The Hindu Business Line : `Sequential' opposition delaying drug patents

Worrisome delays
Multiple pre-grant oppositions are being filed sequentially by different competitors for the same patent application leading to a delay in issuing a decision thereby delaying the grant of a patent.
A patent gives a company a monopoly to make and sell the drug. Delays are worrisome as they eat into the patent term that starts from the date of application.

Mumbai , April 2

Is there a sub-plot being played out at the Indian Patent Office, with drug companies taking turns to oppose patent-applications, in an attempt to delay a decision on the grant of a patent?

Well, big-gun multinational drug companies such as Pfizer, Eli Lilly, Novartis, GlaxoSmithKline and Wyeth certainly think so. And they have raised the issue with authorities at the Centre, under the umbrella of the Organisation of Pharmaceutical Producers of India (OPPI).

The OPPI's President, Mr Ranjit Shahani, confirmed to Business Line that there was concern on whether "a handful of companies acting in concert can indefinitely delay the (grant of a) patent". The proceedings need to be time-bound to truly protect intellectual property rights, he said.

Delaying grant

Multiple pre-grant oppositions are being filed sequentially by different competitors for the same patent application leading to a delay in issuing a decision thereby delaying the grant of a patent, observes a patent attorney familiar with the issue.

Pre-grant opposition allows people to oppose patent applications filed by a company. A decision on the patent is given after the Patent Controller's office hears arguments from different stakeholders. Recently, the Patent Office in Chennai had rejected Novartis' patent on cancer drug Glivec.

Across the country, over 100 pre-grants have been filed, about 45 in Delhi alone. A patent gives a company a monopoly to make and sell the drug. Delays are worrisome as they eat into the patent term that starts from the date of application.

"In one case, after the first set of pre-grant opposition proceedings ended and the order of the Controller was awaited, another competitor and the competitor who initiated the first opposition proceedings filed fresh pre-grant applications on the same grounds leading to continuous and cyclical pre-grant opposition proceedings against the same patent applicant," she observed.

Eli Lilly, for instance, faced sequential opposition to its patent application on erectile dysfunction drug Tadalafil. Pre-grant oppositions from Ranbaxy and Ajanta Pharma came on the heels of one another, allege an official with an MNC drug company.

No evidence

But patent attorneys filing pre-grant oppositions don't buy the argument of their counterparts from across the patent divide. There is no evidence to establish sequential pre-grants. Besides, there is a three-month cut-off for pre-grant opposition. In the case of Glivec, the Patent Controller rejected Novartis' patent application in an order satisfying different pre-grants, he said.

But Ms Krishna Sarma, patent attorney with the Corporate Law Group, observed that pre-grant opposition could be filed after publication till anytime before the grant of patent.

There is a "half-hearted" provision in the law to limit the timeline to three months from the date of publication. But, the second part of the rule renders this mandate superfluous as it adds that opposition can be filed till before the grant of patent, which ever is later, she says.