Tuesday, July 25, 2006

WARF patent dispute driving U.S. scientists overseas?

Lifenews reports: One researcher, Jeanne Loring, who directs human embryonic stem cell research at the Burnham Institute for Medical Research in California, told the Contra Costa Times newspaper that the patent dispute is driving some scientists overseas.

"The patents are impeding our research," Loring said. "They're more important than what's going on in the Senate right now.

"It is making scientists go overseas to do this sort of research," she added. "It isn't the funding that's sending us overseas. It's the patent issues."

IPBiz notes that under the U.S. Supreme Court decision in Merck v. Integra, researchers in the U.S. would have an exemption from patent infringement for purely research activities. Thus, an argument that patent issues are driving stem cell researchers overseas is purely bogus.

The issue is the ties of researchers TO COMMERCIAL ENTITIES. Further, if a product were developed overseas that fell within the scope of claims of a U.S. patent, making the product overseas would not immunize the product from patent infringement if the product were imported into the U.S.

The lifenews article referred to the re-exam request of PubPat and FTCR as a "lawsuit," which it is not: The Public Patent Foundation, a nonprofit group that represents the public in patent policy, joined in the lawsuit.

The re-exam request asserts that U.S. Patent No. 5,166,065 anticipates under 35 U.S.C. 102(b) the claims of U.S. Patent No. 5,843,780 and 6,200,806. The problem is that the '065 patent does NOT disclose the existence of primate or human embryonic stem cells. Further, the re-exam request failed to note that the '780 patent explicitly noted that the use of LIF (disclosed in the '065 patent) failed to create human stem cell lines. The chances of the anticipation argument raising a substantial new question of patentability at the USPTO are slight. Whether the obviousness argument might fly is a different issue, especially with the uncertainty introduced by the Supreme Court review in KSR v. Teleflex. As a headsup in the Supreme Court case, petitioner KSR’s main brief to the Supreme Court is due on or before August 22, 2006. An amicus brief in support of KSR, or in support of neither party, is also due on August 22.

Separately, the general argument in the re-exam request that all the work was done 25 years ago and that Thomson was following a pre-existing recipe is a two-edged sword. If it were true that all the work on human embryonic stem cells were done 25 years ago, then why would PubPat and FTCR be seeking to invalidate the patents in order for researchers to do work in 2006? By their reasoning, the work on mouse embryonic stem cells renders work on human embryonic stem cells "obvious".


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