Slightly More Gloss — On The Gleevec®/India “No Patent” Decision

To understand the decision, we must remember that India has made it possible to obtain patents on drugs only fairly recently, and has set a relatively-high bar for what sorts of innovations may earn a patent — in the field of drug compounds.

Thus, a minor change in the chemical process used to produce Gleevec® doesn’t qualify to extend any patent life, in India — though it almost certainly would, in the US. That means generic copies will remain on market in India, effectively in perpetuity.

But before we simply accept the notion that branded innovators will no longer introduce their drugs in India (and by inference, China — an almost-unimaginably vast market), we should recognize that a “generic” — authorized by law, or not so — will likely appear in these markets, regardless. And branded pharma should think deeply about that possibility. Will the innovators really forego these markets, altogether? I am skepical of that.

In any event, here is a bit of the later-morning reporting, in the New York Times — again go read it all — but this is a more nuanced issue than many of the current talking heads are suggesting, regardless of ones’ perspective (branded v. generic):

“. . . .What is happening in the United States is that a lot of money is being wasted on new forms of old drugs,” Mr. Grover said. Because of Monday’s ruling, “that will not happen in India.”

Indeed, the vast majority of drug patents given in the United States are for tiny changes that often provide patients few meaningful benefits but allow drug companies to continue charging high prices for years beyond the original patent life.

In a classic example, AstraZeneca extended for years its franchise around the huge-selling heartburn pill, Prilosec, by performing a bit of chemical wizardry and renaming the medicine as Nexium. Amgen has won such a blizzard of patents on its hugely expensive erythropoietin-stimulating drugs that the company has maintained exclusive sales rights for 24 years, double the usual period. . . .

If the [branded innovator] companies decide not to introduce high-priced drugs in India, the country could legalize generic copies under international law. . . .

And so, I predict this debate will most significantly affect the introduction of new — not old — drugs, in India and the rest of the BRIC countries. If the branded innovators simply refuse to introduce in China or India, it is highly likely that a generic (perhaps even of dubious quality) will be introduced — and someone else will reap revenue from the branded manufacturer’s innovation — even prior to the expiry of the applicable patent’s life.

So, yes, this is a shift in the paradigm — indeed. More thought will be required, on the innovators’ part.

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