Sanofi-Aventis v. Pfizer Inc.

Decision Date05 November 2013
Docket NumberNo. 2012–1345.,2012–1345.
Citation733 F.3d 1364
PartiesSANOFI–AVENTIS, Appellant, v. PFIZER INC., Appellee.
CourtU.S. Court of Appeals — Federal Circuit

OPINION TEXT STARTS HERE

Thomas J. Vetter, Lucas & Mercanti, LLP, of New York, NY, argued for appellant.

Z. Ying Li, Ropes & Gray, LLP, of New York, NY, argued for appellee. With her on the brief was James F. Haley, Jr.

Before NEWMAN, and LOURIE, Circuit Judges, and DAVIS, District Judge. 1

NEWMAN, Circuit Judge.

Sanofi–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) 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).

Nucleotides 103 to 1242 constitute the protein-encoding portion of the complementary deoxyribonucleic acid (“cDNA”) for the human interleukin–13 receptor binding chain (“IL–13bc”).

The parties disagree as to the dispositive question in the interference. As summarized by Pfizer, the question is “who first had in hand the actual isolated DNA of the count and appreciated its IL–13bc function.” Pfizer Br. 1. As summarized by Sanofi, the question is “the date each party first knew the complete sequence” of nucleotides 103 to 1242. Sanofi Br. 4. The Board agreed with Pfizer that possession and appreciation of the actual isolated DNA is the dispositive question for priority of conception for an interference count directed to the isolated DNA, and on that basis awarded priority to Pfizer.

Background

IL–13 is a regulatory molecule called a cytokine. Cytokines function by interactingwith cytokine receptors located on target cells. The 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.

In accordance with the applicable law,3 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.”). This law is implemented in accordance with rules and precedent, administered by the PTO Board (“Board”). On appeal to the Federal Circuit, we review the Board's rulings of law for correctness, and factual findings for support by substantial evidence. See Dawson v. Dawson, 710 F.3d 1347, 1353 (Fed.Cir.2013) (“The issue of conception turns in large part on the facts, and we review the Board's many factual findings in this case for substantial evidence.”).

Sanofi 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. Pfizer 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. The 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.

On appeal, Sanofi argues that Pfizer cannot be credited with conception because although Pfizer's sequence analysis before the Sanofi date was correct as to 1135 of the 1143 nucleotides, the analysis was in error as to eight nucleotides. The Board found that Pfizer corrected this analysis by February 7, 1996. The Pfizer patent application filed on March 1, 1996 contained the correct analysis. Sanofi argues that conception of the claimed cDNA could not be established for priority purposes until the fully correct nucleotide sequence was determined, because the interference count is directed to the isolated polynucleotide. Sanofi argues that until Pfizer had correctly analyzed the polynucleotide, neither conception nor reduction to practice could occur. Sanofi states that Federal Circuit precedent requires the full and correct nucleotide sequence to establish conception, because reduction to practice, whether actual or constructive, requires the full and correct nucleotide sequence.

The Board did not share Sanofi's view of law and precedent. The Board held that Pfizer had established conception of the subject matter of the count when it selected, isolated, and obtained the desired IL–13bc full-length polynucleotide and verified that it was the desired product, regardless of whether the fully correct sequencing of the polynucleotide was complete. Sanofi argues on this appeal that the Board erred in law.

Discussion

As junior party with the burden of proof, Pfizer presented evidence of its research with murine and human IL–13 starting in early 1995. The Board found that coinventor Lori Fitz performed binding assays with commercially supplied human IL–13 in conjunction with recombinant murine IL–13bc protein fused to an antibody fragment known as the Fc domain. Ms. Fitz verified that the murine IL–13bc protein bound human IL–13 and that the interaction was specific, conducting experiments that showed that the protein could be blocked with excess murine IL–13bc fusion protein or with anti-human IL–13 antibody.

