INTRODUCTION
In the Patent system, natural laws are not patentable. Many countries having established Patent laws denied the natural laws as patentable subject matter. In Indian Patents laws, sub clause (a) of section 3 clearly states that the invention which claims anything obviously contrary to well established natural laws is not patentable. Also in the United States patents laws under 35 U.S.C. § 101, the claims which relates to the natural laws are not patentable. According to the USPTO, all claims (i.e., machine, composition, manufacture and process claims) reciting or involving laws of nature/natural principles, natural phenomena, and/or natural products should be examined. The examiner will determine whether a claim reflects a significant difference from what exists in nature and thus is eligible, or whether a claim is effectively drawn to something that is naturally occurring1. Thus inventions which are fully or partially related to the natural laws/ natural principals are not patentable.
In one of the case delivered by the Supreme court of United States in the year 2012, the court states that the "laws of nature, natural phenomena, and abstract ideas" are not patentable subject matter. This judgment was given in the patent infringement case between Mayo Collaborative Services V. Prometheus Laboratories, INC.2
The patents in issue were related to therapeutic diagnostic tests for determining the level of drug. This is the much awaited case after the Bilski's verdict. (In 1997, Bernhard Bilski applied for a patent on a method of hedging risks in commodities trading. The process claimed by Bilski is one of initializing a series of sales transactions between brokers and sellers based on a (fixed) historical price rate, identifying sellers and initializing a series of sales between brokers and sellers in order to balance out the risks of sellers and buyers. The patent was rejected by the US Patent and Trademark Office as well as the Court of Appeals for the Federal Circuit). The issue in this case was that the process of the patents was not patentable as the same is covered under laws of nature. The much awaited decision for the entire IP folks particularly the healthcare industry was delivered by the Supreme Court along with a very well reasoning on the issues. In this article, important issues related to the case will be discussed and the possible impact of the case in the future will also be discussed.
BRIEF BACKGROUND OF THE CASE
Prometheus Laboratories, Inc. (hereinafter Prometheus) is the sole licensee of the US Patent no. 6,355,623 (hereinafter 623) and 6,680,302 (hereinafter 302). Both these patents are related to the use of thiopurine drugs in the treatment of autoimmune disease. The main objective of introducing the Patent is that when a patient ingests a thiopurine drug, the body of the patient metabolizes the drug, causing metabolites to form in the Patient's bloodstream. The way in which the people metabolize thiopurine varies, the same dose will affect different people differently and it will be difficult for a doctor to determine the dose of a drug. Both these Patents identify the concentration in a patient's blood of 6-TG or of 6-MMP metabolite beyond a certain level (400 and 7000 picomoles per 8X108 red blood cells respectively) indicate that the dosage is too high for the patient, while concentration in the blood of 6-TG metabolite lower than certain level (about 230 picomoles per 8X108red blood cells) indicate that the dosage is too low to be effective.
The Mayo Collaborative Services (hereinafter Mayo), a service firm bought and use some test of the Prometheus and in 2004 they started using and selling their own test - using somewhat higher metabolite levels to determine toxicity. After knowing the Mayo practice of selling the Prometheus invented test kit, Prometheus filed a suit against the Mayo for infringing its patents by using and selling identical test. On filing the Patent infringement case at District court, the Court asserted that the Mayo's test infringe the '623 patent. The District Court accepted the Prometheus view that the toxicity-risk level numbers in Mayo's test and the patent claims were too similar. The Court also accepted that the doctor using the Mayo's test could violate the patent. Nonetheless the District Court granted the summary judgment in favour of the Mayo that the patents effectively claims natural laws i.e. the correlation between the thiopurine metabolite levels and the toxicity and efficacy of the drug dosages.
After the Prometheus filed an appeal in the Federal Court against the decision of the District Court, the Federal Court reversed the judgment, stating that the claimed process specify the steps of "administering a [thiopurine] drug" to a patient and "determining the [resulting metabolite] level." These steps involved the transformation of human body or the blood, thus satisfying the "machine or transformation test" and bringing the claims into compliance with section 101 of US Patent laws.
