Abiraterone – USA

Abiraterone – USA

On May 14, 2019, Federal Circuit affirmed PTAB & District Court’s decision that Zytiga® method of use patent is invalid as obvious.
This is a consolidated appeal (may be first of its kind, fast paced) from PTAB & District Court which J&J filed after claims were found obvious over prior arts. US 8,822,438 claims treatment of prostate cancer with Abiraterone & Prednisone. Most of the arguments of J&J were on claim construction of term “treatment” by PTAB. J&J said it was errenous.

The PTAB construed the term “treatment” as “including the eradication, removal, modification, management or control of a tumor or primary, regional, or metastatic cancer cells or tissue and the minimization or delay of the spread of cancer.”
But CAFC found no error in claim construction based on internal records. It found that treatment covers both “anticancer effect” & “palliative effect”.  The specification states that antibiotic agents are one example of anti-cancer agents. Therefore, the specification explains that prednisone may be used as both a steroid and an anti-cancer agent. Thus, Prednisone disclosure as palliative effect in prior arts is relevant for obviousness analysis. Court said that if J&J wants to limit it to “anticancer effect” only then they should have done it in claims and should have kept the specification according to it. Even arguing that Prednisone effect should be limited to “anticancer effect”, CAFC said that Wockhardt petition has additional “Sartor” reference which discloses role of Prednisone in prostate cancer. Therefore, in either way it does not alter the ultimate obviousness conclusion.

For more details visit previous posts mentioned below.

District court’s decision reported here:
PTAB’s short summary is here:

Leave a Reply

Leave a Reply

Your email address will not be published.

Disclaimer
All content provided on this blog is for informational purposes only. By using the blog, you agree that the information on this blog does not constitute legal or other professional advice on author's or on his company's behalf.

Copyrights 2022 Pharma IP Circle. All Rights Reserved