Even as the jurisprudence on the patent regime is still evolving in the country, the Prime Minister?s Office (PMO) has intervened in the matter in a manner that could significantly impact and even alter the future course of policy making in the area of intellectual property rights. The PMO is currently in the process of forming its view on many critical patent issues and has asked the department of pharma to spearhead the exercise even though department of industrial policy and promotion (DIPP) is the nodal agency concerned with the legislation related to patents.
According to sources, PMO?s interest in the patent territory follows a high powered meeting with heads of many pharmaceutical multinational companies. Representatives of pharma MNCs are learnt to have urged the government to build judicial capacities to protect intellectual property rights in the country.
The pharma MNCs have submitted before the PMO that legislation in the country should be aligned in a manner that rights granted under one statute should not be defeated under the other.
The MNCs have been advocating ?patent linkage? in the country which implies linking the status of patent grant in case of a drug to the marketing approval given by the drug regulator. However, domestic industry and public health activists have opposed such a move vehemently arguing that it would lead to increase in drug prices in the country by delaying the entry of low cost generic version of the drugs.
Early this year, the Delhi High Court also dismissed an appeal of multinational drug-maker Bayer Corporation which had sought patent linkage in the country by arguing that the Drug Controller General of India (DCGI) should not give marketing approval to Cipla?s generic version of the former?s renal cancer drug Nexavar. In its judgment, the court had said the scheme of both the Patents Act and the Drugs and Cosmetics Act (DCA) are ?distinct and separate? and that the attempt by Bayer to establish a linkage cannot be ?countenanced?. However the court had further said, ?Whether patent linkage should be introduced is an issue that requires a policy decision to be taken by the government. It is not for the court to determine if the Government should bring in a system of patent linkage.?
Bayer?s initial writ petition, filed in November 2008 had been dismissed in August 2009 by the Delhi High Court. Following that Bayer filed an appeal before a division bench of the court which upheld the single-judge verdict.
The MNCs have also told the PMO officials that the government should step in to clearly define ?efficacy criteria? and review the scope of section 3(d) of Indian Patent Act that deals with incremental innovation.
Additionally, the pharma MNCs have said, ?Any revocation application filed subsequent to a suit for infringement shouldn?t get tagged with the injunction application or affect its merits. The ?balance of convenience? for a granted patent right should not be affected by the price consideration.?
Domestic pharma experts point out that Swiss drug maker Roche, had sought an injunction from the Delhi High Court against the sale of the generic version of its anti-cancer drug Tarceva by Cipla. The high court denied the injunction on the grounds of ?public interest? because Cipla was selling the drug at one-third of the price set by Roche. Roche later appealed to the appellate bench of the Delhi High Court. The division bench, however, upheld the judgement of the trial court on the grounds of lack of prima facie evidence and imposed a fine of Rs 5 lakh on Roche. Interestingly, trial court judge Justice Ravindra Bhat had held against Roche on the ?balance of convenience? point, ruling that ?public interest? and lower pricing of Cipla?s drug tilted the ?convenience? in favour of Cipla.