8 ms·

How India's Patent Office Destroyed Gilead's Global Game Plan

121 points by suprgeek 12y ago

deleted 12y ago
[deleted]
pkaye 12y ago
Can people in now go to India on medical tourism and get the treatment much cheaper?
- girishso 12y ago
  Not only that, I think Indian pharmas can market the drug as generic in USA too. I am not really an expert in legal stuff though.
  - pkaye 12y ago
    I feel if companies want to operate globally then consumers so be able operate globally.
  - PhantomGremlin 12y ago
    Before you all rush out to book your flights to India to stock up on inexpensive generic drugs, read this article: http://www.bloomberg.com/news/2014-03-06/flies-found-by-fda-threaten-indian-town-built-on-generics.html http://www.bloomberg.com/news/2014-03-06/flies-found-by-fda-... It's a link I posted in this[1] HN discussion. Any amount of Google-fu can turn up a plethora of similar articles. I hope you're feeling lucky, because IMO the potency and efficacy of Indian generics is very hit or miss. I don't mean to single India out. The "race to the bottom" is one of the overarching global themes of the previous few decades of late stage capitalism. [1] https://news.ycombinator.com/item?id=8773481 https://news.ycombinator.com/item?id=8773481
    - MichaelGG 12y ago
      Or this article: http://fortune.com/2013/05/15/dirty-medicine/http://fortune.com/2013/05/15/dirty-medicine/ http://fortune.com/2013/05/15/dirty-medicine/http://fortune.... Basically the largest Indian Pharma company is corrupt to the core. Falsifying records, blatantly disregarding scientific method, omitting even basic engineering practises, lying on regulatory submissions, etc. The FDA only does bans on a per-facility basis, so Sun (which acquired Ranbaxy) can continue to sell many things so long the FDA has not shut down that specific location. Even in non-Indian locations, the plants were terribly run. One Ranbaxy location in NJ shipped pills with glass in them. (And was penalized by a temporary restriction on selling the pills.)
      - pkaye 12y ago
        There are certainly issues of concern and needs to be improved. There have been recalls and bans elsewhere also. Ultimately though given the state of the medical industry in the US, if the only choices are get in insurmountable debts or die due to lack of medical care, a third option of affordable medicine and some small risk might be worthwhile.
- vishnugupta 12y ago
  This has always been the case [1] :-). Medicines and medical care in India is cheaper, by many folds, compared to US. Anecdotaly, whenever my Indian friends working in US visit India (parents, family) one thing they never forget is to visit dentists. I initially found it very surprising but understood their reasoning when I came to know that in US you can easily go bankrupt due to medical condition, something that's unheard of in India. [1]: http://en.wikipedia.org/wiki/Medical_tourism_in_India http://en.wikipedia.org/wiki/Medical_tourism_in_India
  - pradn 12y ago
    It's hard for me to believe that people don't run out of money getting treatment in India. While prices for medical goods and services are lower than the United States, many Indians can't afford all the care they need.
  - gryph0n 12y ago
    >>something that's unheard of in India. Maybe not if you're in the 'upper middle class'. If you're from the lower income classes (maids, drivers, helpers), it's very likely that health issues can bankrupt you. I personally know an entire family that has sunk into debt that they couldn't possibly pay-off, due to health related expenses for someone in the family.
- tn13 12y ago
  Yes of course.
- tn13 12y ago
  Yes of course.
alricb 12y ago
Here's the decision (pdf): http://freepdfhosting.com/985d1c013c.pdf http://freepdfhosting.com/985d1c013c.pdf It relies on section 3(d) of the The Patents Act, 1970 (as amended up to Patents (Amendment) Act, 2005) [1]: > What are not inventions. —The following are not inventions within the meaning of this Act,— (d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. Explanation. — For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy; This is the same section that was opposed to Novartis in 2013 [2] 1: http://www.wipo.int/wipolex/en/text.jsp?file_id=295102 http://www.wipo.int/wipolex/en/text.jsp?file_id=295102 2: http://articles.economictimes.indiatimes.com/2013-04-01/news/38189492_1_glivec-intellectual-property-appellate-board-indian-patent-act http://articles.economictimes.indiatimes.com/2013-04-01/news...
- alricb 12y ago
