I heard a blurb on the news about patent protection denied on Gleevec. Will we finally get pricing reduction?
Gleevec patent litigation impact on pricing?
Posted 01 April 2013 - 09:29 AM
I think RCT is correct that in markets where they can manipulate the patent laws and get extensions for minor tweaks to the drugs they will likely charge more. Since the drugs are generally paid for by third party, consumers really don't have ability to drive traditional market forces that would bring price down. For most people if they have insurance they will continue to get their drug from traditional channels, however what this does for people who do not have insurance is provide a potential avenue to obtain the drug from India. Technically not legal to import it, but if your life depends on it, then most people will do what they have to do.
The bigger question will be to see if any other countries follow suit. It will be interesting to see if other countries start to make it more difficult to extend patents. I think the thing that needs to be kept in perspective is that no one is saying screw patents, what they are saying is that when a patent expires the manufacturer can't make a minor tweak to the formulation that does not make a difference to efficacy and get a new patent to continue charging higher prices. Novartis recovered their investment in Gleevec years ago and it is pure profit since then. The argument that they need those profits to drive research in other drugs is somewhat manipulative reasoning. They deserve to make a profit, and they deserve to make a very good profit but gouging people to the tune of $5000 per month to live is incorrigible.
Will also be interesting to see what Novartis does going forward, it seems like they were pouting about losing and stated they will not do development in India going forward. I don't see how realistic that is. It sounds threatening but given there are over a billion people there seems like it would be hard for any global corporation to ignore them.
Posted 01 April 2013 - 01:13 PM
This case is somewhat different in that Glivec was never patented in India.
Novartis charges less in India than in the US but the Indian manufacturers charge only a few dollars a pill.
I have not heard of any cases of Indian made Glivec being illegally imported into the US.
Posted 01 April 2013 - 03:44 PM
I can see CML India tourism:
Once a year visit to the Gateway of India (pictured above) or to the Taj Mahal - and while there, stock up on Gleevec for a year's supply.
p.s. I've been to Mumbai - wonderful place - outstanding food, warm people. Low cost Gleevec. 2 hour drive from airport 12 miles away.
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Posted 01 April 2013 - 04:16 PM
I'm also not aware of any mass importing of the generic drug into the US however I have heard of people who have someone in India buy it for them and mail it to US.
For a full understanding of what the India case is about, this is the most informative write up I found. http://www.medscape....warticle/775186
This was written before the case was decided but explains the details behind the patent debate and talks in depth about Gleevec.
Posted 02 April 2013 - 08:53 AM
India has routinely violated international patent rights. Most countries enforce the patents from other countries but India has refused to enforce patents for a number of leukemia, cancer, and HIV drugs. Importing Gleevec generics from India is illegal in the U.S and most other nations.
Posted 02 April 2013 - 02:15 PM
Seems like it is matter of local law conflicting with an international law. My reading of it is not that they outright ignore the patent, they have laws prohibiting the practice of evergreening, and in their opinion, changing the form of the drug, without changing the efficacy, was in violation of their evergreening laws, for that reason they denied the application for a patent. In the absence of the patent the generic companies were legally permitted to manufacture the drug.
I'm not saying one is right or wrong, but certainly India is not the only country in the world that has chosen to follow their own laws when in conflict with an international law. It also seems that laws agreed upon by wealthy nations are usually in the interest of wealthy nations and it is not surprising that a poorer nation takes exception with some of the practices. The issue is if India's evergreening laws are unreasonable. There are plenty of people on both sides of the argument with an opinion.
With regard to importing generics from India being illegal, that is 100% accurate, but if I found myself in that situation I would rather be "judged by twelve than carried by six".
Posted 02 April 2013 - 08:12 PM
I don't agree. India uses triviality to justify their illegal behavior. The article below says "India's Supreme Court ruled that the patent that Novartis sought for Gleevec did not represent a true invention." Huh? So the most important invention in the history of targeted cancer therapy was "not a true invention". That is the definition of triviality to justify illegal behavior. Note also that they call their drug "imatinib". What other information is needed to see that this is a clear patent violation. I would at least understand a bit if they said "we stole the patent so we could give our people cheap drugs". But when they try to justify their illegal behavior in such trivial ways they make fools of themselves.
Posted 02 April 2013 - 10:27 PM
This case turns on an arbitrary technicality of the Indian law. The original formulation of Gleevec was discovered in 1993 and Indian law does not allow drugs discovered before
1995 to be patented. That is why Novartis was trying to patent a modification to Gleevec. It's not clear how much of precedent this case will set for newer drugs.
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