India: Drug Patents for True and Genuine Inventions, but not for Gleevec

By Dennis Crouch

In the U.S., Gleevec costs around $70,000 per year. In India, that price is only $2,500 (for a generic version). The difference is that the Indian government has refused to grant patent rights over the Swiss-created drug while five different patents cover the drug and its use in the US.

Today’s Indian Supreme Court decision is online here: http://judis.nic.in/supremecourt/imgs1.aspx?filename=40212.

The Indian Supreme Court focused on the question of obviousness:

Does the product for which the appellant claims patent qualify as a “new product” which comes by through an invention that has a feature that involves technical advance over the existing knowledge and that makes the invention “not obvious” to a person skilled in the art?

India recognizes that its inventive step is a higher standard than that of different countries around the world – especially in the area of pharmaceuticals. And pushing in that direction is India’s statute stating that:

(3)(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.

In reading the statute, the Indian Supreme Court found that section 3(d) “clearly sets up a second tier of qualifying standards for chemical substances/pharmaceutical products in order to leave the door open for true and genuine inventions but, at the same time, to check any attempt at repetitive patenting or extension of the patent term on spurious grounds.”

The active ingredient in Gleevec is a beta crystal form of Imatinib Mesylate. It turns out that Imatinib was already known to be useful for inhibiting BCR-Abl tyrosine kinase (the function of Gleevec) and the court found that the difference between the two insufficient to allow the new patent.

The decision is important because it attempts to offer wide leeway for India’s generic drug industry while also fit within the TRIPS guidelines. The inventors of Gleevec were awarded both the Lasker Award and the Japan Prize for their contributions to medicine and science.

36 thoughts on “India: Drug Patents for True and Genuine Inventions, but not for Gleevec

  1. Charles Bieber Hurst

    I had to Google this to see what Malcolm is talking about. So I guess that Leopold not aiming at the right target is understandable (to some degree; although certainly not when looking at the total picture).

    I think it even more creepy that Malcolm has intimate knowledge of such a story, and reveals a bit more about Malcolm than he might imagine. Given his penchant for accusing others of what he does, this fascination of his with this topic is a bit unsettling.

    And aside from the dust kicked up, Malcolm you avoided my question – where did you get the name Francis?

  2. As I read the statute, one cannot re-patent an old product upon discovery of an new use. I think this is consistent with US law, and Section 100.

    As to the first part, change in “form” without a change in “substance,” this seems also consistent with US law, but 103. What you are saying in your post is that the PTO patents form changes all the time without showing any “enhancement” of known efficacy. Without that requirement, it seems, one could repatent the computer by painting it blue, then green or yellow or any color that had some minor benefit unrelated to the computer, such as being visible in certain lighting.

  3. Eliza, Les : good question. And for that matter – why does the indian generic not deploy the prior art form and build their own brand in india? Obviously the beta form has a therapeutic effect.

    anon, having read more, it appears that in india gleevic lost its patent application priority date. Question are the judge’s positions lifetime appointments?

  4. The Indian Section 3(d) clearly does not “fit within the TRIPS guidelines” because this provision is directed to limiting patentability of pharmaceutical products, in particular, whereas Article 27.1 of TRIPS prohibits member states from discrimination between different fields of technology in their patent regimes.

  5. If this:

    “The active ingredient in Gleevec is a beta crystal form of Imatinib Mesylate. It turns out that Imatinib was already known to be useful for inhibiting BCR-Abl tyrosine kinase (the function of Gleevec).” And there is no significant difference between the two, then why is there a fight over the patent?

    Why not just make and sell Imatinib? If there is no advantage to the beta crystal form…why try to invalidate the patent?

  6. Question – if the original form works about as well and is in the public domain why aren’t U.S. doctors just prescribing that and refusing to pay for the newly patented version?

  7. Much like the (mis-maligned) Hilmer Doctrine, I think that you are not evaluating this position quite correctly.

    The Indian law applies regardless of who is attempting the type of patent as covered by the law, and applies equally to any Indian national company so seeking such a patent. The law is not facially unfair.

    Of course, in application, you don’t have the Indian national firms (the lower price generic copycats) even attempting to obtain any such patents. But rest assured, if any did attempt to do so, they too, would be limited by the law.

