FTC Opposes Bristol-Myers in BuSpar Lawsuit

The Federal Trade Commission has filed a brief with a federal court saying that Bristol-Myers Squibb Co. "shouldn't be immune to antitrust claims" in its legal fight with two generic drug makers over the anti-anxiety drug BuSpar, the Wall Street Journal reports. Because the FTC is not a party in the legal action brought by Mylan Laboratories and Watson Pharmaceuticals, the brief "may have little direct effect." But the agency's action -- another step in its investigation of anti-competitive behavior throughout the drug industry -- "suggests [it] is becoming interested in battles and deals between branded and generic drug makers that potentially delay the arrival of cheaper generics," the Journal reports. The dispute involves a "last-minute" patent on BuSpar that Bristol-Myers submitted to the FDA in November 2000 just as generic versions of the drug were set to come to the market, preventing their launch for several months. Mylan and Watson claim that the last-minute patent "had little to do with the drug" and that Bristol-Myers "misrepresented the scope of its patent to the government to earn months more of exclusive sales" of BuSpar.

The FTC's legal brief said, "A ruling in (Bristol-Myers) favor would potentially give a branded drug manufacturer an almost unlimited ability to stifle generic competition, a result that could cost American consumers billions of dollars annually and would be plainly at odds with Congress' intent." The FTC also challenged Bristol-Myers' assertion in court papers that even if it made "misrepresentations" to the FDA when it filed the last-minute patent for BuSpar, such action was constitutionally protected as "petitions," similar to protections granted lobbyists. "In essence, (Bristol-Myers) claims that a pharmaceutical company is at liberty, as a matter of antitrust law, to monopolize a market by means of falsely asserting to the FDA that a new patent claims its approved branded drug, despite knowing that the patent does not, in fact, claim the drug," the brief said. Attorneys general from 29 states and Puerto Rico have also filed suit against Bristol-Myers over the BuSpar patent (Harris, Wall Street Journal, 1/10).