Federal Circuit reverses district court ruling on Suprep kit

The US Court of Appeals for the Federal Circuit has reversed and remanded a ruling by a district court in a patent dispute between pharmaceutical company Braintree Laboratories and Breckenridge Pharmaceutical.

Handed down on Friday, May 5, the decision stems from an appeal by Braintree from the US District Court for the Southern District of New York.

The district court had ruled that Breckenridge does not directly infringe the patent-in-suit, US number 6,946,149.

The ‘149 patent is directed to compositions and methods for purging a patient’s colon, for example before a colonoscopy.

Braintree markets a bowel prep kit known as Suprep, which is covered by the ‘149 patent.

In March 2012, Breckenridge submitted an Abbreviated New Drug Application (ANDA) to the Food and Drug Administration seeking approval to market a generic version of Suprep, which led to the complaint by Braintree.

The district court granted Breckenridge’s motion for summary judgment of non-infringement.

The court also agreed that Breckenridge’s ANDA label could not induce infringement.

But the Federal Circuit said: “We have considered all of Breckenridge’s arguments on appeal and find them to be without merit.”

It added: “For the foregoing reasons, we reverse the district court’s grant of summary judgment of non-infringement and remand for entry of judgment for Braintree.”

The Federal Circuit also awarded Braintree costs.

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