Supreme Court begins hearing in Novartis case Gopal Subramanium argues for Glivec patent

The Supreme Court of India yesterday started hearing final arguments in the petition filed by Swiss drug maker Novartis against the order of the Intellectual Property Appellate Board (IPAB) refusing to grant a patent for the anti-cancer drug Glivec. The patent was refused on the ground that the drug is not a new molecule but an amended version of a known compound.

The Supreme Court of India yesterday started hearing final arguments in the petition filed by Swiss drug maker Novartis against the order of the Intellectual Property Appellate Board (IPAB) refusing to grant a patent for the anti-cancer drug Glivec. The patent was refused on the ground that the drug is not a new molecule but an amended version of a known compound.

Novartis has challenged the IPAB’s interpretation of Section 3(d) of the Indian Patents Act, 1970, which disallows patenting of new forms of known substances, unless the new form exhibits a significant enhancement in efficacy over existing compounds. This is a provision to stop the common industry practice of 'evergreening’ of patents. 

Senior Counsel Gopal Subramanium, appearing for Novartis, began arguments before the Division Bench comprising of Justice Aftab Alam and Justice Ranjana Desai.

Subramanium informed the Court that the questions for adjudication are “what invention is patentable” and “what qualifications are required for granting a patent”.

Justice Aftab Alam asked several questions in the course of arguments, including a query regarding the cost of the treatment. The Senior Counsel informed the Court that the treatment costs about Rs. 1,20,000 per month.

When, the Bench opined that the cost of the treatment is too high, Subramanium informed the Bench that Novartis has a program called the ‘Patient Assistance Program’ for patients experiencing financial hardship. He also informed the court that 85% of affected people are treated free for leukemia, while 10% get the drug at subsidised rate and only 5% pay this cost.

"We are socially conscious of our responsibility. The conduct of Novartis is socially responsible….But, am I not entitled to a patent under the Act," argued Subramanium.

Novartis also submitted that the company has spent around $800 million on research to produce this drug and that the patentability is required to encourage research and development.

While further arguing the matter, Subramium said, "We are giving something new to the patients”. 

Subramanium told the Supreme Court that it had demonstrated the improved efficacy of its cancer drug Glivec, reports Reuters.

This is the first time the interpretation of Section 3(d) of the Patent Act has come up before the Supreme Court.

It is understood that Novartis will continue its arguments for the next few days.

HSA Advocates and Anand and Anand are representing Novartis along with Senior Counsels Gopal Subramanium and T.R. Andhiyarujina. Newly appointed Additional Solicitor General Paras Kuhad is representing the Union of India. Senior Counsel Anand Grover is appearing for Cancer Aid Patients Society while IP lawyers Pratibha Singh along with Senior Counsel Harish Salve are representing Cipla, the opposing party.