Written Description Is Determined Based on What Is Claimed, Not What the Patentee Invented Years After the Priority Date

In Novartis Pharmaceuticals Corporation v. Torrent Pharma Inc., No. 2023-2218 (Fed. Cir. Jan. 10, 2025), the Federal Circuit reversed the district court’s determination that the claims of U.S. Patent No. 8,101,659 Patent (“the ’659 Patent”) lacked adequate written description but affirmed its determination that the claims were enabled and not obvious.

The ’659 Patent is directed to a combination of valsartan and sacubitril. The district court construed the claims to cover valsartan and sacubitril as a combination. Based on Novartis’s post-filing discovery of valsartan and sacubitril complex, the district court determined that the claims lacked adequate written description. But it found that the claims were enabled and non-obvious. Novartis appealed.

The Federal Circuit reversed the district court’s written description determination, holding that the ’659 Patent does not claim valsartan-sacubitril complexes, so it need not describe them. The claims only required valsartan and sacubitril combination, which was adequately described in the specification. The Federal Circuit affirmed that the claims were enabled, holding that the later-discovered complexes cannot be used to reach back and invalidate the claims. The Federal Circuit also affirmed the district court’s non-obviousness finding, holding that there was no motivation for a POSA to combine valsartan and sacubitril.