Drugs and the patent system

More affordable to whom?? The seller or the buyer? Sure it would be cheaper for the seller.. Thats not the point..

Plus, if the majority of the research costs are covered by grants (which are allotted only due to patients also being taxpayers), then perhaps the real key to the research facility's profit margins should be in cutting costs in the first place, instead of doing this "community-wide collection of funds" common to insolvent businesses.

Well, that is not the fault of the people with MS, is it now? Again, we can not make excuses for companies becoming insolvent due to their own overspending and underplanning.
I've seen studies of the research costs involved in getting a single new drug to market. The government is not investing as much as you might imagine; my understanding is that Pharmaceutical companies get less than 10% of their research costs subsidized, but I would gladly see any current figures as mine are a decade out of date.
By more affordable I meant for the patients, and I mentioned MS because I know the research there is spotty for "lack of profit potential" - despite the number of people with MS, the cost of developing treatment options is seen as too high. The investment cannot be recouped, so the research is not done. This is what I intended to convey; that the current Patent laws may not give a chance for companies in certain fields to recoup their investment, so the research lags, and people have no treatment option at all.

Coming up with a new drug is a labor intensive task, requiring skilled laborers and expensive equipment. The costs are staggering not due to mismanagement, but because the task faced is so difficult. The choice faced is not "Make drugs only for the rich OR Make drugs for everyone" the true choice is "Research no new drugs OR acknowledge that they will be very expensive for the first decade or two after their development."

There is no magic answer that lets us have new drugs cheap. Acknowledging that fact does not make me a heartless monster.

Thank you very much.. Your post was very enlightening and helpful. I wasn't calling you heartless, by the way.. =)
 
Another area of interest that impacts this issue is the increasing difficulty in obtaining biotech-related patents due to obviousness over the prior art. Over the years biotech has becomes a more predictable art, according to the courts, and it is harder to get a patent (and to enforce one over invalidity arguments) because of this. So companies may not be looking as at much of a sure thing as a decade ago.

For example, if you know the amino acid sequence of a protein, is the DNA obvious? What about if you know the conformation? What about if you know the conformation of the receptor? What if you know the sequence of an naturally-occurring agonist for the receptor and you're making synthetic drugs that target the same area?

Even usefulness (or utility) standards have changed so that isolated DNA sequences that may be of interested have to have a concrete utility when you file for a patent. You can't, for example, claim that they are useful as probes for complementary sequences. They ARE useful as probes, but it won't support a patent anymore. This is a good change.

But as the patent system catches up with the science there's a question as to what extent drug companies or others involved in life sciences can reasonably expect to protection many of their products through patent.
 
Another area of interest that impacts this issue is the increasing difficulty in obtaining biotech-related patents due to obviousness over the prior art. Over the years biotech has becomes a more predictable art, according to the courts, and it is harder to get a patent (and to enforce one over invalidity arguments) because of this. So companies may not be looking as at much of a sure thing as a decade ago.

It sounds as if we need specialized judges who are primarily scientist for specialized Patent courts. We, as a society, could insist they have strong scientific degrees and continue their education, say working 9 months a year and taking classes three. Corruption of such judges would be such a temptation that we would need to insure the punishment for such were severe.
JD - does the 2B indicate you know some law professors? Perhaps you cold talk to one of them and see if a study might be done, interdisciplinary naturally, to investigate this problem. I would not know where to start getting the attention of anyone the government might heed, more's the pity.
 
Another area of interest that impacts this issue is the increasing difficulty in obtaining biotech-related patents due to obviousness over the prior art. Over the years biotech has becomes a more predictable art, according to the courts, and it is harder to get a patent (and to enforce one over invalidity arguments) because of this. So companies may not be looking as at much of a sure thing as a decade ago.

It sounds as if we need specialized judges who are primarily scientist for specialized Patent courts. We, as a society, could insist they have strong scientific degrees and continue their education, say working 9 months a year and taking classes three. Corruption of such judges would be such a temptation that we would need to insure the punishment for such were severe.
JD - does the 2B indicate you know some law professors? Perhaps you cold talk to one of them and see if a study might be done, interdisciplinary naturally, to investigate this problem. I would not know where to start getting the attention of anyone the government might heed, more's the pity.

