NOVARTIS CASE - IT'S THE FINAL COUNTDOWN
By RumaDubey
In India, the only thing which does not cost the earth and moon is probably medicines. With the Govt having a tight control on the pricing of drugs, thankfully this is one thing the aamaadmi can still afford to buy when plagued by other soaring costs.
Currently a legal storm is brewing in the Indian pharma sector and in the eye of the storm is Novartis and if it wins the case it will mean two things – medicines will get costlier and companies will file for patents on frivolous grounds, making very minor changes in existing drugs and thereby establish or expand its monopolyon a drug. This will mean, companies will sell existing ‘me-too’ products with some minor changes, which in no way would change or improve the efficiency, as new drugs and because it is patented, it will get Exclusive Marketing Rights (EMR). The final judgment will decide how pharma MNCs conduct business in India; it would not be a big financial loss for Novartis but it would send the strong message across the world that getting patents for drugs in India is not easy. Other companies fighting for such similar patenting, like Gilead Sciences HIV/AIDS medicine Viread and Roche Holding’s cancer drug Tarceva (lost against Cipla in Delhi HC), will also know which side the wind blows in India.
In USA, drugs are patented even when a minor or meaningless change is made and this makes drugs costly but it would be surprising to know that in India, every patent is very closely examined and the objective is to ensure that such patenting of ‘me-too’ drugs does not happen thus managing to keep costs for patients low.
A quick understanding of what exactly what the Novartis case is all about:
1997: Novartis AG, filed a patent application in the Chennai (Madras) Patent Controller’s office for the beta-crystalline of imatinibmesylate, brand name Glivec(Gleevec) on the ground that it invented the beta crystalline salt form (imatinibmesylate) of the free base, imatinib. The drug is used to treat a rare type of cancer and stomach tumours.
2003: Novartis obtained EMR for marketing Gleevec for 5 years in India due to which others like Cipla, Ranbaxy and Sun Pharma were prevented from manufacturing and selling generic versions of the medicine. Due to the monopoly, the price of the drug soared from Rs.10,000 for a month’s requirement to about Rs 1.2 lakh.
2005: India amended its patent law to comply with its obligations under the TRIPS Agreement to provide process and product patent protection in all fields of technology, including pharmaceuticals and agrochemicals.
2005: Post amendment to the Patent law, Cancer Patients Aid Association (CPAA) and other generic companies filed pre-grant oppositions against Novartis’ patent application, stating that it was just a alteration of the existing drug, which neither sufficed the novelty criterion of the Patent Act nor did it improve efficacy.
Jan 2006: Patent Controller in Chennai, in a landmark decision, refused to grant Novartis a patent. This meant other generic manufacturers could now make and market generic version of the drug in India and abroad. It was sold at a price less than one tenth of what Novartis was selling.
June 2006: Novartis AG and its Indian subsidiary, Novartis India, filed a series of writ petitions in the Madras High Court against the Government of India, CPAA, and four Indian generic manufacturers - Natco, Cipla, Hetero and Ranbaxy.
April 2007: The Govt notified the Intellectual Property Appellate Board (IPAB), the country’s judiciary tribunal that handles intellectual property related disputes and the Novartis matter was transferred to IPAB.
August 2007: The Madras High Court issued its decision rejecting Novartis’ writ petitions challenging the validity of section 3(d). Novartis AG did not challenge the judgment of the Madras High Court but commenced litigation against the IPAB.
June 2009: IPAB rejected Novartis’ appeal and refused to grant it a patent, consequent to which Novartis approached the Supreme Court directly by filing a petition challenging the IPAB’s interpretation and application of section 3(d).
Aug 2011: Supreme Court commenced final hearing and judgment is now awaited.