How to succeed in the business of biotech patentability

Following several high-profile decisions by the US Supreme Court making it harder to patent biotech inventions, parties should follow several best practices to give their products the best chance of being patented. Kathryn Hull of Gordon Rees provides some tips.

The US Supreme Court has thrown down the gauntlet for patent eligibility in the biotechnology field. In spite of (or due to) their significant contributions to medicine, Mayo v Prometheus, Association for Molecular Pathology v Myriad Genetics, and Ariosa Diagnostics v Sequenom exemplify the harsh reality of recent changes in defining patent-eligible subject matter. These recent changes have left companies wondering how best to protect their products.

In the US, patent eligibility is defined under 35 USC §101, which states that “whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor”. Historically, patents have been issued for compounds purified from nature such as adrenaline, acetyl salicylic acid (aspirin), and the antibiotic streptomycin.

Furthermore, in Diamond v Chakrabarty the Supreme Court set the precedent that “anything under the sun that is made by the hand of man” is patent-eligible subject matter. Post Diamond, tens of thousands of biotech-based patents have been issued—most notably, patents directed to “purified” matter such as nucleic acid or amino acid. Roughly 30 years after Diamond, the courts have begun to severely restrict what is considered patentable subject matter in the biotech field.