MAJOR NEWS:Sorry, Wisconsin: The Jig is Up on Patents in Embryonic Stem Cell Research

From The Foundation for Taxpayer and Consumer Rights in California and The Public Patent Foundation (PUBPAT) via Jon Merz comes the most important news in stem cell research since 2000:

PTO REJECTS HUMAN STEM CELL PATENTS AT BEHEST OF CONSUMER GROUPS:

Santa Monica, CA -- April 2, 2007 -- The U.S. Patent and Trademark Office has upheld challenges by consumer advocates to three over-reaching patents on human embryonic stem cells and rejected patent claims by the Wisconsin Alumni Research Foundation (WARF), the Foundation for Taxpayer and Consumer Rights (FTCR) said today.

"This is a a great day for scientific research," said John M. Simpson. FTCR stem cell project director. "Given the facts, this is the only conclusion the PTO could have reached. The patents should never have been issued in the first place."

The challenges were filed last July by FTCR and the Public Patent Foundation (PUBPAT) because the three WARF patents were impeding scientific progress and driving vital stem cell research overseas. FTCR and PUBPAT argued that the work done by University of Wisconsin researcher James Thomson to isolate stem cell lines was obvious in the light of previous scientific research, making his work unpatentable. To receive a patent, something must be new, useful and non-obvious. The PTO agreed with the groups.

Its decision said, "It would have been obvious to one skilled in the art at the time the invention was filed to the method of isolating ES cells from primates and maintaining the isolated ES cells on feeder cells for periods longer than one year. A person skilled in the art would have been motivated to isolate primate (human) ES cells, and maintained in undifferentiated state for prolonged periods, since ES cells are pluripotential and can be used in gene therapy."

The PTO decisions were dated Friday, March 30 but were received today. WARF has two months to respond to the PTO ruling and seek to change it. Third party requests for patent re-examination, like the ones filed by FTCR and PUBPAT, are ultimately successful in having the subject patent either changed or completely revoked roughly 70% of the time.

Dr. Jeanne Loring, a stem cell researcher at the Burnham Institute for Medical Research, filed statements in support of the re-examination requests.

"The real discovery of embryonic stem cells was by Martin Evans, Matt Kaufman, and Gail Martin in 1981, and none of these scientists considered patenting them," said Loring. "It is outrageous that WARF claimed credit for this landmark discovery nearly 15 years after it was made."

In the face of the challenges by FTCR and PUBPAT WARF announced in January that it would ease its licensing requirements on human embryonic stem cells. "Now that the PTO has ruled, WARF should simply drop all its claims," said Dan Ravicher, PUBPAT Executive Director. [ed: yeah, hold your breath indeed...]

The groups said the patents' dubious validity is underscored by the fact that no other country in the world honors them. As a result, U.S. researchers have sent research monies abroad where they can avoid paying royalties to WARF. California voters approved the nation's largest publicly funded stem cell research program in 2004 with Proposition 71, which allocated $3 billion in grants over the next 10 years.

More information about FTCR and PUBPAT's challenges to the WARF stem cell patents (U.S. Patents Nos. 5,843,780, 6,200,806 and 7,029,913), including copies of the Patent Office's Orders rejecting the patents, can be found here, and you canr ead John Simpson's Op-Ed explaining the need for the patent challenges here.

Patenting Genes and Stem Cells

Danish Council of Ethics released this report on patenting of genes from humans and of hES cells.

Geron: Behemoth of the Stem Cell Race

Sacremento Bee reports on the importance of Geron and its patents for the race to acquire and license stem cell research technologies. It is a field in which there is a great deal of patent protection, as I wrote in a survey of the existing patents for a book Magnus, Caplan and I co-edited: Who Owns Life?. And now there are three billion dollars available for research that will in many cases produce licensing arrangements that filter automatically through Geron. This will be an interesting time for those who invest in biotechnology, but more interesting still for those who follow patent law in the life sciences, where the patent and trade offices in the US and European Union seem to have lost their minds. GM

Cuba's Biotech Revolution

Cuba is broke. So it is investing in biotechnology, specifically in the development of a pharmaceutical industry in Cuba to make and sell generic versions of patented pharmaceuticals (and, naturally, they do not hold the patents). It is an interesting strategy:

Faced with economic calamity, Castro did something remarkable: He poured hundreds of millions of dollars into pharmaceuticals. No one knows how - Cuba's economy, with its secrecy and centralized structure, defies market analysis. One beneficiary was Concepcion Campa Huergo, president and director general of the Finlay Institute, a vaccine lab in Havana. She developed the world's first meningitis B vaccine, testing it by injecting herself and her children before giving it to volunteers. "I remember one day telling Fidel that we needed a new ultracentrifuge, which costs about $70,000," Campa says. "After five minutes of listening he said, 'No. You'll need 10.'"...

It's like Castro said: They don't really like patents. They like medicine. Cuba's drug pipeline is most interesting for what it lacks: grand-slam moneymakers, cures for baldness or impotence or wrinkles. It's all cancer therapies, AIDS medications, and vaccines against tropical diseases.

[Link] Cuba has long had discussions about bioethics with faculty teams led by Stuart Youngner of Case Western Reserve University. It will be interesting to hear how that group reacts to this development; they have done a great deal for bioethics in that small nation.

Chinese News Service: Brazilians Sell DNA Online

This piece is extraordinary: Chinese news agency reporters uncover the dimensions of the Brazilian government probe into online trading of Brazilian Indian DNA. This would appear to be an extraordinary extension of Internet technology in terms of commercialization of DNA outside the scope of the law. What Brazil will do to regulate or enforce existing regulations to restrict such commercialization is, of course, anybody's guess. Brazil supplies research subjects and organ sales to the world, with only limited attempts by the government to restrict such trade. Still, trade of this type in DNA samples goes far beyond what was alleged to be "colonialism" by organized scientific groups gathering samples from indigenous groups around the world. We're translating Brazilian newspapers who have reported on this probe.