An Iron Curtain Has Descended Upon Psychopharmacology - blog post about Russian drugs and their lack of research in the US

Our patent system for chemical compounds is one of the main reasons for this effect. I did not even know the extent of it till a couple months ago, when I sat down with a patent firm for a compound we are working on. For one, the cost to patent is extremely high. This is because of the amount of research your legal team needs to do. If a compound has been mentioned in a paper anywhere in the world, in any language, even in passing, you lose your novelty protection. It's crazy. If a Croatian pharmacology journal from 1991 mentioned the structure of a compound in a single sentence, then you cannot claim novelty on the patent. That is why these drugs never make it here. That is why drug companies push for completely new structures, even if effective ones are already known, but not used. The drug's mechanism of action does not even need to be described for you to lose novelty. It could be mentioned as an intermediate for another drug's synthesis, or just mentioned in passing. Boom, novelty gone. It's nuts.

I also learned a lot more about the international patent treaties that were signed, and how they effectively create barriers for development of drugs between the treaty signors. Sure, you can take a drug that was mentioned in an overseas journal, and pay at least $100 Million to get it through FDA trials. However, if the author of that journal later wants to come after you, then you at the very least lose your exclusivity to the patent, at worst you lose it altogether. This is even if you prove you never read their paper, and even if it was in a language you don't understand. That is why companies do not risk it, and why legal teams cost so much to do their due diligence. If the company cannot be sure they can protect the patent on the compound, there is no way in hell they are going to front the money for FDA trials. They might even go so far as to actively campaign against the drug, if they have a competing one.

We need a big change to our patent system, and the way drugs are approved in the US. Perhaps a government funded system for drugs that show promise, but will never see the light of day because of patent technicalities. We have the orphan drug program, but that is only for diseases that affect very few people, and have no other effective treatment. We need a better system for drugs that are improved over the currently approved substances, but are not going to be sponsored by companies. However, that is not going to happen with all the money in pharma right now.