Indian Supreme Court Rejects Trivial 'Evergreening' Of Pharma Patents

from the saving-lives dept

Mon, Apr 1st 2013 3:13pm — Glyn Moody

Back in October last year, in the context of India showing itself increasingly sceptical about pharma patents that drive up drug prices beyond the reach of its citizens, we wrote about an important court battle over Novartis's drug Gleevec, sold as Glivec in India. The definitive judgement from India's Supreme Court was announced today, reported here by The Guardian:

The Indian supreme court has refused to allow one of the world's leading pharmaceutical companies to patent a new version of a cancer drug, a decision campaigners hailed as a major step forward in enabling poor people to access medicines in the developing world.

Novartis lost a six-year legal battle after the court ruled that small changes and improvements to the drug Glivec did not amount to innovation deserving of a patent. The ruling opens the way for generic companies in India to manufacture and sell cheap copies of the drug in the developing world and has implications for HIV and other modern drugs too.

The key issue at stake is a practice known as "evergreening": making small changes to a drug, often about to come off patent, in order to gain a new patent that extends its manufacturer's control over it. It's a way of cheating on the implicit bargain of patents: that a government-backed monopoly is granted in exchange for the invention entering the public domain at the end of the patent's lifetime.

That's what makes today's decision so important. It's not just about allowing Indian generics manufacturers to offer Glivec for a fraction of the Novartis price; it's equally about establishing the principle that "evergreening" patents won't be as easy in India as it is elsewhere, where the practice is common. This will allow India's pharma companies to produce a wide range of drugs at low prices that can then be sold to emerging countries unable to afford Western prices.

Doubtless, many lives will be saved as a result, but that doesn't seem to be any comfort to the head of Novartis in India, who is quoted in a press release as saying:

"We strongly believe that original innovation should be recognized in patents to encourage investment in medical innovation especially for unmet medical needs," said Ranjit Shahani, Vice Chairman and Managing Director, Novartis India Limited. "We brought this case because we strongly believe patents safeguard innovation and encourage medical progress, particularly for unmet medical needs. This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options."

That's pretty much what you'd expect him to say, since we've heard it here on Techdirt so many times before: without patents that allow monopoly pricing and big profits, there will be no investment in new drugs, and everyone will suffer etc. etc. But this simply isn't true. Much of the fundamental research that leads to important new drugs is done in public laboratories, paid for by taxpayers around the world, not by pharma companies.

Here, for example, is the story of how Novartis came to gain its highly-lucrative monopoly on Gleevec/Glivec, as told by the key researcher who actually developed it: Brian Druker, chair of Leukemia Research and professor of medicine at the Oregon Health and Science University Cancer Institute. He explained how the crucial initial research was carried out in an opinion piece published on the Livemint site in 2007:

The basic research that led to the identification of enzyme inhibitors for CML [Chronic Myeloid Leukaemia -- the main condition that Glivec is designed to treat] dates back to 1960 with the identification of the Philadelphia chromosome in patients with CML by researchers at the University of Pennsylvania, Peter Nowell and David Hungerford. In 1973, Janet Rowley at the University of Chicago determined that the abnormal chromosome was due to a translocation of genetic material.

No pharmaceutical companies seem to have been involved in this early work, and they were also minor players in the crucial move out of the laboratory, into product development, as Druker explains: In 1993, I moved to Oregon Health Sciences University in Portland and had a single goal of finding a company that had the best inhibitor for Bcr-Abl [the cancer-causing protein] and to bring it into clinical trials. My work in Oregon on a therapy for CML was primarily funded by public sources, particularly the National Cancer Institute. My persistence with scientists at Ciba-Geigy (now Novartis) helped to keep the development of imatinib on their agenda despite uncertainty from product managers.
So not only was the drug developed largely thanks to public funds, but the pharma company that ended up making all the profits from it wasn't even hugely enthusiastic about the project initially: it was only Druker's "persistence" that led to the drug being approved. And if you're wondering about his views on the current world of pharma, with its stratospheric prices and a habitual recourse to evergreening to extend patents way beyond their original life-span, here's what he wrote back in 2007: Pharmaceutical companies that have invested in the development of medicines should achieve a return on their investments. But this does not mean the abuse of these exclusive rights by excessive prices and seeking patents over minor changes to extend monopoly prices. This goes against the spirit of the patent system and is not justified given the vital investments made by the public sector over decades that make the discovery of these medicines possible.
The fact that many key drugs have only been possible thanks to those "vital investments made by the public sector" is nearly always overlooked by defenders of the pharma patent system. It's another reason why the Indian Supreme Court's decision is not only right, but just.

