KU researchers receive inventorship credit on NIH-owned Velcade patents

Pillsbury today announced that its clients, the University of Kansas (KU) and the University of Kansas Center for Research, Inc. (KUCR), a nonprofit corporation affiliated with KU, prevailed in a closely watched legal battle over cancer drug formulation patents after an arbitration panel ruled in KUCR's favor following years of litigation against the National Institutes of Health (NIH). The favorable arbitration outcome for KU and KUCR means that KU's University Distinguished Professor, Dr. Valentino Stella, and his laboratory assistant, Ms. Wanda Waugh, will receive inventorship credit on patents the NIH owns covering Velcade®, a highly successful medication for treating blood cancers. Dr. Stella and Ms. Waugh, while working under contract to NIH, co-invented crucial formulations that give Velcade® long-term shelf-life and stability, but they were never credited as co-inventors on the patents at issue (U.S. Patent Nos. 6,713,446 and 6,958,319), depriving them of recognition and legal entitlements under U.S. patent laws.

“This protracted dispute with the NIH serves as a cautionary tale for organizations pursuing breakthroughs in cutting-edge research under government contracts, whether in health care, defense, or other science and technology fields.”

"We are extremely pleased with this outcome for our clients, KU and KUCR, and two very deserving co-inventors who - after helping create a breakthrough cancer drug formulation - were denied credit for years following their integral, essential contributions," said Pillsbury Intellectual Property partner William P. Atkins, who led a team of Pillsbury IP attorneys including associate Christopher K. Dorsey, senior associate Benjamin L. Kiersz, partner George M. Sirilla, and partner Dr. John R. Wetherell representing KU and KUCR.

"KU, KUCR, Dr. Stella, and Ms. Waugh will finally receive the co-inventorship credit they are entitled to under the law." Atkins said. "This protracted dispute with the NIH serves as a cautionary tale for organizations pursuing breakthroughs in cutting-edge research under government contracts, whether in health care, defense, or other science and technology fields."

Atkins explained that, although certain provisions of the U.S. Federal Acquisition Regulation (FAR) governing federal contracts address IP rights and ownership, the FAR does not clearly address scenarios where both federal and contractor employees work together on a project and are co-inventors of a resulting invention. He noted that universities performing much of the government's research could find themselves in such scenarios and have much to lose if they are unaware of the regulations' nuances.

"Universities may not even realize they have been deprived of inventorship credit until after a patent at issue has been licensed to industry by the government, as in KUCR's case," Atkins added. "Given the complexity of multi-party research contracts in fields like pharmaceutical development, the lesson this case offers for contractors and academia is to be proactively aware of how your contributions are utilized, document your inventions for the agency before their patent applications are underway, and prepare to challenge mistakes."

Under a research agreement with the NIH's National Cancer Institute (NCI), Dr. Stella was asked to study innovative drug delivery methods for cancer patients. Dr. Stella, a tenured professor listed as an inventor on more than 33 patents covering treatments for AIDS, epilepsy and others, led KUCR's work on NCI's challenging assignment - formulating an effective anti-cancer treatment from a promising, but unstable, chemical compound. Dr. Stella and Ms. Waugh, who each had twenty plus years working on such complex drug formulation problems, devised a method that made the new medication stable - and therefore effective. Their breakthroughs led to NIH's 2001 patent application, which recited Dr. Stella and Ms. Waugh's formulation but listed the NCI's project officer as the sole inventor.

In 2002, the NIH exclusively licensed the patents to Millennium Pharmaceuticals, which developed and branded Velcade®. The drug brought in $83.5 million in the first quarter of 2008 alone. In May of 2008, Millennium was acquired for $8.8 billion by Takeda Pharmaceutical Co. Ltd. Realizing its inventors had been omitted, KUCR turned to Pillsbury. When the NIH denied KUCR's appeal for credit, Atkins' team filed a lawsuit against the NIH in November 2008 in the U.S. District Court for the District of Kansas seeking co-inventorship credit for Dr. Stella and Ms. Waugh. Millennium later intervened in the case on the side of NIH, along with Johnson & Johnson subsidiary Centocor Ortho Biotech Products LP (COBI), the company Millennium licensed to market Velcade® overseas. In 2010, the parties agreed to submit the case to binding arbitration.

Source Pillsbury Winthrop Shaw Pittman LLP