Indian generic pharma companies delay patent protection by pre grant opposition proceedings.

The Economic Times (India) has reported that Since India’s commitment to the World Trade Organisation’s intellectual property regime in January ’05, domestic pharma companies have filed nearly 150 pre-grant oppositions to patent applications in India.

Torrent Pharma, has opposed the grant of a patent relating to Rosuvastatin a cholesterol drug developed by Astra Zeneca, while Ranbaxy has filed a pre-grant opposition against Pfizer’s anti-fungal drug Voriconazole.

Ajanta Pharma has opposed Eli Lilly’s patent application on erectile dysfunction drug Tadalafil, and Cipla and Hetero have opposed Wockhardt’s patent application on anti-bacterial drug Nadifloxacin.
India’s new patent regime allows anyone to oppose a patent application by bringing to the patent examiner’s notice, information which would show that the patent is deficient.

Pre-grant oppositions are designed to give interested parties such as domestic pharma companies a chance to provide the patent examiner with information he may otherwise be unaware of. After hearing the patent holder and the opposition, the Indian patent office eventually grants or rejects the drug firm’s application for a patent.

It has been alleged that Indian pharma companies are indefinitely delaying the granting of patents, witohut sufficient grounds.

We note that a similar opposition procedure exists in Israel and has been used to delay / prevent drugs getting protection locally, which has enabled Israeli drug manufacturers to develop and manufacture generic versions.

Due to the relative population sizes, the Israel scene is somewhat different from the Indian, in that Israeli generic drug manufacturers are primarily interested in the International market.

Similar opposition procedures are available in the UK and New Zealand.
 

Leave a comment