How India's Patent Office Destroyed Gilead's Global Game Plan • Hacker News Board

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

#51

Post by wheaties » Fri, Jan 16, 2015, 1:02 PM UTC

chdir wrote: post #27

norikki wrote: post #11

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…

> spend billions ... adequate period to recoup ... earn enough ... huge amounts of capital All these words don't carry meaning without proper data. Unless we know how much they've spent, how much they need to recoup & grow, these claims are vague. > stealing the fruits of other people's labor Without studying the merits/demerits of the patent, this is a hyperbole. I'm saying, maybe your statements are true, maybe not…

Many generic drug manufacturers did not have the proper acilities to meet drug standards. The recent prow increases are a direct result of those direct manufacturers having to spend to bring their processes up to code.

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

#52

Post by analog31 » Fri, Jan 16, 2015, 1:06 PM UTC

throwawaykf05 wrote: post #45

analog31 wrote: post #15

Earlier quoted context omitted.

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 i…

> 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. But it is not the activity (which describes, essentially, most research) being patented, it is the result of that activity. If the search space is very large, that is actually an indication…

Yes, you're quite right. As I understand it, drug discovery has special rules. The search space is large but not infinite. It involves the original drug compound in different "forms" such as crystal structures, particle sizes, counter-ion (whatever thingy attaches to the molecule and makes it soluble, etc.). The chemical effect of the drug in the body is the same, i.e., it bonds with the same receptor molecule in some cell somewhere. But changing those things can have a pharmacological effect such as the speed with which the drug is taken into the body, thus it is a different drug within the context of US and I believe European patent law, but I can't talk about India.

This could be a case of a bad decision in India, of course, but it also could be one where the patent examiners in US and Europe were more lenient than they should of been.

(Disclaimer: I helped work on equipment designed to assist in this kind of chemical searching).

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

#53

Post by giis » Fri, Jan 16, 2015, 1:42 PM UTC

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'.

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

#54

Post by okpatil » Fri, Jan 16, 2015, 1:49 PM UTC

throwawaykf05 wrote: post #46

okpatil wrote: post #36

Earlier quoted context omitted.

You don't understand gravity of situation. India has third highest population of AIDS patients. Around 2.1 million people are infected[1]. That is twice the population of Cyprus. Around 170k children and adults lost their lives in 2009 [2]. India has 32.7 % of its population below poverty line [3]. That's an income below $1.25 per day. If they can't pay for the drugs doesn't make them less deserving. And as far as dr…

> And as far as drug developments go, due to GPU computing and molecular dynamics and monte carlo simulation methods, the cost of developing drugs has gone significantly down [4][5]. I don't see where they show that the cost of clinical trials etc. for getting drugs through the FDA is affected. From what I can tell, those are the largest costs involved. Especially considering that most of the drugs discovered, even u…

> I don't see where they show that the cost of clinical trials etc. for getting drugs through the FDA is affected. From what I can tell, those are the largest costs involved. Especially considering that most of the drugs discovered, even using those advanced methods, fail in the trial phase after hundreds of millions invested.

Agreed, but I compared the costs of developing drugs 20 years ago. They had to synthesize and experiment with each and every drug. Not that's not the case. And most of the drugs which being developed now, use the principals I explained above. If clinical tests are proven successful then they file patents, but it's not an "innovative" process as per say. India has been working to get rid of such patent trolls for some time now.

> "Siphon money" or "capture the rewards of the value they provide"? Undermining global incentives to invest billions in research that could save hundreds of millions around the world does not seem like the "right direction". Not the first time the Indian government has done something selfish but shortsighted. (Pokhran comes to mind.)

Agreed, these kinds of researches has to be done, but not at cost of people's lives, I have explained statistics of people affected by AIDS above. It is a grave social injustice. These research and development processes are flawed in the sense that they cannot provide affordable alternatives to existing methods. These companies must adapt to affordable and agile development processes or someone else will replace them, remember "Mars Orbiter Mission" by ISRO.

And speaking of Pokhran, it was not a short sighted decision. India has Pakistan, an irresponsible nuclear capable neighbor, with whom India has been in state of war since 1947. Effects of Pokhran economic sanctions were not severe, because foreign trade of India constituted to 4% of it's GDP, while USA participation was only 10%. After Pokhran, under then PM Atal Bihari Vajpayee, India achieved record breaking 6-7 % growth rate in GDP. A few problems could be pointed out, but it was not a short sighted decision at all.

I am not being a socialist, but I must add that such innovation and development should be done for the people, not American people, not British people, but keeping people of the world in mind. Please don't monopolize products which can save a lot of peoples lives.

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

#55

Post by danielweber » Fri, Jan 16, 2015, 2:13 PM UTC

adventured wrote: post #42

chdir wrote: post #8

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

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.

> 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.

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

#56

Post by tormeh » Fri, Jan 16, 2015, 2:21 PM UTC

shoyer wrote: post #20

girishso wrote: post #16

Earlier quoted context omitted.

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-…

It's not what they spent developing Sovaldi -- it's the fortune the industry as a whole spends developing drugs that never make it to market. That said, it's quite likely true that marketing is a bigger share of costs than R&D. Pharma companies are out there to maximize revenue, just like any other corporation. It's a reflection of the poor state of regulation in the US that we pay far more of than our share (compare…

Isn't that because the US disallows importing drugs? It's supposedly for safety but of course it's just protectionism as I, at least, have heard of no other country doing the same.

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

#57

Post by striking » Fri, Jan 16, 2015, 2:24 PM UTC

throwawaykf05 wrote: post #44

alricb wrote: post #10

Earlier quoted context omitted.

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.

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?

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.)

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

#58

Post by rasz_pl » Fri, Jan 16, 2015, 2:38 PM UTC

fizixer wrote: post #25

norikki wrote: post #11

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…

This is a textbook example of why some economic activities cannot be based on a profit motive. There should be an international drug research agency, to which every country should contribute, and that agency should be responsible for exploring cures for diseases, by funding academics, labs, etc.

There are national labs. Canadian one sold Ebola vaccine license for $200K to some no name US lab, that same lab turned around and resold it to Merck for $50mil. Merck bought it only because it is standing to make few billion off of it.

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

#59

Post by Agustus » Fri, Jan 16, 2015, 3:49 PM UTC

eps wrote: post #35

girishso wrote: post #16

Earlier quoted context omitted.

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-…

Not every drug reasearch ends up in a commercial big bang. From what I understand very few do, so the money they bring in end up financing all of the research.

No one on the other side of your statement considers the failures, just the successes.

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

#60

Post by refurb » Fri, Jan 16, 2015, 3:53 PM UTC

striking wrote: post #57

throwawaykf05 wrote: post #44

Earlier quoted context omitted.

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?

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.)

You don't have to have head-to-head data to claim your drug is superior to existing therapies. Yes, head-to-head data is the best way to show it, but if you have two separate trials, each comparing to a placebo, you can draw conclusions about relative efficacy. It's not perfect, but in the case of Gilead, their drug blows away anything else currently on the market.