There's a balance to how much IP protection actually encourages innovation, and we're far on one side of it.
I think patents are okay, but the maximum duration should be 5 years and there needs to be some proof of utilization of the patent to sue for damages.
20 year patents are ridiculous, and it seems like even in the 1800's that should have been considered a bit extreme.
The term you want is "prosecute" not "litigate."
A JHU study found median costs for clinical trials of $19 million.
That's expensive relative to software. If I piled HIPAA, payments processing, and whatever telcos might require for hooking up to SS7 in one app (call it "X") I doubt I could get halfway to $19 million.
But $19 million is peanuts compared to pharma revenue. I stand by the assertion that pharma gets undeserved sympathy for long patent terms.
Sure. That's an assertion that's easy to stand by because it's so easy for it to be true because it's so open ended and unbounded.
I think most people believe the pharma companies are playing it up some and getting some undue sympathy, but 10x the sympathy and 10% more sympathy are vastly different situations and your assertion is "true" for both. It's less a question of whether that assertion is true, and more about to what degree, because that's what really matters in a discussion like this.
A statement about the median cost of a single study across an industry compared to pharma revenue (across an industry, across all studies done, whether resulting in a successful product that can make it to market and earn revenue), is not something we can make useful assertions from, whether or not I believe your assertion to be true (I do). It's just throwing disjointed numbers around and using implications instead of data to link them, which isn't a useful way to convince people who want to understand what's going on.
It could also be that there's lots of low cost trials around $20 million, but slightly less than half of the trials that are done are very expensive, and 4-5 times the cost. This would be more obvious if there were values for bot mean and median, instead of just median.
The looser the data, the less you can actually infer. Any time someone tells me the median cost for something across an entire industry, my immediate reaction is to wonder what that means, not assume I actually know what it means, because it's far too little data to really know. How many trials are done in a year on average? How many a year do companies average based on revenue? Or simple, what's the actual amount spent on trials compared to revenue, and over how many years are those trials run? Is yearly cost of a trial really a good indicator, if trials take 5-10 years to run, so a failed one results in not just loss of money spent but opportunity cost over many years?
Note: If you provided a reference for that median number I would have actually looked it up to see if it made sense to me, or if I had additional questions about how they went about their measurements. Instead, all I have a questions about what the numbers mean because I have no context.
You will like some of the numbers on that site even less than the $19 million median cost for a trial.
The study was published in JAMA, link on the JHU page. I hope this does not sound like an appeal to authority, but good luck discrediting the numbers.
> You will like some of the numbers on that site even less than the $19 million median cost for a trial.
> good luck discrediting the numbers.
I'm not sure why you would think I wouldn't like the numbers. I'm not pro-pharma, I'm just pro-informed reasoning.
That said, the article you reference is a bit more nuanced than your take. By the studies they're citing, while the trials for drugs that were approved have a median cost of $19 million, they are clear to outline that it does cost a lot to develop a new drug:
The $19 million median figure represents less than one percent of the average total cost of developing a new drug, which in recent years has been estimated at between $2 to $3 billion.
“The cost of generating this fundamental scientific information is surprisingly low given the total cost of drug development and the high price tags on many drugs,” says study senior author G. Caleb Alexander, MD, MS, associate professor of epidemiology and medicine at the Bloomberg School.
So, while studies may not be a large cost center for new drug development, they state that new drugs are very costly to develop. Or maybe studies are costly, and it's just that it takes very many of them until one shows success. Ten concurrent studies on ten variations of a drug to look for something promising would cost ten times the amount, and there's still no guarantee that any one study will end in a positive outcome.
If we're talking about the justification for patents for pharma companies, it seems like we should focus on the "total cost to develop a new drug is estimated at $2 to $3 billion" part and not the "$19 million median cost to run a study" part[1], which as I noted is lacked enough context to know exactly how much it relates to drug development cost.
That said, I'm not sure the total cost number referenced above is accurate (to my taste) either. How much of that is advertising? How much of that is kickbacks and trips and drug rep lunches and free samples to doctors? I'm not sure because I don't have access to the full paper, so I'm not sure what their methodology includes. It wouldn't surprise me to learn that a few "blockbuster" drugs had 80% of the cost in massive advertising and good-will pushes to seed the public consciousness about them so they could make more money in the end, so I'm really skeptical that $2 to $3 billion is an accurate indication of drug development cost just as much as I'm skeptical that a $19 million median trial cost equates directly to the drug development cost in a way that's obvious from that number alone.
