Pharmaceutically Speaking, Part 5: Stem Cell Patents

Danie Roy

Lately, I’ve become quite interested in medical IP: overturned patents, how generics are made, biologics, and which meds are coming off patent. Today, I’m going to try to tackle something slightly more controversial: stem cell patents.

Now I’m going to stop the ethical/political debate before it starts: I’m not going to give you an opinion on the ethicality of stem cell research and patenting. I’m not going to try to spin this article one way or the other. I am going to give you facts and some (noted) speculation on something that is happening and has the potential to be particularly interesting. That being said, let’s dive in.

I was originally going to write about a stem cell patent recently granted to Kyoto University, but when I looked for the patent, I could not find a record of anything issued in Google Patents or Public PAIR. It is entirely possible that the internet documents simply aren’t up to date, but I was mildly confused when I saw the second claimed filing date. Whatever is going on there, it seems to be related to induced pluripotent stem cells, because, in addition to being the topic of the articles in question, almost all of the Kyoto University patent applications I found were directed to the subject matter.

I’m not an expert on stem cells, but I managed to glean that pluripotent stem cells can form any kind of cell type, and induced pluripotent stem cells are pluripotent stem cells formed from non-pluripotent cells, usually adult somatic cells. Somatic cells are just a organ-specific cell type. I would like an expert to correct me if I’m wrong, but I interpreted this as the folks at Kyoto University found a way to create stem cells without the controversial origins.

If stem cell research were made to be no longer controversial, the potential applications for regenerative therapy are really exciting. Need an organ transplant? Take a few skin cells and grow one. Nerve damage? Regrow them. Granted, none of these have happened yet, and I’m thinking of best-case scenarios for this sort of thing.

A quick reminder: just because something is patented does NOT mean it has been FDA approved or tested on humans (MPEP §2107.03(IV)). Nor does it mean it’s good for you. A patent just means that someone invented something, and that something is now protected by law. Technically, a patent doesn’t even necessarily mean that the invention will work for its intended purpose (it just has to work for a legitimate purpose).

As for not finding the Kyoto University patent, that’s not to say stem cell research/therapy hasn’t already been patented. I found a rather nice article on the history of said patents and the resulting litigation.

I’ll be sure to update as soon as I can find the actual patent.