The USPTO is paving the way for generic challengers to J&J’s prostate cancer drug Zytiga.
The U.S. Patent & Trademark Office is paving the way for generic challengers to Johnson & Johnson’s prostate cancer drug Zytiga (abiraterone). On Wednesday, the court nullified one of the pharma giant’s patents that covered the administration of the drug.
The administrative court said the particular patent it nullified should never have been granted because the process that it described was obvious, Reuters reported. The ruling was a victory for Argentum Pharmaceuticals which had challenged the patent. In its ruling, the Patent & Trademark Office said Argentum “satisfied its burden of demonstrating, by a preponderance of the evidence, that the subject matter of claims 1–20 would have been obvious,” the company announced in a statement this morning.
The PTO ruling shaved 10 years off of the time that companies could field a generic of Zytiga. The patent, which was the sole remaining one J&J’s pharma division Janssen maintained on the cancer drug, was set to expire in 2027. With the patent out of the way, other companies will be ready to move forward and seek to take a slice of the $2.6 billion pie that Zytiga earned for J&J in 2016.
One company that will surely benefit is Pfizer and its prostate cancer drug Xtandi. Pfizer added Xtandi to its pipeline following the $15 billion acquisition of Medivation.
With billions of dollars on the table, J&J certainly won’t step aside and make it easy for the other companies to field a rival generic. Reuters noted that the company “strongly disagreed” with the PTO’s ruling and is considering an appeal to the U.S. appeals court. In a statement, the company said it believes the patent is valid and will “continue to vigorously defend it.”
Argentum, which brought the challenge, disagreed.
“We believe that the PTO’s decision will be upheld if appealed by Janssen, and will save the US healthcare system billions of dollars over the next decade,” Argentum Pharmaceuticals’ Chief Executive Officer Jeffrey Gardner said in a statement. “Argentum’s core mission is to lower the cost of prescription drugs by challenging patents that are not innovative and which artificially support high drug prices.”
While Janssen could lose its protections for Zytiga, Endpoints News noted the company has another late-stage prostate cancer drug before the FDA that could provide new revenues. Apalutamide (ARN-509) won a priority review of apalutamide for nonmetastatic castration-resistant prostate cancer, Endpoints said. The PDUFA date is set for April. The company will present Phase III data next month at the ASCO Genitourinary Cancers Symposium, Endpoints added.