1: Referenced and linked in JLU article, but here's the link as well: https://www.sciencedirect.com/science/article/abs/pii/S01676...
Random resellers on China have no reason to care about US patents.
I'm thinking of the 'sawstop' and 'festool domino' woodworking tools here. Which are important innovations that were probably motivated by patents, but whose patents have run long.
The inventor reached out to several saw makers to license his new invention. None of them took it seriously. So he went and started a company with his new patent and became successful. Then other companies (Bosch specifically) tried to rip his tech off after they saw how effective it is, and he got to sue them and win.
Also, their patents are about to or have already expired (https://www.reddit.com/r/Tools/comments/p6bhhb/so_are_the_sa...)
Sounds like the 20 years gave him just enough time to:
1. Attempt to license the product and fail 2. Create a company 3. Market the company / product effectively 4. Exit ( https://www.sawstop.com/news/sawstop-to-be-acquired-by-tts-t... )
And now competition will begin to roll out their similar saws. I think 5 years would've been far too short for him. He would've been squashed. There would've been no motivation for companies to license his tech or buy out his company. They would've just waited 5 measly years and then stomped him.
Now. If this was software, this whole thing would've played out in what? 5 years? 10 tops? So 20 years, to me, seems to be about right for some things. but absolutely TERRIBLE for others.
And the lawsuit over it: https://generalpatent.com/professor-s-company-wins-1-6-milli...
> November 26, 2012 - Innovention Toys LLC, a company headed by a Colorado professor named Michael Larson, won its patent infringement lawsuit against MGA, Wal-Mart Stores and Toys "R" Us. A federal jury in New Orleans found that the defendants had infringed Innovention's patent on a strategy board game using lasers and mirrors.
---
Back in the days of http://www.gamecabinet.com being one of the primary sources for board games on the web you'll note a search on it: http://www.gamecabinet.com/info/PatentSearch.html
One of the things this let people do is find games that were patented, but never published.
Sid Sackson wrote in A Gamut of Games:
> The files of patents that have been granted are a fruitful hunting ground for forgotten games, although going through these files, as anyone who has ever been involved in a patent search well knows, is a time consuming job. Often the patented games are downright silly, such as a set of dominos made of rubber so that they can double as ink erasers (No. 729,489) or a sliding block puzzle with edible pieces so that a player who despairs of a solution can find collation in gratifying his stomach (No. 1,274,294). Often the patents are repetitious: There are over a thousand different baseball games.
The publishing of a patent maintains the ideas - even if they never got anywhere. If you know how to look, its an archive of decades of board games rules... written in patentease.
Note that despite the above, don't buy a tool without those safety features. Better to spend more now and live than get your heirs a pile of money.
It's frustrating because I'd much rather have a proper European sliding table saw like the Robland CZ-300 II, but I don't want to give up the safety of a Sawstop system.
The bosch system was significantly different. Notably having the advantage of not destroying the blade when triggered. The sawstop patent removed this major innovation from the market. A clear example of stifled innovation.
Moreover, sawstop doesn't sell in Europe, nor license. Which leaves me with no option to make use of this great innovation. Not quite stiffling innovation, but still making the world worse.
With a 5 year patent, sawstop would still have been profitable I believe. But we would have safer tablesaws around the world, we would have systems that don't ruin blades when triggered, and probably have many other innovations on top of that.
Everyone wins: the inventor gets a payday even if he can't deliver directly, consumers don't have to choose between "brand I trust" and "patent-exclusive feature I need", and manufacturers stay out of the courts.
You get the payday, whether it's your one man startup or a massive industrial that actually delivers the product to market.
We have. Public funded (also via universities) and donation based research.
But investment money is kind of big and if it would suddenly disappear, it will hurt current research as most (?) of it is dependant on it. But all that money would not necessarily disappear, when patents suddelny gets abolished, as there is also the option of increased secrecy.
Meaning they make effective pills, and work with regulators to test them - but share little about the manufacturing process. I believe that is already happening to some extent, but would likely increase a lot.
Not sure the increased secrecy would help all that much. Is drug manufacturing that complicated that a motivated company could not reverse engineer a new drug solely from its off-the-shelf product, without too much trouble?
