New Delhi: When the patent law was amended to provide for product patents, the big fear was aspike in the price of medicines, especially life-saving ones.

But eight years down the line, the government has managed to use provisions available to it under World Trade Organization’s Trade-Related Aspects of Intellectual Property Rights (Trips) to ensure that drug companies do not abuse the monopoly rights vested in them through patents. To begin with, Section 3(d) was inserted to ensure that minor changes were not passed off as invention.

“At the heart of every international agreement and national laws is consumer interest, especially when it comes to medicines and food. So, you can’t put patents on a machine and on a medicine at the same level,” a government official said.

But the law was still seen to be favouring multinationals with the monthly supply of some life-saving cancer drugs adding up to Rs 1 lakh or more. That prompted local manufacturers to resort to the use of a virtually unused provision in India — known as compulsory licensing, which allows the Patent Office to waive the patent rights in favour of a cheaper drug, provided a royalty is paid to the patent holder.

The compulsory licence (CL) for Nexavar, a renal cancer drug, seemed to open the floodgates for those seeking patent waiver. Health ministry has already moved a proposal for three cancer drugs — Trastuzumab, Ixabepilone and Dasatinib — citing “extreme urgency” and “public non-commercial use”, whose fate is yet to be decided. In the meantime, little-known BGR Pharma sought a CL for Dasatanib with the Patent Office.

The rush for CLs even prompted local players such as Cipla, known for its generic acumen, to start paring prices in the domestic market.

While all this was underway, there were instances of patents on some medicines being revoked. The Intellectual Property Appellate Board revoked Roche’s patent on hepatitis C drug Pegasys, citing lack of evidence that the drug was any better than existing treatments as also the high price. Schering Corporation and Novartis’s patents on two asthma medicines and Pfizer’s patent on cancer drug Sutent were also revoked.

Separately, the government has set up an inter-ministerial group to put in place norms on negotiated price for patented medicines, a practice followed in several developed countries such as the UK, Canada and Australia. “A CL is like a death sentence, which can’t be given in every case. A negotiated price system will be in the interest of foreign companies,” said a government official privy to the developments. SC verdict a blow to MNCs Big Pharma’s Ability To Sell Blockbuster Drugs May Be Hit Rupali Mukherjee TNN

Mumbai: The Supreme Court’s decision on Monday came as a big relief to patients suffering from serious diseases like cancer, and is a huge positive for generic companies which manufacture affordable drugs. But at the same time, it deals a big blow to Novartis, and on MNCs’ ability to sell lucrative blockbuster medicines in the country.

The main beneficiaries of the Supreme Court ruling will be generic companies like Cipla, Natco Pharma and Sun Pharma which already market generic Glivec in India at a fraction of the cost of the Novartis product. The ruling cements the role of domestic companies as major suppliers of inexpensive generics not only to its Rs 70,000-crore domestic market, but also across the developing world, and further establishes India as a “the pharmacy of the world” (nearly 98% of anti-retrovirals are exported to developing countries from India).

Says Cipla chairman Dr Y K Hamied, “India can continue to produce affordable, high quality medicines without the threat of patents for minor modifications of known medicines. This judgement will not only benefit patients in India, but patients around the world. This stops evergreening and all this is good for the patients in our country and for the generic industry in general. Competition also leads to reduction in prices and therefore this judgement is of benefit to everyone. Apart from cancer, Section 3(D) applies to all drugs. Hence this judgement will benefit all therapies, which again will be good for everyone.”

D G Shah, secretary general of the Indian Pharmaceutical Alliance, said, “The judgement serves to rest the controversy that was raised regarding the scope of section 3(d) in the Patents Act, which is a crucial safeguard against the extension of patent monopolies of known drugs and the consequent delay in the availability of affordable generic versions.”

If Novartis had won the case, it would have impacted access of affordable medicines by extension of monopoly rights to new forms of known medicines, hence delaying and blocking affordable versions, for India and for millions across the world.

However, MNC industry body, Organisation of Pharmaceutical Producers of India, said the decision would only inhibit India’s own pharmaceutical industry from developing products for India, while doing little to improve accessibility of medicines for its population. “Sustainable solutions to India’s healthcare concerns should be found through programs that address the lack of healthcare financing,” it said.

Said Novartis India VC and MD Ranjit Shahani, “The current climate for intellectual property in India is uncertain, as so many pharmaceutical companies have experienced patent challenges. Besides, domestic companies need to first be a pharmacy to India rather than the world. This is a significant threat to medical advances since it seriously jeopardizes further investment in innovation.”

MNCs will turn cautious in making capital investments in the country, and may delay the launch of patented products. “Money flows only where it is welcome,” said a MNC executive.

Kewal Handa, who recently retired as MD of Pfizer India, said, “The Indian government needs to do introspection. Innovation will not flow to a place where there is no respect for patents. On the other hand, MNCs will also have to re-look at their strategies to build scale, and how to balance their portfolio more in terms of volume, rather than price.”

“What the ruling basically does is, provide a safe environment for generic companies to operate without the fear of injunctions, infringement suits, and the threat of secondary patents. The ruling will curb the practice of frivolous patents and �vergreening, and provides a better interpretation of law for patent offices who have been lax by allowing secondary patents,” said Leena Menghaney, an IPR expert and coordinator of MSF, an international NGO.