The Niche

Companies are starting to position themselves to deal with the complex patent situations around stem cells.

A stem-cell reagents company has joined forces with a young therapeutics company to create a third entity to share intellectual property around induced pluripotent stem cells. StemGent, which sells reagents and other products to differentiate and dedifferentiate stem cells, has joined forces with Fate, which is developing small-molecules that stimulate adults’ own stem cells. They have created Catalyst, which will provide services to biotech and pharmaceutical companies that want to use reprogramming technologies in drug development. I spoke with Fate Therapeutics CFO Scott Wolchko about the new entity, and the company is either unsure or isn’t saying exactly what Catalyst will do.

Continue reading "StemGent and Fate Therapeutics Form Latest iPS IP teams" »

Posted by Monya Baker on May 04, 2009
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Geron is unhappy that the European Patent Office has rejected claims of patents it has licensed from the Wisconsin Alumni Research Foundation. The argument as I understand it is that the European Patent Office followed rules forbidding patents on inventions that involve the destruction of embryos. Geron argued that nowadays researchers don’t have to destroy embryos because they can get embryonic stem cell lines from a cell bank, but the EPO didn’t buy that. (But you can read the arguments for yourself at the EPO.) For Geron’s side, see the press release . WARF’s press release emphasized that the decision was based on laws peculiar to Europe and had no bearing in the US.

Despite opposition from many scientists and activists, WARF’s claims over embryonic stem cells were upheld earlier this year. The first two in March, (See Nature news story) and the third in June.(See WARF press release.
(See also A perfect storm in patents )

Posted by Monya Baker on December 05, 2008
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In a couple unrelated patent filings, Kyoto University has announced a patent for reprogramming differentiated cells to an embryonic stem-cell like state, and Geron announced that it has a patent on using cardiomyocytes created from human embryonic stem cells as medicines or drug-screening technology.

The Geron patent covers cells whether they will be used as medicines directly or to test new medicines. I’m not sure yet how this will effect the use of ES cells for drug screening, but a growing number of companies are already hoping to use cells for such purposes, and they probably were not planning on getting a license from Geron first. (See New tools for drug screening)

Geron holds an exclusive license for commercializing certain hES cell lines for various therapies from the Wisconsin Alumni Research Foundation, and both entities have been accused of styming research, a charge they deny. (See A patent challenge for human embryonic stem cell research)

Also, Kyoto University has obtained a domestic patent for producing induced pluripotent stem cells, ES-like cells that can be made without embryos, according to JapanToday. The iPS IP (intellectual property) field promises to stay complicated, since two different methods of making human iPS cells were published on the same day, and another company, iZumi, which is backed by California venture capital is also in the space. (See Japan ramps up patent effort to keep iPS lead)

Posted by Monya Baker on September 16, 2008
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Here’s this from the Korea Times.
Just after pet-cloning company RNL Bio announced that it had cloned five puppies from a beloved pit bull named Booger, another cloning company is preparing to sue it. The second company, Start Licensing, a Texas-based, holds licenses for the patents surrounding Dolly the sheep, the first cloned mammal.

Patent wars are plenty common in this field (See Perfect storm in patents ). The patents held by WARF and licensed to Geron have drawn protest from the research community (See A patent challenge for stem cell research ). And the intellectual property over the techniques for reprogramming cells is playing out. (See Japan ramps up patent effort to keep iPS lead )

So, it is a bit surprising to learn that Harvard plans to distribute over 20 iPS cell lines representing more than 10 disease conditions for free, and additional lines will also be deposited in the ‘iPS core’ facility, dedicated to improving, curating, and distributing lines. These first-generation iPS cells are made through a genetic engineering that renders them unsuitable for therapy and causes unwanted variation between cell lines. Even two cell lines made from the same person are genetically different. But the Harvard folks say they are going to keep making the cell lines available even as production techniques improve to make cells more valuable.

Posted by Monya Baker on August 09, 2008
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One way of knowing that a technology might have commercial applications is when the patent wars start. This week BioCentury reports that a North Carolina company called Artecel just won an exclusive right to a composition-of-matter patent covering stem cells derived from adipose tissue. According to some reports, stem cells in fat appear to be capable of differentiating into other tissue types. Cytori, a California-based stem cell company that no longer has rights to the patent, was developing the cells for heart disease and reconstructive surgeries. Artecel is less specific about its goals, saying the cells will be used for “soft tissue and cosmetics applications.”

At issue was whether University of California, Los Angeles scientists who had licensed their technology to Cytori had a right to the patent. In 2004, University of PIttsburgh, who had licensed the technology to Artecel, filed a suit to remove the UCLA scientists from the patent. Earlier this month, a United States district court in California ruled in their favor.

Here is the press release from Artecel. In Cytori’s press release, the company said that the decision did not affect its ongoing business practices because the device that enriches collected samples for stem cells for reinjection is still patented. The decision might affect their product pipeline, though.

Posted by Monya Baker on June 25, 2008
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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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