|[April 06, 2012]
University of Kansas Researchers Win Co-Inventorship Dispute over Cancer Drug Formulation Patents
MCLEAN, Va. --(Business Wire)--
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.
"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, th 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
"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.
Pillsbury has handled patent and trademark litigation since 1893. Now,
with more than 90 IP practitioners firmwide, Pillsbury advises clients
on developing successful and comprehensive IP strategies by protecting,
managing, asserting, defending and leveraging their IP assets. The IP
team spans a number of offices and countries, with team members in
Northern Virginia, San Francisco, Silicon Valley, Los Angeles, Houston,
Washington, DC, New York, San Diego, Sacramento, Tokyo and London.
Domestically, Pillsbury has advocated for clients in 77 of the 94 U.S.
district courts, as well as before the ITC in Section 337 cases, the
International Chamber of Commerce and the World Intellectual Property
Organization. Pillsbury's IP lawyers have a wide range of advanced
scientific and technical degrees in areas including electrical and
mechanical engineering, chemistry, biology, physics and a number of
other technical disciplines.
About Pillsbury Winthrop Shaw Pittman LLP
Pillsbury is a full-service law firm with a keen industry focus on
energy & natural resources, financial services, real estate &
construction, and technology. Based in the world's major financial,
technology and energy centers, Pillsbury counsels clients on global
regulatory, litigation and corporate matters. We work in
multidisciplinary teams that allow us to anticipate trends and bring a
360-degree perspective to complex business and legal issues-helping
clients to take greater advantage of new opportunities and better
mitigate risk. This collaborative work style helps produce the results
our clients seek.
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