This post was first published on April 23, 2012.
In a landmark decision on a generic drug-maker’s ability to introduce a generic drug for uses not indicated on the branded product’s label, the US Supreme Court ruled in favour of Caraco Pharmaceutical Laboratories, a unit of Sun Pharmaceutical Industries, in its patent litigation against Novo Nordisk over Caraco’s generic version of Prandin, repaglinide tablets, a blood glucose lowering drug.
The drug in question, Prandin, generically known as repaglinide, is used for treatment of Type-2 diabetes. The drug is approved for three different uses, out of which Novo had valid patent on one. However, in the use code, which is the description of the scope of the patent submitted by the brand – name manufacturer to the FDA, Novo had covered all the three uses. The FDA uses the information in the use code to decide on whether a generic manufacturer can make a copied version of the drug.
Caraco contended that Novo’s description of Prandin was too broad and raised a counterclaim challenging the description. The counterclaim provision is laid out in section viii of Hatch-Waxman Act’s which facilitates generic competition by permitting copy drug manufacturers to market their products for FDA-approved uses not covered by any patent.
Caraco originally filed suit against Novo in 2009 and in April, 2010 the US Court of Appeals for the Federal Circuit decided in favour of Danish insulin giant, Novo Nordisk, and denied Caraco’s ability to challenge the Novo patents, stating that the patent descriptions provided by branded companies are not ‘patent information’ as defined by relevant statutes. Caraco appealed this decision to the Supreme Court, which upheld that generic drugs help to reach out to masses being cost effective and ruled in favour of Caraco.
Sun Pharma welcomed the court’s decision by stating that this landmark decision will help all generic companies prevent brand companies from improperly delaying or preventing the marketing of generic drugs against their products by misrepresenting their patents to the US Food and Drug Administration. Caraco’s Abbreviated New Drug Application for generic Prandin is still awaiting approval at the FDA.
The decision was also commended by USA’s Generic Pharmaceutical Association. “This ruling is a win for generic competition and, more importantly, a win for consumers,” said Ralph Neas, president and chief executive of the GPhA.
Contributed by Rajni Mishra
