Davidson v. Cao, CIV.A. 00-11046-DPW.

Decision Date11 April 2002
Docket NumberNo. CIV.A. 00-11046-DPW.,CIV.A. 00-11046-DPW.
Citation211 F.Supp.2d 264
PartiesDonald DAVIDSON and Abbott Laboratories, Plaintiffs, v. Yihai CAO, Judah Folkman, Michael S. O'Reilly, the Children's Medical Center Corporation and Entremed, Inc., Defendants.
CourtU.S. District Court — District of Massachusetts

Kathleen B. Carr, Edwards & Angell, Boston, MA, Kimball R. Anderson, Winston & Strawn, Chicago, IL, Barbara L. Moore, Edwards & Angell, LLP, Boston, MA, Tracy J. Allen, Raymond C. Perkins, Winston & Strawn, Chicago, IL, for Donald J. Davidson, an individual, Abbott Laboratories, an Illinois corporation, Plaintiffs.

Ralph T. Lepore, III, James D. Smeallie, James D. Smeallie, Holland & Knight LLP, Boston, MA, William F. Lee, Lisa Pirozzolo, Amanda P. Masselam, Hale & Dorr, Boston, MA, James T. Lepore, for Yihai Cao, defendant.

William F. Lee, Lisa Pirozzolo, Amanda P. Masselam, Hale & Dorr, Boston, MA, for Yihai Cao, Michael S. O'Reilly, Children's Medical Center Corp., defendants.

Lisa Pirozzolo, Amanda P. Masselam, Hale & Dorr, Boston, MA, George Abrams, Boston, MA, for Judah Folkman.

John H. Henn, Donald R. Ware, Foley, Hoag & Eliot LLP, Boston, MA, for Entremed, Inc., defendant.

Kimball R. Anderson, Tracy J. Allen, Raymond C. Perkins, Winston & Strawn, Chicago, IL, Barbara L. Moore, Edwards & Angell, LLP, Boston, MA, for Donald J. Davidson, defendant.

Barbara L. Moore, Edwards & Angell, LLP, Boston, MA, for Abbott Laboratories, defendant.

REPORT AND RECOMMENDATION RE: PLAINTIFFS' RULE 12(B)(6) MOTION TO DISMISS ENTREMED, INC.'S AMENDED COUNTERCLAIMS (DOCKET ENTRY # 181); PLAINTIFFS' MOTION TO DISMISS COUNTS I, II, III, IV, V, AND VII OF THE THIRD AMENDED COUNTERCLAIM OF YIHAI CAO, JUDAH FOLKMAN, MICHAEL S. O'REILLY AND THE CHILDREN'S MEDICAL CENTER CORPORATION (DOCKET ENTRY # 180)

BOWLER, Chief United States Magistrate Judge.

Plaintiffs Donald Davidson ("Davidson") and Abbott Laboratories ("Abbott") (collectively: "plaintiffs") move to dismiss counts I, II, III, IV, V and VII of the third amended counterclaim (Docket Entry # 175) filed by defendants Yihai Cao ("Cao"), Judah Folkman ("Folkman"), Michael S. O'Reilly ("O'Reilly") and The Children's Medical Center Corporation ("CMCC") (collectively: "CMCC defendants"). (Docket Entry # 180). Plaintiffs also move to dismiss the amended counterclaims of defendant Entremed, Inc. ("Entremed").1 (Docket Entry # 181). After conducting a hearing on March 19, 2002, this court took the motions (Docket Entry ## 180 & 181) and the related filings (Docket Entry ## 18, 20, 30, 32, 34, 36, 61, 63, 76, 89, 178, 184, 187, 188, 202, 203 & 225) under advisement.

BACKGROUND2

The parties' dispute centers around the inventorship of methods of using the Kringle 5 region of plasminogen to treat cancer and other angiogenic diseases such as diabetic retinopathy. Folkman, Director of the Surgical Research Laboratory at Boston's Children's Hospital and a widely respected scientist in the area of cancer research, first posited the theory that tumors require angiogenesis3 for their growth in a 1971 article published in The New England Journal of Medicine.

Since 1971, Folkman's laboratory has been a leader in the area of angiogenesis research. Indeed, his laboratory is the source of the discovery of two promising cancer drugs, angiostatin and endostatin, which are now in human clinical trials.

In early 1994, Folkman, O'Reilly and Cao4 conceived the idea of investigating the anti-angiogenic effects of the Kringle fragments in plasminogen. Folkman theorized that tumors produce anti-angiogenic substances as well as angiogenic substances that stimulate their growth. If identified, these anti-angiogenic substances might suppress tumor growth.

In April 1994 O'Reilly and Folkman filed a patent application wherein they disclosed and claimed the discovery of the protein known as angiostatin that inhibits the proliferation of blood vessels. Entitled "Angiostatin Protein," the patent issued in June 1997 (United States Patent No. 5,639,725). Angiostatin, presently in phase I clinical trials, is part of a larger protein commonly known as plasminogen which contains five distinct regions known as "Kringles" and one non-Kringle region known as the protease domain. Angiostatin consists of Kringles 1 through 4 of plasminogen and does not include Kringle 5.

