Drugs and the patent system

[Steerpike]

Link to slashdot, with a further link to the Baltimore Sun if anyone is interested:

Slashdot Science Submission | Should a new technology change the patent system?

Interesting topic - finding the boundary here.

 

[JD_2B]

Link to slashdot, with a further link to the Baltimore Sun if anyone is interested:

Slashdot Science Submission | Should a new technology change the patent system?

Interesting topic - finding the boundary here.

The vast right-wing conspirators are hard at work on this one. No doubt the Republicans will approve it. Its just the Conservative side's way of "proving" how Obama's health care reform devastated the economy, etc, and win back their party.

Retards.

 

[Charles Stucker]

The vast right-wing conspirators are hard at work on this one. No doubt the Republicans will approve it. Its just the Conservative side's way of "proving" how Obama's health care reform devastated the economy, etc, and win back their party.

The source is not as clear as I would prefer, but the concept is defensible.
If developing a new concept (Drug, energy saving device, what have you) becomes too expensive for the current patent protection to give a net positive return, but the concept is strong enough to be viable, should an effort be made to change the patent laws in these cases?
I don't see this as having anything to do with Obama or the current economic problems.
It is an effect of increasingly narrow specialties; the general fields are well developed and getting further into a specialty is increasingly costly.

 

[Steerpike]

I don't see this as having anything to do with Obama or the current economic problems.
It is an effect of increasingly narrow specialties; the general fields are well developed and getting further into a specialty is increasingly costly.

I don't think it has anything to do with the current economic problems per se. It will make for an interesting aside in the debate on health care costs, though. These proposals can't go anywhere without Democratic backing, such as that of Democrat Barbara Mikulski, mentioned in the source article. Support for such Bills will provide political fodder for critics.

That's putting aside whether the idea is good or bad. The problem lies mostly in biotech/pharma. And I agree you want to provide sufficient incentive for innovation in these areas.

 

[JD_2B]

The vast right-wing conspirators are hard at work on this one. No doubt the Republicans will approve it. Its just the Conservative side's way of "proving" how Obama's health care reform devastated the economy, etc, and win back their party.

The source is not as clear as I would prefer, but the concept is defensible.
If developing a new concept (Drug, energy saving device, what have you) becomes too expensive for the current patent protection to give a net positive return, but the concept is strong enough to be viable, should an effort be made to change the patent laws in these cases?
I don't see this as having anything to do with Obama or the current economic problems.
It is an effect of increasingly narrow specialties; the general fields are well developed and getting further into a specialty is increasingly costly.

Hey, I have nothing against capitalism, whatsoever.. I think that the patent time limits the pharmaceutical companies have on their designs (10 years, I believe, or 5 years, for sure- Cant very well tell if a typo was made on the site). I think those patent timelines are well deserved, considering that the biotech companies deserve to get a fair return on their investments.

This does come at an interesting time, though, does it not? At the precipice of the health care reform debate? I mean, lets be real here.. Republicans have lately been of the mindset to give to the rich and steal from the poor..

Examples:

Republican plan to sabotage health care reform // Current

Last week Republicans on Capitol Hill held a strategy summit on how to defeat key parts of the president’s health care plan.

At one point, Republican pollster Frank Luntz declared, “You’re not going to get what you want, but you can kill what they’re trying to do.”1

Luntz wrote a confidential memo that laid out the Republican strategy: Pretend to support reform. Mislead Americans about the heart of Obama’s plan, the public health insurance option. Scare enough people to doom real reform.

The choice of a public health insurance plan is crucial to real health care reform. But right now, it’s being smeared by conservatives and insurance-industry front groups. Here’s what you really need to know:

Glenn Beck usng Vicks Vapo-Rub to induce tears...

Glenn Beck's sobbing secrets revealed: A little Vicks Vaporub gets the tears flowing | Crooks and Liars

Republicans, even when all of their demands for health care reform are met- still vote no..

The Washington Monthly

 

[Care4all]

it should stay at 5 years MAX....regardless of the type of drug, and they should not be allowed to modify it slightly for another 5 years of exclusivity....

this 12 year plus another 12 is 24 years before a more affordable life saving drug hits the market....

this is sooooooo wrong, especially when i would bet it is our government grants, our tax dollars, that funded the research.

 

[Steerpike]

Hey, I have nothing against capitalism, whatsoever.. I think that the patent time limits the pharmaceutical companies have on their designs (10 years, I believe, or 5 years, for sure- Cant very well tell if a typo was made on the site). I think those patent timelines are well deserved, considering that the biotech companies deserve to get a fair return on their investments.

This does come at an interesting time, though, does it not? At the precipice of the health care reform debate? I mean, lets be real here.. Republicans have lately been of the mindset to give to the rich and steal from the poor..

