Latha Jishnu: Is the balance in favour of public interest?

PATENTLY ABSURD

Justice S Ravinder Bhat of the Delhi High Court is a hero to some. His decision last month to allow generic drug manufacturer Cipla to continue manufacturing its version of Roche's patented lung cancer drug erlotinib (sold as Tarceva in India) has made him the toast of public health activists worldwide. Don't forget that this is the first case where a company in India, hub of generic manufacture, has brazenly broken a patent "" a patent that was granted in July 2007 "" and where the judge has refused to grant a temporary injunction against the company till a final verdict is given.

Why is this temporary respite cause for cheer? For the highly vocal lobby which believes that generic companies should be allowed to make cheaper versions of the prohibitively expensive life-saving drugs developed by global pharma giants, Justice Bhat's order is significant. For several reasons. For one, the judge has given primacy to 'public interest' as in the patient's access to life-saving drugs. For another, he has said that courts should follow the rule of caution and not always presume that patents are valid. As he emphasised, "In several judgments in India, including judgments of this court, it has been consistently held that where the patent is of recent origin and its validity has not been tested, the courts should not grant injunctions where infringement is alleged."

There are other observations by Justice Bhat that have made his March 19 judgement a talking point. Little wonder that the global pharma industry and patents experts worldwide are going through his 35-page interim order with a fine-tooth comb to understand how the country's product patent regime is being interpreted by Indian courts. Will public interest prevail over patent rights? Will the right to 'affordable' generic copies of life-saving medication determine the outcome of patent battles in India? After all, public interest did figure in the headline-grabbing case two years ago involving Novartis's blood cancer drug Gleevec, and Justice Bhat invoked this in his judgement.

Pharma giants might find this a bitter pill to swallow but it must be said that Justice Bhat's decision has international precedents. His order has cited landmark American (eBay versus Merck Exchange) and British (American Cyanamid Co Versus Ethicon) cases to flesh out his argument. In the eBay case, the US Supreme Court had held that injunctions are necessary only if the plaintiff can prove that he has suffered an irreparable injury and that monetary compensation is inadequate for the damage suffered. This apart, there are two other questions that need to be considered "" the balance of convenience between the defendant and the plaintiff and the question of 'public interest'.

Thus, while cautioning Cipla to maintain scrupulous records on the manufacture of the disputed drug (quantity, sales, and so on), the judge observed: "...this Court is of the opinion that as between the two competing public interests, that is, the public interest in granting an injunction to affirm a patent during the pendency of an infringement action, as opposed to the public interest in access for the people to a life saving drug, the balance has to be tilted in favour of the latter. The damage or injury that would occur to the plaintiff in such a case is capable of assessment in monetary terms. However, the injury to the public which would be deprived of the defendant's product, which may lead to shortening of lives of several unknown persons, who are not parties to the suit, and which damage cannot be restituted in monetary terms..."

The interesting point here, as the court noted, is that no one has a clue as to how many small cell lung cancer patients there are in India. Figures can only be interpolated from broad estimates given by the National Cancer Registry Report that every hour, 50 persons are diagnosed with cancer in the country and that almost a quarter of these cases are to do with the lung. Roche says in an affidavit that since 2006, its sales of Tarceva have touched Rs 13.2 crore. Now, if each capsule costs Rs 4,800 and a full course of treatment (two months) costs Rs 2.56 lakh, how many patients would have bought the drug? Cipla is selling Erlocip at Rs 1,600 a capsule and perhaps when its records are made public, we will have some idea of how great the demand is. Or it might tell us how much more affordable the generic drug is.

Meanwhile, there are other some typically Indian reasons why the Roche-Cipla courtroom battle is proving riveting. As with the notorious Enron case, this confrontation, too, is rife with political ironies as two stalwart figures from rival parties fight it out in court. There's Abhishek Manu Singhvi, spokesman for the Congress, appearing on behalf of the Swiss multinational, while Arun Jaitley, a leading light of the BJP, is defending Cipla. It was the Congress which added Section 3 (d) to the Indian Patent Act in 2005 which made the terms of patentability more stringent compared to the draft law introduced by the BJP in 2003. Jaitley, interestingly, was citing the very same section to argue that the patent should not have been granted to Roche in the first place.