FYI! :)

Government funding for medical research amounts to approximately 36% in the U.S. The government funding proportion in certain industries is higher, and it dominates research in social science and humanities. Similarly, with some exceptions (e.g. biotechnology) government provides the bulk of the funds for basic scientific research.

In the United States, the most recent data from 2003[2] suggest that about 94 billion dollars were provided for biomedical research in the United States. The National Institutes of Health and pharmaceutical companies collectively contribute 26.4 billion dollars and 27.0 billion dollars, respectively, which constitute 28% and 29% of the total, respectively. Other significant contributors include biotechnology companies (17.9 billion dollars, 19% of total), medical device companies (9.2 billion dollars, 10% of total), other federal sources, and state and local governments. Foundations and charities, led by the Bill and Melinda Gates Foundation, contributed about 3% of the funding.

The enactment of orphan drug legislation in some countries has increased funding available to develop drugs meant to treat rare conditions, resulting in breakthroughs that previously were uneconomical to pursue.

Medical research - Wikipedia, the free encyclopedia
 
It sounds as if we need specialized judges who are primarily scientist for specialized Patent courts. We, as a society, could insist they have strong scientific degrees and continue their education, say working 9 months a year and taking classes three. Corruption of such judges would be such a temptation that we would need to insure the punishment for such were severe.1

Charles:

We do have the Federal Circuit, which is to a degree specialized in terms of hearing patent cases. Not that the judges necessarily have a technical proficiency, but they have a good understanding of IP law. Of course, the swing there recently has been away from IP owners, particularly in certain patent areas.

As for a study - what sort of thing are you looking for? I've been practicing in this area, and a couple others, for a decade now, and I've also been a law professor (Constitutional law as well as IP), and I will be teaching Constitutional law again in the fall. I know some current patent law professors who spend a lot of time academically on these issues and I could probably point you at some source if you give me a few more specifics about what you're looking for.
 
In 2000, a report from from a Joint Economic Committee of Congress outlined the benefits of NIH research. It noted that some econometric studies had given its research, which was funded at $16 billion a year in 2000, a rate of return of 25 to 40 percent per year. It also found that of the 21 drugs with the highest therapeutic impact on society introduced between 1965 and 1992, public funding was "instrumental" for 15.

National Institutes of Health - Wikipedia, the free encyclopedia
 
Another area of interest that impacts this issue is the increasing difficulty in obtaining biotech-related patents due to obviousness over the prior art. Over the years biotech has becomes a more predictable art, according to the courts, and it is harder to get a patent (and to enforce one over invalidity arguments) because of this. So companies may not be looking as at much of a sure thing as a decade ago.

It sounds as if we need specialized judges who are primarily scientist for specialized Patent courts. We, as a society, could insist they have strong scientific degrees and continue their education, say working 9 months a year and taking classes three. Corruption of such judges would be such a temptation that we would need to insure the punishment for such were severe.

Well, patent law (and all law) is really a matter of prior case law, and the effectuation of reason, more than anything. It is up to the lawyers to prove the case itself worthy of approval. Judges should not have a bias.. It is always better to have someone who is simply reasonable and fair, even if they are completely stupid, to sit on a bench, than it is to have, say, family law judges have to go to social worker school three months out of a year, or in this case, genetics classes.. =)


JD - does the 2B indicate you know some law professors? Perhaps you cold talk to one of them and see if a study might be done, interdisciplinary naturally, to investigate this problem. I would not know where to start getting the attention of anyone the government might heed, more's the pity.

Yeah you got it right. I am not in law school yet, but I know a few law professors that are still active, and a few who are retired..

I don't think the problem is in the judicial system's lack of education on the subject.. It is more effective to say that the courts have not been made aware by clear and convincing evidence, along with expert witness testimony, that there is a problem with the patent system. The same thing was happening with abortion cases, prior to Roe.. the people filing were not pregnant, so they did not have standing, and their cases were subsequently thrown out, as a result.

