In a recent decision of the Federal Circuit (Biogen MA Inc. v. EMD Serono, Inc.) claims reciting methods using a recombinant polypeptide were held to be anticipated by prior art methods using a “native” version of the same polypeptide. 

Claim “1” was directed to a method….that consisted of administering a recombinant polypeptide…made by…(product-by-process)

The district court interpreted the claim as a “one-step” method of treatment claim comprising of administering the recombinant peptide without even considering the part of the claim directed as how the peptide was prepared (product-by-process limitation).

The Federal Circuit disagreed.

According to the Federal Circuit, the recombinant origin of the recited composition cannot alone confer novelty on that composition if the product itself is identical to the prior art non-recombinant product.

In this case, the novelty of the method of administration rests wholly on the novelty of the composition administered, which in turn rests on the novelty of the source limitation.  Thus,for the assessment of novelty, the comparison of the structures of the recombinant and the native peptides results in the same conclusion of anticipation for both forms of claims.

This case shows that claims reciting methods using recombinant products may face anticipation and patent eligibility challenges, unless the recombinant product is distinct from the corresponding native product.

Please contact me at silvia@salvadorilaw.com with questions or comments.