Docket No. 2013-1335
LOURIE, SCHALL, REYNA
September 26, 2013
Brief summary: DC claim construction determination based on prosecution history affirmed but infringement decision reversed because ANDA falls within scope of disputed patent.
Summary: Sunovion appeal DC grant of SJ to Dr. Reddy’s that it does not infringe claims 1, 2 and 8 of US 6,444,673 encompassing pharmaceutical compositions of the single-enantiomer drug (S)-eszopiclone (the sleep medication Lunesta®). In approving Lunesta®, the FDA required it to contain not more than 0.3% of the corresponding levorotatory enantiomer, (R)-zopiclone. Following a Markman hearing, the DC construed the term “essentially free” [of its levorotator isomer] of the disputed claims to mean “less than 0.25% of [the] levorotatory isomer”. The DC found no plain meaning or definition in the intrinsic evidence but found Sunovion to be bound by the prosecution history (inventor declaration, amendments and arguments). It also rejected Sunovion’s expert, whose testimony was “limited by the fact that he did not read the entire file history of the patent”. Reddy’s original ANDA specification requested approval for generic eszopiclone products with “[n]ot less than 0.3% and [n]ot more than 1.0%” levorotatory isomer. Ultimately, Reddy received approval for a product restricted to 0.0-0.6% levorotatory isomer. Reddy also submitted a declaration to the DC, but not the FDA, that it would not produce a product containing less than 0.3% levorotatory isomer. The DC then granted SJ of noninfringement. The FC panel agreed with the DC claim construction finding, for instance, that “[t]he term ‘essentially free’ appears only in the claims…and does not appear anywhere in the written description” and “the prosecution history…demonstrates that the applicants repeatedly and consistently defined their claimed invention to be as exhibited by Example 1” (citing Computer Docking Station, FC 2008 (“[t]he definition of a claim term can be affected through ‘repeated and definitive remarks”); Honeywell (FC 2006); Phillips Petroleum (FC 1998) (appropriate to rely on the record of interference proceedings in construing claim terms)). However, the panel disagreed with the DC regarding infringement, finding that “if a product that an ANDA applicant is asking the FDA to approve for sale [0.0-0.6%] falls within the scope of an issued patent [less than 0.25%], a judgment of infringement must necessarily ensue” (citing Abbott Labs., FC 2002) (e.g., Reddy’s declaration to the court was irrelevant (“Simply saying ‘But I won’t do it’ is not enough to avoid infringement.”) The claim construction determination was affirmed but the infringement decision reversed.