There have been several historical studies done on the effects of patents on innovation, and the results are mixed. For an example of the "patents may hurt innovation" side, see http://levine.sscnet.ucla.edu/papers/ip.ch.1.m1004.pdf , which argues that the steam engine patents actually held back the development of superior steam engines, reduced the total horsepower deployed, and even distracted Watt (the inventor) from his business.
I've seen more detailed studies of patent history (which I can no longer find, alas), and they make a good case that patents have an ambiguous effects on industrial innovation. I'm not sure if I believe these studies, but I don't think it's an open and shut case either way. Also, steam engines may have different issues than drug development, and drug developent may have different issues than software.
Drug development is an interesting case, because the costs aren't associated with the research: they're associated with the safety testing. This has horribly distorting effects.
This is an interesting postulation and one I can support in theory.
My reaction though is tempered in the same way when I hear a US Federal Government person (ex: Secretary of Health) claim that a system of "Patient Empowerment and Patient Choice" is an ideal situation. I disagree. Looking at Health Statistics Reality (cough) a large portion of the US Population has made categorically bad decisions. Obesity. Heart Disease by way of contributing factors.
I get the rationale behind empowerment and allowing patients to find the "best" care around, but trusting Average Health Consumer to make Medical choices when they can't even get Dietary choices right is problematic.
While I agree with your overall sentiment, the Levine book is not a good reference. Here's a comment I'd posted about the book in the past:
I would be wary of taking that book at its word. The authors have an agenda and they are not afraid to twist historical facts to suit their narrative. I mean, their very first chapter begins with a lie which perpetuates the myth that Watt's patent retarded steam development [1].
When the authors of [1] called out Boldrin and Levine on this, the latter responded by fabricating new myths rather than admit that the truth undermined their narrative [2].
The very chapter you cite itself has such inaccuracies. I did not track down all the stuff they cite, but I did find an instance of mischaracterizing references to suit their view points. For instance, when they discuss the German dyestuff industry, they cite a study by Murmann to support their narrative that Germany dominated in that industry due to the lack of patents. But if you look at the actual study itself, Murmann paints (heh) a very different picture: German dominance in that industry was fueled by close ties with academic research, and later by R&D labs encouraged by, of all things, the newly introduced patent laws:
>When in 1877 German patent law protected dye innovations, a few German firms such as Hoechst, BASF, and AGFA saw the advantage of hiring organic chemists whose sole task was to synthesize new dyes. After these research chemists turned out economically successful dyes, firms hired more and more chemists and pioneered an entirely new corporate function, formally organized research. The birth of corporate research and development (R&D), which today is a standard activity in high-tech industries ... can be traced to the German synthetic dye firms in 1880s. By the 1890s the vast majority of dyes were being discovered in the R&D laboratories of Bayer, Hoechst, and BASF.
> Whereas in the early days of the industry a firm could exist by copying dyes invented somewhere else, patent laws made the systematic application of science within the boundaries of the firm a critical dimension of remaining a leader in the industry.
Moreover:
> The most important institution in the early success of the German dye industry was the university system, but patent laws were a second key factor that allowed the German firms to capture a dominant position.
With that many assertions in the study that refute their view, they cherry-pick a few comments and actually cite the study as one that supports their view.
With so many accuracies in there, I find it hard to take anything else they say in that book at their word.
For another famous example, the Wright brothers spent most of their latter life litigating patents [1]. Who knows what other great things they might have invented otherwise.
Patents are actually proven harmful in certain domain, including software. More than half of the R&D costs are now patent legal bullshit related & stuff, which is insane.
This view is often taken, especially historically, that complicated/expensive things to figure out wouldn't exist without such protection.
The problem with this line of thought, which can and often-has been true in specific instances... is that protection outcome will always need to be the case, and always remain the case, and that the funder-of-creators get to decide that.
Often something complicated/expensive to think about and solve for one group, is easy and obvious to others. Especially over time and with other out-of-bound advances applied.
Comedic routines would still exist for example, if people repeated other people's jokes/sets. Granted that would be copyright in that case... but the logic applies there also, and we have the same challenge and arguments, by people who insist there would not be nice things without the protection to justify the cost of the outcome generation method.
It's interesting to note Lexmark tried to (ab)use other kinds of so-called "intelectual property" laws earlier: the copyright law and DMCA. When they failed, they decided to use patents instead. And all this for what purpose? To prevent people from using cartridges manufactured by other companies, i.e. blocking competition and acting against free market and user rights. If this isn't abuse, I don't know what it is.
If you can't build a superior product supported by good marketing, don't try to save yourself by legal action. If you do, you only alienate your customers, the very people you should serve first.
The thing is there are printers without the stupid on the market.
So the EFF is wrong, patents haven't savaged the printer marketplace, there are nice printers available that are not expensive. And it's wrong that the market will punish shitty products, Lexmark is one of the few survivors in the printer business.
Sure, it's not a free market. What does that have to do with what I said?
My claim is that reasonable printers that are free of bullshit exist for most purposes (prior to Epson switching to reservoir printers, the home color printer market was pretty thin) and yet companies that do use bullshit tactics continue to exist. So the printers exist (patents have not particularly held them back) and for some reason enough people ignore these reasonable printers for companies using abusive tactics to survive.
The strategy people should be following is to buy the printer based on the cost of consumables. It's what I do. But most people do the strategy of
1. find the model where the company subsidizes the printer to sell the ink
2. Then try to work around the lockouts the company has on the ink market.
Both sides are trying to screw each other over. I see no reason to care. If the people trying to use third-party ink really succeed, all that will happen is that the market strategy will disappear, and so the third-party ink market will vanish. (I really wonder how you run a business where if you really win you go out of business. You need to hope the other side keeps on fighting just enough that you can attract all the people who enjoy fighting over pennies.)
You are assuming that the average customer knows that the company is subsidizing the printer to sell the ink. . . I don't think that is true. I think the average person sees a great deal on a printer and is genuinely surprised when they find it drinks ink like it's Octoberfest.
At the time of purchase you can find these things out by researching the price of the replacement ink cartridge and its page rating. (Page rating is soft/fudgeable but should at least be a reasonable way to ballpark the lifespan of the cartridge.) I would consider this cursory research when evaluating a purchase that takes an ongoing supply of consumables.
To me it sort of seems like you're saying "Wow this dryer uses way more electricity than I thought it would!" or "Wow I bought this razor handle and the blades are really expensive!" or "Wow Swiffer really screws you with the replacement wipes!" or "Wow this car takes expensive tires!" -- even though the numbers for the ongoing consumables were available at the time of purchase.
So every time I buy a swifter or razor or dryer I have to do thorough research on things like power consumption, cost of replacement parts etc. No! I have a life, I have other things to do. I buy from large brand names like Lexar because I expect them to be honest and engage in fair dealing and because researching every aspect of products I buy would be a full time job in itself.
I get where you're coming from, but this concept you take issue with goes by another name: "due diligence"
I'd even argue that selling a cheap ~$50 printer and then expecting to make it back on consumables is a legitimate business model. If you're the kind of person who prints once in a blue moon, it makes more sense than buying a ~$200 laser printer.
Printers are generally expensive and generally last a few years. They're not casual, off-the-cuff purchases. Much like a computer, they are a precision machine, but with many more moving parts. I really don't believe it's unreasonable to do a couple hours worth of research on something that'll be in your home or office, possibly doing Important Serious Business Things, for years.
The problem is lack of knowledge, the average customer, including me when I bought my current crappy printer, doesn't have enough knowledge to know that certain printers eat ink. In fact, printer companies that use these sales tactics are relying on lack of customer knowledge. So it's not really reasonable to say that people are ingoring good companies and going to ones that use abusive tactics, its' more that people just don't know.
I get that the customer has some responsibilities, but it doesn't make sense to say that the customer has to exhaustively reserach the ethics of every single company they buy something from. That would make buying a full time job considering our complex modern economy where customers regularly interact with many many companies and buy many many things
The problem with the "it's not a free market" argument is that ultimately almost nothing is a purely free market when you drill down. Not only that, but wether a market free or not has only tangential relation to the question of if the market is competitive - which is what most people are actually after when they start talking about free markets.
I think the question is what would competitors find more lucrative, calling out Lexmark through marketing, or using the precedent set to do the same thing. Unfortunately, I suspect it's the latter.
Given that it's a new tactic, I think previously they didn't consider it or discounted it as not worth pursuing, but now that it's in court they are waiting to see how it goes. It's not like other companies haven't aggressively fought against third party ink refilling in other ways[1].
I'd _agree_ with you if the EFF claimed that, but they didn't in the article linked. The EFF here isn't making broad brush claims about market structures, except maybe for this section:
> "Courts and legal scholars have long acknowledged that such restrictions impair the purchasers’ personal autonomy, interfere with efficient use of property, create confusion in markets, and increase information costs"
But even here I argue that's the wrong reading. When taken in the context of the rest of the article, this appears to be a traditional consumer advocacy approach taken from the Ralph Nader playbook.