I agree re: companies getting a return on their investment as well as providing incentives for research and development.

I don't think the partisan view on it holds up to scrutiny, however. Democrats are supporting this idea, and the GOP can't do anything like this on their own. The truth is that both parties are heavily laden with corruption and ties to special interests. The Democrats are heavily tied to pharma, with important portions of the industry residing in areas controlled by the Dems. So I think you have to credit both parties (or discredit them both, as the case may be).

 

[Charles Stucker]

This does come at an interesting time, though, does it not? At the precipice of the health care reform debate? I mean, lets be real here.. Republicans have lately been of the mindset to give to the rich and steal from the poor..

The timing may be suspicious, but I am unsure if we should allow that suspicion to cripple a modification to the patent system IF it is needed.
I stress the IF because I am not sure it is needed, though the question is extremely relevant to national prosperity. All the rights forgotten in the Constitution that had to be addressed by the Bill of Rights, but Intellectual property rights were remembered. I am under the impression, from books and papers/articles I have read in the past, that the US patent system has been a major source of wealth for the US as it has encouraged more innovation than occurs where the protection is less. Should this impression prove well founded then failing to address the situation could result in lagging research.

On the concept that "greedy companies want more money and want to deny life-saving treatment to deserving people." Where would anyone ever get the treatment if the companies/researchers never developed them? If the process is uneconomical then the research won't get done; costs are enormous and the major return is the patent. If the patent were removed entirely it would mean that no new research, save the tiny trickle funded by the government would be done. Thanks, but I'd rather have the drugs available at high cost than unavailable at any cost.

 

[Care4all]

Hey, I have nothing against capitalism, whatsoever.. I think that the patent time limits the pharmaceutical companies have on their designs (10 years, I believe, or 5 years, for sure- Cant very well tell if a typo was made on the site). I think those patent timelines are well deserved, considering that the biotech companies deserve to get a fair return on their investments.

This does come at an interesting time, though, does it not? At the precipice of the health care reform debate? I mean, lets be real here.. Republicans have lately been of the mindset to give to the rich and steal from the poor..

I agree re: companies getting a return on their investment as well as providing incentives for research and development.

I don't think the partisan view on it holds up to scrutiny, however. Democrats are supporting this idea, and the GOP can't do anything like this on their own. The truth is that both parties are heavily laden with corruption and ties to special interests. The Democrats are heavily tied to pharma, with important portions of the industry residing in areas controlled by the Dems. So I think you have to credit both parties (or discredit them both, as the case may be).

to let a company, keep a life saving drug off the market in a generic form that is more affordable, for possibly 24 years, is unethical.... I don't care what party is supporting this, it is unethical lunacy.

They do not have to make their money back on one specific drug to make themselves profitable....it can be spread out to every drug they make , to come in to an acceptable profit margin....

 

[JD_2B]

This does come at an interesting time, though, does it not? At the precipice of the health care reform debate? I mean, lets be real here.. Republicans have lately been of the mindset to give to the rich and steal from the poor..

The timing may be suspicious, but I am unsure if we should allow that suspicion to cripple a modification to the patent system IF it is needed.
I stress the IF because I am not sure it is needed, though the question is extremely relevant to national prosperity. All the rights forgotten in the Constitution that had to be addressed by the Bill of Rights, but Intellectual property rights were remembered. I am under the impression, from books and papers/articles I have read in the past, that the US patent system has been a major source of wealth for the US as it has encouraged more innovation than occurs where the protection is less. Should this impression prove well founded then failing to address the situation could result in lagging research.

On the concept that "greedy companies want more money and want to deny life-saving treatment to deserving people." Where would anyone ever get the treatment if the companies/researchers never developed them? If the process is uneconomical then the research won't get done; costs are enormous and the major return is the patent. If the patent were removed entirely it would mean that no new research, save the tiny trickle funded by the government would be done. Thanks, but I'd rather have the drugs available at high cost than unavailable at any cost.

Well, nobody said they want to deny life saving treatment to anyone- but, just like Care4all said, to keep it at such a high cost, and to put that high cost at the hands of the very people who funded the research required, for SO long- is essentially highway robbery..
Besides, in 24 years- the companies (and the FDA) would have already either found out that the drug is more dangerous than it was thought to have been, OR come up with some other revolutionary treatment that far surpasses the beneficial components of the one that eventually made it to the generic market..

I ask.. Where do we draw the line between capitalism and greed, really? Because that line MUST be drawn, to ensure the welfare and stability AND, yes- the economic prosperity of this country.

