Sanofi-Aventis v. Pfizer: Pre-AIA Conception for DNA Sequences

Category: Interferences
 By: Jesus Hernandez, Blog Editor/Contributor
TitleSanofi-Aventis v. Pfizer Inc., No. 2012-1345 (Fed. Cir. Nov. 5, 2013).
Issue"[In order to establish conception and reduction to practice before the Sanofi benefit date,] Pfizer argued that its initial sequence was 99.3% accurate, and that the sequencing errors were routinely detected and corrected. […] Sanofi argues that as a matter of law Pfizer did not have a complete conception until Pfizer had the full correct nucleotide sequence […].
Sanofi-Aventis at *6 (text added).
HoldingWe conclude that the Board correctly based conception and reduction to practice on the possession of the isolated DNA segment that was shown to have the desired properties [because although a complete DNA sequence is the gold-standard for identifying a species with precision, it is not the only way to identify proteins and polynucleotides precisely.]"
Id. at *9 (text added).

Procedural HistorySanofi-Aventis (“Sanofi”) appeals the decision of the United States Patent and Trademark Office (“PTO”) Board of Patent Appeals and Interferences (“the Board”),2 awarding priority of invention to Pfizer Inc. (“Pfizer”) […].
Sanofi-Aventis at *2.
Legal Reasoning (Newman, Lourie, Davis)
Competing InventorsThe subject of this patent interference is a DNA polynucleotide that encodes the protein binding chain of the IL-13 receptor. Both Sanofi and Pfizer were conducting research in this field of scientific endeavor, for therapeutic and diagnostic purposes, and both Sanofi and Pfizer discovered and filed patent applications directed to the polynucleotide encoding the relevant IL-13 binding chain.
Sanofi-Aventis at *3.
Filing Date Establishes BurdensSanofi was awarded the benefit of its December 6, 1995 priority date. Pfizer’s filing date is March 1, 1996; Pfizer thus bore the burden of proving a date of conception earlier than the Sanofi benefit date.
Id. at *4.
Conception without Full DNA SequencingPfizer presented documentary and testimonial evidence that it had isolated and identified the desired cDNA before the Sanofi benefit date. However, due to sequencing errors, Pfizer did not then have a completely accurate analysis of the entire nucleotide sequence.
Id. at *4.
Board FindingThe Board found 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 within the scope of count 3” before the Sanofi benefit date. Bd. Op. at 17.
Id. at *4.
In the Absence of Actual DNA Sequencing, Conception of DNA Segment may be shown by Adequate Description of said DNA Segment
Legal Standards
InventivenessIn accordance with the applicable law, the patent is awarded to the first party to conceive and reduce to practice the invention represented by the interference count. See Cooper v. Goldfarb, 154 F.3d 1321, 1327 (Fed. Cir. 1998) (“[P]riority of invention goes to the first party to reduce an invention to practice unless the other party can show that it was the first to conceive of the invention and that it exercised reasonable diligence in later reducing that invention to practice.”).
Sanofi-Aventis at *3.
Conception of DNA SegmentWhen the subject matter is a DNA segment, conception requires possession and appreciation of the DNA segment that is claimed. See Invitrogen Corp. v. Clontech Labs., Inc., 429 F.3d 1052, 1063-64 (Fed. Cir. 2005) (“[C]onception requires that the inventor appreciate that which he has invented. . . . The priority determina- tion requires evidence that the inventor actually first made the invention, and that he understood his creation to have the features that comprise the inventive subject matter at bar.”).
Id. at *9.
Precedent permits conception to be shown without full DNA SequencingPrecedent illustrates a variety of circumstances in which [the conception] requirement was met although the complete nucleotide sequence was not known. 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.
Id. at *8-9.
Defining DNA Sequence in a manner to distinguish over materials enough to show conceptionDiscussing the consequences of Pfizer’s flawed sequence analysis that was corrected after the Sanofi priority date, the Board stated that “[f]or proteins and polynucleotide species, a sequence is the gold standard for identifying species with precision . . . . It does not, however, thereby follow that a sequence is the only way to identify the composition precisely.” Bd. Op. at 15. Upon selecting, isolating and characterizing clone 11 Pfizer was “able to define [the IL-13bc] so as to distinguish it from other materials, and to define how to obtain it.” Amgen, 927 F.2d at 1206. The Board’s findings are supported by substantial evidence […] We conclude that the Board applied the correct law.
Id. at *9-10.
The award of priority to Pfizer is affirmed.
Sanofi-Aventis at *10 (text added).

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