The Indian Supreme Court has made a decision to deny patent protection for the drug Glivec. Glivec is a cancer drug developed by Novartis AG. The decision may make it more difficult for other foreign drug manufacturers to apply for patent protection in India and encourages local Indian firms to manufacture cheap generics.
What is Glivec?
Glivec is a medication used to treat certain forms of leukemia, gastrointestinal cancer and some rare tumours. However, the original patented form was never suitable for tabletting.
Novartis say that they spent years developing the final chemically stable form of Glivec. They consider that it is this final stable form of Glivec that allows patients to be treated easily which is an innovative breakthrough.
The Glivec patent in India
Novartis filed for their chemically stable form of Glivec in 1997. The patent was refused in 2005 when India finally began providing patent protection for pharmaceutical drugs in accordance with its delayed obligations under the World Trade Organization’s TRIPS Agreement.
In 2005, a new section 3(d) was introduced to Indian patent law to control a practice called ‘evergreening’, by requiring ‘improved efficiency’. This section prevents the patenting of minor improvements on inventions that already exist.
The patent for the original form of Glivec has already expired. Glivec’s new form is patented in nearly 40 countries, including United States and China.
In 2009, Novartis lost an appeal on the patent at the Intellectual Property Appellate Board (IPAB) which while, agreeing that the new form of Glivec was both novel and inventive, rejected the patent under section 3(d) asserting that it did not have significantly higher efficacy.
Novartis then appealed against the IPAB decision in the Supreme Court. On April 1 2013, the Supreme Court upheld the IPAB decision.
Effect of the rejection on pharmaceutical patents and the drug market in India
India’s domestic drug market is the 14th largest in the world, but is considered a market with huge potential as India has the world’s second biggest population. The drugs market in India is considered to be worth $13 billion a year.
Glivec is sold generically in India for $175; just one tenth of the price of the branded drug. The decision on Glivec is expected to allow generic drug makers to continue selling cheap versions of the drug.
This decision will force multinational pharmaceutical companies to be cautious about investing in India, especially in relation to new drugs. Novartis has already decided to refrain from research and development activities in India.
The Supreme Court decision will also make it more difficult for other pharmaceutical companies fighting for their drug’s patent status. Drugs that lost their patent status in India recently include the cancer drug Sutent (Pfizer) and hepatitis C treatment Pegasys (Roche).
The Indian government claims that the decision will force companies to make inventions with substantial innovation before patent protection will be issued.