Mumbai: Having failed so far to secure an Indian patent for Glivec, its blood cancer drug, Swiss drug giant Novartis AG appears set to face a similar battle over another pending 2004 patent application for a different form of the same drug.
Novartis’ patent filing in the Chennai patent office, for an alfa crystal form, or another modified form of its cancer drug imatinib mesylate, has come to light only now following a pre-grant opposition filed by Okasa Ltd, a Mumbai-based small pharmaceuticals company.
Novartis is still challenging Indian patent laws after the first patent application it filed for this drug, which was a beta crystal form, was rejected by the Chennai patent office in 2006 on the grounds that a mere modification of a pre-1995 invention does not qualify for a patent grant in the country.
Novartis, which holds a patent for the beta crystal form in several international markets at present, appears to have filed the patent application for the alfa crystal form in India toward the end of 2004.
“It was yet another frivolous patenting attempt by Novartis in India, since the company was not very sure about a patent grant on the first application,” insists R.K. Dewan, a patent attorney with RK Dewan and Co., who filed the pre-grant opposition to Novartis’ application on behalf of Okasa.
A Novartis India spokesperson said, she “is unable to comment on the matter as the patents are handled by the parent company.” At the time of going to print, Mint was yet to hear from Novartis.
Dewan said the Chennai patent office had scheduled two hearings on the Okasa filing, but added that Novartis had sought an adjournment on both occasions, citing an inability to send a representative to the hearing.
Although Novartis is yet to launch a brand of the alfa crystal form of this cancer drug in India, a local drug maker, Cipla Ltd, has been selling a generic version of the drug here the last couple of years.
Cipla chairman Yusuf K Hamid said: “We are holding a process patent for this particular product globally through a Patent Cooperative Treaty or PCT filing. The Novartis move to file a product patent in India will not hold merit not only because of mere modification, but also owing to the prior knowledge of the product in the public domain.”
Rajiv Nannapaneni, chief operating officer, Natco Pharma Ltd, which opposed Novartis’ first patent application, claims: “Novartis did not apply for a patent for the alfa crystal form of imatinib mesylate elsewhere because it was considered inferior to the beta crystal form as far as the treatment efficacy is concerned.”
Still, Mumbai patent consultant Gopakumar Nair notes that, “the original patent document for imatinib mesylate (filed in) 1993 in the US by Novartis has mentioned that a beta crystal form of the drug was found more efficacious.”
Novartis is fighting a case at the country’s Intellectual Property Appellate Board, where it challenged the Chennai patent office’s decision to reject its first patent application for Glivec.
The company, which was granted an exclusive marketing right, or EMR, for the cancer drug, which is marketed here under the brand name Glivec, first invited controversy when it secured a court order to restrict manufacturing and marketing of the generic version of the same by local drug makers.
But, the patent application was rejected under India’s newly amended patent rule—Section 3 (d), which was triggered by a pre-grant opposition filed by mainly six Indian drug makers including Ranbaxy Laboratories Ltd, Cipla, Natco and Sun Pharmaceuticals Industries Ltd.
Novartis challenged India’s patent law, which does not allow a pre-1995 invention or a mere modification of known drug to be granted a patent unless the modification claims for enhanced efficacy for the treatment, in the Madras high court, saying that the country’s law does not comply with the World Trade Organization’s trade related intellectual property rules.
The court rejected the case in April 2007.