Johns Hopkins University v. CellPro, Inc.
| Decision Date | 11 August 1998 |
| Docket Number | Nos. 97-1495,98-1017,s. 97-1495 |
| Citation | 152 F.3d 1342,47 USPQ2d 1705,1998 WL 466633 |
| Parties | The JOHNS HOPKINS UNIVERSITY, Baxter Healthcare Corporation and Becton Dickinson and Company, Plaintiffs-Appellees, v. CELLPRO, INC., Defendant-Appellant. |
| Court | U.S. Court of Appeals — Federal Circuit |
Donald R. Ware, Foley, Hoag & Eliot LLP, of Boston, Massachusetts, argued for plaintiffs-appellees. With him on the brief were Peter B. Ellis and Philip C. Swain. Of counsel on the brief was Michael C. Schiffer, Attorney, Baxter Healthcare Corporation, of Irvine, California.
Don W. Martens, Knobbe, Martens, Olson & Bear LLP, Newport Beach, California, argued for defendant-appellant. With him on the brief were Joseph R. Re, Michael K. Friedland, and Dale C. Hunt. Also on the brief were Gary D. Wilson and Steven M. Dunne, Wilmer, Cutler & Pickering, Washington, D.C. Of counsel were Robert C. Weiss, Allan W. Jansen, and Jerrold B. Reilly, Lyon & Lyon, Los Angeles, California.
Before LOURIE, Circuit Judge, SMITH, Senior Circuit Judge, and SCHALL, Circuit Judge.
CellPro, Inc. appeals from the decision of the United States District Court for the District of Delaware in favor of Johns Hopkins University, Baxter Healthcare Corporation, and Becton Dickinson and Company (collectively, Hopkins) in their patent infringement suit against CellPro. The court (1) granted Hopkins' motion for judgment as a matter of law that CellPro infringed claims 1-5 of U.S. Patent B1 4,714,680, see Johns Hopkins Univ. v. CellPro, 931 F.Supp. 303, 319 (D.Del.1996) [hereinafter Hopkins I ]; (2) excluded certain evidence allegedly relevant to the obviousness of those claims, see Johns Hopkins Univ. v. Cellpro, Civ. No. 94-105-RRM (D.Del. Oct. 1, 1996); id. (D.Del. Jan. 29, 1997); (3) granted Hopkins' motion for summary judgment that CellPro infringed claims 1 and 4 of U.S. Patent 4,965,204, see id. (D.Del. Nov. 27, 1996); (4) granted Hopkins' summary judgment motion concerning CellPro's enablement and written description defenses, see id. (D.Del. Feb. 24, 1997) (enablement); id. (D.Del. Oct. 31, 1996) (written description); (5) sustained the jury's verdict of willful infringement and treble damages, see Johns Hopkins Univ. v. CellPro, 978 F.Supp. 184 (D.Del.1997) [hereinafter Hopkins II ]; and (6) ordered certain vials of CellPro's product to be repatriated to the United States and destroyed, see Johns Hopkins Univ. v. CellPro, Civ. No. 94-105-RRM (D.Del. Jul. 24, 1997). We affirm-in-part, vacate-in-part, and remand.
The '680 and '204 patents (the "Civin patents") issued from continuations of the same parent application 1 and pertain generally to relatively pure suspensions of immature blood cells and monoclonal antibodies used to produce such suspensions. These immature cells, known as "stem" cells, develop into many different forms of mature blood cells, including lymphoid cells (T-cells and B-cells) and myeloid cells (red cells, platelets and granulocytes). See generally Hopkins I, 931 F.Supp. at 308 ().
Because stem cells are killed by radiation therapy, these cells must be replaced in leukemia patients who have undergone this treatment. While bone marrow transplants can provide a patient with new stem cells, this procedure carries risks. Notably, the presence of mature cells in transplanted bone marrow can give rise to Graft Versus Host Disease (GVHD), a potentially fatal condition. 2 Accordingly, one of the stated objectives In the early 1980s, scientists began making monoclonal antibodies 3 that would recognize and bind to the antigens contained on the surface of blood cells. Once an antibody binds to an antigen on a cell surface, that cell is flagged and can be separated from other cells using known techniques such as the "FACS" method. 4 Monoclonal antibodies, which are uniform in their binding properties, are produced by cloned cells known as hybridomas. 5 Hybridomas grow and reproduce rapidly and can be frozen for later use to produce additional monoclonal antibodies.
of the invention of the Civin patents "is to provide a method for preparing a cell population useful for stem cell transplantation that is enriched in immature marrow cells and substantially free of mature myeloid and lymphoid cells." '680 patent, col. 2, ll. 1-5; see also Hopkins I, 931 F.Supp. at 309.
Dr. Curt Civin, the inventor named in the 6 specifications disclose a monoclonal antibody, which Civin named anti-My-10, which recognizes the My-10 antigen and is useful in separating stem cells from mature cells. The patents further disclose how a hybridoma which manufactures the anti-My-10 antibody can be produced and note that a sample of the hybridoma has been deposited with the American Type Culture Collection (ATCC), ATCC Accession No. HB-8483, in Rockville, Maryland.
The '680 and '204 patents claim, respectively, a purified cell suspension of stem cells and monoclonal antibodies useful in producing such a suspension. The parties do not draw distinctions between the various claims in the patents, and instead premise their arguments as to each patent solely on independent claim 1 of each patent. These claims are set forth below with the disputed limitations from each claim emphasized:
'680 Claim 1: "A suspension of human cells comprising pluripotent lympho-hemapoietic stem cells substantially free of mature lymphoid and myeloid cells."
'204 Claim 1: "A monoclonal antibody which specifically binds to an antigen on nonmalignant, immature human marrow cells, wherein said antigen is stage specific and not lineage dependent, and said antigen is also specifically bound by the antibody produced by the hybridoma deposited under ATCC Accession No. HB-8483. ..." 7
Four years after the filing date of the parent application of the Civin patents, Dr Berenson and others at Hutchinson formed CellPro in 1989 and obtained licenses from Hutchinson for the use of Berenson's cell separation technology. In July 1990, CellPro produced, by cloning, a master cell bank constituting 100 vials of 12.8 hybridoma. Some of these vials were subsequently thawed and cloned to create a working cell bank to produce the 12.8 antibody. CellPro began to sell two machines, the Ceprate LC and the Ceprate SC, which its customers used in conjunction with the 12.8 antibody to perform Berenson's cell separation method.
Ronald Berenson, a scientist at the Fred Hutchinson Research Center, developed a method of physically separating stem cells from mature cells that was similar to that disclosed in the Civin patents. The monoclonal antibody developed by Berenson for this purpose was designated the 12.8 antibody. 8
At the time CellPro was formed, representatives of CellPro knew of the '680 cell suspension patent, which issued on December 12, 1987. They had also monitored the Official Gazette of the Patent and Trademark Office to determine if Civin had been issued any antibody-related patent; the '204 antibody patent, which issued on October 23, 1990, was so discovered. See Hopkins II, 978 F.Supp. at 187-88. CellPro does not in fact dispute that it was aware of the existence of the Civin patents when it began its allegedly infringing activity.
Ostensibly concerned that CellPro's activities might fall within the scope of the '680 patent, Thomas Kiley, a member of CellPro's Board of Directors and the company's legal advisor, engaged the law firm of Lyon & Lyon LLP and its partner Coe Bloomberg in early April 1989 to provide an opinion on the validity of the claims of the '680 patent. Bloomberg apparently reported to the CellPro board in May and September 1989 that he had reviewed the prosecution history of the patent and had concluded that the patent was invalid. Bloomberg's oral opinion was first reduced to writing on February 27, 1990. That later written opinion concluded that the claims of the '680 patent were invalid over several pieces of prior art and were unenforceable for inequitable conduct. CellPro used Bloomberg's opinion letter to assist it in raising an additional $7.5 million from investors. See id.
In the spring of 1991, CellPro's board asked Bloomberg for an opinion concerning the '204 patent. Bloomberg apparently prepared a draft opinion and submitted it to Kiley, who reviewed it and provided Bloomberg with comments. This opinion, like the '680 opinion, concluded that the claims were invalid and unenforceable. Bloomberg also opined that CellPro did not infringe claims 2, 3, 5, and 6, but was silent as to infringement of claims 1 and 4, the claims asserted in this action. The '204 opinion letter was also used by CellPro as a mechanism for inducing investment in the company. In the prospectus accompanying CellPro's public offering, the company reported that "[b]ased on the advice of Lyon & Lyon, special patent counsel to the company, CellPro believes that [the Civin] patents are invalid and unenforceable." Id. at 189 (internal quotations omitted).
By December of 1991, CellPro had set aside $3 million as a reserve for potential litigation involving the Civin patents. CellPro also made provision in its financial forecasts for the possibility that it would litigate and lose, and be forced to pay a "stiff royalty" of 15% as damages. Id.
Hopkins, assignee of the Civin patents, and its licensees, Baxter Healthcare and Becton The case was tried to a jury beginning on July 24, 1995. The district court reserved construing the claims until after the presentation of evidence. At that time, the court considered but did not provide the jury with...
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