CAFC-DCTJune 8, 2026·25-1060·Affirmed the district court's final judgment that claim 18 of the '908 patent is invalid as obvious under 35 U.S.C. § 103.
KNOA PHARMA LLC v. ACCORD HEALTHCARE, INC.
District Court for the District of Delaware
Holding
The Federal Circuit affirmed, holding that the district court did not clearly err in finding motivation to use a coating pan and a reasonable expectation of success in modifying the Bartholomäus prior art. The court also rejected Purdue/Knoa's objective-indicia arguments, finding no clear error on long-felt need and treating the shifted scalability theory as forfeited and, in any event, not commensurate with the claim.
Why It Matters
The decision underscores that scaling a known pharmaceutical process using conventional manufacturing equipment can be obvious where credited expert testimony supplies a practical motivation and reasonable expectation of success.
Full Summary
KNOA PHARMA LLC v. ACCORD HEALTHCARE, INC.
The Federal Circuit affirmed, holding that the district court did not clearly err in finding motivation to use a coating pan and a reasonable expectation of success in modifying the Bartholomäus prior art. The court also rejected Purdue/Knoa's objective-indicia arguments, finding no clear error on long-felt need and treating the shifted scalability theory as forfeited and, in any event, not commensurate with the claim.
The decision underscores that scaling a known pharmaceutical process using conventional manufacturing equipment can be obvious where credited expert testimony supplies a practical motivation and reasonable expectation of success.
Affirmed the district court's final judgment that claim 18 of the '908 patent is invalid as obvious under 35 U.S.C. § 103.
The only claim pursued on appeal was dependent claim 18, directed to an oxycodone extended-release dosage form that incorporated claim 17's requirement that the tablet be heated in a coating pan.
The prior art Bartholomäus disclosed abuse-deterrent PEO opioid tablets but used a heated tablet press; Accord's expert testified that coating pans were common, scalable pharmaceutical equipment and would have been an attractive substitute for curing and later coating tablets.
The Federal Circuit found no legal error in the district court's discussion of convection heating and coating pans together, because the court separately recognized the coating-pan limitation for claim 18.
The panel deferred to the district court's credibility findings and held that Purdue/Knoa's contrary evidence did not establish clear error on motivation to modify or reasonable expectation of success.
On secondary considerations, Bartholomäus already addressed the alleged need for abuse-deterrent opioid tablets; Purdue/Knoa's appellate reframing as a need for scalable commercial manufacture was forfeited and not commensurate with the dosage-form claim.
§ 103 Hatch-Waxman / ANDA waiver / forfeiture non-precedential
§ 103 Hatch-Waxman / ANDA waiver / forfeiture non-precedential
§ 103 Hatch-Waxman / ANDA waiver / forfeiture non-precedential
Key Points
- The only claim pursued on appeal was dependent claim 18, directed to an oxycodone extended-release dosage form that incorporated claim 17's requirement that the tablet be heated in a coating pan.
- The prior art Bartholomäus disclosed abuse-deterrent PEO opioid tablets but used a heated tablet press; Accord's expert testified that coating pans were common, scalable pharmaceutical equipment and would have been an attractive substitute for curing and later coating tablets.
- The Federal Circuit found no legal error in the district court's discussion of convection heating and coating pans together, because the court separately recognized the coating-pan limitation for claim 18.
- The panel deferred to the district court's credibility findings and held that Purdue/Knoa's contrary evidence did not establish clear error on motivation to modify or reasonable expectation of success.
- On secondary considerations, Bartholomäus already addressed the alleged need for abuse-deterrent opioid tablets; Purdue/Knoa's appellate reframing as a need for scalable commercial manufacture was forfeited and not commensurate with the dosage-form claim.