Defendant Merck filed a motion to dismiss BMS’s claims under U.S. Patent No. 9,069,999 due to lack of patentable subject matter under Section 101, arguing that the patent claims “the natural operation of the body’s immune system via the PD-1 pathway” and does not contain an inventive concept sufficient to render that natural phenomenon patent-eligible. Merck contended that the patent-in-suit was similar to the patent found to be ineligible in Mayo because it contained only a natural phenomenon and an administering step. Bristol-Myers Squibb Co., et al. v. Merck & Co., Inc., et al., C.A. No. 15-560-GMS, Or. at 2 n.1 (D. Del. Mar. 17, 2016). BMS responded that the challenged claim was a method of treatment claim and that “every method of therapeutic treatment at its basic level relies on the biological activity of the patient’s immune system.” Id.
Judge Sleet first rejected BMS’s contention that the patent-in-suit did not touch upon a natural phenomenon: “The inventors relied on the fact that inhibiting ‘signals of PD-1, PD-L 1 or PD-L2 inhibit cancer proliferation through the mechanism of the recovery and activation of immune function.’ This interaction is a natural phenomenon.” Id. at 3 n.1 But Judge Sleet went on to find that there were factual disputes regarding whether the claims “add enough” to the natural phenomenon that could not be resolved on a motion to dismiss: “Whether the claims amount to an implementation step is a complicated factual determination that the court could better resolve after discovery. Additionally, the’999 patent is entitled to a presumption of validity under 35 U.S.C. § 282. Rarely can a patent infringement suit be dismissed at the pleading stage for lack of patentable subject matter.” Id. Accordingly, Judge Sleet denied the motion to dismiss.