US appeals court sides with Sun Pharma in Lipitor antitrust case

In an intimation to the stock exchange, the Mumbai-based drugmaker said, “the court of Appeals has affirmed the order of the District Court granting summary judgment in its entirety in favour of the Company and brings the litigation substantially to a close.

 

Mumbai: The United States Court of Appeals for the Third Circuit has delivered a favourable ruling for Sun Pharma in a litigation concerning the US market entry of widely used stain, atorvastatin generic alternative.

In an intimation the stock exchange, the Mumbai-based drugmaker said, “the court of Appeals has affirmed the order of the District Court granting summary judgment in its entirety in favour of the Company and brings the litigation substantially to a close.”

“The court in its ruling has also affirmed the District Court’s orders denying class certification as to the plaintiffs,” it added.

The litigation traces back to a 2008 settlement between Pfizer, the maker of Lipitor (atorvastatin), and erstwhile Ranbaxy Laboratories. The US pharma giant had sued the generic competitor, alleging infringement of its patents.

Later the two companies inked a settlement which blocked Ranbaxy to launch its generic copy until November 2011.

Accordogn to Pfizer, the patents covered under the agreement, included the basic compound patent, which was valid till 2010; the enantiomer patent (2011); as well as various process and crystalline form patents, which extended till 2016 and 2017.

However, consumers and third-party payors challenged the settlement, alleging that the settlement unlawfully delayed generic competition.

The plaintiffs alleged that Pfizer unlawfully obtained a patent for the drug and the subsequent agreement with Ranbaxy “unlawfully delayed generic competition in the US”, violating certain state antitrust and consumer protection laws.

In June 2024, the New Jersey District Court ruled that the plaintiffs had failed to establish that the settlement was unlawful and enabled Pfizer to maintain its monopoly. Meanwhile, Pfizer agreed to pay $93 million to settle the lawsuit.

Sun Pharma acquired Ranbaxy (it’s second largest) in 2014 from Japanese giant Daiichi Sankyo for a total consideration of around $4billion — $3.2 billion for the acquisition and around $800 million for debt.

The latest ruling concludes a decade-long antitrust dispute and was among several legal battles involving Ranbaxy.

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