Novartis makes, the world takes
India, a nation known for its innovation in many areas, has decided that incremental innovation in pharmaceuticals isn't important—at least when it comes to patent protection.
The Supreme Court of the world's largest democracy has rejected Novartis' attempt to patent a new version of cancer treatment Gleevec. But what India has really rejected is medical innovation. And what activists are applauding as a road to broader patient access is a phony and pyrrhic ruling.
Citing a legal provision in India's 2005 patent law aimed at preventing companies from getting fresh patents for making only minor changes (“evergreening”), India's patent office didn't issue a fresh patent for the medicine because it was not a new medicine but an amended version of its earlier product. But what makes this ruling even more absurd is that Novartis wasn't asking for a patent on an incremental innovation—their request was for a beta crystal reformulation to make the existing product more stable.
In other words, Gleevec isn't innovative enough for India.
According to the New York Times, "The court's ruling confirmed that India's criteria for the granting of such patents remain far higher than those in the United States, where patents are so easy to win that one was given in 1999 for a peanut butter-and-jelly sandwich."
That's a nice anecdote but as the saying goes, the plural of “anecdote” isn't “data.” What does the Indian decision mean?
It means the Indian court doesn't understand how pharmaceutical innovation happens—or why it's relevant. As any medical scientist will tell you, there are few "Eureka!" moments in health research. Progress comes step-by-step, one incremental innovation at a time. Even the smallest innovations are made only after large amounts of very expensive research is done.
Once a lifesaving drug or treatment exists, it's seductively easy to take it for granted. We sometimes forget the years of toil these things take to develop; the millions spent to bring a new drug or treatment from theory to actuality.
Abraham Lincoln wrote, patents “add the fuel of interest to the passion of genius.”
There is a reason why virtually all the world's “miracle drugs” have been developed in Western countries. It's called incentive. Because innovation is honored and protected and inventors are rewarded for their work.
Where there is no patent protection there is no investment. And where there is no investment there is no innovation.
Minus patent protection, an innovator company can't earn back what it invested in R&D, ergo they can't reinvest their profits in further R&D—further delaying crucial incremental innovation, which is how medical progress is made.
(But large Indian generic manufacturers can make a bundle.)
Not surprisingly, the usual suspects of so-called “civil society” are trumpeting the Indian decision as a victory for patient access. Nonsense. Price isn't the problem.
Obvious by its omission is the fact that about 99% of all the Gleevec in India is given for free. Patents have not prevented access. In fact, when you examine the WHO's model Essential Drug List, very few of the 400 or so drugs deemed essential are new or patented or were ever patented in the world's poorest countries. In category after category, from aspirin to Zithromax, in almost every case and in almost every country, these medicines have always been (or have been for many years) in the public domain. That is, the medicine is fully open to legal and legitimate generic manufacture.
If we allow our emotions (and sloppy reporting) to trump reason, we'll end up with a lot less innovation.
And fewer lifesaving drugs to take for granted.
The Indian decision is a horrible blow to global public health -- and particularly to the Third World, because economically-driven, short-term decisions have deadly unintended consequences.
Peter J. Pitts, a former FDA Associate Commissioner, is President of the Center for Medicine in the Public Interest