The Hidden IP Challenge of Precision Medicine
In precision medicine, intellectual property is not merely a legal consideration. It is a core business issue. Investors, partners, and acquirers increasingly look beyond the patents a company owns. They also want to understand whether the company can develop and commercialize its product without being blocked by third-party rights.
Precision medicine is rapidly transforming drug development by tailoring treatment to the biological characteristics of specific patient populations and, in some cases, individual patients. It spans technologies such as cell and gene therapies, CRISPR-based genome editing, biomarkers and RNA-based approaches. RNA technologies became widely familiar through the mRNA vaccines used during the COVID-19 pandemic; today, related RNA platforms are also being developed for increasingly targeted therapeutic applications.
For many companies, the focus naturally centers on their own innovation:
- Do we have a novel therapy?
- Can we patent it?
But in precision medicine, an equally important question is often overlooked:
Do we actually have the right to use the technologies required to bring our product to market?
Unlike traditional pharmaceuticals, modern cell and gene therapies frequently rely on multiple underlying technology platforms. A single therapy may involve:
- Viral vector technologies
- Gene-editing tools
- Cell engineering methods
- Manufacturing processes
- Biomarkers
- Analytical and quality control methods
Each of these components may be protected by patents owned by different companies, universities, or research organizations.
As a result, even a company with strong patent protection for its final product may still depend on intellectual property rights controlled by others.
Owning a patent does not automatically grant freedom to operate.
A common misconception is that holding a patent gives the right to use the patented technology. In reality, patents primarily provide the right to exclude others from using an invention. Developing and commercializing a product may still require licenses from third-party patent holders.
This is particularly relevant in precision medicine, where innovation often builds on existing technology platforms. Companies that fail to identify these dependencies early may encounter significant obstacles later in development, when investments are already substantial.
Why Freedom-to-Operate matters
Many organizations invest heavily in patentability assessments to ensure their innovations can be protected. Equally important are Freedom-to-Operate (FTO) analyses, which help identify patents that could affect development, clinical trials, manufacturing, or commercialization.
A well-executed FTO analysis can help companies:
Identify potential infringement risks, i.e. the risk of infringing third-party patent rights
Anticipate future licensing requirements
Evaluate alternative technical approaches
Strengthen their position in fundraising and partnering discussions
Reduce the risk of costly disputes later
Identifying such issues early can create room to redesign, secure necessary licenses, or adjust development strategy – and ultimately enable commercialization of the product.
A strategic business issue, not just a legal one
Early analysis of patent landscapes, licensing requirements, and freedom to operate can create substantial value long before a product reaches the market. It can influence development priorities, investment decisions, partnering opportunities and the commercial path forward.
Do you know which third-party rights your technology depends on?
At Bergenstråhle, we help companies map the relevant IP landscape, identify potential freedom-to-operate risks and turn the findings into practical options for development and commercialization.
