BioTechnology Patents: Kyoto Claims iPSCs

Can you patent a gene? What about a cell? When it comes to the components of life, and more importantly the ideas, processes, and procedures developed to manipulate these components, what belongs to who? This is a question that is certainly going to be fought out from the patent office to the courts as more and more biomedical discoveries are made.

iPS cell cluster. Source: NINDS.NIH.gov

One discovery that has recently (meaning August) been in the news for patent applications is Shinya Yamanaka's 2006 discovery of the combination of genes that can be used to reprogram adult cells to a pluripotent (capable of becoming any kind of cell) state. With these induced pluripotent stem cells (iPSCs) lies the hope of a suitable answer to the debate over the need for pluripotency, but the social and religious controversy over using human embryonic stem cells (which are naturally pluripotent).

While working at Kyoto University in Japan, Yamanaka found that the genes Oct3/4, SOX2, c-Myc, and Klf4 are key to pluripotency. This discovery led to the creation of the first iPSCs. Now, five years and millions of dollars in research later, Kyoto University has obtained patent rights for iPSC technology in six nations and two regions, including the United States. This development leads me back to the question I started with, can you patent a gene? What about the ideas or technology based on those genes? Apparently, you can because Kyoto University has. But, I'm still quite curious about how this will play out functionally.

The discovery of iPSCs was huge news. It prompted researchers around the world to start working with iPSCs, many of whom have subsequently made their own discoveries, published their own research in peer reviewed journals (just type pluripotent into PubMed you'll see what I mean), and expanded greatly on the existing body of knowledge about pluripotency. This includes the discovery of numerous variations of gene combinations that play a role in pluripotency. So if Kyoto University owns the original idea, do they own everyone elses' work too? According to university spokeswoman Akemi Nakamura, they do. Nakamura says the patent broadly covers variations of the technology developed since 2006 in laboratories around the world.

In a press release the University stated:

"The US patent covers combinations of nuclear reprogramming family factors comprising an Oct family gene, a Klf family gene, and Myc family gene; or an Oct family gene, a Klf family gene, and a cytokine. This means that if companies use a combination of the nuclear reprogramming genes and generate iPSCs, regardless of the kinds of vectors, they need to get the patent license."

So if Kyoto University owns the right to the genes, and the subsequent developments based on the genes what does that mean for iPSC researchers? Right now the university says it will not restrict research using iPSCs for non-profit purposes, so that would mean research whose end goal isn't the marketing of a specific product based on iPSC technology will be able to continue unhindered. Companies that want to work with iPSCs for profit may have to pay a licensing fee. Although, it is important to note that not all iPSC research is based on these genes - there are other combinations of genes that can induce pluripotency, and thus lines of inquiry in this field that don't belong to Kyoto University.

How important all of this will be, and when it will be important is a bit murky. iPSCs have their own problems (namely, teratomas) and haven't yet been developed for widespread, let alone commercial, use. Though, with all of the resources being poured into iPSC development, I think it is only a matter of time until the cells become more useable. This is a story to watch, it is hard to say exactly how it will work out but it is sure to be an issue that continues to come up.

As for me, I'm not really sure where I fall on this issue. I can see the need to protect intellectual achievements and make sure that the wrong people don't profit, but at the same time I wish it wasn't necessary and open inquiries could be pursued without people having to worry about others cashing in on their ideas. If only it could be that way.

Stem Cells On The Brain

Human Embryonic Stem Cells. Source: Wikimedia Commons.

An interesting clinical trial just began in Russia, where doctors intend to inject stem cells into the brains of stroke patients to see if the cells can serve as a potential cure for the negative effects of a stroke. The BBC article: Stem Cells Used in Stroke Trial

So far only one patient has been injected with the stem cells (which are embryonic pluripotent cells) but it is notable because he is the first patient to ever have stem cells injected into the brain as a potential cure. It is also controversial to use humans for this type of study considering how much still remains to be learned about the brain and about stem cells.

