Diagnostic and Treatment Patent Eligibility Update

The Federal Circuit has been active in clarifying what constitutes patentable subject matter in the medicinal and biotechnology fields, issuing a precedential and nonprecedential opinions over the last few weeks. The cases highlight the importance of including manipulation steps in patent claims, i.e. where a human provides an active step in the claimed subject matter that is not readily known.

In a precedential opinion, the Federal Circuit found modifying a person for his or her natural state is sufficient to overcome the subject matter requirement of the patent laws under 35 U.S.C. §101. [i]  At issue was a composition and method of using dietary supplements to enhance athletic performance.  The language in the claims provides for adding amino acids that “increases beta-alanyl-histidine dipeptide synthesis”[ii] The lower court found the claims were directed to consuming beta-alanine, which is a natural substance, making the claims patent ineligible.[iii] The Federal Circuit noted that the application defined “dietary supplement” as a non-natural or conventional food of the human diet.[iv]  Further, the claims provide for adding beta-alanine to overcome a subject’s natural homeostasis and produce greater levels of creatine.[v] Noting that while using a natural law, modifies the subject to an unnatural state.[vi] Further, the Court noted that the dietary supplement is not a natural or conventional food, but an addition to the diet, 13 much greater than that of a standard diet.[vii] The Federal Circuit also looked at compositions of glycine and beta-alanine, finding that some evidence appears to indicate the two components interact, which would make the compositions patent eligible.[viii] Read More