This summer, the Australian Federal Court went the other way in Sequenom, Inc. v. Ariosa Diagnostics, Inc. than the US, finding that the method of detecting fetal DNA in maternal blood to be eligible subject matter and that the patent was valid and infringed. While the Federal Circuit described the invention as “truly meritorious” and “ground breaking”, they found it to be invalid because it was directed to a natural law.
Both Australia and the US are members of the WTO, which means they both have to operate under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. TRIPS, which was championed by the US in the 90s, commits signatory countries to adopt a set of patent standards. Section 5, Article 27(1) of TRIPS states, “patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.”
Judge Moore in her dissent in Athena Diagnostic v. Mayo Collaborative Services argued that there is now a per se bar on diagnostic patents because, since Mayo, the Federal Circuit has “held every single diagnostic claim in every case before us ineligible” and cites to a number of cases, including Ariosa. Now that Ariosa has come out two different ways in two WTO member countries, it may be possible for the governments of parties involved in such cases, such as England on behalf of Oxford, to file a complaint at the WTO against the US for violating TRIPS Article 27(1) because of this effective ban on diagnostic patents.
While TRIPS under Article 27(3)(a) does allow for members to exclude “diagnostic, therapeutic and surgical methods for the treatment of humans or animals,” Congress has not done so and Justice Kavanaugh writing for the court in an unanimous opinion in Henry Schein, Inc. et al. v. Archer & White Sales, Inc. states, “we may not engraft our own exceptions onto the statutory text.” Therefore, not only do the judicial exceptions to Section 101 apparently violate Supreme Court precedence, their application has had an effect of violating the TRIPS Agreement.