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Pfizer statement on High Court ruling on the distribution and sale of Generic Atorvastatin by Day Lewis Ltd and Asda Stores Ltd

July 22 2011 - Pfizer announced that the High Court of Justice in London decided today to allow Pfizer’s request to add Day Lewis Ltd as a defendant in the ongoing legal action against Teva and three major wholesalers (AAH, Phoenix and Trident) concerning the supply and sale of generic atorvastatin in the UK. In the legal proceedings Pfizer will now pursue an injunction and full financial recompense from Day Lewis.

In open court Asda Stores Ltd agreed to not deal or dispense generic atorvastatin between now and the expiry of the patent protection or any judgment of the Patents Court that the generic atorvastatin product is not protected by valid patent protection. Asda Stores Ltd also undertook to comply with the outcome of the full trial on infringement and validity of the Lipitor® patent protection (whilst reserving the right to argue about the level of financial recompense they may need to pay to Pfizer on the basis of an alleged "innocent infringement" argument). In return for these undertakings, Pfizer agreed not to join Asda Stores Ltd as a defendant in the ongoing legal action against Teva and others.

In considering a date for the full trial on the infringement and validity of the Lipitor patent, Mr Justice Floyd decided that a full trial would be heard in late November 2011. Pfizer strongly believes in the strength of its patent protection and looks forward to the opportunity to defend its patent vigorously at full trial.

The UK patent at issue is covered by a supplementary protection certificate (SPC) that does not expire until May 2012. In 2005, the same Court rejected a challenge to the patent by Ranbaxy, finding that a generic atorvastatin product would infringe Pfizer’s patent covering atorvastatin, the active ingredient in Lipitor®. That decision was affirmed on appeal.

Pfizer believes that without robust protection of intellectual property, its ability to deliver innovative medicines is placed at risk. Patents are vital to a research-based pharmaceutical company such as Pfizer as they allow a defined period during which a company has the opportunity to recoup investment and to make profits that fund future investment and research. Once a patent expires, the science becomes available to all, competition comes in and prices fall to the benefit of healthcare systems. The system works, and will continue to do so as long as patents are not wilfully and cynically undermined.

Pfizer is fully sympathetic to the difficult position that many pharmacies find themselves in having purchased generic atorvastatin in good faith. Pfizer has no desire to pursue individual pharmacies who continue to act in good faith over the supply of generic atorvastatin. We can reassure any pharmacy who confirms that they will not dispense any generic atorvastatin and have returned any packages of it to their suppliers/wholesalers or, if not returnable, otherwise disposed of it or stored it for use after 6th May 2012; that Pfizer will be satisfied that our rights will not be infringed going forward and would not pursue any claim for damages against them.

Following the trial in late November, Pfizer will pursue full financial recompense against all relevant infringing parties, as appropriate.