Three Indian drug manufacturers have been sued by various pharma companies in the US so far in August, as part of patent litigations against Indian companies vying for a pie of blockbuster patented drugs in the US market. Companies like Dr Reddy?s Labs and Orchid Chemicals, were sued by Swiss drug major Roche, while Sun Pharma was sued by Canadian firm Biovail Labs.
In 2007, generics accounted for 67% of the US market, up from 63% in 2006. In 2008, drugs worth $20 billion will lose patent protection and as per IMS data, and $130 billion of prescription pills will go off patent by 2012, creating a huge opportunity for generics firms.
Roche?s osteoporosis drug, Boniva (ibandronate sodium), the drug that came under the dispute, has achieved sales of $305 million for the first six months of this year. Interestingly, both Orchid and Dr Reddy?s Labs were sued in September last year at the same court over the alleged infringement of other patents of Boniva by Roche. Orchid was accused of infringing US patent nos. 7,192,938 (method of treatment using bisphosphonic acid) and 6,294,196 (pharmaceutical composition containing diphosphonic acid or salt) following its paragraph IV ANDA submission to manufacture a generic version of Boniva. DRL was sued for alleged infringement of US patent no. 6,294,196 following its paragraph IV ANDA submission. This time, the firms are alleged to have infringed US patent no. 7,410,957 for Boniva. Sun Pharma was sued by Biovail for infringing the latter?s US patents for Cardizem, used to treat hypertension, with Sun?s proposed generic version of Cardizem. In the first half of 2008, Cardizem generated revenues of $20.7 million, compared with $46.6 million in the first half of 2007. Indian generic firms with a focus on the US market seem to be in a dilemma as they wanted to make a pie of each patented blockbuster drugs which are going off patent despite the costs of patent litigations soaring up. According to experts, on an average, para IV ANDA filing with the USFDA costs about $2 million including bio-studies preparation, ANDA draft. In addition, it costs on average about $15 million to litigate a drug patent case through appeal.