Enzo Life Sciences, Inc. v. Roche Molecular Systems, Inc. et al. (Becton Dickinson (BD), GeneOhm, Aboott) Docket Nos. 2017-2498, -2499, -2545, -2546 (public opinion: July 25, 2019)
Brief Summary: DC grant of SJ for invalidity of Enzo’s claims for lack of enablement affirmed (e.g., “almost no limitations on the structure of the claimed polynucleotide”, “the art was highly unpredictable”).
Summary: Enzo appealed DC grant of SJ for invalidity of Enzo’s US 6,992,180 (directed to oligonucleotides) and US 8,097,405 (directed to in situ and liquid hybridization) for lack of enablement (section 112, first paragraph). The FC panel opinion explains that this appeal results from four consolidated DC cases in which the ‘180 patent is at issue but that the ‘405 patent is only at issue with respect to Abbott. The FC panel explains that, in the cases against Roche and BD, the DC held all of the asserted ‘180 claims to be invalid for lack of enablement (not written description) and, in the Abbott cases, Enzo agreed the same holding applied and the DC held the ‘405 patents to be invalid for lack of enablement (not written description). “The enablement requirement”, the FC panel wrote, “asks whether ‘the specification teach[es] those in the art to make and use the invention without undue experimentation” (“sufficient disclosure to enable an ordinarily skilled artisan”) (In re Wands, FC 1988 (eight Wands factors); MagSil, FC 2012; Alcon, FC 2014 (“a challenger must show” lack of enablement “by clear and convincing evidence”)). The question at issue here was described at relating “not simply [to] whether the specification enables labeling” but “whether it enables creation of a labeled probe that is both hybridizable and detectable upon hybridization” (a “focus upon functionality” (Wyeth, FC 2013 (affirming invalidity for lack of enablement of claims “construed to require a compound having certain functionality (e.g., immunosuppressive effects)”, unpredictable technology)). Here, “the asserted claims…require not just a particular structure, but a particular functionality (i.e., the labeled polynucleotides must be hybridizable and detectable upon hybridization)” and “the specification fails to teach one of skill in the art whether the many embodiments of the broad claims would exhibit that required functionality” (e.g., ’180 patent: “almost no limitations on the structure of the claimed polynucleotide, other than the fact that the label is attached to the phosphate portion”, “broad categories” of “non-radioactive label(s)”, “at the time of the invention, the art was highly unpredictable”, “serious doubts held by those of skill in the art regarding whether labels could be attached to non-Ward positions without disrupting hybridization”, “merely stating that a labeled polynucleotide will work as a probe is not sufficient”, “deficiencies in the description as to enablement cannot be cured in this case by looking to the knowledge of those skilled in the art at the time of the invention” (Genentech, FC 1997; Alza, FC 2010; Atlas Powder, FC 1984 (prophetic examples not disallowed); In re Fisher, CCPA 1970); ‘405 claims “are broader” and also not enabled). Thus, the DC’s grant of SJ for lack of enablement was affirmed.