Even as Novartis ($NVS) is fighting a long anticipated battle in India to protect the patent on its cancer drug Gleevec, another Swiss drugmaker must decide if it will appeal a ruling that it believes essentially ignored patent protections on its own cancer drug.
Late last week, an Indian court upheld Roche's ($RHHBY) patent for Tarceva, but said that Cipla's generic, Erlocip, did not step on Roche's patent. Roche has been wrestling Cipla for four years over what it considered an illegal attack on Tarceva, PMLive points out. The court dismissed Roche's complaint, finding that the molecular structure of Cipla's generic is different than that of Roche's drug. That case was followed closely by other Indian generic producers, like Natco and Dr. Reddy's Laboratories, which also have been sued by Roche over infringement of its patent for Tarceva.
Cipla has been particularly aggressive in its attack on branded drugs, and its chief Yusuf Hamied in June said he intends to shake up the cancer drug market in the same way it did with HIV medications in India a decade ago. Cipla earlier this year made headlines when it said he would price the company's copycat version of Bayer's Nexavar at $130 per month, 75% lower than its previous price and one-fortieth the $5,500-per-month cost of the branded version. Cipla rival Natco Pharma had won a compulsory license from Bayer on the kidney cancer drug, but priced its version at $175. Cipla also cut prices on two of its other oncology treatments.
All of these maneuvers have branded drugmakers trying to determine what their best approach is in India, which has a growing market but not a strong allegiance to patent law. That is why they are watching the Novartis case so closely because instead of taking on a company, it attacks the government's decision to deny Novartis a patent. The trial over Gleevec, its long-sought patent for the leukemia drug in India, began yesterday after years of legal maneuvers in India. They will have some time to wait. That trial is expected to last two months.
- here's the PMLive story