On October 26, 2018 Johnson & Johnson (NYSE: JNJ) reported that the United States District Court, District of New Jersey has issued a ruling invalidating all asserted claims of U.S. Patent No. 8,822,438 for ZYTIGA (abiraterone acetate) (Press release, Johnson & Johnson, OCT 26, 2018, View Source [SID1234530301]). 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.

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Janssen strongly disagrees with the court’s ruling and will continue to defend the patent. We plan to appeal the decision. The Court has ordered that the 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. Janssen has filed a motion for rehearing with the U.S. Patent & Trademark Office (USPTO) in connection with the prior Inter Partes Review decisions related to the ‘438 patent.

Commercial launch of generic abiraterone acetate prior to the outcome of the appeals would be considered an at-risk launch. In Europe, ZYTIGA is protected by regulatory exclusivity through September 2022.

Janssen will continue to defend intellectual property rights relating to its innovative medicines. The company reaffirms its guidance provided on October 16, 2018 for operational sales growth of 5.5% to 6.0% and its adjusted earnings per share guidance of $8.13 – $8.18 for the full-year 2018.