Sanofi v. Pfizer (Fed. Cir. November 5, 2013) illustrates one situation in which the older, pre-America Invents Act (AIA), first-to-invent rules benefited a junior filer, and the patent was awarded to the junior filer. Under the current first inventor to file rule, the senior filer would have been awarded the patent. In this case, Sanofi first filed a patent application on December 6, 1995, whereas Pfizer filed a patent application later on March 1, 1996 having claims directed to the same invention as that of the Sanofi patent application. Under the first inventor to file rule, this dispute would not have arisen and the patent would have been awarded to Sanofi. The Patent Office would have looked to the filing dates. The first person (i.e., Sanofi) to win the race to the Patent Office wins.
However, in this case, the result is different. During an interference proceeding before the United States Patent and Trademark Office, now obviated under the first to file rules of the American Invents Act, Pfizer presented documentary and testimonial evidence that it had isolated and identified the desired cDNA before the Sanofi benefit date. However, Pfizer did not have a completely accurate analysis of the entire nucleotide sequence prior to the Sanofi benefit date. The issue in this case was whether Pfizer’s activities constituted conception and reduction to practice before the filing date of Sanofi’s patent application.
Sanofi argued that conception requires that Pfizer have the full correct nucleotide sequence. In support thereof, Sanofi directed the Court’s attention to Amgen v. Chugai (927 F. 2D 1200 (Fed. Cir. 1991), Fiers v. Revel, 984F. 2D 1164 (Fed. Cir. 1993) and Burroughs Welcome Co. v. Barr Laboratories, Inc., 40 F. 3D 1223, 1229 (Fed. Cir. 1994). In each of the instances, the Federal Circuit distinguished the facts and holdings of those cases from the present case.
In relation to Amgen, the Federal Circuit interpreted Amgen as holding 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.”
In relation to Fiers, Sanofi argued that this case established a per se rule that conception of an isolated DNA requires the full and correct nucleotide sequence. Sanofi also pointed to the Burroughs case which clarified that Fiers requires knowledge of the complete nucleotide sequence as a condition of conception.
The Board distinguished Fiers and Amgen as holding that conception and reduction to practice did not occur until the gene was isolated, for in those cases neither structure nor definitive properties had been established for the isolated gene. Burroughs did not change those requirements, in holding that conception requires that the claimed DNA is possessed as a physical embodiment. Knowledge of the specific nucleotide sequence was not required in Burroughs.
The Federal Circuit agreed with the Board in finding that the isolation of the operative DNA and identification by distinguishing properties of the isolate was the proper standard for determining conception. The proper standard did not require complete sequencing but, rather, “whatever characteristics sufficiently distinguishes it.” Indeed, there are a variety of circumstances in which this requirement could be met even though the complete, correct nucleotide is not known. One cited example that would be sufficient to prove conception was depositing a sample of DNA in a public depository.
As such, the Federal Circuit concluded 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. Although complete sequencing is the gold standard for identifying species with precision, it is not the only way. Hence, the Federal Circuit affirmed the Board’s award of priority to Pfizer.
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