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Breaking America’s Patent Stalemate (project-syndicate.org)
49 points by nabla9 56 days ago | hide | past | favorite | 21 comments



Sorta a tangent but

> 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.


I think you make a good point in saying that patents vary in annual value, and that the costs that they help recouperate also vary. That said, I think pharmaceuticals patents are bad examples, because the patent system is being used to compensate for regulatory costs; this creates all sorts of strange problems and incentives.


The implied argument in your statement seems to be that we should lower the regulatory costs of developing new pharmaceuticals. Is that what you are implying? My outsider view is that large-scale phased testing of medication is the primary cost required by regulations, and the primary assurance of quality of a medication. Since you can't get rid of those test stages without sacrificing quality, removing regulation would have the primary effect of allowing companies to sacrifice quality.


I did not intend for that post to imply that regulations should be loosened on pharmaceuticals. That said, I am not sure whether regulatory approvals should take 5-15 years, when it seems like everyone's happy working through a coronavirus vaccine in less than 1 year.

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.


I wonder how much of the delay is due to FDA staffing levels. If they had more staff they can evaluate more trials in parallel?


According to the FDA, 2/3 of their spending on human drug regulation is covered by user fees. Given that some or most of the rest must be non-approval related (ongoing supervision and overhead), and the approval work doesn't go away if they delay it, I'd guess that they have the resources to evaluate as many trials as are ongoing.

https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glan...


In that case the priority review voucher process doesn't make sense if they can evaluate them concurrently.


> That said, I am not sure whether regulatory approvals should take 5-15 years, when it seems like everyone's happy working through a coronavirus vaccine in less than 1 year.

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.


>"This has nothing to do with regulations and everything to do with how much money the companies are willing to throw at the problem."

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?


Thank you for the clarification. Hacker News tends to lean toward free market solutions, even in cases like healthcare where the free market has many significant failure modes.

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.)


IMO the main issue with allowing patents to be of different lengths is that you are opening up a process to change the length of patents. You'll immediately see corps pushing that their type of patents are special and need longer coverage.

There's little a corp loves more than rent seeking and so-called IP laws are all about rent seeking.


Yea, that's the sort of explanation I'm sympethetic to and tried to gesture at in my last sentence. The thing is, you can say this about any law, yet we wouldn't want to argue that laws can never account for differences in different industries.


20 years is beyond insane, because software patents shouldn't exist in the first place.


Intuitively, I agree with you that software patents are a bad idea, but patents are supposed to be available for both devices and processes (along with plants and some other more complicated things).

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.


Patents actually are not supposed to be available for processes! That was something invented by the courts (in 1998: State Street Bank & Trust Co. v. Signature Financial Group). Congress has passed no legislation regarding process/business method patents and software patents are a further extension of business method patents.

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.


It's better to err on the side of not granting them, than on the side of what we have now with sickening patent trolling and patent protection racket slowing down progress.


>> 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.

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.


What would be the fallout of moving patents to only be physical objects and have to at least have a prototype?

The patent timelines make sense for non IP goods.


> Patent insiders distinguish prophetic examples by verb tense: examples based on work that has actually been done are typically in the past tense, whereas prophetic examples must be in the present or future tense. Thus, when a patent describes a chemical reaction in which “230 milliliters of hydrogen is attained,” or treatment of a patient whose “pain is substantially alleviated,” or a diagnostic patch with micro-needles that “automatically draw small quantities of blood,” the present tense signals that the work needed to support these claims most likely had not been carried out at the time the application was filed.

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.


I don't know how chem/bio pros do it, but I was trained to never include "is" in detailed descriptions only in the claims. In the description we use "may be" instead.


Oh for sure, it’s all just an embodiment may blah blah. But it’s present tense.




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