Legal battle not over, experts say
Patent rights, belonging to a Wisconsin academic foundation, to grow human
embryonic stem cells were affirmed, but narrowed, by a federal agency
this week.
The technology is seen by many as a key to treating such incurable diseases as Parkinson’s, Alzheimer’s and multiple sclerosis.
Control
of the technology is critical for companies such as those in San Diego
County’s large biotech community that aim to turn research into
therapies. Biotech scientists say that the patents, assigned to the
Wisconsin Alumni Research Foundation, could hold back embryonic stem
cell research. The foundation insists it is simply trying to protect
its financial interests.
The U.S. Patent and Trademark Office
upheld the main claims of two patents to the technology Tuesday. A
related patent was also upheld on Feb. 25.
The foundation says
it does not want to inhibit research and is willing to license its
technology. However, Larry Goldstein, head of UC San Diego’s stem cell
research program, said that the foundation had demanded overly strict
licensing terms that would discourage companies from turning research
into products.
Goldstein said the foundation has eased up lately
on its demands, due to an uproar from the scientific community and the
legal wrangling.
The so-called "WARF patents" were challenged as
obvious, nonpatentable technology, said Jeanne Loring, a researcher
from San Diego County’s large stem cell science community. Loring and
the Santa Monica-based Foundation for Taxpayer and Consumer Rights
filed the patent challenge.
Despite the decision, the patents
are still vulnerable, said Loring, director of the Center for
Regenerative Medicine at The Scripps Research Institute in La Jolla.
"The
patent office has made WARF narrow their claims considerably," Loring
said. For example, technology to make embryoniclike stem cells from
skin cells is not covered by the patents, she said.
The Wisconsin foundation said in a news release that the patent decisions are "final and cannot be appealed."
However, Loring disagreed.
"We
have a great deal of evidence that we didn’t use in our first request
to revoke the patents," Loring said. "For one of them, we can directly
file an appeal, and we will do so. For the other two, we need to put in
our new information and ask for re-examination."
Evan Snyder, a
leading stem cell researcher at the Burnham Institute in La Jolla, said
that the patents, if finally upheld, would inhibit translating research
into therapies.
The patents can be appealed at two levels, said
Lisa A. Haile, a biotech intellectual property attorney who said she
has clients on both sides of the issue.
The decision can be
appealed to the patent office’s Board of Patent Appeals and
Interferences, she said. And, a board decision can be appealed to the
federal district court, said Haile, a partner at DLA Piper’s San Diego
office.
"This still has a long life in it," Haile said of the patent challenge.
Even
if the core patent claims are ultimately upheld, Haile said, it’s not
certain that they will cover technologies that now exist for deriving
embryonic stem cells.
"Who knew back in 1998 when they filed
these applications that you could reprogram adult stem cells to look
like human embryonic stem cells," Haile said. "Nobody knew that."
Another biotech intellectual property attorney, Cathryn Campbell, agreed that the decision could be appealed.
Media
reports that the decision is final are "incorrect," said Campbell, who
is with the San Marcos office of Needle & Rosenberg.
"Why
the press has gotten that wrong is that it’s called a ‘final office
action,’ " Campbell said. "That means they’re done with this stage of
it, when it’s in front of the examiner for re-examination. But now the
decision of each examiner on the three patents can be appealed."
The two patents examined in the new decision are numbers 5,843,780 and 6,200,806. The first patent is 7,029,913.
— Contact staff writer Bradley J. Fikes at (760) 739-6641 or [email protected].
