CAFC reasoning would find that “Humans” resulting from the process of manufacture are eligible subject matter for patenting!

Humans moved one step closer to becoming eligible subject matter for patenting after today’s decision in Prometheus Labs. v. Mayo Collab. Serv. Slip op. 2008-1403 (Fed. Cir. Sep. 16, 2009).  Two active judges of the CAFC applied Bilski’s transformation test and held that the district court erred when it found claims to a method of optimizing therapeutic efficacy were ineligible subject matter.  In the opinion, the judges equated “humans” to “articles,” a term used in the definition of “manufacture” per § 101.  Thus Prometheus provides authority to urge that a human, or a part thereof, resulting from a process of manufacture is eligible subject matter for patenting.

Below, a district court found the following claim ineligible subject matter for patenting:

1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:

(a) administering a drug providing [6-TG] to a subject having said immune-mediated gastrointestinal disorder; and

(b) determining the level of [6-TG] in said subject having said immune-mediated gastrointestinal disorder,
wherein the level of [6-TG] less than [a recited concentration range] indicates a need to increase the amount of said drug subsequently administered to said subject and
wherein the level of [6-TG] greater than [a recited concentration range] indicates a need to decrease the amount of said drug subsequently administered to said subject.

(For more details, see my blog from July 6, 2009, regarding Prometheus Labs., Inc. v. Mayo Collaborative Servs., No. 04-CV-1200, 2008 WL 878910 (S.D. Cal. Mar. 28, 2008) (“Invalidity Opinion”)).

On appeal, the CAFC applied Bilski’s transformation test: “A claimed process is surely patent-eligible under § 101 if: … it transforms a particular article into a different state or thing.”  Regarding the disputed claims, the panel reversed the holding of ineligibility, reasoning that “[t]he transformation is of the human body following administration of a drug.”   Clearly, and unequivocally, the CAFC equated a “human” with an “article.”  

The term “article” is part of the definition of the term “manufacture” per 35 U.S.C. § 101, meaning “‘articles’ resulting from the process of manufacture.”  See In re Nuijten, 500 F.3d 1346, 1356-57 (Fed. Cir. 2007).   Because Prometheus equated an article to a human, it seem logical to conclude that a human resulting from a process of manufacture is a “manufacture” per § 101. 

And with that folks, authority exists to urge that a human is eligible subject matter for patenting, a hot-potato issue. 

For an even hotter issue, argue that if the whole human is eligible subject matter, then parts of the human are too.  And with this argument, stem cells, organs, etc. resulting from a process of manufacture would be eligible subject matter for patenting.

For more on this topic, see my earlier blogs, including the one on Jul. 4, 2009.