Breaking America’s Patent Stalemate
project-syndicate.org
project-syndicate.org
> In a recent policy proposal, we argue that there currently is little credible evidence to support strengthening or weakening patent protection, such as by modifying patent-eligibility standards.
What is the best argument that, for example, software patents and pharmaceutical patents should continue to have the same lifetime (20 years)? On the face it seems insane.
In their longer white paper, the authors acknowledge that it might make sense for the specific case of pharmaceuticals to get a special carve out:
> Although it is unclear what the optimal length of patent protection is, we suggest a pharmaceutical-specific reform that begins the effective market exclusivity period for new drugs at the time of approval for sale in the United States, rather than at the time of patent filing.
https://www.hamiltonproject.org/assets/files/Ouellette_Willi...
But I don't understand this claim that, putting certain regulatory barriers aside, we should expect patent lifetime to be independent of field:
> ...the patent system’s goal of providing uniform protection across inventions.
Why would we want uniformity? The best argument I can think of is just that it reduces individual industries from lobbying for greater protection contrary to the public interest.
My point about pharmaceuticals was more about the problem of having the Patent and Trademark Office trying to compensate for costs imposed by the Food and Drug Administration. I think the FDA is imposing costs, and if these are causing problems, the FDA should be held responsible for finding a solution; this would also have the effect of incentivizing the agency to balance costs and benefits more carefully.
This has nothing to do with regulations and everything to do with how much money the companies are willing to throw at the problem.
If your budget is a billion+ dollars, a 30,000 person Phase III trial is no big deal. If your budget is a million+ dollars, a 30,000 person Phase III trial is painfully expensive.
The problem is that those 10K+ Phase III trials are where you first really see low probability problems.
Regulations are the cause of the costs; I am not saying that regulatory compliance is a waste of money, but it definitely is a cost which should be considered.
Delays also cost money and reduce return on investment (ROI), so I am sure the pharmaceutical companies do spend a great deal of money to expedite the process. Could all drug approvals go through faster if the pharma companies were willing to run larger trials? Would the FDA allow for these larger trials, and expedite the process for approval? What about rarer diseases, are they worth curing or treating on a timely basis?
https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glan...
Regarding the different time scales for most approvals as compared to the coronavirus approval, my understanding is that there is a vast difference in the amount of resources being put into the preliminary studies. When you have 5-10 thousand deaths every day, it is reasonable to study as many possible routes as possible in parallel, such that one may result in a working vaccine. For diseases with a smaller impact, there may be several candidates on the back burner, but only enough funding to investigate one at a time. If something fails in Stage 3 trials, then in may mean going back to Stage 1 trials on the next option.
(Caveat: I am a data scientist, but not in the medical field, so there are almost certainly considerations that I am missing here.)
An algorithm is a process, and while it's clear that just doing something on a computer shouldn't be patent-able; I think there's a case for granting patents to innovative and useful algorithms.
The core of the problem is method patents to begin with. I think everyone here pretty much agrees at this point that software patents shouldn't exist but really, why should any process/method patent exist?
Most of the arguments against software patents also apply to business method patents. I say do away with both.
While this idea has common sense appeal, it would seem to be a way to return to submarine patents. If the patent was filed for a specific drug which is pending approval for many years (or many decades), use of that technique by others would be infringing and subject to licensing, should the patent ever issue.
Having a expiration from filing date, combined with a filing deadline of one year from invention is simpler and sets a fixed bound on exclusivity.
There's little a corp loves more than rent seeking and so-called IP laws are all about rent seeking.
The patent timelines make sense for non IP goods.
Definitely never heard this rule. Every patent I’ve written has been in the present tense regardless of whether it was “prophetic” or not. That’s just how patents are written.