It is almost impossible for new competition to enter the printer market because it is so patent encumbered. That's why you can only buy a printer from Canon (inc. HP brand), Epson, Lexmark (inc. Dell brand), Samsung, and Brother.
Anyone trying to start a new printer company will get sued into the ground or blocked by a US court from even importing their printers. That's why countries without strong patent protections have a local printer brand that costs half as much or less.
It is also why we witnessed such a strong 3D printer marketplace for a while, different companies entering an unencumbered market and trying to establish a monopoly via IP protections.
Printer innovation is non-existent (outside of innovate ways to make more money, like subscriptions). That's because there's no threat to their position, nobody can go near printers and they know it.
That hasn't been true for years. HP's original Inkjet patents are long expired. That technology was a major breakthrough. They had to do fluid simulations on a supercomputer to get the ink control to work right. Someone involved once told me that intuition totally fails on that problem - fluid behavior on that scale is not at all like what one might expect.
They'd very likely try (hard), even if they eventually end up losing. Then try again a different way using a different approach, then again (etc). "Drown the opposition" in legal fees seems to be a commonly used tactic by larger (bullying) companies.
The company, HF Global, Inc., is privately held, and as far as I can tell with a Google search, no other razor company owns a majority of the stock, or any stock at all.
It may feel logical, but it isn't. The Lexmark suit isn't about free products, it's about them being able to restrict what you do with a product AFTER you paid for it. You probably should read the entire article before chiming in.
while this may be, when it comes to the EFF I give them some latitude. I think they're fighting the good fight in general and if they get more exposure then I'm ok with that.
Time and time again the EFF articles throw so many coats of fear mongering and "Chicken Little" doom over worthwhile subjects and causes for Review / Reform / Revision that they become an art of self-parody. If they'd drop the National Enquirer song and dance of extrapolating one to three case examples into an epidemic it would be to their benefit, in my opinion. They're free to behave as they please and raise funds if it works for them, and I'm fortunate enough to live in a place where I can criticize openly, because I do share some guiding principles I'm certain.
The title is a play on the phrase "this is why we can't have nice things." To me, this reminds us that the things we have, we might not own.
"Control what you do with your stuff" sounds like the concept of ownership.
Yes patents do other things but according to Lexmark their patent means you don't get to do the things you traditionally get to do with the printer you bought.
To me, the phrase has always referred to a scenario where someone misuses a privilege, which is then taken away from everyone. And I don't see what that has to do with this circumstance.
Without the guarantee of a patented marked up drug, would drug companies waste the same amount of money that they currently do on R&D? I'm of the opinion that we would see a major slow down in drug innovation without patents.
R&D is very wasteful and expensive. Patents prevent competition for a short period of time to help the business recoup losses from failed experiments and to deliver profits which serve as an incentive for more innovation.
Maybe tie the patent duration to some measure of how long the invention took to develop? An algorithm that took a day from napkin to filing for the patent? You get a day of protection. A drug that took 10 years to develop? You get 10 years.
The difficulty there preventing companies from exaggerating about the time it took to develop. I suppose it's not too much to ask companies to show written evidence of the date that a specific invention process commenced.
> Patents prevent competition for a short period of time to help the business recoup losses from failed experiments and to deliver profits which serve as an incentive for more innovation.
Is 20 years a short period of time? It seems like we'd get most of the benefits with fewer drawbacks by just shortening the time patents are granted for.
See my other comment. 20 years may be too long for some industries (software), but may not be long enough/ structured properly for R&D heavy industries like pharmaceuticals and biosciences.
Biologics (all the -mab drugs, monoclonal antibodies, adalimumab Humira) are a treat because you have to share your methodology, but you do not have to share your cell culture line. Since the cell line itself needs to be approved, the me-too's have to go through ALL the trouble themselves.
The problem is that there can be a significant amount of time between wanting to protect an idea and when you can effectively monetize that idea. It might take an inventor 10 years to work out the kinks in an invention and build a market for it to the point that they can really reap the rewards. I think anywhere between 10 and 20 years is a reasonable range.
On the other hand, copyright terms are just bat-shit insane and needs to be scaled back tremendously.
Why can't patents have a duration? If you're the first to come up with an idea, you get 5 years head start before competitors can use your patent for their own ends. If you never have the resources to materialize your idea or can't find a seat in the market, that's unfortunate but oh well. We can't keep allowing battery technology to be held back because Exxon bought up all the patents years ago.
I don't believe patents, as they are, are doing very much toward their original goal. Right now, and perhaps this is my frustrated cynicism here, they just look like one more method for those with money to bully those without.
Drugs fall into a problematic territory here. I don't know enough about big pharma to have an informed conversation but I feel like there are other options available to us. Pharma R&D is what is always, always, always trotted out as a defense for our absurd patent system. The whole world has to get shafted with a bad system because one industry can't figure out another way?
A big part of the high price of drugs is that the pharmaceutical companies have essentially a mad dash to recoup the (m/b)illions of dollars spent on R&D and clinical trials. Patent process has to begin once the target is discovered (e.g. assayed). Now you have to do further assays (0.5-1y), non-clinical safety studies (0.5-2y), route scouting and scale up (a few months), several years of clinical trials, then scale up the process to manufacturing. You've just burned 5-8 years of your patent protection. You have 15 years or less to recoup the cost of not only this drug, but all others that failed to get through the pipeline (which can be as much as 5-to-1).
Once it goes off patent, 80% of the sales of brand name can vanish [1]. Getting a generic approved is a fraction of the time and cost as getting the original through the pipeline. It's like P vs NP, since the FDA approval means publishing pretty much a how-to guide (synthesis route) and much of the safety data. You just have to demonstrate "our stuff is the same as the proven stuff".
I've long been a proponent of "15 years from FDA approval" - this gives a reliable, predictable cushion, without having to predict clinical failure rates. More time can be spent on safety studies (NCSS) and less costly Phase I and II trials, ideally leading to safer and more effective drugs. There is still pressure to move quick, because as soon as the clinical trials start, other companies have access to the leads you are looking at, and can simulate the structure and look for similar leads.
I'm not opposed to a different system for different industries.
I'm just saying that, for example, I don't think we would've discovered a hep-c drug without the incentive of exclusive rights to sell the drug. I think the individual researchers are probably motivated by their desire to help people, but corporations don't run on altruism.
I see this sentiment a lot- "yes patents are bad for individuals and from a macroeconomic perspective, but we need them so that Big Pharma can ultimately improve our quality of life."
I wonder though, has anyone studied to see if that holds up? I suspect that our quality of life improvements come from infrastructure like access to safe drinking water, and general accessibility to medicines not protected by intellectual property monopolies.
Yes, this has been studied. Pharmaceuticals are actually one of the few areas where patents and other IP protections do actually encourage innovation. For most areas tho the protections seem to be of (significantly) net negative utility.
A good part of R&D are not made with the companies money but with the taxpayers money, the company work on the 50% final part after the government took most of the risks.
We just need shorter patents. For example drug companies spend far more on marketing than they do on R&D and a substantial amount of the research that generates new drugs comes from government funded research (>50%). Also, it's been demonstrated that taxpayer funded research drives private R&D up. So if I was dictator, I'd make it illegal to advertise drugs on tv/radio/web, double the current government budget for drug development R&D and make medical patents expire much more quickly. (And maybe something to allow Americans to buy drugs from overseas markets? Not sure on that one yet)
I'm a proponent of these ideas. Patent duration as a function of private capital spent? It would have to be immune to "profit-shifting" but maybe that could be a good alternative.
You are getting close to advocating for "cost plus" which sounds really good to outsiders who are concerned about "too much profit" but have stunted every industry into which they have been deployed, and end up driving prices as suppliers look for ways to increase how much they spend. (The more they spend, the more profit they can make.) Look at the aerospace industry.
I'm not concerned about too much profit. I'm just concerned about stifling competition for too long. Patents feel like crony capitalism in some industries.
After posting I did consider the lone software engineer who comes up with a great idea, creates an app, and his app is then copied by Google who has much better marketing and distribution resources.
If patent duration was a function of investment in R&D, this software developer would be SOL because he invested little into his "eureka" idea.
The government does not pay for development, they pay for a portion of basic research across all research areas (and it's nowhere near 50% of all research funds or drug research funds). The entire NIH budget is about 32 billion. Large pharma companies spent around 50 billion on R&D in 2010: http://www.nature.com/nrd/journal/v9/n3/full/nrd3078.html
The incredibly expensive pharma and device development costs are shouldered by industry. The government does not have the risk tolerance or patience for development.
Right now a significant portion of the patent lifetime is spent with the drug in clinical trials unable to be sold. Shortening the patent lifetime would increase prices until the drug went generic, not decrease them,as companies would have less time to get ROI.
The industry is much more complicated than you are making it out to be, and trying to make it unprofitable would not help innovation.
>Once a company has good data, the FDA approval process is moving faster than ever. According to the agency’s most recent progress report, the standard review process now takes a median 10 months, down from nearly 13 months in 2005. Companies can shave another two months off if they get a priority review. In fiscal year 2014, the most recent data available, 92 percent of drugs were approved on first pass, up from 60 percent in 2005.
