4. Papp is incompatible with AURA-LV
Papp’s renal criteria are not even compatible with the intended purposes of AURA-LV. EX2003, ¶¶¶165-171. Because AURA-LV’s intended patients would be excluded with Papp’s renal criteria, “n effect, [AURA-LV] teaches away from the... proposed modification.” In re Gordon, 733 F.2d 900, 902 (Fed. Cir. 1984) (inoperable modification teaches away). Sun did not even address this critical consideration.
Consistent with other psoriasis trials, Papp excludes subjects with eGFR<60. EX1006, 1; EX2065, 55:2-56:13, 99:9-23; see supra, §II.D (trend of more restrictive criteria for psoriasis studies). Excluding subjects with eGFR<60, however, is incompatible with the treatment of LN generally, where “most patients with lupus nephritis will have abnormal kidney function” and around 50% will have CKD. EX2065, 10:22-11:15, 105:6-106:9. As Sun’s declarant admits, “if you include only people with normal kidney function in a lupus nephritis trial, you will not have any subjects to include because most patients will have some degree of kidney impairment.” EX2065, 105:6-106:9; see supra, §II.A (treating LN patients with baseline eGFR as low as 15). Papp’s renal criteria are specifically incompatible with
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AURA-LV, where the intended population has baseline eGFR as low as 45. EX1005, 8. Papp is thus excluding from treatment any patients with impairment of renal function, including starting eGFR of 45-60, within the population AURA-LV sought to treat, and would render AURA-LV no longer suitable for its intended purpose. EX2003, ¶¶166-167.
Further, Papp teaches terminating treatment if eGFR drops by 30%, regardless of the absolute starting or ending values. EX1006, 1. This means that patients with starting eGFRs of 120 and 110, for example, would be discontinued from voclosporin treatment if their eGFR dropped below 84 or 77, respectively. EX2003, ¶168; EX2065, 198:22-199:13. This directly contradicts AURA-LV, where a final eGFR>60 could be consistent with achieving the “complete remission” even if it had dropped to that level by 30% or more. EX1005, 5; EX2003, ¶169. By excluding these intended patients, Papp would preclude successful treatment according to AURA-LV and render AURA-LV no longer suitable for its intended purpose.
Relatedly, institution was premised on finding that “[1] voclosporin treatment may be performed while eGFR values remain above 60 ml/min and [2] should be terminated at a minimum when eGFR values are reduced below 45 ml/min....” ID, 19. This finding is inconsistent with up to 20% reduced eGFR being part of “complete remission” according to AURA-LV and “a good approximation, basically, to a stable kidney function.” EX2065, 168:18-170:20; EX1005, 5, 8.
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Limiting treatment when eGFR remains above 60 or discontinuing treatment when values are reduced to below 45 thus would be inconsistent with and render AURA- LV no longer suitable for its intended purpose. EX2003, ¶¶170-171. Discontinuing treatment at eGFR less than 45 is also incompatible with the treatment of LN generally, where baseline eGFR criteria of as low as 15 were common and continued treatment following up to 50% eGFR reductions did not result in modifying treatment. Supra, §II.A; EX2032, 2; EX2065, 82:2-83:14, 93:11-94:3; EX2003, ¶¶170-171.
C. The Petition Does Not Establish a Reasonable Expectation of Success
As the Board found, independent claim 1, from which all claims depend, entails administering a daily dosage of voclosporin that is effective to treat a PKD under the claimed conditions. ID, 8-9; supra, §III.D. Sun’s Grounds 1-2 fail to establish a reasonable expectation of success for this claimed method.
1. Sun does not assert any reasonable expectation of success
Sun fails to assert, much less establish, that a POSA would have had a reasonable expectation of success in achieving the claimed pharmacodynamic dosing regimen. See Pet., 1-62 (not mentioning reasonable expectation of success). This precludes obviousness. Arctic Cat Inc. v. Bombardier Recreational Prods. Inc., 876 F.3d 1350, 1360-61 (Fed. Cir. 2017) (party arguing obviousness “must show the artisan ‘would have had a reasonable expectation of success’” (citation omitted)).
