Johnson & Johnson’s patent on the prostate-cancer drug Zytiga is invalid, a federal judge in New Jersey ruled Friday, clearing the way for generic competitors.
The decision was a victory for generic-drug companies including Teva Pharmaceutical Industries Ltd., Mylan NV, and Amneal Pharmaceuticals Inc. It’s the second blow for J&J on the patent — a parallel review by the Patent Trial and Appeal Board earlier this year also resulted in a decision that the patent was invalid.
Other generic-drug companies seeking to sell copies include Hikma Pharmaceuticals Plc, Endo International Plc’s Par Pharmaceutical Inc. and Dr. Reddy’s Laboratories Ltd.
“We strongly disagree with the court’s ruling and will continue to defend the patent,” said Caroline Pavis, a spokeswoman for J&J’s Janssen unit. “We plan to appeal the decision.”
The generic-drug companies can’t launch their copies until Oct. 31, U.S. District Judge Kevin McNulty said. The judge said he wants to maintain the status quo while considering whether to block the generics until an appeals court rules on the patent.
A Teva representative declined to comment. Officials at Endo, Mylan and Amneal didn’t immediately respond to requests for comment.
Zytiga had U.S. sales of $1.4 billion in the first nine months of 2018, a 72-percent leap from the $826 million it had during the same period in 2017, J&J said Oct. 16 in its quarterly earnings report. J&J and partner BTG Plc have been counting on the patent to block the copycat medicines until August 2027.
The patent covers the use of the active ingredient of Zytiga with the steroid prednisone. The generic-drug makers had argued that it wasn’t a new idea, and McNulty agreed. He also said that if the patent is found to be valid upon appeal, the generic-drug companies would infringe it.
Prednisone’s ability to reduce pain and side effects in cancer patients “would furnish a powerful motivation” to combine it with Zytiga’s active ingredient, McNulty said. “That road led straight to the practice of the patented method,” he said.
More than 85 percent of Zytiga prescriptions are being filled in proximity to prednisone, the judge said.
J&J has asked the patent office to reconsider its earlier decision, which was based on a different legal standard than that used by McNulty. The drugmaker must win in both cases.
The case is BTG International Ltd. v. Amneal Pharmaceuticals LLC, 15-cv-5909, U.S. District Court, District of New Jersey (Newark).