How on earth is there not prior art (I think that's the term I want) for the functioning of a small part of the human metabolism? It seems to me rather obvious that the researcher, her/his ancestors, friends, you, and me all other humans constitute prior art to that patent. I struggle with similar questions when I see articles on how companies are patenting specific DNA sequences.
I guess my problem boils down to this. Isn't there a difference between a discovery and an invention? Logically I think there is. A discovery is a new understanding of an already existing reality while an invention is the creation of something new. On that difference it seems that the latter should be patentable but not the former. But if they truly have the patent claimed by the article, then our system allows for the patenting of discoveries! How bizarre.
Are there other fields where discoveries are patentable. (Should Einstein have patented his theory of general relativity or E=mc^2?)
If Prometheus Labs had created a machine that measured and calculated the needed dosage change in a new and innovative way I could see a patent being granted, but not on this.
Could someone who has patent experience/expertise way in and help me here?
Discovery/invention is one of the classic ways of differentiating (you can patent inventions but not mere discoveries of facts), but even going back hundreds of years the line gets a bit murky. For example, a ton of 19th-century patents were for chemical synthesis processes, which more or less boils down to a patent on discovering that certain reaction pathways exist and can be feasibly used with standard equipment.
I think the issue is initially when things were being invented there was a general lack of understanding of things. When car manufacturers first discovered how to bind metal to rubber (think tires), they didn't even patent it. There wasn't enough knowledge or skilled people to do the experimentation needed. They didn't want to patent it at that point they would just be teaching competition how to do it and within X number of years lose their advantage, and a minor variation in the process could allow them to compete anyway.
And what is the difference between discovery and invention? Anything science related is discovery.
Worse, money only goes into research that has a high level of profit potential, meaning that only if it can be patented. This structure is very detrimental to all societies.
Who knows how many times things that could be very beneficial to society never see the light of day. And if there is something so beneficial to society that is discovered then the cost skyrockets giving companies huge profits. Even worse, what if something is found to totally eliminate a disease but isn't patentable? The company surely isn't going to release that information if it's in an area they're trying to generate profits. On top of that the low-profit-margin solution will have to fight the big-profit companies marketing campaigns directly or indirectly against them. That is totally the opposite behaviour behind the point of innovation and capitalism.
The purpose of capitalism is to drive innovation, and the point of innovation is to reduce costs to zero, so then those savings can be past onto increasing innovation in other needed areas; Currently those profits are used to further research of other profit-potential patentable drugs. Thankfully we have universities but even those people resources and their efforts are driven much of the time by big companies looking for profitable options.
Discovery and innovation should be rewarded by society, however preventing others from easily furthering an innovation or using it in further inventions causes a huge delay (and potentially even permanently) to
People fear monger and say innovation won't happen if you can't have patents, which I don't believe to be true. One of the main keys is you need education systems in place, and we have those.
I dont know how/what to think about this, also I didn't mean to include any other links , so this will be my last take for today. http://croak.eu/rDCDm9
This specific example definitely feels like an abuse of the patent system. However, the rest of this article relies on weak connections and examples from other industries to argue that medical patents must die. If medical patents die, medical innovation dies.
For a moment, let's apply the realities of "medical innovation" (researchers across private and public fields) to internet innovation. Imagine that every app you published took four years and $100M to get to a testable product. Keep in mind, this is still unusable. You go out and spend millions more testing it on "fake users" (animals). If this works, you need to go raise hundreds of millions more to test it on your first batch of real users... then a second... then a third.
Billions of dollars later, you realize that your app doesn't work as it was intended. You've just spent 6 years and billions of dollars figuring that out. There is no fail fast, in this world.
Lets say your product actually makes it to market. Congrats, now you need to compete against copy cat app developers who can replicate your app at a fraction of the price. How do you defend yourself? Innovative marketing? Large email list? Good SEO? SEM? None of that works in medicine, because the switching costs are positive for a patient.
This is why we need patents. Without them we would see a significant reduction in medical innovation. When markets don't create enough risk-adjusted incentives to promote innovation, the government must step in to create those incentives. I'm not saying our system is perfect, but it's better than nothing (at least in medicine).
