The federal government has upheld two more UW-Madison stem-cell patents, meaning all three patents under contention can stand.
But expected appeals on one of the patents could linger for years. And the government review caused the university to narrow some patent claims and loosen its licensing policies, the patent challengers say.
The Wisconsin Alumni Research Foundation, UW-Madison’s tech-transfer organization, holds the patents, based on work by campus stem-cell pioneer James Thomson. The patents essentially cover all human embryonic stem-cell research in the country.
WARF, which has earned more than $3.2 million from patents, stands to gain many millions more. Scientists are using the cells to better understand and develop possible treatments for diabetes, Parkinson’s disease and other conditions.
The U.S. Patent and Trademark Office’s decision to uphold the two patents, announced Tuesday, was made last week. The patent office upheld the third patent last month.
"This is a home run," said Carl Gulbrandsen, managing director of WARF. "I said from the beginning that we feel they were patentable inventions and that we would ultimately prevail."
Dan Ravicher, executive director of the New York-based Public Patent Foundation, said he would appeal last month’s ruling in the patent office — and, if necessary, in federal court. This month’s decision on the two patents can’t be appealed.
Ravicher’s group and the California-based Foundation for Taxpayer and Consumer Rights challenged the patents in 2006, prompting the patent office review. Ravicher said the groups have scored victories by forcing WARF to narrow the patent claims and waive licenses and fees for noncommercial stem-cell research.
"We’re in the second quarter of the game and about to go into halftime," he said. "We’ll see what happens next."
WARF has said its decision last year to stop requiring scientists at universities and nonprofit organizations to buy licenses at up to $400,000 had nothing to do with the patent challenges. WARF also started allowing scientists to share stem cells, meaning some could forgo a $500 access fee.
The patent claim changes were made in response to the patent office review, Gulbrandsen said. But they are relatively minor, amounting to a "clarifying" of the claims and not a narrowing of them, he said.
The main change specifies that the cells covered by the patents come from pre-implantation embryos. That means the patents don’t cover certain specialized cells, such as germ stem cells or cancer stem cells.
"We never intended to have our claims cover" those kinds of cells, Gulbrandsen said.
Grady Frenchick, a Madison patent lawyer who has done work for WARF but not involving stem cells, said even though some claims were slightly altered, the patent office’s decision strengthens the patents.
The patent office, which issued the patents in 1998, 2001 and 2006, has now reviewed but rejected the arguments raised by the challengers, Frenchick said.
The challengers said Thomson followed the recipe of other scientists in 1998 when he became the first scientist in the world to grow a colony of human embryonic stem cells. He did the same things with primate stem cells three years earlier.
"If you’re a (patent) infringer," Frenchick said, "you’re really going to have think hard about what you’re doing because the patent office has now blessed these patents twice."
Appeals over the third patent, which underwent a new kind of review that allows more input from challengers, could take two or three years, Frenchick said.
For the other two patents, "things will pretty much return to normal now," he said.
All three patents expire in 2015.
WARF has some nine other stem-cell patents and about 45 applications for patents involving stem-cell research that are pending.
Thomson gained international attention again in November when his UW-Madison team reported having triggered human skin cells to revert to their embryonic state. Those cells could someday replace the patent-protected stem cells,
derived from embryos about five days old.
What’s new: The U.S. Patent and Trademark Office upheld two UW-Madison stem-cell patents; it upheld a third one last month.
What it means: The Wisconsin Alumni Research Foundation, which holds the patents, can continue requiring companies to buy licenses to use the cells.
What’s next: Foundations from New York and California, whose challenge in 2006 led to the patent office review, vow to appeal. Court action could take years.