  8. Zeke,

    Your point is (possibly) valid, but does obscure the fact that the process of vetting a new drug is fraught with peril and a lot of (expensive) failures.

    That’s why I state that Big Pharma will get its cut. This, however, does not make the development costs disappear. Someone is going to pay those costs. If developing nations are successful in forcing price concessions, someone else will be stuck with the bill. I believe any sense of ‘ultruism’ being bandied about is an illusion, and to think that US citizens are not footing the bill for this ‘ultruism’ is to be way, way too pollyanna.

    There are no free lunches (in this world).

  9. In reading the statute, the Indian Supreme Court found that section 3(d) “clearly sets up a second tier of qualifying standards for chemical substances/pharmaceutical products in order to leave the door open for true and genuine inventions but, at the same time, to check any attempt at repetitive patenting or extension of the patent term on spurious grounds.”

    translate – our local home grown well connected companies get patents – we take the IP from the others. A king’s court if there ever was one.

  10. “drug development is a risky venture”

    Yeah because look at all those drug companies going bust all the time (eye roll).

  11. You have your eyes closed Leopold.

    If you cannot see the most vile person on these blogs is Malcolm, well…

    (but isn’t it curious that you cheer him on and never – and I do mean never call him out for his vile posts, insults, strawmen, mischaracterizations of law, fact and what others post)

    You charge at the slightest hint of “anon said,” and want me to “just shut up,” all the while Malcolm spews on and on without a whisper from you.

    Why is that? What is it that you have bought?

    And nice “virtuous philospher king” line – hey I have made no bones about my slinging ad hominem – but let’s be clear – I sling at those who have shown themselves to be deserving of it, and I have made it more than clear how to reduce my slinging: don’t ask for your head to be handed to you. Point is, I may not be a saint, but I am justified.

    Or is this another play at the Crybaby veto, wherein “Oh why can’t we have a nice gentlemen’s conversation” is trotted out, when NO SUCH CONVERSATION WAS EVER INTENDED? I have also made it perfectly clear that I am willing to play by any rules as evident on these boards. But the real posters of low quality never seem to gather your attention, Leopold, and your comments are ONLY directed (badly) to one side. Sorry Leopold, from you, such comments have no credibility.

  12. Paul,

    I disagree with a basic assumption you are making. You assume that the cost structure is purely in play in order to recover research and promotion costs.

    However, the issue is not that at all. At least not in this case.

    Similar to the Kirtsaeng case, the issue here is geographic splitting of those costs (and the fact that drug development is a risky venture), and the distribution of those costs for penetrating different markets. Here, the players are a little different, in that the Indian government wants to artificially cap profits, thereby shunting costs elsewhere. Sure, it “sounds good” to be “altruistic” and cut developing countries a break, but don’t do it on my dime, and without me having a say, thank you. Big Pharma will get its cut, that’s for d_@mm sure, and if not from the developing country, then it comes directly from me (the royal me).

    If you want to take the ultra-altruistic angle, simply nationalize all pharma development and remove the big Pharma Corps (and their profit angle) from the picture. Oh wait, we have seen that that philosophy does not work. Hmmm, well then, I prefer to not subsidize Big Pharma’s other country market penetration efforts, thank you.

  13. …clearly my posts merely capture what he is about.

    Your posts more clearly capture what you are about. But go ahead, keep imagining yourself as the virtuous philosopher king. I can think of at least one other person who is buying it.

  14. There would be much to be said in extending the patent term for pharmaceuticals to 50 years in return for a more gradual recovery of research and promotion costs. thwe benefit to mankind of the medical research in the drugs we presently enjoy amply supports the suggested extended monopoly. And it would put an end to the need for “ever-greening” patents with which many will be familiar. In the present regime, patent attorneys are forced to play that game, which is less than totally spurious but sometimes less than totally to the point either.

    Forcing the industry to recover research costs over a practical patent term of say 10-15 years front-loads costs for patients and does nobody any good. What is needed is a better, more thoughtful and more just regime both to drug companies and to patients.

