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Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.

Method of Treatment Utilizing Natural Law Held Subject-Matter Eligible

Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.919 F.3d 1347 (Fed. Cir. Mar. 28, 2019) (Wallach, Clevenger, STOLL) (D. Del.: Andrews) (4 of 5 stars)

Fed Cir reverses Rule 12 dismissal for § 101 patent ineligibility. Endo’s patent related to the use of oxymorphone to treat pain in patients with impaired kidney function. Applying the two-step Alice/Mayo test, the claims were not directed to a natural law. Citing Vanda Pharmaceuticals, 887 F.3d 1117 (Fed. Cir. 2018), the opinion describes how the claims specifically require administration steps (based on the results of kidney function testing), and so are directed to a “specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome.” Op. at 12 (quoting Vanda, 887 F.3d at 1136). The claims were distinct from those in Mayo because Endo’s patent was specifically directed to “the application of a drug to treat a particular disease,” and because Endo’s patent specifically recited “giving a specific dose of the drug based on the results of kidney function testing.” Id. (emphasis added). The opinion also reasons that Mayo specifically noted how method of treatment claims would pose limited preemption issues.

The opinion rejects appellee’s attempt to distinguish Vanda. That Vanda included a step of taking/assaying a sample in a particular way was not a meaningful distinction. And like the claims in Vanda, Endo’s claims included sufficient detail to “allow the claims to do more than just recognize a need to lower or decrease a dose.” Op. at 14. The opinion also cites CellzDirect, 827 F.3d 1042 (Fed. Cir. 2016), as supporting, and finds neither Ariosa, 788 F.3d 1371 (Fed. Cir. 2015), nor Athena, 915 F.3d 743 (Fed. Cir. 2019), contradictory, noting that claiming a new treatment (albeit using a natural law) is not the same as claiming the natural law.

KEYWORDS: SUBJECT-MATTER ELIGIBILITY; PERSONALIZED MEDICINE; NATURAL LAW