I did misread your statement. I interpreted "a contribution has been made, and what that contribution consists of" as "a contribution by specific people" not "a contribution to humanity." I apologize.
However, that does not change the overall intent of my reply, which is that drug discovery is not so clear-cut as you make it out to be.
Take "A previously unknown molecule had been synthesized". Part of drug development includes finding previously known molecules which have new and unexpected actions. Again I point out sildenafil, which was synthesized for use in hypertension and angina pectoris. It was a nurse, during phase I trials, who discovered that was an effective against erectile dysfunction.
As another example, insulin is found in the body. It was first synthesized in the 1960s, but diabetics had to use insulin from animal sources, which was expensive and hard to acquire. Genentech, in 1982, started selling insulin made using E. coli genetically modified with human DNA. Now insulin is relatively inexpensive.
Insulin was not new. The medical use of the chemical was not new. But the method of creating the chemical was new, and for that Genentech received a patent, and a lot of money. This case does not fit your description of how the drug discovery market.
Then there's combination therapies, where the use of two different and already existing drugs has a synergistic effect. Here's a list of some combination therapies which were patented in 2011: http://sciclips.wordpress.com/2011/09/19/recent-combination-... . Again, these are known chemical compounds, while you've twice asserted that the chemicals has to be "previously unknown" in order to be patented.
To summarize: getting a drug patent does not mean that the chemical has never been seen before.
Then again, your thesis doesn't require that it be unique. You point to drug patents because you believe they must have an "objective evidence of nonobviousness", and you want patents to have the same requirement.
However, that non-obviousness criterion is already required to get a patent. Quoting from Wikipedia: "In modern usage, the term patent usually refers to the right granted to anyone who invents any new, useful, and non-obvious process, machine, article of manufacture, or composition of matter."
It looks like you want patents to have an additional burden of proof of non-obviousness. For example, "publication in a peer-reviewed journal or conference proceedings" may count. However, you don't realize how easy that is to achieve. Peer review is a relatively low bar. There are any number of so-called 'predatory journals' which are advertised as peer-review, and which take your money and publish, but which don't have an meaningful peer-review system. Someone who pays $10,000 to get a patent will not find it difficult to spend another $1,000 to publish in one of these journals.
It's trivial to start a new academic journal, and have it staffed by friends of yours. In that way, everyone can published peer-reviewed literature. And "conference proceedings"? That's an almost trivial bar.
Your proposal is so easily gamed as to be worthless. How much do you know about the patent system? How much do you know about drug development?
I really need to write a much longer essay to develop my argument here. I was trying to express its broad outlines very succinctly. That tends to work only with a sympathetic audience.
My reference to drug patents was intended as an example of a typical case, not an exhaustive exposition of how all such inventions are made.
> It looks like you want patents to have an additional burden of proof of non-obviousness.
Actually I want to shift the burden of proof. Instead of the PTO or a alleged infringer having to prove that a patent is obvious, I want the burden to be on the applicant to prove that it is nonobvious. I also want objective evidence to be required so the question isn't just a judgment call.
The suggestion that publication could serve as prima facie evidence of nonobviousness was also an example. (For more examples, look up "Graham factors".) That said, I don't accept your criticism. I think courts can tell the difference between well-established, prestigious journals and fly-by-night operations.
Do you have a counterproposal? What do you think should be done, if anything?
"My reference to drug patents was intended as an example of a typical case"
Drug patents are perhaps the most unusual type of patent. They have special time extensions, in part because they have an extremely high burden of proof before they can be released, and information about the drug is public long before it can be sold. There are also special exceptions to allow countries to use a patented drug in case of an epidemic.
So I don't think it's useful to regard drug patents as 'a typical case.'
"I want the burden to be on the applicant to prove that it is nonobvious"
As I said, that requirement is already present. In that Graham v John Deer case you mentioned: "The determination of "nonobviousness" is made after establishing the scope and content of prior art, the differences between the prior art and the claims at issue, and the level of ordinary skill in the pertinent art."
In that sentence you included "alleged infringer". I think you've mixed two different phases. In the first phase, the patent office must be satisfied that the patent is non-obvious. Once done, the applicant is granted the limited monopoly and the right to sue infringers. The only defense of the alleged infringer is to show that the patent office's determination was incorrect, and one way is to show that it was obvious.
Why should the person with the patent grant have to re-establish non-obviousness when the patent office has already certified that it's non-obvious? More specifically, couldn't the patent grantee simply resend the same information used to get the patent in the first place?
