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

businessweek.com

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

#61

Post by refurb »

okpatil wrote: post #36
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…

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…

Drug development costs are not that high now, compared to twenty years ago. Most of the money goes in marketing.

That is entirely false.

1. Why would you include marketing in the cost of developing a drug? They don't market it until it's launched.

2. The cost of drug development is not lower than it was 20 years ago, even by a long shot. FDA approval requirements have gotten more and more complex each year. 20 years ago you could run a trial on a few thousands patients and call it a day. Now the FDA would require a 10,000 person trial over two years for approval. That costs money.

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

#62

Post by refurb »

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

The funny part is that a common criticism of the pharmaceutical industry is that they don't want to create cures because they make more money with drugs that have to be taken chronically.

So a drug company releases a cure for a disease and everyone complains about the price. Ironic.

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

#64

Post by Agustus »

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-cos... [2] http://en.wikipedia.org/wiki/Drug_development

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

#65

Post by dman »

Agustus wrote: post #64

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 wi…

Can you cite a source for the $1000 to manufacture a car?

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

#66

Post by pkaye »

MichaelGG wrote: post #30
PhantomGremlin wrote: post #21

Earlier quoted context omitted.

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-... 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 sing…

Or this article: 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…

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.

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

#67

Post by throwawaykf05 »

okpatil wrote: post #54
throwawaykf05 wrote: post #46

Earlier quoted context omitted.

> 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 a…

Getting way off-topic, but...

> And speaking of Pokhran, it was not a short sighted decision.

Pokhran very certainly was a short-sighted decision. It benefited absolutely nobody except the government by buying it some temporary popularity while actively retarding the country's economics for years afterwards.

> India has Pakistan, an irresponsible nuclear capable neighbor, with whom India has been in state of war since 1947.

Pointing to Pakistan is not an excuse: the whole world knew India had nuclear weapons capability. It had nothing to gain by proving the world what it already knew. Consider Israel: it's geopolitical situation is even worse, being a tiny country surrounded on all sides by many, much larger nations that would see it destroyed. Israel also is known to have nuclear weapons capability. Did they have to go perform a demonstration so the world?

And despite Pokhran, Pakistan has not wavered. Pokhran did nothing to slow Pakistan's regular shelling across the borders. Pokhran did not prevent 26/11. Pokhran did not reduce the number of subsequent terrorist attacks and infiltration attempts. It has done nothing at all to improve the Pakistan situation, and very likely made it worse.

> 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.

I don't think anyone knows the true extent of the economic effects, but they are much worse than you suspect. It was not just the US that imposed sanctions. Many countries and companies imposed official and unofficial sanctions that directly impacted business relations and international collaborations. It was not only foreign trade. Companies that were going to set up local manufacturing plants and partner with Indian companies pulled out. That was a direct loss to the local economy. I personally know of business deals with private companies in Germany and Japan that abruptly fell through because of this. Nobody has measured the real impact. The 6 - 7% GDP growth may well have been much higher, but we will never know.

Funny you should mention ISRO because they were also directly impacted: https://news.ycombinator.com/item?id=6552947 It's a credit to ISRO that they delivered despite the governments actions. ISRO could have dedicated resources towards newer and more interesting projects rather than re-inventing technology that became unavailable purely due to political posturing. The opportunity cost is unmeasurable.

The only thing Pokhran bought was national pride that was short-lived and had ultimately no practical value, economic or otherwise. I have seen nothing positive come out of it, only a large amount of negative impact. I cannot see how it was anything but a terrible decision.

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

#68

Post by Agustus »

dman wrote: post #65
Agustus wrote: post #64

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 wi…

Can you cite a source for the $1000 to manufacture a car?

Unfortunately, this is anecdotal information as my professor, he had worked at Ford, in our finance engineering class made a lecture that raw materials and labor for a vehicle would be $1,000. The additional costs are from tooling, r&d, and other items that ensure a profit margin for the company. I have very unreliable page here: http://www.answers.com/Q/How_much_does_it_cost_to_manufactur...

I tried to find additional information to back up this claim through the web, sadly, sources will either be: 1. Sales representatives within car sales pointing to an invoice sheet from the manufacturer showing a percent difference or dollar difference, but this would include the tooling, r&d, and operation costs. http://www.reddit.com/r/cars/comments/2bvxn5/how_much_does_i...) 2. Manufacturers who make statements about profitability. http://singletrackworld.com/forum/topic/how-much-does-a-new-... 3.

You can find further information about how the $40,000 Volt obfuscates its costs: http://www.treehugger.com/cars/how-much-does-chevy-volt-cost...

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

#69

Post by dman »

Agustus wrote: post #68
dman wrote: post #65

Earlier quoted context omitted.

Can you cite a source for the $1000 to manufacture a car?

Unfortunately, this is anecdotal information as my professor, he had worked at Ford, in our finance engineering class made a lecture that raw materials and labor for a vehicle would be $1,000. The additional costs are from tooling, r&d, and other items that ensure a profit margin for the company. I have very unreliable page here: http://www.answers.com/Q/How_much_does_it_cost_to_manufactur... I tried to find addition…

Thanks!

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

#70

Post by rcha »

forrestthewoods wrote: post #22

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.

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.
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