or transfected COS cell according to claim 25.

  14. A transformed or transfected CHO cell according to claim 25.

    * * * * * *

  15. A procaryotic host cell stably transformed or transfected with a DNA vector according to claim 28.

    PROCEDURAL HISTORY

    On October 27, 1987, the same day that the '008 patent was issued, Amgen filed suit against Chugai and GI. It alleged that GI infringed the '008 patent by the production of recombinant EPO (rEPO) and by use of transformed mammalian host cells containing vectors with DNA coding for the production of human EPO, and that Chugai, as a result of a collaborative relationship with GI, had induced and/or contributed to the direct infringement of the '008 patent by GI. Amgen further sought a declaration that GI's '195 patent is invalid under 35 U.S.C. Secs. 102, 103, and 112, or, in the alternative, that Amgen does not infringe the claims of the '195 patent, and a declaration that GI and Chugai's future activities in the production and sale of rEPO will infringe the '008 patent. 2

    GI and Chugai answered and counterclaimed, asserting several affirmative defenses, including invalidity under 35 U.S.C. Secs. 101, 102, 103, and 112; non-infringement; failure to make deposits at a public depository of biological materials allegedly necessary for enabling the best mode of practicing the invention; and unenforceability of the patent because of Amgen's alleged inequitable conduct before the PTO. GI also counterclaimed, alleging that Amgen infringed the '195 patent, asserting unfair competition, and seeking a declaratory judgment that the '008 patent was invalid and not infringed.

    GI and Chugai then filed a joint motion for a partial summary judgment that Amgen

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    infringed the claims of the '195 patent. Chugai also filed its own motion for summary judgment. On February 24, 1988, the district court granted GI's and Chugai's motion for partial summary judgment and, on January 31, 1989, the court granted Chugai's motion for partial summary judgment only to the extent of ruling that the '008 patent does not contain a process claim, an issue that is not now before us.

    In response to Amgen's motion for a preliminary injunction, the district court, on February 7, 1989, issued an order finding that "Amgen had shown a reasonable likelihood of success on the merits of the validity of its patent; that it would suffer irreparable injury due to the needs of an incipient market and the attendant burdens on a new company; ..." and that, as to the public interest, "recombinant EPO is an extraordinarily valuable medicine that promises marked relief from renal failure." Because of this public interest finding, the court determined that it would not enter an order to delay or prevent production or shipping of EPO, but would require the defendant GI to place with the court all profits from the sale of EPO.

    In order to expedite trial, the parties consented to trial before a magistrate. The judge entered judgment upon findings of fact and conclusions of law set forth by the magistrate. With respect to Amgen's '008 patent, the court held that claims 2, 4, and 6 are valid, enforceable and have been infringed by GI; that infringement was not willful; that claims 7, 8, 23-27, and 29...

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