NAVIGATING LEGAL ISSUES AND DISPUTES IN THE BIOTECH SPACE
The global biotech industry has witnessed significant growth in the past decade. In 2024, the global biotech market was valued at around $1.68 trillion. By 2033, this is expected to reach approximately $3.54 trillion.
Advancements in biotechnology such as gene therapy, mRNA technology and targeted cancer therapies have attracted a substantial amount of venture dollars. Investors increasingly look to capitalise on deals to develop biologics or small molecules, which are at the forefront of early-stage investment and licensing deal values.
Nonetheless, the uncertainties in the economic landscape in recent years, coupled with the uncertainties inherent in drug development, have resulted in a rise in disputes within the biotech industry, especially when milestone payments are missed.
This litigious environment has given rise to a heightened risk of multijurisdictional disputes over intellectual property (IP) ownership, licensing and commercialisation, and sale and acquisition of assets, which sometimes turn on the interpretation of clinical data and trial endpoints under the relevant regulatory requirements.
In light of this, a cross-functional dispute resolution framework should no longer be an afterthought for key stakeholders. Proper deployment of key strategies at the outset of collaboration can minimise the risk of disputes later, especially given the uncertainties inherent in drug development.
IP protection
IP protection is an essential component to safeguard the intrinsic value of bio-assets. As the research and development of successful products often involves significant capital investment over multiple years, it is imperative for companies to ensure that they have clear and enforceable IP rights, particularly to prevent competitors from replicating an identical product, component or function.
Jul-Sep 2025 issue
Skadden, Arps, Slate, Meagher & Flom LLP and Affiliates