The Situation: In a Hatch-Waxman litigation, a district court determined that the claims covering a method of using the drug everolimus to treat kidney cancers were not obvious. The court found a motivation to "pursue" everolimus, but the defendant failed to show a motivation to "select" everolimus over other treatment options.
The Result: On appeal, the Federal Circuit faulted the district court for applying the "lead compound" analysis and requiring a motivation to select everolimus over other treatment options as a prerequisite for obviousness. The Federal Circuit distinguished method-of-treatment claims from compound claims to which the lead compound analysis applies.
Looking Ahead: In Novartis, the district court found a motivation to pursue, and the Federal Circuit faulted it for additionally requiring a motivation to select and for applying the lead compound analysis to method-of-treatment claims. It remains to be seen the effect of this holding on other types of claims and in cases without a finding of motivation to pursue. In a recent case, the Federal Circuit held that the heightened requirement of preferring the claimed invention over other known alternatives found in the lead compound analysis does not apply to method-of-treatment claims. Novartis Pharm. Corp. v. W.-Ward Pharm. Int'l Ltd., 923 F.3d 1051, 1059 (Fed. Cir. 2019). The Federal Circuit distinguished method-of-treatment claims from other types of claims to which the lead compound analysis applies under its precedent, finding that the district court erred in applying the lead compound analysis to determine whether a skilled artisan would have had a motivation to combine the prior art. But ultimately, the Federal Circuit affirmed the district court's non-obviousness determination because the district court did not clearly err in finding no reasonable expectation of success.
AFINITOR® (everolimus) is approved for treating advanced renal cell carcinoma ("RCC"). Novartis owns U.S. Patent No. 8,410,131 ("'131 patent"), which claims a method of using everolimus to treat advanced kidney cancers, including advanced RCC. In a Hatch-Waxman litigation, generic defendant West-Ward sought to invalidate the '131 patent as obvious.
As of the priority date of the '131 patent, everolimus was known to inhibit mTOR, a protein that regulates cellular processes relating to cancer. Another mTOR inhibitor, temsirolimus, had been tested in Phase I clinical trials in which a small...