Supreme Court ruling supports generic drug makers

April 18, 2012

The US Supreme Court ruled Tuesday 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 of Prandin.

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

The FDA cannot approve the sale of a drug that breaks 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 (about one billion Danish kroner), according to the firm.

Explore further: Paula Deen pledges money to diabetes association

Related Stories

Paula Deen pledges money to diabetes association

January 19, 2012

(AP) -- Celebrity chef Paula Deen on Wednesday pledged a portion of her earnings from a lucrative endorsement deal with a diabetes drugmaker to the nonprofit American Diabetes Association.

S. Korea to approve Viagra generics

March 14, 2012

Three South Korean pharmaceutical firms will soon be allowed to produce generic versions of the anti-impotence drug Viagra despite a row over patents, officials said Wednesday.

Recommended for you

CVS generic competitor to EpiPen, sold at a 6th the price

January 12, 2017

CVS is now selling a rival, generic version of Mylan's EpiPen at about a sixth of its price, just months after the maker of the life-saving allergy treatment was eviscerated before Congress because of its soaring cost to ...

Many misuse OTC sleep aids: survey

December 29, 2016

(HealthDay)—People struggling with insomnia often turn to non-prescription sleep remedies that may be habit-forming and are only intended for short-term use, according to a new Consumer Reports survey.

The pill won't kill your sexual desire, researchers say

December 15, 2016

Taking the pill doesn't lower your sexual desire, contrary to popular belief, according to research published in the Journal of Sexual Medicine. The authors of the research, from the University of Kentucky and Indiana University ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.