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>Shortening the patent lifetime would increase prices until the drug went generic, not decrease them,as companies would have less time to get ROI.
Hence why I also consider opening up the drug market to other countries. If drugmakers need to make all their profit front-loaded then they can at least spread it geographically so Americans don't have to suffer under these prices.
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>and trying to make it unprofitable would not help innovation.
Here is a comparison between the biotech industry and the S&P 500 starting from approximately the lowest point of the recession. Now come on, do you really think this industry is struggling? How is it that these companies get away with telling investors one thing ("business is great, invest!") and the public another ("regulatory overreach is killing us!")?
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>The government does not pay for development, they pay for a portion of basic research across all research areas (and it's nowhere near 50% of all research funds or drug research funds). The entire NIH budget is about 32 billion. Large pharma companies spent around 50 billion on R&D in 2010: http://www.nature.com/nrd/journal/v9/n3/full/nrd3078.html
I'll admit, it looks like my number of over 50% came from 1995. Also, I spent a long time tracking down this 50 billion number and it's original source (took a bit). It looks like it was originally published here(and other PHRMA industry reports):
So PHRMA is an industry group and I was interested in their methodology which is also very hard to find but lo and behold:
>In 1991, Joseph DiMasi and colleagues from the Tufts Center for the Study of Drug Development published a widely quoted, comprehensive study of drug development costs. Using project data from confidential surveys, the study estimated cash outlays of around $169M to successfully bring a drug to market during a period beginning in the 1970s. PhRMA relies on this research as the foundation for their statements about the cost of drug development. However, PhRMA uses different assumptions about a "hidden" expense called "opportunity cost" that boosts t...
> >And for most new drugs, patents expire approximately 12 years after market introduction.
The length of a drug patent is 20 years, 8 of which by your statement are spent in development. So yes, almost half the patent duration is spent with the drug off the market. This is burden almost no other industry has to deal with. My original statement is completely valid.
> Hence why I also consider opening up the drug market to other countries. If drugmakers need to make all their profit front-loaded then they can at least spread it geographically so Americans don't have to suffer under these prices.
Other countries place more stringent price ceilings on the cost of pharmaceuticals, which is why there is such a disparity between what we are paying and what others are paying. If we want to spread the cost burden geographically, countries benefiting from these products should be pressured to remove their price ceilings, which would lower costs in the US. Opening up the markets to other countries is just regulatory arbitrage, not spreading of cost burden.
Also, if I'm interpreting this correctly, nothing you posted suggests that the government is the primary backer of pharmaceutical research. We can argue over whether the research costs are 50 billion or 30 billion or whatever, but your original claim is still incorrect unless the numbers are off by literally an order of magnitude.
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>The length of a drug patent is 20 years, 8 of which by your statement are spent in development. So yes, almost half the patent duration is spent with the drug off the market. This is burden almost no other industry has to deal with. My original statement is completely valid.
And yet they seem to be doing just fine, check that stock price chart above. Part of this is because 12 years is already pretty long, they're obviously making their money back. Also, there are all sorts of strategies these companies use in order to avoid true patent expiration.
>The problem is, these modified drugs don’t offer enough of an advantage over generic versions of the original molecules, says Jim Keon, president of the Canadian Generic Pharmaceutical Association. So the sophisticated lifecycle plans brand-name companies have for their products — rolling out new versions when patents near expiry — are created primarily to help bottom lines rather than patients. And the argument that this is necessary to earn enough money to reinvest in new R&D doesn’t hold much weight, suggests Keon, if that research only results in more “me-too” drugs. “They have to recoup R&D costs, yes, but the question is: Is it useful R&D? If the R&D is just to tweak a product to get more monopoly protection without really providing an improved medication, then maybe it doesn’t deserve a patent,” says Keon.
>Nexium illustrates the drug makers’ strategy. Many chemicals come in two versions, each a mirror image of the other: an L-isomer and an R-isomer. (The “L” is for left, the “R” is for right.) Nexium’s predecessor Prilosec is a mixture of both isomers. When Prilosec’s patent expired in 2001, the drug maker was ready with Nexium, which contains only the L-isomer.
>AstraZeneca somehow managed to convince the US Patent Office that Nexium was substantially different from Prilosec, and thus should be granted its own patent, along with 20 years of protection
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>Also, if I'm interpreting this correctly, nothing you posted suggests that the government is the primary backer of pharmaceutical research. We can argue over whether the research costs are 50 billion or 30 billion or whatever, but your original claim is still incorrect unless the numbers are off by literally an order of magnitude.
I admitted that was a tad misleading, here's the fact I was thinking of. I should have linked it earlier.
>An internal National Institutes of Health (NIH) document, obtained by Public Citizen through the Freedom of Information Act, shows how crucial taxpayer-funded research is to top-selling drugs. According to the NIH, taxpayer-funded scientists conducted 55 percent of the research projects that led to the discovery and development of the top five selling drugs in 1995. (See Section III)
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>Other countries place more stringent price ceilings on the cost of pharmaceuticals, which is why there is such a disparity between what we are paying and what others are paying. If we want to spread the cost burden geographically, countries benefiting from these products should be pressured to remove their price ceilings, which would lower costs in the US. Opening ...
>Nexium illustrates the drug makers’ strategy. Many chemicals come in two versions, each a mirror image of the other: an L-isomer and an R-isomer. (The “L” is for left, the “R” is for right.) Nexium’s predecessor Prilosec is a mixture of both isomers. When Prilosec’s patent expired in 2001, the drug maker was ready with Nexium, which contains only the L-isomer.
And yet, prilosec is an OTC medication which anyone can buy for about 10 dollars, so who gives a shit. So what if a reformulation leads to a new patented product if the old formulation becomes a generic and is readily available? Also, reformulating to reduce dosage requirements to improve adherence is a legitimate product improvement so I don't see why it's problematic at all to seek another patent.
>An internal National Institutes of Health (NIH) document, obtained by Public Citizen through the Freedom of Information Act, shows how crucial taxpayer-funded research is to top-selling drugs. According to the NIH, taxpayer-funded scientists conducted 55 percent of the research projects that led to the discovery and development of the top five selling drugs in 1995. (See Section III)
Yup. I'm a huge proponent of basic research and I think we can do more of it. But saying basic research "leads to" drugs is also misleading. Basic research typically only establishes that a compound has basic efficacy in a cell model or an animal model. There's a lot more work that needs to be done to validate that the compound works in a human.
> American citizens alone bear the cost of R&D for the world because every other country sets price ceilings?
Yes, pretty much. We subsidize drug development for much of the world.
> Also, I'll just once again point out that our drug development industry is not struggling! It's doing great right now, they spend lots of money on dividends and stock buybacks and advertising and still make fantastic profits. They're fine.
The whole stock market is doing great right now. By this logic everyone should drop the price on all goods because their stock prices are going up.
This is nuts. By the time a major drug is ready for market, out of a 20 year patent there are usually only 5 years left. How much shorter do you think it should be? When they are operating under that kind of deadline, they don't have time for word-of-mouth marketing.
For software, sure, I'm really willing to hear arguments that 20 years is too long. But drug patents lifetimes are already very small. If something is too expensive, wait a few years.
> In medicine, you often can't just wait it out. Healthcare is not a normal market
Then you pay.
I have family members who are only functional because of prescription drugs. When I see someone on HN talk about how "oh, it will probably be okay if we mess with this market, I read this really cool article online that said so," I see them no different than someone who decided on their own to start tinkering with grandpa's iron lung, because "oh, it will probably be okay." You don't know what you are messing with. Stop it.
>And for most new drugs, patents expire approximately 12 years after market introduction.
I don't know what the HBR's source is because they don't tell me. I am telling you to find any drug you see newly on the market, particularly one you see on tv since you worry about marketing budgets, and look up when its patent expires.
Why is one length of patent good for all drugs. Create the cure for cancer I can see you getting 30 years, add a antacid to an existing drug you should get 5.
Perhaps they should be different, but people get most upset about the awesome drugs that cure things completely being under patent for so long. They don't care about that antacid drug so much. You would find yourself very short on allies with your proposal.
All the money going towards marketing would instead go towards lobbying, towards getting the government agency in charge of deciding "what really counts" for deciding that this drug should be one of them. When the US government was looking at how to create incentives for invention, they did look at rewards systems, and this was the common problem. Using the market system, for all its faults and ways it could be improved, at least sends proper price signals to producers and consumers.
We are being asked to make the same hard decisions that each generation before us has made. And we are doing it while being far richer and having a greater repository of knowledge than them. Something's wrong with us if we quit where they preserved in worse conditions.
WHO is far richer, and WHO should pay for it? Are we fine with these companies spending 1/4 of their combined profits and marketing on R & D, as J&J does? At best, this is a remarkably inefficient way to drive innovation.
The largest 10 pharmaceutical companies spent a combined $32.5B more on sales and marketing than R & D. No problem here? People are skipping dosing to stretch their meds further. Some people can't afford meds at all.
And if you can't afford it? Does society pay? Do we let them die? I'm interested in your answer.
>I have family members who are only functional because of prescription drugs.
Me too.
