EMR: Right to market or controversy?

India’s first exclusive marketing right for a pharma product, Glivec, granted to Swiss pharmaceutical giant, Novartis has made news for all the wrong reasons. Has all the hype been worth it? Apparently, no, finds out Megha Lodha

It’s been over a month since the first EMR was granted for a pharmaceutical drug in the country. But there still is confusion whether the right is valid or not. On the one hand, there are the generic companies that are adamant on challenging the grant, while on the other hand, there are opinions floating that the generics do not need to challenge but can continue with the production of their products without any trouble.

The generic manufacturers do not need to bother about challenging Novartis, feels Dr Gopakumar Nair, IPR consultant and advisor. “Technically speaking, the EMR grant does appear to be incorrect. If one reads the Patents Act, one will know that the concerns for EMR differ from those for patents.”

Stressing on these legal aspects also, is the Indian Pharmaceutical Alliance (IPA) which has written to Dr S N Maity, the Controller General of patents, designs and trademarks about the same. They have written to the controller requesting action on three grounds, the first one being the date, second being the article or substance for which the EMR was sought and lastly whether an EMR can be granted for a polymorph.

“We are concerned not about the commercial aspect, but about the policy,” said D G Shah, secretary general of IPA. Says he, “If the EMR has been granted for just a polymorph, then it goes against the provisions of law and in that case, it has been wrongly given.” To be eligible for an EMR, the substance or article has to be a new Chemical Entity (NCE) and not a modified version of an existing one.

Supporting his statement is the Indian Drug Manufacturers’ Association (IDMA). Yogin Majmudar, President of IDMA says, “ It is a question of principles. Right now, it is the validity of the EMR that is a point of contest.” Whether the EMR has been correctly granted or not is unknown yet, he said. Speaking on how this might even affect the market share of the generics, he said that it was too premature to say what will happen, as there still are chances that the generics may have to pull out their products. If that is to happen, “Will the Indian population be able to afford the drug in that case?” asks Majmudar.

Talking on the pricing, he said that the costing is another angle that the government has to look into, adding that once EMRs and patents are granted, prices of such protected drugs are anyway bound to go up.

The question is that even if one were to think that the EMR is valid, and if Novartis were to market it, how many takers would it have, considering the price factor as well as the patient incidence. There are about 15,000 people suffering from chronic myeloid leukaemia (CML) and this killer disease adds about 5000 individuals every year to its kitty. Looking at that, and then going by the fact that there are about six generics of this drug already available at a much lower price, how many would buy Glivec and why? How many would be able to afford it? Is all the attention being given to Glivec worth it, or are we making a mountain of a molehill?

What if this just turns out be a gimmick or a stunt by our very own Indian patent office. Maybe this sounds too bold, but why strike out this possibility? All these years, when 16 companies had applied for EMR, about four or five applications were rejected. It is only now, in 2003, that not one or two but three companies have been granted EMRs, all in quick succession of each other. It could be because the year 2005, when we enter the product patents regime, is just an year away.

Take a look at this: United Phosphorus was the first company to be granted an EMR for its fungicide brand, SAAF in September this year. Then came Novartis that got an EMR for Glivec, on November 10. The more recent is the one granted to Wockhardt for its drug, tropical antibacterial drug Nadoxin (Nadifloxacin), on December 16.

Don’t these successive grants raise an eyebrow? How come all of a sudden, out of the blue are all these applicants submitting the correct documents?More over even the grounds on which they seek the EMR appear to be justified. Does no one smell anything fishy here? It seems that all the hype and hoopla surrounding this issue has been mainly because of all the confusion about the rights and wrongs involved. Hopefully the government does a thorough check before it passes the Third Amendment of the Indian Patents Act, so that the next time if there is a controversy, it is because there is clarity in the issue and not confusion!

meghalodha@express2.indexp.co.in