Early Shift To New Regime To Open 2,500 Patent Cases
Over 2,500 product patent applications in the agricultural chemicals and the pharmaceutical sectors will have to be opened and examined, and patents granted wherever the case merits, in case India decides to adopt the product patents regime earlier than 2005, the deadline set by the World Trade Organisation (WTO).
Revealing this, officials said there are differences of opinion on the issue. While a section favours amendments legislating a mailbox provision and grant of exclusive marketing rights, another section prefers the introduction of product patents earlier than 2005, the year in which the 10-year transition period ends.
The Indian Drug Manufacturers Association and the industry ministry are against advancing the deadline for the introduction of product patents, as this would remove the built-in cushion provided by the WTO agreements. They stressed that Indian companies need this transition time. However, commerce ministry officials claimed that an earlier shift to product patents would result in several advantages for Indian firms.
They argued that a patent law that recognises product patents in the drugs and agro-chemicals sector will enable India to issue compulsory licenses for essential drugs. Further, it will allow the government to introduce zero duty imports for several drugs, so that their prices can be prevented from soaring. They claimed that manufacturers would have to price drugs such that the market could absorb them. They cannot be made unrealistically high as the final intention is to sell, the officials pointed out. Besides, the officials added, many drugs and pharmaceuticals that would become too expensive would be locally available.
They pointed out that several drugs and treatments are, at present, simply not available in the country as their manufacturers fear copying by local producers since Indian law recognises only process patents and not product patents in these areas.
However, those in favour of amendments allowing only exclusive marketing rights argued that this is the better option as no application for exclusive marketing rights has been filed by foreign companies. Besides, they added, India has already notified the WTO that it will avail of the full transition period and should stick to its earlier stand.
Also, EMRs are to be granted only if the applicant has filed the patent application in another WTO member country after January 1, 1995, has got it and has received marketing approval both in that country and in India.
"By the time this happens and the company is eligible for an EMR in India, it will be at least 5-7 years and we will be close to moving over to product patents", explained an official.
There is, therefore, nothing to be lost from allowing EMRs. On the contrary, if the pending product patent applications have to be opened and examined, at least some out of the 2500-odd applications will have to be granted.