It would probably take an actual company that is attempting to get a patent, or to copy one, to be able to get the ball rolling on this. They should have their facts ready to go, long before they go to court, so that the court can be fully informed of what the problems are. =)
 
Well, patent law (and all law) is really a matter of prior case law, and the effectuation of reason, more than anything. It is up to the lawyers to prove the case itself worthy of approval. Judges should not have a bias..

I don't think the problem is in the judicial system's lack of education on the subject.. It is more effective to say that the courts have not been made aware by clear and convincing evidence, along with expert witness testimony, that there is a problem with the patent system.
I see your point, but my worry is that honest science may run afoul of dishonest corporate lawyers. The technology for creating and improving medicine sounds as if it is about to take a big step forward. Excellent news as that may make developing treatment of more esoteric diseases possible. But it may open a window for some really unfair, and short sighted rulings.
I say short sighted because we can never tell if some biological researched won't flip out over some egregiously unfair ruling - a lot of researchers are a bit distant form legal realities and having a decades worth of individual initiative destroyed by the greed and smooth presentation of a slick lawyer is certain to aggravate people getting the short end of the stick - and create a WMD bioweapon in their garage. I understand an expert truly could wipe out thousands with stuff commonly found in any household drain.
Even if this worst case is hyperbole, I don't know for sure, it still fails to address the fairness of allowing lawyers to cripple medical advances for their own pocketbooks.

Yeah, no good solution, I'm just wondering aloud if there is a better one than the current system.
 
We do have the Federal Circuit, which is to a degree specialized in terms of hearing patent cases. Not that the judges necessarily have a technical proficiency, but they have a good understanding of IP law. Of course, the swing there recently has been away from IP owners, particularly in certain patent areas.

As for a study - what sort of thing are you looking for?
Almost overlooked this response, sorry about that.
How much is biotech changing? How can we, as a nation, most efficiently make the judges who rule on patents aware of those changes? How do we get judges able to sift pseudo-science from true science when presented with smooth talkers on both sides?
This is what I am thinking about.
 
Well, patent law (and all law) is really a matter of prior case law, and the effectuation of reason, more than anything. It is up to the lawyers to prove the case itself worthy of approval. Judges should not have a bias..

I don't think the problem is in the judicial system's lack of education on the subject.. It is more effective to say that the courts have not been made aware by clear and convincing evidence, along with expert witness testimony, that there is a problem with the patent system.
I see your point, but my worry is that honest science may run afoul of dishonest corporate lawyers. The technology for creating and improving medicine sounds as if it is about to take a big step forward. Excellent news as that may make developing treatment of more esoteric diseases possible. But it may open a window for some really unfair, and short sighted rulings.
I say short sighted because we can never tell if some biological researched won't flip out over some egregiously unfair ruling - a lot of researchers are a bit distant form legal realities and having a decades worth of individual initiative destroyed by the greed and smooth presentation of a slick lawyer is certain to aggravate people getting the short end of the stick - and create a WMD bioweapon in their garage. I understand an expert truly could wipe out thousands with stuff commonly found in any household drain.
Even if this worst case is hyperbole, I don't know for sure, it still fails to address the fairness of allowing lawyers to cripple medical advances for their own pocketbooks.

Yeah, no good solution, I'm just wondering aloud if there is a better one than the current system.
fyi
many scientists and researches do this for name recognition at most and NOT for the money involved.... scientists usually have contracts with their employer that gives most all rights to the employer for their invention.....

In other words, the scientists themselves will keep questing....they have the mind and souls to want to create things that help people or help science advance.....money is not what keeps them interested in finding cures....

Granted, government money invested in their research keeps their quests going in the monetary sense....and so does the money from private firms and private charities....

But I have no doubt that scientists would do what they do best, regardless of their own personal enrichment.
 
Well, patent law (and all law) is really a matter of prior case law, and the effectuation of reason, more than anything. It is up to the lawyers to prove the case itself worthy of approval. Judges should not have a bias.