>I don't know what the HBR's source is because they don't tell me.
And I don't know where your 5 year number comes from because you didn't provide a source.
When I see someone on HN talk about how "oh, it will probably be okay if we leave the market alone, I read this really cool article online that said so," I see them no different than someone who stood by a river and watched their grandfather struggle against the current, because "oh, it will probably be okay." You don't know what you are talking about. Stop it.
> And if you can't afford it? Does society pay? Do we let them die? I'm interested in your answer.
The same thing that happens with the people whose lives could be saved right now if we stopped funding roads, or basic research, or investing in the city's water system, or educating first-graders, or researching drugs, or enforcing the property rights of rich people, or a bunch of other things that aren't going to pay off for years and are not associated with one's political party. It's not that the parties being funded are all completely honest and trustworthy, but that the money still needs to be spent. Drug research is one of the small number of things society does that actually add to the public good forever. Every year amazing drugs that do amazing things go off-patent. It's an amazing system and our children should be awed by how much stuff they will have. "Hepatitis C" will be like "polio" for them.
There is no reason to think the years 2010-2025 are some magic perfect ground where the drugs from pre-2010 are completely unsuitable and all the drugs that will be invented in year 2025 and beyond are unimportant or will still be found if a bunch of people who understand neither biochemistry nor economics rebuilt the economic system around it.
Every generation has the option to quit investing in the future. There are always people who want to stop all the painful sacrifices that are required right now, and just live off of yesterday's accumulated sacrifices and then go to sleep.
There will always be some procedure that keeps people alive but that costs Too Much Money. It's how most countries have kept their health care costs under control without noticeably impacting QALYs. There should be no doubt that there are people who died sooner because of these decisions, but the system works and doesn't bankrupt them. If "but we can't let someone die for a reason as stupid as money" is your terminal argument, be thankful you weren't in charge, or else society would have gone bankrupt a long time ago. These are hard decisions but adults need to make them, and generally adults do make them and things work out.
> When I see someone on HN talk about how "oh, it will probably be okay if we leave the market alone
I think there's a lot that can be improved about the market. I have a lot to say about that, but you are trying so hard to be cute and using children's arguments that goodwill can no longer be assumed. Good night and good luck.
Unfortunately I'm one of those guys who just really enjoys having the last word lol.
>The same thing that happens with the people whose lives could be saved right now if we...
I'm just looking for an answer to the question. Right now society pays for treatments that can't be afforded. Furthermore, I'm actually pro drug development when most of your response seems to think I'm not. I actually think that the current system does not support R&D like it should.
>I think there's a lot that can be improved about the market. I have a lot to say about that, but you are trying so hard to be cute and using children's arguments that goodwill can no longer be assumed. Good night and good luck.
I'm a mirror, you're glue... :P But seriously, I am citing my sources, there's even a huge post in here a bit upstream you can read with all sorts of sources debunking a couple industry claims. The point of turning your quote around is to show that those sorts of diatribes aren't particularly useful.
I think it would probably work out better to have a 15% excise tax on all pharmaceutical chemicals and preparations, charged on the wholesale price, collected at the shipping dock of the manufacturer or at the port of entry. This would go exclusively to fund a "research royalty" to the individuals who conduct drug research into utility, safety, and efficacy.
I don't have any specifics as to how that would be distributed, but it should likely emphasize the importance of replication and value purity of the methods over whether the results are positive or negative.
Right now, there are significant financial incentive that may bias research studies towards positive results. The patent system is magnifying those incentives.
I think some regulation is needed though. I can't look at a generic white pill and tell whether it's oxycodone or acetaminophen. Also, I don't want to take your acetaminophen if it hasn't been proven that whatever is in it won't cause other more serious issues or that I've at least been adequately informed of those side-effects on the front-end.
R&D is also in-part expensive because of the success rate of drug trials and the expertise necessary to conduct the experiments. I'm mostly a free-market proponent, but when a corporations own interests collide with the larger market's interests by killing or otherwise removing a large portion of the productive population from the workforce, I believe there should be regulation.
Therefore the government should pay for all of it. In the USA, since 1970, funding for science has declined. If we could merely get funding back to the trend line of 1930 to 1970, then the government would certainly be able to cover this kind of research. More so, it is completely incoherent for anyone to argue "We should leave this to the private sector because the private sector is more efficient than the government, but this process is wasteful and so we must grant a monopoly to whoever is willing to do this." Rather, as soon as someone says "We must grant a monopoly" they are also saying "the private sector market place has failed" and therefore they are also implicitly saying "The government should do this."
I'm definitely not in favor of granting more than a temporary monopoly to recoup losses and provide profit incentives.
I just don't believe that the government should be in the business of drug research. If they fund all of it, they get to decide which drugs will be researched. Let's assume that these decisions are somehow shielded from the influence of politicians. What becomes your KPI for what to research?
Profit? - we already have a system set up for that.
Number of lives saved? - How do you balance quality of life improvements against mortality?
If you took 20 minutes, you could easily look up the answer to your questions. We already have a system, and it works well, it only needs more money. SSRIs (serotonin reuptake inhibitors), Viagra, and countless other blockbuster drugs grew out of government funded research.
Drugs are the only industry where this really matters. The government can just offer research subsidies to make up for the reduced patent protections, and everyone would still be better off. It's silly to keep our broken patent system just for the pharmaceutical industry.
>I'm of the opinion that we would see a major slow down in drug innovation without patents.
My observation is we've seen a major slowdown already. $600 epi-pens, Turing Pharmaceuticals, my cousin's psoriasis medication that went from $10 a tube last year to $700 a tube this year. There's no innovation left. It's on to price gouging now. Pulling their patents might not solve their lack of ability to innovate, but it should be of some help with the price gouging.
I had exactly this argument with someone. It broke down to me figuring out where most of the new medicines are developed and it was something like 98%+ of medicines are developed by universities with public funds.
Of "new" medicines developed by actual pharmaceutical companies about half are just jamming two medicines that ought to be safe together into one.
Combine that with how most of the that R&D budget is to get drugs certified by the FDA and not to invent new ones and I fail to see how patents help the situation. It might be that without patents pharma companies might feel compelled to innovate more to stay ahead of their competition, but that is pure conjecture.
> It broke down to me figuring out where most of the new medicines are developed and it was something like 98%+ of medicines are developed by universities with public funds.
I don't think patents are inherently evil; and I also believe that "obvious" patents will get less common with time (relatively speaking we're still in the early days of patent law for many areas).
That being said, I think the big issue we're seeing these days is that some patent categories simply last too long. Technology moves a mile a minute, a patent system with a duration of 20 years is absurd, something that was innovative in 1997 doesn't continue to provide the same level of value in 2007 let alone 2017.
At absolute MOST the patent duration for technology patents should be halved. Ten years is still too long but at least there's a chance the entire industry doesn't overtake the patent too much, five years would be better but realistically patents are fairly expensive to file so the whole system might collapse.
I'm personally against patents, but even if I were to assume they do provide the common good used to justify them, the #1 problem with patents is that the people who grant them appear to be either completely unqualified, or under too great a workload. Or both.
Even if they did do a better job of reviewing patents in certain countries, people would just shop around until they found the most lenient international patent office and file there.
The US Patent office in particular decided many years ago that they simply weren't qualified to review all patents and just left it to the courts to deal with the fallout.
Realistically a patent examiner cannot be qualified in all areas; so they'd need to gather industry experts which would make patent filing pretty expensive (plus a lot of experts disagree, so where do you set the standard?).
> The US Patent office in particular decided many years ago that they simply weren't qualified to review all patents and just left it to the courts to deal with the fallout.
Right... but then, in the courts, an issued patent has a presumption of validity! This is arguably the biggest problem. I believe that before a patent can be used in litigation, the patentee should have to show its validity in more depth than the PTO requires, including objective evidence of nonobviousness [0].
I think I'd prefer it if filing for a patent would cost like $500, or even less, but then the USPTO would reject most applications by default, instead of accepting most applications by default, as they do now.
I'd prefer a rejection bias over an acceptance one. And I think a patent costing however many thousands of dollars it does now puts some pressure on USPTO employees to accept most patents.
When I was at a start-up and had someone literally rip-off our product (including typos), we would have really liked some faster protection than the patent, which took around 2 years to issue.
As a business matter, we would have happily accepted a shorter lifespan in return for a quicker decision.
You say typos so I assume you are referring to software, which has an automatic copyright on creation, and can be enforced much easier and faster than a patent.
They're a law firm that specializes in _patents_. When all you have is a hammer....
Also, presumably you failed to register your software with the copyright office before the infringement began. In such a case you're less likely to get a fat damages award. Which is actually a good reason to pursue a patent claim, but if we're being cynical it's also a good reason for a firm to _prefer_ a patent claim.
The fact of the matter is that if the case was a slam dunk as you say, you should have been able to get an injunction fairly quickly, depending on when this occurred. Step one to seeking an injunction would have been to register your software (or a component of the software, if you didn't want to divulge the whole thing) with the Copyright Office. Currently their e-filing website says it'd take 6-10 months. It used to be much shorter than that. A few years ago, IIRC, I received a certificate in less than 90 days. In any event, that's much shorter than 2 years.
