On March 4, 2014, the United States Patent and Trademark Office (USPTO) issued a highly anticipated Guidance for Determining Subject Matter Eligibility of Claims Reciting or Involving Laws of Nature, Natural Phenomena & Natural Products (“Guidance”). The Guidance is promulgated for the purpose of providing a formalized process for examination of patent claims in view of United States Supreme Court decisions in Mayo Collaborative Services, et al. v. Prometheus Laboratories, Inc. (“Prometheus”) and Association for Molecular Pathology v. Myriad Genetics, Inc. (“Myriad”) in 2012 and 2013, respectively.
35 U.S.C. § 101 has been limited through case precedent to exclude fundamental principles, such as “laws of nature, natural phenomena, and abstract ideas” from patent eligibility. According to the new Guidance, if a patent claim appears to recite a fundamental principle, then for the claim to qualify as patent-eligible subject matter, the applicant must show that it recites something “significantly different” from the law of nature, natural phenomena, or abstract idea. This showing is subject to a newly formalized “balancing test” involving defined factors.
Factors that weigh toward patent eligibility include whether “[a] claim is a product claim reciting something that initially appears to be a natural product, but after analysis is determined to be non-naturally occurring and markedly different in structure from naturally occurring products,” as well as other factors related to the addition of extra elements or steps (provided that such extra elements or steps are not merely routine) that would distinguish a claim from a fundamental principle.
The Guidance also provides a number of examples that apply the new balancing test factors. In one, the factors are utilized to conclude that a pair of synthetic oligonucleotide primers is not patent-eligible subject matter, whereas an amplification process employing the pair of oligonucleotide primers qualifies as patent eligible.
The new Guidance will significantly impact biotechnology patent prosecution, at least until court challenges can confirm whether the USPTO has properly interpreted and applied the Supreme Court’s Myriad and Prometheus decisions.
Most notably, the Supreme Court’s Myriad decision narrowly addressed the patentability of isolated DNA derived from genes possessing high diagnostic value, where a perceived threat to the public interest posed by allowing a monopoly to continue over the genetic information of a medically-relevant diagnostic gene was a significant factor that motivated the Supreme Court’s ultimate finding of isolated DNA being patent-ineligible subject matter. However, the new USPTO Guidance expands the scope of the Myriad decision well beyond isolated DNA.
While the ultimate impact of the new USPTO Guidance remains to be seen, applicants and patentees should review their portfolios to determine their susceptibility to § 101 rejections by the U.S. Patent and Trademark Office under the broadened balancing test framework. Where a claim appears to recite a fundamental principle, further consideration should be given as to whether man-made modifications or applications of the principle can also be claimed – thereby rendering the claimed subject matter significantly different under the balancing test of the new Guidance – while retaining the commercial value of such protection.