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Novartis agrees Gleevec patent deal

Published on 19/05/14 at 11:46am
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Novartis has settled patent litigation with Sun Pharmaceutical Industries in the US, paving the way for the Indian company’s subsidiary to launch a generic version of blockbuster blood cancer drug Gleevec next year.

The basic compound patent for Gleevec (imatinib mesylate) expires in the US on July 4 2015 and in major European countries in 2016 – although the first territory in which it disappears will be Japan later this year.

The drug remains one of Novartis’ biggest sellers, bringing in $4.7 billion last year.

Novartis has already warned of increasing generic pressure on its own products, saying that the impact on net sales during 2014 is expected to be as much as $3 billion.

Analysts at EvaluatePharma say news that Novartis has managed to delay the inevitable launch of generic versions of Gleevec for a mere six months in the US “will provide small comfort for the Swiss pharma giant”, given its ‘painful period’ of patent losses.

However, as one of the biggest looming losses facing the industry, the settlement represents a small win for big pharma against low-cost rivals, EP says.

Last year India’s Supreme Court made clear it would not grant new patents for improvements to old medicines such as Gleevec (known as Glivec in Europe) unless change led to much improved therapeutic efficacy.

The new litigation settlement upholds the validity of US patents covering certain polymorphic forms of Gleevec, which are set to expire in 2019.

As a result of the agreement – most of whose terms are confidential – Sun Pharma can market a generic version of Gleevec in the US from 1 February 2016.

India’s largest drugmaker already has tentative approval from the US Food and Drug Administration for its version of imatinib mesylate.

“Patents are vital to the ability of innovative companies like Novartis to invest in high-risk research to advance breakthrough treatments for patients without treatment options,” Novartis insisted in a statement.

“This settlement validates the Novartis patents while allowing Sun Pharma’s subsidiary to enter the market with its generic product,” it went on.

Novartis’ own generics and biosimilars arm, Sandoz, increased sales by 5% to $9.2 billion in 2013.

Sun Pharma has had its own well-publicised problems recently, recalling almost 400,000 bottles of anti-depressant and antihistamine medications in the US, because the pills failed to dissolve properly.

Adam Hill

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