It's also a good lesson: always register at least some component of your software with the Copyright Office; a component that an infringer would necessarily have to copy. To get through the courthouse doors you need a certificate from the Copyright Office, but it doesn't have to cover the entire, larger work. It's more of a procedural hurdle of the copyright statute that courts construe very liberally, so you needn't be afraid of having to publish all your source code just to get a certificate.
The nice thing about copyright is that it's simple enough that you don't really need to involve a lawyer. Of course, you don't do this to the exclusion of any patent filings, but it's a smart move that is almost zero cost. Paste your software into a TeX document, generate a PDF, and upload it to the Copyright Office website. Easy peasey.
> They're a law firm that specializes in _patents_.
What the fuck. Oh, you got that when you googled them, and you think the fucking top-tier national IP law firm had no other ideas at all because the patent hadn't issued yet.
They blamed it on a rogue employee, and then claimed that they had removed all our typos and that we would need to sue them if there was anything more we needed to demand. It wasn't until the patent came out, two years later, that we could finally get them to stop shipping their crap.
If we had been offered something that lasted half as long but issued twice as fast, we would have taken that in a heartbeat.
This is just an extension of a tied sale. Tying agreements are already illegal under anti-trust law. The only difference here is that Lexmark (and other companies) are skipping the contract/agreement part of it and going directly to forcing the hand of the consumer by adding new changes and inserting technology that has no other purpose than to specifically limit the consumer to purchase a related product (in this case, ink), where no such restriction previously existed and therefore is not naturally occurring. This is even worse than a regular tied sale arrangement because the consumer never agrees to it.
The only wrinkle I can see is that the tied sale laws seem to relate to unrelated products or services. The ink that goes with the printer is obviously related, but I think that's irrelevant here because of the history of inkjet printers. We all know that there never used to be any inherent, natural limitation to obtaining ink from another manufacturer as long as it was designed specifically for your make and model. The new changes were deliberately put in by Lexmark and other printer manufacturers for the sole purpose of restraining trade/commerce. That is blatantly in violation of anti-trust law.
Obviously, this wouldn't apply to the case at hand, though, as Lexmark is not a newcomer to the industry nor is the industry itself relatively new, thus requiring facilitation from tied sales.
If the USSC ends up ruling against Lexmark, the Justice Department should follow it up with indictments for felony violations of 15 USC.
I worked at Lexmark shortly after they spun off from IBM. As an intern in the early 90s I was tasked with researching crypto methods of securing their printer cartridges. Whoever bought or was running Lexmark from day one had these goals in mind as a key part of the value-add in buying IBM's old typewriter division.
My answer, at the time, was 'no' there is no foolproof way of using crypto because the keys would have to be stored in the chip that the refiller has access to. I'm sure there were actual engineers working on the same task, who I assume gave the same answer since they moved on to legal instead of technological means.
Even at the time, I was disheartened by the leadership's attitude and goals. Kind of amazing that for 20+ years they haven't abandoned this approach.
I wonder if the founder of Lexmark started the company with the big idea, "Hey, let's apply the razor/blade business model to printers!" If so, then "abandoning the approach" is impossible, and the approach will only be abandoned with company failure.
And you know, I have to say it: it's unethical, immoral, but it's not illegal to have a nefarious business plan, and I'm glad. To me, the larger issue is that the justice system has itself become a weapon to punish competitors, particularly through the use of IP claims. Punishment occurs long before conviction, when the cost of defending yourself can mean a significant and ongoing expense. A justice system that ignores reality, including economic reality, cannot be just.
I don't get it. If Lexmark is so hell-bent on preventing refilling, they could just simply change the purchase to a rental. Then, if don't return the cartridge to them you don't get your deposit back. They could even spin it as some sort of "we're being really green by making sure all of our cartridges are recycled" campaign.
The same goes for all of the farm equipment manufacturers that are fighting the right-to-fix movement. Why even have that fight and look like the bad guy? Again, I just don't get it.
I would like to thank whoever changed the title of this post. The old title led this comment section to the generic patents are bad discussion while not addressing the substance of the article. It was clear the people commenting hadn't actually read the article. The new title has already started steering the conversation towards what the article actually says and people will be educated about the exhaustion doctrine.
I'm in my 70s and I've seen a complete change of atmosphere since the 1950s when I first interacted with tecnology.
In 1950, apart from a small number of ready-made products, if you wanted something out of the ordinary, you designed and built it (I was a ham radio operator at the age of 13). I would build my radio gear out of the salvaged parts from neighbors' discarded TV sets (which in those days were very short-lived).
Decades later I saw people lose interest in either understanding technology or building/repairing their own. I found this change discouraging, but I failed to see where that was headed.
Now corporations are using the political/legal system to forbid people from closely examining their technical purchases or changing them to suit new needs. For most people the level of required knowledge is quite beyond imagining, so it may not seem much of a burden, but for a shrinking minority with technical skill, it nips creativity in the bud.
It's a variation on the classic Time Machine plot (H. G. Wells) -- the minority Eloi live on the surface, designing and building IPods for the troglodytic Morlocks.
To me personally, the real tragedy will be when people can't even imagine understanding, repairing or building their own equipment.
Lexmark and the Federal Circuit are now a direct and actual threat to the notion of the ownership of property, both real and personal, in the United States of America.
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[ 5.1 ms ] story [ 273 ms ] threadI've seen more detailed studies of patent history (which I can no longer find, alas), and they make a good case that patents have an ambiguous effects on industrial innovation. I'm not sure if I believe these studies, but I don't think it's an open and shut case either way. Also, steam engines may have different issues than drug development, and drug developent may have different issues than software.
http://www.cambridge.org/catalogue/catalogue.asp?isbn=978052...
Don't have patents, have certificates of safety. That way anyone can make a drug, and show consumers that it's been tested safe.
(the drug was long out of patent, his company bought the FDA approved production line and such)
My reaction though is tempered in the same way when I hear a US Federal Government person (ex: Secretary of Health) claim that a system of "Patient Empowerment and Patient Choice" is an ideal situation. I disagree. Looking at Health Statistics Reality (cough) a large portion of the US Population has made categorically bad decisions. Obesity. Heart Disease by way of contributing factors.
I get the rationale behind empowerment and allowing patients to find the "best" care around, but trusting Average Health Consumer to make Medical choices when they can't even get Dietary choices right is problematic.
I would be wary of taking that book at its word. The authors have an agenda and they are not afraid to twist historical facts to suit their narrative. I mean, their very first chapter begins with a lie which perpetuates the myth that Watt's patent retarded steam development [1].
When the authors of [1] called out Boldrin and Levine on this, the latter responded by fabricating new myths rather than admit that the truth undermined their narrative [2].
The very chapter you cite itself has such inaccuracies. I did not track down all the stuff they cite, but I did find an instance of mischaracterizing references to suit their view points. For instance, when they discuss the German dyestuff industry, they cite a study by Murmann to support their narrative that Germany dominated in that industry due to the lack of patents. But if you look at the actual study itself, Murmann paints (heh) a very different picture: German dominance in that industry was fueled by close ties with academic research, and later by R&D labs encouraged by, of all things, the newly introduced patent laws:
>When in 1877 German patent law protected dye innovations, a few German firms such as Hoechst, BASF, and AGFA saw the advantage of hiring organic chemists whose sole task was to synthesize new dyes. After these research chemists turned out economically successful dyes, firms hired more and more chemists and pioneered an entirely new corporate function, formally organized research. The birth of corporate research and development (R&D), which today is a standard activity in high-tech industries ... can be traced to the German synthetic dye firms in 1880s. By the 1890s the vast majority of dyes were being discovered in the R&D laboratories of Bayer, Hoechst, and BASF.
> Whereas in the early days of the industry a firm could exist by copying dyes invented somewhere else, patent laws made the systematic application of science within the boundaries of the firm a critical dimension of remaining a leader in the industry.
Moreover:
> The most important institution in the early success of the German dye industry was the university system, but patent laws were a second key factor that allowed the German firms to capture a dominant position.
With that many assertions in the study that refute their view, they cherry-pick a few comments and actually cite the study as one that supports their view.
With so many accuracies in there, I find it hard to take anything else they say in that book at their word.
1. http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1589712
2. http://econpapers.repec.org/article/bpjrlecon/v_3a5_3ay_3a20...
3. Murmann JP, 2003, "Knowledge and Competitive Advantage – The Coevolution of Firms, Technologies and National Institutions." - http://catdir.loc.gov/catdir/samples/cam041/2003043048.pdf
[1] https://en.wikipedia.org/wiki/Wright_brothers#Patent_war
I jest.
Often something complicated/expensive to think about and solve for one group, is easy and obvious to others. Especially over time and with other out-of-bound advances applied.
Comedic routines would still exist for example, if people repeated other people's jokes/sets. Granted that would be copyright in that case... but the logic applies there also, and we have the same challenge and arguments, by people who insist there would not be nice things without the protection to justify the cost of the outcome generation method.
