However, obtaining patent protection for artificial intelligence and machine learning based inventions in life sciences can be challenging, particularly due to specific legal requirements relating to the patentable nature of this combination of subject matter.

Patentable subject matter

Patent applications combining AI and life sciences are frequently rejected by a Patent Office due to subject matter ineligibility grounds far more frequently than other life sciences inventions.  Common objections are based on the claims being directed to subject matter that is excluded from patentability because they are abstract and relate to discoveries, scientific theories, or they are non-technical in nature.  To be patentable an invention must be of both a concrete and technical character.  

Strategies 

Life science inventions that incorporate AI technology often use data processing methods for the analysis of acquired biological data.  Patent claims that are directed to data processing methods can be assessed to be directed to an abstract idea without technical features, and as such relate solely to excluded subject matter.

A claim will not be excluded from patentability if it includes both technical subject-matter and an abstract or non-technical subject-matter.  If a patent claim is to have any hope of surviving prosecution, then it must ground the invention to a specific technical application such as the process for isolating and obtaining a new drug; or the structure of a newly discovered compound. 

It is also important to draft claims that are not overly broad or focus only on a set of general computational steps.  A patent claim that merely includes a series of data processing steps such as receiving data, analysing data, and generating a result without the specific technical implications within a defined technical pathway risks being rejected.  This is a common challenge for life science inventions that use AI for diagnosis of a disease from data associated with a medical scan or the prediction of susceptibility to a disease based upon a known relationship to a detected gene within a biological sample.  These inventions must be claimed with language linking the inventive concept into the practical and technical application.    

From the initial drafting of the application and the claims it is important to clearly set out how the AI system can improve a particular life sciences process. For example, for an AI system used to diagnose a disease based on sample data, the claims should include new processing techniques, improved sample processing methods, or the specifics of the data processing that contribute to more accurate diagnostics.  Concentrating on the technical features that allow the AI system to reduce error rates, improve efficiency, or provide real-time results will provide a demonstration of the technical character of the claims.

A further strategy is to link the AI system to physical hardware such as diagnostic tools and medical devices, for example wearable monitors or laboratory equipment to process biological samples.  Linking the AI system to a piece of physical hardware for a defined outcome ensures that the claim will not be rejected purely on the grounds of excluded subject matter. 

Finally, it is also important to consider implications of the AI system learning as it operates to improve outcomes, or to implement error corrections in the data handling.  A patent application should include any innovative data processing features the inventors may have developed and it will further help to differentiate the invention from generic data processing methods and data manipulation.

Conclusion

As artificial intelligence continues to revolutionize the life sciences, an informed and robust patent strategy is vital for obtaining and maintaining a competitive edge. Careful consideration is needed for life science innovators developing AI systems and AI assisted technologies to successfully navigate the specific patent requirements.  It is therefore important to develop a strong relationship with your patent attorney from the start to clearly define and characterise your invention and to obtain strong and useful protection.  To explore way in which Lewis Silkin can help you develop your life sciences patent strategy please contact one of our attorneys.