As Belviq Goes Off India Market, Patent Case May Fizzle
Eisai and partner Sun to take lorcaserin off the Indian market. It remains to be seen whether the Japanese firm sees merit in pursuing a simmering patent infringement suit against Dr Reddy’s, which may need to review its own plans for lorcaserin.
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An Indian court has granted an interim injunction against Dr Reddy’s in a case concerning the alleged infringement of Eisai’s patent on Belviq. Dr Reddy’s, however, claims that Eisai is a “patent squatter” and expects to appeal against the order.
The coronavirus pandemic has thrown up unprecedented challenges for the Indian clinical trials segment, as in other parts of the world. Experts tell Scrip how things are poised in the country including potential impact on some critical milestones, but efforts are underway to tackle the crisis.
FDA action awaits Sun’s manufacturing facility in Halol after it failed to adequately address GMP deviations, though India’s top-ranked drug firm appears to have effectively lowered its dependence on the site that has had a patchy compliance run.