  Gilead argued that 1) its compound is not a mere "new form" of a substance known in the prior art, and 2) even if it were, it differs significantly since it is less toxic and more active than other similar compounds. But the Patent Office says that "efficacy" here means therapeutic efficacy, and it would need to be proven by a clinical trial.
  - throwawaykf05 12y ago
    Not very sure what they mean exactly, but the FDA mandates clinical trials, right? Can that data not be used to show increased efficacy, if any?
    - striking 12y ago
      FDA trials are only required to compete against a placebo. A drug is accepted if it is safe and more effective than a placebo in a double-blind clinical trial. That's it. So they have no data to show with, unless they went above and beyond to get it. (Which should teach them a lesson about testing their drugs.)
refurb 12y ago
If India wants to break patents in order to make drugs available to low income citizens that's one thing (in this case Gilead was already offering a cheap generic), to say the patent on Sovaldi is not innovative is a bit ridiulous.
- chdir 12y ago
  The article explains it better instead of simply saying it's not innovative. It's worth reading these 2 paragraphs: "India believes that the patent standards are so low that companies can get patents for inventions very easily," Amin said in an interview. The patent office's examiner ruled Gilead's patent claim "lacks novelty and inventive step," as Bloomberg News noted, and also doesn't demonstrate it's significantly more effective than already known compounds. Amin explains that the controller general's decision holds that "there are a number of earlier compound structures that are very close to what Gilead is trying to get a patent for." But Sovaldi is a breakthrough drug. Shouldn't that be worth something? "It's important to recognize that what the patent office deals with is whether something is new in science," Amin said. "The decision says there are a number of earlier compound structures that are very close to what Gilead is trying to get a patent for. It's a scientific decision and has nothing to do with the utility of the drug." Gilead didn't offer comment on Wednesday.
  - analog31 12y ago
    This is what I think is the vital issue. Taking a known compound and searching for every possible form in order to find one that doesn't happen to have been documented is in fact something that is "obvious to one skilled in the art," because it's a widespread activity. There are specific rules in the US patent system surrounding this issue. So it's not like the drug maker was necessarily whacked by some rogue judge issuing a weird decision out of the blue. It may very well be that Gilead was taking a known risk at the hands of the Indian patent system. Does Sovaldi satisfy India's standards for novelty? I don't know. I've had a patent application struck down over novelty, so I know it's not a happy day when it happens.
    - throwawaykf05 12y ago
chdir 12y ago
According to Wikipedia: Sofosbuvir costs US$84,000 for 12 weeks of treatment used for genotypes 1 and 2 (about US$1,000 per pill) [...] health care costs in California could increase by US$18–29 billion per year because of this medication
- getsat 12y ago
  It's also much more effective than the competition (i.e., its cure rate is higher). It also doesn't make you feel like you have the flu during the treatment period. The higher % of people who relapse on alternative treatments could end up costing more than just paying for the better drug in the first place. The cost of the medication alone is not enough information.
- forrestthewoods 12y ago
  I wanted to call bullshit on those numbers, but wow. They're accurate. The math is almost exact even. It turns out 3.2 million people in the US have hep c (1%). Although most have no symptoms. However the per year is bullshit. That's the cost to treat every person is California who has it. But it's expensive and popular because the cure rate is very high. That makes it more of a one time cost, not a per year cost.
- adventured 12y ago
  Calculate the annual cost (which isn't $18-$29 billion, that's the one time cost to cure everyone in CA with it) to cure a portion of the population in CA that has Hep C. Most likely we're talking $3-$5 billion per year. Calculate the savings that curing those people produces over time (1, 5, 10, 20 years). I'd be willing to bet the math works out in favor of spending $84,000 one time.
  - danielweber 12y ago
