May 31, 2006

A lawsuit charging that Abbott Laboratories tried to block generic competition to its cholesterol drug TriCor can go forward, a federal court has ruled. The decision provides a "roadmap" for how courts handle some antitrust lawsuits involving drugmakers, according to one antitrust lawyer.

In the suit, filed last summer in the U.S. District Court in Delaware, Teva Pharmaceutical and Impax Laboratories claimed that Abbott made minor changes to TriCor (fenofibrate) to block generic competition by extending the exclusivity period of the drug, a practice detractors call "product hopping." Several other parties, including drug wholesalers and consumers, have filed similar suits against Abbott. Abbott made the request to dismiss the case March 15.

The court's ruling against Abbott's request to dismiss is the first court decision in a product-hopping case against a pharmaceutical company, noted David Balto, an attorney with Robins, Kaplan, Miller and former policy director in the FTC's Bureau of Competition.

"The decision is a sweeping victory for the plaintiffs and provides a thoughtful roadmap for the adjudication of these product hopping claims in the pharmaceutical industry," Balto wrote in an analysis. "These issues were developed through a series of cases in the 1970s involving software and telecom interfaces. Now the battle has turned to pharmaceuticals."

At issue are allegations by Teva and Impax that Abbott -- which markets TriCor in the U.S. for French drugmaker Fournier Laboratories -- switched TriCor from capsule to tablet form and changed the labeling and dosage solely to make it harder for other firms to launch generic versions of the drug. The plaintiffs also allege that Abbott tried to block generic competition by removing the code for TriCor capsules from the National Drug Data File (NDDF) so pharmacists could not fill TriCor prescriptions with Teva's generic product.

Abbott made three arguments as to why the product changes did not violate antitrust law, Balto said. First, the plaintiffs conceded that the changes were improvements and that any product change that introduces an improvement is legal under antitrust laws; second, Teva and Impax's generic TriCor products have not been completely blocked from the market; and third, Abbott's withdrawal of their TriCor capsule products and changes to the NDDF codes were not antitrust violations because it was not obligated to help its rivals. But in his May 26 ruling, Judge Kent Jordan rejected all three claims on "factual and legal grounds," Balto said. (http://www.fdanews.com/did/5_106/)