As you will recall, in Prometheus v. Mayo, the Supreme Court held that a claim reciting a natural law had to have other non-conventional steps to pass muster under s. 101. The natural law in Mayo was the correlation between the concentration of the metabolite of the immunosuppressive drug and the efficacy of the drug – unpleasant side effects at the high end of the recited range and lack of efficacy at the low end. The Mayo Court wrote: “We need not, and do not, decide whether were the steps at issue here less conventional, these features of the claims [the administering, determining and recognition steps] would prove sufficient to invalidate them.” It was unnerving that the invalidated claims were method-of-treatment claims.
In his opinion in a Hatch-Waxman litigation involving the anti-schizophrenia drug Iloperidone, Vanda Pharms., Inc. v. Roxane Labs., Inc., Civil Action No. 13-1973-GMS; 14-757-GMS (D.Del., 2016), Judge Sleet upheld the validity of the compound and the method claims in Reissue Patent No. 39,198 and US Patent No. 8,586,610. (more…)