In a development that could hasten the entry of the generic version of Gleevec into the US market, Indian drug major Sun Pharma has sued Novartis Pharmaceuticals Corp in the District Court of New Jersey, demanding rights to launch a generic version of the cancer drug before the Novartis patent expires.
According to an industry source, the law suit filed by Sun Pharma Global FZE - Sun Pharma’s US subsidiary - seeks a declaratory judgement against Novartis, allowing the Mumbai-based drug maker to sell generic imatinib mesylate in the US before one of the patents of the drug expires in the market. Imatinib mesylate is an active ingredient of Gleevec.
Novartis said it has “confidence in the integrity of the Gleevec patent” and will “vigorously defend” its intellectual property rights.
“Patents are vital to the ability of innovative companies like Novartis to invest in high-risk research to advance breakthrough treatments for patients without treatment options or hope. We have confidence in the integrity of the Gleevec patent and will vigorously defend our intellectual property rights,” Novartis’
“The complaint challenges the validity of the crystal form patent for Gleevec, which expires in 2019,” Novartis said.
The industry source says Sun Pharma, which has made a Para IV filing for the drug in the US around 2006, claims Novartis missed its 45-day window to file an infringement suit after it was informed of Sun Pharma’s application for generic or abbreviated new drug application (Anda) in August 2007.
Sun Pharma declined to comment. “We do not comment on ongoing patent litigation,” its spokesperson said.
Industry experts opine that under the Hatch Waxman Act, a generic drug applicant with a Para IV filing is permitted to file a declaratory judgement suit against a innovator company if the Anda applicant is not sued for infringing the patent within the 45 day period.
Gleevec contributed $4.7 billion of revenues in 2012 to Novartis’ sales. The drug faced crisis even in India in April this year when it lost a battle against generic drug makers.
The Supreme Court of India passed a landmark judgement against the Swiss drug major, denying it a patent protection for the drug in India.