By Walter F. Roche Jr.
Two labor affiliated organizations have filed suit in U.S. District Court in Boston, Mass. charging Novartis Pharmaceuticals with illegally blocking the entry of a cheaper generic cancer drug in order to increase its revenues by hundreds of millions of dollars.
In the 89-page complaint filed this week, the United Food and Commercial Workers Union Midwest Health Benefits Fund charges that Novartis "illegally extracted an additional seven months of exclusivity from generic maker Sun Pharma."
According to the complaint, Novartis' patent on Gleevec is due to expire on July 4, but under a settlement agreement between the two firms, the exclusivity will extend to February of next year.
The suit states that Gleevec "radically improves the lives of patients suffering from chronic myeloid leukemia."
But the monthly cost for a patient is $9,000 and the drug has generated $13.5 billion in revenues in the United States alone.
Novartis officials called the claims unsubstantiated and promised a vigorous defense against the suit.
"The patents covering Gleevec remain legally in force and are
covered by a statutory presumption of validity. The patents are clearly
directed to our marketed product and are properly listed
in the FDA’s Orange Book and the settlement with Sun is a lawful
settlement agreement resolving the declaratory judgement action filed by
Sun challenging the validity of one of the Gleevec patents," the company said in a statement.
Filed for the food workers and the Laborers Health and Welfare Trust Fund for Northern California, the class action suit charges that Novartis first made illegal add-on amendments to its existing filings for Gleevec with the U.S. Food and Drug administration and then used that filing to sue Sun Pharma charging it with infringing on its patent.
The suit was settled in May of last year with the agreement that Sun Pharma would delay its introduction of the generic form of the cancer drug until February 2016.
"But for the anticompetitive, illegal and ongoing conduct alleged in this complaint, plaintiff and members of the class would begin paying less for their imatinib mesylate as of July 5," the suit states, adding that the resulting overcharges could potentially total hundreds of millions of dollars."
Filing the suit were Massachusetts attorneys Thomas Sobol and Kristen Johnson.
They are asking the court to invalidate the May 14 settlement between Novartis and Sun Pharma.