Novartis sues Chinese firm over attempts to make generic heart failure drug
Pharma giant Novartis has filed a patent suit against Crystal Pharmaceuticals after the rival sought to create a generic version of its heart failure drug Entresto (sacubitril/valsartan).
The Basel-based firm acted against the Suzhou, China-based rival in the US District Court for the District of Delaware.
It demanded the court block Crystal’s attempts to market their generic drugs, contending their patents covering the drug don’t expire until 2033.
The Swiss pharma firm also demanded cash compensation from the defendants should generic versions of its patented drug be made before it expires.
In August, Novartis obtained a Paragraph IV notice letter from one of the firms seeking to create a generic version of Entresto.
A Paragraph IV certification certifies that the relevant patents are invalid or will not be infringed by the generic drug to be approved.
Applicants must provide notice to the patent holders.
In retaliation, Novartis filed a lawsuit asserting its two Ernesto patents against the Chinese company.
A Novartis spokesperson confirmed to LSIPR that it had received the Paragraph IV notice as well as filed the suit.
Heart failure
Sacubitril/valsartan is a fixed-dose combination medication for use in heart failure.
Consisting of a neprilysin inhibitor sacubitril and the angiotensin receptor blocker valsartan, the drug was approved for use in 2015 for the treatment of patients with heart failure.
Earlier this year, the agency then expanded its indication to include some patients with chronic heart failure with lower than normal eft ventricular ejection fraction (LVEF)—the measurement of the percentage of blood leaving the heart each time it contracts.
Despite the expansion, the FDA failed to specify as to the cutoff to define abnormal.
Not Novartis’s year
Novartis hasn’t had too much IP luck of late, with a California jury ordering it to pay $178 million to rival drugmaker Daiichi Sankyo for willfully infringing two cancer drug patents back in July.
That same month, Daiichi Sankyo subsidiary Plexxikon argued it was due $47 million in overdue IP royalties from the Swedish firm.
And then in May, its attempt to halt US imports of Regeneron’s Eylea pre-filled syringes were abandoned.
The plans were dropped following outcry that such a move could hinder public access to essential treatments.
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