I spent a long time working on a medical startup and it's orders of magnitude more complex than most of the apps we see celebrated in our hacker community. I would bet that the typical FDA application is longer than the entire printed code base of most web apps.
While I think you probably have a point that drug trials costs are difficult to recoup without patents, I also have the impression pharma patents introduce a whole bunch of other distortions - to the point that patents in that field probably do more harm than good.
I'm sure w can find a better way to handle the cost and risks of trials.
As an aside: it seems history seems to agree that having no patent protection seems to work better for the pharmaceutical industry, see for instance, here:
Well, the issue is simply that testing (to FDA standards) is expensive. You could either have the FDA fund all testing, or just allow patents on well tested products.
You could even allow retrospective patents on some orphan drugs, if a company is willing to invest in testing it.
Most people think it's fine to patent stuff to cover the costs of bringing a new drug to the market.
They peg the cost of bringing a new drug to market at about $800m on average. It's a roughly 40%/60% split between pre-clinical and clinical phases. So even without any testing at all you're still looking at several hundred million dollars of expenditures. And testing at a lower standard than the FDA currently requires can only save you so much. The paper shows that about 50% of the clinical costs are just from the cost of capital (having expensive capital lying around while waiting to go through testing). It's hard to imagine any practical sort of testing that doesn't incur these costs, even if you deviate from FDA standards and involve less patients, etc.
Also, you have to look at the cost avoided through rigorous testing. Human lives are expensive, purely from an economic standpoint. Say the average 50 year-old makes about $50k/year and has another 15 working years. That's about $750k in income alone. Since an employer would never hire someone that wasn't worth at least their salary, the economic value of the worker is probably well over $1m.
Now you have a study here about a new cholesterol drug: http://www.npr.org/templates/story/story.php?storyId=6577591. On a test of 15,000 people, with half taking the new drug and half taking Lipitor, the new drug resulted in 60% more deaths, or about 0.41% as a fraction of the overall test group. And this was a drug already deep into human trials.
Now, consider that a popular drug like is prescribed to tens of millions of people. What is 0.41% of 10 million? About 41,000. At $1m a pop, that's $41 billion.
Now, I'm just throwing some numbers around. The point is that even extremely small variations in the effectiveness of drugs can have huge economic impacts when you consider how widely prescribed these drugs are (to a demographic, I might add, that's often at the peak of their earning power). And there is just no way the market would be able to uncover this information without rigorous clinical testing. A 0.4% difference in efficacy can have billions of dollars in impacts, but if you're talking about a sample group where 2-3% might die in a given sample period anyway, nobody would ever know about that difference.
Letting the FDA fund clinical trials could create conflicts of interest. I think it would be more beneficial if the FDA started conducting long term efficacy studies to determine if newer treatments outperform older, lower cost options.
Believe it or not, new surgical procedures are neither patentable nor approved by any Federal regulator. Typically I think there's an IRB and you ought to have hacked around with some pigs or something. Other than that - take a knife, start cutting. At least that's my understanding.
Has this regime resulted in (a) an absence of innovation, (b) an epidemic of horrific quack surgery disasters, (c) both? I'd love to hear someone argue for applying the drug/device regulation regime to surgical procedures. The argument for the converse sure seems pretty obvious.
Clearly, you can't have the FDA process without patent monopoly protection. If you kill one, you need to kill both. Bearing in mind, of course, that Washington being Washington, nothing short of a revolution can kill either...
Just to be clear, I think software and business model patents are ridiculous, but I think the hate the patent system gets on HN is not very constructive. Obviously it was put in place to solve some problems, but ended up causing/exacerbating other problems. My question is this, what is the better way of encouraging innovation and protecting the rights of inventors? I am not defending the current system here, I am just curious to see what people think would be a better system instead of endlessly bashing the system we have.
The main issue seems to be the inability of the patent office to realize what's trivial and what's not when reviewing a patent.
It fails to do that because it's actually not a trivial thing to do at all when you're not familiar with the field: it is very difficult for a non-IT professional to take a look at Kruskal's pseudocode ( http://en.wikipedia.org/wiki/Kruskal%27s_algorithm#Descripti... ) and to state if it solves an existing pain or it's just describing trivial and intuitive, common-knowledge steps.
