US patents 5,843,780 and 6,200,806 claim preparations of, respectively, primate and human embryonic stem cells and methods for their isolation. The technology was developed by the scientist who established the world’s first human embryonic stem cell line, James Thomson , and he assigned the patent applications to the Wisconsin Alumni Research Foundation (WARF) who licensed the technology to biopharmaceutical company, Geron .
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| James Thomson |
The two patents, along with US
patent 7, 029, 913 , were originally challenged by the
Public Patent Foundation (PUBPAT) and the California-based
Foundation for Taxpayer and Consumer Rights (FTCR) in 2006, and the USPTO launched a reexamination proceeding. The groups held that “the three WARF patents were impeding scientific progress and driving vital stem cell research overseas” and argued that the patents were invalid for reasons of obviousness.
Although the USPTO initially upheld the challenges by the two groups on all three patents in April 2007, WARF appealed, and examiner Gary Kunz upheld the ‘913 patent on February 25. That patent underwent a different review process which allows for public comment and appeal, and PUBPAT and FTCR have said they plan to fight the decision all the way to the US Court of Appeals for the Federal Circuit if necessary.
According to statements issued by Geron and WARF on Tuesday, the USPTO has now issued Notices of Intent to Issue Ex Parte Reexamination Certificates for the remaining two patents. The Geron statement indicated that the certificates were issued after WARF made “minor amendments” to some of the claims “to improve clarity and consistency” and also added three new claims to each patent. The statements also said that the decisions on the two patents are final and cannot be appealed.
But Dan Ravicher, executive director of PUBPAT, characterized those statements as “misleading” and “false” in an interview with Managing IP :
“We can still file a whole new challenge against them,” said Ravicher, although he could not confirm what course of action the groups planned to take. Ravicher also pointed out that the revised patents were amended based on some of the concerns PUBPAT and FTCR presented in its reexamination request. A recent FTCR statement also said that the groups’ challenges helped to convince WARF in January to ease its licensing requirements on human embryonic stem cells.
Despite these changes, Ravicher said he still does not believe the claims constitute patentable subject matter.
“We still disagree with the amended claims and think the patent is obvious,” said Ravicher. “This is just the second decision in a line of decisions to come. [Geron and WARF] want to make it seem as though this is the final word, but nothing could be further from the truth.”