We do have problems elsewhere in the system, though:
1) Drug ads. They should be pretty much nuked from orbit. Drugs are a medical decision, any promotion activities should be directed at doctors, not patients. I would make an exception for drugs that radically improve treatment for something patients might have considered something they just have to live with and not told their doctors about. (I have Viagra in mind here--and that's the only one that comes to mind.) In such a case I would only permit "there is a new treatment for X, talk to your doctor", no names of either the drug or the company.
2) Dodgy approval decisions. The recent Alzheimer's drug comes to mind.
3) Drug companies should not be able to find out what doctors prescribe. That creates a conflict of interest.
4) I question whether drug makers should even be allowed to do the phase III testing at all. That puts the researchers in a position where a no decision could be bad for them down the road.
On the flip side, I think we could benefit from having an appears-to-work type of approval. It would require extensive real-world use data (either from foreign use or like what we have seen with marijuana being widely used for chemotherapy nausea) but not the usual approval process. Obviously, no patents, but all companies selling it would be required to put some specified percent of sales into a pool used to fund more research. (And I wouldn't mind doing something like that for all drugs, albeit at a lower percentage. Every drug has say a 5% tax that goes into a FDA account for that drug. When there's enough money in the account to fund useful research about it the FDA does so. Common off-label uses would be prime candidates for such studies.)
...because it's an argument in bad faith? I too don't see why drug patents are "obvious" or clear case that it is helpful enough to be in the public interest to maintain drug patents. Is there any evidence that drug patents can actually enter the public domain productively at their end of their expiration period?
I mean, if James Collip and Charles Best sold the insulin patent to the University of Toronto for a mere $1 each, "so that everyone could have it" and we still don't have universal low-cost insulin over 100 years later, and prices continue to skyrocket, I'm more inclined to believe that for-profit medicine is just evil.
https://publichealth.jhu.edu/2023/eli-lilly-lowers-insulin-p...
> “Even though they're dropping their list price by 70% and capping their cost to patients at $35, it’s important for us to make this very, very clear—the company is still making a profit,”
...
> During a 2019 congressional hearing, insulin makers admitted that there’s pressure to keep list prices high so that PBMs can also profit.
> PBMs favor the drugs that will yield them higher profits. By lowering prices, Lilly runs the risk of being excluded from formularies, meaning the insurance companies will no longer cover the product for their patients.
Are you actually serious? Practically all generic drugs are available because the original drug is off-patent. You picked one (insulin) and ignore, oh, take Alprazolam :
https://www.drugs.com/alprazolam.html generic for Xanax.
or all the others:
https://www.healthgrades.com/right-care/patient-advocate/dru...
From the page you linked:
> While these drugs are nearing the end of their patent term, the release of generics may be delayed due to litigation, acquisitions, or other exclusivities. As a result, some expected generics from previous years may still be in progress.
The point about the PBMs is that apparently, drugs have to be profitable or they are not made anymore. So even the generic companies need to position themselves in a way where their products are profitable, not only for them but for the insurance (or they will be dropped by formularies, and nobody's insurance will cover it.)
If patents are the only way for firms to protect the profitability of their drugs then we are doomed.
I picked one, sure, and you provided a list as counter-example. But the FDA also ships its own list... of off-patent approved drugs without an approved generic (and the current publication is a full 16 pages of drug names):
https://www.fda.gov/drugs/abbreviated-new-drug-application-a...
If the pharma companies can make a change to the formula so that the new formula of a drug is no longer covered by the original patent, they can get a new patent. I'm not an expert, but this is how I've understood the problem through reading about it. Yes, we have generics, but what doctor will prescribe "worse-pirin" when there's a better aspirin on the market now? What insurance company will cover it?
So, with 20 years of head start and a deep war chest, the companies you mentioned can all iterate, stop research on the previous drug, put up legal roadblocks in the way of their competition, put out a new drug which cannot be copied, while it costs a lot of money for competition to get their generic form of the drug tested and approved. It's not as automatic as the term "patent cliff" might suggest.
I'm just saying that the intent of patents in general is for innovations to enter the public domain after the period of exclusivity on the idea that enables their creators to enjoy profitability and a legally protected (temporary) monopoly on the idea. It seems like a fair question to ask, is that really what's happening? (What percent of time does it happen like that, what percent of time does it go down some other way?)
