Launch First, Fight Later
“The Delhi high court is currently hearing a high-profile patents lawsuit that has the potential to change the rules of the game in India. In a first, Mumbai-based drug maker Cipla has launched a copycat or generic version of a drug with the full knowledge that the original has been patented in India. The product is lung cancer drug erlotinib marketed here by Switzerland’s F. Hoffmann-La Roche under the brand name Tarceva. Last week, Roche claimed patent infringement and asked the court to restrain Cipla from hawking its copies. Cipla, media reports say, will use the opportunity to prove in court that Roche’s patent should not have been granted in the first place. At Rs 1,600 a tablet, Cipla’s drug costs a third of Tarceva.
So far, companies or other entities like non-governmental organisations have opposed patents in two ways. One is by objecting to a patent application when it is being examined in the Indian Patent Office. Called ‘pre-grant opposition’, this is allowed under India’s patent laws. Over a hundred such oppositions are being made and heard. Some drugs on which patents have been challenged pre-grant are AstraZeneca’s cholesterol reducer Crestor (opposed by Ahmedabad’s Torrent Pharmaceuticals) Eli Lilly’s Cialis (opposed by Mumbai’s Ajanta Pharma), and Pfizer’s anti-fungal Vfend (opposed by Gurgaon’s Ranbaxy Laboratories).
Second, the Indian patent law also allows opposition to a patent after it has been granted. This is called ‘post-grant’ opposition. Mumbai-based drug company Wockhardt, for instance, objected to a different Roche patent — on the hepatitis C drug Pegasys — in the patent office, after it had been granted. In a broad sense that is what Cipla is doing — opposing a patent ‘post-grant’. But Cipla has chosen a far more provocative, and Roche’s lawyers argue illegal, route. It has first launched its copycat thus courting a lawsuit, and will now argue its case of patent invalidation before a court of law. Roche and Cipla refused to comment on the case since it is sub judice. However, Amar Lulla, joint managing director of Cipla, confirmed to BW that it had launched erlotinib a few weeks ago. “It is available with the trade,” he said.
Cipla has supporters. “There is nothing remotely improper about Cipla preparing to launch a generic if it has concluded that Roche’s patent is invalid,” says Frederick Abbott, professor of international law at the Florida State University College of Law. “Patents create a legal presumption in favour of the patent holder, but they remain susceptible to challenge and invalidation. That is the way the patent system is designed,” he says. Abbott was adviser to the South African government in a famous lawsuit brou- ght by 39 multinationals against the country’s patent laws. It was eventually dropped.
But some believe that Cipla has weakened its hand. By not opposing the patent through the usual channels, and directly launching its copy, it may convey the impression that “it does not respect the law”, says Shamnad Basheer, a New Delhi-based associate of the Oxford Intellectual Property Research Centre who runs a popular blog on patents. “This infringement strategy might backfire against them in court.” Basheer points out that Cipla does not seem to have approached the patents office with its opposition prior to this. Nor has it sought a licence, such as rival Natco Pharma of Hyderabad, from Roche in exchange for royalty payments. At the time of writing, the court had yet to finish hearing the case though proceedings began last week.
Cipla’s audacious move has doubtless caused consternation among companies who hold patents or have applications pending. The question on everyone’s mind is if Cipla get its way, will it open the floodgates?”
