There are valuable lessons that patent professionals can learn from the Novartis (Glivec) Patent Saga. The Hindu Business Line carried an interview with me in this regard. For those interested, please click here. I also attach the note that I passed on to them below:
“Recently, in a legal dispute involving the patentability of Novartis’s famed anticancer drug, Gleevec, the Madras High Court ruled that section 3(d) of the Indian Patents Act was constitutional. It also ruled that it did not have jurisdiction to adjudicate on the TRIPS challenge by Novartis. Having just signed a bilateral IP treaty with India, the Swiss government indicated that it is not interested in taking up cudgels on behalf of Novartis before the WTO.
To this extent, Novartis lost the battle. But will it win the war? One ought not to forget that the IPAB is still to decide on whether or not Gleevec is “patentable”.
Novartis is clearly upset with the Madras High judgment and now threatens to move its investments to China—a country that paradoxically figures in every press release as having one of the worst IP records. In fact, the US recently moved forward on its WTO action against China, alleging that the Chinese IPR machinery falls significantly short of TRIPS standards.
Novartis ought to know that the Indian government is more sophisticated than falling prey to this bullying tactic and caving in to the use of the “C” word. Gone are the days when the bureaucrat in charge of “fisheries” one day would be negotiating WTO agreements the next. We now have a fine cadre of government folks that specialize in IP issues and whose sophisticated voices have become a force to reckon with in the corridors of international IP law making, particularly WIPO.
Taking on a government that is slated to become a leading economic superpower in the years to come and challenging it’s pro public health legislation is poor strategy. Particularly so, when one is pitted against powerful public health activists, that have strategically positioned the debate as one that hinges more on “morality” and less on patent law “technicality”.
The short sightedness of Novartis’ strategy is compounded by a recent McKinsey report that predicts that the Indian pharmaceutical market will treble to 20 billion dollars in the next 10 years. Quite clearly, by moving away to China, Novartis will lose out on some of this valuable pie.
Compare and contrast Novartis’ aggressive and weakly thought out patent strategy with that of Roche, which has gone on to acquire four patents already. Its patent covering pegylated interferon (Pegasus) has now been challenged in a post grant opposition, but one hardly hears of this in the press. Roche has been strategic enough to play it quiet, increasing the chances of it’s patent applications being decided in a more objective manner. Novartis has only excacerbated the politicization of this dispute—and given that most adjudicators are not hermetically sealed off from society, it is likely that a steady stream of anti Novartis headlines pouring out of leading newspapers will have their desired impact.
In short, the Novartis patent saga teaches us that pharmaceutical companies may not get very far in India by deploying aggressive bullying tactics. Rather, a sophisticated long-term strategy and a robust PR policy that appreciates the “politics” of patents and helps generate goodwill is likely to prove more fruitful.
Novartis is right to be concerned about the vagueness in section 3(d). Indeed, section 3(d), though noble in intent, and “innovative” in several respects, is very poorly drafted and leaves much to be desired. Probably in the run up to the legislation, and given the pressure of the Left Parties, speed was of essence and the precise contours of section 3(d) weren’t thought through carefully.
Amending section 3(d) by an Act of Parliament to iron out drafting errors/ inconsistencies may not be politically feasible. But some of the vagueness in this section can be cured by working out appropriate guidelines. And this is what Novartis ought to have focused on—rather than alienating itself from the government and the pubic by challenging a legislation that seeks to prevent ever-greening.
In particular, these guidelines ought to address the following issues:
1. What amounts to “efficacy”? Is it limited to therapeutic efficacy (as the Madras High Court seems to suggest), or does it include clinical efficacy and other advantages such as heat stability?
2. What amounts to a “significant difference in property with regard to efficacy”? Will a 30% increase in bio-availability do or does it have to be much more significant?
Dating back to 2003, the Gleevec patent dispute has taken up considerable time, energy and resources. Indeed, in the Chennai High Court alone—it near monopolized the attention of 2 judges, 9 parties, 15 counsels and several law firms—not to mention the several hundred commentators that rushed to air their views. It will be a pity if all this attention comes to naught—at the very least, one hopes that it generates more clarity on what the term “efficacy” means.
On a broader note, this saga offers very valuable lessons for patent strategy in India. It teaches us that pharmaceutical companies and patent lawyers representing them cannot remain obsessed with the technical nuances of patent law. Rather, a successful patent strategy will be one that works within the framework of an increasingly politicized patent regime to yield results that help generate more goodwill for the pharmaceutical company in question. In short, patent attorneys ought to think about some serious training in PR!! “