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24 March 2015Americas

Federal Circuit agrees that Exela infringed Ofirmev patents

The US Court of Appeals for the Federal Circuit yesterday (March 23) upheld a district court's decision that pharmaceutical company Exela infringed two patents covering Cadence Pharmaceuticals’s injectable Ofirmev (acetaminophen), used for pain relief.

Cadence sued Exela for alleged patent infringement at the US District Court for the District of Delaware in 2011 after the generic drug maker filed an Abbreviated New Drug Application at the US Food and Drug Administration seeking approval to market a generic version of Ofirmev.

In November 2013, the court determined that both patents were valid and infringed by Exela.

Exela appealed against the court’s construction of claims for the two patents at suit, US numbers 6,028,222 and 6,992,218, and its ruling of infringement. It also challenged the court’s validity decision on the ‘218 patent but not for the validity decision related to the ‘222 patent.

The ‘222 and ‘218 patents are owned by SCR Pharmatop, which licenses them exclusively to Cadence.

The ’222 patent covers a method for preparing stable liquid paracetamol compositions, which are created by adding “a free-radical capturing agent and a buffer”. The buffering agent is added to avoid the product’s decomposition into potentially toxic products.

The ‘218 patent is titled “method for obtaining aqueous formulations of oxidation-sensitive active principles” and claims a method of obtaining stable acetaminophen formulation.

Both patents included terms that were disputed by the parties, including “buffering agent”. However, the federal circuit said it agreed with how the district court construed the claims in both patents.

It rejected Exela’s construction of the claims, also affirming the district court’s finding of infringement. The court also agreed that the ‘218 patent had not been shown to be invalid.

Cadence is a part of Mallinckrodt Pharmaceuticals, which published the following statement: “Mallinckrodt is pleased with the court’s decision and will continue to vigorously enforce the company’s intellectual property rights relating to Ofirmev.”

Exela did not respond to LSIPR’s request for comment.

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