We would, however, be much better off having patent judges who have a technical proficiency as well. Part of the reason the Federal Circuit is set up the way it is has to do with the recognition that there are certain problems associated with areas like patent law that would benefit from having more specialized judges. The law is applied per statute and precedent, but it is applied to the facts of a situation, and those facts often turn on a fairly detailed knowledge of genetics, biochemistry, mechanical engineering, etc.
 
How much is biotech changing? How can we, as a nation, most efficiently make the judges who rule on patents aware of those changes? How do we get judges able to sift pseudo-science from true science when presented with smooth talkers on both sides?
This is what I am thinking about.

Biotech has changed dramatically in the last 20 or 30 years, and the pace of innovation is fairly rapid. You aren't going to have judges who can have expertise on the latest innovations, specifically, though you could have judges who have a basic grounding in a particular field of endeavor (biochemistry for example) who would be able to readily understand new innovations that might come before them in a case. In the least, they need clerks with a firm grounding.

To deal with science v. pseudo-science you can, of course, enlist experts, but this usually turns into a situation where each side has its experts. For something rather amorphous like "obviousness" in patent law, the best situation you could have, in my view, is a judge who had a top-notch grounding in patent law coupled with an adequate understanding of the art are to which the patent applies, so that the judge has some basis upon which to make a determination after hearing what the parties and their experts have to say.

Unfortunately, even in the patent office you have actual patent Examiners who don't have a good grounding in the technical area to which a patent they are examining applies.
 
... - a lot of researchers are a bit distant form legal realities and having a decades worth of individual initiative destroyed by the greed and smooth presentation of a slick lawyer is certain to aggravate people getting the short end of the stick - and create a WMD bioweapon in their garage. I

Yeah, no good solution, I'm just wondering aloud if there is a better one than the current system.

Not too worried about that extreme, but you bring up a good point about researchers. There is a cultural perspective among researchers that it at odds with patent law (and well should be in my view). Part of what I do is spend a lot of time educating researchers, particularly academics, on the realities of patent law. A scientist typically wants to publish data and get it out in to the literature quickly. This can be deadly to patent rights. On the other hand, if you bottle everything up and keep it quiet because there might be a potential for a patent filing, you start to impede the sharing of information in the scientific literature. The trick is finding a balance. I try to work with my clients to get protections in place as quickly as possible so that they can move ahead with publication or other disclosures. Sometimes, though, I end up having to recommend they keep things quiet for quite a while because they aren't at the stage yet where they can file a patent, but any disclosure can nevertheless be used against them when they DO file.
 
Unfortunately, even in the patent office you have actual patent Examiners who don't have a good grounding in the technical area to which a patent they are examining applies.

I've seen that one. I was working with Dr Mike Stickney on a pulse detonation engine and practically my first thought (after solving some underlying physics - my field) was "Hey we could use this to drive a gas turbine" - very obvious application. But when I mentioned it to him, he holds the patent on using pulse detonation for Chemical synthesis and a couple other uses, he answered that a Japanese company had already patented that concept. Using a toy turbine similar to the ones the Greeks built over a 1000 years ago.
Sitckney's work, which was getting an 85% efficiency on chemical to mechanical conversion, was stunning - brilliant really, but those guys just jumped on the wagon and got the "electrical power production" sewn up for the foreseeable future.

At least no one has challenged Mike's patent (to my knowledge) - that would be a crime.
 
I've seen that one. I was working with Dr Mike Stickney on a pulse detonation engine and practically my first thought (after solving some underlying physics - my field) was "Hey we could use this to drive a gas turbine" - very obvious application. But when I mentioned it to him, he holds the patent on using pulse detonation for Chemical synthesis and a couple other uses, he answered that a Japanese company had already patented that concept. Using a toy turbine similar to the ones the Greeks built over a 1000 years ago.
Sitckney's work, which was getting an 85% efficiency on chemical to mechanical conversion, was stunning - brilliant really, but those guys just jumped on the wagon and got the "electrical power production" sewn up for the foreseeable future.