So the EFF is wrong, patents haven't savaged the printer marketplace, there are nice printers available that are not expensive. And it's wrong that the market will punish shitty products, Lexmark is one of the few survivors in the printer business.
If your business cannot survive without a government-granted monopoly, it's not a free market.
My claim is that reasonable printers that are free of bullshit exist for most purposes (prior to Epson switching to reservoir printers, the home color printer market was pretty thin) and yet companies that do use bullshit tactics continue to exist. So the printers exist (patents have not particularly held them back) and for some reason enough people ignore these reasonable printers for companies using abusive tactics to survive.
1. find the model where the company subsidizes the printer to sell the ink
2. Then try to work around the lockouts the company has on the ink market.
Both sides are trying to screw each other over. I see no reason to care. If the people trying to use third-party ink really succeed, all that will happen is that the market strategy will disappear, and so the third-party ink market will vanish. (I really wonder how you run a business where if you really win you go out of business. You need to hope the other side keeps on fighting just enough that you can attract all the people who enjoy fighting over pennies.)
To me it sort of seems like you're saying "Wow this dryer uses way more electricity than I thought it would!" or "Wow I bought this razor handle and the blades are really expensive!" or "Wow Swiffer really screws you with the replacement wipes!" or "Wow this car takes expensive tires!" -- even though the numbers for the ongoing consumables were available at the time of purchase.
I'd even argue that selling a cheap ~$50 printer and then expecting to make it back on consumables is a legitimate business model. If you're the kind of person who prints once in a blue moon, it makes more sense than buying a ~$200 laser printer.
Printers are generally expensive and generally last a few years. They're not casual, off-the-cuff purchases. Much like a computer, they are a precision machine, but with many more moving parts. I really don't believe it's unreasonable to do a couple hours worth of research on something that'll be in your home or office, possibly doing Important Serious Business Things, for years.
I get that the customer has some responsibilities, but it doesn't make sense to say that the customer has to exhaustively reserach the ethics of every single company they buy something from. That would make buying a full time job considering our complex modern economy where customers regularly interact with many many companies and buy many many things
And yet, if Lexmark were successful here, what would stop competitors from using that against them? As in, "Only fools buy Lexmark printers."
1: http://www.therecorder.com/id=1202769608088/HP-Sued-Over-Mas...
2: https://www.wired.com/2016/09/hp-printer-drm/
3: http://webcache.googleusercontent.com/search?q=cache:-G4w0dP...
I'd _agree_ with you if the EFF claimed that, but they didn't in the article linked. The EFF here isn't making broad brush claims about market structures, except maybe for this section:
> "Courts and legal scholars have long acknowledged that such restrictions impair the purchasers’ personal autonomy, interfere with efficient use of property, create confusion in markets, and increase information costs"
But even here I argue that's the wrong reading. When taken in the context of the rest of the article, this appears to be a traditional consumer advocacy approach taken from the Ralph Nader playbook.
Anyone trying to start a new printer company will get sued into the ground or blocked by a US court from even importing their printers. That's why countries without strong patent protections have a local printer brand that costs half as much or less.
It is also why we witnessed such a strong 3D printer marketplace for a while, different companies entering an unencumbered market and trying to establish a monopoly via IP protections.
Printer innovation is non-existent (outside of innovate ways to make more money, like subscriptions). That's because there's no threat to their position, nobody can go near printers and they know it.
They'd very likely try (hard), even if they eventually end up losing. Then try again a different way using a different approach, then again (etc). "Drown the opposition" in legal fees seems to be a commonly used tactic by larger (bullying) companies.
https://www.wsj.com/articles/p-gs-gillette-sues-dollar-shave...
I would guess that this influenced their decision to sell to P&G, thus protecting the razor duopoly.
http://www.bloomberg.com/research/stocks/private/snapshot.as...
"Patents Are a Big Part of Why We Can’t Own Nice Things for free."
What would happen if lexmark made wood for houses instead of printer cartridges? Would they have control over your home made with wood?
> Supreme Court to Rule on Whether Patent-Holders Can Control What You Do With Your Stuff
or something like that.
"Control what you do with your stuff" sounds like the concept of ownership.
Yes patents do other things but according to Lexmark their patent means you don't get to do the things you traditionally get to do with the printer you bought.
R&D is very wasteful and expensive. Patents prevent competition for a short period of time to help the business recoup losses from failed experiments and to deliver profits which serve as an incentive for more innovation.
For ideas that take a week to "invent", patents are probably stifling innovation instead of promoting it.
Most software patents (if not all) fall into the 2nd category. That's why in Europe we don't have software patents, and rightly so.
So it indeed depends on whether you are able to recover your R&D costs after going to market.
The difficulty there preventing companies from exaggerating about the time it took to develop. I suppose it's not too much to ask companies to show written evidence of the date that a specific invention process commenced.
Is 20 years a short period of time? It seems like we'd get most of the benefits with fewer drawbacks by just shortening the time patents are granted for.
Biologics (all the -mab drugs, monoclonal antibodies, adalimumab Humira) are a treat because you have to share your methodology, but you do not have to share your cell culture line. Since the cell line itself needs to be approved, the me-too's have to go through ALL the trouble themselves.
On the other hand, copyright terms are just bat-shit insane and needs to be scaled back tremendously.
I don't believe patents, as they are, are doing very much toward their original goal. Right now, and perhaps this is my frustrated cynicism here, they just look like one more method for those with money to bully those without.
Drugs fall into a problematic territory here. I don't know enough about big pharma to have an informed conversation but I feel like there are other options available to us. Pharma R&D is what is always, always, always trotted out as a defense for our absurd patent system. The whole world has to get shafted with a bad system because one industry can't figure out another way?
They do.
Once it goes off patent, 80% of the sales of brand name can vanish [1]. Getting a generic approved is a fraction of the time and cost as getting the original through the pipeline. It's like P vs NP, since the FDA approval means publishing pretty much a how-to guide (synthesis route) and much of the safety data. You just have to demonstrate "our stuff is the same as the proven stuff".
I've long been a proponent of "15 years from FDA approval" - this gives a reliable, predictable cushion, without having to predict clinical failure rates. More time can be spent on safety studies (NCSS) and less costly Phase I and II trials, ideally leading to safer and more effective drugs. There is still pressure to move quick, because as soon as the clinical trials start, other companies have access to the leads you are looking at, and can simulate the structure and look for similar leads.
[1]https://www.forbes.com/2002/05/02/0502patents.html
I'm just saying that, for example, I don't think we would've discovered a hep-c drug without the incentive of exclusive rights to sell the drug. I think the individual researchers are probably motivated by their desire to help people, but corporations don't run on altruism.
Where does the money come from for large capital expenditures like a research facility or production line?
I wonder though, has anyone studied to see if that holds up? I suspect that our quality of life improvements come from infrastructure like access to safe drinking water, and general accessibility to medicines not protected by intellectual property monopolies.
Could you provide some examples of these?
After posting I did consider the lone software engineer who comes up with a great idea, creates an app, and his app is then copied by Google who has much better marketing and distribution resources.
If patent duration was a function of investment in R&D, this software developer would be SOL because he invested little into his "eureka" idea.
The incredibly expensive pharma and device development costs are shouldered by industry. The government does not have the risk tolerance or patience for development.
Right now a significant portion of the patent lifetime is spent with the drug in clinical trials unable to be sold. Shortening the patent lifetime would increase prices until the drug went generic, not decrease them,as companies would have less time to get ROI.
The industry is much more complicated than you are making it out to be, and trying to make it unprofitable would not help innovation.
>And for most new drugs, patents expire approximately 12 years after market introduction.
https://hbr.org/2014/11/the-real-cost-of-high-priced-drugs
Also:
>Once a company has good data, the FDA approval process is moving faster than ever. According to the agency’s most recent progress report, the standard review process now takes a median 10 months, down from nearly 13 months in 2005. Companies can shave another two months off if they get a priority review. In fiscal year 2014, the most recent data available, 92 percent of drugs were approved on first pass, up from 60 percent in 2005.
https://www.statnews.com/2017/01/31/trump-pharma-reality-che...
* >Shortening the patent lifetime would increase prices until the drug went generic, not decrease them,as companies would have less time to get ROI.
Hence why I also consider opening up the drug market to other countries. If drugmakers need to make all their profit front-loaded then they can at least spread it geographically so Americans don't have to suffer under these prices.
* >and trying to make it unprofitable would not help innovation.
Here is a comparison between the biotech industry and the S&P 500 starting from approximately the lowest point of the recession. Now come on, do you really think this industry is struggling? How is it that these companies get away with telling investors one thing ("business is great, invest!") and the public another ("regulatory overreach is killing us!")?
https://www.google.com/finance?chdnp=1&chdd=1&chds=1&chdv=1&...
* >The government does not pay for development, they pay for a portion of basic research across all research areas (and it's nowhere near 50% of all research funds or drug research funds). The entire NIH budget is about 32 billion. Large pharma companies spent around 50 billion on R&D in 2010: http://www.nature.com/nrd/journal/v9/n3/full/nrd3078.html
I'll admit, it looks like my number of over 50% came from 1995. Also, I spent a long time tracking down this 50 billion number and it's original source (took a bit). It looks like it was originally published here(and other PHRMA industry reports):
http://www.phrma.org/sites/default/files/pdf/2015_phrma_prof...
