Amgen, Inc. v. Chugai Pharmaceutical Co., Ltd.
| Decision Date | 31 January 1989 |
| Docket Number | Civ. A. No. 87-2617-Y. |
| Citation | 706 F. Supp. 94 |
| Court | U.S. District Court — District of Massachusetts |
| Parties | AMGEN, INC., Plaintiff, v. CHUGAI PHARMACEUTICAL CO., LTD., and Genetics Institute, Inc., Defendants. |
D. Dennis Allegretti, Allegretti & Witcoff, Michael Borun, Richard Schnurr, Edward O'Toole, Marshall, O'Toole, Gerstein, Murray & Bicknell, Chicago, Ill., Allan Van Gestel, Goodwin Procter & Hoar, Boston, Mass., for plaintiff.
Ian Crawford, William Lee, Hale & Dorr, Boston, Mass., for defendants.
This action involves the alleged infringement of several patents covering erythropoietin, a protein which circulates in the blood and stimulates the production of red blood cells. Erythropoietin is used primarily for the clinical treatment of anemia, particularly anemia caused by renal disease.
In essence, this case is a battle over turf. The plaintiff Amgen, Inc. ("Amgen") owns a patent, the claims of which include purified and isolated DNA sequences encoding erythropoietin as well as host cells transformed or transfected with a DNA sequence. The defendant Genetics Institute, Inc. ("Genetics") owns, and the defendant Chugai Pharmaceutical Co., Ltd. ("Chugai") licenses, a patent which involves compositions comprised of highly purified erythropoietin. Although the contested property rights may revolved about fundamental scientific principles, the issues raised here rattle, ostensibly at least, the traditional foundations of patent law; that is, how do putative proprietary interests in recombinant technology interact with traditional concepts of patent law?
This matter is presently before the Court on the motions of Chugai and Genetics for summary judgment pursuant to Fed.R.Civ. P. 56 on various claims asserted by the parties.
Erythropoiesis, which is the production of red blood cells, occurs continuously throughout the human life span in order to offset cell destruction. This process enables a sufficient number of red blood cells to be available for proper tissue oxygenation, but not so many that such cells would impede blood circulation. Red blood cells are formed in the bone marrow, and this formation is stimulated by erythropoietin, a circulating glycoprotein.
The life of human red blood cells is about 120 days. Thus, about 1/120 of the total red blood cells are destroyed daily in the reticuloendothelial system.1 Concurrently, a relatively equal number of red blood cells are produced daily to maintain the level of such cells. Red blood cells are produced by the maturation and differentiation of erythroblasts2 in the bone marrow; erythropoietin is the factor which acts on less differentiated cells and induces their differentiation to red blood cells.
Because erythropoietin is a stimulating factor in the production of red blood cells, it is a promising therapeutic agent in the treatment of those blood disorders characterized by low or defective red blood cell production such as anemia and, in particular, renal anemia. The use of erythropoietin, however, is not common in practical therapy at the present time because it is not yet widely available.
The preparation of erythropoietin products generally has been accomplished through the concentration and purification of urine from both healthy patients and those exhibiting high erythropoietin levels, such as those patients suffering from aplastic anemia. Erythropoietin also can be recovered from sheep blood plasma; however, such erythropoietin is expected to be antigenic in humans. Another technique for producing erythropoietin is recombinant technology in which erythropoietin is produced from cell cultures into which genetically engineered vectors containing the erythropoietin gene have been introduced. Regardless of the source, however, the erythropoietin protein must be purified to homogeneity in order to use it therapeutically.
It had been thought in the scientific community that erythropoietin purified by methods described by Miyake3 was homogeneous as measured by a specific activity on the order of 80,000 International Units (IU) per absorbance unit (AU) at 280 nanometers (A280) (hereinafter, "IU/AU"). Dr. Rodney Hewick ("Dr. Hewick"), however, discovered that truly homogeneous erythropoietin has a specific activity of at least about 160,000 IU/AU and, further, that Miyake's erythropoietin composition is not in fact homogeneous, but contains large amounts of several non-erythropoietin protein contaminants. Dr. Hewick was subsequently successful in producing homogeneous erythropoietin.
On June 30, 1987, the United States Patent and Trademark Office ("the Patent and Trademark Office") awarded Dr. Hewick United States Patent No. 4,677,195 entitled "Method for the Purification of Erythropoietin and Erythropoietin Compositions" ("the '195 patent")4 covering both a nonrecombinant method for purifying erythropoietin and compositions of highly purified erythropoietin. Dr. Hewick assigned the '195 patent to Genetics, a Delaware corporation having a principal place of business in Cambridge, Massachusetts. Genetics then licensed the rights of the '195 patent to Chugai, a Japanese corporation having a principal place of business in Tokyo, Japan.