    > I'd be willing to bet the math works out in favor of spending $84,000 one time. I'd love for the state to announce ahead of time how much they would pay for, say, a cure for diabetes. Have them calculate what the NPV is for a lifetime of diabetes treatment. Publish that figure. Then some drug company can show up with a cure, charge 90% of that figure, and we can see people whine that the drug company is costing the state money.
norikki 12y ago
I'm disappointed this article doesn't mention the effect this will have on future pharmaceutical investment. Companies spend billions researching and testing drugs for safety and effectiveness. Companies capable of developing successful drugs need an adequate period in which to recoup their investment and earn enough to fund new drug research. If companies know they won't have meaningful ownership over medicines they develop, they won't spend the huge amounts of capital necessary to develop them. When countries like India let competitors produce generics of American drugs, they are stealing the fruits of other people's labor. That isn't to say this theft isn't justified; generics will save the lives of those who can't afford the original. But those lives would have been lost all the same if no such drug had been developed in the first place. Stealing drugs will certainly help India in the short run, but it will slow the advance of medicine in the long run, for Indians and everyone else.
- meric 12y ago
  Not like your average Indian who makes $6 a day can afford the patented medicines that costs $10 a tablet anyways.
- anupshinde 12y ago
  There is a difference between: 1. Getting justified fruits for people's labor (researchers). Say- getting a great ROI like 1000% or huge ROI of 100000% 2. Getting greedy and trying to multiply the the ROI at the cost of human lives. I have seen pretty stupid patents (that are logically obvious or near common sense) granted to American companies in tech sector (and have been astonished since I helped create some of those). I believe pharma is no different.
- girishso 12y ago
  I don't think companies spend as much as we believe in researching drugs. Companies spend most on advertising and incentivizing the doctors to prescribe their medicines. The book: Bad Pharma [1] is an eye opener. The drug "Sovaldi" is making them $2.8ish billion dollars per quarter, that is almost $12 billion a year. I don't believe they spent tens of billions in developing the drug. [2] 1: http://www.amazon.com/Bad-Pharma-Companies-Mislead-Patients-ebook/dp/B008RLTUUA/ref=cm_cr_pr_product_top http://www.amazon.com/Bad-Pharma-Companies-Mislead-Patients-... 2: http://www.bloomberg.com/news/2014-10-28/gilead-reports-lower-than-estimated-sales-of-sovaldi.html http://www.bloomberg.com/news/2014-10-28/gilead-reports-lowe...
geetee 12y ago
I'm all for patents to protect pharmaceutical companies, but there needs to be a profit limit where the patent expires early.
- refurb 12y ago
  What would that profit limit be? How would it be enforced? What is a "fair" profit?
forrestthewoods 12y ago
And the US continues to subsidize health care across the world. You're welcome world, you're welcome. Ok, so that's unnecessarily strong sarcasm, but it has more than a few ounces of truth to it. Even Canada has significantly cheaper drugs because US citizens get the privilege of paying more.
- rcha 12y ago
  Thats so great, But remember the all old technologies/ Maths/Science/Writing system/ Languages are not developed in US, US is using rest of world patents with paying anything, May this how they should pay back.
deleted 12y ago
[deleted]
danmaz74 12y ago
I'm all against "obvious" patents, but suing to be free to produce a product because it "also doesn't demonstrate it's significantly more effective than already known compounds" is a contradiction in terms. If the other compounds were just as good, then you wouldn't be suing to be able to produce this new one.
- another-one-off 12y ago
  One way of looking at this is the legal system keeping a clear distinction between patents and copyright.
- Drakim 12y ago
  That logic doesn't always hold up. You could make tiny tiny alterations to some plastic container, put some random bump here or there, or make the flap stick out a little more, and the plastic container might suddenly not be usable due with a third party automatic coffee maker. That's a huge effect, despite the tiny change. But I doubt that would make that case that because of that huge effect, those random bumps and extended flap deserve patents. We are after all talking about basic shapes here, nobody should be able to patent "a round shape with a tiny bump sticking out" so that others cannot use that shape.
