Two Lab Cases Lead U.S. Patent Office to Update Interim Guidance on Natural Phenomena

The United States Patent and Trademark Office (USPTO) has updated interim guidance regarding the interpretation of patents based on natural phenomena. The guidance stems from significant U.S. Supreme Court rulings issued in 2012 and 2013 regarding patent battles over laboratory tests. The update responds to more than 60 public comments received concerning initial interim patent eligibility guidance issued in 2014. Those comments address six themes including a request for additional examples addressing abstract ideas and laws of nature, how examiners identify abstract ideas, and an explanation of “the markedly different characteristics analysis.” Public comments on this update must be submitted by October 28, 2015. Three years ago, the high court ruled in favor of the Rochester, Minn.-based Mayo Clinic in a patent dispute with Prometheus Laboratories over an esoteric blood test. Prometheus had sued regarding Mayo’s development of a similar test. Prometheus had claimed that the observation of natural phenomena—such as the results of the test—could be patented. The Supreme Court said that natural phenomena could not be patented. The high court took a similar tack the following year, when it ruled that a patent Myriad Genetics held on BRCA testing was invalid, concluding that a single human gene could not be protected under patent law. The loss of Myriad’s patent on the BRCA gene led to a variety of other laboratories offering the tests at a much lower price than what Myriad charged, cutting into the Utah-based lab’s revenues and bottom line. Myriad has since been engaged in other lawsuits regarding how BRCA testing is conducted or combined with other assays. The legal wrangling in the former case led to what is known as the “Mayo exception,” or “Mayo test,” wherein the USPTO subjects patents to a two-part examination: Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea? If so, does the claim contain additional elements that amount to “significantly more” than the Mayo exception? For the purposes of illustration, the USPTO noted that gunpowder, although comprised of ingredients that occur in nature, could be patented because the ingredients do not occur in nature in the combination required to create an explosion—a function significantly more than what the ingredients do in their normal, natural state. And if the gunpowder is packaged with other substances to create a specific device, such as a firework, that is also patentable. The Mayo test has had implications in other legal cases over patents. Earlier this year, Sequenom, Inc. lost a patent case in a federal circuit court regarding its amplification and detection of paternally inherited cell-free fetal DNA in order to perform non-invasive prenatal genetic testing. The court in that case ruled that the testing method, although considered a scientific breakthrough, did not meet the Mayo test because the activity behind obtaining test results “is purely conventional or obvious.” (See NIR, June 25, 2015, p. 7) According to a recently published article by Irena Royzman and Andrew D. Cohen, attorneys in the law firm Patterson Belknap Webb & Tyler LLP, “the federal circuit’s application of Mayo puts in stark relief the limitations of Mayo’s reductionist approach. A ground-breaking invention somehow became patent-ineligible subject matter because the genetic information being detected exists in nature and that information was not altered in amplifying and detecting it by known techniques. The decision reflects the need for a legislative solution….”

Takeaway: Changes to patent law as the result of litigation in the laboratory sector will likely impact the patenting of lab tests for the foreseeable future.