The Niche

News that the patent office has upheld the final two of three patents covering the derivation and use of embryonic stem cells held by the Wisconsin Alumni Research Foundation. The topic generated more buzz when the first, and reportedly least important, patent was upheld. (See our blog.)

The most extensive coverage I found was in the and the Business Journal of Milwaukee. and Wisconsin Technology Network., which reported the following:
During the re-examination, all three patents were modified in ways that narrowed their scope, and WARF lost its eligibility to claim certain damages, but most of the patent claims in 780 and 806 have been upheld.

WTN also quotes WARF officials saying that the ruling was good news for biotech investors:
Gulbrandsen also said that if the patent ruling had gone the other way, it would have had ramifications beyond WARF, especially given the many patents issued for other biological material and cells. "It would be saying that very little is patentable in the technology area due to the obviousness issues," he said. "In this environment, people are worried enough about investing due to the credit crunch."

The patent challengers say that the patents have limted investment in stem cell technologies that their efforts have already succeeded because WARF is being more generous in supplying embryonic stem cell lines and licenses.

What I did not see was looking outside the US; both Singapore and the UK are gearing up to supply embryonic stem cell lines that could, when differentiated, be used in clinical trials. The patent situation on induced pluripotent stem cells (differentiated cells treated to behave like embryonic stem cells) will be much more open, since multiple methods seem to work on the cells and more than one group of scientists have reported them at about the same time.

Posted by Monya Baker on March 12, 2008
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The US patent office has upheld one of three patents on embryonic stem cells that had been challenged as overly broad. The patents are held by the Wisconsin Alumni Research Foundation, which has broad patent claims on the derivation, use and culture of human and primate embryonic stem cells. These have been challenged by researchers who say, among other things, that the patents unduly stall research and development. (See our an accounton these challenges by Jeanne Loring.)

Ken Taymor of the Centerfor Law, Business, and Economy at Berkeley told the The Wall Street Journal's Health Blog that even though the the first is still ongoing over two other patents, both WARF and its icensee Geron have plenty of other patents they can enforce. Taymor has prevsiously argued that the patent challenges could actually strengthen WARF's position. (See our blog on that topic here; it starts in the fourth paragraph) Patent challengers already say that they've seen success because WARF is narrowing its claims and being more generous with researchers who want to use its cell lines.

Here's the release from Geron.
Here's the challenger's release.

Posted by Monya Baker on February 29, 2008
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Chris Scott, who researches ethical and legal issues involving stem-cell research at Stanford had this to say about Jeanne Loring's recent commentary on Nature Reports Stem Cells.

Jeanne Loring's commentary on the WARF patent situation is an insider's look at the motives and arguments for challenging one of biology's most contentious and important set of patents. Her statements, "WARF has tried to get the same patent issued in multiple countries and failed. Other countries have not even allowed patenting of human ES cells," give clues to the complexity of the international scene. In the EU, legal challenges to hESC patents can center on ethical, rather than technical arguments. Invoking so-called "morality clauses" contained in the European Union's 1998 Directive on Biotechnological Inventions, some jurisdictions and agencies (including the European Patent Office and the German Intellectual Property Office) rule unpatentable any invention that results from
the uses of a human embryo "for industrial or commercial purposes."
But other countries do not. The United Kingdom, for example, has granted patents using hESC lines to a number of for-profit and academic institutions. Sweden has issued one such patent. Even the EPO itself has been inconsistent in its rulings.

Therefore, the situation in Europe is quite fluid and not monolithic, because individual nations can interpret the Directive's language in ways that are consistent with national frameworks of values and beliefs. As the US challenge unfolds, the enemy (or ally, depending on your point of view) is time. Patent reexaminations can take years to resolve. Here, time may favor the patent holders.

Posted by Monya Baker on November 14, 2007
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The Wisconsin Alumni Research Foundation has lashed out against a group of stem-cell scientists who argue that the Foundation’s patents on human embryonic stem cells are invalid.

Continue reading "WARF patent case gets uglier still" »

Posted by Monya Baker on July 26, 2007
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