Novartis AG v. Torrent Pharmaceuticals Ltd.
853 F.3d 1316
Fed. Cir.2017Background
- The ’283 patent (Novartis) claims solid oral pharmaceutical compositions combining an S1P receptor agonist (notably fingolimod/FTY720) with a sugar alcohol (notably mannitol); Gilenya (fingolimod+mannitol) was FDA-approved in 2010.
- Petitioners (Torrent, Apotex, Mylan) sought inter partes review (IPR) challenging all claims as obvious, primarily based on Chiba (teaching fingolimod and oral solid formulations) combined with Aulton (teaching mannitol as a common tablet excipient).
- The PTAB instituted IPR on the Chiba+Aulton ground, rejected Sakai as a primary reference for solid oral forms (Sakai disclosed fingolimod+mannitol in liquid/lyophilized forms), and later combined the consolidated records.
- In its Final Written Decision the Board found all original and proposed substitute claims obvious, relying on Chiba and Aulton as the core combination and treating Sakai and other background references as additional motivation-to-combine support.
- Novartis appealed, arguing (1) APA/due process error because the Board relied on Sakai in the Final Decision after declining it at institution; (2) legal and factual errors in the Board’s motivation-to-combine analysis; and (3) improper treatment of objective indicia (unexpected results, nexus, commercial success).
Issues
| Issue | Novartis' Argument | Petitioners' Argument | Held |
|---|---|---|---|
| Did the Board violate the APA by relying on Sakai in the Final Written Decision after declining Sakai at institution? | Novartis: Board effectively removed Sakai from the case at institution; relying on it later deprived Novartis of notice and opportunity to respond. | Petitioners: Sakai was argued throughout as background motivation; parties litigated Sakai and had ample opportunity to respond. | Held: No APA violation — Board’s Final Decision use of Sakai was consistent with institution ruling and parties had notice and chance to be heard. |
| Was there substantial evidence of a motivation to combine Chiba and Aulton to yield fingolimod+mannitol solid compositions? | Novartis: Prior art taught away from mannitol (cost, impurities, manufacturability); Board failed to weigh negatives. | Petitioners: Aulton taught mannitol as common diluent; Chiba taught solid formulations of fingolimod; other references support mannitol’s advantages. | Held: Substantial evidence supports motivation to combine; Board considered negatives and was not required to recite every argument. |
| Did Novartis show unexpected results commensurate in scope with the claimed claims (esp. dependent claims with low-dose limits)? | Novartis: Fingolimod+mannitol unexpectedly solved low-dose stability; applies to dependent claims and proposed amended claims. | Petitioners: Unexpected-results evidence was presented only generally (focused on claim 19 / full range), not tied to specific dependent-claim dosages. | Held: Argument waived for dependent/amended claims because Novartis did not present specific claim-level unexpected-results evidence to the Board; Board’s commensurability ruling on claims 1 and 19 stands. |
| Was there a nexus between objective indicia (commercial success, praise, long-felt need) and the claimed invention? | Novartis: Gilenya’s market success (first commercially available solid oral MS drug) establishes nexus. | Petitioners: Solid oral MS treatments were disclosed in prior art; commercial success is due to features known in prior art, so no nexus. | Held: No nexus — claimed feature (solid oral MS treatment) was known in the prior art, so Gilenya’s commercial success does not establish nonobviousness. |
Key Cases Cited
- Dickinson v. Zurko, 527 U.S. 150 (agency factual determinations reviewed for substantial evidence under APA)
- Belden Inc. v. Berk–Tek LLC, 805 F.3d 1064 (Fed. Cir.) (APA notice/opportunity-to-be-heard principles in PTAB proceedings)
- KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (obviousness framework regarding combination of known elements)
- Wyers v. Master Lock Co., 616 F.3d 1231 (Fed. Cir.) (nexus requirement between objective indicia and claimed invention)
- In re Gartside, 203 F.3d 1305 (Fed. Cir.) (motivation-to-combine is a factual inquiry reviewed for substantial evidence)
- Asyst Technologies, Inc. v. Emtrak, Inc., 544 F.3d 1310 (Fed. Cir.) (commercial success must be tied to features that are novel over prior art)
- Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157 (Fed. Cir.) (when prior art contains conflicting teachings, court must consider their relative persuasive power)