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Filed Under: drugs, evergreening, gleevec, glivec, india, patents, pharma, pharmaceuticals, small improvements, supreme court
Companies: novartis

24 Comments

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Anonymous Coward, 1 Apr 2013 @ 3:41pm

I'd hope alot of countries reject the evergreening of patents.
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TheBigH (profile), 1 Apr 2013 @ 3:52pm

I heard about this on the radio this morning. Someone was making the case that a lot of scientific progress is incremental improvements on existing things, rather than entirely new things. That is true, of course. But that doesn't excuse the cynical practice of making trivial changes to existing products as a legal ploy; that's not innovation.
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Anonymous Coward, 1 Apr 2013 @ 3:57pm

Re:
"Someone was making the case that a lot of scientific progress is incremental improvements on existing things, rather than entirely new things"

Seems to me like an argument for less patents, after all, if most scientific progress is based on incremental progress to existing science, then allowing people to patent that science only impedes scientific progress.
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Anonymous Coward, 1 Apr 2013 @ 3:59pm

/ Accent
Fantastic... just fantastic
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Steerpike (profile), 1 Apr 2013 @ 4:07pm

Even if an "evergreen" patent goes through, can't the public still practice the claims of the original patent?

In other words, if a drug company patents a medicine having components A, B, and C, and then when that patent expires they get another patent for the medicine, but having components A, B, and C' (where C' is some modified version of C), then generic drug companies should still be able to produce a medicine having A, B, and C without infringing the new patent.
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Anonymous Coward, 1 Apr 2013 @ 4:22pm

Cue an effort to make the patent term the same as the copyright term.
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Anonymous Coward, 1 Apr 2013 @ 4:23pm

This will allow India's pharma companies to produce a wide range of drugs at low prices that can then be sold to emerging countries unable to afford Western prices.

I wonder what the US will do about this? Send SWAT teams? Sue India's delivery companies for $40 million? Or maybe just rant about how unfair it is and threaten to put India on some meaningless list?
One thing's for sure: they're going to react somehow. This is the government whose motto is "We HAVE to do SOMETHING!", after all.
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Watchit, 1 Apr 2013 @ 5:34pm

Response to: Steerpike on Apr 1st, 2013 @ 4:07pm
I was thinking the same thing. I suppose how it works in reality is that they make it exactly the same and add something so it's A + B + C + D and since A, B, and C are part of the new formula it's also under the "new" patent
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Steerpike (profile), 1 Apr 2013 @ 5:38pm

Re: Response to: Steerpike on Apr 1st, 2013 @ 4:07pm
Yeah, but that wouldn't matter. If you eliminate elements from a patent claim, you don't infringe. So if a patent claim covers A, B, C, & D, you can make A, B, & C all you want without infringing. It's when you add D that you're in trouble.

Nevertheless, I think it is a good idea that courts look at these kind of incremental 'innovations' more closely to determine whether something truly inventive is going on or not. If not, no patent should be allowed.
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redrum, 1 Apr 2013 @ 5:50pm

Here's my question
Yes, I believe that never-ending patents on life saving medication is patently immoral .. But if Drug A is about to come out of patent, and they make a small change and call it Drug B .. Then couldn't they make a generic of the original Drug A regardless of any patent on new Drug B? Why does a change and new patent on what they are calling a "New" drug, affect the patent expiration of the original? Seriously, I'm not trying to be a wise ass, I'm just wondering why it matters. If they want to patent a "New" drug, then can't they just make generics of the "Old" one.
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bigpicture, 1 Apr 2013 @ 6:26pm

