Institut Pasteur & Universite Pierre Et Marie Curie v. Focarino
738 F.3d 1337
Fed. Cir.2013Background
- Institut Pasteur owns three patents (U.S. Nos. 7,309,605; 6,610,545; 6,833,252) claiming use of group I intron-encoded (GIIE) endonucleases to cleave DNA and enable site-directed insertion via homologous recombination in eukaryotic chromosomes.
- Precision BioSciences requested inter partes reexamination of the three patents; the PTO Examiner rejected many claims as obvious and the Board affirmed, relying principally on Quirk and Bell‑Pedersen (GIIE-mediated gene transfer in prokaryotic non‑chromosomal DNA) and on Frey and Dujon (read as supporting eukaryotic chromosomal cleavage).
- During reexamination Pasteur amended claims in the ’605 and ’545 proceedings (narrowing to chromosomal DNA/eukaryotes in some claims); the patents expired May 6, 2012.
- On appeal to the Federal Circuit, the court considered (1) whether the ’605 amended claims were moot because the patent expired and amended claims cannot now issue; (2) whether claims 10 and 12 of the ’545 patent were obvious; and (3) whether the Board’s obviousness ruling on the ’252 patent (claims to recombinant mammalian chromosomes containing a GIIE site) should stand or be remanded.
- The Board’s obviousness determinations rested on (a) whether a person of ordinary skill would reasonably expect success in applying prokaryotic/plasmid-based GIIE methods to eukaryotic chromosomal DNA and (b) how to weigh objective indicia (toxicity teachings, licensing, praise, copying).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Mootness of amended claims in the ’605 patent | Pasteur: appeal should proceed; amended dependent claim 14 is implicitly limited to chromosomal DNA, so scope unchanged. | PTO: amendments substantively narrowed claims; court cannot enter amended claims after patent expiry, so issues are moot. | Dismissed as moot: amendments substantively narrowed claims (original claim could cover non‑chromosomal targets), so appeal on amended claim 14 is moot. |
| Obviousness of claims 10 & 12 of the ’545 patent (site‑directed recombination in yeast/mammals) | Pasteur: prior art did not teach cleavage of chromosomal DNA in living eukaryotic cells; prior art warned of toxicity; industry licensing/praise/copying supports non‑obviousness. | PTO/Board: Quirk and Bell‑Pedersen taught GIIE‑mediated targeted transfer; Frey and Dujon gave a reasonable expectation of success in eukaryotic chromosomes; objective indicia insufficient to overcome strong prima facie case. | Reversed: Board’s factual findings that Frey/Dujon showed chromosomal cleavage in vivo lacked substantial evidence; Board improperly discounted toxicity teaching and objective indicia (licensing/praise); skilled artisan would not have had reasonable expectation of success, so claims are not obvious. |
| Validity of ’252 patent claims (recombinant mammalian chromosome with GIIE site) | Pasteur: claims are foundational and supported by industry activity; prior art gave reasons to insert sites for downstream homologous recombination. | PTO/Board: motivation to create such recombinant chromosomes existed to apply homologous recombination methods (same motivation underlying ’545 rejection). | Vacated and remanded: because the court reversed the ’545 obviousness rationale, the Board must reassess whether there was any motivation at the time to make recombinant chromosomes absent a reasonable expectation of successful site‑directed insertion; other motivations (lab tools, mapping) require factfinding. |
Key Cases Cited
- KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (Sup. Ct. 2007) (framework for obviousness—design need, predictable solutions, reasonable expectation of success)
- Bloom Eng’g Co. v. N. Am. Mfg. Co., 129 F.3d 1247 (Fed. Cir. 1997) (effect of substantive claim amendment on intervening rights and reexamination)
- In re Vaeck, 947 F.2d 488 (Fed. Cir. 1991) (reasonable expectation of success standard in chemical/biotech obviousness)
- Crocs, Inc. v. Int’l Trade Comm’n, 598 F.3d 1294 (Fed. Cir. 2010) (objective indicia can be most probative evidence of non‑obviousness)
- Rambus Inc. v. Rea, 731 F.3d 1248 (Fed. Cir. 2013) (objective indicia must be reasonably commensurate with the claim scope)