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Gilead Sciences, a California-based bio-pharmaceutical research firm, along with its patent partner Roche Holding AG, sued the Indian generic drug maker Natco Pharma here for allegedly infringing a US patent for Tamiflu, a drug used in the treatment of bird and swine-flu infections.
Tamiflu (Oseltamivir phosphate) was developed by Gilead, and the company receives royalties on the drug sale from Roche Holding AG. The company has requested a federal court in Wilmington, Delaware to block the generic versions of Tamiflu until its patent expires in 2017.
In February, Natco filed an Abbreviated New Drug Application with the USFDA under Para-IV with the USFDA and alleged that Gilead’s patent on the drug is invalid and sent a notice to it to that extent.
Natco was the first company to file an application with the USFDA for the generic version of Tamiflu. According to reports, revenues from Tamiflu clocked global annual sales in the region of $1 billion.
Natco is the ‘first applicant’ to file an ANDA for the generic version of Tamflu and may be entitled to 180 days of generic market exclusivity after approval. The company has tied up with the Luxemburg-based Alvogen IPCO S.a.r.l., for marketing and sale of Oseltamivir phosphate in the US.
Gilead has the basic patent rights of Oseltamivir phosphate until August 2, 2016.
Meanwhile, Natco shares are being traded at Rs 252 on the Bombay Stock Exchange today.
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