India Supreme Court rejects Novartis' right to patent new version of cancer drug

Important context, and if you didn't RTFA:<p>India recognizes patents just like anywhere else. What they don't recognize is when drug makers trivially re-formulate their drug upon patent expiration in such a way that the old medicine cannot be made generically without also infringing on the new patent. India called BS on that, and rightfully so. Now millions of people in India don't have to die because even though a drug company made several multiples on their investment already, billions in exclusive profits per year still isn't enough.<p>Edited to add: This is informally called "Evergreening". I'm not an expert in that field but you can read more at <a href="http://en.wikipedia.org/wiki/Evergreening" rel="nofollow">http://en.wikipedia.org/wiki/Evergreening</a> and linked sources.<p>In this case, they wanted to charge Indians $2600/month, and the generic is $175/month. If you have this condition and do not take this drug, you die.

Thank you, India.<p>Let me tell your my story. I am on a pill called Colchicine that I have to take 3 times a day for life. The pill's formula is hundreds of years old and would cost me pennies. That was until a company convinced FDA to ban the generics and only allow its own brand. The same pill that used to cost 10 <i>cents</i> now costs $5/pill to me here in the US. Meanwhile in India, it still costs pennies.<p>I wish US would take a page from India.

If a private company has the duty to maximise profits, shouldn't a sovereign state have the duty to maximise the benefits to its citizens while fulfilling its minimum international treaty obligations.<p>The cost of gleevec/year is $36,000. The average per capita income is $1219[1]. If patented about 99% of people who need this drug can not afford it. Why should any state keep 99% of its people away from a life saving drug, if it doesn't have a legal obligation to do so.<p>Property rights are a means to an end. Even if all of Asia and Africa refused to recognize Novartis patents, they would still have enough incentive to continue developing cancer drugs.<p>1. <a href="http://en.wikipedia.org/wiki/Income_in_India" rel="nofollow">http://en.wikipedia.org/wiki/Income_in_India</a>

To put this in perspective, Novartis Glivec is the beta crystalline form of 'imatinib mesylate' - an already known compound which went out of patent. Novartis failed to establish that the new form has demonstrable efficacy over non-crystalline form. As per section 3 (d) of Indian Patent Law designed to prevent Evergreening - inventions that are mere "discovery" of a "new form" of a "known substance" and do not result in increased efficacy of that substance are not patentable. Indian patent law follows guidelines set forth by WTO under TRIPS agreement. So Novartis has exhausted all their legal defences. Novartis did not get even one favourable verdict in the entire legal battle which played out in 3 different courts of law.

Why drugs cost so much isn't really that hard to figure out.<p>Drugs cost a lot of money to develop. On average it costs somewhere between $250M (for an orphan disease) to $1B (for a primary care drug). The problem is that most drugs fail during development and when you take that into consideration, it's typically over $1B to develop a drug.<p>Where does that money come from? Just like money for anything else, it comes from the marketplace. People (not unlike readers of HN) take their money and put it into investments that get them an optimal return. If you eliminate patents, you eliminate the mechanism to get a return on R&#38;D dollars invested. No patent (or at least a mechanism to get a return on an R&#38;D investment) and you have no drug.

Seriously? You want to start a company under the pretext of making humans' lives better, but only worsen it for them?<p>I will justify my sentiments:<p>By worsening, I mean, nothing is terrible in life than knowing there is a solution/cure to your problem, but you have to die just because you can't afford it.<p>India is a developing country, even something as moderate as $100 is actually a luxury for many people - Remember, we are talking about a country where millions slog their lives to death for $0.01 to $0.5 per hour (even in call centers, etc) and anything between $100-200 is NO JOKE for them.<p>Just don't put barriers to such things - Everybody has the same blood inside them and has a right to live on this planet irrespective of having enough money or not. You want money? Don't charge the peasants - Charge the R&#38;D departments of the billion dollar companies that want to sponsor you and compete for fame. These peasants are already selling their blood (literally) to make their both ends meet, and this should be the last thing they should die to pay for - Their very own life.

I believe this is where India has got it's patent system right. I am not a lawyer, but as I understand it, the Patent Office (Controller General of Patents Designs and Trademarks) rejects patents that are obvious and not a genuine invention.<p>Furthermore, you can only patent a <i></i>process<i></i> not an idea or a product. This was the key reason that you have so many generic alternatives for otherwise patented medicines. The process encourages competition and its the consumer who wins.<p>Perhaps this is something that US can learn from.

And this is why medical research should be directly funded by goverments, exactly like they fund military research, the cost shared among the developed nations, and directly throw away the patent system.

Question remains, if they had gotten a new patent. Wouldn't the old version still be open for the public?

“We certainly do not wish the law of patent… to develop on the lines where there may be a vast gap between the coverage and the disclosure under the patent; where the scope of the patent is determined not on the intrinsic worth of the invention but by the artful drafting of its claims by skilful lawyers; and where patents are traded as a commodity not for production and marketing of the patented products but to search for someone who may be sued for infringement of the patent.” said by Bench of Justices Aftab Alam and Ranjana Desai.<p>Well! This says it all

An hypothetical question is : Would Brian Drucker apply at <a href="https://www.microryza.com" rel="nofollow">https://www.microryza.com</a> ?<p>As I understand, all hue and cry from Novartis is - they have invested big in R&#38;D and yet not reaped reasonable returns. Also, they claim that this dents their effort to come with better drugs in future as profitability is at stack and such judgements are demotivating for any actual R&#38;D to take place. Just wondering with crowdfunding gaining acceptance would this be a relevant argument ? What are real chances of getting a life saving drug as good as Imatinib seeing light of the day. What are practical challenges ?

It might be worth mentioning that India has a large generic pharmaceutical manufacturing industry. Many generics sold in the US and around the world are manufactured in India.

I would love such a provision in US law for patents if it does not yet exist. I'd hate to see someone patent linked lists where the "previous" node pointers are at the top of the data structure and the "next" node pointers are at the end. Or some other silly re-structuring.

Bravo india Bravo. hope USA learn something from you

Why would you patent a cancer drug?

What's the legality (in US) for a Kickstarter model R&#38;D and clinical trials for new drugs?

I you find this stuff interesting I found Bad Pharma an interesting read (Random Review: <a href="http://boingboing.net/2012/11/06/bad-pharma-account-o.html" rel="nofollow">http://boingboing.net/2012/11/06/bad-pharma-account-o.html</a> )<p>They talk about tricks like mirror versions of a drug can then be patented after the first drug expires. Then the company can push them over the original, which is not necessarily bad, mirror versions can be better or sometimes worse.

I do not understand the hoopla. When the patent on the old version expires, anybody can make it for pennies a day. An expensive new formulation hurts no one, since they are free to huy the cheap one.

this is India playing with fire. and it is not about securing access to important drugs to Indian patients - it is about boosting the native Indian generic pharma industry. while India itself does not provide any significant output in R&#38;D spending in pharma.<p>so yeah, big pharma is evil and greedy, however no one else takes 1bn$ to try out a new product and have it fail in front of the FDA - which is the usual scenario, as most(!) new products get denied.<p>how many other industries out there need to PROVE that their products are not only safe but also have an actual benefit? as this is HN, let's see all those fancy task/email/collab/social apps <i>prove</i> their usefulness in scientific trials - and get denied if they fail to be better than notepad.<p>so yeah, awesome, let's kill pharma's business model without any alternative in sight.<p>how about having generic makers pay a fixed % of their revenue into a R&#38;D fund? without it they are just leeching off.