28 January 2020

IP trends for 2020: AI and personalised medicine

The third article in our ‘IP trends for 2020′ series focuses on personalised medicine in the pharmaceutical and biotech sectors, and how this will be impacted by developments in AI.

Following the recent excitement surrounding technologies such as CAR-T therapy and CRISPR, the focus on targeted therapeutics looks set to progress in 2020. This year is likely to witness a continued drive towards personalised medicine within the pharmaceutical and biotech sectors, together with an increased focus on developing the data capture and analytics capabilities necessary for these new therapies to realise their full potential.

To maximise impact across areas such as drug discovery, diagnostics, patient selection and treatment optimisation, there is a growing interest in new ways of acquiring and analysing patient data. Recent developments in fields such as artificial intelligence (AI) and machine learning (ML) are also playing an increasingly influential role in the biotech space, with FDA approvals of AI algorithms increasing exponentially over the past few years, and the AI healthcare market predicted to reach $6.6 billion by 2021.

This has led to the formation of new partnerships between the tech and healthcare industries: AI startup Concerto HealthAI is currently working with BMSPfizer and Astellas to support their precision oncology initiatives, while Roche’s acquisition of Flatiron Health and Foundation Medicine recently provided proof-of-concept that clinically meaningful insights can be generated through large-scale analysis of genomic and clinical data.

Meanwhile, major tech players such as Google, IBM and Microsoft have all taken steps into the biotech space. Among other developments, 2019 saw the announcement of several new healthcare-related collaborations by Alphabet-owned Verily, and a partnership between Microsoft and Novartis aimed at integrating AI across clinical development and commercialisation.

While these partnerships have the potential to drive significant technological progress, they also give rise to a new set of legal, ethical and regulatory issues. In addition, healthcare and tech partners will need to consider how to align their IP strategies in order to maximise licensing opportunities across fields which may have historically taken different approaches to issues such as the extent of protection they choose to obtain, and which jurisdictions they choose to obtain it in.

These new approaches are also likely to lead to a shift in IP strategy within biotech. As therapeutic interventions target ever-smaller patient populations with increasingly specific treatment regimens, we are likely to see a greater emphasis on ensuring that value is captured not only within final therapeutic products and protocols, but across the entirety of the clinical development process. In particular, obtaining appropriate protection for the processes which contribute to drug discovery, patient selection and treatment optimisation, as well as for the data capture and analytics tools underpinning them, is likely to become increasingly important.

Furthermore, the EPO’s approach to patentability in this area is still evolving. In 2018, the EPO updated their Guidelines for Examination to include, for the first time, specific guidance on how the patentability requirements for algorithms and computer programs should be understood in the context of AI and ML. Meanwhile, in decision T 0694/16, the EPO’s Technical Board of Appeal acknowledged that a claim directed to the use of a known drug in a purposively selected patient subgroup could be considered novel, even where the identified subgroup overlapped with the previously treated patient group.

In view of the complexities of this subject matter, careful drafting will be required to navigate overlapping exclusions relating to software, mathematical models and methods of diagnosis and treatment. In addition, addressing these issues surrounding the role of data and AI within the biotech field will be fundamental to realising the full potential of personalised medicine, and will require specialist advice. Mathys & Squire’s multidisciplinary team, with experts in biotech, pharmaceuticals, vaccines, diagnostics, medical devices and healthcare products / services, can assist clients in this sector with the complete range of intellectual property services, including devising an IP strategy in order to identify and maximise the value of their intellectual property.

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