
A Federal Circuit panel affirmed a bench-trial judgment finding that Lupin’s tolvaptan ANDA process does not infringe Otsuka’s patents and that asserted method claims are invalid as obvious over a 1999 small-scale synthesis paper. The broader point is that, with inter partes review effectively unavailable for many filers, district courts are increasingly responsible for performing §103 obviousness invalidation. PTAB decisions have developed extensive operational guidance on obviousness, including motivation to combine or modify, reasonable expectation of success, lead compound and lead reference selection, and weighing secondary considerations. That corpus can be cited as persuasive authority in bench trials because judges act as factfinders, but it is harder to deploy in jury trials because the jury performs the factfinding role.
"For bench trials, where the judge wears the factfinder hat, that corpus should be treated as persuasive authority and cited directly. For jury trials, the same corpus is much harder to deploy because the PTAB did the bulk of its work as a factfinder, and that role belongs to the jury, not the court."
"The PTAB has spent more than a decade building out the operational process of obviousness adjudication, with thousands of final written decisions parsing motivation to combine, motivation to modify, reasonable expectation of success, lead compound and lead reference selection, and the weighing of secondary considerations. That body of decisional law is the most extensive working corpus of patent obviousness doctrine in the United States."
"Pre-AIA, defense counsel often steered away from §103 invalidity in district court and were especially wary of putting obviousness to a jury. The presumption of validity and clear-and-convincing burden, and the natural complexity of almost every patent made an obviousness finding seem like a long shot."
"But, I believe we are at a different place now. The PTAB has cancelled thousands of claims on obviousness grounds over the past dozen years, demonstrating that many issued patents have §103 vulnerabilities that may also be exploited in district court litigation."
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