Cumberland Pharmaceuticals Inc. v. Mylan Institutional LLC
846 F.3d 1213
| Fed. Cir. | 2017Background
- Cumberland owns U.S. Patent No. 8,399,445 claiming intravenous acetylcysteine formulations that are "stable" and "free of chelating agents" (no EDTA or other chelators).
- Prior art acetylcysteine formulations used EDTA to chelate trace metals and prevent oxidative degradation; the skilled art generally viewed chelators as necessary for stability.
- During FDA review of an EDTA-containing Acetadote® (2002–2004), the FDA asked Cumberland to justify EDTA’s inclusion and requested post-approval studies comparing current EDTA levels to lower or no EDTA formulations.
- Cumberland (through its inventor Pavliv) proposed and ran a stability study (protocol Pavliv drafted and FDA approved) that tested an EDTA-free formulation; positive data led to patent filings (priority Aug 24, 2005) and later FDA approval of EDTA-free Acetadote®.
- Mylan stipulated to infringement but challenged validity at bench trial, asserting (1) derivation—someone at the FDA conceived the invention and communicated it to Cumberland, and (2) obviousness—prior art and FDA communications would have motivated a skilled artisan to remove EDTA with a reasonable expectation of success.
- The district court rejected both challenges; the Federal Circuit affirmed, finding Mylan failed to prove prior conception/communication and failed to show a reasonable expectation of success for a chelator-free stable product.
Issues
| Issue | Plaintiff's Argument (Cumberland) | Defendant's Argument (Mylan) | Held |
|---|---|---|---|
| Derivation under 35 U.S.C. §102(f) | Cumberland: inventor Pavliv conceived the EDTA-free invention first; documents showing FDA requested studies do not show FDA conceived the claimed invention. | Mylan: FDA’s requests and approval conditions showed FDA conceived removing EDTA (and communicated that) before Pavliv. | Held: Mylan failed to prove by clear and convincing evidence that anyone at FDA conceived the claimed chelating-agent-free formulation and communicated it to Pavliv; affirmed for Cumberland. |
| Obviousness (§103) | Cumberland: prior art taught EDTA (or other chelators) were needed; no reasonable expectation that removing chelators would yield a stable product. | Mylan: prior-art Acetadote®, FDA chemistry review/approval letter, and Guilford patent would have motivated removal of EDTA and skilled artisans had a reasonable expectation of success. | Held: No clear error in district court’s factual finding that skilled artisans would not have reasonably expected success in achieving a stable chelator-free formulation in 2005; affirmed. |
Key Cases Cited
- Price v. Symsek, 988 F.2d 1187 (Fed. Cir.) (conception and communication required for derivation)
- Gambro Lundia AB v. Baxter Healthcare Corp., 110 F.3d 1573 (Fed. Cir.) (derivation requires proof of prior conception and communication)
- Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223 (Fed. Cir.) (conception requires a definite and permanent idea, not a general plan)
- Shum v. Intel Corp., 633 F.3d 1067 (Fed. Cir.) (presumption that named inventors are correct; challengers bear heavy burden)
- Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342 (Fed. Cir.) (obviousness requires motivation to combine and reasonable expectation of success)
- Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359 (Fed. Cir.) (reasonable expectation of success is a factual inquiry)