Docket No. 2015-1957
NEWMAN, LOURIE, CHEN
September 8, 2016
Brief Summary: DC grant of SJ of non-infringement based on its construction of claim term “monoclonal antibodies” in claim 1 (not amended during prosecution) as excluding chimeric and humanized antibodies due to prosecution history estoppel affirmed.
Summary: UCB was granted SJ that its Cimizia® chimeric and humanized antibodies do not infringe Yeda’s US 6,090,923 claiming “[a] monoclonal antibody which specifically binds a human cytotoxin” defined by molecular weight, as “obtainable from stimulated human monocytes” and “in a state of enhanced purity” by a particular process, and “exhibiting a cytotoxic effect on cyclohexamine-sensitized SV-80 cells”. “The question” addressed here “is whether the monoclonal antibody of claim 1 includes chimeric or humanized antibodies, when the patent specification describes only murine (mouse) antibodies.” The DC construed “monoclonal antibody” to mean “a homogenous population of a single type of antibody produced via hybridoma and not including chimeric or humanized antibodies”, based on the specification and prosecution history. During prosecution, Yeda introduced new claims specifically claiming “rat, hamster and human antibodies and chimeras thereof” and “nonmurine” mAbs but these were rejected as including new matter and lacking enablement. Yeda argued against the rejections but ultimately cancelled the claims and the patent issued. Yeda argued “that generic terms in claims are construed in light of that which is already known” and the FC agreed but also noted that the specification and prosecution history “must also be considered” (Advance Transformer, FC 1988). The DC condluded that Yeda’s expert witness testimony did not support its position that in 1984 “monoclonal antibodies” was understood to include “either chimeric or humanized antibodies” and that “for the first ten years of prosecution, neither Yeda nor the examiner understood the term…to include” the same. Since there was no “narrowing amendment” to claim 1, Yeda argued prosecution history estoppel should not apply. But the FC concluded “estoppel was reasonably applied to claim 1” since “statements and actions of the patentee before the PTO during prosecution” are examined to “ask what a competitor reasonably may conclude the patentee surrendered to gain issuance of the patent” (Builder’s Concrete, FC 1985 (“the court rejected to argument that ‘file wrapper estoppel cannot arise without amendment”)). It therefore concluded the DC had correctly applied the law and “Yeda is estopped from including chimeric and humanized antibodies within the scope of” claim 1.