Another Chapter on Stem Cells

More news today about the controversy over federal funding of embryonic stem cell research. A federal appeals court has temporarily reinstated the ability of federal funds to be used for embryonic stem cell research, while it takes more time to review the Obama Administration's appeal of an earlier court decision banning federal funding for embryonic stem cell research. The issue just seems to go round-and-round.

Coverage of the court's new decision:
The New York Times: Appeals Court Ends Ban on Stem Cell Financing, for Now
The BBC: Court delays ban on federal funds for US stem cell work
The Washington Post: Stem cell funding gets reprieve
The Associated Press (In The LA Times): Court allows funding of embryonic stem cell research for now, but projects still remain uncertain

The Battle Over Stem Cells

Stem cells have always been a controversial issue, but for a while it seemed that the Obama administration had brought some kind of direction to the issue by allowing federal funding of research based on embryonic stem cells. But recently, stem cells have been back in the news because a US district court filed suit to block the Obama administration's attempts to provide more funding for embryonic stem cell research.

Reporting on the issue by the BBC has been informative. I think giving the hard facts of the story in a way that doesn't entertain the emotional components and personally held beliefs (on either side) is really necessary. I think their reporting on the issue does just that.

One component of the story that I do want to comment on is the argument that limiting federal funding for embryonic stem cell research won't be detrimental to the research. The National Institutes of Health (NIH) is the largest funding organization in the United States. The amount of funding that private institutes can provide is completely dwarfed by the NIH.

Restricting funding on embryonic stem cell research in the United States will be detrimental to our progress, that is why under the Bush administration we lost researchers to other countries in Europe and Asia where that research is supported.  The research that took place during those years is indicative of what we'll accomplish under a new ban. Personally, I am glad the White House is fighting this. When religious beliefs start to take a role in shaping policy it can become incredibly dicey.

I do think that adult stem cell research has value, and research into induced pluripotent stem (iPS) cells has made tremendous progress, but researchers do still need to study pluripotency and iPS cells aren't an adequate model yet. I don't think you can replace one avenue of research with another, they just aren't the same no matter how much we might wish that they were because it would eliminate the ethical issues.

Here are a few highlights of articles that I wrote for BioTechniques recently on Stem Cell research:

Vatican to support international intestinal stem cell consortium
Induced pluripotent stem cells create first living animal
The shape of things to come: helping stem cells shape their future
iPS cells still fall short of embryonic capabilities
Are iPS cells a thing of the past?

Science Writing Highlights

For the last year (2009-2010) I've been writing for the journal BioTechniques. In that time I've written way to many articles to post here, but here are a few favorites from Spring/Summer 2010:

"Ending cell line contamination by cutting off researchers" is my most recent piece, about how the biological research community can end the widespread use of contaminated cell lines for published (and peer reviewed) research. New York Times bestselling author Rebecca Skloot (who literally wrote the book on HeLa cell contamination) posted a link to the article on her Twitter.

"Fastest case of adaptation documented in Tibetans" reported on (what I think is) a really interesting development in the study of human genetic adaptation to environmental conditions. Basically, Tibetans adapted rapidly from Han Chinese to thrive in low-oxygen environments.

"The sequencing race: the home stretch" was a follow up to an article that I wrote that appeared in the February 2010 print edition of BioTechniques. The whole suite of articles reports of the progress that has been made (and is anticipated) in the field of genome sequencing technologies.

"Plant biology blasts off: shuttle missions explore biofuels" reported on experiments featured on the last few NASA shuttle missions exploring the affects of zero-gravity on possible new biofuels.

"Facial expressions quantify pain in lab mice" is about a method to quantify whether or not laboratory mice are experiencing pain due to their role in an experiment based on the way the features of their face change, indicating pain. It raised some important issues about animal rights, specifically what constitutes suffering and whether the animals are aware of what is happening to them.