  15. There is, or course, a self-contradiction here.

    Low innovation evergreening is largely a marketing strategy. In a world where there is going to be a generic, it lets the innovator claim a moderate premium on its reduced market share.

    If the improvement were trivial, then there is little downside to granting a patent. Generic manufcturers could still sell copies of the original Gleevec.

    The fact that there was so much public involvment here says much more.

    First, it says that this may really have been a substantial innovation.

    Second, there is a politically savvy group of generic manufacturers and politicians manipulating Indian public opinion with wild conspiracy theories. In a country where indoor plumbing penetration is a century behind the first world, that ruling class has to constantly distract the underclass into believing that their problems are the result of sinister external conspiracies.

  16. Leopold,

    More of your errant arrow shooting. You direct a comment at me, when it is Malcolm whom should be your target. Clearly, he is making baseless accusations (when have I ever been known to run from the likes of him?) and clearly my posts merely capture what he is about.

    Yet, you fail (once again) to see what is going on about you, and you aim at me.

    Time for you to look for that wagon to climb back up onto. But please be careful and do not trip over the arrows around your feet.

  17. Dr Amit,

    Do you think it fair that other countries support the developing countries with a ‘shift’ in profit, subsidizing in an unequal amount, the making money that you acknowledge that pharma companies have every right to do?

    Do you realize that this type of ‘taxation without representation’ strikes at the very core of the US sensibilities?

  18. Pharma companies have every right to make money of their inventions. But in developing countries, making 10-fold profit is not acceptable. They need “affordable healthcare”. Most people there don’t have insurance (I don’t think it helps and insurance industry is another big fraud). There has to a a good balance between R&D spending & product pricing w.r.t countries you are targeting. They can make money in India by “more sales, less profit margin” rather than “less sales and more margins”.

  19. You missed the point about accusing others of that which you do.

    How do you stand to be nailed so often? To be handed your vacuous head so often?

    No wonder you despise yourself (and this profession) so – you svck at it.

  20. How can what I say be a smear if you don’t understand it?

    Your ASSumptions are showing, and it’s not pretty.

  21. Basic and consistent logic in your post.

    Where’s the failure in “consistent logic,” Mr. SmearAndRun?

  22. Meanwhile, key aspects of our awesomely compromised health care (non)-solution are apparently too difficult for our massive (and massively wealthy) insurance industry to implement on time:

    in recent weeks, insurance companies urged the administration to delay the “employee choice” option.

    “Experience with Massachusetts has demonstrated that employee choice models are extremely cumbersome to establish and operate,” Aetna said in a letter to the administration in December. …

    John C. Arensmeyer, the chief executive of Small Business Majority, an advocacy group, said the delay of “employee choice” was “a major letdown for small business owners and their employees.”

    Oh well. I’m sure the record number of patent grants will provide more than enough revenue for those small businesses to make up the difference.

  23. Oh, I get it

    Oh, no you don’t.

    If you don’t get it, how can you label it a smear?

    Um, er, um…

    (typical Malcolm FAIL).

    Better trolling please.

  24. Your projection of nonunderstanding is a trite and obvious ploy of a rhetorical tool, and contributes (mightily) to the overall understanding that you have nothing but vacuous comments (or undeserved insults) to add.

    Oh, I get it: it’s Smear and Run Day. Sort of like everyday for anon, except ramped up after the weekend.

    If anyone has any clue what anon is driving at with his dance or “different in kind” comments, I’d welcome a translation.

  25. Malcolm,

    Your projection of nonunderstanding is a trite and obvious ploy of a rhetorical tool, and contributes (mightily) to the overall understanding that you have nothing but vacuous comments (or undeserved insults) to add.

    Way to go, son.

  26. Yet another area for Malcolm to dance too early.

    Huh?

    Different in kind’ anyone?

    Can anyone translate this into English? anon’s machine translation program seems particularly buggy today.

  27. 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.

    In the US, at least, the USPTO seem to get rolled quite often into accepting any difference as “significant.” Throw some salt into an old drug formulation and concoct some study showing that “it improves shelf life of the medicament by 15-65% in climates with higher than average relative humidity” or “it’s easier to swallow for people with Snickersenn’s syndrome” and voila! welcome to the world of “evergreening”.

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