Gleevec- The Indian Court Nails it.
| 7 Comments |

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.

7 Comments

Thank you for a great article clarifying this subject. Something like this was what I guessed from reading and hearing the story but, as you point out, it was obscured and obfuscated by the misreporting and unwarrented commentary.

Nigel, thanks very much.

How about a different approach? If this new formulation isn't that novel, just grant the patent and let the market sort it out. Novartis will have a hard time selling a high-priced Gleevec, even with the patent, in a market with a low-priced unpatented Gleevec. If the new formulation of Gleevec is substantially better, then Novartis should have an easier time selling the "new, improved" Gleevec. Physicians, patients, pharmacists, and payers can decide whether the new, improved version is worth the extra cost.

Patents are a necessary, but not sufficient, condition for market success. For market success, the medicine will still need to be better than established medicines. By denying Novartis' patent, the Indian court denied Novartis a chance to show whether the new Gleevec was really better.

Sorry Josh. This case was not about the patent requirement of novelty. This case involved India's Section 3(d) which involves an exclusion from patentability pharmaceutical patent claims which do not "result in the enhancement of the known efficacy." The Supreme Court's job was not to analyze novelty but whether the application satisfied 3(d). Novelty is a separate requirement under Indian patent law and the India Intellectual Property Appellate Board actually found that the novelty and non-obviousness requirements were satisfied in this case.

Second, this patent is valid in 40 other countries including China, Russia, and a Taiwan. This patent application was approved by examiners with extensive patent and pharmaceutical science training. The conclusion of these experts represent a broad objective consensus that this patent application was novel and inventive. I respect your opinion of the novelty of this drug but I think it is unwise to completely disregard the collective opinion of many trained professionals from a variety of developed and developing countries with only a cursory analysis.

Finally, it is impossible to "make an obvious modification to extend patent life." Any generic company can produce and market the earlier version of the branded drug when the original patent expires regardless of the patent on the modified drug. If the brand company ‘tweaks’ the drug and files for a new patent on the modified drug, the generic company only infringes the new patent if they produce the ‘tweaked’ drug (which is exactly what the generic company wants to do because the old drug is not as effective). If this was truly a meaningless modification/invention then the generics would just make the old drug and there would be no controversy here.

For more on the Evergreening myth see http://www.biotech-now.org/public-policy/patently-biotech/2012/03/patent-ever-greening-novartis-confronts-patent-myth-in-india#

Thanks for the response and for being one of the few common sense articles out there on this topic. And yes, sorry, as an IP attorney, I think it is important for people to understand that novelty, utility, and section 3d are separate and distinct concepts which I realize is more of a pet peeve of mine.

However, I am not so sure that this is a science based decision. The first half of a 112 page decision reviews the policy and political history of the patents act and how that enabled the growth of the generic industry and access to poor people of affordable medicines. Not only is this section debatable and completely unnecessary to evaluate the legal claims at issue, but there are several statements that makes the decision vulnerable to the suspicion that any discussion of science is a mere smoke screen for industrial policy and access to medicines concerns.

Further, when they did get to the science, they ignore the scientific determinations of those of the lower courts and examiners around the world which have much more scientific and patent training then they do. Yes, you and I can debate the science but do we really want the Supreme Court of India (or our Supreme Court for that matter) making science-based determinations with no deference to those who do have the training when the last time they had a biology class was probably in the 60s? Are they the right people to make a determination based on prior art and how difficult it is to go from one step to the other.

What is particularly odd in this case is that the original molecule Gleevec is based a drug that could not be administered to patients at all. It was only after the mesylate salt and beta crystal forms were developed that a patient could be treated in consistent, safe and effective levels of the medicine.

Finally, not to get too far off topic but since you raised the issue, if Nexium is a worthless invention, then how is Nexium ranked second in sales of all U.S. pharmaceuticals? Did Astra Zeneca trick doctors, insurance companies, and patients into thinking that Nexium was better than Prilosec? Hasn't the market proven that there is a patient population that cannot be treated effectively with the older medicines? The more plausible explanation of Nexium's success is that it IS a valuable invention that insurance companies, doctors, and patients want and, therefore, deserving of patent protection as the drug has cleared other scientific and legal hurdles of novelty, obviousness, etc. It is important to remember that there are multiple hurdles to patentability in every jurisdiction which are designed to take care of truly "questionable practices" that scientists, like yourself, worry about.



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