Indian pharma firms seem to be in an upbeat mood as far as entering into patent litigations with MNCs in the US generics market is concerned. For the year 2007, Dr Reddy?s Labs (DRL) and Sun Pharma remain in the leading slots in this aspect, filing more paragraph IV abbreviated new drug applications (ANDAs) with the USFDA, challenging the validity of the patented drugs concerned. However, IP experts believe that there will be a fall in the paragraph IV ANDA filings from India, thanks to increasing competition among Indian firms in the US.
Interestingly, Ranbaxy, who has spent billions of rupees to challenge the validity of the world?s largest selling drug, Lipitor, seemed to have lost interest in other litigations, as the company has filed only 3 paragraph IV ANDAs for the last year with the USFDA, seeking marketing approval for the patented drugs. Both DRL and Sun have filed about 6 paragraph IV ANDAs with the FDA and have been sued by the innovator companies in various US courts. As the FDA does not disclose the identity of the applicant of the para IV ANDA, one has to depend on court reports for the details. Last year also witnessed the entry of mid-sized players like Torrent Pharma and Dabur Oncology into patent litigations. The 180-day marketing exclusivity in the US, that will be granted if a litigation is won, makes para IV ANDA more attractive to generic firms.
According to IP experts, the lack of advice from experienced attorneys is one among the reasons for why Indian companies never win a patent litigation for a major drug in the US. A Mumbai-based patent expert said, ?The cost cutting mentality of Indian firms remains the main reason. About 60% of the litigation costs goes as an attorney?s consultation fees. Indian firms, which always look for cost cutting, are hiring less experienced attorneys that may result in loss of the litigation,? he added. As the litigation costs vary from company to company and drug to drug, the average cost comes to about $10-20 million.
Companies like Lupin, Wockhardt, and Zydus Pharma have entered into two litigations each, while Mumbai-based Glenmark has been sued by three companies in the US last year.