Gilead, Roche move court against Natco over Tamiflu

Biopharmaceuticals major Gilead Sciences, along with its partner Roche, has sued Hyderabad-based Natco Pharma for infringing the patents of its blockbuster bird flu drug Tamiflu (oseltamivir phosphate).

The drug is believed to have clocked $1 billion in sales in the US last year.

Gilead is the innovator of the drug, whereas Roche markets it by paying royalty to the innovator.

In a filing with a federal court in Welmington, Delaware, Gilead, which was issued the patent in 1998, has sought an order restraining other companies from selling the drug in the US market till the patent on the drug expires in 2017.

Natco is claiming the first to file status in generic Tamiflu. The company has filed an abbreviated new drug application (ANDA) with the US FDA in February 2011.

Tamiflu royalties from Roche to Gilead were about $21.9 million in the fourth quarter of 2010, way below the $194 million paid out in the fourth quarter of 2009. The companies saw a spike in sales in the drug in 2009 owing to fears about the spread of influenza around the world.

The lawsuit by Gilead and Roche is triggered by the ANDA filed by Natco. The suit would stop the FDA from approving the application for up to 30 months or till the court gives out its verdict in favour of Natco.

According to USFDA records, a successful patent invalidation will allow Natco to launch its generic Tamiflu version on August 2, 2016, the date on which the basic patent over the drug gets expired.

Natco officials said the lawsuit was on expected lines.
“This is how a patent holder reacts to a challenge. There is nothing unusual. The process has just begun and it should take 30 months for some clarity on the issue,” an official source said.
Though the sales of Tamiflu are said to have peaked out in 2009, it is also believed that the drug has been seeing a cyclical sales trend.