Claims drawn to methods of treating a disease by administering a pharmaceutical agent have long been thought to be patentable in the US, but is this still the case?
The US Supreme Court has been taking a closer look at the patent eligibility of life science inventions as demonstrated with its decisions in Mayo Collaborative Servs v Prometheus Labs, Inc, 566 US 66 (2012) and Ass'n for Molecular Pathology v Myriad Genetics, Inc, 569 US 576 (2013), and lower courts have followed.
One particular class of invention that courts have examined involves claims drawn to methods of treating a disease by administering a pharmaceutical product. Such claims have long been recognised as patent eligible under US patent law. However, in 2016 and 2017, there were several district court decisions and Patent Trial and Appeal Board (PTAB) ex parte appeals finding such claims ineligible for patent protection. Patent prosecutors should keep the differing approaches of district courts and the US Patent and Trademark Office (USPTO) in mind when drafting claims, to avoid rejections and invalidity challenges under 35 USC section 101.
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Previously published in Intellectual Property Magazine
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