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22 August 2014Americas

Federal Circuit upholds invalidity decision on Humira patent

The US Court of Appeals for the Federal Circuit yesterday (August 21) upheld a lower court’s decision that a patent covering rheumatoid arthritis drug Humira (adalimumab) is invalid.

Biopharmaceutical company AbbVie makes and markets Humira, an antibody that can be used either alone or in combination with methotrexate to treat rheumatoid arthritis. It holds the licence to patent ‘766, which covers the combination therapy, and expired in 2012.

AbbVie brought the case to the US District Court for the Southern District of New York in 2011 after patent holder The Mathilda and Terence Kennedy Institute of Rheumatology Trust, since renamed The Kennedy Trust for Rheumatology Research (Kennedy), demanded it obtain an additional license on the disputed patent, ‘442, which is due to expire in 2018.

It asked for declaratory judgment that claims of the patent were invalid over the ‘766 patent for obviousness-type double patenting, and, last July, the district court agreed with AbbVie and dismissed Kennedy’s claim.

In its appeal to the Federal Circuit, Kennedy argued that although the claims of the ‘442 patent are “encompassed by those of the ‘766 patent”, the claims of the ‘442 were separately patentable.

The ‘766 patent is directed towards all individuals in need of rheumatoid arthritis treatment, while the ‘442 patent claims treatment of a more “specific patient group”, it said.

The Federal Circuit concluded: “The ’442 patent does not claim a species manifesting unexpected results. The ’442 patent would have been obvious over the ’766 patent.”

Humira is one of the world’s biggest selling drugs. In 2013 it generated worldwide sales of $10.6 billion.

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2 July 2013   Pharmaceutical company AbbVie has won a patent case against UK research body The Kennedy Institute of Rheumatology Trust relating to the arthritis medication Humira.

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Americas
2 July 2013   Pharmaceutical company AbbVie has won a patent case against UK research body The Kennedy Institute of Rheumatology Trust relating to the arthritis medication Humira.

More on this story

Americas
2 July 2013   Pharmaceutical company AbbVie has won a patent case against UK research body The Kennedy Institute of Rheumatology Trust relating to the arthritis medication Humira.