3 Feb 2015
Gilead is looking at another pre-grant opposition to its patent application for Sovaldi in India, on the grounds of the drug being ineffective
The drug has previously been opposed by I-Mak and the Delhi Network of Positive People, Natco Pharma, and BDR Pharmaceuticals International Limited.
Sovaldi has been facing serious opposition in India, with questions regarding its efficacy. On January 13, 2015, India’s patent office rejected the patent application for Sovaldi, using Section 3(d) of the Patents Act, on the grounds that it does not offer any significant improvement and delivers only minor changes.
As per the ruling, Gilead was required to prove otherwise. To defend its intellectual property, the pharma giant appealed the patent office’s ruling in the Delhi High Court, which then set aside the patent office’s order for rejection of the application. This gave birth to a fresh round of proceedings for the progress of Gilead’s patent application.
The recent pre-grant opposition submitted by Sankalp Rehabilitation has further deteriorated the hopes of Gilead succeeding with its patent application for Sovaldi.
“We have studied the patent application closely and are convinced that it has no merit,” Director of Lawyers Collective, Anand Grover said. “It fails to satisfy any grounds required to meet the threshold of what is patentable under India’s patent law. Not only is it not new or inventive, it also does not comply with the requirements of Section 3 (d).”
If the final ruling results in rejection, Gilead will face huge losses and new doors will open for generic competition to enter the market. Given local drug makers’ ability to produce generic versions of Sovaldi for as low as $1 a pill, Sovaldi’s demand will be out of the Indian market.
With its plans to bring in low-cost versions of Sovaldi, Gilead has already signed agreements with seven large drug-makers in India, who will help manufacture and commercialize cheaper versions in approximately 91 developing countries. If Gilead fails to withhold the patent for Sovaldi, then all of the company’s agreements and efforts will become redundant.
Gilead’s high pricing for Sovaldi is another factor behind the opposition to its requested patent in India. Sovaldi costs $84,000 for a 12-week treatment course in the US. But as part of its cost-reduction efforts, Gilead plans to launch the drug in India for less than $1,000 for the 12-week treatment. However, generic drug makers will be able to produce low-cost versions priced around $300-900 per treatment, pointed out a pro-health group that was against Gilead’s patent application for sofosbuvir. This means Gilead’s low-cost version would still be unaffordable to a majority of the Indian population.
Sankalp Rehabilitation Trust director Eldred Tellis talked about Gilead’s unfair pricing strategy, saying, “We know that even $300 is too expensive for the average person in India, let alone the poor. Open, unrestricted competition by Indian generic companies was responsible for drastic price reductions in ARV (anti-retroviral or anti-AIDS drugs) prices which allowed scaling-up of treatment to millions.”
Gilead has already received regulatory approval in India for marketing Sovaldi, with its launch expected in April. But after the recent spur of opposition against the patent application, Gilead’s hepatitis C drug might not fare that well in India.
Out of 180 million people affected by hepatitis C worldwide, 12 million reside in India. If the patent fails, Gilead will lose the opportunity to tap a huge market share in India.