Turning back a threat to sales of Abbott Laboratories’ most lucrative drug, a federal appeals court Wednesday overturned a lower-court ruling that claimed the North Chicago-based drug giant used Johnson & Johnson’s technology to make a blockbuster rheumatoid arthritis therapy.
Humira is one of the world’s top-selling drugs, generating more than $5 billion in annual sales for Abbott as a treatment for rheumatoid arthritis, Crohn’s disease and psoriasis, among other autoimmune disorders.
The ruling in the U.S. Court of Appeals for the Eastern District of Texas overturned a $1.67 billion verdict in 2009 against Abbott in U.S. District Court in Marshall, Texas. The verdict was one of the largest patent-infringement judgments in U.S. history.
J&J’s Centocor subsidiary, which sued Abbott in 2007, claimed Humira was made with technology developed by New York University and exclusively licensed to the New Jersey-based drug giant, which sells a similar drug known as Remicade, which also has had about $5 billion in annual sales.
Abbott has argued that Humira was the first of its kind, fully derived from human DNA, compared with Remicade, which is partially made from mouse DNA. Abbott also argued that Centocor’s patents did not cover the human antibodies used to produce Humira and that such a fully human antibody did not exist in 1994.
“Centocor simply failed to support its contention that generating fully-human antibodies with the claimed properties would be straightforward for a person of ordinary skill in the art given the state of human antibody technology in 1994,” the appeals court said in reversing the lower court’s ruling.
The stakes in the case have been high for Abbott. In 2001, Abbott paid nearly $7 billion to acquire Knoll Pharmaceuticals, largely to get Humira in what at the time was the largest acquisition in the company’s history.
Both drugs, which can cost more than $18,000 a year, are part of a class of biotechnology drugs that are each in the top 10 in global brand-name pharmaceutical sales, according to market research firm IMS Health.
Centocor President Rob Bazemore said the company is disappointed by the decision, adding that it is “considering whether to ask for reconsideration by the panel or by the court of appeals as a whole.”
