The second and final day of a federal hearing in Manhattan saw Bristol-Myers Squibb and Sanofi-Aventis back up their request for a preliminary injunction to stop generic sales of blockbuster anticoagulant Plavix.
The generic version, made by Apotex, has been flooding the market for more than a week, and an expert witness brought by the two big drug firms said their market share will continue to erode even if they win at the hearing.
According to the witness, an MIT economist, that’s because retail pharmacy chains, hospitals and pharmaceutical benefits managers have stockpiled the generic pills, which have a shelf life of two years, The (Newark) Star-Ledger reported.
Apotex copycats are being dispensed to fill 78% of new Plavix prescriptions, according to data from IMS Health also admitted into evidence.
The plaintiffs seek a halt to Apotex sales and a court-ordered recall of its pills. BMS and Sanofi argue the generic drug infringes a US patent for Plavix (clopidogrel). The patent expires in 2011, and the brand drug firms say Apotex shouldn’t sell the knockoffs until the patent issue is resolved at trial, which is scheduled for January. Apotex maintains that the patent is invalid and that the public and Apotex will suffer if the injunction is granted.
Apotex has shipped generic Plavix valued at $500 million, and it has orders for an additional $1.3 billion, the company’s attorney said in court. It is selling the generic pills at a 30% to 40% discount over the $4-a-pill retail price of Plavix.
BMS and Sanofi, which markets Plavix outside the United States and holds the patent, stand to take a tremendous hit. If BMS loses the trial, the company may have to slash its dividend, analysts have said, because Plavix is its biggest-selling drug, accounting for $3.7 billion in US sales. The firm has a 50% chance of winning. Even if the preliminary injunction is granted, third-party providers may insist on keeping a rebate in place, the plaintiffs’ witness said.
Judge Sidney Stein is expected to take several days before ruling. His decision on a preliminary injunction, according to the Star Ledger, turns on whether Apotex can demonstrate it has sufficient evidence to prove the Plavix patent is invalid during the 2007 patent trial.
On Friday, the first day of the hearing, plaintiffs mapped out the scientific basis for their patent defense. They questioned a Sanofi researcher, whom Apotex sought to discredit saying he failed to disclose key details of how Plavix was discovered.
Apotex’s attorney on Friday also outlined a series of miscalculations by Sanofi and BMS over the drug. The two sides agreed to a settlement in March that reportedly paid Apotex at least $40 million to delay the generic introduction for several years. The agreement was later amended to include a five-day window for Apotex to launch the drug without legal action if regulators scuttled the deal, as a group of state attorneys-general eventually did in June.
Meanwhile, the FDA has granted an expanded indication for Plavix to treat patients who have had a type of heart attack called acute ST-segment elevation myocardial infarction (STEMI) and are not going to have coronary artery repair or angioplasty.
About 500,000 Americans have a STEMI heart attack each year.