News

Posted On: 06/25/2007

Supreme Court Dismisses Generic Case Alleging Big Pharma Breast Cancer Drug Monopoly

PharmaManufacturing.com

The Supreme Court on Monday refused to consider a lawsuit alleging two pharmaceutical companies conspired to monopolize the market for a drug used to treat breast cancer. Consumers who filed the suit asked the justices to consider when an agreement not to market a generic drug is a violation of federal law.

The 2nd U.S. Circuit Court of Appeals upheld a federal judge, who concluded the agreement between the two companies did not restrain trade in violation of federal law. The Bush administration had urged the court not to step into the case, even though the government said the appeals court failed to apply the correct legal standard in analyzing the matter.

In 1992, a federal judge ruled that AstraZeneca PLC's patent for the drug tamoxifen was invalid. The decision came in a dispute between AstraZeneca and Barr Laboratories Inc., which wanted to market a generic version of tamoxifen.

Barr abandoned its successful challenge in exchange for the right to begin selling a competing tamoxifen product under a distributorship agreement with AstraZeneca, well before the expiration of the patent. Barr also received a $21 million payment and AstraZeneca also agreed to pay $45 million over 10 years to Barr's intended supplier.

Lawyers for the consumers say the arrangement resulted in tamoxifen remaining "a single-source, monopoly product," with Barr distributing unbranded tamoxifen at a price 5 percent less than Zeneca's Nolvadex brand.

Generic drugs, lawyers for the consumers alleged, are usually priced 30 percent to 80 percent below brand-name products. The case is Betty Joblove v. Barr, 06-830. Shares of Barr Pharmaceuticals Inc. dropped 5 cents to $50.76 in early trading Monday.