A solution would be to have patent reviewers splited in categories based on their professional accreditation and limit their ability to accept or deny patents to their field of expertise.
I think that's an approach that--on the outset--anyone can agree with. But the problem is that any decent professional of a field capable of doing that are also not the ones willing to sit in the patent office merely reviewing applications.
It's the same principle as PG mentioned in his essay that first rate technical people do not hire themselves out to do due diligence work for VC's, and as a result the "experts" VC's do send over are generally a joke. What's to prevent the same from happening in the patent review office?
You could pay them at their true value; high-end 6 figures would compensate the dulness and they would work for a healthy cause - the patent office could rise the patent review fees to cover up the costs, which would also have the benefit of eliminating the trivial patent applications that can't pull the weight of the review fees.
I doubt this will raise final consumer prices since for new inventions the price is more often than not what the market tolerates - I think companies will be forced to drop trivial applications as a response to the fee increase.
The other change I would make would be to limit the patent validity to 10 - 15 years max, so after the rich people pay for the research, the invention becomes available to the masses close to the actual production cost.
Just to add on to what hendzen said, they are already rather expensive as it is: $15,000 for 20 years (in Canada, where I'm from). Hardly affordable for the average small-time inventor. A friend of mine whom just patented a method of preventing over-the-shoulder spying for PIN input devices and could only afford to buy patent protection for 1 year (and for some odd reason, it cannot be increased with future payments--so whatever you commit to buying in the outset is how much protection you'll receive, period.) Increasing it further would simply make the price far too prohibitive.
As for limiting the patent validity period, the current 20 years that most nations follow is not all that long depending on the circumstance. A better method (if it's even regulatable) is X years of protection OR until you recoup your original investment + X % of return (whichever occurs first). The problem is to then police the claims of cost to invent the patent, which is a whole can of worms on its own.
This would also hamper the original purpose of patents - to protect small time inventors from large companies duplicating their inventions. Sure, maybe Apple could afford greatly increased patent fees, but if you raised them enough to pay for six-figure salaries of patent examiners, it would be prohibitively expensive for ordinary people to use the system.
All patents must die. After some time. Creators and investors are entitled to their money, their inventions must be protected somehow. That's all right. But not forever for god's sakes. Let's make it 5-15 years depending on the industry or something else. So much it's enough time to make fortune. But not so much that you can troll with that patent after half of the century. Even though the investors are paid and inventor is dead.
The patent system reminds me of an airplane going down, but whenever I read statements like "Medical Patents Must Die" I remember that nobody has a solution to make it fly again. The captain might be wrong, but the first officer doesn't know how to fix it (which is a fundamental step of communicating concerns inside the cockpit - see http://en.wikipedia.org/wiki/Crew_resource_management#Commun... ).
We don't know enough about the human body, the human genome, the diseases around us and their cure. Those things take huge amount of money to research and huge one-time payments that have no certainty at the end of the research tunnel. When a cure is found, no person alone can reimburse its cost. Abolishing patents via a blanket rule would make all medical capital fly out of the window and the only research performed would be the one in government-sponsored laboratories. If that's the solution we want to agree upon, be upfront and state it clearly, otherwise let's not destroy what works without better alternatives.
The article is not talking about drug patents. It is talking about a current case which will decide whether or not to allow patents on medical treatment, even when the patents on the drugs have expired. The patent in question in the case regards a method for adjusting the dose of a drug. Medicine has done without these patents until now.
Ars Technica had an article about this the other day, which I thought was more compelling than the linked post:
As much as I understand your argumentation from your first post, the author has a point.
Whatever reasons about money, investment or other perfectly valid reason you bring up while advocating medical patents: No one on earth should be KEPT FROM SAVING SOMEONE ELSE'S LIFE. That always trumps any endeavor to make a company or ultimately a single person richer.
>> No one on earth should be KEPT FROM SAVING SOMEONE ELSE'S LIFE. That always trumps any endeavor to make a company or ultimately a single person richer.
