Partner Paul Hunter published the article, “AI’s Growing Impact in Health Science” in the Daily Journal.
The article discussed the application of artificial intelligence to the health sciences, current trends driving AI uptake in the field and updates on patent eligibility rules. Highlights include:
- AI Tech in the Health Sciences
AI broadly defines both deep learning and machine learning fields. Attempts have been made to apply these fields to the health sciences. Notable areas of impact include drug discovery and clinical trial design, optimization of drug administration (e.g., digital therapeutics), and diagnostics and personalization of treatment.
- Digital Therapeutics
Digital therapeutics refers to the use of software-based devices to help increase patient compliance using pill sensors or combining an algorithm with wearable tech to assess when to administer drug for optimal effectiveness.The FDA can grant up to three years of data clinical investigation exclusivity from date of FDA approval. An example of how clinical exclusivity can work is the case study of Abilify MyCite made by Otsuka. In 2002, the FDA initially approved Abilify for schizophrenia. Then, 11 years later in 2013, Otsuka partnered with Proteus Digital Health (a maker of ingestible sensors). In 2017, the FDA approved Abilify MyCite, an ingestible sensor in each capsule to track patient compliance, including three years of data exclusivity from 2017 new label approval date. This work also led to a new Orange Book patent from Proteus.
- Updates on Patent Eligibility
The recent decision in Linden has added to the on-going drama of patent eligibility for software/AI health science. The USPTO designated Linden decision as informative in December 2019. Under step one of the patent-eligibility analysis in Linden, the patent examiner found the claim found to be abstract. Under step two, the patent examiner found claim did not amount to "significantly more" than the abstract concept. The Patent Trial and Appeal Board disagreed on both points and applied the USPTO's January 2019 Eligibility Guidance.
The implications of the Linden case for health care and life sciences are significant. It demonstrates that the USPTO may find relatively broad claims that are AI-related eligible. Many diagnostic and therapeutic optimization claims involve implementation of AI. While these methods may duplicate the results of what doctors can do, they may not be done with "steps that can practically be performed mentally" as stated in Linden.
Read the full article here. (Subscription required)