Mumbai: Basel-based drug maker Hoffman-La Roche Ltd plans to drag Cipla Ltd to the Supreme Court, challenging an April ruling of Delhi high court that dismissed Roche’s appeal on a patent infringement case.
Roche had in April appealed to a higher bench of the high court against a lower bench ruling that allowed Cipla, a manufacturer of generic medicines, to continue selling a generic version of the Swiss firm’s cancer drug Tarceva despite it having been granted a patent in India.
In March, a single judge bench of Delhi high court had refused Roche’s plea for an injunction to restrain Cipla from selling the drug, saying it would cause irreparable damage to patients who would have their lives cut short if a cheaper version of the drug was denied to them.
Like another Swiss drug maker Novartis AG’s legal battle against Indian patent office and the country’s intellectual property law on cancer drug Glivec, the Roche case is another high-profile drug patent litigation by a multinational drug company that involves research claims and patient access—two key issues that India gives priority to while dealing with drug patents.
Gearing up: Roche’s India arm MD Girish Telang says the firm’s legal team is preparing to challenge the HC verdict in the apex court. Abhijit Bhatlekar / Mint
Novartis had last month lost its five-year battle to patent Glivec on these grounds after India’s patent appellate tribunal rejected its appeal.
Roche’s legal team is preparing to challenge the high court verdict in the country’s apex court, said Girish Telang, managing director, Roche Scientific Co. (India) Pvt. Ltd, a fully-owned subsidiary of Roche.
In its April ruling, a bench of the court, headed by chief justice A.P. Shah, also imposed a Rs5 lakh penalty on Roche for suppressing facts and not making full disclosure to the court.
“We have three months to contest the court ruling and we will do it within the stipulated time, ” said an executive of the legal department of Roche in India on Wednesday asking not to be identified.
Roche’s appeal to Supreme Court will also seek to reverse the high court finding that it suppressed facts as it is quite damaging to the company, a lawyer familiar with the development said on condition of anonymity.
The patent infringement case on Tarceva was triggered when Cipla launched a generic version of this drug, known by the chemical name erlotinib hydrochloride, in the domestic market in January.
Cipla decided to launch a cheaper version of the drug despite a patent granted to Roche for this drug in the country. Cipla had launched its version, branded Erlocip, in December 2007 at a price of Rs1,600 a tablet. Roche’s Tarceva sells for Rs4,800 a tablet in the country.
Roche had earlier said Tarceva actually costs Rs3,200 and that the higher price was because of import duty.
In January last year, Roche filed an infringement suit in the Delhi high court and asked for an injunction that would prevent Cipla from sellingErlocip.
Cipla submitted to the court that no injunction should be granted till its post-grant opposition filed in the Delhi patent office was heard and decided upon.
According to a patent law expert, the validity of Roche’s patent was in serious doubt. “In view of the existence of Gefatinib, an earlier known molecule, the court appeared to suggest that Erlotinib, Roche’s patented molecule, may not be inventive,” said Shamnad Basheer, a professor in intellectual property law at the National University of Juridical Sciences, Kolkata. “Secondly, there is a serious doubt about whether or not Cipla infringes the Roche patent at all.”
Several competitors as well as patient groups had raised objections to Roche’s patent application for Tarceva by filing pre- and post-grant oppositions to Roche’s claims at the Indian patent office.