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Pfizer wins $2.15 billion patent case

pharmafile | June 13, 2013 | News story | Sales and Marketing Pfizer, Takeda, Teva, protonix 

Pfizer and Takeda are to split $2.15 billion in damages from two generics manufacturers as a settlement for lost sales, following the launch of versions of their branded acid reflux blockbuster Protonix in the US.

Teva Pharmaceuticals Industries and Sun Pharmaceutical Industries will pay up after a ten-year legal battle which has left both companies admitting that their production of generic pantoprazole – Protonix’s key ingredient – infringed a valid patent.

It is thought to be the most that a generics manufacturer has been forced to pay out for a so-called ‘at-risk’ launch – that is, launching a copy of an existing drug whose patent has yet to expire.

In a business where intellectual property is a key revenue driver, the case could therefore set what pharma companies would see as a welcome precedent when it comes to defending their ground in future.

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Japanese firm Takeda owned the patent and it was licensed exclusively to Pfizer subsidiary Wyeth in the US. The gamble for generics companies is that at-risk launches mean they can get their version of a drug to market quickly while there are still legal question marks over a patent.

The downside for them is that, if a patent is upheld at some point down the line, they may be liable to pay damages – and in this case Teva and Sun’s strategy has come unstuck.

The upshot of the decision by a jury in New Jersey federal court is that Teva will shell out $1.6 billion to Pfizer and Takeda – half this year and the remainder by October 2014 – with Sun’s entire payment of $550 million coming before the end of 2013.

The settlement was reached between the companies soon after a trial in the same court began to sort out what the damages should be.

The money will be divided between Pfizer and Takeda, with the former taking the lion’s share – 64% of the total – as compensation for generic launches which happened before Protonix lost protection in January 2011.

“We are pleased with today’s settlement, which recognizes the validity and value of the innovation that led to Protonix,” said Amy Schulman, executive vice president and general counsel of Pfizer.

“Protecting intellectual property is vital as we develop new medicines that save and enhance patients’ lives,” she went on. “Today’s settlement reflects our resolve to enforce our patents both in and out of the courtroom.”

Adam Hill

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