Search Team

Search by Last Name
A
B
C
D
E
F
G
H
I
J
K
L
M
N
O
P
Q
R
S
T
U
V
W
X
Y
Z

Bristol-Myers Squibb Co. v. Merck

Representative Claim(s)

1. A method of treating a lung cancer comprising administering a composition comprising a human or humanized anti-PD-1 monoclonal antibody to a human with the lung cancer, wherein the administration of the composition treats the lung cancer in the human.

Posture:

Merck did not meet its burden of proving by clear and convincing evidence that the ‘999 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 process method consists of administering a synthetic agent through a single step to induce a natural reaction.” Thus, there are material factual disputes that cannot be resolved on a Motion to Dismiss).

Exception Category: Natural Phenomenon

“[E]very method of therapeutic treatment at its basic level relies on the biological activity of the patient’s immune system.”

“The ‘999 patent relies on the scientific fact that blocking activation of the PD–1 pathway enables the patient’s T cells to perform their normal biological activity of removing cancer cells.”

“The court concludes that . . . the ’999 patent touches upon a natural phenomenon by using T cells to activate the immune system.”

“By preventing PD–1 ligands from binding to the PD–1 receptor, the anti–PD–1 antibodies prevent the PD–1 pathway from suppressing the immune system, which, in turn, kills and clears the body of the “foreign” cancer cells using the body’s own natural processes.”

“This interaction is a natural phenomenon.”

Significantly More: Not Decided

Not fully decided; “[t]he determination of the Patent Office that the ‘999 Patent was patent-eligible is presumed to be correct.”