It's a good-news, bad-news sort of day for Novartis' cancer drugs. First, the good news: Tasigna won European Union approval for treatment of chronic myeloid leukemia. A potential follow-up to Gleevec, Novartis' second best-selling drug with $2.55 billion in revenues last year, Tasigna was approved in the U.S. last month.
The bad news? FDA accepted a Paragraph IV generic challenge to Gleevec from India's Sun Pharmaceutical. Novartis, of course, has 45 days to respond. But this isn't just your usual generic challenge. Gleevec, you'll recall, is the drug that caused such a brouhaha in India a few months ago, when that country's patent office refused to grant the drug protection. Under Indian law, modifications of existing compounds aren't eligible for patents. Novartis took the matter to court--and lost. Since then, drug makers have been arguing that lack of patent protection for incremental improvements equals lack of innovation, period; some have even pledged to take their R&D elsewhere.
Enter Tasigna. If that drug can step into Gleevec's shoes as Novartis hopes, the Swiss drug maker may be shielded from copycats in India and elsewhere. But with generic Gleevecs around, who'll need Tasigna? We'll have to tune in to Novartis' marketing materials to find out.
Novartis patent challenge spurs protests in India. Report
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Novartis makes the "Biggest Splash". Report
Novartis wins FDA approval for Tasigna. Report