Nextcea Inc. V. Lipotype, Inc. et al. (D. Mass. 24-cv-12624).

Nextcea accused Lipotype of inducing and contributing to infringement of method claims concerning testing for isomers indicative of phospholipidosis and other lysosomal storage disorders.  Such testing can be of value in testing for drug-induced excess lipid storage or for evaluating whether a drug under evaluation for approval may cause phospholipidosis.  Nextcea’s claims related to a biomarker found in urine or plasma that was discovered to correlate with drug-induced phospholipidosis.

Lipotype moved to dismiss, asserting that the claims were directed to unpatentable laws of nature.   All of the asserted claims required the performance of three steps – obtaining a sample, determining the levels of the biomarker(s) in the sample, and comparing the level(s) with a corresponding pre-determined level obtained from a control sample.  Applying the two-step Alice test for patentable subject matter, Judge Kobick looked to whether the claims were directed to a patent-ineligible law of nature.  Analogizing the facts to those of prior Federal Circuit decisions, he determined that the claims at issue were so directed, as they effectively sought to claim the correlation between the biomarkers and phopsholipidosis, with no further treatment steps involved.

Looking to step two of the Alice test, Judge Kobick determined that the remainder of the claim did not contain elements that transformed the claim into being patent-eligible.  He found that the remainder of the claim simply recited well-known, conventional steps specified at a high level of generality, which are consistently found to be insufficient.  Accordingly, he granted the motion and dismissed the claims.