Pitt researcher Kolls reverses stance on vaccine patent
June 5, 2013 8:00 AM
Jay Kolls in 2004.
By Mark Roth Pittsburgh Post-Gazette
Two months after he denied using research from another lab to seek a patent on a potential vaccine, University of Pittsburgh researcher Jay Kolls reversed course, writing a letter admitting that some of the ideas and material that led to the application may have come from the lab of Pitt scientist Karen Norris.
The September 2012 letter, a copy of which has been obtained by the Pittsburgh Post-Gazette, was written to John Runnels, a Baton Rouge, La., patent attorney representing Louisiana State University Health Sciences Center, where Dr. Kolls was located when he filed the patent application.
Patent law requires any information that would affect the validity of a patent to be shared with the U.S. Patent Office, but there is no indication that the letter has yet been sent to the agency.
The dispute involves research on a sometimes fatal lung infection known as pneumocystis, which is a particular threat to people whose immune systems have been suppressed, such as HIV patients, organ transplant recipients, those with chronic lung infections and people undergoing cancer treatment.
The patent application, first filed in January 2010 by Dr. Kolls and fellow researcher Mingquan Zheng, is for a vaccine that would be based on a particular fragment of the pneumocystis fungus.
While Drs. Kolls and Zheng filed the application when both were working at LSU, they moved back to Pittsburgh together in September 2011, when Dr. Kolls took over as director of the new Richard King Mellon Foundation Institute for Pediatric Research at Children's Hospital of Pittsburgh of UPMC.
Dr. Norris, a Pitt immunology professor, raised her complaints about the misuse of her lab's research around the same time, and in November 2011, Pitt medical school dean Arthur Levine found Dr. Kolls guilty of misconduct and ordered him to remove himself from work on two federal grants and to try to add Dr. Norris as a co-inventor on the patent, according to a letter obtained by the Post-Gazette.
It had been unclear until the letter to Mr. Runnels surfaced whether Dr. Kolls tried to comply with the co-inventor request.
Now that it appears he did ask to add her name to the patent nearly a year after the misconduct findings, the questions are: Why hasn't anyone at either Pitt or LSU sent the document to the U.S. Patent Office, and why hasn't the patent been amended to add her name?
Pitt spokeswoman Anita Srikameswaran said late Tuesday that university officials did know about Dr. Kolls' letter and knew that it had been sent to Mr. Runnels last year. She said "it is unlikely that anyone from Pitt notified the Patent Office of the letter, because the patent application was filed by LSU and not Pitt."
As to why Dr. Norris has not yet been added to the patent, she said that "we have retained independent counsel to assess whether or not Professor Norris or others in her lab are legally entitled to be added to the patent application. If that assessment is positive, it should strengthen her case."
LSU officials did not respond Tuesday to questions on the patent issue.
Andrew Cornelius, a Pittsburgh patent attorney who is not involved in the case, said that if the inventors or the patent attorney in a case fail to provide information that could affect the validity of a patent to the Patent Office, it not only can invalidate a patent, but can lead to sanctions against patent attorneys and agents, and even potential loss of their licenses.
On the other hand, he noted that the inventors or the patent attorney can provide the information anytime before the patent is issued, so the fact that the 8-month-old letter has not been sent does not mean they have violated the law yet.
At the same time, he said, "I can say that, in general, if an inventor gives detailed facts to their patent attorney that call inventorship into serious question, probably to be safe, that [letter] is something that should be disclosed to the patent office."
Dr. Norris, reached by phone Tuesday, said "I was told by university officials that a letter was written by Dr. Kolls that could affect inventorship and that it was received by LSU, and I would be informed of their response, and that was last October. I have had no information on the disposition of the letter since."
Dr. Kolls himself did not respond to questions on the matter.
A key part of the scientific dispute has been Dr. Norris' contention that some of the research Dr. Kolls cited in his patent application and federal grant requests was drawn from unpublished work by her doctoral student, Heather Kling, and that Dr. Kolls had access to that information because he sat on Dr. Kling's dissertation committee.
In the letter he wrote to Mr. Runnels, Dr. Kolls acknowledged that Dr. Kling was the first to show that monkeys had an immune response to a part of the pneumocystis fungus known as "mini-kexin," and that it helped to prevent infections in monkeys that had a simian version of HIV.
"It is definitely possible that the interactions we had with Dr. Norris and possibly my service on Heather Kling's committee, in hindsight, influenced our work," he wrote. "Thus, I am recommending that the patent application be amended to add Dr. Norris as an inventor."
He also backed away from statements he had made that he and Dr. Zheng had independently developed a vaccine based on this "mini-kexin" fragment, writing that "the development of this invention was possibly influenced by interactions [with] and the ongoing work of the Norris lab. I concede this point."
While Dr. Norris told Pitt officials in 2012 that she believed she, Dr. Kling and another lab member, Siobhan Guyach, should all be added as inventors, Dr. Kolls' letter recommends adding only Dr. Norris.
The long-running dispute eventually led last year to the appointment of a high-level Pitt faculty committee to investigate Dr. Kolls' actions. That committee has not yet finished its work.
The dispute also involves a company that was started by Dr. Kolls to develop a pneumocystis vaccine based on his and Dr. Zheng's patent. Officials from that New Orleans firm, MiniVax, have declined to comment on how news of the patent arguments might affect its future.