I see that authors are from Stanford University. Can someone from the US clarify if this will be in public domain/knowledge, or is it possible some drug company will patent this later on?
If some drug company doesn't pick this up it will fall by the wayside and never make it to market.
On this topic when I was an academic a few years ago I had one of my undergraduate student project groups go through an entire year of Cancer Research (one of the highest ranked cancer journals) from 10 years previously and have them find out what happened to the work published. Rather depressingly the vast majority went nowhere and when my students contacted the PIs to find out why most of the time it was for totally non-scientific reasons like the group lost funding or someone left.
This is just not true. Drug companies will make slight modifications to existing drugs and can get new patents on the new formulations and for new indications. If it works, a drug company can make money off of it even if it's been off-patent for years. See https://en.wikipedia.org/wiki/Lenalidomide vs thalidomide for an example.
For every therapeutic target there are many chemical/biological solutions that can work. If an off-patent compound shows some effect in a pathway, a patentable variant can usually be made.
How can you say this is not true then give all example that require a patent? Yes you can mine drugs that are out of patent and find new uses for it that can be patented. Do you know of one new drug that has come to market in recent years without patent protection?
The difference between (a) an existing, off-patent molecule and a (b) patentable variant of that molecule is somewhat trivial compared to all of the other costs of bringing a drug to market.
But to address your specific question, generics are drugs that come onto the market all of the time without patent protection.
There's plenty of drugs that are made by multiple companies. It might not make sense for a very specific drug which sees low use, but I think it's viable to produce a drug that might be beneficial to virtually anyone even if you don't have exclusivity.
Yes once a drug goes off patent and becomes generic then lots of drug companies will pick it up and start making it, but no new drugs are developed these days without patent protection.
Of course if you wanted to you could make this treatment yourself - it is not that complex.
The issue is who is going to pay for the extensive testing required to get from lab to hospital. That takes years, and lot of organizational skill, and a lot of money. If a drug has gone off-patent, all that is already done, so many companies will be glad to manufacture it. But for new treatments, somebody has to push it through clinical trials, with the (quite substantial) risk that something which looked good in the lab fails to work in larger studies, or has unforeseen side effects.
The approach is in the public domain - in that it could be attempted by anyone else.
According to the paper, these were the two drugs used:
* "CpG SD-101 was provided by Dynavax Technologies"
* "Fc-silent Anti-OX40 (CD134) mAb was purchased from Absolute Antibody"
SD-101 is already in clinical trials. http://www.dynavax.com/our-pipeline/cancer-immunotherapy/sd1...
The anti-OX40 was a laboratory antibody, presumably as this was for a study in mice. However, there are various anti-OX-40 molecules in clinical trials, which could be used.
To get clinical trials going with this approach isn't a matter of patents - it's a matter of one or two companies (depending on ownership of suitable molecules) deciding its something they want to do, and then doing it. My guess is that Dynavax will already be exploring this.
> that authors are from Stanford University. Can someone from the US clarify if this will be in public domain/knowledge
This type of research tends to be publicly funded. However, that doesn't prevent it from being privately patented because of the https://en.wikipedia.org/wiki/Bayh-Dole_Act
One drug is already FDA approved. They have a clinical trial for lymphoma. Stanford may patent many parts of it, the two drug combo.. depends on the novelty and the formulation, how it's delivered. It also depends on how obvious it is in the patent sense. You might find other researchers and companies who optimize the system as well (e.g. fine tune the checkpoint inhibitor). But these drugs are manufactured already. So it seems safe to say that the research will be done and if it works we will see clinical use.
Also by definition a patent is in the pubic domain (for knowledge) and the publication is of course a public disclosure.
Just for clarity, neither drug is FDA approved in the conventional sense (i.e. not approved to be sold). However, both SD-101 and also various anti-OX40 MAbs are in clinical trials.
Also for clarity (and responding to the concerns of the original questioner) it's highly unlikely that this combination will be patented by anyone - this isn't how patents are used in drug development. Anyone with access to the necessary drugs would --in theory-- be free to open a clinical trial to test this approach.
Conflating public domain with public knowledge risks a meaningful error. To patent something requires that you make it publicly knowable, but this knowledge would not be usable by other companies.
well... you can write a patent that is so obfuscated that the public cannot learn from it...
>> well... you can write a patent that is so obfuscated that the public cannot learn from it...
In such case the patent office should reject your patent claim as patent laws usually require that the description of the invention being patented should be understandable to professionals of relevant domain, who should be able to replicate it based solely on that description.
I assune you can patent part of an overall process (certainly that's the case in virtually all software patents), which could be a way to prevent others from replicating your process without explaining the whole thing, no?
On this topic when I was an academic a few years ago I had one of my undergraduate student project groups go through an entire year of Cancer Research (one of the highest ranked cancer journals) from 10 years previously and have them find out what happened to the work published. Rather depressingly the vast majority went nowhere and when my students contacted the PIs to find out why most of the time it was for totally non-scientific reasons like the group lost funding or someone left.