Sunday, September 17, 2006

Hundreds of Millions at Stake? Draft CIRM IP Policy for Business Now Available

The 37-page "deal" for businesses seeking grants from the California stem cell agency – at least the preliminary version of it – is now ready for some flinty-eyed dissection.

CIRM has posted the draft on its web site ahead of Thursday's meeting of its Intellectual Property Task Force in San Francisco.

The document grew out of the Aug. 29 meeting of the Task Force, chaired by Ed Penhoet. He says he wants to bring recommendations to the Oversight Committee Oct. 11 for its approval.

No one knows how much money could be at stake in connection with CIRM's plans for sharing the wealth with businesses, but it could be rather large. The agency itself could eventually give hundreds of millions of dollars to businesses to stimulate the development of stem cell therapies.

The IP proposals appear to be line with the principles offered on Aug. 29. The draft also attempts to clarify such terminology as the meaning of net revenue – important because the draft contains a 17 percent net revenue trigger on one revenue sharing feature.

The draft offered a little more detail on the "blockbuster" payments on successful commercial products. It proposed a payment equal to three times the original award(inflation adjusted) – paid back over five years – after revenues exceed $250 million.

Also clarified was the percentage of funding that would trigger a requirement that awardees provide a plan for access to CIRM-assisted therapies for uninsured Californians. The proposed figure is 25 percent of the funding of the invention or project. That would also kick in a requirement to provide the therapies to public agencies at the Medicaid price. However, some members of the Task Force say there is no such thing as the Medicaid price.

Oversight Committee member Duane Roth says California businesses need certainty in any proposal that requires financial commitments. They need to know "that this is the deal," he says.

Whether businesses on Thursday will make any counter offers on the deal is unknown. But only a handful were on board for the meeting last month.

A side note: Penhoet and the CIRM staff, especially Mary Maxon, well served the stem cell community, businesses and public by having the IP draft up on the web site last Friday. Also up was the transcript of Aug. 29 meeting. Early postings genuinely help all involved make intelligent and timely contributions to the discussion. Sphere: Related Content

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