The U.S. Patent & Trademark Office (PTO) issued a final written decision in Argentum Pharmaceuticals inter partes review (IPR) against the sole unexpired patent listed as covering Janssen Oncology ZYTIGA (abiraterone acetate) drug in the Food & Drug Administration's Orange Book. Janssen Oncology is a subsidiary of Johnson & Johnson. Argentum challenged all claims (claims 1−20) of Janssen's U.S. Patent No. 8,822,438, which the 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."
Argentum Pharmaceuticals' CEO Jeffrey Gardner issued the following statement regarding the ruling:
"We are pleased that the PTO has ruled in Argentum's favor by holding all claims of the last remaining Orange Book patent for Zytiga to be obvious. 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 core mission is to lower the cost of prescription drugs by challenging patents that are not innovative and which artificially support high drug prices. 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. 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."