According to Salix:
“Two patents claim methods of treating IBS-D using a specific dosage of rifaximin: 550 mg administered three times a day (1,650 mg per day) for 14 days.”
1. “In finding these claims invalid as obvious, the district court relied on a press release (‘the RFIB2001 Press Release’), which quotes a named inventor and reports some results of a study that is discussed at length in the IBS-D Patents. Did the district court err by relying on the RFIB2001 Press Release as prior art under pre-AIA Section 102(a) without evidence that it reported work by ‘others’?”
2. “Even considering the RFIB2001 Press Release, the highest dosage for which the district court found prior art reported successful results in treating IBS-D was 1,200 mg per day. Did the district court err in applying this Court’s ‘prior-artrange’ cases to find a reasonable expectation of success in treating IBS-D using the claimed dosage (1,650 mg per day) because it was ‘within the known range’? Issue Concerning Polymorph Patents: Two patents claim rifaximin in a form labeled ‘polymorphic form β.’”
“Two patents claim rifaximin in a form labeled ‘polymorphic form β.’”
3. “At the time of the patent filing, it was unknown whether rifaximin was even polymorphic, much less whether form β existed. Did the district court err in finding that a skilled artisan would have had a motivation and reasonable expectation of success in preparing the claimed rifaximin form β?”
According to Norwich:
1. “Whether the District Court legally erred in implementing the remedy for an act of infringement mandated by 35 U.S.C. § 271(e)(4)(A) in its Final Judgment by declining to reference the hepatic encephalopathy (‘HE’) indication in Norwich’s ANDA – the only basis for the court’s infringement finding – and abused its discretion in denying Norwich’s motion to modify the Final Judgment under Federal Rule of Civil Procedure 60(b)?”
2. “Whether Salix has demonstrated that the District Court committed clear and reversible error in finding that ‘there was no evidence’ that Salix’s September 2007 RFIB2001 Press Release disclosed information derived from the work of any inventor(s) and that the District Court therefore erred in finding the RFIB2001 Press Release is prior art under pre-AIA Section 102(a)?”
3. “Whether Salix has demonstrated that the District Court committed clear error in finding that the prior art disclosed a dosage range of rifaximin that encompassed the claimed dosage of 1650 mg per day, or that a POSA would have a reasonable expectation of success in combining the prior art based on evidence of widespread off-label use, success reported in the prior art, and two clinical studies?”
4. “Whether Salix has demonstrated that the District Court committed clear error in finding that the prior art disclosed crystalline rifaximin that a POSA would have been motivated to characterize and would have had a reasonable expectation of identifying rifaximin β having the claimed XRPD peaks and water contents?”
5. “Whether the District Court erred in finding that Norwich did not prove that claim 4 of the ’199 patent is inherently anticipated?”
To Norwich
1. “That the ANDA further recited a non-patent-protected indication does not negate the infringement resulting from the ANDA’s submission.”
2. “We need not decide whether or not the Press Release was prior art because, even assuming that it was not, the Protocol and Pimentel alone established the obviousness of the claims.”
3. “Norwich challenged the IBS-D claims’ validity by asserting as prior art references a clinical trial protocol . . . (‘the Protocol’) and a 2006 journal article (‘Pimentel’) . . . [t]he district court did not clearly err in finding that a skilled artisan would have looked to both of those references, considered their limits, and had a reasonable expectation of success as to the efficacy of 550 mg TID dosing.”
4. “Salix has done no more than combine known elements of the prior art to verify readily accessible information concerning a compound already in the hands of those of ordinary skill in the art, and such routine efforts do not justify removing this polymorph from the public domain.”
5. “Because we affirm the court’s holding that the polymorph patent claims would have been obvious over the asserted prior art, we need not consider Norwich’s separate argument that the polymorph claims would have also been invalid as inherently anticipated.”
