Novartis has lost a seven-year patent battle over its cancer therapy Glivec in India, a heavy setback for western pharmaceutical firms, which will find it much harder to sell enhanced drugs in the second most populated country.
India’s top court has refused marketing exclusivity for a new form of Glivec on the grounds that it is not a novel medicine but an amended version of an existing compound. The decision means that generic drug makers are officially allowed to sell more affordable copies of the cancer treatment in India.
The Supreme Court’s ground-breaking ruling sets a benchmark for several intellectual property disputes in India, the world’s pharmacy for the poor. Western pharmaceutical companies now have certainty that there is only “limited” patent protection for their products. In future it will be very difficult to get enhanced drugs patented in India.
Novartis said that the denial of the patent “provides clarification on Indian patent law and discourages innovative drug discovery”. For Doctors Without Borders, on the other hand, the Supreme Court “ended Novartis’ attack on affordable medicines”, calling it a “win for millions of people in developing countries”.
Monday’s ruling is a boost for advocacy groups, which have been accusing western drugmakers of evergreening their drug patents. They claim that pharma companies extend the duration of patents on top-selling drugs by making minor changes to existing medicines. The activists claim that a patent for Glivec would have weakened the Indian generics industry, which supplies affordable drug copies to poorer countries.
The large majority of the Indian drug market are generics, unbranded copies, which contain the same ingredients as the original but which are sold at a much lower price. Groups such as Doctors Without Borders say that these cheaply made generics save the lives of millions of patients who cannot afford to pay Western prices to treat cancer, malaria or HIV.
Doctors Without Borders welcomes the decision, which it says is an important victory for patients in poorer countries. It will prevent companies from abusing the system in order to obtain unjustified patents on existing drugs and block price competition on essential medicines, it said.
“Novartis wanted to set a precedent, which would have levered out an important clause of Indian patent law,” said Oliver Modenhauer, coordinator of the drugs campaign for the group in Germany. According to the clause, a new version of a known medicine only deserves a patent if it works clearly better than the original, a rule which illustrates that access to affordable drugs has more weight in India than profits, Modenhauer said.
According to Leena Menghaney, responsible for the group’s Acces to Essential Medicines campaign all the patent offices in India must apply this verdict. She says the law is clear and must be strictly applied. The organisation hopes that many countries will follow the Indian example and include corresponding clauses in the patent laws.
Setback for patients?
India, the world’s leading exporter of generics, introduced drug patenting in 2005 with a provision to exclude the protection for medicines, which it considers a modification of an existing compound. The majority of patent applications in Europe fall into this category.
Novartis has been fighting since 2006 to challenge this clause of the Indian Patents Act to win a patent for an enhanced form of Glivec. The original version of the drug never had an Indian patent because it was introduced before India adopted the patent law.
“We brought this case because we strongly believe patents safeguard innovation and encourage medical progress, particularly for unmet medical needs,” said Ranjit Shahani, vice chairman and managing director of Novartis India in a press release. “This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options.”
Growth of India's market for pharmaceutical products has a massive potential compared with western markets, where sales are slowing down. Still, the ruling is unlikely to have an immediate impact on earnings at Switzerland’s largest pharmaceutical company. Indian sales of the cancer drug only account for a fraction of the $56.7 billion in total sales last year.
Novartis says that more than 95 per cent of patients who are prescribed Glivec in India receive the medicine free of charge – currently more than 16,000 patients. It also said that since 2002 it has provided more than $1.7 billion worth of the drug to patients in India through its donation programme.
The ruling is particularly interesting for Novartis, because the Swiss drugmaker also generates about $9.5 billion (CHF9 billion), or 16 per cent of its total sales, with generic medicines.
Other drugmakers, including Switzerland's Roche, Germany's Bayer and Pfizer of the United States have over recent months lost patent cases in India.