J&J’s blockbuster prostate cancer drug loses patent battle

By PharmaCompass

2018-11-01

Impressions: 136 Article

Johnson & Johnson lost the case in a US district court wherein it asserted its patent claims for Zytiga (abiraterone acetate), its blockbuster prostate cancer drug. This will potentially enable the launch of generics in the coming one week or so.

The Court held that the patent claims would be infringed if the patent were valid. The patent infringement case was filed against several companies who have submitted Abbreviated New Drug Applications for 250 mg and/or 500 mg tablets.

Johnson & Johnson though isn’t giving up the fight for Zytiga. Janssen (a J&J company) said it “strongly disagrees with the court's ruling and will continue to defend the patent”.

The company has filed a motion for rehearing with the US Patent & Trademark Office (USPTO) in connection with the prior inter partes review decisions related to the 438 patent.

The Court has ordered that status quo be maintained through October 30, 2018, and no generic launch shall occur before October 31, 2018, so that Janssen’s preliminary injunction motion to enjoin defendants from launching their generic products pending the appeal process can be decided.

Zytiga has been driving growth for J&J ever since its launch back in 2011. Even now, its sales are growing at a fast clip — Zytiga generated US$ 1.42 billion in the US in the first nine months of 2018, a 71 percent boost year on year. In Europe, Zytiga is protected by regulatory exclusivity through September 2022.

However, J&J executives insist they don’t need Zytiga for sales growth. On the company’s third-quarter conference call, they said the company has a broad pharma portfolio that turned in 8.2 percent growth excluding currency effects. Without Zytiga, the unit still grew by 6.6 percent. Moreover, Zytiga’s international growth can help soften the blow.

Internationally, the drug posted sales of US$ 1.29 billion through the first nine months of this year, marking an increase of 40 percent.

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