U.S. Supreme Court Rules in Favor of Generic Drugmakers

(April 18, 2012) – The U.S. Supreme Court handed a victory to the generic drug companies yesterday, ruling that they are allowed to file certain legal counterclaims against the brand name pharmaceutical companies in an effort to get their cheaper versions of the drugs on the market.

 

In a unanimous decision yesterday by the nine Supreme Court justices, Justice Elena Kagan wrote their opinion, stating that generic drug makers should be allowed to challenge the way brand name manufacturers describe their patents to the U.S. Food and Drug Administration.

 

The generic companies argued that their brand rivals were allowed to describe their patents broadly in submissions to the FDA, as their way of shutting out possible generic competition, even for unpatented use of a drug.

 

This decision overturned a 2010 appeals-court ruling, saying that generic makers could not bring those legal claims against the brand name companies.

 

Caraco Pharmaceutical Laboratories, the U.S. subsidiary of the Indian firm Sun Pharmaceutical Industries, is looking to introduce a generic version of Novo Nordisk diabetes drug, Prandin, known as repaglinide.

 

Novo Nordisk had changed the wording of their patent to extend it, in order to block Caraco’s request to the FDA to produce a generic version of the drug.

 

Although one Novo Nordisk patent on the drug has expired, the company holds another patent, which will not expire until 2018, which involves the drug in combination with another drug.

 

The FDA cannot approve the sale of any drug which breaks patent protection laws.

 

The FDA has approved three uses for the drug. Caraco is seeking to introduce a generic version for the two uses that are not patented. Caraco said that this could not be done because Novo Nordisk’s description of its patent to the FDA was very broad, preventing the FDA from approving a generic version.

 

Sun Pharmaceutical’s spokesperson called yesterday’s ruling “a very important victory,” not just for the company, but for the generic industry as a whole.

 

A senior official with Novo Nordisk Inc, USA, stated that although they are disappointed with the decision, it appears to them that the Supreme Court has held only that Caraco may challenge the use code narrative for Novo Nordisk’s patented method of treating diabetes with repaglinide in combination with metformin. He was confident that the use code narrative for Novo Nordisk has always been and is still correct and feels confident that further proceedings will show Caraco’s challenge to the use code narrative to be meritless.

 

In a related dispute, the two companies are still fighting over the validity of the Novo patent, which a Michigan federal judge had invalidated a year ago. The case is awaiting appeal.

 

The Big Pharma’s are greedy, and care only about profit.  They continue to employ tactics that undermine the efforts of generic drug manufacturers and block production of generic drugs.  Generic drugs serve to enable us access to drugs at affordable prices.  It would be so helpful to millions of Americans who depend on medications for their health and who live on fixed incomes to be able to obtain drugs at more affordable prices. 

 

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