Yeah, it is an interesting field. The Patent Office is first and foremost a government bureaucracy, and many of its troubles (including problems in the examination process) can be traced to that. I have received office actions on patent filings that were so bad it was clear the examiner hadn't even read the application. He just wanted 'credit' internally for issuing a first action.

Unfortunately, your best analysis and 'examination' of a patent comes later in court or during re-exam, when someone is challenging the validity of a patent that is already issued.
 
Well, patent law (and all law) is really a matter of prior case law, and the effectuation of reason, more than anything. It is up to the lawyers to prove the case itself worthy of approval. Judges should not have a bias.

We would, however, be much better off having patent judges who have a technical proficiency as well. Part of the reason the Federal Circuit is set up the way it is has to do with the recognition that there are certain problems associated with areas like patent law that would benefit from having more specialized judges. The law is applied per statute and precedent, but it is applied to the facts of a situation, and those facts often turn on a fairly detailed knowledge of genetics, biochemistry, mechanical engineering, etc.

I understand what you are getting at here, but I still do not see the need for having judges be akin to experts in any given field.
Expertise gives way to bias.. Who wants a judge with a bias?

The attorneys should be capable of presenting the judge with all the factual information they require to make a decision..

In a court of family law, for instance- it is necessary for the judge to have a vast knowledge of the family law system, but absolutely irrelevent for them to have even a working knowledge of how the sociological inner workings of any individual family functions, to render a just verdict..

In a bankruptcy court, the judges need to be aware of bankruptcy law and credit reporting, etc.. but they don't need to go to a class and get educated to know all the whosits and whatsits as to why an individual is filing.. The individual, or their attorney, will tell that judge what he needs to know.

Specialized courts do NOT need judges with specialized training or expertise.
 
I understand what you are getting at here, but I still do not see the need for having judges be akin to experts in any given field.
Expertise gives way to bias.. Who wants a judge with a bias?

The attorneys should be capable of presenting the judge with all the factual information they require to make a decision..

In a court of family law, for instance- it is necessary for the judge to have a vast knowledge of the family law system, but absolutely irrelevent for them to have even a working knowledge of how the sociological inner workings of any individual family functions, to render a just verdict..

In a bankruptcy court, the judges need to be aware of bankruptcy law and credit reporting, etc.. but they don't need to go to a class and get educated to know all the whosits and whatsits as to why an individual is filing.. The individual, or their attorney, will tell that judge what he needs to know.

Specialized courts do NOT need judges with specialized training or expertise.

Patents are different than the above, though. By law, the outcome of a patent case very often hinges on specific technical differences between the inventions at issue. If you have a complex biochemical product, with sequence data, crystal structures, and the like, it is really impossibly to give the judge a very good understanding. I've seen patent cases where the outcome relied, for example, on a conformational difference in the three-dimensional structure of a protein.

From a practical standpoint it would be nice if the judge's had enough of a technical proficiency that they could understand these things. They wouldn't have to be experts. And judges on the Federal Circuit do pick up technical expertise over time. But from a practical matter they end up relying on the expertise of clerks or others when they lack their own technical proficiencies. If expertise breeds bias, then the decisions ultimately come down to expert bias in one form or another, just the bias of the clerk or other expert instead of the judge.

The biggest problem, though, with judges on the Federal Circuit not having a technical proficiency is that they set public policy for patents, and without an understanding of the technology at issue in a case you end up with some decisions that are really quite bad just because the judges didn't understand the technical ramifications or impact of the decision. One might argue that this is in part the attorney's fault, but in reality you can't educate a judge enough in briefs and oral arguments to really understand well some of the complicated art areas.

Judges make decisions regarding patent validity, for example. Technical decisions. Is this invention obvious over the art. There's no way to do that without having a good understanding of the technical area, which is why both patent attorneys and patent examiners have to have a technical background. So imagine a strange scenario where a patent attorney with a degree in biochemistry has drafted and prosecuted an application, the patent examiner with a degree in biochemistry has allowed it over the prior art, and then a judge with absolutely no knowledge of biochemistry says "Oh, I think this is obvious." As you might imagine, you get some pretty strange outcomes.
 

Forum List

Back
Top