The Swiss pharma major Novartis AG has filed a special leave petition with the Supreme Court of India against the of Intellectual Property Appellate Board (IPAB) decision to reject the company's plea for patenting its imatinib mesylate - the blood cancer drug Glivec - in the country. The case, which was scheduled for hearing today, was not taken up in the Court and another date for hearing will be announced later, according to sources.
In its petition, the company has urged that the IPAB has wrongly relied on the interpretation of section 3(d) by the Madras High Court, that a patent applicant has to show an increase in therapeutic efficacy. Novartis, confirming its new move, has earlier revealed that the reference of the high price of the drug and the affordability in allowing patent is irrelevant for considering the patentability of the product.
The IPAB, in June, has refused the company's application for patent rights for the beta-crystalline form of imatinib mesylate - the key ingredient in Glivec - as the claimed product did not meet the requirement of increased therapeutic efficacy. The IPAB, however, reversed the findings of the Patent Controller on novelty and inventive step. It held that imatinib mesylate was novel and not obvious to a person skilled in the art, but also allowed Novartis to proceed with certain process claims.
The company has approached the Supreme Court directly even as normally a challenge from an order of the IPAB lies to the High Court. The move comes as a fresh development from Novartis on its long and continuous effort to patent the particular drug form in India.
The non governmental organisations related to healthcare sector and the patient groups along with the Indian generic manufacturers of the drug has challenged the company's move to avail patent, right from the beginning. While generic versions were available at a cost of around Rs 8,000 (USD 160) to Rs 12,000 (USD 240) per month, Novartis sold its version at Rs 120,000 (USD 2400) per month, says NGOs.
With the Chennai Patent Office's rejection of patent after 2005, Novartis approached the Madras High Court challenging the decision of Patent Office along with questioning the relevance of section 3(d) of Indian Patent Act.
In 2007, the Madras High Court rejected Novartis' challenge to section 3(d) and held that it had no jurisdiction to determine the issue of TRIPS compatibility. In determining the issue of constitutional validity, the court held that the word "efficacy" used in section 3(d) had a definite meaning in the pharmaceutical field. The case was then transferred from the Madras High Court to the IPAB, which in turn rejected the application.