"I also want objective evidence to be required so the question isn't just a judgment call."
Here's the relevant citation from Graham:
> This is not to say, however, that there will not be difficulties in applying the nonobviousness test. What is obvious is not a question upon which there is likely to be uniformity of thought in every given factual context. The difficulties, however, are comparable to those encountered daily by the courts in such frames of reference as negligence and scienter, and should be amenable to a case-by-case development. We believe that strict observance of the requirements laid down here will result in that uniformity and definiteness which Congress called for in the 1952 Act.
The courts seem to believe (at least in 1966) that the current factors are reasonably objective.
This is all the more interesting because, on the topic of journals you wrote "I think courts can tell the difference between well-established, prestigious journals and fly-by-night operations."
I agree with you. But means that a court uses to make that judgement with a journal is the same means that a court uses to judge non-obviousness in a patent, so you've only redirected the burden of proof, not made it higher.
"Do you have a counterproposal?"
Most assuredly I do not. My attempts at understanding the complexity of the patent system flounder every time.
For example, if the patent lifetime is reduced to 10 years, then I don't know how to handle drug patents, which have a high cost and long public exposure before they can be sold. Perhaps there's a viable alternative business model, but it calls for a huge shift in the industry.
And so on, with more variations than I care to discuss.
> I don't think it's useful to regard drug patents as 'a typical case.'
Okay, point taken.
> Why should the person with the patent grant have to re-establish non-obviousness when the patent office has already certified that it's non-obvious?
I already addressed that in my initial post (first paragraph).
There's another reason as well. One of the Graham factors is commercial success. At application time, there has not been time to establish the commercial value of the invention. The PTO has to give the applicant the benefit of the doubt. Assuming that most patent litigation doesn't reach trial until several years after the patent is granted, more information will be available then.
> My attempts at understanding the complexity of the patent system flounder every time.
You're getting bogged down in details. You need to back up and look at the big picture.
Anyway, if you don't like my proposal, here's another one by someone with actual credentials[0]. They're not mutually exclusive, though, and I'm inclined to think both could be valuable.
However, that does not change the overall intent of my reply, which is that drug discovery is not so clear-cut as you make it out to be.
Take "A previously unknown molecule had been synthesized". Part of drug development includes finding previously known molecules which have new and unexpected actions. Again I point out sildenafil, which was synthesized for use in hypertension and angina pectoris. It was a nurse, during phase I trials, who discovered that was an effective against erectile dysfunction.
As another example, insulin is found in the body. It was first synthesized in the 1960s, but diabetics had to use insulin from animal sources, which was expensive and hard to acquire. Genentech, in 1982, started selling insulin made using E. coli genetically modified with human DNA. Now insulin is relatively inexpensive.
Insulin was not new. The medical use of the chemical was not new. But the method of creating the chemical was new, and for that Genentech received a patent, and a lot of money. This case does not fit your description of how the drug discovery market.
Then there's combination therapies, where the use of two different and already existing drugs has a synergistic effect. Here's a list of some combination therapies which were patented in 2011: http://sciclips.wordpress.com/2011/09/19/recent-combination-... . Again, these are known chemical compounds, while you've twice asserted that the chemicals has to be "previously unknown" in order to be patented.
To summarize: getting a drug patent does not mean that the chemical has never been seen before.
Then again, your thesis doesn't require that it be unique. You point to drug patents because you believe they must have an "objective evidence of nonobviousness", and you want patents to have the same requirement.
However, that non-obviousness criterion is already required to get a patent. Quoting from Wikipedia: "In modern usage, the term patent usually refers to the right granted to anyone who invents any new, useful, and non-obvious process, machine, article of manufacture, or composition of matter."
It looks like you want patents to have an additional burden of proof of non-obviousness. For example, "publication in a peer-reviewed journal or conference proceedings" may count. However, you don't realize how easy that is to achieve. Peer review is a relatively low bar. There are any number of so-called 'predatory journals' which are advertised as peer-review, and which take your money and publish, but which don't have an meaningful peer-review system. Someone who pays $10,000 to get a patent will not find it difficult to spend another $1,000 to publish in one of these journals.
It's trivial to start a new academic journal, and have it staffed by friends of yours. In that way, everyone can published peer-reviewed literature. And "conference proceedings"? That's an almost trivial bar.
Your proposal is so easily gamed as to be worthless. How much do you know about the patent system? How much do you know about drug development?