University of California v. Broad Institute, Inc.
903 F.3d 1286
Fed. Cir.2018Background
- This appeal arises from a Patent Trial and Appeal Board (PTAB) interference-in-fact decision: University of California (UC) v. Broad Institute (Broad). The Board found no interference because Broad’s claims (limited to use in eukaryotic cells) were not rendered obvious by UC’s broader claims (not limited to cell type).
- The patents involve CRISPR-Cas9 genome editing: UC’s ’859 application claimed use of a single-guide RNA/Cas9 system (not restricted to eukaryotes); Broad’s patents claimed CRISPR-Cas9 methods specifically in eukaryotic cells.
- UC’s 2012 Jinek paper showed CRISPR-Cas9 function in vitro (non-cellular); Broad published successful use in human cells in 2013. UC argued Broad’s eukaryotic claims were obvious in view of UC’s disclosures.
- The Board concluded a person of ordinary skill would not have had a reasonable expectation of success applying CRISPR-Cas9 in eukaryotes, citing substantial differences between prokaryotic and eukaryotic environments, prior failures/adaptations of prokaryotic systems, expert testimony, and contemporaneous inventor statements.
- The Federal Circuit affirmed, holding the Board’s factual findings are supported by substantial evidence and that the Board applied the correct legal standards for obviousness and interference-in-fact.
Issues
| Issue | Plaintiff's Argument (UC) | Defendant's Argument (Broad) | Held |
|---|---|---|---|
| Whether UC’s claims (prior art) rendered Broad’s eukaryotic claims obvious (interference-in-fact) | UC: A skilled artisan would have had a reasonable expectation of success moving CRISPR-Cas9 into eukaryotes; thus claims are not patentably distinct | Broad: Differences between prokaryotes and eukaryotes made success unpredictable; no reasonable expectation of success | Held: Affirmed Board — substantial evidence supports lack of reasonable expectation of success; no interference-in-fact |
| Whether the Board required “specific instructions” in prior art to find a reasonable expectation of success | UC: Board improperly demanded specific prior-art instructions and ignored ordinary creativity (KSR) | Broad: Board permissibly considered lack of specific, relevant prior-art guidance among other evidence | Held: Board did not adopt a rigid specific-instructions test; its consideration of specificity and failures was permissible |
| Relevance and weight of simultaneous invention evidence | UC: Multiple independent groups achieving eukaryotic CRISPR soon after Jinek supports obviousness and expectation of success | Broad: Simultaneous invention is relevant but does not alone prove expectation of success given context and unpredictability | Held: Board properly considered simultaneous invention as evidence of motivation but reasonably declined to treat it as dispositive of expectation of success |
| Standard of review for obviousness-related interference findings | UC: challenges Board’s fact findings and their interpretation of statements | Broad: Board’s factual findings reviewed for substantial evidence; ultimate obviousness reviewed de novo | Held: Federal Circuit reviews underlying facts for substantial evidence and affirmed Board’s fact findings as supported by substantial evidence |
Key Cases Cited
- Graham v. John Deere Co., 383 U.S. 1 (Sup. Ct. 1966) (sets forth Graham factors for obviousness)
- KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (Sup. Ct. 2007) (obviousness flexible approach; common sense/inferences permitted)
- In re Stepan Co., 868 F.3d 1342 (Fed. Cir. 2017) (motivation to combine and reasonable expectation of success are factual inquiries)
- In re Mouttet, 686 F.3d 1322 (Fed. Cir. 2012) (standard of review: ultimate obviousness de novo, underlying facts for substantial evidence)
- Arctic Cat Inc. v. Bombardier Recreational Prods. Inc., 876 F.3d 1350 (Fed. Cir. 2017) (Graham factors are factual issues reviewed for substantial evidence)
- Lindemann Maschinenfabrik GMBH v. Am. Hoist & Derrick Co., 730 F.2d 1452 (Fed. Cir. 1984) (simultaneous invention relevant but not alone dispositive on obviousness)
- Monarch Knitting Mach. Corp. v. Sulzer Morat GmbH, 139 F.3d 877 (Fed. Cir. 1998) (simultaneous invention bears on skill level and objective considerations)
- Abbott Labs. v. Sandoz, Inc., 544 F.3d 1341 (Fed. Cir. 2008) (case-specific context matters in expectation-of-success analysis)