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It’s a relief for the HIV-infected

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Deccan Herald » Edit Page » Detailed Story
IN PERSPECTIVE
By Gopal Dabade
Deccan Herald

If patents are granted to a company, the price of the drug would be beyond the reach of the masses.

Just a few days back several groups of individuals, known popularly by their acronyms as INP+ and PWN, which stand for Indian Network of People Living with HIV/AIDS and the Positive Women’s Network, working and campaigning for the rights of those having HIV/AIDS (most of them need medicines just for their just survival) celebrated it. Not many know and appreciate this victory. It was because Boehringer Ingelheim, the Germany based giant — a profit making drug manufacturing company — had its patent application rejected by the Indian Patent Office at Delhi, for a drug by name Nevirapine.

Boehringer Ingelheim is one of the world’s 20 leading pharmaceutical companies operating globally in 47 countries. In 2007, the company posted net sales of 10.9 billion euro, thus proving to be among the most profitable and also a powerful drug company in the world.

The drug nevirapine sold by the company under the trade name Viramune is used by AIDS patients. It is specially useful when the pregnant mother is HIV positive, as it needs to be either administered to her just before the baby is born or given to the baby soon after birth as it prevents the new born getting HIV.

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Novartis may suffer jolt in Glivec case

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Financial Express, June 20, 2007
The Intellectual Property Appellate Board (IPAB), which has been formed to give a verdict on various patent cases across the country, may reject Novartis objection on the presence of S Chandrasekharan, the former patent controller, on IPAB.

Novartis had objected to Chandrasekharans presence on the board saying he was responsible for Glivec being denied product patent in 2006, when he was the controller general of patents.Experts close to the development say that IPAB will consider the fact that Chandrasekharan was actually not responsible for the decision on Glivecs patent application. IPAB will consider Novartis objection on July 2. Continue reading →

If Novartis wins, other MNCs would also claim patents for well-known medicines

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The case filed by the big pharmaceutical company Novartis has attracted global attention. “Doctors Without Borders” winner of the Nobel Prize for best medical relief in 1999, has requested people all over the world to write to the company to drop the case. Over two lakh people have written to Novartis. Why is this case so important?

Novartis, the Swiss Multinational pharmaceutical company, has filed a case in the Chennai High Court against the order of the Chennai Patent office rejecting the patent application filed by them for getting a patent on imatinib mesylate, a medicine useful in the treatment of chronic myeloid leukemia (CML) – a form of blood cancer. Currently it is being produced in its generic form by NATCO, Cipla, Ranbaxy and Hetero as well as by Novartis under the brand name Gleevec. Treatment with Gleevec, the Novartis brand costs Rs 1.2 lakh per month, whereas the Indian generic versions cost about Rs 8000 ($175)! If product patent is granted to Novartis, the Indian generic versions will be forced to go out of the market, while the treatment of the CML would cost Rupees 1.2 lakh per month and this would go out of the reach of 99 per cent of the patients of CML. There is no explanation as to why Novartis is not offering different prices depending on the circumstances in a country like India. Continue reading →

Solheim urges Novartis not to challenge Indian Patent Act

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THE HINDU, May 01, 2007
Norwegian Minister of International Development Erik Solheim has urged Novartis to withdraw its case against India, challenging a clause of the Indian Patent (Amendment) Act, which does not grant patents to medicines that are new forms of an existing drug or “ever-greened” rather than innovations.
Last year, Doctors Without Borders (Mdecins Sans Frontires or MSF) had made a similar appeal to the Swiss company as its legal challenge could restrict access to affordable medicines in the developing world. HIV/AIDS advocacy groups and the pharma company’s shareholders have also called on the company to withdraw the case filed before the Madras High Court.

Brief background of the Gleevec case

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In 1997, Novartis AG filed a patent application in the Chennai ( Madras) Patent Controller’s office for the beta-crystalline of Imatinib Mesylate, brand name Glivec (Gleevec) on the ground that they invented the beta crystalline salt form (imatinib mesylate) of the free base, imatinib. In 2003, it was granted Exclusive Marketing Rights (EMR) for marketing Gleevec in the Indian market. On the basis of the EMR, Novartis AG obtained orders preventing some of the generic manufacturers from generic equivalents of Gleevec.

Novartis was selling Gleevec at USD 2666 per patient per year. Generic companies were selling their generic versions at USD 177 to 266 per patient per month.In 2005, the CPAA and the other generic companies filed a pre-grant opposition against Novartis’ patent application for imatinib mesylate, claiming, among other things, that Novartis’ alleged “invention” lacked novelty, was obvious to a person skilled in the art, and that it was merely a “new form” of a “known substance” that did not enhance the substance’s efficacy, and was thus not patentable under section 3(d) of the Patents Act. These arguments were based on the fact that Novartis had already been granted a patent in 1993 for the active molecule, imatinib, and that the present application only concerned a specific crystalline form of the salt form of that compound.The CPAA and the generic companies contended that the 1993 patent effectively disclosed both the free base, imatinib, and the acid-addition salt, imatinib mesylate. Further, the CPAA and generic companies argued that different crystalline forms of imatinib mesylate did not differ in properties with respect to efficacy, and thus the various forms of imatinib mesylate must be considered the “same substance” under section 3(d) of the Patents Act.

In January 2006, the Patent Controller in Chennai, in a landmark decision, refused to grant Novartis a patent, agreeing with the contentions of the CPAA and generic companies that the subject application lacked novelty, was obvious, and was unpatentable under section 3(d) of the Act.The patent rejection meant that generic companies could manufacture and market their drug, both in India and abroad, who make available the generic imatinib mesylate priced at less than one-tenth the price that Novartis was charging (USD 166 to 266 instead of 2666 per person per month).