  - throwawaykf05 12y ago
    I don't see how this addresses grandparent's comment: if it does not have increased efficacy, why are so many people desperate to use it? The amount of alteration is a separate issue.
- chetanahuja 12y ago
  The original article has an interview with an Indian patent examiner that clarifies that the efficacy was not a factor in deciding whether the drug was patentable. It's difference(in chemical structure) from previously well known molecules -- or lack thereof -- was the decisive factor in rejecting that patent.
  - 12y ago
lazylizard 12y ago
1. they'd already licensed it, so the patent holders are already compromising 2.patents are really not that long..5yrs? 20 yrs? nothing like life+99 or whatever it is for copyright.. 3.because patents are relatively short lived the pharma firms have to turn up "hits" which have to pay for all the other misses.. i'm guessing they would really rather market+brand their existing products than invent new ones if the protection they get from patents start to get eroded..not sure thats a good thing..
mariuolo 12y ago
What I don't understand is how this would ease the export of this now-generic drug to other countries. Surely each of them has a patent office, doesn't it?
giis 12y ago
Is it 84,000 USD(~50 lakh) per person in India too? That's very very expensive,even for India's software professional with 10 to 12 years of experience where average yearly salary will be around 14,000 USD to 20,000 USD. This 84,000 not affordable even for so-called 'upper middle class'.
Agustus 12y ago
A definite case of seen and unseen consequences. Developing a biopharmaceutical product requires the following: 1. A professional who discovers the possibility of a new chemical entity, requires infrastructure: comprised of medical grade equipment (centrifuges, beakers, pipets, filters, microscopes, testing equipment, etc.), experts capable of understanding applications of drug, and many iterations of tests. There will be about 5,000 to 10,000 opportunities for these to address something like Hepatitis C. 2. The NCE is developed for dosage and scheduling. Again more testing. 3. The drug needs to be optimized for manufacturing: infrastructure requires additional experts and assessments 4. Preclinical testing is completed. Only 250 products out of that initial 5,000-10,000 NCE group make it here. 5. Only now is a submission made to the FDA. 6. Go through the process of FDA approval starting with human trials. Only around 10 of these from the 250 will be instigated. 7. FDA human trials, a three to four step process that only 21.5% entering the process will make it through. 8. Production of drug. 9. Sale of drug for seven years to recoup costs 10. Post-Surveillance of drug 11. In people with an asymetric heart ventricle that exhibits heart murmurs but only on Wednesdays, the approved drug causes uncontrollable urination. The drug company has to deal with trial lawyers who develop a lawsuit in the general area of $300 million. And this lawsuit can be brought against the company throughout the lifecycle of the drug and in some cases, the original patent holder can be held liable for the generically produced NCE's. 12. Drug finally goes to generic and the generic manufacturers in Brazil and India sell it for pennies, wiping out all profit margins for your product. 13. A third world nation tries and successfully invalidates a patent that you hold, wiping millions off of the revenue forecasts, thus eliminating the monies needed to test up and coming NCE's. Then someone on a forum The amazing part in all of this is that a drug gets made at all. The argument that it costs pennies to make, apply the same logic to a cars production. The modern car costs about $1,000 to manufacture, this includes materials and labor costs, the other monies include research, development, marketing, and all the other accouterments that make it possible; why are people not screaming for the costs to be lower, because they understand that there are costs and regulatory capture involved. [1] http://www.forbes.com/sites/matthewherper/2013/08/11/the-cost-of-inventing-a-new-drug-98-companies-ranked/ http://www.forbes.com/sites/matthewherper/2013/08/11/the-cos... [2] http://en.wikipedia.org/wiki/Drug_development http://en.wikipedia.org/wiki/Drug_development
- 12y ago

