Sunday, July 5, 2009

Novartis loses battle for cancer drug patent- Glivec

Novartis famed cancer drug, Glivec, will not get patent protection in India. The apex body on patent and trademark disputes, the Intellectual Property Appellate Board (IPAB), has ruled that the drug “lacks innovation” and the high price tag of Rs 1,20,000 per month per patient would be too high for the common man. “Any patent granted to support such a high monopoly price would be against ‘public order’,” the ruling said. Source: Business Standard

This brings the curtains down on a high profile three-year legal battle over patent rights between the Swiss multinational drug major and the Indian government.

Case History:

In May 2006, Novartis started a legal procedure to tackle the refusal of the Chennai Patent Office to grant a patent over the ‘Beta crystalline form of imatinib mesylate’: the active ingredient of the leukaemia medicine ‘Glivec'.The Patent Office considered ‘Beta crystal’ to be a new form of an existing compound and decided therefore, although it had been patented in 35 other countries, to accept the opposition filed by a group of cancer patients (‘Cancer Patients Aid Association’).

The actual case was divided into two groups of arguments: those challenging the constitutionality of Section 3(d) and those aimed at refuting the refusal of patent protection in that particular case. Novartis alleged incorrect application of Section 3 (d) of the Patents Act in view of the factual situation; and nonconformity with TRIPS to prove that India, in enacting Section 3 (d), had acted unconstitutionally. under Article 253 and 51 (c) of the Indian Constitution it would be held that national laws need to be in accordance with India’s international obligations and the contested Section would be TRIPS non-compliant. Secondly, Novartis argued that Gleevec as applied before the Indian Patent Office had greater manufacturing stability and could be more easily absorbed by the body: and even under Section 3 (d) the applied substance should be patentable, Novartis said. Thirdly, apart from non-compliance with TRIPS, Novartis also invoked internal constitutional arguments in claiming that Section 3 (d) is unconstitutional because of its vagueness and the resulting unjustified discretionary power granted to the patent offices (violating article 14 of the Indian Constitution).

In section 3 of the principal Act, for clause (d), the following shall be substitued, namely:—
"(d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. [as per the Indian patent act amended in 2005]

Impact of the case:

The case has triggered massive international reactions. NGO’s like the ‘Berne Declaration’67 contested that the challenge of Section 3 (d) of the Indian Patents Act is not about access to medicines by referring to the damages Novartis’s exclusive market rights on that medicine would already have led to.

Back to the Novartis Latest decision:

The IPAB panel, comprising Chairman ZS Negi and Technical Member PC Chakraborti, ruled that the beta crystalline version of the drug was not patentable under section 3(d) of the Indian Patent Act and lacked “significant enhanced efficacy” over and above the prior known molecule. The panel, in its decision on June 26, also ruled that the patents granted for the drug in about 40 countries may not be applicable to India.

In its recent ruling, the IPAB denied Glivec’s patentability by upholding objections under Section 3(d) of the amended Patent Law — under which a patent is granted only if a product proves to be more efficacious than the existing drug molecules.

On novelty and innovation, though, the judgment seems to make a favourable mention of Novartis’ Glivec, observed another lawyer

In an e-mail response, Novartis said, “We are pleased that IPAB acknowledged that our patent application fulfils all international patentability criteria. Unfortunately, IPAB upheld the objections under Section 3(d), a legal provision unique to Indian patent law, which constitutes a hurdle to innovation in the pharmaceutical field.”

Shubha Mudgal, executive director of Cancer Patient Aid Association, which opposed the patent application in 2006, was predictably happy and said the “landmark judgement is a victory for patients as it will set a precedent in India to offer critical drugs at affordable prices.”[as per business standard article]

Details of the judgment are still being digested by different parties to the case. On the face of it, domestic drug companies will be able to continue to sell their versions of Imatinib Mesylate, though they will not be able to use the two processes that have been sent for reassessment, said company representatives.

The legal wrangle over Glivec has attracted international attention because it is the first test on the ground of India’s amended Patent Law. The product patent regime became effective in the country in 2005.

At the heart of the patent debate also appears to be the emotive price issue, with Novartis’ Glivec costing over Rs 1 lakh a month to a patient, while local drug companies make similar versions of the drug available at Rs 10,000 a month.

Novartis Arguments:

Novartis said it was concerned about the patent system in India and was looking to have a system that supported innovation in the pharmaceutical field. “We are currently reviewing the decision and will look at the various options available to us,”

Novartis, however, has maintained that it has, as part of its GIPAP (Glivec International Patient Assistance Programme), given patients the medicine at no cost. “In India, more than 11,000 patients currently receive their medicine through GIPAP. Since the inception of the programme in India in late 2002, Novartis has distributed Glivec valued at close to Rs 3,000 crore to patients enrolled under GIPAP absolutely free of any charge,” Novartis said.

Further, it added that more than 99 per cent of patients on Glivec in India receive it free of charge under GIPAP, while less than one per cent of patients pay for it, and these are patients who are reimbursed.[Source: The Hindu]

On the next step, lawyers observe that the judgment could be appealed at a High Court.

No comments: