Pitt seeks to add researchers to disputed patent application

Action marks first time university has given two immunologists direct credit for work on vaccine

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The University of Pittsburgh is asking the U.S. Patent Office to add the names of researchers Karen Norris and Heather Kling to a controversial patent application for a vaccine against a deadly lung infection.

In papers filed this week, Pitt attorneys asked that the two immunologists join researchers Jay Kolls and Mingquan Zheng on the application for a vaccine against pneumocystis, a lung disease that can be fatal for people with HIV or others whose immune systems have been suppressed.

Pitt also is taking over the legal work on the patent process from Louisiana State University, where Drs. Kolls and Zheng were based when they first sought the patent, before both returned to Pitt in 2011.

The action on the application marks the first time Pitt has taken direct steps to give Dr. Norris and Dr. Kling credit for their work in developing the vaccine.

It comes nearly two years after Dr. Norris first accused Drs. Kolls and Zheng of misusing research that she and Dr. Kling had developed in their monkey lab at Pitt.

Specifically, she charged that the two doctors, who are based at Children's Hospital of Pittsburgh of UPMC, had falsely claimed in federal grant documents that they had been collaborating with her lab on the monkey research and then falsely claimed in the patent application that they had actually done the monkey experiments.

The new patent paperwork also comes a little more than month after a faculty committee at Pitt concluded that Dr. Kolls was not guilty of research misconduct for his actions but was guilty of "research impropriety."

While this week's action seems to partly support Dr. Norris' contention that her lab was the first to develop the biological basis for the pneumocystis vaccine, it also raised some new questions.

For one thing, it is not clear whether LSU would stand to benefit if the patent were granted and there were any revenues from it. Pitt spokesman Ken Service said he did not know, and LSU officials could not be reached for comment.

In the official statement released by Pitt, the university also said it had asked for a four-month extension from the Patent Office in "a good faith effort by Pitt to preserve the rights of all concerned until a thoughtful decision can be made on whether to continue prosecution of this patent application."

"Prosecution" is a technical term meaning an organization is pursuing a patent, and the statement suggests that Pitt might eventually decide to withdraw the patent application altogether.

The Pitt move also raises questions about the status of a company that Dr. Kolls helped found to commercialize the pneumocystis treatments.

MiniVax, which was started with federal grant money and is centered in New Orleans, says on its website that it hopes to develop both a vaccine to prevent pneumocystis and a direct treatment for those already infected by the fungus. Officials there could not be reached for comment Friday.

Dr. Norris declined to comment on the latest developments, but her attorney, James Beasley of Philadelphia, said the Pitt action "is a good first step for Dr. Norris and Dr. Kling."

"I hope that this is a signal that we can make this [patent process] work for Drs. Norris and Kling, because they want to make this right."

In its June report, the Pitt faculty committee said statements in the current patent application in which Drs. Kolls and Zheng say they carried out certain monkey experiments were clearly false, but it blamed the misstatements on LSU patent attorney John Runnels, who no longer appears to be involved with the patent.

The new patent attorney representing Pitt is Steven Lendaris of Baker Botts, a New York intellectual property law firm.

Another lawyer in that firm, Lisa Kole, recently finished an analysis of the patent for Pitt, and the request to add Drs. Norris and Kling seems to be based on her conclusions about the invention of the vaccine.

The key piece of research involved in the dispute has been a 100-amino acid segment of the outer coat of the pneumocystis fungus that has been used to trigger immune reactions in laboratory animals.

Both the Norris and Kolls labs contended they had developed the segment, known as "mini-kexin," on their own, the Norris lab in rhesus monkeys and the Kolls lab in mice.

Dr. Norris contended that there was no evidence to support the idea that Dr. Kolls' lab had cloned this protein segment on its own, but the Pitt faculty committee concluded that there were research documents showing that the Kolls lab had been able to carry that out in mice.

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Mark Roth: mroth@post-gazette.com, 412-263-1130 or on Twitter @markomar.


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