Pfizer announced on 7 October 2011 that it had settled its patent infringement case against Teva and several other parties in respect of Teva’s generic form of Lipitor (atorvastatin) in the UK.

Under the terms of the settlement agreement, Teva UK, along with Phoenix Healthcare Distribution, Barclay Pharmaceuticals, AAH Pharmaceuticals, L Rowland & Co (Retail) and Day Lewis, agreed not to sell Teva’s generic atorvastatin in the UK before the Lipitor patent expires in May 2012. Teva acknowledged that Pfizer’s Lipitor patent is valid and infringed by Teva’s generic product. Other terms of the settlement remain confidential.

Teva had previously claimed that Pfizer’s patent for Lipitor (atorvastatin) was invalid. The patent invalidity case was scheduled to be heard at the High Court of Justice in London during November 2011.

The stakes are high. Lipitor had sales of US$10.8 billion in 2010 alone and has been the world’s best-selling drug for the last 10 years, generating 27% of Pfizer’s income [1]. A clinical trial carried out by rival cholesterol drugmaker AstraZeneca indicated that AstraZeneca’s leading cholesterol drug Crestor (rosuvastatin) showed no statistically significant benefit over Pfizer’s Lipitor (atorvastatin) [2]. This could be good news for generics manufacturers. If generic versions of atorvastatin can also impact on Crestor sales, then there is a huge market of which generics manufacturers can grab a piece, and huge savings to be made.

Meanwhile on 6 October 2011, Pfizer and King Pharmaceuticals (King) filed a lawsuit against Watson to try and prevent Watson from commercialising its generic version of Embeda (morphine and naltrexone).

Watson believes it may be the ‘first to file’ an ANDA with FDA for generic morphine and naltrexone, giving it the right to 180 days of generic market exclusivity should its ANDA be approved.

For the twelve months ending on 31 August 2011, Embeda had US sales of approximately US$42 million according to data from IMS Health.

However, maybe a settlement will soon materialise in this case too? The EU Commission’s 2009 Pharmaceutical Sector Inquiry found that ‘in 55% of patent litigation cases between originator and generic companies that involved a question of the disputed patent’s validity … the patents were annulled.’ Therefore, maybe it is better to settle and at least have the full life of the patent than risk the patent being annulled.

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References

1. GaBI Online - Generics and Biosimilars Initiative. Mylan tries to block Ranbaxy’s Lipitor exclusivity [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 October 14]. Available from: www.gabionline.net/Generics/News/Mylan-tries-to-block-Ranbaxy-s-Lipitor-exclusivity

2. GaBI Online - Generics and Biosimilars Initiative. Generic atorvastatin may be better than Crestor [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 October 14]. Available from: www.gabionline.net/Generics/Research/Generic-atorvastatin-may-be-better-than-Crestor