121 points by suprgeek 12y ago

deleted 12y ago

[deleted]

pkaye 12y ago

Can people in now go to India on medical tourism and get the treatment much cheaper?

girishso 12y ago
Not only that, I think Indian pharmas can market the drug as generic in USA too. I am not really an expert in legal stuff though.
- pkaye 12y ago
  I feel if companies want to operate globally then consumers so be able operate globally.
- PhantomGremlin 12y ago
  Before you all rush out to book your flights to India to stock up on inexpensive generic drugs, read this article: http://www.bloomberg.com/news/2014-03-06/flies-found-by-fda-threaten-indian-town-built-on-generics.html http://www.bloomberg.com/news/2014-03-06/flies-found-by-fda-... It's a link I posted in this[1] HN discussion. Any amount of Google-fu can turn up a plethora of similar articles. I hope you're feeling lucky, because IMO the potency and efficacy of Indian generics is very hit or miss. I don't mean to single India out. The "race to the bottom" is one of the overarching global themes of the previous few decades of late stage capitalism. [1] https://news.ycombinator.com/item?id=8773481 https://news.ycombinator.com/item?id=8773481
  - MichaelGG 12y ago
    Or this article: http://fortune.com/2013/05/15/dirty-medicine/http://fortune.com/2013/05/15/dirty-medicine/ http://fortune.com/2013/05/15/dirty-medicine/http://fortune.... Basically the largest Indian Pharma company is corrupt to the core. Falsifying records, blatantly disregarding scientific method, omitting even basic engineering practises, lying on regulatory submissions, etc. The FDA only does bans on a per-facility basis, so Sun (which acquired Ranbaxy) can continue to sell many things so long the FDA has not shut down that specific location. Even in non-Indian locations, the plants were terribly run. One Ranbaxy location in NJ shipped pills with glass in them. (And was penalized by a temporary restriction on selling the pills.)
    - pkaye 12y ago
      There are certainly issues of concern and needs to be improved. There have been recalls and bans elsewhere also. Ultimately though given the state of the medical industry in the US, if the only choices are get in insurmountable debts or die due to lack of medical care, a third option of affordable medicine and some small risk might be worthwhile.
vishnugupta 12y ago
This has always been the case [1] :-). Medicines and medical care in India is cheaper, by many folds, compared to US. Anecdotaly, whenever my Indian friends working in US visit India (parents, family) one thing they never forget is to visit dentists. I initially found it very surprising but understood their reasoning when I came to know that in US you can easily go bankrupt due to medical condition, something that's unheard of in India. [1]: http://en.wikipedia.org/wiki/Medical_tourism_in_India http://en.wikipedia.org/wiki/Medical_tourism_in_India
- pradn 12y ago
  It's hard for me to believe that people don't run out of money getting treatment in India. While prices for medical goods and services are lower than the United States, many Indians can't afford all the care they need.
- gryph0n 12y ago
  >>something that's unheard of in India. Maybe not if you're in the 'upper middle class'. If you're from the lower income classes (maids, drivers, helpers), it's very likely that health issues can bankrupt you. I personally know an entire family that has sunk into debt that they couldn't possibly pay-off, due to health related expenses for someone in the family.
tn13 12y ago
Yes of course.
tn13 12y ago
Yes of course.

alricb 12y ago

Here's the decision (pdf): http://freepdfhosting.com/985d1c013c.pdf http://freepdfhosting.com/985d1c013c.pdf It relies on section 3(d) of the The Patents Act, 1970 (as amended up to Patents (Amendment) Act, 2005) [1]: > What are not inventions. —The following are not inventions within the meaning of this Act,— (d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. Explanation. — For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy; This is the same section that was opposed to Novartis in 2013 [2] 1: http://www.wipo.int/wipolex/en/text.jsp?file_id=295102 http://www.wipo.int/wipolex/en/text.jsp?file_id=295102 2: http://articles.economictimes.indiatimes.com/2013-04-01/news/38189492_1_glivec-intellectual-property-appellate-board-indian-patent-act http://articles.economictimes.indiatimes.com/2013-04-01/news...

