US court favours Aurobindo in patent case on cough & cold drug

The court has scheduled a five-day bench trial beginning April 17 to deliver a final judgment

A US court has ruled in favour of Indian generic drug company Aurobindo Pharma in a patent infringement suit filed by New Jersey-based Reckitt Benckiser on a generic version of the latter’s cough and cold drug, Mucinex DM.

In 2014, Aurobindo had filed an Abbreviated New Drug Application (Anda) to market a generic version of Mucinex DM tablets, one of the popular over-the-counter brands in the US, containing dextromethorphan hydrobromide and guaifenesin. 

The patents claimed controlled-release formulations of the drug guaifenesin, containing both immediate-release and sustained release portions or quantities, based on which Reckitt Benckiser challenged Aurobindo’s move to launch a generic version. 

According to the available information, Mucinex and Mucinex DM had sales revenue over $300 million in 2015 in the US market.

A district court in the state of Delaware said it would grant a summary judgement of non-infringment as pleaded by Aurobindo, as the patent claims were not backed by proof that the immediate and extended release portions were distinct formulations. 

“Reckitt’s infringement position essentially comes down to bio-equivalence. Aurobindo’s Anda seeks to demonstrate that its proposed product is bio-equivalent to Mucinex DM. But, bio-equivalence is not the test for infringement; (that) requires an  element-by-element comparison of the patent claim and the accused product. Thus, without identifying how Aurobindo’s product contains two formulations, which Reckitt has failed to do, bio-equivalence does not establish that it contains two distinct formulations,” the court observed.

The court has scheduled a five-day bench trial beginning April 17 to deliver a final judgement in this and related matters.