Sanofi-Aventis v. Pfizer Inc.
733 F.3d 1364
Fed. Cir.2013Background
- Sanofi-Appellee and Pfizer-Junior party dispute priority of invention for Count 3 (isolated DNA of IL-13bc).
- Board awarded priority to Pfizer based on possession and appreciation of the actual isolated polynucleotide prior to Sanofi’s December 6, 1995 date.
- Pfizer argued it isolated and identified the IL-13bc cDNA before Sanofi's date, despite sequencing errors later corrected.
- Sanofi contends conception required a complete, correct nucleotide sequence; Pfizer’s partial sequencing would not suffice.
- Board held Pfizer established conception and reduction to practice before Sanofi’s date by isolating and characterizing the polynucleotide, with later sequence corrections not negating conception.
- Court reviews Board’s law for correctness and factual findings for substantial evidence and affirms Pfizer’s priority.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Conception before Sanofi date despite incomplete sequence? | Sanofi: complete, correct sequence required for conception. | Pfizer: possession and appreciation of isolated DNA suffices; full sequence not necessary. | Pfizer conception prior to Sanofi date; Board correct. |
| Law governing when conception occurs for DNA pericounts—Fiers/Amgen interpretation? | Sanofi: Amgen and Fiers require full sequence to conceive. | Pfizer: statutory precedent allows possession and distinguishing properties to establish conception. | Board correctly applied law; conception can occur without full sequence. |
| Whether precedent supports conception based on isolation and characterization of DNA with partial sequence? | Sanofi: lack of full sequence negates conception. | Pfizer: isolation and characterization with substantial sequence information suffices. | Yes; conception and reduction to practice before Sanofi date. |
Key Cases Cited
- Amgen Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200 (Fed. Cir. 1991) (gene conception may occur with possession and method, not require full sequence)
- Fiers v. Revel, 984 F.2d 1164 (Fed. Cir. 1993) (per se rule that full sequence may be required for conception)
- Burroughs Wellcome Co. v. Barr Laboratories, Inc., 40 F.3d 1223 (Fed. Cir. 1994) (conception requires possession of DNA but not necessarily complete sequence)
- Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367 (Fed. Cir. 1986) (conception requires a definite idea of the invention's structure or properties)
- Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956 (Fed. Cir. 2002) (deposited DNA enables certain claims despite undefined sequence)
- University of New Mexico v. Knight, 321 F.3d 1111 (Fed. Cir. 2003) (chemical structure not the invention itself)
- In re Wallach, 378 F.3d 1330 (Fed. Cir. 2004) (partial amino acid sequence plus characteristics can identify protein)
- Invitrogen Corp. v. Clontech Labs., Inc., 429 F.3d 1052 (Fed. Cir. 2005) (conception requires inventor appreciation of invention with identifiable features)
- Dawson v. Dawson, 710 F.3d 1347 (Fed. Cir. 2013) (review standard for Board factual findings is substantial evidence)
- Cooper v. Goldfarb, 154 F.3d 1321 (Fed. Cir. 1998) (priority goes to first conceiver with reduction to practice absent diligent subsequent effort)