As of 26 January 2006, Novo Nordisk Inc, like the majority of hormone therapy product manufacturers in the US, is a defendant in product liability lawsuits related to hormone therapy products. These lawsuits currently involve a total of 37 individuals who allege to have used a Novo Nordisk hormone therapy product. These products (Activella® and Vagifem®) have been sold and marketed in the US since 2000. Until July 2003 the products were sold and marketed exclusively in the US by Pharmacia & Upjohn Company (now Pfizer Inc). According to information received from Pfizer, an additional 13 individuals currently allege, in relation to similar lawsuits against Pfizer Inc, that they have also have used a Novo Nordisk hormone therapy product. Currently, it is expected that the first trial may take place in the third or fourth quarter of 2006. However, Novo Nordisk is not expecting the claims to impact its financial outlook. In September 2005 Novo Nordisk filed a patent infringement lawsuit against sanofi-aventis, Aventis Pharmaceuticals Inc, Aventis Pharma Deutschland GmbH and Aventis Pharma AG alleging that the OptiClik® pen system marketed in the US by Aventis Pharmaceuticals infringes US patent no. 6582408. In the complaint, Novo Nordisk has asked for an injunction and monetary damages that have and will result from sale of the OptiClik® pen system. The lawsuit was filed in the US District Court for the district of Delaware. An initial conference was held on 10 January 2006, at which time the court scheduled the trial for August 2007. The discovery phase will commence in early 2006. In June 2005 Novo Nordisk filed a patent infringement lawsuit against Caraco Pharmaceutical Laboratories Ltd in response to their Abbreviated New Drug Application (ANDA) for repaglinide, the active ingredient in Prandin®. In its ANDA, Caraco requests approval to sell repaglinide following the 2009 expiration of a US patent relating to repaglinide, and provides Paragraph IV certification under the statutes of the Drug Competition and Patent Term Extension Restoration Act (Hatch–Waxman Act) alleging non-infringement and invalidity of a Novo Nordisk patent relating to the fixed combination or simultaneous administration of repaglinide with metformin, which expires in 2018. The discovery phase is expected to commence in early 2006. Novo Nordisk Inc is currently a defendant in three separate cases filed in the US alleging that Novo Nordisk and a number of other pharmaceutical companies provided a false average wholesale price for certain drugs covered by Medicaid. These cases have been brought by the State of Alabama, the State of Mississippi and Erie County, New York. Novo Nordisk was recently dismissed from 31 similar cases by counties in the State of New York. In December 2005 the office of the US Attorney for the Eastern District of New York served Novo Nordisk with a subpoena calling for the production of documents relating to the company's US marketing and promotional practices. The company believes that the investigation is limited to its insulin products. The subpoena indicates that the documents are necessary for the investigation of potential criminal offences relating to healthcare benefit programmes. Novo Nordisk is cooperating with the US Attorney in this investigation. Novo Nordisk is one of several pharmaceutical companies under investigation for illegal activities related to public tenders in Brazil in which it is alleged that businesses conspired with Health Ministry officials and others to inflate the prices of ministry purchases, including insulin. Two Novo Nordisk employees are defendants in the case, which is pending. In Poland, the local customs authorities have investigated a number of international companies, including Novo Nordisk, alleging misstatement of customs values for the period 1999-2001. Regarding Novo Nordisk, the authorities have investigated 1999, 2000 and part of 2001 and claimed misstatement of approximately 360 million Danish kroner. The case is still pending. In January 2005 Novo Nordisk, Teva and Savient (formerly known as Bio-Technology General) agreed to a partial settlement of their disputes over human growth hormone (hGH) intellectual property. Under the terms of the agreement, the three parties have granted each other cross-licences to any patents covering the hGH-active ingredient. An appeal of a Disctrict Court judgment regarding one portion of the dispute continued, but is now closed. In a report published in October 2005 by an inquiry committee under the United Nations (UN), Novo Nordisk was mentioned as one of around 2,200 companies that allegedly paid so-called after sales service fees in connection with contracts entered into under the UN Oil-for-Food Programme. The case is under investigation. See contingencies for pending litigation. | 
