Method of treatment claims patent ineligible under 101 for being “focused on screening for a natural law” (“the invention does not improve treatment…by taking advantage of the body’s natural process”)

INO Therapeutics LLC, et al. v. Praxair Distribution Inc., et al.

Docket No. 2018-1019
August 27, 2019

Brief Summary: DC finding that “method of treating patients” claims ineligible under section 101 affirmed as the claims are “focused on screening for a natural law” and “the invention does not improve treatment…by taking advantage of the body’s natural process”. DC finding of no infringement also affirmed.

Summary: INO and Mallinckrodt (“INO”) asserted five patents related to methods for administering inhaled nitric oxide (“iNO”) (US 8,282,966; 8,293,284; 8,795,741; 8,431,163; and 8,846,112; all sharing a common specification (the “heart failure” or “HF” patents)), and five patents related to devices and methods for administering gas (US 8,573,209; 8,776,794; 8,776,795; 9,265,911; and 9,295,802 (the delivery system infrared” or “DSIR” patents)).

Claim 1 of the ‘741 patent was considered representative of the HF patents, and claims “[a] method of treating patients” by “identifying a plurality of…patients who have hypoxic respiratory failure”, “determining that a first patient…does not have left ventricular dysfunction” and that “a second patient…has” it, “administering” iNO “to the first patient”, and “excluding the second patient from treatment”. The DC held the HF patents to be patent ineligible under section 101 and the FC panel agreed since the claim “does not recite giving any affirmative treatment for the iNO-excluded group, and so it covers a method in which, for the iNO-excluded patients, the body’s natural processes are simply allowed to take place” (e.g., “the claim here is directed to the natural phenomenon”, “apart from the natural phenomenon itself, involves only well-understood, routine, and conventional steps”, “instructs a physician to administer iNO gas to non-LVD patients as before, while now excluding the LVD patients”, “the exclusion step merely restates the natural law”, “this added step is simply an instruction not to act”, “the patented method does not propose a new way of treating LVD patients that leverages this discover (e.g., by titrating the iNO dose)”, “a claim not to treat…risks monopolizing the natural processes themselves”, “the focus of the invention is not on a new way of actually treating the underlying condition”). The FC panel also wrote that reliance on Vanda (FC 2018) is “misplaced” because in Vanda “the invented treatment recited a specific new way to provide a therapeutic benefit” while here “the invention does not improve treatment…by taking advantage of the body’s natural process” and “the claim language stops well short of an improved treatment method” (“the broad directive to exclude…collapses into a claim focused on the natural phenomena”, “focused on screening for a natural law”) (distinguishing this case from Nat. Alternatives (FC 2019) and Endo (FC 2019) (patent eligible since “the invention used the law to produce a change in the natural state of a patient to treat a condition”, “the focus of the invention was a ‘treatment’”) and CellzDirect (FC 2016) (patent eligible since the claims “used the law to improve the process”)). Thus, the first step in the Mayo/Alice (US 2012, US 2014) analysis was satisfied. And the FC panel found “nothing more than routine and conventional steps” (no “inventive concept’ sufficient to transform the claimed naturally occurring phenomena into a patent-eligible application” in its Mayo/Alice step two analysis (Cleveland Clinic, FC 2017; Mayo, US 2012), and therefore affirmed the DC decision that the HF patents are patent ineligible under section 101.

The DSIR patents, which the DC found not to be infringed, are represented by ‘794 claim 1 directed to “[a] gas delivery device comprising…a gas source” and “a processor and transceiver” used to control gas delivery and “verify one or more of the gas identification, the gas concentration and that the gas is not expired.” Mallinckrodt argued the court’s interpretation of “verify” was erroneous, and did not dispute no infringement under the DC’s definition, but the FC panel explained that the term was not construed by the DC and found the DC’s reliance on “[t]he plain language of the representative claim” to be correct (“confirmed by the specification”). The DC decision of no infringement of the DSIR patents was therefore affirmed. The FC panel remanded the decision to allow the DC to correct its erroneous “blanket ruling that each…patent in its entirety was invalid or not infringed” (“no authority to expand[] judgment…to unasserted claims”).

This entry was posted in Claim Construction, Patent Eligibility (101), Patentability, Uncategorized. Bookmark the permalink.

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