They would if they could
The problem now is that India and China are not banana republics like the US used to push around. Nor are they middle east dictatorships. Between India and China they have about a third of the world's population, their combined economies exceeds the US, and they both have nuclear weapons and independent space programs. They are not the little boys on the playground that the bullies can push around. They won't be buying any of the lopsided monopoly trade agreements that the US is selling.
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Steerpike (profile), 1 Apr 2013 @ 6:45pm

Re: Here's my question
Yes, they could. The pharma corps push doctors to prescribe the new version. Also, doctors are sometime more likely to do it for liability reasons. If the patient dies, they don't want to be sued for malpractice and asked why they were using the older version when there's a "new and improved version" on the market.
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Davey, 1 Apr 2013 @ 6:57pm

Great decision,
but the headline makes it seem like the "evergreening" is trivial, when the whole point is that it's the exact opposite of trivial. Sometimes you need to juat let the techies just fix the software and bring in the liberal arts guys when you want to communicate.
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Anonymous Coward, 1 Apr 2013 @ 8:34pm

Re: Great decision,
How difficult is to create a mirror compound?

Because that is the level of difficulty one has to get one patent on a new "improved" drug.
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Anonymous Coward, 1 Apr 2013 @ 8:48pm

"The fact that many key drugs have only been possible thanks to those "vital investments made by the public sector" is nearly always overlooked by defenders of the pharma patent system."

Easy to say without resort to proof. Surely there are a plethora of examples you have immediately at hand.
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Jesse (profile), 1 Apr 2013 @ 9:03pm

Open Access doesn't go far enough. Patents shouldn't be allowed to build off of publicly funded research.
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Tobias Harms (profile), 1 Apr 2013 @ 11:30pm

"We strongly believe that original innovation/../"
Ya,I stopped reading the press release around here. I've heard it all before.
I could support original innovation but this as so much other patents are patents for patents sake. They don't bring any new to the game and they only exist to stop others.
"Play by my rules or I'm taking my ball and goes home"
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balayogi, 2 Apr 2013 @ 1:25am