So PHRMA is an industry group and I was interested in their methodology which is also very hard to find but lo and behold:
>In 1991, Joseph DiMasi and colleagues from the Tufts Center for the Study of Drug Development published a widely quoted, comprehensive study of drug development costs. Using project data from confidential surveys, the study estimated cash outlays of around $169M to successfully bring a drug to market during a period beginning in the 1970s. PhRMA relies on this research as the foundation for their statements about the cost of drug development. However, PhRMA uses different assumptions about a "hidden" expense called "opportunity cost" that boosts t...
The length of a drug patent is 20 years, 8 of which by your statement are spent in development. So yes, almost half the patent duration is spent with the drug off the market. This is burden almost no other industry has to deal with. My original statement is completely valid.
> Hence why I also consider opening up the drug market to other countries. If drugmakers need to make all their profit front-loaded then they can at least spread it geographically so Americans don't have to suffer under these prices.
Other countries place more stringent price ceilings on the cost of pharmaceuticals, which is why there is such a disparity between what we are paying and what others are paying. If we want to spread the cost burden geographically, countries benefiting from these products should be pressured to remove their price ceilings, which would lower costs in the US. Opening up the markets to other countries is just regulatory arbitrage, not spreading of cost burden.
Also, if I'm interpreting this correctly, nothing you posted suggests that the government is the primary backer of pharmaceutical research. We can argue over whether the research costs are 50 billion or 30 billion or whatever, but your original claim is still incorrect unless the numbers are off by literally an order of magnitude.
And yet they seem to be doing just fine, check that stock price chart above. Part of this is because 12 years is already pretty long, they're obviously making their money back. Also, there are all sorts of strategies these companies use in order to avoid true patent expiration.
>The problem is, these modified drugs don’t offer enough of an advantage over generic versions of the original molecules, says Jim Keon, president of the Canadian Generic Pharmaceutical Association. So the sophisticated lifecycle plans brand-name companies have for their products — rolling out new versions when patents near expiry — are created primarily to help bottom lines rather than patients. And the argument that this is necessary to earn enough money to reinvest in new R&D doesn’t hold much weight, suggests Keon, if that research only results in more “me-too” drugs. “They have to recoup R&D costs, yes, but the question is: Is it useful R&D? If the R&D is just to tweak a product to get more monopoly protection without really providing an improved medication, then maybe it doesn’t deserve a patent,” says Keon.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3680578/
>Nexium illustrates the drug makers’ strategy. Many chemicals come in two versions, each a mirror image of the other: an L-isomer and an R-isomer. (The “L” is for left, the “R” is for right.) Nexium’s predecessor Prilosec is a mixture of both isomers. When Prilosec’s patent expired in 2001, the drug maker was ready with Nexium, which contains only the L-isomer.
http://sm.stanford.edu/archive/stanmed/2005summer/drugs-meto...
>AstraZeneca somehow managed to convince the US Patent Office that Nexium was substantially different from Prilosec, and thus should be granted its own patent, along with 20 years of protection
http://acsh.org/news/2017/01/18/nexium-dark-side-pharma-1054...
* >Also, if I'm interpreting this correctly, nothing you posted suggests that the government is the primary backer of pharmaceutical research. We can argue over whether the research costs are 50 billion or 30 billion or whatever, but your original claim is still incorrect unless the numbers are off by literally an order of magnitude.
I admitted that was a tad misleading, here's the fact I was thinking of. I should have linked it earlier.
>An internal National Institutes of Health (NIH) document, obtained by Public Citizen through the Freedom of Information Act, shows how crucial taxpayer-funded research is to top-selling drugs. According to the NIH, taxpayer-funded scientists conducted 55 percent of the research projects that led to the discovery and development of the top five selling drugs in 1995. (See Section III)
http://www.citizen.org/publications/publicationredirect.cfm?...
* >Other countries place more stringent price ceilings on the cost of pharmaceuticals, which is why there is such a disparity between what we are paying and what others are paying. If we want to spread the cost burden geographically, countries benefiting from these products should be pressured to remove their price ceilings, which would lower costs in the US. Opening ...
And yet, prilosec is an OTC medication which anyone can buy for about 10 dollars, so who gives a shit. So what if a reformulation leads to a new patented product if the old formulation becomes a generic and is readily available? Also, reformulating to reduce dosage requirements to improve adherence is a legitimate product improvement so I don't see why it's problematic at all to seek another patent.
>An internal National Institutes of Health (NIH) document, obtained by Public Citizen through the Freedom of Information Act, shows how crucial taxpayer-funded research is to top-selling drugs. According to the NIH, taxpayer-funded scientists conducted 55 percent of the research projects that led to the discovery and development of the top five selling drugs in 1995. (See Section III)
Yup. I'm a huge proponent of basic research and I think we can do more of it. But saying basic research "leads to" drugs is also misleading. Basic research typically only establishes that a compound has basic efficacy in a cell model or an animal model. There's a lot more work that needs to be done to validate that the compound works in a human.
> American citizens alone bear the cost of R&D for the world because every other country sets price ceilings?
Yes, pretty much. We subsidize drug development for much of the world.
> Also, I'll just once again point out that our drug development industry is not struggling! It's doing great right now, they spend lots of money on dividends and stock buybacks and advertising and still make fantastic profits. They're fine.
The whole stock market is doing great right now. By this logic everyone should drop the price on all goods because their stock prices are going up.
This is nuts. By the time a major drug is ready for market, out of a 20 year patent there are usually only 5 years left. How much shorter do you think it should be? When they are operating under that kind of deadline, they don't have time for word-of-mouth marketing.
For software, sure, I'm really willing to hear arguments that 20 years is too long. But drug patents lifetimes are already very small. If something is too expensive, wait a few years.
Isn't that the point? In medicine, you often can't just wait it out. Healthcare is not a normal market.
>By the time a major drug is ready for market, out of a 20 year patent there are usually only 5 years left.
>And for most new drugs, patents expire approximately 12 years after market introduction.
https://hbr.org/2014/11/the-real-cost-of-high-priced-drugs
>When they are operating under that kind of deadline, they don't have time for word-of-mouth marketing.
Word-of-mouth marketing isn't really "slow" if the drug is very effective.
Then you pay.
I have family members who are only functional because of prescription drugs. When I see someone on HN talk about how "oh, it will probably be okay if we mess with this market, I read this really cool article online that said so," I see them no different than someone who decided on their own to start tinkering with grandpa's iron lung, because "oh, it will probably be okay." You don't know what you are messing with. Stop it.
>And for most new drugs, patents expire approximately 12 years after market introduction.
I don't know what the HBR's source is because they don't tell me. I am telling you to find any drug you see newly on the market, particularly one you see on tv since you worry about marketing budgets, and look up when its patent expires.
All the money going towards marketing would instead go towards lobbying, towards getting the government agency in charge of deciding "what really counts" for deciding that this drug should be one of them. When the US government was looking at how to create incentives for invention, they did look at rewards systems, and this was the common problem. Using the market system, for all its faults and ways it could be improved, at least sends proper price signals to producers and consumers.
The largest 10 pharmaceutical companies spent a combined $32.5B more on sales and marketing than R & D. No problem here? People are skipping dosing to stretch their meds further. Some people can't afford meds at all.
And if you can't afford it? Does society pay? Do we let them die? I'm interested in your answer.
>I have family members who are only functional because of prescription drugs.
Me too.
>I don't know what the HBR's source is because they don't tell me.
And I don't know where your 5 year number comes from because you didn't provide a source.
When I see someone on HN talk about how "oh, it will probably be okay if we leave the market alone, I read this really cool article online that said so," I see them no different than someone who stood by a river and watched their grandfather struggle against the current, because "oh, it will probably be okay." You don't know what you are talking about. Stop it.
The same thing that happens with the people whose lives could be saved right now if we stopped funding roads, or basic research, or investing in the city's water system, or educating first-graders, or researching drugs, or enforcing the property rights of rich people, or a bunch of other things that aren't going to pay off for years and are not associated with one's political party. It's not that the parties being funded are all completely honest and trustworthy, but that the money still needs to be spent. Drug research is one of the small number of things society does that actually add to the public good forever. Every year amazing drugs that do amazing things go off-patent. It's an amazing system and our children should be awed by how much stuff they will have. "Hepatitis C" will be like "polio" for them.
There is no reason to think the years 2010-2025 are some magic perfect ground where the drugs from pre-2010 are completely unsuitable and all the drugs that will be invented in year 2025 and beyond are unimportant or will still be found if a bunch of people who understand neither biochemistry nor economics rebuilt the economic system around it.
Every generation has the option to quit investing in the future. There are always people who want to stop all the painful sacrifices that are required right now, and just live off of yesterday's accumulated sacrifices and then go to sleep.
