Pharma Giants Face Renewed Legal Push Over Delayed Generic Lipitor Release

A coalition of drug wholesalers, retailers, health plans and other groups have petitioned a U.S. appeals court to revisit lawsuits accusing pharmaceutical giants Ranbaxy and Pfizer of colluding to delay the release of a generic version of the popular cholesterol medication, Lipitor. The appeal, filed before the 3rd U.S. Circuit Court of Appeals in Philadelphia, aims to revive claims that the companies engaged in an unlawful scheme to maintain Lipitor’s market dominance longer than warranted, according to Reuters.

Leading plaintiffs in the case, including pharmacy chain CVS, Rochester Drug Cooperative and distributor Value Drug, contend that the lower court’s decisions to deny class action status and dismiss the case before trial were unjust. The lawsuits, consolidated in New Jersey federal court, allege that Pfizer sought to protect its Lipitor monopoly through an illegal agreement with Ranbaxy, an Indian pharmaceutical company acquired by Sun Pharma in 2014. According to Reuters, neither Sun Pharma nor Pfizer responded immediately to requests for comment, nor did the primary attorneys representing the plaintiffs.

Lipitor, launched by Pfizer in 1997 to treat high cholesterol, amassed over $130 billion in sales within its first 14 years, cementing it as one of the most profitable drugs in history. The plaintiffs argue that Pfizer took deliberate steps to extend its patent protections, allegedly compensating Ranbaxy to delay the introduction of a cheaper generic version. They further allege that Pfizer and Ranbaxy engaged in “sham litigation” to sustain Lipitor’s market exclusivity. The wholesalers argue that if a generic version of Lipitor had been introduced earlier, by 2011, they would have paid considerably less for the medication.

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The appeal follows Pfizer’s agreement earlier this year to pay $128 million to settle claims with direct purchasers and other plaintiffs. However, Ranbaxy remains involved in the ongoing litigation. According to the filing, Ranbaxy, represented by the law firm Kirkland & Ellis, has maintained that the plaintiffs lack evidence that the U.S. Food and Drug Administration (FDA) would have approved a generic Lipitor any earlier than it did.

In June, U.S. District Judge Peter Sheridan dealt a blow to the plaintiffs by denying two motions to certify the case as a class action, while also dismissing the claims against Ranbaxy. Sheridan stated that the FDA is not obligated to approve generic drugs at the “earliest possible entry dates,” per Reuters. In their appeal, the plaintiffs argue that this decision prevented them from presenting a comprehensive case, including a model showing an alternative timeframe for a generic Lipitor’s release.

The appeals case, titled In Re: Lipitor Antitrust Litigation, underscores the high stakes in pharmaceutical patent disputes, where delayed generic competition can have a significant financial impact on healthcare providers and patients alike. The 3rd U.S. Circuit Court of Appeals has yet to announce when it will hear arguments on the matter.

Source: Reuters