The plaintiff Amgen is a Delaware corporation having a principal place of business in Thousand Oaks, California, and is engaged in the development and the eventual commercialization of recombinant erythropoietin for human pharmaceutical applications. A division of Amgen, Amgen Biologicals, has manufactured and sold erythropoietin produced by recombinant DNA techniques since June 30, 1987, the date on which the '195 patent was issued. Chugai and Genetics assert that this recombinant erythropoietin5 infringes the claims of the '195 patent.
The other principal patent in this litigation is United States Patent No. 4,703,008 entitled "DNA Sequences Encoding Erythropoietin" ("the '008 patent"). On October 27, 1987, the Patent and Trademark Office issued the '008 patent to the inventor Fu-Kuen Lin, who assigned it to Kirin-Amgen, Inc. ("Kirin-Amgen"), a California corporation owned equally by Amgen and Kirin Brewery ("Kirin"). Kirin-Amgen was created under a joint venture agreement between Amgen and Kirin for the purpose of the further development and eventual commercialization of recombinant erythropoietin for human pharmaceutical applications. The '008 patent "relates generally to the manipulation of genetic materials and, more particularly, to recombinant procedures making possible the production of polypeptides possessing part or all of the primary structural conformation and/or one or more of the biological properties of naturally-occurring erythropoietin." United States Patent No. 4,703,008 at col. 1 (Complaint, Exhibit A). The claims of the '008 patent include numerous purified and isolated DNA sequences encoding erythropoietin in addition to host cells transformed or transfected with a DNA sequence. See id. at cols. 39-42.
On October 27, 1987, the same day that the '008 patent was issued, Amgen filed this action against Chugai and Genetics, alleging that 1) the defendants' production, use and sale of recombinant erythropoietin infringe the '008 patent; 2) the '195 patent is invalid, or, in the alternative, Amgen does not infringe the claims of the '195 patent, and; 3) the defendants' future activities vis a vis the production and sale of recombinant erythropoietin will infringe the '008 patent.
Thereafter, Amgen filed a complaint with the International Trade Commission ("the Commission") on January 4, 1988, alleging that Chugai's importation of recombinant erythropoietin, which is manufactured in Japan using genetically engineered host cells, violates Section 337 of the Tariff Act of 1930 (19 U.S.C. sec. 1337) and 19 U.S.C. sec. 1337a.6 Chugai filed a motion for summary determination seeking to terminate the Commission's investigation. The Administrative Law Judge, however, denied the motion on March 7, 1988.
Chugai and Genetics answered and counterclaimed in the present action, alleging that 1) Amgen has infringed the '195 patent; 2) the '008 patent does not provide patent protection for recombinant erythropoietin; 3) the filing of a complaint by Amgen with the Commission constitutes unfair competition; 4) the '008 patent is invalid; and 5) Amgen's utilization of the '008 patent constitutes a violation of Section 2 of the Sherman Act. Chugai and Genetics then filed a motion for partial summary judgment on the claim that Amgen infringes the claims of the '195 patent. On February 24, 1988, the Court heard oral argument and then granted the motion. Chugai filed a motion for summary judgment on May 12, 1988, and, after oral argument on June 24, 1988, the Court took the motion under advisement.
The Court will here treat the following matters:
(1) the motion of Chugai and Genetics for partial summary judgment—heard and decided on February 24, 1988—on the issue whether Amgen's product infringes the '195 patent; i.e., the Court will set forth the reasoning underlying its February 24 ruling;
(2) the motion of Chugai for summary judgment seeking a determination that the '008 patent is unenforceable due to Amgen's alleged acts of patent misuse or, in the alternative, that the '008 patent contains no process claims, and thus does not cover Chugai's process of manufacturing recombinant erythropoietin.
Under Fed.R.Civ.P. 56, summary judgment is appropriate if "there is no genuine issue as to any material fact and ... the moving party is entitled to a judgment as a matter of law." Fed.R.Civ.P. 56(c). Since one principal purpose of summary judgment "is to isolate and dispose of factually unsupported claims or defenses," Celotex Corp. v. Catrett, 477 U.S. 317, 323-24, 106 S.Ct. 2548, 2553-54, 91 L.Ed.2d 265 (1986), it is now well established that Fed.R.Civ.P. 56(e)7 "requires the nonmoving party to go beyond the pleadings and by her own...
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