Novartis moves Supreme Court on Glivec patent

Swiss drugmaker Novartis AG has challenged before the Supreme Court the patent rejection of its key cancer drug Glivec based on Sections 3(d) and 3(b) of the Indian Patent Act.

In early July, the patent application for Glivec was rejected by the Intellectual Property Appellate Board (IPAB) as it failed to satisfy the efficacy requirements under Section 3(d) of the Indian Patent Act, and its high price was judged to be against “public order.”

Ordinarily, a IPAB order is challenged before the high court. However, Novartis has filed a special leave petition with the Supreme Court directly. The matter is likely to come up for hearing on Monday.

According to a Novartis India spokesperson, the company believes that Section 3(d) is not applicable to Glivec. “Novartis also takes issue with the IPAB’s contention, citing Section 3(b), that the price of the drug is “too unaffordable. In no other country is price looked at when considering patentability,” the spokesperson said.

Section 3(d) says that new forms of known drugs are not patentable, unless they demonstrate significantly enhanced efficacy over existing molecules.

Section 3(b) holds that patents cannot be granted to an invention, the primary or intended use or commercial exploitation of which could be contrary to public order, or morality, or which causes serious prejudices to human, animal or plant life.

Pricing of the drug is taken as part of this, and Glivec costs Rs 1.2 lakh per month, against the generic versions that cost Rs 11,000.

At the centre of the issue is the beta crystalline form of imatinib mesylate (Glivec), which is to be taken lifelong for treating chronic myeloid leukemia, a life threatening type of cancer characterised by increased and unregulated growth of myeloid cells in the bone marrow and their accumulation in the blood.

India has approximately 200,000 CML patients, with 40,000-50,000 people getting affected each year, says Y K Sapru, founding chairman and CEO of Cancer Patients Aid Association (CPAA), the Mumbai based NGO which locked horns with Novartis over patent for Glivec.

An official from a local drugmaker that makes the Glivec generic says the very fact that Novartis has directly approached the Supreme Court is something to ponder.

The Glivec case is one of the oldest patent-related ones in India and goes back to 2003 when Novartis obtained an exclusive marketing right (EMR) for the drug based on its patent application.

The EMR meant that generic versions of Glivec were stopped from being manufactured.
Later, the patent application was rejected in 2006 by the Chennai Patent Office on several grounds, including Section 3 (d), which says that new forms of known drugs will not be patented unless they demonstrate enhanced efficacy over existing products.
Subsequently Novartis challenged the patent office decision in the Madras High Court.

Later on, the appeals filed by Novartis were transferred to the IPAB, which held in July that Glivec did not meet the requirement of increased therapeutic efficacy.