There will always be some procedure that keeps people alive but that costs Too Much Money. It's how most countries have kept their health care costs under control without noticeably impacting QALYs. There should be no doubt that there are people who died sooner because of these decisions, but the system works and doesn't bankrupt them. If "but we can't let someone die for a reason as stupid as money" is your terminal argument, be thankful you weren't in charge, or else society would have gone bankrupt a long time ago. These are hard decisions but adults need to make them, and generally adults do make them and things work out.
> When I see someone on HN talk about how "oh, it will probably be okay if we leave the market alone
I think there's a lot that can be improved about the market. I have a lot to say about that, but you are trying so hard to be cute and using children's arguments that goodwill can no longer be assumed. Good night and good luck.
>The same thing that happens with the people whose lives could be saved right now if we...
I'm just looking for an answer to the question. Right now society pays for treatments that can't be afforded. Furthermore, I'm actually pro drug development when most of your response seems to think I'm not. I actually think that the current system does not support R&D like it should.
>I think there's a lot that can be improved about the market. I have a lot to say about that, but you are trying so hard to be cute and using children's arguments that goodwill can no longer be assumed. Good night and good luck.
I'm a mirror, you're glue... :P But seriously, I am citing my sources, there's even a huge post in here a bit upstream you can read with all sorts of sources debunking a couple industry claims. The point of turning your quote around is to show that those sorts of diatribes aren't particularly useful.
I don't have any specifics as to how that would be distributed, but it should likely emphasize the importance of replication and value purity of the methods over whether the results are positive or negative.
Right now, there are significant financial incentive that may bias research studies towards positive results. The patent system is magnifying those incentives.
+ Pile up mountains of red tape through the FDA
+ Provide patent protections for those with enough money to wade through the red tape
+ Give R&D grants to companies with taxpayer money to take up the slack in their budget
So since R&D is so expensive, only large companies can afford it, which is just fine for them: it keeps out competitors.
R&D is also in-part expensive because of the success rate of drug trials and the expertise necessary to conduct the experiments. I'm mostly a free-market proponent, but when a corporations own interests collide with the larger market's interests by killing or otherwise removing a large portion of the productive population from the workforce, I believe there should be regulation.
Therefore the government should pay for all of it. In the USA, since 1970, funding for science has declined. If we could merely get funding back to the trend line of 1930 to 1970, then the government would certainly be able to cover this kind of research. More so, it is completely incoherent for anyone to argue "We should leave this to the private sector because the private sector is more efficient than the government, but this process is wasteful and so we must grant a monopoly to whoever is willing to do this." Rather, as soon as someone says "We must grant a monopoly" they are also saying "the private sector market place has failed" and therefore they are also implicitly saying "The government should do this."
I just don't believe that the government should be in the business of drug research. If they fund all of it, they get to decide which drugs will be researched. Let's assume that these decisions are somehow shielded from the influence of politicians. What becomes your KPI for what to research?
Profit? - we already have a system set up for that. Number of lives saved? - How do you balance quality of life improvements against mortality?
Maybe new drug development shouldn't be done by for profit companies at all.
Have the government fund research institutes instead.
My observation is we've seen a major slowdown already. $600 epi-pens, Turing Pharmaceuticals, my cousin's psoriasis medication that went from $10 a tube last year to $700 a tube this year. There's no innovation left. It's on to price gouging now. Pulling their patents might not solve their lack of ability to innovate, but it should be of some help with the price gouging.
Of "new" medicines developed by actual pharmaceutical companies about half are just jamming two medicines that ought to be safe together into one.
Combine that with how most of the that R&D budget is to get drugs certified by the FDA and not to invent new ones and I fail to see how patents help the situation. It might be that without patents pharma companies might feel compelled to innovate more to stay ahead of their competition, but that is pure conjecture.
Do you have a reference for this?
That being said, I think the big issue we're seeing these days is that some patent categories simply last too long. Technology moves a mile a minute, a patent system with a duration of 20 years is absurd, something that was innovative in 1997 doesn't continue to provide the same level of value in 2007 let alone 2017.
At absolute MOST the patent duration for technology patents should be halved. Ten years is still too long but at least there's a chance the entire industry doesn't overtake the patent too much, five years would be better but realistically patents are fairly expensive to file so the whole system might collapse.
The US Patent office in particular decided many years ago that they simply weren't qualified to review all patents and just left it to the courts to deal with the fallout.
Realistically a patent examiner cannot be qualified in all areas; so they'd need to gather industry experts which would make patent filing pretty expensive (plus a lot of experts disagree, so where do you set the standard?).
Which is why the USPTO has a large number of specialist patent units.
Right... but then, in the courts, an issued patent has a presumption of validity! This is arguably the biggest problem. I believe that before a patent can be used in litigation, the patentee should have to show its validity in more depth than the PTO requires, including objective evidence of nonobviousness [0].
[0] https://en.wikipedia.org/wiki/Graham_v._John_Deere_Co.#The_P...
I'd prefer a rejection bias over an acceptance one. And I think a patent costing however many thousands of dollars it does now puts some pressure on USPTO employees to accept most patents.
Why? Fear of lawsuit?
As a business matter, we would have happily accepted a shorter lifespan in return for a quicker decision.
Also, presumably you failed to register your software with the copyright office before the infringement began. In such a case you're less likely to get a fat damages award. Which is actually a good reason to pursue a patent claim, but if we're being cynical it's also a good reason for a firm to _prefer_ a patent claim.
The fact of the matter is that if the case was a slam dunk as you say, you should have been able to get an injunction fairly quickly, depending on when this occurred. Step one to seeking an injunction would have been to register your software (or a component of the software, if you didn't want to divulge the whole thing) with the Copyright Office. Currently their e-filing website says it'd take 6-10 months. It used to be much shorter than that. A few years ago, IIRC, I received a certificate in less than 90 days. In any event, that's much shorter than 2 years.
It's also a good lesson: always register at least some component of your software with the Copyright Office; a component that an infringer would necessarily have to copy. To get through the courthouse doors you need a certificate from the Copyright Office, but it doesn't have to cover the entire, larger work. It's more of a procedural hurdle of the copyright statute that courts construe very liberally, so you needn't be afraid of having to publish all your source code just to get a certificate.
The nice thing about copyright is that it's simple enough that you don't really need to involve a lawyer. Of course, you don't do this to the exclusion of any patent filings, but it's a smart move that is almost zero cost. Paste your software into a TeX document, generate a PDF, and upload it to the Copyright Office website. Easy peasey.
NOTE: IANAL
What the fuck. Oh, you got that when you googled them, and you think the fucking top-tier national IP law firm had no other ideas at all because the patent hadn't issued yet.
> NOTE: IANAL
No shit.
HN is such a fucking clown show.
If we had been offered something that lasted half as long but issued twice as fast, we would have taken that in a heartbeat.
The only wrinkle I can see is that the tied sale laws seem to relate to unrelated products or services. The ink that goes with the printer is obviously related, but I think that's irrelevant here because of the history of inkjet printers. We all know that there never used to be any inherent, natural limitation to obtaining ink from another manufacturer as long as it was designed specifically for your make and model. The new changes were deliberately put in by Lexmark and other printer manufacturers for the sole purpose of restraining trade/commerce. That is blatantly in violation of anti-trust law.
Obviously, this wouldn't apply to the case at hand, though, as Lexmark is not a newcomer to the industry nor is the industry itself relatively new, thus requiring facilitation from tied sales.
If the USSC ends up ruling against Lexmark, the Justice Department should follow it up with indictments for felony violations of 15 USC.
My answer, at the time, was 'no' there is no foolproof way of using crypto because the keys would have to be stored in the chip that the refiller has access to. I'm sure there were actual engineers working on the same task, who I assume gave the same answer since they moved on to legal instead of technological means.
Even at the time, I was disheartened by the leadership's attitude and goals. Kind of amazing that for 20+ years they haven't abandoned this approach.
And you know, I have to say it: it's unethical, immoral, but it's not illegal to have a nefarious business plan, and I'm glad. To me, the larger issue is that the justice system has itself become a weapon to punish competitors, particularly through the use of IP claims. Punishment occurs long before conviction, when the cost of defending yourself can mean a significant and ongoing expense. A justice system that ignores reality, including economic reality, cannot be just.
The same goes for all of the farm equipment manufacturers that are fighting the right-to-fix movement. Why even have that fight and look like the bad guy? Again, I just don't get it.
In 1950, apart from a small number of ready-made products, if you wanted something out of the ordinary, you designed and built it (I was a ham radio operator at the age of 13). I would build my radio gear out of the salvaged parts from neighbors' discarded TV sets (which in those days were very short-lived).
Decades later I saw people lose interest in either understanding technology or building/repairing their own. I found this change discouraging, but I failed to see where that was headed.
Now corporations are using the political/legal system to forbid people from closely examining their technical purchases or changing them to suit new needs. For most people the level of required knowledge is quite beyond imagining, so it may not seem much of a burden, but for a shrinking minority with technical skill, it nips creativity in the bud.
It's a variation on the classic Time Machine plot (H. G. Wells) -- the minority Eloi live on the surface, designing and building IPods for the troglodytic Morlocks.
To me personally, the real tragedy will be when people can't even imagine understanding, repairing or building their own equipment.