Lipitor’s Legal and Marketing Challenges

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On August 02, 2006, Pfizer Inc. (Pfizer), the world’s largest pharmaceutical company, received a legal setback in its patent battles with generic pharmaceutical companies with regard to Lipitor (Atorvastatin), its blockbuster cholesterol-reducing drug.

The U.S. Court of Appeals for the Federal Circuit (CAFC) in Washington rejected Pfizer’s claim that the generic version of Lipitor, manufactured by Ranbaxy Laboratories Ltd. (Ranbaxy), had infringed Pfizer’s Atorvastatin patent ‘995, which gave Pfizer protection from generic manufacturers till June 2011. With this ruling, the CAFC had overruled the judgment of a lower federal court (Delaware District Court), which had ruled in Pfizer’s favor in December 2005.

However, the CAFC upheld Pfizer’s other Atorvastatin patent ‘893, which gave Pfizer protection from generic manufacturers till March 2010.

The ruling was a result of a lawsuit filed by Pfizer, in 2003, against Ranbaxy for its attempts to sell its generic version of Lipitor in the US market. Ranbaxy could now advance the launch date of its generic version of Lipitor by one year to March 2010, and enjoy a 180-day exclusivity period to market its product in the US market. This was subject to any appellate process by Pfizer against the ruling and Ranbaxy receiving the authorization of the US Food and Drug Administration (FDA) for its product. After the ruling, analysts expected Lipitor’s revenues in the US to reduce in 2010.

In addition to its legal battles with generic companies, Pfizer also faced a few problems with regard to its marketing of Lipitor. With sales of US$ 12.2 billion in 2005, Lipitor was the largest pharmaceutical brand in the world. Analysts attributed the huge success of the brand to Pfizer’s strong marketing efforts. But in 2005 and early 2006, Pfizer’s marketing of Lipitor came under scrutiny. In early 2005, its decision to combine its experimental drug Torcetrapib 1 with Lipitor raised concerns as it was seen as a ploy by Pfizer to extend the patent of Lipitor which was due to expire in the year 2011.

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[1] Torcetrapib is a drug being developed to treat elevated cholesterol levels and prevent heart disease. It results in higher levels of “good” cholesterol and reducing the “bad” cholesterol. As its action complements that of Lipitor, Pfizer planned to launch it as a combination pill that was expected to be very effective in the treatment of elevated cholesterol levels.

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