Global Insight Perspective | |
Significance | Denmark's Novo Nordisk has sued France's Sanofi-Aventis, alleging that the SoloSTAR insulin pen breaches U.S. patent protection on its own pen, NovoPen 4. |
Implications | The lawsuit includes an injunction filed by Novo Nordisk that could see all U.S. sales of SoloSTAR suspended until litigation is concluded. |
Outlook | This is not the first legal tussle between the two firms concerning diabetes products, nor is it likely to be the last, given the steady growth in the size of the U.S. diabetes market and the expected rise in popularity of pens over syringes as the preferred method of insulin administration. Both firms will face competition from a new quarter by the end of the year, however, as Eli Lilly prepares to launch its own range of insulin pens on the U.S. market. |
Danish drug-maker Novo Nordisk has launched legal action against French pharma heavyweight Sanofi-Aventis, claiming that the French firm's SoloSTAR insulin pen breaches one of the U.S. patents on Novo's own insulin pen, NovoPen 4. The trial will take place in a New Jersey courtroom, where Novo Nordisk has also sought an injunction on any U.S. sales of SoloSTAR until the conclusion of litigation. According to Dow Jones, Novo Nordisk is now waiting for the court to set a date for the trial to begin. SoloSTAR was approved by the U.S. FDA earlier this year (see France: 1 May 2007: Sanofi-Aventis Secures U.S. FDA Approval for SoloSTAR Prefilled Insulin Pen), and was due to be launched on the U.S. market within a matter of months.
Both SoloSTAR and NovoPen 4 differ from traditional syringes use to administer insulin to diabetes patients in that they are prefilled, reportedly making injection easier, while SoloSTAR is also disposable. Novo Nordisk will be aware that Sanofi-Aventis is hoping to see SoloSTAR become the standard form of administration wherever its top-selling insulin product Lantus (insulin glargine) is already prescribed in the United State, potentially allowing widespread and rapid market access.
The impending patent-infringement battle is not the first time Sanofi-Aventis and Novo Nordisk have clashed over insulin products. Indeed, while Sanofi-Aventis told the Wall Street Journal yesterday that it had not yet been directly served the complaint by the Danish company itself and that its understanding of the allegations was "very preliminary", it revealed that Novo Nordisk had already brought two more lawsuits against Sanofi-Aventis relating to insulin delivery products, but had recently agreed to dismiss them. Just over a year ago, the U.S. International Trade Commission (ITC) launched an investigation into Sanofi-Aventis's U.S. sales of another insulin pen, OptiClik, at the behest of NovoNordisk, which again claimed that the pen violated its own product patents. However, on the insulin side of the diabetes market, it was the turn of the French drugs giant to suffered a courtroom loss against Novo Nordisk just weeks later, when—once again in New Jersey—a judge ruled that Sanofi's allegations of false advertising against Novo Nordisk for its long-acting basal insulin, Levemir (insulin detemir [rDNA origin] injection) would not succeed in guaranteeing an injunction against further U.S. sales of the product (see France: 28 June 2006: Court Defeat for Sanofi-Aventis as Denmark's Novo Nordisk Wins “False Advertising” Case).
Outlook and Implications
The launch of legal action and a potential injunction suspending U.S. sales of SoloSTAR is not the best imaginable news for Sanofi-Aventis at the moment, given the company's recent troubles in the U.S. market (see France: 2 July 2007: Zimulti Marketing-Application Withdrawal Slims Down U.S. Prospects for Sanofi-Aventis). As such, the company can be expected to mount an impressive legal challenge against the Danish biotech. The popularity of insulin pens in the United States is not yet at the same level as that in European countries, mainly due to different treatment patterns, poor marketing and initial reluctance of health insurers to reimburse the pens. At this point in time, however, insulin pens have been available in the United States in one form or another for well over a decade, and a new generation of sleeker, smaller and easier-to-use pens is about to hit the market. SoloSTAR and NovoPen 4 are at the forefront of this mini-revolution in diabetes care, but they will not dominate the market for long. Eli Lilly (U.S.) is set to launch no less than three different pens in the United States by the end of this year.