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what constitutes patentable subject matter in the medicinal and biotechnology fields, issuing a precedential and nonprecedential opinions over the last few weeks.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]

In a nonprecedential opinion, the Federal Circuit determined specific dosing regimens, when included in the claims, can apply a natural law, thereby making the claims patent eligible.[ix] The Federal Circuit reviewed links between plasma AUC1 for oxymorphone and a patient’s degree of renal impairment, which is not affected until a patient has moderate or severe impairment in his or her creatinine clearance rate.[x] The invention was directed to methods of administering oxymorphone for renal impairment pain, by administering about 5 mg to about 80 mg of oxymorphone and adjusting subsequent dosages to fit AUC levels.[xi] The Federal Circuit determined that the invention applied a natural law of treating pain in renal impairment,[xii] using a dosing regimen, even though the dosing regimen is based on kidney function.[xiii] The court focused on the claims of the patent, and noted that the claims provide for specific dosing based on the results of kidney function testing, making it more than just a recitation of a natural law.[xiv] The analysis suggests that a simple claim that the drug dosage must be increased or decreased , without prescribing a specific dosage regimen, would result in a different outcome.[xv]

The Federal Circuit also addressed diagnostic claims correlating enzyme levels in blood to cardiovascular disease in a nonprecedential option, finding a correlation is insufficient to overcome the eligibility requirement.[xvi] The patents at issue analyzed the link between levels of naturally occurring heme protein myeloperoxidase to coronary artery disease.[xvii] Cleveland Clinic argued that the diagnostic required use of detection systems to determine a correlation between blood MPO levels and atherosclerotic CVD, and that use of the detection system to detect blood MPO levels transformed the invention into patent eligible subject matter.[xviii] However, the Federal Circuit stated that the invention applied known methods to detect MPO levels, followed by determining if the MPO levels were elevated by comparing results to standard MPO levels of control group.[xix] Further, the use of a known diagnostic technique does not make an invention patent eligible, with the Federal Circuit noting almost all diagnostic methods require the use of some testing technique to observe results.[xx]

The three cases highlight the importance of included manipulation steps in claims that are not readily known at the time of the application filing.  The inclusion of steps that either (1) take a subject out of his or her natural state; or (2) provide a specific application of a natural state or correlation are important in the patent eligibility determination.  Further, greater specificity in the claim language can, in some instances, be more advantageous that broad and generic language in the post-Alice/Mayo landscape, as seen in the Endo Pharma. decision.



[i][i] Natural Alternatives, Int’l, Inc. v. Creative Compounds, LLC, No. 2018-1295, slip opinion at 10-11 (Fed. Cir. 2019).

[ii] Natural Alternatives, Int’l, Inc., slip opinion at 7-8.

[iii] Natural Alternatives, Int’l, Inc., slip opinion at 8.

[iv] Id.

[v] Id.

[vi] Natural Alternatives, Int’l, Inc., slip opinion at 10-11, 12.

[vii] Natural Alternatives, Int’l, Inc., slip opinion at 14.

[viii] Natural Alternatives, Int’l, Inc., slip opinion at 18.

[ix] Endo Pharma. Inc. v. Teva Pharma. USA, Inc., Nos. 2017-1240, 2017-1455, 2017-1887, slip opinion at 13-14 (Fed. Cir. 2019).

[x] Endo Pharma. Inc., slip opinion at 3-4.

[xi] Endo Pharma. Inc., slip opinion at 5.

[xii] Endo Pharma. Inc., slip opinion at 10.

[xiii] Endo Pharma. Inc., slip opinion at 11.

[xiv] Endo Pharma. Inc., slip opinion at 12-13.

[xv] Endo Pharma. Inc., slip opinion at 13-14 (the claims “identif[y] the appropriate schedule and dose of oxymorphone to administer, as a function of how much oxymorphone is in the patient’s system. It is the combination of the administering step and wherein clause claim language, taken together, that make the claims-at-issue as specific as those in Vanda such that the patent claims do not “tie up the doctor’s subsequent treatment decision.”).

[xvi] Cleveland Clinic Foundation v. True Health Diagnostics LLC, No. 2018-1218, slip opinion at 10 (Fed. Cir. 2019).

[xvii] Cleveland Clinic Foundation, slip opinion at 3.

[xviii] Cleveland Clinic Foundation, slip opinion at 9.

[xix] Cleveland Clinic Foundation, slip opinion at 10.

[xx] Id.