Alleged violation of US patent on osteo drug.
Swiss drugmaker Hoffmann-La Roche and Warner Chilcott Company have sued Sun Pharma Global Inc, an arm of Sun Pharmaceutical Industries, in the US for alleged patent infringement of Actonel (risedronate sodium tablets in 150 mg form), used for treating bone disorder disease osteoporosis.
The once a monthly dosage form, an improved version of Actonel, is manufactured and sold by Warner Chilcott and was approved by the US Food and Drug Administration (FDA) on April 22, 2008. Roche is the owner of the patent under dispute.
Roche and Warner Chilcott filed the case with the United States District Court for the District of Delaware on December 10, said the court document verified by Business Standard.
A Sun Pharma spokesperson declined to comment. “As a policy, we don’t comment on our patent litigation strategy,” he said.
In December 2008, Sun had informed Roche and Procter and Gamble (last year, Warner Chilcott acquired Procter and Gamble’s prescription drug business for $3.1 billion) that it had submitted a marketing application to the FDA to sell a generic version of once a monthly form of the tablet, without challenging the patent of that drug. In a letter dated October 27, Sun Pharma Global said the same application had been converted into a ‘Para IV certification’, which meant challenging the validity of the patent, said the court document.
Actonel and its various versions accounted for $1.4 billion of Procter and Gamble’s (P&G’s) prescription business of $2.3 billion in the year ended June 30, 2009. Actonel has patent validity till 2013 and beyond for various versions.
In September 2008 and January 2009, P&G and Roche had filed suits in the US District Court of Delaware in response to Israeli drugmaker Teva and Sun Pharma Global’s applications, respectively, to market generic versions of 150mg Actonel tablets. Teva lost the case and the motion against Sun Pharma was later withdrawn by P&G and Roche.
Patent litigations are a common strategy of generic companies to boost their US business. According to the rules for generic business in the US, a patent holder has to sue the patent challenger within 45 days to enforce an automatic ban on marketing approval for the applicant for the next 30 months. The first to challenge the patent of the drug will also get 180-days of exclusive sales in the US market.
