US Supreme Court rules against generics delaying tactics

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US Supreme Court rules against generics delaying tactics

Generics/News | Posted 23/04/2012 0 Post your comment

On 17 April 2012, the US Supreme Court ruled in favour of India-based generics company Sun Pharma in its case against Danish pharmaceutical company, Novo Nordisk, a case that could have provided a route for brand-name drug companies to delay generics competition.

The case against Novo Nordisk was brought to the US Supreme Court by Sun Pharma subsidiary Caraco Pharmaceutical Laboratories (Caraco) on 5 December 2011 and was related to Caraco’s generic version of Novo Nordisk Prandin (repaglinide).

Novo Nordisk had been attempting to delay generics competition and prevent Caraco from introducing a generic drug for uses not covered in the Prandin patent by changing its ‘use code’ – a description of the patent required to be filed by FDA. The action by Novo Nordisk effectively prevented FDA from approving Caraco’s Abbreviated New Drug Application (ANDA) for a ‘carve-out’ label.

However, in a unanimous opinion, the US Supreme Court concluded that Caraco can seek correction of Novo Nordisk’s ‘inaccurate use code’ regarding the combination use of repaglinide and metformin (Prandimet) for the treatment of type 2 diabetes. The decision was a reversal of the Federal Circuit’s April 2010 decision, which dismissed Caraco’s request to correct the use code for the Danish drugmaker’s patent.

Sun Pharma announced that the company was ‘pleased that this landmark decision will help all generics companies prevent brand-name companies from improperly delaying or preventing the marketing of generic drugs against their products by misrepresenting their patents to FDA.’

The Generic Pharmaceutical Association (GPhA) applauded the decision stating that it was a ‘win for generics competition and, more importantly, a win for consumers’ in a ‘case that threatened to eliminate a critical check on brand-name drug manufacturers’ ability to block generics competition by providing FDA with misleading and overbroad descriptions of their patents.’

Caraco’s ANDA for generic repaglinide is still awaiting approval by FDA. According to Sun Pharma, Prandin has annual sales of approximately US$230 million in the US. A separate appeal concerning the validity of patents for Prandin is currently pending before the Court of Appeals for the Federal Circuit after a lower court ruled in favour of Caraco.

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Source: GPhA, Novo Nordisk, Sun Pharma, US Supreme Court