Docket No. 2012-1223, -1224
MOORE, BRYSON, WALLACH
June 26, 2013
Brief summary: District court grant of summary judgment for nonenablement affirmed because “having to synthesize and screen each of at least tens of thousands of candidate compounds constitutes undue experimentation”.
Summary: Wyeth et al. appealed from DC grant of SJ that claims 1 and 2 of US 5,516,781 and claim 1 of US 5,563,146 relating to treatment of restenosis are invalid for lack of enablement with respect to the “antirestenosis effective amount of rapamycin” limitation (also written description and nonenablemnt of another limitation, but not discussed in this opinion). The parties agreed that the only rapamycin species dislcosed by the specification is sirolimus as well as its immunosuppressive and antirestenoic properties (in vitro tests on rat cells and in vivo IP injection). The DC adopted Wyeth’s proposed construction of “rapamycin” as “a compound containing a macrocyclic triene ring structure produced by Streptomyces hygroscopius having immunosuppressive and anti-restenoic effects.” The opinion focused on “whether practicing the full scope of the claims requires excessive-and thus undue-experimentation” (citing MagSil, FC 2012). Wyeth argued that “the claims do not cover a new genus of compounds, but rather a new use for an existing class of compounds” that would require only routine experimentation (acknowledging through experts that it could cover millions of compounds but that those with the functional effects would be much less (e.g., MW<1,200 daltons)). Abbott argued that "the specification is silent on how to structurally modify sirolimus", disagree that the skilled artisan would have known which compounds to select and would have to "at a minimum…engage in a laborious iterative process to determine what candidates fall within the claimed genus". The panel agreed with Abbott, holding that "having to synthesize and screen each of at least tens of thousands of candidate compounds constitutes undue experimentation" (citing ALZA, FC 2010 (nonenablement where specification provides only "a starting point, a direction for further research"); Cephalon, FC 2013 (defendant did not establish required experimentation "would be excessive, e.g., that it would involve testing for an unreasonable length of time"); and In re Vaeck, FC 1983 (nonenablement where nine of 150 cyanobacteria disclosed). In this case, the panel found that "the specification similarly discloses only a starting point for further iterative research in an unpredictable and poorly understood field" (e.g., synthesis "could…require a complicated and lengthy series of experiments" and one "would need to assay each of at least tens of thousands of candidates"). Thus, the DC grant of SJ was affirmed.