Johnson & Johnson announced that a US district court in New Jersey issued a ruling invalidating all asserted claims of a patent for Zytiga (abiraterone). The company, which plans to appeal the decision, filed the lawsuit after several drugmakers, including Teva, Mylan and Amneal Pharmaceuticals, had submitted FDA filings to market generic versions of the prostate cancer therapy.
According to Johnson & Johnson, the court ordered that there can be no generic launches of the product before October 31, so that the company's preliminary injunction request "to enjoin defendants from launching their generic products pending the appeal process can be decided."
The patent in question, which is the only unexpired patent protecting Zytiga, covers the use of Zytiga's active ingredient with prednisone. District Court Judge Kevin McNulty noted that prednisone's ability to reduce pain and side effects in patients suffering from cancer "would furnish a powerful motivation" to combine it with Zytiga's active ingredient, adding "that road led straight to the practice of the patented method." McNulty also pointed out that more than 85 percent of Zytiga prescriptions are being filled in proximity to prednisone.
Johnson & Johnson stated that it "strongly disagrees" with the district court ruling and has also filed a motion for rehearing with the US Patent & Trademark Office (PTO) in connection with prior inter partes review decisions related to the patent in question. In January, the PTO issued a similar ruling invalidating the patent.
Meanwhile, Johnson & Johnson warned that a commercial launch of generic Zytiga prior to the outcome of the appeals would be considered an at-risk launch, while the drug is protected in Europe by regulatory exclusivity through September 2022. Besides Teva, Mylan and Amneal, other drugmakers seeking to commercialise generic versions of Zytiga include Hikma Pharmaceuticals, Endo International's Par Pharmaceutical and Dr. Reddy's Laboratories.
Johnson & Johnson also reiterated its most recent guidance for operational sales growth ranging from 5.5 percent to 6 percent and full-year earnings of between $8.13 per share and $8.18 per share. Zytiga, which had about $2.5 billion in sales in 2017, beat revenue forecasts of $795 million during the third quarter, climbing 43.2 percent year-over-year to $958 million.
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