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Ruling Removes Final Patent Protection for Zytiga
The U.S. Patent & Trademark Office (USPTO) has overturned the sole unexpired patent keeping generic competition at bay for the prostate-cancer medication abiraterone acetate (Zytiga, Janssen Oncology). Generic drug-maker Argentum Pharmaceuticals LLC successfully challenged all claims of a Janssen patent that would not have expired until August 24, 2027.
The USPTO concluded that Argentum "satisfied its burden of demonstrating, by a preponderance of the evidence, that the subject matter of [the claims] would have been obvious," and therefore ordered that the claims “are held unpatentable," Argentum said.
"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,” Argentum CEO Jeffrey Gardner said after the ruling. ““We believe that the PTO's decision will be upheld if appealed by Janssen, and will save the U.S. health care system billions of dollars over the next decade."
Johnson & Johnson (Janssen’s parent company) said it believes the patent is valid “and will continue to vigorously defend it.”
“We are disappointed in and strongly disagree with the U.S. Patent and Trademark Office’s … decisions relating to Zytiga as part of the Inter Partes Reviews,” Johnson & Johnson said. “We are evaluating our options with respect to a request for rehearing and/or appeal to the Court of Appeals for the Federal Circuit.”
Inter Partes Review decisions by the USPTO do not result in termination of a 30-month stay triggered under the Hatch-Waxman Act by the timely filing of a patent infringement lawsuit against a generic drug applicant, Johnson & Johnson added. But Fierce Pharma quoted Credit Suisse analyst Vamil Divan as anticipating a generic entry following the expiration of a 30-month stay in October 2018.
Zytiga is used along with prednisone to treat men with castration-resistant prostate cancer. In 2016 in the U.S., the drug generated $1.1 billion in sales.