alricb 12y ago
Gilead argued that 1) its compound is not a mere "new form" of a substance known in the prior art, and 2) even if it were, it differs significantly since it is less toxic and more active than other similar compounds. But the Patent Office says that "efficacy" here means therapeutic efficacy, and it would need to be proven by a clinical trial.
- throwawaykf05 12y ago
  Not very sure what they mean exactly, but the FDA mandates clinical trials, right? Can that data not be used to show increased efficacy, if any?
  - striking 12y ago
    FDA trials are only required to compete against a placebo. A drug is accepted if it is safe and more effective than a placebo in a double-blind clinical trial. That's it. So they have no data to show with, unless they went above and beyond to get it. (Which should teach them a lesson about testing their drugs.)

refurb 12y ago

If India wants to break patents in order to make drugs available to low income citizens that's one thing (in this case Gilead was already offering a cheap generic), to say the patent on Sovaldi is not innovative is a bit ridiulous.

chdir 12y ago
The article explains it better instead of simply saying it's not innovative. It's worth reading these 2 paragraphs: "India believes that the patent standards are so low that companies can get patents for inventions very easily," Amin said in an interview. The patent office's examiner ruled Gilead's patent claim "lacks novelty and inventive step," as Bloomberg News noted, and also doesn't demonstrate it's significantly more effective than already known compounds. Amin explains that the controller general's decision holds that "there are a number of earlier compound structures that are very close to what Gilead is trying to get a patent for." But Sovaldi is a breakthrough drug. Shouldn't that be worth something? "It's important to recognize that what the patent office deals with is whether something is new in science," Amin said. "The decision says there are a number of earlier compound structures that are very close to what Gilead is trying to get a patent for. It's a scientific decision and has nothing to do with the utility of the drug." Gilead didn't offer comment on Wednesday.
- analog31 12y ago
  This is what I think is the vital issue. Taking a known compound and searching for every possible form in order to find one that doesn't happen to have been documented is in fact something that is "obvious to one skilled in the art," because it's a widespread activity. There are specific rules in the US patent system surrounding this issue. So it's not like the drug maker was necessarily whacked by some rogue judge issuing a weird decision out of the blue. It may very well be that Gilead was taking a known risk at the hands of the Indian patent system. Does Sovaldi satisfy India's standards for novelty? I don't know. I've had a patent application struck down over novelty, so I know it's not a happy day when it happens.
  - throwawaykf05 12y ago

chdir 12y ago

According to Wikipedia: Sofosbuvir costs US$84,000 for 12 weeks of treatment used for genotypes 1 and 2 (about US$1,000 per pill) [...] health care costs in California could increase by US$18–29 billion per year because of this medication

getsat 12y ago
It's also much more effective than the competition (i.e., its cure rate is higher). It also doesn't make you feel like you have the flu during the treatment period. The higher % of people who relapse on alternative treatments could end up costing more than just paying for the better drug in the first place. The cost of the medication alone is not enough information.
forrestthewoods 12y ago
I wanted to call bullshit on those numbers, but wow. They're accurate. The math is almost exact even. It turns out 3.2 million people in the US have hep c (1%). Although most have no symptoms. However the per year is bullshit. That's the cost to treat every person is California who has it. But it's expensive and popular because the cure rate is very high. That makes it more of a one time cost, not a per year cost.
adventured 12y ago
Calculate the annual cost (which isn't $18-$29 billion, that's the one time cost to cure everyone in CA with it) to cure a portion of the population in CA that has Hep C. Most likely we're talking $3-$5 billion per year. Calculate the savings that curing those people produces over time (1, 5, 10, 20 years). I'd be willing to bet the math works out in favor of spending $84,000 one time.
- danielweber 12y ago
  > I'd be willing to bet the math works out in favor of spending $84,000 one time. I'd love for the state to announce ahead of time how much they would pay for, say, a cure for diabetes. Have them calculate what the NPV is for a lifetime of diabetes treatment. Publish that figure. Then some drug company can show up with a cure, charge 90% of that figure, and we can see people whine that the drug company is costing the state money.

