According to recent research, these worries are becoming reality as inventions that qualify for patent protection in Europe and Asia face the prospect of 101 rejections in the US. In March, a paper by Adam Mossoff and Kevin Madigan from George Mason law school analysed a dataset of 1,400 patent applications, finding marked differences between patent eligibility in the US compared with Europe and China.

Mayo vs. Prometheus case

Prometheus Laboratories had patented a diagnostic kit which was able to determine the correct dosage level for some medications used to treat autoimmune diseases. As different patients metabolised the medicines differently, the diagnostic test could determine metabolite levels in the individual patient’s blood so that a physician could either raise or lower dosage based upon patient needs. Mayo Collaborative Services then created their own diagnostic test, and Prometheus sued for patent infringement. The US Supreme Court determined that the patent was invalid, stating that the connection of metabolites produced by patients and potential changes to medicinal dosage was a “natural law”, and therefore unpatentable. The method of determining dosage was also determined to be routine and conventional, used by scientists in the field prior to the patent.
The Amos and Miller study is based on a small sample, but the degree to which applications have been rejected should still act as a wake-up call in the US and a sharp reminder that eligibility concerns are not all about business methods and software. To get a little more insight into how uncertainty around 101 is causing problems for various life sciences industries I got in touch with Hans Sauer, the deputy general counsel of the Biotechnology Industry Organisation (BIO). Sauer has become a familiar voice in recent years pointing out the dangers of various changes to the US patent system, including the threat to his organisation’s members from inter partes reviews (IPR).

Hans Sauer concern

No subject of substantive patent law is raised and discussed more frequently by BIO member companies. Current jurisprudence in the area of patent-eligible subject matter is unstable, it creates unnecessary business uncertainty, and it is an astonishing anomaly in international patent law. There are biotechnologies for which it is now easier to get a patent in Europe and China than it is in the United States. When American biotech companies go to compete on the Chinese market, they will have to respect Chinese patents. When Chinese companies come to compete on the US market, it will be a free-for-all. This has real implications for US competitiveness in a field that was created and led by the United States.
Patentable subject matter is a core question of substantive patent law. This is not something better left to the courts or administrative agencies. The courts have been unable to identify the outer boundaries of the Supreme Court’s sweeping pronouncements. And the USPTO, however well intentioned, can only regulate around the margins.


If legislators are looking for pointers on how 101 should be changed, the Intellectual Property Owners Association (IPO), the American Bar Association’s (ABA) IP section and the American Intellectual Property Law Association (AIPLA) have all released proposals including new draft language. That all have now done so is a clear reflection of the groundswell of support for 101 reform that has built up among patent owners and private practice lawyers. In recent years Congress has shown little interest in passing a subject matter reform bill, but that appears to be changing. As companies in sectors like medical diagnostics would probably all agree, a change can’t come soon enough. The US can only inflict so much harm on itself before permanent damage is done.