AbbVie triumphs in Humira case
Pharmaceutical company AbbVie has won a patent case against UK research body The Kennedy Institute of Rheumatology Trust relating to the arthritis medication Humira.
In April 2011 AbbVie brought an action against Kennedy, then called The Mathilda and Terence Kennedy Institute of Rheumatology Trust, trying to invalidate claims within Kennedy’s patent directed to a method of treating rheumatoid arthritis ( ‘442), arguing the claims were already covered in one of its previous patents ( ‘766).
A decision handed down by the US District Court for the Southern District of New York on June 20 found that 13 claims of Kennedy’s ‘442 patent are invalid for “obviousness-type double patenting.”
The doctrine of obviousness-type double patenting “prevents the extension of the term of a patent via the patenting of an obvious variation of the original patent”, Judge Protty wrote in the decision.
Kennedy’s counterclaim that the ‘442 patent is valid was dismissed.
AbbVie was once the specialty pharmaceutical business of healthcare company Abbott Laboratories. Since January 2013 it has operated independently.
In 2002 Abbott received approval from the US Food and Drug Administration to market Humira. Before launching the drug, it sought a licence to Kennedy’s ‘766 patent, which was licensed to pharmaceutical company Centocor.
Centocor sublicensed to patents to Abbott, under the agreement that Abbott would pay royalties to Kennedy for sales of Humira.
Abbott has since paid Kennedy more than $100 million for sales of Humira in the US.
Humira is used in the treatment of more than 500,000 patients and, in 2011, had sales revenue of $3 billion. In January 2013 Forbes reported it was the third best-selling drug of all time.
Jeremy Oczek, partner at Bond Schoeneck & King PLLC, said it is common for companies assess their patent portfolios to determine where they need to shore up coverage, or identify possibilities to extend coverage.
“In the pharma space, patents are critically important to maintain market position,” he said.
He said that Kennedy’s arguments that their second patent was valid appeared to be “the right arguments”, as the method of administration covered by the latter patent differed from the method covered by the first: “In the second patent, the claims in what they call an adjunctive administration was new and unexpected from the co-administration in the first patent,” he said.
However Kennedy presented virtually the same test data to support the patents covering both the co-administration and adjunctive administration of the drug.
“If they had different proof, it could have helped them,” Oczek said.
He added that given the amount of money at stake, it is likely Kennedy will appeal against the district court decision.
“In the pharma space, it is very typical that these types of rulings are appealed,” he said.
