Artificial Intelligence and Pharmaceutical Industry: The Transformation in the Technology and Patent System Shaping the Future
Artificial intelligence influences every aspect of our lives and has revolutionary impact in the pharmaceutical industry, as well as in many other sectors. From DeepMind’s AlphaGo success to Tempus’ personalised approaches to cancer treatment, AI-enabled innovations offer, not only scientific achievements, but also wide-ranging advantages such as operational efficiency, cost reduction and risk mitigation. However, this technological leap also raises critical questions about the traditional processes of the pharmaceutical industry and the patent system.
According to data from the Tufts Center for the Study of Drug Development, it takes approximately 10 years for a pharmaceutical product to be developed and put on the market, and the cost is $2.558 billion. Clinical trials account for the majority of this cost, while the success rate is below 10%. These challenges drive the pharmaceutical industry to look for more sustainable and rapid solutions.
The discovery of new compounds and molecular design that takes months with traditional methods can be reduced to weeks thanks to artificial intelligence algorithms; clinical trial processes are completed 20% faster and at a lower cost. For example, BenevolentAI has demonstrated this potential by leveraging artificial intelligence platforms in the rapid discovery of a drug such as Baricitinib in the treatment of COVID-19.
It should be emphasised that the contributions of artificial intelligence to the pharmaceutical industry are not limited only to cost and time efficiency; artificial intelligence also provides a great transformation in areas such as customisation of treatment process, detection of side effects and analysis of patient data. IBM Healthcare’s use of artificial intelligence in clinical trial matching is a good example of this.
Increased use of artificial intelligence in the pharmaceutical industry also raises new discussions in terms of patent protection and legal grounds. Although the Turkish Industrial Property Code No. 6769 (“IP Code”) stipulates that computer programs are not patentable, there is no regulation in the IP Code on how artificial intelligence-supported inventions will be evaluated in this context.
On the other hand, since Türkiye has been a party to the European Patent Convention since 2000, the European Patent Office’s position on the patentability of artificial intelligence-supported pharmaceutical inventions has been binding for Türkiye. As a condition of its accession to the Convention, Türkiye accepts and undertakes that European patents granted by the European Patent Office shall be deemed to have the same legal effect as national patents registered in Türkiye.
The European Patent Office adheres to conventional criteria when evaluating the patentability of artificial intelligence- supported inventions. For example, using the Problem-Solution approach, it is evaluated whether or not an artificial intelligence created invention is obvious to those skilled in the art. However, whether the problem-solution approach can always be applied in patentability of inventions in regard to artificial intelligence and artificial intelligence-supported pharmaceutical development processes is subject to controversy.
Artificial intelligence has taken on a ground breaking role in the pharmaceutical industry in terms of cost, speed and efficiency. However, this transformation requires a reinterpretation of the traditional patent system and a clearer drawing of the ethical and legal boundaries of technology. The pharmaceutical industry’s ability to ensure human expertise remains at the centre while embracing the advantages offered by artificial intelligence will be the key to future success. An industry that can achieve this balance will not only be able to offer more effective treatments for patients, but shall also develop sustainable solutions for the global healthcare system.