Novartis Ag v. Noven Pharmaceuticals Inc.
853 F.3d 1289
| Fed. Cir. | 2017Background
- Novartis appealed PTAB final written decisions in two IPRs holding various claims of U.S. Patent Nos. 6,316,023 and 6,335,031 obvious (the Asserted Claims).
- PTAB found combinations of prior art—principally UK Appl. GB 2,203,040 (Enz) and JP Appl. 59-184121 (Sasaki)—would have rendered the asserted claims obvious; Novartis does not contest some claim-specific findings.
- Novartis argued the PTAB erred by reaching conclusions inconsistent with prior judicial rulings (this court in Watson and the D. Del. decision) and by lacking substantial evidence for key factual findings (e.g., motivation to combine, predictability of oxidative degradation).
- PTAB relied on additional prior art and expert declarations not in the earlier judicial records, and applied the IPR preponderance-of-the-evidence standard rather than the district-court clear-and-convincing standard.
- The Federal Circuit affirmed: prior judicial decisions did not bind the PTAB under the circumstances, and substantial evidence supported the PTAB’s factual findings and its obviousness conclusion.
Issues
| Issue | Novartis's Argument | Noven / PTAB's Argument | Held |
|---|---|---|---|
| Whether PTAB must follow prior district-court/Fed. Cir. decisions addressing same art | PTAB was legally required to reach same result as Watson and D. Del. decision when evidence and arguments were the same | PTAB may reach a different result in IPRs due to different evidence and lower burden of proof (preponderance) | PTAB not bound; differing records and standards permit different outcomes; affirmed |
| Whether record differences existed to justify PTAB divergence | The record was substantively the same; Baxter requires USPTO to avoid different conclusions if same evidence | PTAB identified additional prior art and declarations not before the courts, supporting different analysis | PTAB properly relied on additional evidence; Baxter not a mandate to match prior rulings |
| Motivation to combine Enz and Sasaki (obviousness) | A PHOSITA would only add an antioxidant after observing oxidative degradation in testing | PHOSITA could predict degradation from chemical structure and literature; Sasaki teaches antioxidants stabilize drugs in acrylic polymers | Substantial evidence supports PTAB finding of motivation to combine; affirmed |
| Predictability of rivastigmine oxidative degradation from structure | Expert testimony (Novartis) claimed structure alone insufficient to predict oxidation | PTAB credited literature and expert testimony showing PHOSITA would assess functional groups and predict likely degradation | Substantial evidence supports PTAB's finding that PHOSITA would predict oxidative susceptibility; affirmed |
Key Cases Cited
- Graham v. John Deere Co. of Kansas City, 383 U.S. 1 (Graham factors for obviousness)
- In re Gartside, 203 F.3d 1305 (Fed. Cir.) (obviousness is legal conclusion based on factual findings)
- In re Baxter International, Inc., 678 F.3d 1357 (Fed. Cir.) (USPTO ideally should not differ when facing same evidence, but not an absolute bar)
- Cuozzo Speed Technologies, LLC v. Lee, 136 S. Ct. 2131 (Sup. Ct.) (IPR uses different burden and can yield results inconsistent with courts)
- In re Kahn, 441 F.3d 977 (Fed. Cir.) (motivation to combine need not be explicit in prior art)
- In re Warsaw Orthopedic, Inc., 832 F.3d 1327 (Fed. Cir.) (review of factual findings on motivation to combine is for substantial evidence)