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Bristol-Myers Squibb Co. v. Merck

Representative Claim(s)

1. A method of treating a metastatic melanoma comprising intravenously administering an effective amount of a composition comprising a human or humanized anti-PD-1 monoclonal antibody and a solubilizer in a solution to a human with the metastatic melanoma, wherein the administration of the composition treats the metastatic melanoma in the human.

Posture:

Merck did not meet its burden of proving by clear and convincing evidence that the ‘994 Patent is invalid on its face for failing to cover patent-eligible subject matter under 35 U.S.C. § 101.  (Discovery is needed to determine whether the claims amount to an implementation step.    Bristol–Myers argues that administering anti-PD1 antibodies is not a diagnostic step, but provides the treatment itself.  Thus, there are material factual disputes that cannot be resolved on a Motion to Dismiss).

Exception Category: Natural Phenomenon

“The ’994 patent relies on the known scientific fact that blocking activation of the PD–1 pathway causes [an] effect in the body, which enables the patient’s T cells to perform their normal biological activity of removing cancer cells. This interaction is a natural phenomenon.”

Significantly More: Not Decided

“Whether the claims amount to an implementation step is a complicated factual determination that the court could better resolve after discovery.”

“[T]he ’994 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.”