norikki 12y ago

I'm disappointed this article doesn't mention the effect this will have on future pharmaceutical investment. Companies spend billions researching and testing drugs for safety and effectiveness. Companies capable of developing successful drugs need an adequate period in which to recoup their investment and earn enough to fund new drug research. If companies know they won't have meaningful ownership over medicines they develop, they won't spend the huge amounts of capital necessary to develop them. When countries like India let competitors produce generics of American drugs, they are stealing the fruits of other people's labor. That isn't to say this theft isn't justified; generics will save the lives of those who can't afford the original. But those lives would have been lost all the same if no such drug had been developed in the first place. Stealing drugs will certainly help India in the short run, but it will slow the advance of medicine in the long run, for Indians and everyone else.

meric 12y ago
Not like your average Indian who makes $6 a day can afford the patented medicines that costs $10 a tablet anyways.
anupshinde 12y ago
There is a difference between: 1. Getting justified fruits for people's labor (researchers). Say- getting a great ROI like 1000% or huge ROI of 100000% 2. Getting greedy and trying to multiply the the ROI at the cost of human lives. I have seen pretty stupid patents (that are logically obvious or near common sense) granted to American companies in tech sector (and have been astonished since I helped create some of those). I believe pharma is no different.
girishso 12y ago
I don't think companies spend as much as we believe in researching drugs. Companies spend most on advertising and incentivizing the doctors to prescribe their medicines. The book: Bad Pharma [1] is an eye opener. The drug "Sovaldi" is making them $2.8ish billion dollars per quarter, that is almost $12 billion a year. I don't believe they spent tens of billions in developing the drug. [2] 1: http://www.amazon.com/Bad-Pharma-Companies-Mislead-Patients-ebook/dp/B008RLTUUA/ref=cm_cr_pr_product_top http://www.amazon.com/Bad-Pharma-Companies-Mislead-Patients-... 2: http://www.bloomberg.com/news/2014-10-28/gilead-reports-lower-than-estimated-sales-of-sovaldi.html http://www.bloomberg.com/news/2014-10-28/gilead-reports-lowe...

geetee 12y ago

I'm all for patents to protect pharmaceutical companies, but there needs to be a profit limit where the patent expires early.

refurb 12y ago
What would that profit limit be? How would it be enforced? What is a "fair" profit?

forrestthewoods 12y ago

And the US continues to subsidize health care across the world. You're welcome world, you're welcome. Ok, so that's unnecessarily strong sarcasm, but it has more than a few ounces of truth to it. Even Canada has significantly cheaper drugs because US citizens get the privilege of paying more.

rcha 12y ago
Thats so great, But remember the all old technologies/ Maths/Science/Writing system/ Languages are not developed in US, US is using rest of world patents with paying anything, May this how they should pay back.

deleted 12y ago

[deleted]

danmaz74 12y ago

I'm all against "obvious" patents, but suing to be free to produce a product because it "also doesn't demonstrate it's significantly more effective than already known compounds" is a contradiction in terms. If the other compounds were just as good, then you wouldn't be suing to be able to produce this new one.