It's not about richness, it's about resource allocation. What you're describing is idealistic but not at all applicable in real life.
There are always situations and treatments that might prolong a person's life with X% for Y USD. What if X=0.01%, Y=500'000 USD (i.e. some highly advanced chemo sessions), and the person is 100 years old? What if you could fund with the same 500'000 USD a study that has a 10% probability to improve the cure rate of the treatment by 10%? You need to establish some boundaries and to allocate the resources according to those thresholds; leaving aside the emotionality of those decisions, at the end of the day the society needs to decide how it splits 1 billion in building new bridges, doing medical research or applying existing solutions to marginal patients. It doesn't matter if the government or the free market makes those decisions, but saying "no one" is unrealistic.
In your example the treatment simply becomes too expensive with a slim chance of success.
The relevant situation is one where a treatment is readily available (no assumptions about cost are being made) but covered by a patent, thus keeping the doc from using it because someone legally (= on paper) keeps the doc from using the treatment method.
And yes, patents are about money and property rights and richness. Not about treatment cost.
One cannot patent anything that naturally exists. But one can patent strategies. Business methods, medical, and, until recently, tax strategies can be patented. Tax strategy patents were recently banned in the America Invents Act. There has been legislation to ban medical strategy/method patents, and frankly I'm surprised it hasn't been banned yet legislatively. And the federal courts in the past have limited business strategy patents (Bilski v. Kappos). It seems to me SCOTUS should move to limit medical strategy patents in their decision. But if they don't, this may spur Congress to actually do something.
Whether or not the correlation is obvious is not the point. There is a long-standing doctrine that SCIENTIFIC DISCOVERIES ABOUT NATURAL LAWS AND PROCESSES should not be patentable.
If a discovery is made about the correlation between a measurement of something NATURAL in the body, and a dosage of a drug that should be administered, or between the dosage that is administered, and the effect is has on the body, this is MEDICAL KNOWLEDGE. THIS IS SCIENCE. It is not a patentable thing, because doctors cannot dispossess themselves of this knowledge once being told it. They are always able to USE THE KNOWLEDGE IN THEIR HEAD when treating a patient.
Therefore, this development seems to me to be atrocious, as it represents the first step in patenting KNOWLEDGE of natural phenomena.
IP law wants to encourage creativity by giving exclusive monopoly rights in creations, but at the same time BALANCE it with giving the public the freest possible access to the results. This is now being attacked at every turn. MPAA, RIAA are lobbying for SOPA and PIPA. Copyright lengths are still being extended. And now, new forms of patents are being considered. If these come to pass, I am afraid for freedom in America -- we will get the great firewall of China -- and all because of IP.
You can't patent the fact that a cotton gin works, nor can you patent the use of a cotton gin. You can only patent the design of the gin itself.
With drugs, you should only be able to patent the design of the drug itself, and probably also the method of synthesizing the drug. You should not be able to patent the idea of using aspirin to treat headaches.
The difference is that one is knowledge, and another is a mechanism. Someone has to build and produce a cotton gin, to infringe on a patent. On the contrary one only has to learn about the correlation and now doing anything with this knowledge is "patent infringement" ?
This is basically the medical equivalent of a business process or strategy patent. I am really not sure how a law needs to be worded, but this whole class of patents needs to be removed.
I read this as "Medical Patients Must Die", but it might as well have actually said that, since money and "getting mine" is really the only thing that matters the vast majority.
If the troublesome patent goes away, you can rest assured that something equally as troubling will almost immediately fill the void. Until we live in a world where something else is more important, we can't have nice things.
I guess my problem boils down to this. Isn't there a difference between a discovery and an invention? Logically I think there is. A discovery is a new understanding of an already existing reality while an invention is the creation of something new. On that difference it seems that the latter should be patentable but not the former. But if they truly have the patent claimed by the article, then our system allows for the patenting of discoveries! How bizarre. Are there other fields where discoveries are patentable. (Should Einstein have patented his theory of general relativity or E=mc^2?)
If Prometheus Labs had created a machine that measured and calculated the needed dosage change in a new and innovative way I could see a patent being granted, but not on this.
Could someone who has patent experience/expertise way in and help me here?