Roche and Cipla are writing a new chapter in the bitter battles that have been fought by Western drugmakers over their patents in India. They are in mediation over the patent for Roche's blockbuster cancer fighter Tarceva, in what may be the first case to take this route.
A Roche ($RHHBY) spokeswoman told the Economic Times only that the two were in talks: "We can confirm, that pursuant to court orders, we are in mediation with Cipla." The Delhi court ordered the mediation in April, the newspaper said.
The two companies have been waging a legal battle over Roche's patent for years. In September 2012, an Indian court upheld Roche's patent for Tarceva, but said that Cipla's generic, Erlocip, did not violate Roche's patent. The court dismissed Roche's complaint, finding that the molecular structure of Cipla's generic is different than that of Roche's drug. Roche continued to pursue protection of Tarceva, which generated global sales last year of $1.5 billion, making it Roche's fifth best-selling cancer drug.
India has taken a populist stand on patents, often setting them aside to assure the country's hospitals and poor patients have access to life-saving drugs at cheap prices. That has been a bane for drugmakers who say they can't afford to develop life-saving drugs if they can't get a reasonable return for them.
Roche also is fighting over the patent coverage on the hepatitis C treatment Pegasys which has been revoked there. Bayer is fighting cheap copies of its cancer treatment Nexavar, allowed onto the market by a government-issued compulsory license. Novartis ($NVS) is still fighting for patent protection on its blood cancer treatment Gleevec. And the Indian government has moved toward compulsory licenses on Roche's Herceptin and Bristol-Myers Squibb's ($BMY) Sprycel.
Congress has been urged to make India's egalitarian attitude about patents a part of trade talks with the country. During hearings on the matter in March, Pfizer's Chief Intellectual Property Counsel Roy Waldron told a subcommittee, "India has essentially created a protectionist regime that harms U.S. job creators." Pfizer ($PFE) last year had its patent on cancer drug Sutent revoked by the Indian patent office. Waldron asked the subcommittee to open talks with India over the drug-patent measures and to "review all available policy tools" to pressure the country. Some think the newly elected prime minister Narendra Modi will be more pro business and therefore more receptive to a new approach.
Indian patent expert Shamnad Basheer suggested to the Economic Times that in the Tarceva case, the court's novel approach may have missed an opportunity. "This is the first time such a big-ticket patent litigation has been referred for mediation," Basheer said. "It is highly unusual for the courts to send such cases for mediation at such a late stage in the proceedings, particularly since the trial has concluded in this case. While the court may have done so to save time and resources, India has lost an opportunity to evolve patent jurisprudence on an important matter."
- read the Economic Times story