Last month, the Government came out batting on the front foot, defending the implementation of the amended Patents Act.

Nothing unusual there, as Governments are expected to defend their laws. What was out of character though, was that the Government was responding to developments involving individual multinational drug companies — Roche and Novartis.

Two official responses in a month are an unusual occurrence, say legal experts, adding that the battle over medicines and patents are actively being fought beyond the courts. There is increased back-room activity — to educate, change or rally public perception and support — they point out.

Take for instance, the recent patent battle between Bristol-Myers Squibb and BDR Pharmaceuticals. There are different versions on whether or not BDR’s application seeking a compulsory licence (CL) on the former’s blood cancer drug dasatinib has been rejected. A CL would allow BDR to make its less expensive version of the drug on the payment of royalty to Bristol-Myers. The two companies also fight a separate case at the Delhi High Court and a hearing is scheduled for Monday.

High stakes

A source familiar with the development points out that different versions on such issues arise as the stakes are high for drug companies.

Governments like to be seen as protecting the health of its people, which is why the Government was seen stepping up its offensive recently. The action comes in the wake of increased and high-profile lobbying in some global quarters against the implementation of India’s patent regime, observes a lawyer.

In the first week of August, the Kolkata Patent office rebutted Roche’s claim on its divisional patents on advanced breast cancer drug Herceptin. The divisional patents had not been “revoked” but were treated as withdrawn or abandoned, as the multinational had not adhered to procedural timelines, the Patent office said. 

Later that month, reports quote Commerce Secretary S.R. Rao defending the country’s patent regime, while responding to Novartis CEO Joseph Jimenez, on India’s “deteriorating” environment for the protection of intellectual property (IP).

“Multinational pharmaceutical companies such as Novartis have been major beneficiaries of India’s patent regime, which is evident in the fact that Novartis has 147 patents registered in its name in India,” Rao was quoted as saying.

Earlier in April, the Supreme Court had dismissed Novartis’ plea for patent protection on its blood cancer drug Glivec.

Under fire

Ever since India amended its Patents Act in 2005, it has attracted intense debate, says an IP expert. The Act allows innovations to be patented, thereby getting a 20-year exclusivity to manufacture and distribute the product.

But pro-health groups seek greater scrutiny of patent applications to prevent frivolous ones from getting through. Their concern is that a monopoly on medicines could result in medicines getting priced beyond the reach of the public.

The implementation of the Act has been criticised by US-based industry associations and sections of its Congress-men. And the decibel level around the Act increases, as India explores the option of issuing CLs on more drugs, in the interest of public health, the IP expert observes.

India issued its first CL to Natco allowing it to make its less expensive version of Bayer’s advanced kidney cancer drug Nexavar, on the payment of a revised royalty of 7 per cent.

“Not discriminatory”

The same issue, surfaces in an on-going exchange between the Indian Pharmaceutical Alliance and Pfizer’s Chief IP counsel. In its letter last month, the IPA said, it would have made no difference to the outcome of several patent litigations in India, even if the patentee was an Indian company. Besides, over 1,500 patents for medicinal products had been granted since 2005 to nine foreign companies. About a dozen of these had been challenged in India and one CL was granted, the IPA said, illustrating that the IP environment had not degenerated over the year. The IPA’s exchange was in response to a submission made by the Pfizer executive to a US trade sub-committee.