Judgment on one of the most closely watched legal battles in the pharmaceutical industry is expected to be announced by the Supreme Court on April 1, 2013. At the root of the dispute is Novartis’ drug Glivec, which combats a rare type of cancer and stomach tumours.
In November 2003, Novartis was granted exclusive marketing right (EMR) to sell the drug for five years. Indian companies argued Glivec was merely an alteration of an old drug and, therefore, did not satisfy the novelty criterion under the Patents Act, nor did it introduce any improvement in the efficacy of the drug.
After losing two challenges in the Madras High Court, Novartis approached the Supreme Court, challenging a technicality of section 3(d) of the Patents Act.
Following are the five reasons why the judgment is closely watched worldwide
- If Novartis wins the case, patents in India would be granted as broadly as they are in wealthy countries, and on new formulations of known medicines already in use.
- Novartis had launched Glivec with a price tag of Rs 1.2 lakh for one month’s dosage. After Indian generic companies were allowed to sell the product they brought the price down to Rs 10,000 per month. Prices might shoot up again if Novartis wins.
- India’s status of being the ‘pharmacy of the world’ would also be impacted by the judgment, as domestic companies have played an important role in providing cheap life-saving drugs to under-developed and developing countries across the world.
- Several patent oppositions filed by public interest groups in India cite Section 3d as an argument to reject patent application on key medicines. A judgment in favour of Novartis will open all previous issues
- If the substance is taken out of Section 3(d), abusive ‘evergreening’ practices - where drug companies maintain artificially high prices on medicines for longer by ever-extending patent protection thanks to minor modifications to existing drugs – will be much easier in the future.
No doubt big pharma have a lot to lose, which explains their persistent effort in trying to achieve a breakthrough legally if not through their research and developments.