Johns Hopkins University v. CellPro

• Court: U.S. District Court — District of Delaware
• Writing for the Court: McKELVIE
• Citation: Johns Hopkins University v. CellPro, 931 F.Supp. 303 (D. Del. 1996)
• Decision Date: 28 June 1996
• Docket Number: Civil Action No. 94-105-RRM.
• Parties: The JOHNS HOPKINS UNIVERSITY, a Maryland Corporation, Baxter Healthcare Corporation, a Delaware Corporation, and Becton Dickinson and Company, a New Jersey Corporation, Plaintiffs, v. CELLPRO, a Delaware Corporation, Defendant.

931 F. Supp. 303

The JOHNS HOPKINS UNIVERSITY, a Maryland Corporation, Baxter Healthcare Corporation, a Delaware Corporation, and Becton Dickinson and Company, a New Jersey Corporation, Plaintiffs, v. CELLPRO, a Delaware Corporation, Defendant.

Civil Action No. 94-105-RRM.

United States District Court, D. Delaware.

June 28, 1996.

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William J. Marsden, Jr., Potter Anderson & Corroon, Wilmington, Delaware, Kenneth E. Madsen, Kenyon & Kenyon, New York City, Michael Sennett, Bell Boyd & Lloyd, Chicago, Illinois, Donald R. Ware, Foley, Hoag & Eliot, Boston, Massachusetts, for plaintiffs.

Patricia S. Rogowski, Connolly, Bove, Lodge & Hutz, Wilmington, Delaware, Coe A. Bloomberg, Robert C. Weiss, Jerrold B. Reilly, Bruce G. Chapman, Armand F. Ayazi, Lyon & Lyon, Los Angeles, California, for defendant.

OPINION

McKELVIE, District Judge.

This is a patent case. Plaintiff The Johns Hopkins University ("Hopkins") owns U.S. Patent No. 4,965,204 (the "`204 patent"). Hopkins has licensed the `204 patent to plaintiffs Baxter Healthcare Corporation ("Baxter") and Becton Dickinson and Company ("Becton Dickinson"). The `204 patent claims all monoclonal antibodies that specifically bind to the antigen identified as "CD34." On March 8, 1994, plaintiffs filed a complaint alleging that defendant CellPro, Inc. ("CellPro") is willfully infringing claims 1, 2, 4, and 5 of the `204 patent.

CellPro denied infringement and asserted certain affirmative defenses, including that the `204 patent is invalid and unenforceable. In addition, CellPro counterclaimed for plaintiffs' alleged violation of antitrust law and for a declaratory judgment that the `204 patent and three other patents owned by Hopkins, U.S. Patent Nos. 4,965,680 (the "`680 patent"), 5,035,994 (the "`994 patent"), and 5,130,144 (the "`144 patent"), are invalid, unenforceable, and not infringed. All four patents-in-suit are collectively known as the "Civin patents" after their inventor, Dr. Curt Civin. Civin is a physician and professor at The Johns Hopkins University School of Medicine and The Johns Hopkins University Hospital in Baltimore, Maryland.

In their answer to CellPro's counterclaim, plaintiffs denied the invalidity and unenforceability of the Civin patents. In addition, they alleged that CellPro is infringing, contributorily infringing, and inducing infringement of the `680, `994, and `144 patents. Pursuant to a stipulation by the parties, the court issued an order deferring the antitrust phase of the case until after the patent issues were tried.

The case was tried to a jury beginning on July 24, 1995, on the issues of the infringement, validity, and enforceability of the Civin patents. During the trial, CellPro sought to introduce evidence on two invalidity defenses, indefiniteness and inoperability, that it did not identify in the pre-trial order. The court requires parties to identify their specific contentions, and the evidence in support of those contentions, in the pre-trial in order to give the opposing party sufficient notice of those contentions before trial. Therefore, the court precluded CellPro from presenting evidence in support of indefiniteness or inoperability and from arguing these issues to the jury.

After the presentation of evidence, the court endeavored to construe the disputed claims of the Civin patents in accordance with Markman v. Westview Instruments, Inc., 52 F.3d 967, 979-81 (Fed.Cir.1995), aff'd, ___ U.S. ___, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). See Johns Hopkins University v. CellPro, 894 F.Supp. 819, 826-29 (D.Del.1995) (setting out the court's construction of the claims). The court then instructed the jury on its construction of the claims and on the issues of law raised by the parties, except for the issues of infringement under the doctrine of equivalents and the enforceability of the Civin patents. Id. at 828-40 (setting out the final jury instructions). Shortly after the trial, the Court of Appeals for the Federal Circuit held that infringement under the doctrine of equivalents is an issue of fact for the jury. Hilton Davis Chemical Co. v. Warner-Jenkinson Co., 62 F.3d 1512 (Fed.Cir.1995).

