One question innovators frequently ask is "What is a patentable invention?" This is an important question because patents confer legal rights that enable the patent owner to prevent others from making, using, selling, and offering for sale patented inventions. Thus, patents can be used to prevent competitors from copying a new or improved product or process. This article provides a brief summary of the topic of patent eligibility.
The first patent law enacted in 1793 and authored by Thomas Jefferson, described patentable subject matter as "any new and useful art, machine, manufacture, or composition of matter, or any new or useful improvement [thereof]." This same broad language remains embedded in the law today, although in 1952, Congress replaced the word "art" with "process" but otherwise left Jefferson's language unchanged.
Other sections of the patent statute address the "new" requirement in terms an invention's novelty and non-obviousness. Putting those issues aside, an invention's eligibility for patent is often never challenged by the U.S. Patent and Trademark Office except in certain areas like process claims to business methods. This is in large part due to statements by the Supreme Court broadly construing the patent statute to cover "anything under the sun that is made by man."
The courts, however, have recognized three categories of discoveries that are unpatentable: (1) abstract ideas, (2) laws of nature, and (3) natural phenomena. Practical applications or uses of an idea, law of nature, or a natural phenomenon, however, generally are patentable. Those practical applications are often embodied in the categories of machines, manufactures and compositions of matter.
Process claims appear to be the area in which patent eligibility should be more carefully considered. A recent Supreme Court decision illustrates this point and has now put another category of discoveries under scrutiny—diagnostic methods.
In Mayo Collaborative Services v. Prometheus Laboratories, Inc., the Court reviewed the eligibility of patent claims to processes of using thiopurine drugs to treat autoimmune diseases. When ingested, the drugs produce metabolites in the bloodstream. Because patients metabolize drugs differently, doctors found it difficult to determine whether a particular patient's dose was too high (resulting in toxic side effects) or too low (having no effect). Researchers discovered that precise dosing regimens could be correlated with the concentration of certain drug metabolites.
The U.S. Patent and Trademark Office granted claims to the discovery in U.S. Patent No. 6,355,623. The claims covered processes for "optimizing therapeutic efficacy" and "reducing toxicity associated with treatment" by reciting two steps: (a) administering a drug and (b) determining the level of the drug or metabolite in a patient.
The Supreme Court unanimously found, however, that the claims were ineligible for patent protection. In particular, it ruled that the steps recited in the claimed processes involve "well understood, routine, conventional activity" by scientists and doctors that "effectively claim the underlying laws of nature themselves."
In light of the Supreme Court's most recent decision, patent claims directed to processes may not be eligible for patent protection, if the claims broadly cover a law of nature, natural phenomenon, or naturally occurring relation or correlation. To be eligible, the claim must cover something significantly more than practicing the natural principle itself.
In summary, innovators can patent a wide variety of inventions that fit within the broad categories of machines, manufactures, or compositions of matter. Thoughtful consideration, however, of claims to processes should be made to ensure that they do not cover ideas and natural laws and phenomena.
Previously published in the Summer 2012 issue of the Intermountain West Society of Cosmetic Chemists newsletter.
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