Thereafter, O'Reilly concentrated his research in the area of in vitro testing of Kringles 1 through 4 on mice tumors. Meanwhile, in 1994 and 1995 Cao proceeded to investigate the anti-angiogenic effects of plasminogen fragments including Kringle 5. In order to do so, however, he needed plasminogen fragments in addition to those he prepared himself. Accordingly, in or around April 1994 Cao asked Davidson, a research biochemist at Abbott, if he could provide fragments of human plasminogen for Cao's research at Children's Hospital.

In late May 1994 Davidson supplied Cao with approximately 750 milligrams of human plasminogen. At the time, Davidson did not request a confidentiality agreement or otherwise indicate that the fragments were proprietary to Abbott. In March 1995, again without a confidentiality agreement, Davidson furnished Cao with one milligram of recombinant Kringle 1.

In early June 1995 Davidson sent Folkman a confidentiality agreement ("CDA") signed by Abbott.5 Back dated to April 1995, the CDA attached to the complaint and the amended complaint contains no revisions, underlinings or markings by Christopher Dippel ("Dippel"), an officer in Children's Hospital's Technology Transfer Office. The first sentence of the CDA provides that, "Subject to the full execution of this Agreement," Abbott will provide the Kringle fragments.6

The broad language of the CDA contains a provision stating that Children's Hospital "agrees that any ... inventions ... made or developed independently by Abbott or by [Children's] Hospital ... as a result of exposure to Abbott's [Kringle fragments] ... shall be promptly disclosed to Abbott and shall be the sole property of Abbott." (Amended Complaint ("AC"), No Docket Entry No. Assigned, Filed Dec. 3, 2001, Ex. B, ¶ 5). The CDA also includes a provision giving Abbott a six month period to exercise an exclusive option to purchase the Children's Hospital's share of any joint invention resulting from studies at Children's Hospital utilizing the Kringle fragments from Abbott. In short, the CDA strongly favored Abbott and disfavored Children's Hospital.

When Folkman received the CDA, he signed it without reviewing it in any detail and forwarded it to the Technology Transfer Office. Dippel reviewed the agreement, determined it was unacceptable to Children's Hospital and, as a result, never signed the CDA or returned it in an executed form to Abbott. Rather, he made various revisions, underlinings and markings on the CDA.7

By letter dated July 5, 1995, Dippel sent Davidson an alternate proposal based on the Uniform Biological Materials Transfer Agreement ("the UBA"). The cover letter advised Abbott that the UBA would be Children's Hospital's "version of an agreement for" the transfer of the material from Abbott. In sharp contrast to the CDA, the UBA proposed that Children's Hospital would be "free to file patent applications" and claim inventions through the use of the material supplied by Abbott.

Meanwhile, on June 22, 1995, Davidson sent Cao samples of Kringle 1, Kringle 1-3 and Kringle 1-4 as well as recombinant mini-plasminogen. CMCC did not inform Abbott that the CDA was not acceptable before Davidson sent these fragments to Cao. Nor did CMCC ever return these or other fragments received from Abbott.

In mid-October 1995, Davidson sent Cao additional samples of Kringle fragments, including a novel Kringle 5. This novel Kringle 5 was the first Kringle 5 that Folkman's laboratory received from any source. In return, Cao continued to share experimental results with Davidson in the summer and fall of 1995.8

In November 1995 Davidson's supervisor, Jack Henkin ("Henkin"), wrote to Folkman and proposed a "gentlemen's agreement" under which Davidson would supply Children's Hospital with Kringle fragments "with the understanding that the techniques and knowledge of [Folkman's] lab would be readily available to us." Henkin also suggested allowing Davidson to visit Folkman's lab. Shortly after receiving the letter, Folkman telephoned Henkin and declined the proposal.

In December 1995 a provisional patent application naming Folkman and Cao as inventors9 was filed on the use of Kringle 5 to inhibit endothelial cell growth. At the time, the only Kringle 5 fragment tested was the novel Kringle 5 provided by Davidson. The application eventually issued as United States Patent No. 5,854,221 ("the '221 patent") on December 28, 1998, with CMCC as the assignee. Entitled "Endothelial Cell Proliferation Inhibitor and Method of Use," the '221 patent claims, inter alia, a method of inhibiting endothelial cell proliferation in vitro by administering a Kringle 5 peptide and a method of treating an individual with an angiogenesis mediated disease with a Kringle 5 peptide.10

In January 1996 Abbott sent Folkman two copies of a different Confidential Disclosure Agreement ("CDA-2") signed by an Abbott official. CDA-2 proposed that Abbott supply Children's Hospital with Kringle 5 fragments, Kringle 5 peptides and proprietary information relating to angiogenesis inhibitors. Under CDA-2, "Information and any developments materially based thereon are and shall remain the sole property of Abbott and [Children's Hospital] will assert no patent, copyright or other claim to such information or developments." (Docket Entry # 175, Ex. D).

In a letter dated February 1, 1996, Dippel rejected the proposal and informed Abbott that "there is some misunderstanding between the two parties." (Docket Entry # 175, Ex. E). Dippel, in turn, asked Abbott to send him a materials transfer agreement under which Children's Hospital...

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