Pfizer secures commercial rights to blockbuster statin Lipitor until 2011

The Court of Appeal in the UK has issued its judgement in the case brought by two generic drug manufacturers to challenge global pharmaceutical behemoth Pfizer's major UK patent on its blockbuster cholesterol-lowering drug Lipitor (atorvastatin). This latest ruling upholds the original decision in the High Court (Marketletters passim) and is essentially good news for Pfizer. Lipitor is the world's most prescribed agent for reducing cholesterol and the drug industry's first $10.0 billion product (in fact, achieving turnover of $12.6 billion in 2005), accounting for 21% of Pfizer's annual sales.

The decision means that Pfizer has retained its patent protection in the UK for Lipitor and has exclusive rights to manufacture the drug until 2011, preventing India-based Ranbaxy Laboratories from providing generic competition before this date (see also page 23).

The case centered on two of Lipitor's primary patents: an earlier broad patent which included "genus" claims encompassing atorvastatin, the active ingredient of the drug, as well as a later "species" patent, more specifically directed to this active agent. The Court of Appeal upheld the decision made by Lord Justice Pumfrey back in October last year, which maintained only the broader first patent - but this itself allows Pfizer to market Lipitor exclusively until 2011.