See- Point 1: The more people you have that are spending 500 dollars a month (instead of 50) on a name brand pharmaceutical, then it stands to reason that the fewer people there are spending the remaining 450 dollars on other goods and services. This only diminishes the economy, especially since these same people are generally taxpayers and have already spent a significant amount of money towards the grants and what not that funded this research and forward progress in pharma to begin with. That is double-charging, and, while biotech companies should of course be encouraged to strive for a profit margin, this should not come as an expense to Americans. Let them export their products and charge full price elsewhere, to people who did not fund their findings.

Point 2: If we are in what can easily be defined as an economic depression, or even on the brink, then it also stands to reason that the majority of Americans simply CANT afford to pay for these drugs. This, in turn, leads to them dying for lack of available (affordable) treatment, which leads to earlier death than would be expected, and of course, that leads to people having fewer children. Fewer children leads to our country having less people to spend money in the future. This is a sociological fact.

 

[Steerpike]

They do not have to make their money back on one specific drug to make themselves profitable....it can be spread out to every drug they make , to come in to an acceptable profit margin....

It's already spread out to cover, also, the costs of the many, many drugs the company pursued in research but didn't pan out for one reason or another. It costs a lot to go through the process and end up with one good drug amongst many that fail for whatever reason. So that is something else to be figured into the calculus.

If taxpayer money is used to fund the research and development of a drug, then the government can have rights in the invention even if it is under patent. The government does not often exercise those right, however.

 

[Care4all]

I just wonder if the government guaranteeing their profits for 12yrs + another 12 years is truly considered a free market.....What would these people do if they did not have the government guarantee their profits in this manner of preventing competition? What would they do if they did not have the gvt doing this....how could the true free market regulate themselves on this or protect themselves on this without the gvt doing it for them, I wonder?

 

[Steerpike]

I just wonder if the government guaranteeing their profits for 12yrs + another 12 years is truly considered a free market.....What would these people do if they did not have the government guarantee their profits in this manner of preventing competition? What would they do if they did not have the gvt doing this....how could the true free market regulate themselves on this or protect themselves on this without the gvt doing it for them, I wonder?

Those questions apply to any company using patents, though. Such things were considered by the Founders and they expressly provided in the Constitution for Congress to establish a patent system. Patent policy isn't just (or even primarily) about protecting companies from competition. There are public policy considerations that go into it in terms of encouraging innovation and encouraging inventors to bring their ideas to the public so that the public can benefit from them.

Of course, as new technologies emerge we can consider whether the public policy goals underlying the patent system are achieved with respect to those new technologies. One area of controversy in this respect, for example, is software. Another is drugs.

 

[Charles Stucker]

I just wonder if the government guaranteeing their profits for 12yrs + another 12 years is truly considered a free market.....What would these people do if they did not have the government guarantee their profits in this manner of preventing competition?

They do have Free Market competition - every other company on the Market is Free to develop a competing drug.
The question which has recently arisen is:
With the extremely high cost of developing new drugs, is the current patent protection enough to encourage companies to find new cures?

Patents are about protecting intellectual property, a topic which gets a lot of confused looks from people accustomed to downloading music etc from the internet because "information is free"
Here it is in a nutshell - people who produce new Music, Books, or Inventions, put time and effort into that production. Patent and Copyright protections are in place to keep some petty thief from stealing the fruit of their labors. That fruit is the content of the Music or Book or design of the invention. Denying Patent and Copyright protection from some idiotic "information is free" attitude results in fewer people making the effort to improve society by coming up with new Music, Books or Inventions. So if you have neither morals nor the desire to hear new music again, then go ahead and download all the music you want and hope the authorities never put you on trial for copyright infringement.

 

[Care4all]

I just wonder if the government guaranteeing their profits for 12yrs + another 12 years is truly considered a free market.....What would these people do if they did not have the government guarantee their profits in this manner of preventing competition?

They do have Free Market competition - every other company on the Market is Free to develop a competing drug.
The question which has recently arisen is:
With the extremely high cost of developing new drugs, is the current patent protection enough to encourage companies to find new cures?

Patents are about protecting intellectual property, a topic which gets a lot of confused looks from people accustomed to downloading music etc from the internet because "information is free"
Here it is in a nutshell - people who produce new Music, Books, or Inventions, put time and effort into that production. Patent and Copyright protections are in place to keep some petty thief from stealing the fruit of their labors. That fruit is the content of the Music or Book or design of the invention. Denying Patent and Copyright protection from some idiotic "information is free" attitude results in fewer people making the effort to improve society by coming up with new Music, Books or Inventions. So if you have neither morals nor the desire to hear new music again, then go ahead and download all the music you want and hope the authorities never put you on trial for copyright infringement.

i understand the concept behind intellectual property and the costs behind creating different widgets to sell with proprietary features and benefits.

