Novartis not ready to give up on Glivec

MUMBAI: The Indian subsidiary of Swiss drugmaker Novartis will challenge a decision by the Intellectual Property Appellate Board (IPAB) that said its cancer drug Glivec was not patentable.

Addressing the company���s annual general meeting (AGM) on Friday, its vice-chairman and managing director Ranjit Shahani said the company ���will appeal the decision all the way���.

IPAB had rejected Novartis���s appeal for patent protection for Glivec as Section 3(d) of the Patent Act does not allow patenting of incremental innovation, which refers to innovations based on existing knowledge and products.

Intellectual Property law experts believe that the wording of IPAB judgement was legally flaky and not reasoned out well, which can give Novartis a stronger case should the company appeal further.

���IPAB used pricing as a reason for not granting the patent, which can be challenged. If the board had found that the patent was not inventive that would be a separate issue. But since the board found it inventive and still denied Novartis the patent, it can be challenged,��� said Shamnad Basheer, professor in IP Law at the National University of Juridical Sciences at Kolkata.

The ideal course of action for the company would be to appeal to the High Court, Mr Basheer said
IPAB backed a decision of the patent controller���s office which had, in January 2006, rejected the Swiss MNC���s application. Novartis then filed multiple writs in the Madras High Court challenging the rejection of its patent application as well as Section 3(d), an appeal which was also rejected.

Novartis could also look at taking up the matter at the WTO���s Trade Related Intellectual Property Rights (TRIPS) forum. The focus point of its stand could be to question the lack of the definition of ���inventive��� mentioned in the Act, which is currently an additional criteria for granting a patent. Any action at the TRIPS forum will have to be from a country level with Switzerland lodging a complaint against India.

According to IP lawyers, Novartis���s immediate appeal to the HC would focus on whether the patent fits all the criteria of the Patent Act thus making it valid. ���The HC will not be able to use pricing as a means to deny a patent nor can it introduce a clause of low pricing to approve a patent. The National Pharmaceutical Pricing Authority (NPPA) will have to take a decision on the pricing front,��� Mr Basheer said.

Cancer patient groups and generic companies such as Cipla, which have been challenging Novartis on scientific as well as humanitarian grounds, feel that the company is fighting a losing battle.

���Novartis has already lost two appeals. We have been protesting Glivec being given a patent since it is priced exorbitantly at Rs 1.25 lakh for a one-month course. Patients who suffer from Chronic myeloid leukaemia (CML) have to take this medication for their lifetime,��� said Shubha Maudgal, executive director of the Cancer Patients Aid Association (CPAA), an NGO that has been fighting Novartis on the issue.

However, should the courts grant Novartis the patent, patient groups will not get any relief on the pricing front. ���Novartis has said that they give out the drug to 99% of the patients for free. If they instead charge a price comparable to what generic companies charge (Rs 10,000 per month), more people will buy the original,��� Ms Maudgal said.

Meanwhile, generic companies have the option of challenging Novartis and manufacture the drug on the grounds of affordability. ���Three years after a patent is granted an appeal for compulsory licence can be made, but first the patent has to be approved. The courts could rule in their (generic companies) favour, but this would depend on the outcome of the Roche-Cipla case which is pending in the Supreme Court,��� Mr Basheer said.