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Kubin Analysis Continued

My last post began a rather selective analysis of In re Kubin, which the Federal Circuit decided on April 3, 2009 (see previous post for citations to this and related decisions). Kubin’s claims to DNA molecules encoding sequences including that of the NAIL protein were found to be obvious over a patent (“Valiente”) that did not disclose either the amino acid sequence of the NAIL protein or the nucleotide sequence of the NAIL gene. However, Valiente also had not isolated either the protein or the gene, and only contained a general discussion of how this might be accomplished. Therefore, Valiente clearly could not have claimed either NAIL or the DNA sequence encoding it. Such claims would fail the written description requirement. See Lilly v. UC, 119 F.3d 1559 (Fed. Cir. 1997). However, a reference (or combination of references) must be enabling to the extent that a later invention is legally placed in the hands of the public. In re Hoeksema, 399 F.2d 269 (CCPA 1968). The Kubin panel clearly believed that Valiente, taken with the Sambrook cloning manual (from 1989(!)), met this standard.

This leaves a “patent gap” in the advance of biotechnology that could effectively halt progress in some areas where more progress might be a good thing. Valiente issued in 1997 and was apparently the closest prior art. So at some point Valiente et al. (at the Wistar Institute) stopped working on this project, and Kubin and Goodwin (apparently at Amgen) started. Now Kubin and Goodwin have been stopped by obviousness. According to the Fed. Cir., their successful cloning and sequencing was only “some minor advance in the art”. But without a patent on the NAIL protein or the gene, there is much less incentive to keep on working on finding direct or indirect uses for them. O’Farrell et al. cut themselves off by publishing early work (called “pioneering” by the Court) more than a year prior to filing on their more useful, but ultimately obvious, method. While they had only themselves (or their attorney) to blame, Kubin and Goodwin had every reason to believe they could pick up where Valiente et al. left off.

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