By Paul Knoepfler
Will intellectual property (IP) wars over patent rights to one of the most exciting new stem cell technologies hold back getting novel therapies to patients?
Unfortunately, it’s very possible.
Induced pluripotent stem (iPS) cells are very cool stem cells made from non-stem cells through a process called cellular reprogramming.
iPS cells have essentially all of the same properties and powers as embryonic stem (ES) cells, but without the potential ethical complexity of utlizing a human blastocyst for their generation.
Pretty amazing, huh?
iPS cells have huge therapeutic potential both directly via potential cell therapies (e.g. for treatment of macular degeneration) and indirectly as the basis for disease modeling and drug screens.
All of this sounds wonderful and it is, but of course you know there had to be a catch, right?
The huge potential problem here is the issue of intellectual property (IP) rights to iPS cells.
All the talk and the slew of publications about potentially using iPS cells to develop therapies to help patients is exciting in theory, but unfortunately the reality is that it is not entirely clear if most researchers are, from a legal standpoint, even allowed to develop and commercialize iPS cell-based therapies at all.
The patent landscape for iPS cells is complicated to put it mildly. A Google patent search for “induced pluripotent stem cells” produced almost 200,000 results.
A search for “cellular reprogramming produced more than 1,000 results.
I’m not sure all of these results are really separate patents, but still….that’s a big complicated mess.
To me simplistically it seems like Yamanaka and his institution should own the rights, but clearly it’s not so simple.
Can any Dr. Joe Shmoe clearly without IP rights to iPS cells develop a therapy?
So if, for example, my lab wanted to develop an iPS cell-based therapy to treat an important disease, would it be possible to do so?
I don’t know. It sure seems risky to me to develop a therapy based on a technology that someone else owns even if I’m not entirely sure who that someone else is.
What about other companies or researchers? Many are working feverishly to develop iPS cell-based therapies, but to my knowledge almost none of them have any IP rights to iPS cells.
It seems like a recipe for trouble to me if not an outright nightmare.
And also I wonder could some other companies be challenging (directly or indirectly by their actions) the Japanese IP and patents on iPS cells?
For example, the company Advanced Cell Technology (ACT; stock symbol ACTC) is most well-known perhaps for its ES cell-based therapies in clinical trials for macular degeneration, but it has clearly indicated that it is developing an iPS cell-based platelet product and perhaps other iPS cell-related products.
But does ACTC in fact have the necessary IP rights to do this? Will they have to pay someone else for the right to use iPS cell technology? ACT has indicated that they have some IP rights to iPS cell-like technology, but what exactly does that mean? Will they be sued if they try to commercialize an iPS cell-based product?
I’ve heard that Stanford is also working on an iPS cell-based therapy with every intent to make it into a stem cell-based treatment to be used for patients….but does Stanford have the legal right to do that?
I’m not aware of Stanford have any IP claim to iPS cell technology at all. Have they signed a licensing agreement with another institution that has a patent for iPS cells?
What about all the other universities and researchers working on clinical translation of iPS cells?
It is no exaggeration to say there are likely dozens of institutions around the world wanting to commercialize iPS cell-based products.
Will they all have to pay expensive licensing fees or end up in court?
…or will the patent holders voluntarily and freely allow others to commercialize iPS cell-based medical treatments?
I don’t think so.
This could get really messy.