I never said they did. However, there are giant companies that do almost nothing but generics, like Teva, so obviously lots of generics exist:
https://www.tevapharm.com/our-company/teva-facts-figures/
As for "what doctor will prescribe "worse-pirin" when there's a better aspirin on the market now? What insurance company will cover it?"
nearly all insurance companies require a generic to be used unless there's a very strong reason to use the branded product. In your example, if the new drug genuinely is better, then the patients deserve to have it. If it's a trivial improvement then it won't get approved.
This is an extremely disingenuous reading of our conversation. I made a specific statement about a particular instance (which you dismissed as cherry-picking), and I asked a question at the same time. Which you reduced overall to a "general statement" while dismissing the specific example that was really important to the context of what point I was trying to make:
> James Collip and Charles Best [donated] the insulin patent "so that everyone could have it" and we still don't have universal low-cost insulin over 100 years later, and prices continue to skyrocket
> Is there any evidence that drug patents can actually enter the public domain productively at their end of their expiration period?
There's an impedance mismatch between "nearly all insurance companies require a generic to be used" and "drug patents should be clearly in the public interest" when "drugs have to be profitable or they are not made by companies anymore."
Why not engage a bit more directly with the original example, if you're going to accuse me of generalizing now? Let's talk about insulin, I'm sure I picked it for a reason.
Is there a generic insulin that is chemically identical to a name brand insulin with the same efficacy? No, there apparently is not [1] – I won't claim to be fully informed on these issues, but it seems pretty clear from reading that the issue cannot simply be reduced to "lots of generics exist, so you are mistaken."
Why can't we have low cost insulin from an entity that operates like the post office, that exists as a public benefit corporation without any profit motive?
Does it really make sense that people who have insurance that is not "top tier" will not have access to the better (still patented) drugs, if they are really better? Are they better, or are they really just "evergreening" patents? If insurance typically only covers generics, then it's really problematic that there is no generic form of this lifesaving drug, and the monopoly persists more than 80 years after the patent should have expired on the original invention!
The deal was supposed to be 20 years. What went wrong, does it "go wrong" a lot, and does it "go wrong" more or less frequently when human lives are at stake? These aren't unfair questions, and if Teva (or any company other than Eli Lilly) made a generic form of Humalog insulin then I probably would not ask them at all. But only Eli Lilly does, only Eli Lilly can.
The same company apparently makes the so-called "generic" insulin that also makes the top-tier patented "Humalog" so maybe there are too many regulatory hurdles or something else is wrong. (I thought that the generics were supposed to represent the competition, that comes to save the day after patents expire...)
If we're central planning, wouldn't we want to promote a resource arrangement such that the best drugs with the most promise and the greatest life-saving properties will go to the most people? Is it really so off-base to conjecture that a resource arrangement that actively does something else is "really evil?"
[1]: https://www.healthline.com/diabetesmine/why-is-there-no-gene...
How is it "disingenuous" to quote that? I'm not "accusing you of generalizing" -- you did it.
I don't care to engage with you about insulin or indeed drug patents in general. Just say what you actually mean.
I put it back there because that was the context that I felt was most important, and you just cut it right back out again. You're not arguing in good faith at all.
"...because it's an argument in bad faith? I too don't see why drug patents are "obvious" or clear case that it is helpful enough to be in the public interest to maintain drug patents. Is there any evidence that ALL drug patents actually enter the public domain productively at their end of their expiration period?" [note the ALL]
Since you refuse to just admit you were wrong, we are done here. Go ahead and have the last word if that's important to you. I won't be replying any more.
I'd love to see more of this.
Historically, before the homogenization of IP law, pharmaceuticals had different patent protection in different countries, ranging from very strong (the US), to weak (most of Europe) to excluded (Switzerland). The most successful and innovative pharma companies who were outspending everyone else on R&D were from Switzerland. Patentability of pharmaceuticals suddenly gave US companies a big boost and was really a lobbying success, so they managed to gain strong market positions without much innovation.
I’m trying to workout why Swiss companies would outspend the rest, is it that patents incentivise sitting on your laurels? And did drugs require the huge testing they need now?
If patents were abolished, the FDA could instead be authorized to blanket grant such exclusivity to genuinely new drugs, with pretty much the same effect as patents.
https://www.patentlyapple.com/2020/08/apple-has-been-granted...
The funniest hypocrisy of Silicon Valley/tech culture is that it’s full of people who think the rules and laws don’t apply to them but they vote every year for more and more regulations, that they then brazenly flout and act all indignant that the government has failed to do the things they voted for (and thus we need more government) but then refuse to actually follow.