8 ms·
Not only bogus, but if you get a hit on a scaffold you can combinatorially modify that scaffold and file it with the patent. This effectively blocks the small p
by whymauri 3y ago
Not only bogus, but if you get a hit on a scaffold you can combinatorially modify that scaffold and file it with the patent. This effectively blocks the small permutation space around the drug from further investigation or development.
There's lot of promising science that can't be done because incumbents are so adversarial about patent space for structures they don't even care about. To make matters worse, patent data and notation is:
* Poorly structured and defined,
* Difficult to parse,
* Uses combinatorial/wildcard notation (Markush structures [0], which is what modern drug patent law is based on).
So it's a total mess. The best analogy I could give for software is: imagine if you could patent closed source code (the literal code) and also attach a wildcard to every branch in logic within that closed source code, but all you publish are the filenames (as screenshots of directories, not text). You don't have to run due diligence that the permutations are run to spec or even compile, but now nobody can write logic infringing on your hypothetical code (which you never wrote).
If your reaction is 'what the fuck?', yes I agree.
[0] https://en.wikipedia.org/wiki/Markush_structure https://en.wikipedia.org/wiki/Markush_structure
- AlbertCory 3y agoThanks, let's leave out software. Not that it's not relevant, but it's a black hole for this crowd. One should not try to understand everything by analogy with software.
- dllthomas 3y agoCars, then?
- lotsofpulp 3y agoAnalogies are not necessary all the time.
- dllthomas 3y agoIndeed. My intent with my comment was to jokingly nod in that direction.
- AlbertCory 3y agoNo analogies. It is what it is. Markush groups, as GP mentioned, are there specifically for chemical patents. So that's what's shaped the patent law, not software or cars.
- TeMPOraL 3y agoIt's purposefully a kind of algebraic notation. Algebra is math, particularly a kind of math that maps really well to software (less so, cars). Hence the analogy makes sense.
- AlbertCory 3y ago"Everything can be mapped to software" Perhaps, but chemistry is chemistry. It existed before software did, and you need to understand it on its own terms.
- TeMPOraL 3y agoWell yes, and. It's apples and oranges. And FWIW, chemistry is only a little bit older than software. Like most other fields - there was a qualitative jump in the last ~100 years; arguably we didn't know shit about anything before the 20th century, before the theoretical and practical tools converged to allow some kind of formalized, precise knowledge and experimental work.
- deleted 3y ago[deleted]
- dataflow 3y agoEven ignoring the fact that they block a whole permutation space around the drug, this sounds completely nuts to me: > The company which applies for a patent makes a general claim for the usage of the molecule without revealing to their competitors the exact molecule for which they are declaring a useful application Isn't that against the very point of a patent? That you reveal (make "patent") what you're doing to the public so that the art isn't lost, in exchange for some form of commercial protection? How in the world is this legal?
- refurb 3y agoIt's not bizarre at all. Early hits are step 0.1 in bringing a drug to market. You patent a large space that gives you room to optimize the structure in terms of safety, efficacy, Pk, metabolites, etc. Very rarely would you ever get 1 hit in a huge combinatorial screen. You'd likely get a few dozen. But you have no idea which ones would the best. The company will usually nominate 5 or 6 hits (across the scaffold space) for further screening, then slowly whittle it down from there. By the time it hits humans, it's like 1 with 1 or 2 backups. So you patent them all. If you could only patent one, one of two things would happen: 1) the company would just file thousands of individual patents to accomplish the same thing or 2) not both developing the drug further unless they were 100% certain it was the right one (which I've never seen).
- whymauri 3y agoSure, you can argue that coverage for lead optimization is an unintentional feature, not a bug of Markush. But you have to admit that the current system is leveraged in bad faith i.e. for hedging against generics, staggering patents to maximize exclusivity period, exceptional vagueness and overreach in the structure definitions. Technology and legal practices have far outpaced the USPTO. We have accidentally incentivized sheer volume and intentionally poor record-keeping as a moat. This is a fundamental _inefficiency_, because it de-emphasizes property based engineering and pushes ADMET down the road. Why do so many candidates fail for ADMET reasons a few years down the line? Because people aren't thinking about the risks sooner! Why not? Because surely the patent will cover everything. Add to everything how siloed big pharma is and it becomes impossible to coordinate across the pipeline. IANAL, but certainly there must be some middle ground here -- the last time the USPTO took a stab at redefining this mess was 2007, but they failed. https://www.uspto.gov/sites/default/files/web/offices/com/sol/notices/72fr44992.pdf https://www.uspto.gov/sites/default/files/web/offices/com/so... They more or less proposed what you said: file a claim for each different invention, putting the onus of proof on the filer. In the amendment, Markush is appropriate if you have evidence backing that the chemical space has a true shared utility via structure i.e. test it or forget it OR the chemical space is 'obvious'. When you read the original intent of the Markush decision i.e. "members of [a] Markush group are alternatively usable for the purposes of the invention," it becomes clear that we have strayed waaay from this definition. A Markush can easily contain structures that are impossible to synthesize at all!
- deleted 3y ago[deleted]