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Sanofi-Aventis v. Pfizer – Possession and Appreciation Trump Structure

On November 5, 2013, the Fed. Cir. affirmed a finding by the Board that Pfizer was entitled to an earlier priority date for a claim to  cDNA encoding the IL-13 receptor protein (Sanofi-Aventis v. Pfizer, Inc., App. No. 2012-1345 (Fed. Cir. November 5, 2013). (A copy can be found at the end of this post.) Pfizer was the junior party in a pre-AIA interference, and was required to show conception plus reduction to practice prior to Sanofi’s filing date.  While both applications demonstrated physical possession of the sequent and, in fact, contained the correct sequence, Pfizer argued that it was entitled to an earlier date of invention based on its actual possession of the cDNA combined with a sequence “only” containing eight errors in an 1135 nucleotide sequence.

patent prosecution litigation

I might have easily overlooked this opinion except that it recalled an important written description requirement decision, Enzo Biochem., Inc. v. Gen-Probe, Inc., 323 F.3d 956 (Fed. Cir. 2002) (a copy can be found at the end of this post) in which deposited, but not sequenced, DNA probes were held to meet the written description requirement of s. 112. This decision was cited by the panel, who also approved of the Board’s distinguishing Fiers and Amgen, two key early decisions in the development of the written description requirement. Sanofi argued that these decisions required physical possession of the DNA and knowledge of its complete structure, but the Board held that “neither structure nor definitive properties had been established for the isolated gene…Amgen and Fiers did not hold…that conception requires the complete and correct sequencing of the isolated DNA,” but rather sufficient knowledge of characteristics that sufficiently distinguish it. Slip op. at 8.

The Fed. Cir. panel found that Pfizer met these requirements prior to Sanofi’s filing date, stating: “When the subject matter is a DNA segment, conception requires possession and appreciation of the DNA segment that is claimed.” Luckily for Pfizer, its researchers had conducted tests that confirmed the identity of the DNA sequence so that they were “able to define [the DNA and that it encoded human IL-13bc] so as to distinguish [the DNA] from other materials, and to define how to obtain it.”

This is far from an earth-shaking decision, but it provides a concise summary of some of the key early decisions that shaped the written description requirement. As I have repeatedly noted, the WDR is a requirement to “make it or fake it.” Here, actual possession was at least 99% of the law for researchers who were aware of what they possessed.

12-1345.Opinion.10-30-2013.1

name_enzo__and_name_gen_prob (2)

© 2022 Schwegman, Lundberg & Woessner, P.A. All Rights Reserved.National Law Review, Volume III, Number 311
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About this Author

Warren Woessner, Registered Patent Attorney, Schwegman Lundberg Law firm
Shareholder

Warren Woessner is a registered patent attorney and a founding shareholder of Schwegman, Lundberg & Woessner. His practice focuses on chemical patent law, including biotechnology, pharmaceuticals, vaccines, medical treatments, diagnostics, and biofuels and agricultural chemistry, including related opinion and licensing matters.

Warren received his B.A. in chemistry (1966) from Cornell University, his Ph.D. (organic chemistry, 1971) and his law degree (J.D., cum laude, 1981) from the University of Wisconsin...

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