The recent story about the decision of an Indian court denying Novartis' application to patent Gleevec (Glivec) in India was covered from a number of different angles. The headlines and analyses were sweeping and impassioned. And all wrong.
Predictably, The New York Times framed the issue as a big victory for the poor over the rich drug companies. Their headline, "Low-Cost Drugs in Poor Nations Get a Lift in Indian Court" makes it sound like the issue is the long-overdue redistribution of wealth from the US to poorer countries.
The Huffington Post really missed the point. Their splashy headline "Strong Medicine: Why India's Rejection of Drug Monopoly is a Lesson for America" has virtually nothing to do with the decision. Perhaps HuffPo needs its own lesson on how to read a science story.
On the other side of the opinion aisle, PhRMA, the trade association for the pharmaceutical industry, contributed its own hysteria. "PhRMA is very disappointed with the Indian Supreme Court's decision to deny a patent on Glivec," said Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO John Castellani. "This decision marks yet another example of the deteriorating innovation environment in India."
Well, I'm sure that they are disappointed, and the innovation climate in India is certainly far from ideal, but they also missed the point. This partlcular case does not address these broad issues.
In reality, the Indian court ignored all of these factors (although it did throw out the ridiculous argument that the patent should be denied because of another law that forbids patents for inventions that "offend public order or morality.")
What really happened was a smart and fair, science-based decision where the court got to the bottom of the issue. And it had nothing to do with any of the above headlines. It was based solely on their interpretation of a grey area in patent law, which determines whether a drug is novel or not. In this case, the court chose a strict interpretation of novelty. And, I believe, a fair one.
It's not sexy, but the guts of the decision came down to something called crystalline polymorphism--a fairly common phenomenon with solid chemicals.
Without putting you into a coma, polymorphism means that certain solids can form different types (shapes) of crystals, depending on how they are purified. Sometimes, even though the chemical/drug is by definition compositionally identical, the different crystal forms can have different properties--especially with regard to the solubility of the drug, which can affect its biological properties.
Novartis was trying to patent a different crystal form of Gleevec by arguing that it would provide an advantage over the original form, and thus, novelty--the basic requirement for a new patent. But the court wasn't buying it, and neither do I.
Novartis was clearly seeking patent protection in India, which would allow them to exclusively sell the drug. But in terms of actual innovation, what they were offering is near the bottom of the barrel. Indeed, the Indian court found that the difference between the first and second crystalline forms of the drug was too small to permit the patenting of the "new" crystalline form.
I agree completely. Although there are cases where switching to different crystal forms of a drug can create differences in blood levels of the drug, I believe that it is a stretch for a company to be granted a new patent based solely on this. Others may disagree, since novelty and innovation are to some degree subjective.
In the end, this case had little to do with the disbanding of international patent law, theft of legitimate patents by rogue countries or the responsibility of drug companies to provide medicines for poor countries.
Contrary to all the hype and headlines, the court's decision was based solely on pharmaceutical science and the interpretation of patent law. In considering whether to grant a patent for a slightly modified Gleevec they needed to decide whether to treat it like a new drug, or an obvious modification to extend patent life?
The court chose the strictest interpretation of novelty and innovation. I believe they were dead on.