Generic particulars

From January 2005, a new law was to have brought India into compliance with the WTO on how pharmaceutical products were to be patented. Earlier, patent protection was offered on the process; now the product itself was sought to be protected by patent. This meant that a drug could no longer be reverse engineered and marketed. However, as a case that came in for an interim order in the Delhi high court on Wednesday shows, the new patent regime still has many grey zones which need to be addressed before the public policy implications can be adequately assessed. The court refused to stay drug-maker Cipla from manufacturing and selling a lung cancer formulation which the Swiss company, Roche, says is being done in violation of its patent. The case comes in for hearing again in August. Positions have predictably been taken by activists and pharma players, but the issues raised go beyond the specifics of the Cipla/Roche case.

Roche had in January filed a patent infringement plea, saying that Cipla was selling a generic version of its drug, Tarceva, on which it has been granted a patent. The issues raised in this case are certain to come up again in different contexts. First, how valid for patent protection is incremental innovation? This refers to the fear that drug manufacturers could keep their products on patent by merely making insubstantial moderations to a generic product, that is, by evergreening. The fear is valid 8212; but taken too far, could it not thwart companies from putting resources into R038;D to substantially enhance or modify an existing drug? After all, technological advancement is mostly incremental.

Second, how does one reconcile public health consequences with the price of a drug? By way of example, Roche is marketing Tarceva at Rs 4800 for a once-a-day dose; Cipla has put its 8216;copycat8217; drug on the market for Rs 1600. The argument generally is that life-saving drugs should be as affordable as possible. But if companies do not see ways of recovering their cost of research, it is arguable whether they would put in enough resources to innovate. In any case, governments have the option of compulsory licensing 8212; that is, suspending the patent holder8217;s rights in the public interest. Either way, the Cipla case could set some precedents.