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:
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