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Sure, 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 leve
by whymauri 3y ago
Sure, 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!
- refurb 3y agoI mean, if the argument is PTO should be better resources so that patents can undergo more rigorous evaluation, you won't get an argument from me. You're not supposed to patent anything you haven't actually made, however, there is no validation of that and as a result patent applicants are incentivized to patent as broad a space as possible. However, if we did move to a "single molecule, single patent" approach, the workload on the PTO would skyrocket. For pharmaceutical companies the cost of a patent and its preparation is infinitesimal compared to the cost of developing a drug - pharma companies wouldn't bat an eye at submitting 1000's of patents for each discovery program. But, as I stated above, I don't disagree the process could be made better.
- cycomanic 3y agoThere is an easy solution, you already can't patent cooking recipes. So why allow chemical recipes? To those that say that would stifle innovation, well historic evidence is inconclusive at best, e.g. the development of the pharmaceutical industries in the US, Germany and Switzerland saw thr biggest industry develop in Switzerland who did not have any patent protection followed by Germany, where only processes not chemicals could be patented. The US pharmaceutical industry only become much bigger after they benefited from the harmonisation of patent systems to follow the strong protection in the US.
- AlbertCory 3y agoThe Pharma lobby is one of the most powerful in DC. Zero chance of that ever happening. So let's remove software from the list of patentable subject matter. Then Pharma won't care about us anymore. One thing at a time.
- refurb 3y ago“Recipes” aren’t the key patents in pharma, it’s new molecules - new composition of matter. Occasionally processes are patented but competitors could still make the molecule other ways. And considering the pharma industry never really took off until the mid-century I’m not sure your claim of “saw the biggest industry develop” before the parents we have today holds any weight.
- AlbertCory 3y ago> You're not supposed to patent anything you haven't actually made not true. That's Actual Reduction to Practice. There is also Constructive Reduction to Practice. I wrote about this in depth, for software: https://albertcory50.substack.com/p/no-source-code-no-patent https://albertcory50.substack.com/p/no-source-code-no-patent This is a good place to repeat, "let's just remove software from the patent system." If you don't, then any changes you propose will being the Big Pharma lobby down on you. Once we get our own IP protection laws (or no IP laws), the pharma companies won't care about us anymore.