A 4-year-old dispute at the University of Pittsburgh over who came up with the idea for a lung infection vaccine may finally be winding to a close.
On Thursday, the U.S. Patent and Trademark Office ruled that two of the four doctors listed on Pitt’s patent application did not qualify as inventors or discoverers of the biological substance being used as a basis for a vaccine against pneumocystic pneumonia, a deadly infection for those with suppressed immune systems, such as organ transplant recipients and HIV and cancer patients.
The patent office said Jay Kolls and Mingquan Zheng, who originally filed the patent application in 2010 when they were based at Louisiana State University, “did not invent the claimed subject matter.” The patent office said there was clear evidence that the vaccine idea and the original work on it had come from Pitt researchers Karen Norris, an immunology professor, and Heather Kling, a postdoctoral student in her lab.
“It is clear,” the ruling said, “that Norris and Kling were involved in the conception of the pneumocystic fragments” used to produce an immune response in laboratory animals, and that “the primate data” cited in the patent documents “came from the Norris laboratory.”
In 2011, Dr. Norris complained to Pitt officials that Dr. Kolls and Dr. Zheng, who had moved to Children’s Hospital of Pittsburgh of UPMC from Louisiana State, had falsely claimed they did the monkey research that was the basis for seeking a patent on a pneumocystis vaccine. She contended that the Kolls-Zheng lab had received samples of the pneumocystis protein cited in the patent documents from her lab; that the Kolls-Zheng lab never worked with monkeys, only mice; and that Dr. Kolls had learned about details of her lab’s research when he served as a member of Dr. Kling’s dissertation committee.
In response, Arthur Levine, Pitt’s senior vice chancellor for health sciences, ruled that Dr. Kolls had been guilty of research misconduct, and said he should withdraw his name from federal grants being used for that research, and should seek to add Dr. Norris’ name to the patent application.
When Dr. Kolls failed to add her name, Dr. Norris sought a university investigation. That was carried out by a faculty committee, which ruled in 2013 that even though the Norris lab had made the original discovery of the protein fragment cited in the patent application, it could not determine whether Dr. Kolls and Dr. Zheng had engaged in outright misconduct. Instead, the panel said, the two physicians were guilty of “research impropriety.”
Ironically, the patent office cited the Pitt faculty committee’s own report as the primary basis for ruling against Dr. Kolls and Dr. Zheng on the patent application. “The threshold question in determining inventorship is who conceived the invention,” the office said. “Unless a person contributes to the conception of the invention, he is not an inventor.” The “evidence appears to indicate that Kolls and Zheng do not meet the requirements of inventorship.”
The patent office gave Pitt, which is the lead party in the application, until Dec. 10 to respond to the decision. Pitt released a statement Friday saying it “appreciates the detail and attention the [patent office] is devoting to the careful evaluation of this patent application,” but “would continue its vigorous pursuit of the patentability of the remaining claims, in support of the science and each of the four named inventors.”
Pitt spokesman Ken Service said that meant the university would submit evidence advocating for inventor rights for all four scientists, and then let the patent office make the final decision.
In January 2014, Dr. Norris and Dr. Kling filed a federal lawsuit seeking the patent rights to the pneumocystis vaccine. Action on that suit has been delayed, pending the patent office’s findings. The two women also filed a separate patent application of their own, which the patent office has not yet ruled on.
Dr. Norris declined comment on the patent office findings, and neither patent officials nor Dr. Kolls and Dr. Zheng could be reached for comment.
Mark Roth: email@example.com, 412-263-1130 or on Twitter @markomar
First Published September 11, 2015 3:18 PM