Interlude: Patent Eligible Subject Matter
Now that you know most of the fundamentals of patent law, you might still be wondering about a topic that we skipped over at the start of this unit: other than newness and utility, are there any other constraints on what can be patented? The answer to this question typically involves the topic of patent-eligible subject matter.
One approach to the question of patent eligible subject matter is to begin with two texts: the Intellectual Property clause of the U.S. Constitution and 35 U.S.C. § 101, which states that:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new or useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
“Process,” in turn is defined as “process, art or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material.” 35 U.S.C. § 100(b).
In addition to these texts, there are numerous Supreme Court decisions focusing on the issue of patent eligible subject matter. The Court has simultaneously broadly interpreted the four statutory categories—especially “process”—while also concluding that there are “exceptions” that limit the eligible subject matter for patents. These exceptions generally hold that things that already exist in nature, natural laws, and abstract ideas cannot be patented. In addition, various other subject matters have traditionally been disfavored by the patent office, mostly notably inventions in which the only difference between the prior art and the claimed invention consists of “printed matter” (for example, placing pictures of the University of Iowa Hawkeye Marching Band on a deck of playing cards would not be given patentable weight).
Products of Nature
One category of subject matter that has historically not been considered patent eligible are things that already exist in nature. The general consensus is that naturally occurring products aren’t eligible for a patent. For example, if I were to discover a new tree and pick a leaf off that tree, I couldn’t patent that leaf. The issue, is that often these naturally occurring things require substantial purification processes or other steps to obtain the “natural product.”
Two Supreme Court opinions illustrate this point. In its 1980 decision in Diamond v. Chakrabarty, the Supreme Court rejected the argument that there is a blanket prohibition on patenting living organisms. In the facts giving rise to that case, Dr. Chakrabarty filed a patent application for a genetically modified micro-organism, but his claims were rejected by the examiner who reasoned the claims were unpatentable because (1) the micro-organism was a product of nature, which is not patent eligible, and (2) living things, including the claimed micro-organism, are not patent eligible subject matter. The Supreme Court reversed the examiner’s rejection, concluding that the claims was directed to patent eligible subject matter because the micro-organism is “a non-naturally occurring composition of matter” that is “product of human ingenuity.” In holding that Chakrabarty’s micro-organism is in fact patent eligible, the Court also rejected the idea that there is a per se rule prohibiting patenting of living things.
Thirty-three years later, the question of whether various forms of DNA could be patented came before the Court in AMP v. Myriad. Myriad had obtained patent claims that covered “isolated DNA” fragments of the genes for BRCA 1 and BRCA 2. While substantial work went into identifying these sequences, the Court held that they were not patent eligible subject matter because they simply claimed something that existed in nature—Myriad did not create or alter the genetic sequence or structure. At the same time, the Court held that the claims directed to “cDNA,” which consisted of the isolated DNA with sections that did not code for proteins removed, was patent eligible subject matter because (in the court’s understanding) the cDNA did not exist in that state in nature and Myriad had needed to do things to create it.
Abstract Ideas
While the distinction between products of nature and human-made creations provides an entry into the concept of patent eligible subject matter, the main issues in this space have arisen over claims to processes. Processes, unlike machines, manufactures and compositions of matter, are not “things”; rather, they might generally be described as a series of steps to achieve some desired outcome. Subject matter issues relating to the patentability of processes have manifested in two major ways: concerns that the claimed invention is too “abstract” to be patentable and concerns that the claim monopolizes a natural law rather than a human application of that law.
For the period between 1981 and 2010, disputes over patentable subject matter were relatively minimal and there were no Supreme Court decisions addressing patent eligibility. The Federal Circuit gradually acceded to broader and broader patent eligible subject matter, allowing (among other things) patents on methods of doing business.
This landscape changed, first with the Federal Circuit’s adoption of a strict test for subject matter eligibility in In re Bilski in 2008, and then with the Supreme Court’s 2010 decision in Bilski v. Kappos, 130 S.Ct. 3218. The issue in Bilski was whether a method of hedging risk to maximize investment profits is an abstract idea that would not be considered patent eligible subject matter. Even as it rejected the strict test adopted by the Federal Circuit, the Court concluded that risk hedging was an abstract idea that did not constitute patent eligible subject matter. Mayo v. Prometheus (2012), Ass’n for Molecular Pathology v. Myriad Genetics (2013), and Alice v. CLS Bank (2014) followed.
In two of these cases the Supreme Court developed a two-part framework for analyzing patent eligible subject matter questions. Called the Alice/Mayo framework, this two-step analysis first asks whether the claim is “directed to” a patent-ineligible concept. If it is, the decisionmaker asks whether there is anything else in the claims that constitutes an “inventive concept sufficient to transform the claimed abstract idead into a patent-eligible application.” Alice v. CLS Bank (2014). If the answer to question one is yes and step two is no, then the claim is not directed to eligible subject matter.
Since the Supreme Court’s four patent eligible subject matter cases in 2010-2014, that issue has taken center stage in patent law. It has been characterized by hundreds of appellate decisions, dozens of law review articles, strident commentary, attempted legislative changes, and a variety of responses at the USPTO—first reflecting the position that patent eligible subject matter should be a substantial barrier to patentability and then shifting to reflect a position that the patent office should narrowly interpret the Supreme Court’s decisions in Bilski, Mayo and Alice.
