“Rather, a successful patent strategy will be one that works within the framework of an increasingly politicised patent regime to yield results that help generate more goodwill for the pharmaceutical company,” explains Mr Bashee r, in an email interaction with Business Line. He is Frank H. Marks Visiting Associate Professor in Law in George Washington University Law School, Washington DC, US.

Excerpts from the interview:

Patents may be the lifeline of pharmaceuticals but courts at times have to step in to protect the rights of the patients. Your comments on the recent Madras High Court ruling.

Recently, in a legal dispute involving the patentability of Novartis’s anticancer drug, Gleevec, the Madras High Court ruled that Section 3(d) of the Indian Patents Act was constitutional.

The court also ruled that it did not have jurisdiction to adjudicate on the TRIPS (Trade Related Intellectual Property Rights) challenge by Novartis. Having just signed a bilateral IP treaty with India, the Swiss Government said it was not interested in taking the Novartis case to the WTO (World Trade Organisation).

To this extent, Novartis lost the battle. But will it win the war? The IPAB (Intellectual Property Appellate Board) is still to decide whether Gleevec is “patentable”.

Novartis is clearly upset with the Madras High Court judgment and now threatens to move its investments to China — a country that seems to have 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 fell significantly short of TRIPS standards.

Where does India stand in recognising IP protocols? Your comments on Novartis strategy.

Novartis ought to know that the Indian Government is too sophisticated to succumb to this bullying. Gone are the days when a bureaucrat in charge of “fisheries” one day would be negotiating WTO agreements the next. We now have a fine cadre of officers who specialise in IP issues and whose sophisticated voices have become a force to reckon with in international IP law making, particularly WIPO (World Intellectual Property Organisation).

Taking on a Government that is slated to become a leading economic superpower and challenging its pro-public health legislation is poor strategy. Particularly so, when one is pitted against powerful public health activists who have strategically positioned the debate to hinge more on “morality” and less on patent law “technicality”.

Novartis’s myopia is compounded by a recent McKinsey report that predicts that the Indian pharmaceutical market will treble to $20 billion in the next 10 years. Quite clearly, by moving away to China, Novartis will lose out on some of this pie.

Is there any other firm which showed a better strategic move than Novartis?

Compare and contrast Novartis’s aggressive but weak patent strategy with that of Roche, which has acquired 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 strategy has been to play it quiet, increasing the chances of its patent applications being decided more objectively. Novartis has only exacerbated the politically-sensitive dispute. Given that most adjudicators are not hermetically sealed from society, it is likely that a steady stream of anti-Novartis headlines in 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 public relations policy that appreciates the “politics” of patents and helps generate goodwill is likely to prove more fruitful.

So you say that Novartis erred in its strategy?

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, seems to have been poorly drafted. Probably in the run-up to the legislation, speed got greater weight than the precise contours of the section that may not have been given careful thought.

Amending Section 3(d) by an Act of Parliament to iron out drafting errors or inconsistencies may not be politically feasible. But some of the vagueness can be cured through 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:

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?

What amounts to a “significant difference in property with regard to efficacy”? Will a 30 per cent increase in bio-availability do or does it have to be much more?

What is the most desired least damaging outcome from the imbroglio?

Since 2003, the Gleevec patent dispute has gobbled time, energy and resources. Indeed, in the Madras High Court alone, it near monopolised the attention of two judges, nine parties, 15 counsels and several law firms, not to mention the several hundred commentators who rushed in to air their views. It will be a pity if all this attention comes to naught. One hopes it would lead to greater clarity on what “efficacy” means.

D. MURALI

GOUTAM GHOSH

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