Trustees of the University of Pennsylvania v. St. Jude Children's Research Hospital

982 F. Supp. 2d 518, 2013 WL 5996864, 2013 U.S. Dist. LEXIS 162010
CourtDistrict Court, E.D. Pennsylvania
DecidedNovember 13, 2013
DocketCivil Action Nos. 12-4122, 13-1502
StatusPublished
Cited by12 cases

This text of 982 F. Supp. 2d 518 (Trustees of the University of Pennsylvania v. St. Jude Children's Research Hospital) is published on Counsel Stack Legal Research, covering District Court, E.D. Pennsylvania primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

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Trustees of the University of Pennsylvania v. St. Jude Children's Research Hospital, 982 F. Supp. 2d 518, 2013 WL 5996864, 2013 U.S. Dist. LEXIS 162010 (E.D. Pa. 2013).

Opinion

MEMORANDUM

DALZELL, District Judge.

I. Introduction

These actions concern the nature of an immunotherapy for cancer treatment that Dr. Carl June, M.D., Director of the Translational Research Program and a professor at the University of Pennsylvania (“the University” or “Penn”), developed. The parties’ claims sound in patent and contract law, and the dispute centers on the question of whether Dr. June’s immunotherapy (the “June Construct”) contains “material” within the meaning of two Materials Transfer Agreements the University executed with St. Jude Children’s Research Hospital (“St. Jude”).

We here consolidate the earlier contract action (C.A. No. 12-4122) and the later patent action (C.A. No. 13-1502) and consider St. Jude’s motion for partial summary judgment in the contract action and [521]*521Penn’s partial motion to dismiss St. Jude’s counterclaims in the patent action.1 We also consider St. Jude’s motion for a separate trial. For the reasons discussed herein, we will deny in part the motion to dismiss, deny the summary judgment motion, and deny the motion for a separate trial. We will then set a schedule for discovery and trial.

II. Procedural History

On April 12, 2013, we issued an opinion in which we detailed the procedural and factual history of this dispute. Trustees of Univ. of Pennsylvania v. St. Jude Children’s Research Hasp., 940 F.Supp.2d 233 (E.D.Pa.2013). Because those histories guide our consideration of the instant motions, and because the parties’ recent submissions provide more information about the facts giving rise to the conflict, we will rehearse the procedural history briefly and the factual history in detail.

On July 11, 2012 St. Jude filed a breach of contract action against the University in the Western District of Tennessee seeking injunctive relief and damages on the ground that the University had breached two Materials Transfer Agreements (“MTAs” or “Agreements”) the parties had executed. Apr. 20, 2013 Mem. at 6-7.

Eight days later, the University filed a breach of contract action here. It then submitted an amended complaint in that action in September of 2012.2 On October 10, 2012 the United States District Court for the Western District of Tennessee transferred the St. Jude case to this District pursuant to 28 U.S.C. § 1404(a), and we consolidated the actions.

On March 19, 2013, the United States Patent and Trademark Office issued U.S. Patent No. 8,399,645, (the “'645 patent”) entitled “Chimeric Receptors with 4-1BB Stimulatory Signaling Domain” to St. Jude. Three days later the University filed a separate action in this Court seeking a declaration that it was not infringing on that patent and that the patent was invalid, see C.A. No. 13-1502, Comp. ¶¶ 9, 34-39. St. Jude moved to dismiss, and on June 10, 2013 the University filed an amended complaint in which it again sought our declaration of its non-infringement and the patent’s invalidity. See C.A., No. 13-1502, Am. Comp. ¶¶ 34-39.3

St. Jude filed an Answer and Counterclaims, asserting that Penn is infringing and contributorily infringing on the '645 patent by using and commercializing the June Construct, and that this infringement is willful. Through its counterclaims St. Jude seeks a judgment in its favor in C.A. No. 13-1502, a declaration that the patent is valid and enforceable and that Penn is infringing upon it and that such infringement has been willful and deliberate. It also seeks an injunction from further infringement or contributory infringement, [522]*522and damages. See C.A. No. 13-1502 Counterclaims ¶¶ 22-34. Penn moves to dismiss the willful infringement claim. See C.A. No. 13-1502 Penn MTD.

When the University filed the patent action, we directed the parties to show cause why we should not consolidate it with the contract action, see C.A. No. 13-1502, Docket No. 4. The University responded that it did not oppose consolidation, see April 26, 2013 epistolary submission. St. Jude responded by submitting a motion for partial summary judgment and positing that by the time the parties had submitted briefing in the patent case the contract case might be resolved by summary judgment. St. Jude Resp. to Order to Show Cause.

As an alternative to summary judgment, St. Jude moved for a separate trial on “[t]he question of whether the June Construct incorporates and was made with Material” under the MTAs. St. Jude MSJ at 23.

We thus consider here our initial suggestion of consolidation, the University’s motion to dismiss St. Jude’s counterclaim for willful infringement, and St. Jude’s motion for partial summary judgment or, in the alternative, a separate trial.

III. Factual History

This action between the University and St. Jude concerns two MTAs between the parties, the “2003 MTA” and the “2007 MTA”. We will describe the undisputed facts as the parties have presented them.4

A. The Campana Construct

The MTAs arose out of immunotherapy research Dr. Dario Campana and Dr. Chihaya Imai5 conducted at St. Jude. In the early 2000s Dr. Campana developed a protein molecule called an “anti-CD19 chimeric antigen receptor” (“CAR”). Through a genetic process we will recount below, Dr. Campana inserted the CAR into T cells, a type of white blood cell that directs immune responses and attacks infected or cancerous cells.6 One end of the CAR protruded from the T cell, enabling it to latch onto a tumor cell “antigen.” St. Jude MSJ at 4 (citing Declaration of Dr. John Gray, Ex. to St. Jude MSJ, at ¶ 6). When the T cell connected with the antigen, the other end of the CAR directed the T cell to “attack and destroy” the target cell. Id.

Dr. Campana reproduced this result by developing a cDNA, a DNA7 molecule con-[523]*523taming a nucleotide8 sequence encoding the structure of the CAR, and inserting it into the DNA of a T cell. Thus, when the T cell replicated, the new T cells also included the CAR. Id. Through this process Dr. Campana “creat[ed] a population of T cell progeny that can be used to treat CD19+ B-cell cancers, such as acute and chronic leukemia and non-Hodgkin’s lymphoma”. St. Jude MSJ at 5. In order to insert the CAR-encoded cDNA into the T cell DNA, Dr. Campana used a “retroviral ‘vector’ ” as a “molecular delivery vehicle”. Id.

Dr. Campana presented his findings at an American Society of Hematology conference in San Diego, California, in December of 2003. St. Jude MSJ at 5; Penn Opp. at 3. After the conference, Dr. June wrote to Dr. Campana saying,

Your data at ASH with the CD19 ScFv was striking. I was wondering if you might want to have an inter-institutional collaboration to test this? ... I think that retroviruses are going to be problematic as vectors due to the leukemic risk, and the higher efficiency of the lentivirus is another reason making it attractive to switch.

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