Two University of Pittsburgh researchers have filed a federal lawsuit against the university and two doctors, claiming they should get the sole intellectual property rights to research that could lead to a new lung disease vaccine.
Karen Norris, a Pitt immunology professor, and Heather Kling, a postdoctoral student in her lab, have said that their work with monkeys at Pitt led to the scientific basis for a vaccine against a lung disease known as pneumocystis.
The two have been involved in a long-running dispute with physicians Jay Kolls and Mingquan Zheng of Children's Hospital of Pittsburgh of UPMC, who had filed a patent application for a pneumocystis vaccine and claimed they did the work with monkeys that Dr. Norris said was carried out in her laboratory.
The Children's Hospital doctors also said they had achieved similar immune system results in mice, but Dr. Norris and Dr. Kling said in the lawsuit that the two doctors' laboratory notebooks do not bear that out.
The suit was filed in U.S. District Court late Monday and asked for a declaratory judgment in their favor. The lawsuit also names Louisiana State University, where Drs. Kolls and Zheng previously worked, and MiniVax, a company set up by the two doctors and others to commercialize the pneumocystis work.
In August, Pitt officials had asked the U.S. Patent Office to add Dr. Norris and Dr. Kling to the patent application while also seeking an extension of the application process that is set to run until mid-March.
James Beasley, the attorney for the plaintiffs, said he hopes a judge will act on the lawsuit before that deadline arrives, because there is a risk that the patent process will end altogether if the dispute over inventorship isn't resolved by then.
The lawsuit also notes that Dr. Norris and Dr. Kling have filed their own separate patent application seeking sole rights to the pneumocystis vaccine.
Pneumocystis can kill people who have suppressed immune systems, particularly those with HIV, organ transplant recipients and people with chronic lung diseases.
Mr. Beasley said he did not want to comment on the lawsuit, except to say that its timing was partly to preserve the scientific data in the case. "We just need to make sure that this data is protected, primarily for Karen and Heather, but also because this has enormous importance, because there are a large number of immuno-compromised people who could use this vaccine."
Pitt spokesman Ken Service said he could not comment on the lawsuit because the university had not yet received a copy of it. None of the doctors involved in the lawsuit could be reached for comment.
In September 2011, Dr. Norris accused Dr. Kolls of inaccurately claiming in two federal grant applications that he had collaborated with her on monkey research involving pneumocystis and of wrongly citing the research in the patent application he had filed with Dr. Zheng.
Two months after that, Pitt medical school dean Arthur Levine found Dr. Kolls guilty of research misconduct and ordered him to stop any involvement with the federal grants, one of which set up the Louisiana company MiniVax.
In July, a Pitt faculty committee that followed up on Dr. Levine's original probe found that Dr. Kolls was not guilty of research misconduct but was responsible for a lesser violation, research impropriety.
In its report, the committee said that after interviewing Dr. Norris, Dr. Kolls and Dr. Zheng, it was difficult to determine who first developed the idea of using a portion of the pneumocystis fungus known as "mini-kexin" as a potential vaccine or antibody treatment target.
The lawsuit, on the other hand, argues that all the key lab work on a potential vaccine was carried out in the Norris lab.
"These defendants were part of a continuing and deliberate scheme to steal the plaintiffs' data as their own, thereby enabling them to falsely claim entitlement to this unprecedented and lucrative vaccine," it charges.
"Dr. Kolls and Dr. Zheng abused their positions of trust," the suit continued, "to steal research data from Dr. Norris and Dr. Kling. Dr. Kolls and Dr. Zheng then used the purloined data to file fraudulent patent applications that listed themselves as the sole inventors ... commingling Dr. Norris' and Dr. Kling's legitimate data with data Dr. Kolls and Dr. Zheng fabricated to create the appearance of independent, successful work."
In earlier documents, the two immunologists said Dr. Kolls obtained some of the key information about the monkey research when he sat on Dr. Kling's dissertation review committee.
In August, Pitt officials added Dr. Norris and Dr. Kling to the pending patent application but did not remove Drs. Kolls and Zheng from it. The suit implies that Pitt was influenced by the fact that Dr. Kolls heads a lab at Children's Hospital funded with $23 million in private contributions by the Richard King Mellon Foundation.
"Even though [Pitt] ... was aware of this research misconduct, and that plaintiffs were the rightful sole inventors of the pneumocystis vaccine, Pitt, in a brazen display of intellectual dishonesty, made a Faustian bargain: because it had received a substantial Mellon Grant when Dr. Kolls returned to Pitt, and to avoid public embarrassment, Pitt knowingly misrepresented to the plaintiffs that it was going to correct the filings to identify the rightful inventors and remove the improper ones."
Both the Norris lab and the Kolls lab had worked over the past decade on developing treatments for pneumocystis, with the Norris lab focusing on experiments with macaque monkeys and the Kolls lab using mice.
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Mark Roth: firstname.lastname@example.org, 412-263-1130 and on Twitter: @markomar.
Mark Roth: email@example.com, 412-263-1130 and on Twitter: @markomar. First Published January 27, 2014 5:41 PM