patents
Positive paradigm shifts in the corporate world a boon to humanity.
Positive paradigm shifts in the corporate world positively impacts immensely the quality of both the environment and human life.
This has been visible in the past four decades at least in two areas mentioned below.
1] Modern concept of corporate social responsibility either done voluntarily or enforced by the state is a good thing and that is being followed mostly by big MNCs and all other big and responsible business enterprises.
2] Similarly there is a mounting awareness as well as activist induced concerns towards the welfare of the environment.
Slowly but steadily on these two areas there have been a marked improvements in the past three decades compared to total lack of concern for such things prior to that.
In fact in many parts of the world where the government failed it was the responsible and generous sponsorship of corporate houses that have helped many human beings get basic health care, education and other fundamental human needs.
But having deservingly praised the corporate world for its positive contribution in these areas, there is a major unfulfilled area of concern and if only the collective wisdom of the corporate world can pledge to get the complaints in that area too addressed positively in the interests of human race at large then history will remember such corporate houses and human race would be always grateful for such activities.
I shall come to what it is but before that I would like to make an appeal that this has to be addressed purely in the interests of human race at large and not commercial considerations or legal rights and wrongs. This can be debated and as history has shown many instances where the common good of human race prevailed over all other considerations be it the consideration of interests of a specific nation or a specific profession or specific ideology etc
What I am talking about is doing away with Intellectual Property rights and its off springs Patents, Copy Rights, Trade mark, Trade Secrets to name a few.
Fortunately the UN day of Intellectual Property Rights too falls in the near future on 26th April 2013. So we can start the debate. Please try to go through the entire article for the sake of Humanity.
If this happens then probably we would be rewriting the history of world economy.
I am not a lawyer. What I am going to write may sound high flown philosophical and idealistic but practically not viable. However, that does not stop me from putting forth certain questions that have been bothering me for a very long time regarding the very legitimacy of Intellectual Property Rights and its off springs Patents, Copy Rights, Trade mark, Trade Secrets to name a few.
In evolutionary biology we find that all creations have shed the unnecessary parts or shrunk them for better survival; in evolutionary sociology too human race has shed too many models of social groups and narrowed down on a few that would be easier for global interaction; in languages too, from a few thousands languages that existed humanity has reduced the number to just a few hundred languages. Similarly there is nothing wrong in giving up in the interest of evolution of human race, of course against the interest of a few lawyers who mostly benefit from such laws, we can think of doing away with this whole set of laws connected with Intellectual property.
What is Intellectual property (IP)? It basically refers to creations of the mind. Who is the owner of anyone�s mind? Mind [ a difficult term to define] like everything else in life is a product of evolution and in its course of evolution it is inevitably interdependent and interacts with all other minds either obviously or otherwise, with itself at varying levels of potency based on different levels of perceiving and performing capacities at different times. Besides whether we believe in it or not, it is always aided by a universal mind which works through every individual mind at various frequencies depending upon various factors like readiness, attitude, and priorities for the mind space at a specific time etc within which we can include a whole gamut of things which impact the mind like culture, economic situation, social set up, education etc.
Even granting that we are able to satisfactorily come up with legally sustainable definitions to carry on with this one or two century old legal entity to justify due acknowledgment and adequate commercial compensation to creators of original discoveries, designs, inventions, ideas etc and that patents connect invention to development and manufacturing etc. Still, these definitions leave out of their gambit all the inventions, ideas, discoveries and the creators of those inventions etc prior to these laws coming into play. They cannot forget the fact that even without these patents and trademarks developments and manufacturing were taking place.
Even after the advent of this backward laws came into force many sane discoverers and inventors have opted for not patenting like Madame Curie, one the greatest scientist and the inventor of polio vaccine Jonas Salk to name a few.
However convinced I was about the negative impact of Intellectual Property, I still decided to gather enough material from sources with not only and not necessarily similar thinking individuals but legal professionals with integrity and others with interest of human race as a priority to support and substantiate my side of the argument. All the more now, after recession and intense competition in an age of knowledge enhancement and execution, when commercial enterprises are unnecessarily wasting too much of money, man power etc in unwanted patent litigations which profit only the select group of lawyers and the media which treats these litigation battles as glamour world gossips to be gobbled up by the gullible public.
As the great scholar and my favourite author Bertrand Russell writes in POLITICAL IDEALS (1917)CHAPTER IVINDIVIDUAL LIBERTY AND PUBLIC CONTROL
�The creative impulses, unlike those that are possessive, are directed to ends in which one man�s gain are not another man�s loss. The man who makes a scientific discovery or writes a poem is enriching others at the same time as himself. Any increase in knowledge or good-will is a gain to all who are affected by it, not only to the actual possessor. Those who feel the joy of life are a happiness to others as well as to themselves. Force cannot create such things, though it can destroy them; no principle of distributive justice applies to them, since the gain of each is the gain of all. For these reasons, the creative part of a man�s activity ought to be as free as possible from all public control, in order that it may remain spontaneous and full of vigor. The only function of the state in regard to this part of the individual life should be to do everything possible toward providing outlets and opportunities�.
There are of course many links on the net where we can find excellent articles and materials about the irrelevance of the Intellectual Property laws and their off springs.
I am giving below some ten which I felt dwelt on the subject with correct perspective and reflect similar sentiments as indicated above.
1] From http://www.washingtonpost.com/blogs/wonkblog/wp/2012/10/10/the-case-against-patents/
Wherein Michele Boldrin and David K. Levine for the Federal Reserve Bank of St. Louis write and it�s titled �The Case Against Patents� and argues that our patent laws now do more to hinder innovation than to promote it. And, since there�s no way to salvage the system, the United States would be better off scrapping patents entirely.
2] From http://www.fourmilab.ch/autofile/www/chapter2_105.html
While eliminating software patents would be the best solution, changing the law takes a long time and is uncertain to succeed. I've been trying to puzzle out how the software industry might rescue itself from immolation through litigation and came up with the following proposal....
3] From http://fare.tunes.org/articles/patents.html Patents Are An Economic Absurdity
4] From http://www.aclu.org/blog/womens-rights-free-speech-capital-punishment-criminal-law-reform/james-wats on-discoverer-dna
James Watson, Discoverer of DNA: Patenting Human Genes Is �Lunacy�
By Sandra S. Park, ACLU Women's Rights Project at 12:11pm
5] From http://web.missouri.edu/ikerdj/papers/SFT-Patenting%20Life.htm
The Case Against Patenting Life-John Ikerd
6] http://www.no-patents-on-seeds.org/
7] http://www.quebecoislibre.org/000902-3.htm
8] http://epsem.erin.utoronto.ca/desrochers/desrochers0900.pdf
9] http://www.gene.ch/gentech/2000/May/msg00057.html
10] http://cis-india.org/news/world-day-against-software-patents

