US class action suit seeks to prevent delay of generic Gleevec
A group of individuals has reportedly launched a class action lawsuit against Novartis to stop it enforcing a so-called ‘pay-for-delay’ settlement agreement with generic drug maker Sun Pharma centring on leukaemia drug Gleevec (imatinib mesylate).
The group has argued that Novartis’s patent infringement case against Sun Pharma was a sham, and is seeking to prevent the delay of generic Gleevec from entering the US market.
The case was filed on Monday, June 22, at the US District Court for the District of Massachusetts.
According to a court filing, the plaintiffs have been named as, United Food and Commercial Workers Unions, the Employers Midwest Health Benefits Fund and the Laborers Health and Welfare Trust Fund for Northern California.
Gleevec, known as Glivec in Europe, is used to treat patients with chronic myeloid leukaemia, a cancer of the blood and bone marrow.
Its basic compound patent is due to expire in the US on July 4 (with paediatric exclusivity). Gleevec is also covered by four further patents, which are due to expire between 2019 and 2022.
In May last year, Novartis and Sun Pharma settled their patent litigation centring on Gleevec.
As part of the agreement, Novartis agreed to let Sun Pharma make and sell a generic version of the drug but not until February 1, 2016.
But according to a blog post by US law firm Hagens Berman Sobol Shapiro, the plaintiffs have argued that this agreement was unlawfully made and that a generic version should be available next month.
The blog post added that the suit “marks the first time purchasers of prescription drugs have sought injunctive relief to try to prevent antitrust overcharges or damages stemming from delayed launch of generic drugs”.
A spokesperson for Novartis told LSIPR it believes the claims are unsubstantiated.
The spokesperson added: “The settlement with Sun Pharma is a lawful settlement agreement. We will vigorously defend our patent rights and litigate these improper allegations.”
In 2014, Gleevec generated sales of $4.7 billion, according to Novartis.
Hagens Berman Sobol Shapiro
