Under pre-AIA law, conception of a DNA segment is established by possession and appreciation, not completely accurate sequence knowledge
Bernadette McGann | November 20, 2013
Sanofi-Aventis v Pfizer, Inc.
November 5, 2013
Before Newman (Circuit Judge), Lourie (Circuit Judge) and Davis (District Judge). Opinion by Newman.
A patent is awarded to the first party to conceive and reduce to practice the invention. When the invention is directed towards a DNA segment, conception requires possession and appreciation of the DNA segment that is claimed. A completely correct sequence of the DNA segment is not the standard for establishing conception and reduction to practice.
IL-13 is a regulatory molecule known as cytokine. Both Sanofi and Pfizer discovered and filed patent applications directed towards the polynucleotide encoding the relevant IL-13 binding chain.
The Board awarded priority of invention to Pfizer for based on the following interference count: Count 3: The isolated protein of 6,268,480 claim 4; or The isolated polynucleotide of 5,710,023 claim 1, selection (b) (an isolated polynucleotide comprising a nucleotide sequence of SEQ ID NO: 3 from nucleotide 103 to nucleotide 1242).
The Sanofi application was awarded a priority date of December 6, 1995. Pfizer had a filing date of March 1, 1996. It was Pfizer’s burden to establish a date of conception prior to the December 6, 1995 priority date. Pfizer presented the Board with evidence of their isolation and identification of the desired cDNA, including a nucleotide sequence with some errors as of November 15, 1995, which is prior to the Sanofi benefit date. The completely accurate analysis of the entire nucleotide sequence was obtained after December 6, 1995. The Board held that “Pfizer had ‘the claimed polynucleotide in hand with some additional identifying information including at least a partial sequence’ and ruled that Pfizer ‘established conception and actual reduction to practice of a polynucleotide’” prior to December 6, 1995. See Decision, page 4.
Sanofi appealed the Board’s decision, arguing that the Pfizer date of conception should be based on the date of the completely accurate analysis of the entire nucleotide sequence, which is after the December 6, 1995 Sanofi benefit date. “Sanofi argues that until Pfizer had correctly analyzed the polynucleotide, neither conception nor reduction to practice could occur.” See Decision, page 4. Pfizer argued that the dispositive question is “who first had in hand the actual isolated DNA of the count and appreciated its IL-13bc function.” See Decision, page 2.
The CAFC held that the dispositive issue is “whether conception is negated because the nucleotide sequence was not corrected until after the Sanofi benefit date of December 6, 1995.” See Decision, page 7.
Sanofi argued that the decision by the Board is contrary to established precedent, citing Amgen Inc. v Chugai Pharmaceutical Co., 927 F.2d 1200 (Fed. Cir. 1991); Fiers v Revel, 984 F.2d 1164 (Fed. Cir. 1993); Burroughs Wellcome Co. v Barr Laboratories, Inc., 40 F.3d 1223 (Fed. Cir. 1994). The Board and the CAFC held that the cited case law does not support Saofi’s position. “The court in Amgen held that 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.’” See Decision, pages 6 and 7. The Board distinguished from Amgen and Fiers and further the Board stated that “in this precedent the issue was not identification of the operative DNA by full nucleotide analysis, but isolation of the operative DNA and identification by distinguishing properties of the isolate. Amgen, 927 F.2d at 1206; Fiers, 984 F.2d at 1169.” See Decision, page 8. Further, the holding of Burroughs Wellcome does not require knowledge of the specific nucleotide sequence.
The CAFC cites additional precedent that supports the decision by the Board that conception can occur even when the complete nucleotide sequence was unknown. “In Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956 (Fed. Cir. 2002) this court upheld claims for certain DNA probes that were made available by deposit in a public depository, as provided by the Rules and PTO practice, although the nucleotide sequence had not been determined. In University of New Mexico v. Knight, 321 F.3d 1111, 1122 (Fed. Cir. 2003), the court explained that ‘a chemical structure is simply a means of describing a compound; it is not the invention itself.’ The court stated in In re Wallach, 378 F.3d 1330, 1333 (Fed. Cir. 2004) that when a protein was described by a partial amino acid sequence in addition to other characteristics sufficient to identify it, the inventors were in possession of the protein.” See Decision, pages 8 and 9. The CAFC affirmed the Board decision.
Takeaway: Under pre-AIA law, conception and reduction to practice of a DNA segment can be satisfied when possession and appreciation of properties are known. A completely accurate nucleotide sequence is not required for conception. Inventors should be diligent in timely filing applications.