IP trends for 2022: Personalised medicine and advanced therapy medicinal products

Personalised medicine has been a strong focus of pharmaceutical research and development (R&D) in recent years, and we expect this to continue in 2022 and beyond, with the global personalised medicine market forecasted to grow to $717 billion by 2025. Personalised medicine encompasses technologies enabling cancer prognosis, as well as specific treatments targeting certain cancers associated with specific gene mutation. It also facilitates preventative medicine, allowing the identification of patients with a genetic predisposition for a particular disease to enable pre-emptive treatment. 

Personalised medicines cover a wide range of actives, from more traditional small molecules to advanced therapy medicinal products (ATMPs) such as stem cells and CAR-T cells. ATMPs are also a hot trend, with these products expected to increase markedly from the current level of around a third of pharmaceutical pipelines over the next decade. In view of the complexity of ATMPs compared with traditional pharmaceuticals, the IP landscape around ATMPs is also more complex, which may give rise to an increase in collaborations as companies work to get these products developed, approved and on the market. There is also the potential for an increased number of contentious proceedings, as companies struggle to find freedom to operate in a complex and crowded IP market. 

Sustainable agriculture

The climate crisis and global food crisis are likely to drive the use of biotech to look for alternatives to conventional agricultural products and methods. Increased awareness of the problems caused by chemical pesticides is stimulating research into, and take up of, alternatives which reduce pesticide use and runoff, leading to an increased focus on biopesticides, with the global market projected to grow at a compound annual growth rate of 14.7% through to at least 2025. Whilst the public has historically been wary of genetically modified crops, genetically modified organisms have the potential to provide significant advances in sustainable agriculture, by improving crop yield and resilience, as well as through engineering crops with increased nutritional value or other desirable properties. As well as innovation to support a sustainable future, biotech can also be used to create crops that can actively remove existing pollutants through a process called phytoremediation. The growth in artificial meat was a significant trend in 2021, and the appetite (excuse the pun!) for such products shows no sign of slowing down.

AI and synthetic medicine

Deep tech in general is seen as a massive growth opportunity (as covered in another of our IP trends articles), and it is estimated that deep tech investments will grow to about $140 billion by 2025. Specifically, in the context of biotech, artificial intelligence (AI) and synthetic biology are particular focuses. Synthetic biology is particularly exciting, as it has potential applications in multiple sectors, including cell engineering, biofabrication and drug discovery. The use of AI and machine learning based on large datasets can help accelerate early drug development, facilitating accurate prediction of drug-human interactions and reducing reliance on human trials at every development stage.

Drug development

The COVID-19 pandemic has resulted in an unprecedented effort to accelerate drug discovery, testing and approval. Whereas in the past it would typically take up to 10 years for a new drug to be approved, the COVID-19 vaccines were developed and approved in under a year. These changes in approach will have knock-on benefits for drug development and approval far beyond COVID-19. Machine learning, AI and big data can further accelerate the drug development pathway. This technical acceleration will require commercial strategies to adapt. For example, funding for human trials may be required sooner if the early development and testing phases are completed more quickly, increasing pressure for smaller companies to find partners or investors to help bear the costs. There is also likely to be an effect on pipelines and on IP as nonviable projects may be identified and dropped sooner, leading to more focused R&D and a tighter IP estate.

Changing strategies

After years in the making, it is expected that the new Unitary Patent system and associated Unified Patent Court (a pan-European form of protection and associated court) will come into force in late 2022. All innovators, regardless of their technical focus, will need to evaluate their patent strategies in light of the new system. Some European countries are not part of this system (including the UK, Spain and Switzerland), and so there are also factors to consider regarding the participating/non-participating countries. There are potential pros and cons to opting newly granted patents into this unitary system, which patentees will need to consider on a case-by-case basis to ensure the right decision is made for each of their patents.