J&J reveals plans to appeal cancer drug court ruling

Johnson & Johnson (J&J) has revealed its intention to appeal against a district court’s invalidation of a patent covering its prostate cancer drug Zytiga (abiraterone acetate).

On Friday, October 26, J&J announced that the US District Court for the District of New Jersey had invalidated all asserted claims of US patent number 8,822,438, called “Methods and compositions for treating cancer”.

The court also held that the patent claims would be infringed if the patent were valid.

J&J had filed the patent infringement case against several companies, including Amneal and Teva, that had submitted Abbreviated New Drug Applications for 250 mg and/or 500 mg tablets.

“Janssen [a subsidiary of J&J] strongly disagrees with the court’s ruling and will continue to defend the patent. We plan to appeal the decision,” said J&J.

The court has ordered that generic launch shall not occur before October 31, 2018 so that Janssen’s motion for a preliminary injunction to stop the defendants from launching their generic products pending the appeal process can be decided.

Janssen has also filed a motion for rehearing at the US Patent and Trademark Office in connection with the prior inter partes review (IPR) decisions related to the ‘438 patent. These are still pending.

In January this year, LSIPR reported that the Patent Trial and Appeal Board had invalidated the ‘438 patent after finding that the claims were unpatentable over combinations of two articles and US patent number 5,604,213.

Argentum Pharmaceuticals, the generics company that had applied for an IPR of the patent, was granted review of claims 1 to 20.

Commercial launch of generic abiraterone acetate before the outcome of the appeals would be considered at-risk, added the press release.

In Europe, Zytiga is protected by regulatory exclusivity through to September 2022.

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