Novartis case opens in SC

Company ready to promise assistance scheme for patients will continue even after litigation

Swiss pharmaceuticals major Novartis on Tuesday began its argument in the Supreme Court, asserting its right to a patent for cancer drug Glivec, with the government, four Indian firms and the Cancer Patients Aid Association on the opposite side.

Novartis has appealed against the Intellectual Property Appellate Board’s decision to refuse a patent for the medicine.

Novartis counsel Gopal Subramanian stated the company had faced a lot of criticism on the fact that a month’s supply of the drug was priced at Rs 1.20 lakh and, therefore, it wasn’t affordable for many people in the country. He, however, said there was a patients’ assistance scheme through which 80 per cent of blood cancer victims were given free medicine. He also said the company wasn’t recording huge profits, as alleged.

WAITING TO HEAR FROM THE COURT Drug patent applications that were rejected based  on section 3 (d) and can gain if SC order goes in favour of Novartis
Company	Drugs for HIV
GSK	Zidovudine in combination with lamivudine
Roche	Valganciclovir
Boehringer Ingelheim	Nevaripine syrup
GSK	Abacavir

The bench, headed by Aftab Alam, asked when the company was giving the drug free to some patients, why didn’t it cut its price to ensure it was available to a greater number of patients. The judges said the high prices would also harm rival manufacturers.

The company’s counsel said he would consult Novartis on reducing the price of the life-saving medicine, adding the firm was ready to undertake to ensure the assistance scheme for patients was continued even after the litigation was over.

Arguments in the case would be resumed tomorrow.

Authorities say Glivec is not a new medicine, but an amended version of a known compound. The Intellectual Property Appellate Board’s ruling had stated such an amended version was not eligible for a patent, according to Section 3(d) of the Patent Act.

On Tuesday, the Novartis counsel said though the name of the compound used might be available in journals, the company’s research had enabled the modification for treatment. “It is like the difference between carbon and diamond — though both are carbon; there is substantial difference in use,” he said.

He added the medicine, with a cost of $800 million in research, was a breakthrough. It is registered in 35 countries. If India didn’t grant it a patent, it would have international implications, as Indian companies also approached foreign patent offices for registration of their products, he added. Also, a patent was valid for 20 years, and much of this had already been lost in litigation in the appellate board and the Madras High Court, where seven petitions had been moved, he said.

While patient groups and health activists have raised concern on patenting such an incremental innovation, saying this would lead to ‘evergreening’ of patents, impacting the affordability of medicines, Novartis says it cannot be accused of ‘evergreening’. “The beta crystal form of imatinib mesylate is the active ingredient of the Glivec medicine. No other drug comprising imatinib was available anywhere in the world before Glivec was launched. Scientists at Novartis developed the mesylate salt of imatinib and the beta crystal form of imatinib mesylate to make it suitable for patients to take it in a pill form to deliver consistent, safe and effective levels of medicine. This process resulted in a viable drug which revolutionised cancer treatment,” said Novartis India Vice-Chairman & Managing Director Ranjit Shahani.

The Novartis counsel said the company wasn’t as concerned about the pricing of the drug, as on clarity of Indian law on patents. “Anyone investing would like to know about the patent protection available in this country,” he said, adding, “The purpose of this case is vindication of honour.”

Shahani says the outcome of the case would determine future investments in drug development in India. “Knowing we can rely on patents in India benefits the government, industry and patients, because research-based organisations would know if investing in the development of better medicines for India is a viable long-term option,” he says.

The Supreme Court’s verdict would also be significant because it might have implications on other drugs as well.

“If the court decides in favour of Novartis, there is a possibility that various old cases, in which patents were denied on the basis of Section 3 (d), would be reopened. Besides, there are many drug patent applications from global companies for drugs not made in India so far, generics for which are available. Then, it is possible a large number of new patent applications could be made here,” says Amit Sengupta of Jan Swasthaya Abhiyan.