Yes, there was a related thread a while back, but I want to start a discussion about to what extent patents on natural genetic sequences should be allowed. Plus, I had the really clever thread title.
As I understand it, the requirement now to patent a genetic sequence is that you must have the sequence, and suggest a possible utility of it. You don’t need to have any idea how to achieve that utility, just the vague notion that it’s out there.
This strikes me as a really bad idea, which will lead to overly broad patents (already a problem). But more importantly, I imagine that premature grants of genetic patents will stifle genuine research in legal tangles.
I haven’t any concrete cites, but I fully expect that some of you do, so get to arguing about whether a naturally occuring genetic sequence should be able to be owned at all, whether patents are the right method, and what the qualifications to get said ownership should be.
Eww. I would say that a gene sequence should not be able to be patented, but boy that’s a tough one. Certainly the methods involved in splicing and/or creating genes should be able to be patented.
But boy, considered the beauty of things that could be gained from genetic manipulations I’d hate to simply ban all patents on it, especially due to the lengths with which one must go to accomplish successful genetic manipulations.
No being a member of that community I can’t say how much of it is trial and error and how much of it has reached the level of some understanding.
Hey, missed that “natural” part. It simplifies the issue somewhat. I think that yes, they could be granted, BUT, depends on what exactly they were trying to patent about it.
For example, to clear things up a bit…
If we find a gene sequence in apes that provides immunity to HIV, then surely I think that that application of the gene should be able to be patented (where we splice it, for example). The gene sequence itself is not man-made, and so I don’t feel that patent rights apply.
To say otherwise would imply that Newton could patent the law of gravitational attraction. By analogy, what I’m saying is that a rocket which directly utilizes those equations should be able to be patented.
As well, to create a gene sequence which has an application, though it sems to be beyond our current knowledge, and patent that only to find that it naturally occurs in deep sea bacteria should not invalidate that patent.
Basically, the patents should involve the application and methedology, not the genes themselves alone.
First, disclaimer. I work for a large multinational involved in this field (i.e. biotech), ergo I do have a certain POV.
Having said that, I have a passing familiarity with the issue, having worked on the patent side of things. However, my knowledge is several years old now.
To start, one has to realize that the way the US patent system works is a bit odd. (a) approval of the patent is not a final decision, rather it simply means you meet the minimium hurdles. The American system depends on competitors challenging patents which are no good, i.e. were not in fact non-obvious, not in fact original etc. Ergo obtaining a patent is only the first step. (b) You next have to defend your patent. To my knowledge this is the step in which all biotech gene patents are in. Also, again to my now somewhat dated knowledge, all have failed so far. That is all have been overturned.
Next, I would hazard the opinion that early examiners were not in fact properly prepared and a number of gene patents were granted which did not in fact meet the minimium standards. To an extent I do think it is fair to say that initial over-broad, in fact unsupportable patents have seen valuable resources go to litigation as opposed to other areas. But the American system does encourage that.
I believe it is fair to say that complaints all around have resulted in the US Patent Department upgrading the examiners working with biotech applications. That is they’re hiring more people with biological training (whereas before we had some folks trained in engineering examining applications, not entirely inappropriate given that most applications are methadological and not on the very gene itself: e.g. gene guns and the like.).
I frankly think that, regardless of corporate position, naturally occuring sequences should not be patented, even when one describes their function. That simply does not rise to the level of patentability. (ARL has hit the nail on the head with the Newton analogy) What does is finding mechanisms to alter or modify the same.
In any case, I think it is fair to say that the legal status of all this remains very, very murky and I believe the current EU position excludes the idea of patenting genes per se.
That statement needs a little clarification, I think. When a US patent is granted, it is a valid patent, giving the owner the right to exclude competitors from practicing the subject matter of the patent. Most patents live their lives peacefully, never being the subject of a litigation.
If, however, the patentee decides to sue an alleged infringer, then the defendant has the right to challenge the validity or enforceability of the patent. However, the patent is presumed valid and the defendant carries the burden of proving the patent is invalid or unenforceable.
Anyway, I think we all agree that the sequences themselves should not be patented, but rather the methods of using them.
But what rises to the level of patentability there? Is “Splicing gene sequence A in to promote production of protein B” patentable?
Indeed the legal status is quite murky right now. But what I find very interesting is that I have very little intuition at where the line should be drawn.
Here is an article that highlights why this isn’t just a simple question of “you can’t patent something that you didn’t make”. This is really a complex issue.
The paper I linked reports work that could very well lead to a whole new class of antibiotic drugs. Even in this preliminary work, they found a drug that works as well as streptomycin in vitro. Obviously, if this pans out, it’s a discovery that could be worth billions of dollars.
What’s interesting is the very first thing the authors did is run a computer search comparing the sequence of an E. coli gene to the genome of another bacteria they were interested in, saving them months, if not years of work. They didn’t sequence either genome. All the information they needed was provided by other scientists and freely available online.
So, let’s say their discovery does in fact lead to billions of dollars in the drug market. What about those researchers who originally figured out the genome information that was so vital to the work? Are they entitled to a piece of that profit?
That’s the idea behind the patenting of genes. I hate to say it, but scientists aren’t in science purely for the love of learning things. There’s a LOT of money flying around. And if I spend months producing work that enables someone else to make a ton of money off it, personally I think I’m entitled to some compensation.
Zoff: Thank you for the addition. The thrust of my commentary was to draw attention to the fact that the American patent system leans much more heavily on the legal system to sort out areas of controversy.
Now then:
I’m afraid I have to disagree.
Yes, indeed it is. That’s a decision taken to help spread the data wealth so we can get on to the real meat.
Sure, by making their own developments based on the same descriptive data. This is no different than say chemistry. When you create something, perhaps you can patent it if it is not obvious. When you describe something, that is not patentable.
And it is a distortion. There are plenty of incentives for patenting the normally patentable, there is no reason to allow patenting of descriptions on what occurs naturally. In fact there are many reasons not to. The whole idea rests on the false premise that patenting naturally occuring genes will provide incentives (in a near term possibly, in the long term no. )
Some are, some aren’t. However, at this stage we also need as much exchange of basic information as possible. Ergo, the traditional rules for patentability hold. Or, as one poster above indicated, we would have the absurd situation of patenting the genetic equivalent to the law of gravity.
Which is of course no reason to abandon rationality.
Yes, the fruits of your work. That does not mean it rises to patentability.
Truly. Any idea disseminated in public magazines or ovre the internet can no longer be patented. Sometimes this is a smart move. for obvious reasons.
Have you met many scientists in the biomedical field? They don’t make as much as you seem to think, or at least as that sentence implies. They get a decent share of cash, but the bulk of these pHDs don’t make the mega-bucks. The company I work for sells instrumentation to the R&D side of drug manufacture. These scientists are pretty top-of-the-line, but that doesn’t mean their pay is indicative of that. A decent programmer with a BS will make more than many of them.
Indeed, I just had dinner with a pHD last night (wish me luck ;)) and we were discussing just that… many scientists can only be in it for love of the game, because their pay is not indicative of their intelligence or skill level.