advertisement
18 April 2012

US court supports generic drug makers

The US Supreme Court ruled that generic drug makers can challenge big-name pharmaceutical firms in court to stop them from broadening the scope of their patent descriptions.

0

The US Supreme Court ruled that generic drug makers can challenge big-name pharmaceutical firms in court to stop them from broadening the scope of their patent descriptions.

The measure overturns a 2010 appeals court ruling and confirms an earlier decision by a federal judge that ordered the US subsidiary of Danish laboratory Novo Nordisk to narrow the description of its patent on repaglinide, an anti-diabetes drug sold under the name Prandin.

Caraco Pharmaceutical Laboratories, the US subsidiary of the Indian firm Sun Pharmaceutical Industries, is seeking to produce a generic version of Prandin.

However Novo Nordisk amended the wording of his patent to extend it, and block the Caraco's request to the US Food and Drug Administration (FDA) to produce a generic version of the drug.

Drugs break patent protection laws

The FDA cannot approve the sale of a drug that breaks patent protection laws.

In a unanimous decision by the nine Supreme Court justices, Justice Elena Kagan wrote that "a generic company can employ the counterclaim to challenge a brand's overbrand use code."

"We accordingly hold that Caraco may bring a counterclaim seeking to 'correct' Novo's use code," the ruling read.

"While we are disappointed with the decision," said James Shehan, a senior official with Novo Nordisk Inc, USA, "it appears 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.

"Novo Nordisk's use code narrative is, and has always been, correct, and we are confident that further proceedings will show Caraco's challenge to the use code narrative is meritless," Shehan said.

In 2011, US sales of Novo Nordisk drugs Prandin and PrandiMet totaled $175.96 million, according to the firm.

(Sapa, April 2012) 

Read more:

Drug makers feel the pain in Europe

Lower generic drugs prices won't help consumers

 

More:

GeneticsNews
advertisement

Read Health24’s Comments Policy

Comment on this story
0 comments
Comments have been closed for this article.

Live healthier

Not loosing the weight? »

Your quick guide to Banting Banting for health? Banting vs Heart Foundation Diet – which is cheaper?

8 non-food reasons why your Banting weight loss has stalled

You're religiously sticking to your low-carb programme, but the scales aren’t moving. An extract from The Banting Solution looks at reasons why this could happen.

The struggle is real »

5 things to know before taking an antihistamine How to cope with seasonal allergies

15 tips for students with allergies

For university students, moving out of home can be daunting at the best of times but for those with severe allergies or asthma, it may feel close to impossible.