Biogen MA Inc. v. EMD Serono, Inc., et al.

The patent in this case claims a method of medical treatment that requires use of a “recombinant,” or synthetic version, of a human protein. That synthetic, recombinant version does not exist in nature. The Federal Circuit held, in violation of this Court’s longstanding precedent, that the claim term “recombinant” must be ignored in assessing whether the method of treatment is novel. The question presented is: Whether courts may disregard the express claim term “recombinant” so as to render a method-of-treatment patent anticipated—and thus invalid—in light of prior-art treatments that used the naturally occurring human protein, where it is undisputed that the recombinant protein was not used in the prior art?