On August 4, 1995, the jury returned a verdict in which it found that the claims of all of the Civin patents were invalid as obvious in light of the prior art. The jury also found that, except with respect to unasserted claims 3 and 6 of the `204 patent, each claim of the Civin patents was invalid as not enabled. The jury further found that CellPro did not literally infringe the claims of the `204 patent and that CellPro did not literally infringe, contributorily infringe, or induce infringement of the asserted claims of the `680, `994, and `144 patents.

On October 3, 1995, plaintiffs renewed a motion made during trial for judgment as a matter of law pursuant to Rule 50 of the Federal Rules of Civil Procedure ("FRCP"). Plaintiffs' motion seeks to establish the following: 1) that CellPro infringes the claims of the Civin patents literally and under the doctrine of equivalents; 2) that CellPro failed to prove by clear and convincing evidence that the claims of the Civin patents are obvious; and 3) that CellPro failed to prove by clear and convincing evidence that the claims of the Civin patents are not enabled. In the alternative, plaintiffs renewed a motion made during trial for a new trial pursuant to FRCP 59.

On April 24, 1996, the court heard oral argument on a number of post-trial motions filed by the parties, including plaintiffs' motion for judgment as a matter of law or, in the alternative, for a new trial. This is the court's decision on plaintiffs' motion for judgement as a matter of law or for a new trial.

I. FACTUAL AND PROCEDURAL BACKGROUND

In order to understand and construe the claims of the Civin patents, it is necessary to examine the physiology underlying the inventions claimed in the patents. First, the court will explain the basic physiology of blood. Second, the court will discuss the specific physiology underlying the Civin patents and the goals, methods, and results of Civin's research. Third, the court will recite the relevant claims of the `204, `680, `994, and `144 patents and discuss the construction given to those claims during the trial. Fourth, the court will discuss CellPro's accused processes and products. The court draws the following facts from the testimony and exhibits offered at trial.

A. What is the Basic Physiology of Blood?

Blood consists of a number of components. There is a liquid, known as plasma, that makes the blood fluid and that contains certain proteins for clotting. In addition, there are a number of types of cells, known as red cells, platelets, and white cells, which are also called leukocytes. Red cells carry oxygen in the blood, whereas platelets cause blood clotting. White cells are important for fighting infections and are part of the immune system.

White cells are divided into two large families, known as lymphocytes and granulocytes. There are different types of lymphocytes, such as T lymphocytes or T cells and B lymphocytes or B cells. T cells govern certain immune responses and are the ones that are destroyed by the AIDS virus. B cells make antibodies, which are important for certain kinds of responses to infections. There are also different types of granulocytes, such as neutrophils, eosinophils, and basophils. Neutrophils kill bacteria, whereas eosinophils and basophils respond to certain kinds of immune stimuli that are less well known.

Blood cells have a fairly short lifespan, and thus the body must produce millions of blood cells each day. Blood cells are manufactured in a tissue known as marrow in the cavity of some bones. In bone marrow, there exist cells known as a pluripotent stem cells that produce all types of blood cells. These stem cells, which are called pluripotent or multipotent because of the number of types of cells they can create, are very rare and difficult to locate. A stem cell produces other cells by dividing over and over until thousands of cells have been manufactured. This process of producing blood cells is called hematopoiesis.

At this stage, the stem cells are immature because they have not determined what type of cell they will become. A stem cell may become a lymphoid stem cell that can later become a B or T cell. Alternatively, a stem cell can become a myeloid stem cell that can later become a red cell, a platelet, or a granulocyte. Over time, these stem cells become progressively more differentiated, which is the word used to describe blood cell maturation. Lymphoid and myeloid stem cells differentiate into progenitor cells, which are uncommon but not as rare as stem cells. Progenitor cells still retain some ability to reproduce cells. For simplicity, the court will refer to both progenitor cells and stem cells as stem cells.

B. What Were the Goals, Methods, and Results of Civin's Research?

In the early 1980s, scientists were seeking ways of identifying and isolating blood cells in order to learn about diseases related to these cells. These scientists, including Civin, focused on the use of antibodies to label cells. As discussed above, antibodies respond to infections in the body. For example, if a bacteria is present, the body will produce an antibody that will bind to one side of the bacteria. To be more specific, the antibody binds to a site on the bacteria known as an antigen, which is a mass of protein and sugar on the cell. Since antigens often are larger than antibodies, antibodies sometimes connect with only a portion of the antigen, known as an epitope. Blood cells, including stem cells, have antigens as well. Thus, antibodies also can bind to blood cells that have the appropriate antigen.

There are different types of antibodies, such as IgG and IgM monoclonal antibodies. These types of antibodies have different characteristics, for example, IgM antibodies have...