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by Thebroser 1822 days ago
There are crazy patents throughout the entirety of the insulin production pipeline. Some of these being extremely absurd such as patenting the pH of a buffer for specific protocols! I volunteer for the Open Insulin Foundation on/off when not too focused on my research project and it's basically how can we come up with a roadmap to making this decentralized insulin without violating any existing patents. An added layer of difficulty is like other have mentioned, engineering Ecoli to produce the homolog as well as developing from scratch the devices for extraction and purification (think hplc). Again, these need to be made from scratch as to not violate any patents. At least in the U.S., this is why there is no competition in the market. There is also a significant price barrier as you need to bring up your production to GMP standards which means you need a state of the art clean room and multiple roles to supervise the production of the product every step of the way.
5 comments

Can't you just make Insulin like they made it 20 years ago using expired patents?
yes you can, but that means less profits, and america puts up with it - https://www.iheart.com/podcast/105-behind-the-bastards-29236...
Sure, but I think a substantial problem is getting FDA to approve your manufacturing process.

Even then, modern insulin is apparently quite a bit better than the "classic" stuff.

   it's basically how can we come up with a roadmap to making this decentralized insulin without violating any existing patents
This is how patents are supposed to foster innovation. Wasted effort reinventing the wheel
Both too long time of life, and too easy and cheap to extend.

Most importantly, it's a while set of single thing patents which means you need a thick, expensive cross licensing agreement most of the time. Even finding out which patents you need is hard, and then the patents are written in a way that nakes them hard to use too, including incomplete in crucial details.

It's a mockery of the original intent of the patent system.

Thank you, this is insightful and explains a lot.

For everyone interested, clickable link https://openinsulin.org/

Very noble cause, I appreciate it.

We figured out how to patent everything in software by just adding "with a computer system" to it, so I'm sure we could figure out how to patent novel combinations of these procedures by mixing in "in microgravity".
I wonder if a better effort would be to challenge the patents rather than try to go around them.

(Not that I don't think what you are doing is awesome, because I do.)

Yes! The Open Insulin foundation not only has volunteers with a biomedical background, we have volunteers from many other backgrounds including lawyers that help us try and challenge existing patents. Again, others have said that manpower might be better invested in openly challenging the monopoly that U.S. companies have on some of these patents in court or by appealing to our congressmen. However, I believe that there’s no reason not to do both in parallel. My scientific training can only take me so far and i’ll happily help a project like this if it can open up a new source of affordable insulin in this country, but believe me, I know that at the root this is a legislative issue.