Pfizer Resolves Lipitor Patent and Genotropin Promotions Litigation

Pfizer Inc. announced verdicts on three litigations relating to its cardiology drug Lipitor and human growth hormone Genotropin (recombinant somatropin). Dow Jones reported on a U.S. Supreme Court verdict to not ”intervene” in Ranbaxy Laboratories’ (India) appeal to overturn a federal court ruling in August 2006, in which Lipitor's patent period was confirmed until 2010. Since 2003, Pfizer has been battling to contain Ranbaxy's efforts at a generic launch. The August 2006 verdict upheld the basic Lipitor patent ending in March 2010, but Ranbaxy was able to invalidate associated enantiomer patents that would have extended the period until June 2011. The source noted that Pfizer is preparing to take up the issue of the invalidated patents as well citing them as merely being due to ”technical grounds”. The company has requested the U.S. Patent and Trademark Office to “reissue” the patents, and is thereby expecting to hold on to the additional 15 months.

Also, on an entirely different legal front, Pfizer was able to resolve legal issues relating to the more serious charge of illegal off-label marketing of Genotropin and the use of vendor contracts for its Genotropin patient assistance programme, pushing other drugs in its portfolio, the report stated. Both charges relate to the erstwhile Pharmacia & Upjohn Company that Pfizer acquired in 2003. The pharma firm's subsidiary pleaded guilty to the charges, accepting a fine of US$19.7 million in the second instance. Pfizer reiterated that the court's decision to prohibit the subsidiary's participation in healthcare programmes will not have an effect on the firm's portfolio, including Genotropin.

The other financial settlement with the U.S. Department of Justice involved US$15 million and the assurance of no criminal lawsuit against the company (in this case, a Pharmacia subsidiary). The U.S. drug-maker announced that marketing practices will be subject to stricter controls, and as such they are already in place. The allegations include promoting the human growth hormone product as an anti-ageing product in deference to the U.S. Food and Drug Administration (FDA)'s approved indications for growth failure of paediatric patients, Prader-Willi syndrome, growth failure in children born small for gestational age, Turner syndrome-associated growth failure, and long-term replacement therapy in adults with growth hormone deficiency.

Outlook and Implications

The Lipitor saga, which started in 2003, with the Indian generics firm being sued for patent infringement, is likely to effectively bury the matter of a generics threat from Ranbaxy in the United States. The company is battling the generic competition on several fronts and has an ongoing litigation in over 20 countries. It may also have a bearing on the Caduet (Lipitor/Norvasc) litigation with Ranbaxy that Pfizer is pursuing. On 9 March, Pfizer slapped a lawsuit on Ranbaxy at the Federal Court, Delaware insisting that the Indian firms' Abbreviated New Drug Application (ANDA) for a cheaper version of Caduet will infringe patents expiring in 2010 and 2018. Lipitor generated a sales turnover of close to US$13 billion for Pfizer in 2006, and is the largest selling drug for the company and in the global pharmaceutical market.

On Genotropin, Pfizer has remained on the backfoot ever since accounts of its improper off-label promotions of Genotropin first emerged in 2003, owing to a whistleblower's account. Company officials have insisted that most of the allegations took place before the acquisition of Pharmacia, and that they have been reported and dealt with strongly. The settlement with the Justice department will hopefully put to rest the allegations dogging Pfizer, allying investor fears of the practices continuing in the merged entity. However, the larger issue of greater scrutiny in human growth hormone (HGH) products will remain, maintaining some pressure on Genotropin.

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