After isolating the murine IL–13bc, by October 16, 1995 Pfizer scientists isolated the human IL–13bc, called clone 11, from a human cDNA library. Co-inventor Matthew Whitters testified that he aligned the sequence of clone 11 with the respective sequences of the murine IL13bc, and summarized his conclusions:

[G]iven the size of the clone 11 insert (it corresponded to the mouse A25 full-length clone [ i.e., murine IL–13bc] ), the significant sequence identity and similarity between the amino acid sequence deduced from the nucleotide of the 5' end of the cDNA of the clone 11 insert and the mouse A25 protein, the identification of the 5' end of the cDNA and the confirmation that it encoded the Nterminus of the protein and the fact that the cDNA contained the 3' end of the coding sequence, on October 25, 1995, I was highly confident, and virtually positive, that the clone 11 insert contained the full-length nucleic acid coding sequence for the human homolog of the mouse A25 protein.

Whitters Decl. 6, Feb. 25, 2011. Mr. Whitters also testified that on November 15, 1995 he was provided with a computer printout of the nucleotide sequence of clone 11, and the next day he was provided with the deduced amino acid sequence encoded by that clone. He testified that the nucleotide sequence and amino acid sequence were checked for errors by comparison with the sequences for additional human IL–13bc products that Pfizer had isolated from its cDNA library.

Whitters testified that for the polynucleotide sequence eight possible errors were found out of 1143 nucleotides, and that the encoded amino acid sequence was correct for 379 out of 380 residues. He testified that correction of these sequences was completed by December 12, 1995 and confirmed by February 7, 1996.

It was not disputed that clone 11 was the desired product. Pfizer argued that its initial sequence was 99.3% accurate, and that the sequencing errors were routinely detected and corrected. The Board held that Pfizer had established conception and reduction to practice before the Sanofi benefit date.

Sanofi argues that as a matter of law Pfizer did not have a complete conception until Pfizer had the full correct nucleotide sequence, citing Federal Circuit precedent including Amgen Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200 (Fed.Cir.1991). Amgen does not support Sanofi'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...

To continue reading

Request your trial
3 cases
  • Yeda Research & Dev. Co. v. Abbott GmbH & Co.
    • United States
    • U.S. District Court — District of Columbia
    • 15 Abril 2015
    ... ... was the first to invent the claimed subject matter. Cytologic, Inc. v. Biopheresis GmbH, 682 F.Supp.2d 1, 4 (D.D.C.2010). For this purpose, 35 U.S.C. 135 ... Pfizer Inc., 733 F.3d 1364 (Fed.Cir.2013). SanofiAventis was an interference in which Pfizer claimed ... Hy att , 146 F.3d at 1354. Sanofi Aventis confirms, under In re Wallach, 378 F.3d 1330, 1333 (Fed.Cir.2004), ... when a protein was ... ...
  • Yeda Research & Dev. Co. v. Abbott GMBH & Co., Civil Action No. 10-1836 (RMC)
    • United States
    • U.S. District Court — District of Columbia
    • 15 Abril 2015
    ...The Federal Circuit most recently made this point clear when it adopted the Board's findings in Sanofi-Aventis v. Pfizer Inc., 733 F.3d 1364 (Fed. Cir. 2013). Sanofi-Aventis was an interference in which Pfizer claimed priority of invention of a "DNA polynucleotide that encodes the protein b......
  • Helsinn Healthcare S.A. v. Teva Pharm. USA, Inc.
    • United States
    • U.S. Court of Appeals — Federal Circuit
    • 1 Mayo 2017
    ... ... v. Research & Diagnostic Sys., Inc. , 659 F.3d 1186, 1193 (Fed. Cir. 2011) ; accord Sanofi-Aventis v. Pfizer Inc. , 733 F.3d 1364, 136768 (Fed. Cir. 2013). Before trial, the parties stipulated that they would contest ready for patenting "only with ... ...
1 books & journal articles
  • Case Comments
    • United States
    • California Lawyers Association New Matter: Intellectual Property Law (CLA) No. 39-1, March 2014
    • Invalid date
    ...need not be known. The Board correctly determined priority of invention for an interleukin-13 receptor. Sanofi-Aventis v. Pfizer, Inc., 733 F.3d 1364, 108 U.S.P.Q2d 1741 (Fed. Cir. 2013).PATENTS - CONCEPTION & DILIGENCE Evidence of prior invention sufficient to establish obviousness can ant......

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT