One trick used by pharmaceutical companies to arbitrarily extend the life of their patents is to come up every ten years or so with small, sometime barely significant, improvements and variations that are recognized by the USPO as new inventions and patented accordingly.
After India, giving in to pharma-lobbying and international pressure from the US and the EU, adopted a new patent legislation that allows for patenting of drugs, big pharma decided to test it to see if the same trick could be played there.
The test was carried out first by Novartis, using the case of a relatively minor (in terms of Indian market size) leukemia drug, called Glivec. Was a small improvements on Glivec patentable in India as a new drug? More importantly, shouldn't the Indian courts order local producers of generic drugs to stop producing the generic version of Glivec and export it worldwide, now that its new version was covered by an Indian patent?
The answer, coming from Madras, is NO:
the small improvement does not contain enough innovative content to support the claim for a new patent. Because the original version of the drug goes back to before 1995, it is not covered by an Indian patent and the local producers can continue competing with Novartis worldwide by selling their version of the drug at roughly 1/10 of Novartis' price.
To learn why this is good news not just for people suffering of the particular form of leukemia that Glivec is effective against, but also for a lot of other sick people, read the extended discussion in the excellent NYTimes piece.
Do let me know if I'm misinformed, but I understood that a patent on an improvement didn't constitute an extension of the patent on the underlying invention, merely a patent on the improvement.
So, when the patent on drug A expires, anyone can make drug A or A*, irrespective of whether someone has the patent on drug A'.
Or is practice vastly different from theory, that the mere existence of a patent on A' indicates a future in court demonstrating that A* is not, as it may appear, A'?
You are correct. When the patent on drug A' expires, anyone can make drug A'. In fact, even though the Indian court rejected Novartis' application, an "improved" version of drug A', let us call it drug A", could separately be patented, if it is sufficiently different from A'.
Michele completely missed the point of what drug companies do. Their actual strategy is to file a new patent application on the "improved" drug, and - here is the nefarious part - they tell everyone, through intense sales pitches, that drug A' is not really all that good and A" is better, so they should be using A". Of course, you have to wonder why a drug company would promote A' for a decade or a decade and a half and suddenly it is "no good," but that is another question.
So, doctors, swayed by freebies and often not having the resources to investigate new drugs, just accepts what the drug companies say and start prescribing A", even though A' works just as well, and maybe is completely effective, for most people.
Of course, A' will be available as a generic, so it pays to push your friendly neighborhood doctor for a generic that might fit the bill rather than latest snake oil. Sometimes you may have to push really hard because some doctors are seriously in bed with drug companies.
very interesting article! I will follow your themes.
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