Docket No. 2012-1345
NEWMAN, LOURIE, DAVIS
November 5, 2013
Brief summary: Pfizer found to have possession of isolated nucleic acid sequence even with errors in sequence that were not corrected until after Sanofi’s priority date.
Summary: Sanofi appealed USPTO decision awarding Pfizer priority of invention for its claims encompassing “[t]he isolated protein” and “[t]he isolated polynucleotide” of human interleukin-13 receptor binding chain (IL-13bc). The Board agreed with Pfizer that the question is “who first had in hand the actual isolated DNA of the count and appreciated its IL-13bc function”, not “the date each party first knew the complete sequence” of nucleotides as argued by Sanofi. Sanofi was awarded priority with its December 6, 1995 priority date because Pfizer’s filing date was March 1, 1996. Pfizer presented evidence that it has isolated and identified the cDNA before Sanofi’s priority date but not the complete sequence because of sequencing errors. The Board concluded that Pfizer had “the claimed polynucleotide in hand with some additional identifying information including at least a partial sequence,” and that Pfizer “established conception and actual reduction to practice of a polynucleotide within the scope of count 3” before Sanofi’s priority date. Sanofi argued that until Pfizer had the correct sequence, “neither conception nor reduction to practice could occur” (citing Amgen, FC 1991; Fiers, FC 1993; Burroughs Welcome, FC 1994; and Hybritech, FC 1986 (requiring “definite and permanent idea” of the complete and operative invention)). Pfizer argued that errors such as these were “routinely detected and corrected”, and were actually corrected by December 12, 1995. The FC panel disagreed with Sanofi. For instance, regarding Amgen, the FC explained that the case held “when ‘an inventor is unable to envision the detailed constitution of a gene’ there may nonetheless be conception and reduction to practice of the gene when the inventor is in possession of the gene and a method for its preparation, i.e. ‘after the gene has been isolated,’ accompanied by knowledge of ‘other characteristics sufficient to distinguish it from other genes.’” It also noted that “[p]recedent illustrates a variety of circumstances in which this requirement was met although the complete nucleotide sequence was not known”, citing Enzo (FC 2002), Univ. New Mexico (FC 2003), In re Wallach (FC 2004), and Invitrogen (FC 2005) (conception requires possession and appreciation of the DNA segment that is claimed). The panel found the Board’s findings that “Pfizer was ‘able to define [the IL-13bc] so as to distinguish it from other materials, and to define how to obtain it’” to be supported by the evidence and agreed that “Pfizer had conceived and reduced to practice the isolated polynucleotide of Count 3 before the Sanofi benefit date.”