Going ahead, Mayo filed petition of certiorari. The Supreme Court granted the petition, vacated the judgment and remanded the case for reconsideration. On remand the Federal circuit reaffirmed its earlier conclusion. Mayo again filed a petition for certiorari and the same was granted.
FINAL DECISION OF THE SUPREME COURT
The Supreme Court after hearing the whole length and breadth of the case stated that the Prometheus Patent just sets forth the laws of nature namely the relationship between the concentrations of certain metabolites in the blood and the likelihood that a dosage will be ineffective or cause harm. According to the claims the drug is administered in the body (human action) and metabolization of the thiopurine compounds in the human body– is entirely a natural process. Thus the patents simply describe the natural relations.
The Court raises the question that the patent simply recites the natural relation or do significantly more states that if a law of nature is not patentable then neither is a process reciting the law of nature, unless the process have additional features that provide technical assurance that the process is more than a drafting effort to design around law of nature itself. Further, the Court stated examples of Einstein and Archimedes that they could have patented their famous laws if the laws of nature are subject to Patentable matter.
The patents in question consists of three main steps "administering" step, a "determining" step, and a "wherein" step. Firstly, the administering step refers to the relevant audience i.e. doctors who treat patients with thiopurine. It is worth noting that the doctors are already using the drug thiopurine for treatment of patients suffering from autoimmune disorders. Second wherein step simply tells the doctors the natural laws or at most to take in account the natural laws while treating patient. The third determining step tells the doctor to determine the level of relevant metabolites in the blood through whatever process. In conclusion the patents "methods for determining metabolite levels" are very well known in the art. The doctors and scientists normally measure metabolites as a part of investigations. The Court also stated that while considering the three steps in an ordered combination adds nothing to the laws of nature.
The Court recites old cases of Daimond v. Diehr and Parker V. Flook.3 Both of these cases are most directly on issue in which the Court reached opposite conclusion on the patent eligibility of processes embodied natural laws. The Diehr process was related to method for moulding raw rubber into cured, moulded products using the well known mathematical equation, the Arrhenius equation, to determine the time to open the mould. The Court stated the basis mathematical equation was not patentable, however the entire process was patent eligible because the use of additional steps which integrated the equation into the process as a whole. While Flook provided method for adjusting alarm limits in the catalytic conversion of hydrocarbons. Unlike the process in Diehr, it did not explain "how the variables used in the formula were to be selected, neither processes at work nor the means of setting off an alarm or adjusting the alarm limit.4"
Further considering the argument that the claimed processes are patent eligible as they involve the transforming of the human body by administering the thiopurine and transforming the blood by analyzing it to determine metabolite levels, the Court stated that these transformations are irrelevant, as the administering step is simply picking of patients who are likely to apply the laws of nature and the second step can be satisfied without transforming the blood as no new system was developed for determining metabolites levels that did not involve such a transformation. The claims of the present case are weaker than the claim in Diehr and no stronger than Flook.
Considering the above reasons the Supreme Court concluded that the Prometheus patent claims at issue here effectively claims the underlying laws of nature themselves. The claims are invalid and Federal Circuit's judgment reversed.
CONCLUSION
The Supreme Court sets out the new principles for examiners for determining the patentability for the therapeutic process or medical treatment methods based on or involving natural laws. The Court opined that those processes must have something in addition to the laws of nature which constitute inventive step.
The claims should not be designed to claim the natural phenomenon or the prior art. According to the above decision the novelty and inventiveness of the claims shall be checked individually and not combining all of them. Further the judgment will surely help the examiners in rejecting applications based on natural laws. Also the Court clears that "Machine or transformation test" as propounded by the Bilski case, is a clue for determining patentability of the processes, but is not a determinative test.
Foonotes
1 http://www.uspto.gov/patents/law/exam/myriad-mayo_guidance.pdf
2 http://www.supremecourt.gov/opinions/11pdf/10-1150.pdf
4 437 US 584 (1978)
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