Pfizer, Ranbaxy reach Lipitor deal

Pfizer Inc. has reached a deal with Indian generics manufacturer Ranbaxy Laboratories Ltd. that will end a large part of a five-year patent battle over the blockbuster Lipitor cholesterol treatment and forestall generic competition in the U.S. by 20 months.

The deal comes at a time when pharmaceuticals companies are fighting to have the release dates of their leading drugs' generic versions extended to offset their narrowing pipelines.

Ranbaxy has been challenging some Lipitor patents around the world as it seeks to begin distributing copies of the world's top-selling prescription drug, which generated $12.7 billion in sales last year, about 26% of Pfizer's total.

In Lipitor's case, Pfizer had been arguing that although patents were to expire in March 2010, Ranbaxy's generic would infringe two patents covering the process for making the drug that don't expire until July 2016.

Ian Read, Pfizer's president of world-wide pharmaceutical operations, called the deal "a win-win-win because it is pro-patient, pro-competition and pro-intellectual property." He noted that it "provides patients with access to a generic product much earlier than if Ranbaxy were unsuccessful in obtaining approval for its product and overcoming the relevant patents."

Pfizer noted that the agreement pertains solely to Ranbaxy and affiliates and doesn't extend to legal challenges being fought with other generics makers. In addition, Ranbaxy -- which was been the first of a number of generic challengers to the Lipitor patents -- will be the only firm able to sell generic Lipitor in the U.S. for the first six months.

Beyond the U.S., the deal also details when Ranbaxy will be able to sell generic Lipitor in seven other countries: Canada, Belgium, Netherlands, Germany, Sweden, Italy and Australia. But litigation is still ongoing between the companies over Lipitor patents in five other European countries: Finland, Spain, Portugal, Denmark and Romania.

Caduet, which also is covered in the deal, combines Lipitor's active ingredients with those of Pfizer's hypertension drug Norvasc to treat high blood pressure as well as cholesterol. Caduet had 2007 sales of $568 million.

(Published by The Wall Street Journal - june 18, 2008)