Argentum Pharmaceuticals wins patent invalidation trial against the sole remaining patent protecting Janssen’s Zytiga.
The U.S. Patent & Trademark Office (PTO) issued a final written decision Wednesday in Argentum Pharmaceuticals LLC’s inter partes review (IPR) against the sole unexpired patent covering Janssen Oncology, Inc.’s Zytiga (abiraterone acetate). Janssen Oncology is a subsidiary of Johnson & Johnson.
Johnson & Johnson said it is evaluating its options concerning a possible rehearing request or appeal, according to a company statement.
Argentum had challenged all claims (1−20) of Janssen’s U.S. Patent No. 8,822,438, which the FDA’s Orange Book states will expire in August 24, 2027.
In the decision, the PTO concluded that Argentum “satisfied its burden of demonstrating, by a preponderance of the evidence, that the subject matter of claims 1–20 would have been obvious,” and therefore ordered “that claims 1-20 are held unpatentable.“
“The inter partes review process is an important tool by which generic and biosimilar companies can create prescription drug savings by ensuring that non-innovative patents do not block competition,” Argentum’s CEO Jeffrey Gardner said following the decision. “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.”
Johnson & Johnson, meanwhile, issued the following statement: “We are disappointed in and strongly disagree with the U.S. Patent and Trademark Office’s (USPTO) decisions relating to Zytiga as part of the inter partes reviews. We are evaluating our options with respect to a request for rehearing and/or appeal to the Court of Appeals for the Federal Circuit. We believe the ‘438 patent is valid and will continue to vigorously defend it.”
But, Argentum’s Gardner expressed confidence that, if appealed, the decision would be upheld: “We believe that the PTO’s decision will be upheld if appealed by Janssen, and will save the U.S. healthcare system billions of dollars over the next decade. Those savings will inure to the benefit of American patients by improving their access to the high quality, safe, and effective FDA-approved generic alternatives that they deserve.”
Zytiga is used along with prednisone to treat men with prostate cancer that is resistant to medical or surgical treatments and that has spread to other parts of the body.
(Sources: Argentum Pharmaceuticals LLC via PR Newswire; Johnson & Johnson via PR Newswire)
