On Tuesday, 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.
Archive for the ‘Written Description Requirements (WDR)’ Category
A guest post from Domenico Ippolito of Schwegman Lundberg & Woessner, P.A.
Synthes USA, LLC v. Spinal Kinetics, Inc., 2013-1047, -1059, (Fed.Cir. Oct 29, 2013) concerns a medical device patent, but addresses issues common to all patents. The primary issue was whether Synthes’ claims on a synthetic intervertebral implant (i.e., a spinal disc) were supported by a sufficient written description. The question had been submitted to a jury, which determined that the written description requirement was not met. The patentee requested JMOL from the district court judge (Judge Whyte, of the Northern District of California), but the court found substantial evidence supporting the jury’s decision. The basis of the court’s opinion was that the patent described only a system in which the center layer of the disc was attached to the outer layers via “grooves” penetrating from the circumference of the outer layers, but the claims were directed to “openings.” Thus, a reasonable jury could find that the claims directed to openings lacked adequate support.
I am not sure how I missed this decision, which came down on July 22nd, but it offers a rather scary hi-def picture as to where the written description requirement of s. 112 has been and where it is headed. This decision, Novozymes A/S v. Dupont Nutrition Biosciences, Appeal No. 2012-1433 (Fed. Cir., July 22, 2013) (copy available at end of this post) rendered by a split panel (Judges Schall and Bryson, with Rader dissenting), affirmed a district court’s JMOL ruling nullifying a jury verdict that the claims of Novozymes’ U.S. Patent No. 7,717,723 (a copy found at the end of this post) met the written description requirement.
In July of 2011, I wrote a post for this blog on BSC v. J&J, a Fed. Cir. decision in which four J&J patents claiming stents eluting rapamycin, a drug that inhibits restenosis after balloon angioplasty, were held invalid for failure to meet the requirements of the written description requirement of s. 112 (1) [now s. 112(a)]. While the specification only disclosed stents releasing rapamycin, the claims used broader language, such as “rapamycin or a macrocyclic triene analog of rapamycin.” While such analogs were known, none were named in the specification. Still, J&J must have felt that they had a fighting chance, since a specification need not describe that which is known to the art.
A three-judge panel of Moore, Bryson and Gajarsa found that the claims failed to meet the WDR. However, instead of explaining why the specification read in combination with the knowledge available to the art about rapamycin analogs fails the UC v. Lilly WDR standards, Moore and Bryson relied on the deficiencies they found in the specification:
“Given the absence of information regarding structural characteristics of [rapamycin analogs] in the specification, the unpredictability of the art and the nascent state of using drug eluting stents…we affirm the [grant of SJ]. The patent laws do not reward an inventor’s invitation to other researchers to discover which of the thousands of macrocyclic lactone analogs of rapamycin could conceivably work in a drug-eluting stent.”