Conception And Reduction To Practice Of A DNA May Be Established Without The Full And Correct Nucleotide Sequence

In Sanofi-Aventis v. Pfizer Inc., No. 12-1345 (Fed. Cir. Nov. 5, 2013), the Federal Circuit affirmed the Board's award of priority of invention to Pfizer Inc. ("Pfizer") based on an interference count to an isolated polynucleotide cDNA encoding the human interleukin-13 receptor binding chain ("IL-13bc").

Both Pfizer and Sanofi-Aventis ("Sanofi") were conducting research on IL-13, a regulatory molecule called a cytokine, and both discovered and filed patent applications directed to the polynucleotide encoding the relevant binding chain, IL-13bc. During an interference proceeding, Sanofi was awarded the benefit of its December 6, 1995, priority date. Pfizer's earliest filing date was March 1, 1996, but Pfizer presented documentary and testimonial evidence that it had isolated and identified the desired cDNA before Sanofi's benefit date. Specifically, Pfizer presented evidence that its scientists had isolated full-length human IL-13bc from a human cDNA library by October 16, 1995, and had confirmed its identity by October 25, 1995. However, due to sequencing errors, Pfizer's analysis was in error as to eight of IL-13bc's 1143 nucleotides. Pfizer corrected its sequence analysis by February 7, 1996, after Sanofi's benefit date.

The Board awarded priority of invention to Pfizer, concluding that Pfizer had established conception of the subject matter of the count when it selected, isolated, and obtained the desired full-length IL-13bc cDNA and verified it as the desired product. The Board rejected Sanofi's argument that Pfizer could not establish conception as a matter of law until Pfizer had the full and correct nucleotide sequence of IL-13bc. The Board disagreed with Sanofi's reading of Federal Circuit precedent, including Amgen Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200 (Fed. Cir. 1991); Fiers v. Revel, 984 F.2d 1164 (Fed. Cir. 1993); and Burroughs Wellcome Co. v. Barr Laboratories, Inc., 40 F.3d 1223 (Fed. Cir. 1994). According to the Board, in this precedent, the issue was not identification of the operative DNA by full nucleotide analysis, but rather isolation of the operative DNA and identification of that DNA by whatever characteristics sufficiently distinguished it. Sanofi appealed.

"When the subject matter is a DNA segment, conception requires possession and appreciation of the DNA segment that is claimed." Slip op. at 9.

The Federal Circuit affirmed the Board's priority decision. The Court held that, contrary to Sanofi's reading...