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Posted on 29 August 2019

As new treatments drive a shift towards treating cancer as a manageable disease we are seeing greater collaboration across the life sciences sector.  

An ageing population means that more of us than ever before will be affected by cancer over the next 20 years. Statistics from Cancer Research UK predict that by 2035, the number of new cancer cases in the UK will rise by 40% to over half a million a year.

A new wave of innovative diagnostic techniques and targeted treatments, however, mean that outcomes for those diagnosed with the disease are improving. Cancer Research UK is aiming that by 2034, three in four people with cancer will go on to live for a further ten years or more.

Whilst the search for a cure continues, improvements in the understanding of human biology and the biology of cancers, allow experts in the field to focus on developing treatments that allow cancer to be managed in patients indefinitely.

The aim is to prevent deaths and for those living with cancer to continue to experience a good quality of life, in the same way that millions of people with HIV are now able to live normal lives thanks to antiretroviral drugs.

New wave treatments

This shift is being driven by the opportunities for precision medicines that are tailored specifically to individuals and their cancers. Earlier diagnosis and characterisation of cancers along with better predictions about how and where tumours will develop are now possible due to new diagnostic methods and genetic testing. We expect to see a move away from traditional “one size fits all” approaches towards the use of innovative new treatments and modalities, such as gene and cell therapy, including adoptive cell therapies that uses engineered immune cells, such as CAR-T cells, to attack tumours.  These new approaches may supplement or even replace existing chemotherapy and surgical interventions.

In May this year, the Institute of Cancer Research announced the creation of a new research centre focused on the development of drugs designed to slow down or stop the evolution of cancer cells. This would prevent cancer cells from becoming aggressive and resistant to treatment. The world’s first anti-evolution cancer drug targeting a molecule called APOBEC which is crucial to the workings of the immune system could be available in ten years’ time.  The research centre will also focus on using AI to work out how to drive cancer cells towards forms that are more susceptible to drugs and is working on devising innovative, multi-drug combinations that block several different cancer genes at once.

Collaboration

This new wave of treatments and the move towards cancer as a manageable disease is being accompanied and aided by a collaborative approach within the life sciences sector. Whilst large pharmaceutical companies are still the driving force in cancer treatment – they ultimately manufacture and market the drugs – much of the energy and innovation in the sector comes from other sources.

Unlike traditional drugs based on small organic molecules, new modalities, including biologics, gene and cell therapies, require very specific expertise and are often developed outside big pharma in biotech companies and academic groups. These are often also the source of the innovative applications of the fundamental biology that underpins precision medicine approaches.

A thriving new ecosystem of organisations allows pharmaceutical companies to tap into external expertise within biotech start-ups, universities, and academic groups. Software developers are increasing prominent to provide the platforms and artificial intelligence expertise to process the vast amount of data that needs to be analysed as part of targeted treatment programmes.

A new legal landscape

More collaboration means an increase in the need for different legal relationships and transactions. As well as the traditional acquisition of small biotechs by pharmaceutical companies in order to access key assets, we are seeing new and creative collaboration agreements, licensing deals and service provider contracts being drawn up to drive these relationships.

Many start-ups are structuring themselves to best take advantage of the new landscape. University spin-offs are now being set up with the sole objective of de-risking a single drug candidate from an academic lab. When sufficiently de-risked, the drug candidate can be easily transferred to a pharmaceutical company by simply selling the spin-out. Other models involve a series of subsidiaries working to develop each separate drug or therapy. Once each drug is ready for acquisition, the relevant subsidiary can be easily sold to a pharmaceutical company with minimal disruption to the rest of the business.

These models avoid the acquisition of whole company on the basis of just one of its assets, with the rest of its assets and programmes discontinued and abandoned.  When acquisition is accepted as the aim at the outset, the business structure can be created with this in mind.

IP protection

Greater collaboration between different organisations, especially in the areas of human biology and genomics that support precision medicine, means that intellectual property (IP) strategies need to be re-evaluated.

Key assets resulting from the drug discovery process, such as drug candidates, will still need to be protected by IP.  This in itself can be a complex process – the different treatment modalities that are coming on-stream have their own bespoke IP issues and providing solid protection for these assets may challenge conventional IP strategies honed on traditional small molecule drug development. 

In a collaborative research environment, collaboration agreements need to be very clear about who owns the rights to the assets arising from a project and how any revenues will be shared. In the early stages of a collaborative project, a party may need to share proprietary materials, including experimental data, and other information, with their collaborators. Traditional collaboration models might put a network of confidentiality and other legal agreements in place to govern this sharing.  More nimble models might see parties simply waiving any IP rights to this material so the project can progress swiftly and without distraction.

A positive outlook

It’s an exciting time for the sector with breakthroughs across a range of treatments and the emergence of a vibrant ecosystem of companies collaborating on research and development. Whilst cancer cases will continue to rise, there is a real optimism about the possibility of better controlling the development of the disease.

 

 

Nick Sutcliffe

Contact Nick Sutcliffe

Nick is a member of our life sciences patent team and has experience in the pharmaceutical, biotechnology, agricultural sciences and Cleantech sectors. Nick deals mainly with drafting and prosecution work and also advises on filing strategies and world-wide portfolio management. Nick is also experienced in defensive and offensive European oppositions and due diligence work. His clients include British universities, charities, SMEs and direct foreign clients. Nick has been “recommended” for patent prosecution in “IAM Patent 1000: The World’s Leading Patent Practitioners” 2012, 2013 ,2014, 2016 and 2017 editions. Nick is individually recognised in Managing Intellectual Property’s IP Stars 2014 -2018 as an “IP Star” and in the LMG (Legal Media Group) Life Sciences Europe 2014 Guide as a “Life Science Star”. In the 2018 edition of IAM patent 1000, Nick is heralded as a “local hero” in the Cambridge area.

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