The Supreme Court’s unanimous ruling in Mayo v. Prometheus was announced yesterday. In the 9-0 unanimous ruling the U.S. Supreme Court ruled that “[L]aws of nature, natural phenomena, and abstract ideas” are not patentable subject matter under §101 of the Patent Act,” citing to Diamond v. Diehr, 450 U. S. 175, 185. “[A]n application of a law of nature . . . to a known structure or process may [deserve] patent protection,” id., at187, [b]ut to transform an unpatentable law of nature into a patenteligible application of such a law, a patent must do more than simply state the law of nature while adding the words “apply it.” See, e.g., Gottschalk v. Benson, 409 U. S. 63, 71–72. It must limit its reach to a particular, inventive application of the law.” Prometheus
In Prometheus, the patents at issue addressed a process for drug treatment and how the body reacts to the drug in that certain metabolite levels increase or decrease as a result of the interaction between the body and the drug. The changed metabolite level indicates whether or not the body reacted favorably to the treatment. In the patent, the claims include a limitation to a metabolite level which is between over-treatment and under-treatment.
The Court interpreted the claim as a process of (1) measuring the current level of the relevant metabolite, (2) use a particular law of nature to calculate the current toxicity/inefficacy levels associated with the metabolite within the patient, and (3) evaluating the drug dosage in light of the metabolite level. The law of nature relates to how the body processes the treatment drug and produces the relevant metabolite in response to the drug. According to the Court, the claimed process added nothing to the laws of nature other than what is well-understood, routine, conventional and previously engaged in activity by doctors [those in the field].
The Court rejected the patents by ruling that the correlation of the metabolite level between over/under treatment was an unpatentable law of nature. The metabolite level was a consequence to the way in which the body metabolized the treatment drug — an entirely natural processes. The Court indicated that a patent that simply describes that natural relation is an attempt to claim a law of nature and therefore is unpatentable.
The opinion relies upon prior case law which rejected claims including natural phenomena even though they included certain additional elements. The additional elements were basically equated by the Court to nothing more than a trick to obtain coverage for non-“genuine applications of those laws[, but] rather .. to monopolize the [naturally occurring] correlations.” Of note is that the Court found that the correlation and the additional elements were already known in the art.
Because methods for making such determinations were well known in the art, this step simply tells doctors to engage in well-understood, routine, conventional activity previously engaged in by scientists in the field. Such activity is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law.
Prior to the Court’s ruling in Prometheus, the general rule was that a process was not unpatentable simply because it contained a law of nature. An application of a law of nature to a known process may well be deserving of patent protection. If a claim, considered as a whole, entails a physical transformation of matter and produces useful, concrete and tangible results. The prior standard was known as the machine or transformation test and under the test, “[a] claimed process is patent-eligible if:(1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing.”
While this case deals directly with the medical profession, the case could have farther reaching implications. This case coupled with the recent S.Crt ruling in Bilski v. Kappos could have greater implications in the software and computer technologies. In Bilski, the S. Crt. narrowed the statutory eligibility for business methods in determining that a process for hedging risks of price changes was not patentable.
Patents on software have been debated since their inception. Software can be covered under copyright. They have also been protected as patentable inventions since the S.Crt ruling in State Street. However, the patent protection afforded to Software is a constant source of litigation and has been argued against by lobbyists organization. One example includes, Apple’s multi-national litigation over the “slide to unlock” feature. A reading of Mayo suggests that the Court may extend the challenge to patent elligiblity to software and other computer related inventions as being natural phenomena.
Software patents (and many computer systems tied to a particular software) fundamentally protect a set of computer instructions programmed into a computer chip which as a result of a mathematical calculation causes a task to be preformed. Mathematical calculations themselves are unpatentable. If the machine, because it preforms mathematical calculations is determined to be nothing more than a calculator and if the transformation test previously adopted by the Court’s is denied, then the software may be considered an unpatentable natural phenomena and Software patents may become a thing of the past.
Whatever the implications are, you can be sure in the near future medical process patents will become more difficult to obtain, patent attorneys will learn new ways to write medical process patents and pharmaceutical companies will be lobbying congress to draft new laws to ensure their pharmaceutical patents will be covered.