But i also understand how to market ones product to spread out the costs of its 'creation', and keeping the cost of the product extremely high, so that only the few can afford it is NOT the only way to market a product in a manner where you can recoup your research and development investments.....

you can choose to mass produce your product at a lower retail, selling it to the masses, so to spread out the R&D costs.

there can be more behind this strategy as well, which is cutting off the generic drug industry who is chomping at the bit to get your new drug to sell as soon as possible, in the bud...where them making a generic at very minimal savings to the customer because you priced it well from the get go, is not worth it to them.

Things do not HAVE to stay the way they've always been....especially when there are ways to do it better, that benefit both the company and the people they are supposedly in business for, according to their own company mission statements.

 

[Charles Stucker]

But i also understand how to market ones product to spread out the costs of its 'creation', and keeping the cost of the product extremely high, so that only the few can afford it is NOT the only way to market a product in a manner where you can recoup your research and development investments.....

you can choose to mass produce your product at a lower retail, selling it to the masses, so to spread out the R&D costs.

No, that is completely incorrect. Even moderately small batches of drugs are not that expensive to produce. A tiny portion of the cost is production, the real cost is Research, and only the company which develops a new drug pays that cost. As soon as a patent expires the inexpensive competitor, with no research costs to defray, eliminates any return on the initial research. If companies were allowed to spread the research costs over 12 to 24 years instead of 5 to 10, then they could begin with a lower prices, making them more affordable from the word go.

As far as "Selling to the Masses" - how many people are apt to purchase a new treatment for Multiple Sclerosis? Right, only as many as have MS. If you make treatment available for a billion patients and there are only a thousand people in need, then you wasted a lot of effort.

 

[JD_2B]

But i also understand how to market ones product to spread out the costs of its 'creation', and keeping the cost of the product extremely high, so that only the few can afford it is NOT the only way to market a product in a manner where you can recoup your research and development investments.....

you can choose to mass produce your product at a lower retail, selling it to the masses, so to spread out the R&D costs.

No, that is completely incorrect. Even moderately small batches of drugs are not that expensive to produce. A tiny portion of the cost is production, the real cost is Research, and only the company which develops a new drug pays that cost. As soon as a patent expires the inexpensive competitor, with no research costs to defray, eliminates any return on the initial research. If companies were allowed to spread the research costs over 12 to 24 years instead of 5 to 10, then they could begin with a lower prices, making them more affordable from the word go.

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.

As far as "Selling to the Masses" - how many people are apt to purchase a new treatment for Multiple Sclerosis? Right, only as many as have MS. If you make treatment available for a billion patients and there are only a thousand people in need, then you wasted a lot of effort.

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.

 

[Care4all]

But i also understand how to market ones product to spread out the costs of its 'creation', and keeping the cost of the product extremely high, so that only the few can afford it is NOT the only way to market a product in a manner where you can recoup your research and development investments.....

you can choose to mass produce your product at a lower retail, selling it to the masses, so to spread out the R&D costs.

No, that is completely incorrect. Even moderately small batches of drugs are not that expensive to produce. A tiny portion of the cost is production, the real cost is Research, and only the company which develops a new drug pays that cost. As soon as a patent expires the inexpensive competitor, with no research costs to defray, eliminates any return on the initial research. If companies were allowed to spread the research costs over 12 to 24 years instead of 5 to 10, then they could begin with a lower prices, making them more affordable from the word go.

As far as "Selling to the Masses" - how many people are apt to purchase a new treatment for Multiple Sclerosis? Right, only as many as have MS. If you make treatment available for a billion patients and there are only a thousand people in need, then you wasted a lot of effort.

How many people can't buy the drug because it is unaffordable at $50,000 a shot?

there are millions with multiple sclerosis.

You seem to be making excuses for them instead of trying to figure out a way around this dilemma?

There is a dilemma or two ya know, an ethical issue between intellectual property and profit and being humane....whether you are willing to let someone die or not, when you have the tools that can save their life....or whether only the wealthy privileged have the right to these life savings drugs or treatments, through their millions in liquid cash....on the right to life and liberty...

 

[Charles Stucker]

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.

 

[Steerpike]

Drug development costs are hard to assess in general terms. It can vary quite a bit. A lot of the public end of the funding is going on at the basic research level, with companies looking for private capital even at the point of going into Phase I. That said, public monies do fund Phase I, II, etc. as well.

The last reported success rate I saw in getting a drug through regulatory was 24%, so you basically have 1 out of 4 that you are putting all the costs into for regulatory getting shot down, and that doesn't include the costs you spend on the countless dead ends before you get promising candidates and try to move into regulatory to begin with.

In instances where the government provides substantial funding throughout, then it makes sense to have the public benefit on the other end. The government can exercise rights, and when you file a patent you have to note whether government funding was received so that people are on notice that the government may have rights to the invention. From a practical standpoint, however, it is rare that the government comes in to exercise those rights.