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Stem cell patent battle continues

Opponents of a much-contested set of stem-cell patents are claiming victory with a decision from the US Patent and Trademark Office (USPTO), which declared one of the three patents invalid.

The patents, held by the Wisconsin Alumni Research Foundation (WARF), cover methods for deriving and growing primate and human embryonic stem cells and are based on the work of James Thomson, a University of Wisconsin stem-cell researcher done in the 1990s. In 2006, a group led by the New York-based Public Patent Foundation led efforts to contest them, claiming that the research on which they were based was not novel enough to be patented, that the patents’ claims were too broad, and that they impeded stem cell research. In response, WARF narrowed the claims, and the USPTO upheld all three patents in 2008 (see our coverage here and here). While two of the decisions were final, one was eligible for appeal.

Last week’s reversal of that patent’s validity effectively invalidates the other two patents as well, says Daniel Ravicher, the executive director of the Public Patent Foundation. “The emperor has now been proven to have no clothes.” If WARF were to try to sue anyone with the two valid patents, he says, the decision negating the third one would serve as a precedent.


The battle over the patents is not over, however, since this decision, too, can be appealed. “WARF has been invited by the Board of Patent Appeals to continue prosecution of this application and plans to do so and vigorously pursue these claims with the patent office,” the Wisconsin organization said in a statement.

But the decision may have limited practical implications, says Ken Taymor, who directs the University of California’s Berkeley Center for Law, Business and the Economy. All three patents expire in 2015, and it’s unlikely that efforts to commercialize stem-cell technologies will bear fruit by then, he notes. “Time will be much more likely to moot the significance of the patent than this decision.”

More important, he says, are patents filed since then that address techniques such as differentiation, stabilizing cell fate, and scaling up production, including those filed by WARF and California biotech Geron, which holds licenses to the contested three patents. “Those will be the interesting and operative patents as the field moves out of the laboratory and the experimental phase — and into the commercial space.”

Also, he notes, the decision could provide guidance to future decisions relating to whether a biomedical technique is novel enough to be patented.

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