In a recent United States Supreme Court decision, Mayo Collaborative Services v. Prometheus Laboratories, Inc., the Justices concluded that a certain medical therapeutic process was not entitled to protection under United States patent law. The Court found that this particular process as written consisted solely of a law of nature, and in the United States laws of nature are never (ever) patentable. The Court also emphasized that because the correlation between therapeutic drug dosages and resulting blood levels of biochemical substances (metabolite) is a law of nature, without more this correlation cannot be patent-eligible subject matter.
The process described in the patent is basically as follows:
1. The therapeutic dose is administered to a patent;
2. There is a measurement of the resulting blood level of the particular metabolite; and
3. The physician thereafter evaluates whether the metabolite concentration indicates a harmful side effect or ineffective dosage.
In its detailed an analysis, the Court characterized these three steps as conventional activities that did not add any novel implementation to the drug-metabolite correlation which the patentees had discovered.
What to make of all this? To effectively obtain new processes that are patent eligible, the business owner or researcher must ask: Is my process properly characterized as solely a law of nature, abstract idea, or natural phenomenon (none of which are patent eligible)? Or, is the process a novel APPLICATION of the law of nature and thereby results in a patent eligible process? If one examines Supreme Court decisions over the past forty years, one sees that (i) broadly drafted processes that (ii) do not contain novel implementation of mathematical formulas are not considered patent eligible. Instead these processes were characterized as purported ownership of mathematical formulas. On the other hand, a computer implemented mathematical formula that is integrated into a manufacturing process is patentable subject matter, because additional novel steps limited that algorithm application to a very specific manufacturing process.
As a hypothetical example: To qualify as patentable subject matter the process for isolating identifying a novel type II diabetes gene cannot be written as solely the correlation between the gene’s prevalence and the incidence of diabetes. Instead, the drafter should consider implementation of laboratory steps for isolating the gene into an acceptable process characterization.
In sum, a process should be written with sufficient specificity to include:
1. Specific technical steps to narrow the scope of therapeutic method, computer process, or manufacturing method that may otherwise be characterized as a natural law, mathematical formula, or natural occurrence (such as the correlation of the drug to metabolites described above).
2. In the medical field in particular, steps of the process, other than convention broad requirements such as (i) administration of the drug and (ii) the physician’s interpretation of the results based upon the empirical correlation.
© 2012 Adrienne B. Naumann
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