You can read the article in this link in my blog http://contentwriteups.blogspot.in/2013/04/intellectual-property-rightspatents.html
Or face book wall
https://www.facebook.com/photo.php?fbid=4625877727676&set=a.1465556521621.2062584.1314766080&a mp;type=1&relevant_count=1
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d k agarwal, 2 Apr 2013 @ 2:12am

good analytical capabilities of indian juditiary with humility
a great judgement by Indian apex court...it is a victory of humanity against exploitation by intellectual, legal money extortioner...

It is a great relief to those who are not only unfortunate but poor also.

God forgot to take care of them but they have got justice by their own....

thanks to our judges...
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Anon, 2 Apr 2013 @ 5:32pm

Response to: Anonymous Coward on Apr 1st, 2013 @ 8:48pm
Easily provable fact. You make it sound like a wild accusation!
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RL (profile), 2 Apr 2013 @ 9:02pm

Re: Re: Response to: Steerpike on Apr 1st, 2013 @ 4:07pm
Steerpike is correct in saying: "If a patent claim covers A, B, C, & D, you can make A, B, & C all you want without infringing."
I see no way that a patent newly issued to company X can prevent a generic company Y from producing the original (now off-patent) drug, with its original packaging, delivery system, etc. A buyer may prefer to buy X's "new improved" version, but this is a market-preference, not a legal-blockage, issue. None of Y's rights to make the original drug are abridged by the existence of X's new patent, even if the new drug is only marginally different from the old.

Can anyone here tell me what legal impediment "evergreening" imposes on a generic maker who wants to market the old drug? I'm deeply puzzled by all the claims I've seen about such impediments.

[Note: I do agree with Steerpike that any invention should be sufficiently novel (and nonobvious and useful) to warrant a patent at all. But this is a different legal issue.]
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Juan Villar (profile), 3 Apr 2013 @ 1:29pm

This isn't making any sense. If the original patent expires, how does a minor improvement extend the patent term? The original molecule goes into the public domain and nothing stops anyone from making it. At least that's American patent law.

Does Indian patent law really allow you to extend the original patent?
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Steerpike (profile), 3 Apr 2013 @ 1:32pm

No, Juan. That's why I said the term "evergreening" is really misleading. They can't recover the original subject matter, and from what I know of patents in India, that holds true there just like it does in the U.S.

Instead, when companies patent a trivial modification to a drug, they use the power of their branding, marketing, distribution, and so on to push that new version to prominence. The generic company can produce the original drug, but now you have an incentive for the doctors not to prescribe the "old" version and to go with the "improved" version instead, and on the improved version there is no generic competition.
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Sheogorath (profile), 16 Jan 2014 @ 9:58pm

Re: Re: Re: Response to: Steerpike on Apr 1st, 2013 @ 4:07pm
Proprietary Company makes drug A, B, & C, then when the patent expires, they reformulate it to add D. Generic Company makes drug A, B, & C, then gets sued out of existence by Proprietary Company because the new patent covers A, B, & C. This often leads to more affordable versions of drugs never making it to market because the other generic companies quite rightly and unfairly get shit scared to produce something the law says is legal to manufacture. Simples!
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