Three important human embryonic stem cell patents held by the Wisconsin Alumni Research Foundation (WARF) are invalid, according to a preliminary ruling by the U.S. Patent & Trademark Office. The decision came after PTO reexamined the patents at the request last summer of two nonprofit groups that believe the patents are overreaching and a barrier to promising research in this area (C&EN, Jan. 15, page 31).
"This is a fantastic day for scientific research," says John M. Simpson, stem cell project director at the Foundation for Taxpayer & Consumer Rights, one of the groups that called for the reexaminations. "The patents should never have been issued in the first place."
The trio of patents of concern covers all U.S.-based research using primate embryonic stem cell lines, including those derived from humans. Upon taking a second look at the patents, PTO found prior literature references to work similar to the material claimed in the patents. The prior work was not applied in the original examination of the patent application. PTO rejected the patents on the basis of this previous work, saying the patented material was not novel and, additionally, that it would have been obvious to a person skilled in the field. To be patented, an invention must, among other things, be both novel and nonobvious to a person skilled in the field.
WARF now has two months to respond to the PTO decision. A final decision that can uphold the rejections, limit the patent claims, or reverse the rejections will be issued once PTO completes its evaluation of WARF's response. If the rejections are maintained, WARF can then appeal the decision. WARF can continue to enforce the patents throughout this process, which could take months to years to complete.
"WARF has absolute confidence in the appropriateness and legitimacy of these patents," Managing Director Carl Gulbrandsen says. "We are confident that, when all of the facts are known and the process runs its course, our patents will be upheld."