The Supreme Court has long held that laws of nature along with abstract ideas and natural phenomena are not patentable.1 In particular, the fundamental laws of nature lie outside the realm of patentable subject matter as part of a judge made exception to the general rule that any “new and useful process” may be patentable.2 The policy behind the general rule is that these fundamental laws are so important that no one person or entity may control them.3
Though this policy has not been heavily challenged, there has been controversy as to what constitutes a “law of nature” or an “abstract idea.”4 The Federal Circuit recently considered this question in Genetic Tech. v. Merial,5 which involved the question of whether a method directed to identifying linked coding regions of DNA is patent eligible subject matter.6 The Federal Circuit ultimately ruled that these methods of genetic testing are not patentable subject matter.7
Unpatentable Subject Matter
The Supreme Court in Alice established a two-step “test” for determining whether a patent’s claims are directed to patent ineligible concepts such as laws of nature or whether they are patent eligible.8 The first step is to “determine whether the claims are directed to one of the patent-ineligible concepts.”9 If the patent is directed to a patent ineligible concept, the second step is to determine what else in the claim constitutes an “inventive concept─ i.e., an element  sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the ineligible concept itself.”10 If there is no identifiable inventive concept in the claim, the subject matter is unpatentable.
Genetic Tech. v. Merial
In the 1980’s and 1990’s Genetic Technologies filed several patents directed toward genetic testing ─ many of which have issued.11 One particular patent, U.S. Patent No. 5,612,179. (“the ‘179 Patent”), claimed a method of identifying the coding regions of DNA known to be linked to non-coding regions of DNA and then using well-known techniques to detect the non-coding regions of DNA to detect the presence of the coding regions of DNA.12 In 2011, Genetic Technologies filed suit against Merial, a multinational animal health company, based on infringement of the ‘179 Patent.13 In the district court, Merial filed a 12(b)(6) motion arguing that Genetic Technologies had failed to state a claim of patent infringement because the ‘179 Patent was directed towards unpatentable subject matter.14 The court granted the motion to dismiss for failure to state a claim.15 The court held that the claims were directed to unpatentable subject matter i.e. a law of nature, “as [the claims] merely informs a relevant audience about certain laws of nature.”16
Genetic Technologies appealed the dismissal for failure to state a claim arguing that the ‘179 Patent was valid because the claim contained an “inventive concept.”17 On appeal, the Federal Circuit analyzed a representative claim ─ claim 1.18 Claim 1 is a method claim comprising two steps: first, amplifying the non-coding sections of the DNA that is linked to the coding sections, and second, analyzing the amplified sections of the non-coding sections to detect the allele of the coding sections. The Federal Circuit evaluated the claims using the Supreme Court’s two-step test.19 First, the Federal Circuit held that the claims rely on a “law of nature.” The court held that the claims relied on the correlation between the presence of the “coding regions” and the associated “non-coding regions” that is a consequence of the “body’s natural processes,” analogous to the claims in Mayo.20 Thus, the Federal Circuit held that this correlation on its own would be unpatentable, as it is a “law of nature.”21 Thus, the Federal Circuit turned its attention to whether the claims contained an “inventive concept,” something “beyond mere well-understood, routine, conventional activity.”22 The court found that the steps of amplifying DNA and analyzing the amplified sequence were well known in the art at the time of filing and did not constitute an “inventive concept.”23
Genetic Technologies argued that the term “to detect the allele” provided the requisite inventive concept.24 Genetic Technologies agreed that the amplification process to detect alleles was well known, but the process had only been used to detect the presence of the amplified allele.25 Genetic Technologies argued that in the ‘179 Patent a first allele was amplified to detect the presence of a second allele.26 Genetic Technologies argued that even if the detecting alleles by the amplification process was well known, no one had ever amplified “non-coding regions” to detect “coding regions.”27 The Federal Circuit disagreed, finding that even if detection of an allele was a new concept, it was not an “inventive concept.”28 The court held that “to detect the allele” was not an “inventive concept,” as it was a “mental process” that could be performed entirely in the human mind.29 The court reasoned that a “mental process” can never be an “inventive concept” because mental processes are the “basic tools of scientific and technological work” and as such are free to all much like abstract ideas or laws of nature.30 Thus the court upheld the motion to dismiss from the district court because the ‘179 Patent was directed to unpatentable subject matter.31
Genetic Tech. v. Merial is another decision in a long line of decisions in which the Federal Circuit has rejected methods based on correlations found in nature.32 However, Genetic Tech is one of the few Federal Circuit decisions in which the court applies the logic of Alice to the laws of nature.33 Because of the finding of invalidity, Genetic Tech provides an example of what constitutes a mental step that is not an “inventive concept” but does not provide any guidance on what type of claim language would qualify as an “inventive concept.” What constitutes the exact metes and bounds of an “inventive concept” remains to be seen.