In biomodal Ltd. v. New England BioLabs, Inc., No. 24-cv-11697-RGS, Dkt. No. 78 (D. Mass. Nov. 2024), Defendant New England BioLabs, Inc. (“NEB”) filed a motion to dismiss the claims of infringement of five patents as relating to ineligible subject matter under 35 U.S.C. § 101, while Plaintiff biomodal Ltd. (“biomodal”) filed a motion for a preliminary injunction to enjoin NEB from marketing its allegedly infringing products. The Court denied in part the motion to dismiss and denied the preliminary injunction.

NEB challenged claims in five of the eight patents that biomodal asserted against it. These patents related to (1) methods to deliver a nucleic acid sequence, enzyme, or fragment, to oxidize methylated DNA bases, (2) methods of converting methylated cytosine to a modified base, (3) methods for detecting methylated cytosine in a nucleic acid, (4) isolated nucleic acids that include a hydroxymethylated cytosine that is glucosylated, and (5) compositions comprising methylcytosine dioxygenase, a DNA glucosyltransferase, and a nucleic acid comprising glycosylated 5-hydroxymethyl cytosine.

The District Court granted the motion to dismiss the method claims because they replicated natural processes of enzymes. The Court rejected biomodal’s arguments that language in one of the method claims relating to administering “effective amounts” should make the claims patentable, reasoning that applications of a natural law in a therapeutic context are not sufficient alone to provide an inventive concept. The Court also rejected biomodal’s assertion that one of the methods created a modified, non-naturally occurring nucleotide sequence because that sequence was not evident in the claims.

The Court denied the motion to dismiss with respect to the claims directed to isolated nucleic acids and the composition claims. The Court found that it could not resolve the question of whether these were naturally occurring without further discovery.

The Court denied biomodal’s motion for preliminary injunction on four patents, finding that biomodal had failed to show a likelihood of success on the merits. In part, biomodal was unable to show a likelihood of success on the merits because two of the four patents were already held ineligible by the Court in deciding the motion to dismiss. With respect to the other two patents, the Court found that biomodal had failed to demonstrate that that NEB’s invalidity defenses lacked substantial validity, especially given that biomodal failed to even address some of NEB’s invalidity arguments.

Therefore, the Court granted-in-part and denied-in-part NEB’s motion to dismiss and denied biomodal’s motion for preliminary injunction.

Links & Downloads

[View source.]