927 F.3d 1232
Fed. Cir.2019Background
- Mayne Pharma owns U.S. Patent No. 6,881,745, which claims pharmaceutical compositions of about 100 mg azole antifungal plus one or more acidic-function-group polymers that achieve specified in vivo pharmacokinetic thresholds (Cmax ≥ 100 ng/mL and/or AUC ≥ 800 ng·h/mL).
- Merck Sharp & Dohme (MSD) petitioned for inter partes review (IPR) challenging claims 1–3, 5–7, and 9–14; the Board instituted on limited grounds and later proceeded after Mayne canceled some claims.
- The Board found claims 2, 6, and 9–14 unpatentable: claims 2, 6, 9, 11, 12, and 14 anticipated by Kai (a prior art solid-dispersion study reporting pharmacokinetic data in animals), and claims 2, 6, and 9–14 obvious over Kai in view of Sangekar and Babcock.
- Procedurally, MSD amended its mandatory notice during the proceeding to add Merck & Co., Inc. (MCI) as a real party in interest; Mayne argued the amendment was untimely and should trigger the § 315(b) time bar, but the Board allowed the amendment without changing the petition’s filing date.
- Mayne also argued for narrower claim constructions (limiting “pharmaceutical composition” to nontoxic, therapeutically beneficial compositions and limiting the “in vivo” pharmacokinetic clauses to humans); the Board applied the broadest reasonable interpretation, rejected those narrow readings, and the Federal Circuit affirmed.
Issues
| Issue | Mayne's Argument | MSD's Argument | Held |
|---|---|---|---|
| Whether the IPR petition was time‑barred under 35 U.S.C. § 315(b) because MSD failed to timely identify MCI as a real party in interest | The Board should have treated the omission as fatal; adding MCI later without changing the filing date improperly avoided the one‑year time bar | Board had discretion to permit amendment; the amendment served the purposes of disclosure and estoppel and caused no prejudice | Court affirmed Board: permitting amendment without changing the filing date was not reversible error given no bad faith or prejudice and interests of justice supported it |
| Whether the claim term “pharmaceutical composition” should be limited to nontoxic, therapeutically beneficial compositions | Claims should be read to require therapeutically beneficial, nontoxic drugs (to avoid prior art) | Specification and extrinsic evidence do not impose a toxicity exclusion; some disclosed azoles were toxic yet still fall under the specification’s language | Court affirmed Board: no basis to import a non‑toxicity limitation into the claims |
| Whether the claimed pharmacokinetic “wherein” clauses (Cmax/AUC achieved “in vivo”) are limited to humans | The claims should be limited to humans because the specification’s examples and data are human‑oriented | The specification explicitly defines “in vivo” as in the living body of a plant or animal; pharmacokinetic thresholds exclude plants and claim scope reasonably includes animals | Court affirmed Board: claims are not limited to humans; animals fall within the defined term “in vivo” |
| Whether Kai (and combinations with Sangekar/Babcock) invalidates the claims | Under Mayne’s narrower constructions, Kai would not anticipate/obviousify the claims | Under the Board’s constructions, Kai anticipates several claims and combinations render others obvious | Court affirmed Board’s invalidity findings because it upheld the Board’s claim constructions and factual findings |
Key Cases Cited
- Cuozzo Speed Technologies, LLC v. Lee, 136 S. Ct. 2131 (2016) (deference to PTO rulemaking and scope of review discussion)
- Wi‑Fi One, LLC v. Broadcom Corp., 878 F.3d 1364 (Fed. Cir. 2017) (Director can allow adding a real party in interest)
- Skky, Inc. v. MindGeek, s.a.r.l., 859 F.3d 1014 (Fed. Cir. 2017) (standard of review for Board claim construction)
- Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (claim construction principles)
- Sebelius v. Auburn Regional Medical Center, 568 U.S. 145 (2013) (statutory provisions should not be treated as jurisdictional absent clear statement)