Praxair Distribution, Inc. v. Mallinckrodt Hosp. Prods. Ip Ltd.
890 F.3d 1024
Fed. Cir.2018Background
- Mallinckrodt owns U.S. Patent No. 8,846,112 claiming methods of supplying INO (inhaled nitric oxide) cylinders and providing related prescribing information about risks (e.g., pulmonary edema) for neonates with hypoxic respiratory failure and preexisting left ventricular dysfunction (LVD).
- Independent claims 1 and 7 recite providing a cylinder of "pharmaceutically acceptable nitric oxide gas" and prescribing information; dependent claims add mental-step "evaluating" and a "recommendation" to discontinue treatment if pulmonary edema occurs. Claim 9 requires diagnosing LVD, treating with 20 ppm iNO, the patient experiencing pulmonary edema, and discontinuing treatment "in accordance with" the recommendation.
- Praxair petitioned for inter partes review asserting obviousness over the INOmax label, Bernasconi, Loh, and Goyal. The PTAB held claims 1–8 and 10–19 obvious but found claim 9 not unpatentable as obvious.
- The Board applied the printed matter doctrine, treating the informational and mental-step claim limitations as lacking patentable weight except where a functional relationship to a physical substrate existed (the Board found such a relationship in claim 9 via "in accordance with").
- On appeal, the Federal Circuit affirmed the Board as to claims 1–8 and 10–11 (printed matter lacked functional relationship), but reversed as to claim 9, concluding that under the correct reading Bernasconi and the prior art rendered claim 9 obvious.
Issues
| Issue | Praxair's Argument | Mallinckrodt's Argument | Held |
|---|---|---|---|
| Application of printed matter doctrine to claims 1–8 and 10 | Board properly treated informational and mental-step limitations as printed matter lacking patentable weight | Printed matter doctrine misapplied; cannot be extended to unprinted mental steps and should not be used to excise claim limitations at construction | Affirmed: Board correctly applied printed matter doctrine to those claims and found no functional relationship, so informational/mental limitations carry no patentable weight |
| Construction of "pharmaceutically acceptable" in claims' preamble | Plain meaning refers to gas suitable for pharmaceutical use; does not import prescribing information | Term should encompass supplied prescribing information and thus create functional relationship | Affirmed: term means physically suitable for pharmaceutical use and does not supply functional relationship |
| Construction of "in accordance with" and obviousness of claim 9 | Even under Board’s construction, claim 9 is obvious over Bernasconi and other prior art; no error in construing functional relationship | Board correctly construed "in accordance with" to create functional link and found Bernasconi did not teach discontinuing treatment; secondary considerations support nonobviousness | Reversed: claim 9's "in accordance with" creates functional relationship but, properly read, Bernasconi (plus other undisputed prior art teachings) renders claim 9 obvious; discontinuing treatment in response to pulmonary edema is inherent in prior art monitoring and known response to serious side effects |
| Secondary considerations (e.g., INOT22 study conduct) | Evidence does not show nexus to patentable claim elements when those elements are unweighted printed matter | Study conduct shows nonobviousness and should be given weight | Affirmed for claims 1–8 and 10: secondary evidence lacked nexus because informational limitations lacked patentable weight; for claim 9, Board’s reliance on INOT22 lacked nexus under correct claim reading and cannot save claim 9 from obviousness |
Key Cases Cited
- In re DiStefano, 808 F.3d 845 (Fed. Cir.) (printed-matter inquiry: a limitation is printed matter if it claims informational content)
- In re Gulack, 703 F.2d 1381 (Fed. Cir.) (printed matter given weight only when functionally related to substrate; cannot excise printed matter and analyze remainder in isolation)
- AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042 (Fed. Cir.) (FDA-required labeling/instructions do not create functional relationship for printed matter)
- In re Ngai, 367 F.3d 1336 (Fed. Cir.) (no functional relationship where instructions do not depend on kit and kit does not depend on instructions)
- KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (U.S.) (obviousness may be resolved by common sense when applying known solutions to known problems)
- Graham v. John Deere Co., 383 U.S. 1 (U.S.) (framework for obviousness analysis)