another-one-off 12y ago
One way of looking at this is the legal system keeping a clear distinction between patents and copyright.
Drakim 12y ago
That logic doesn't always hold up. You could make tiny tiny alterations to some plastic container, put some random bump here or there, or make the flap stick out a little more, and the plastic container might suddenly not be usable due with a third party automatic coffee maker. That's a huge effect, despite the tiny change. But I doubt that would make that case that because of that huge effect, those random bumps and extended flap deserve patents. We are after all talking about basic shapes here, nobody should be able to patent "a round shape with a tiny bump sticking out" so that others cannot use that shape.
- throwawaykf05 12y ago
  I don't see how this addresses grandparent's comment: if it does not have increased efficacy, why are so many people desperate to use it? The amount of alteration is a separate issue.
chetanahuja 12y ago
The original article has an interview with an Indian patent examiner that clarifies that the efficacy was not a factor in deciding whether the drug was patentable. It's difference(in chemical structure) from previously well known molecules -- or lack thereof -- was the decisive factor in rejecting that patent.
- 12y ago

lazylizard 12y ago

1. they'd already licensed it, so the patent holders are already compromising 2.patents are really not that long..5yrs? 20 yrs? nothing like life+99 or whatever it is for copyright.. 3.because patents are relatively short lived the pharma firms have to turn up "hits" which have to pay for all the other misses.. i'm guessing they would really rather market+brand their existing products than invent new ones if the protection they get from patents start to get eroded..not sure thats a good thing..

mariuolo 12y ago

What I don't understand is how this would ease the export of this now-generic drug to other countries. Surely each of them has a patent office, doesn't it?

giis 12y ago

Is it 84,000 USD(~50 lakh) per person in India too? That's very very expensive,even for India's software professional with 10 to 12 years of experience where average yearly salary will be around 14,000 USD to 20,000 USD. This 84,000 not affordable even for so-called 'upper middle class'.

Agustus 12y ago

A definite case of seen and unseen consequences. Developing a biopharmaceutical product requires the following: 1. A professional who discovers the possibility of a new chemical entity, requires infrastructure: comprised of medical grade equipment (centrifuges, beakers, pipets, filters, microscopes, testing equipment, etc.), experts capable of understanding applications of drug, and many iterations of tests. There will be about 5,000 to 10,000 opportunities for these to address something like Hepatitis C. 2. The NCE is developed for dosage and scheduling. Again more testing. 3. The drug needs to be optimized for manufacturing: infrastructure requires additional experts and assessments 4. Preclinical testing is completed. Only 250 products out of that initial 5,000-10,000 NCE group make it here. 5. Only now is a submission made to the FDA. 6. Go through the process of FDA approval starting with human trials. Only around 10 of these from the 250 will be instigated. 7. FDA human trials, a three to four step process that only 21.5% entering the process will make it through. 8. Production of drug. 9. Sale of drug for seven years to recoup costs 10. Post-Surveillance of drug 11. In people with an asymetric heart ventricle that exhibits heart murmurs but only on Wednesdays, the approved drug causes uncontrollable urination. The drug company has to deal with trial lawyers who develop a lawsuit in the general area of $300 million. And this lawsuit can be brought against the company throughout the lifecycle of the drug and in some cases, the original patent holder can be held liable for the generically produced NCE's. 12. Drug finally goes to generic and the generic manufacturers in Brazil and India sell it for pennies, wiping out all profit margins for your product. 13. A third world nation tries and successfully invalidates a patent that you hold, wiping millions off of the revenue forecasts, thus eliminating the monies needed to test up and coming NCE's. Then someone on a forum The amazing part in all of this is that a drug gets made at all. The argument that it costs pennies to make, apply the same logic to a cars production. The modern car costs about $1,000 to manufacture, this includes materials and labor costs, the other monies include research, development, marketing, and all the other accouterments that make it possible; why are people not screaming for the costs to be lower, because they understand that there are costs and regulatory capture involved. [1] http://www.forbes.com/sites/matthewherper/2013/08/11/the-cost-of-inventing-a-new-drug-98-companies-ranked/ http://www.forbes.com/sites/matthewherper/2013/08/11/the-cos... [2] http://en.wikipedia.org/wiki/Drug_development http://en.wikipedia.org/wiki/Drug_development

12y ago