Penn sues St. Jude in cancer treatment controversy

The lawsuit is the third in a dispute over a research partnership

· March 31, 2013, 10:34 pm

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The University of Pennsylvania and St. Jude Children’s Research Hospital have been embroiled in two lawsuits related to “groundbreaking” research conducted by Penn professors.

On March 22, the University filed suit in the United States District Court of Eastern Pennsylvania against St. Jude in the matter of a patent issued to St. Jude on March 19, which Penn claims is invalid. This marks the third court action relating to Penn professor of immunotherapy Carl June’s research into cancer treatments.

Current action

The most recent suit pertains to patent 8,399,645, for a cancer treatment method— one inventor of which was Dario Campana, member of the Hematology-Oncology and Pathology departments at St. Jude — which was issued to St. Jude on March 19. In its filing with the court, Penn asserted that it did not violate the terms of this patent and is seeking a judgment not only affirming this claim but also invalidating the patent itself.

In an official statement, St. Jude said it is “confident in the validity of the recent patent” and that it is “committed to sharing its research discoveries to stimulate other discoveries benefitting children and adults.”

The statement also noted that St. Jude provided Penn with “an innovative molecular receptor now covered by this patent.”

Clinton Hermes, senior vice president and chief legal officer of St. Jude, said in an email that Penn’s March 22 complaint “does not state any specific facts to support [the] contention” that St. Jude’s patent is “invalid and unenforceable.”

Vice President for University Communications Stephen MacCarthy said in an email, “We disagree and fully expect to prevail.”

Both the University and St. Jude declined to comment further on this case due to their policies not to comment on pending litigation.

Litigation history

The current dispute stems from a partnership between June and Campana that began in 2003.

In December of that year, Penn and St. Jude signed a materials transfer agreement allowing June access to what Penn’s complaint refers to as the “Campana construct.”

The University’s 2012 complaint alleged that June and his colleagues conducted research that led to the creation of a new construct for cancer treatment — the “June construct.”

The three collective court actions between St. Jude and Penn pertain to a variety of issues related to these constructs and the MTA between the University and St. Jude, including whether the MTA was violated and, more recently, if St. Jude’s patent is valid.

The first action was brought by St. Jude on July 11, 2012, when it filed a complaint against Penn in the U.S. District Court of Western Tennessee regarding the alleged violations of two MTAs between St. Jude and Penn relating to June’s research.

St. Jude also contended in the complaint that Penn was seeking to commercialize the research through discussions with the venture capitalist firm Kleiner Perkins Caufeild & Beyers, and that a paper published by June in The New England Journal of Medicine failed to properly credit St. Jude researchers for their work.

Eight days later, Penn filed the second related action against St. Jude. The suit, which was brought in Pennsylvania rather than Tennessee, maintained that June’s research construct was different than that of Campana.

The University also argued that it had terminated the 2003 MTA with St. Jude in November of 2011 and that St. Jude’s July 11 suit attempted to “unlawfully interfere with the University’s prospective transaction by filing a baseless lawsuit.” The University also claimed that Pennsylvania was the proper jurisdiction for this case.

On Oct. 10, St. Jude’s Tennessee complaint was transferred to Pennsylvania by court order due to a jurisdictional determination by the Tennessee judge. According to court dockets from the Pennsylvania action, the two cases were consolidated on Oct. 19.

June declined to comment based on the advice of University counsel. Campana deferred comment to St. Jude’s general counsel, Hermes.

The University is asking for a trial by jury for the March 22 complaint.

‘Groundbreaking’ work

The research under dispute has the potential for successful cancer treatments, according to Research Assistant Professor of Pathology and Laboratory Medicine Daniel Powell.

Powell explained that this process begins when “the blood is drawn from the patient [through a process] called leukopheresis, wherein white blood cells are selectively harvested from the peripheral blood.”

He said that the white blood cells are then genetically modified to express a certain receptor, which allows the cells to bind a protein found on the surface of some types of leukemia.

The patient’s own cells are re-injected into them after the process, Powell added.

“Under clinical investigation, some patients are experiencing complete tumor elimination,” Powell said.

On March 25, June and some of his colleagues blished a paper on the effects of the clinical trial indicating that acute lymphoid leukemia was treated and nearly eliminated in two female subjects. This builds upon June’s previous 2011 research, which showed cancer regression in chronic lymphoid leukemia.

This field of immunotherapy “holds amazing promise for the effective treatment of a variety of advanced cancer types in patients,” Powell said.

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