Author: Sam Honey
Key Contact: Declan Goodwin and Andrew McGlashan
In the biotechnology sector, innovation is the primary currency. From CRISPR gene editing to life-saving biologics, biotech innovation is reshaping healthcare, agriculture, and beyond. But discovery is only half the story. The other half lies in ensuring your intellectual property (IP) is protected, enforced and commercialised. For biotech start-ups, a considered and forward-thinking IP strategy is essential.
What Makes Biotech IP Unique?
Biotech is unlike most industries for one simple reason: the journey from discovery to market is long, expensive, and uncertain. Developing a new therapeutic can take more than a decade and cost well over £1 billion. In the meantime, the company’s principal assets are intangible: its ideas, its data, its know-how.
That is why biotech IP is the lifeblood of the sector. A strong IP position does not just keep competitors at bay; it reassures investors, unlocks partnerships, and ultimately determines whether a venture can survive the marathon from petri dish to patient.
The IP Toolkit: Patents, Trade Secrets, Copyright and Branding
Biotech companies have several tools at their disposal:
- Patents: Still the cornerstone of biotech IP, patents provide exclusive rights of up to 20 years from filing. In practice, biotech companies may build a portfolio of patents covering not only the core molecule or platform but also downstream innovations such as formulations, dosing regimens, manufacturing processes, or new therapeutic indications. This approach helps extend protection and mitigate the “patent cliff” once initial rights expire. Timing is critical: file too early and the claims may lack the supporting data to be credible; file too late and public disclosure may destroy novelty.
- Trade secrets: Sometimes, silence is golden. The formula for WD-40 has never been patented, and 70 years later it remains a profitable mystery. Trade secrets in the UK benefit from protection under The Trade Secrets (Enforcement, etc.) Regulations 2018, which allows legal challenge of any misappropriation, unauthorised acquisition or disclosure of trade secrets. However, enforcement remains challenging as trade secrets do not confer exclusive rights against independent discovery or reverse engineering. Robust safeguards, such as NDAs, IP assignment in employment contracts, confidentiality clauses, and careful structured licensing agreements, are essential.
- Copyright: Particularly relevant for biotechnology software, copyright protects computer code, algorithms, and digital outputs (e.g., bioinformatics platforms, AI drug discovery tools, data pipelines). Arising automatically under the Copyright, Designs and Patents Act 1988, it protects the expression of ideas rather than the underlying concepts.
- Trademarks: Science sells, but branding matters. Protecting the names, logos and distinctive branding or packaging elements of a product can cement market recognition once the therapy reaches the public. Trademarks also offer a commercial lever beyond patent expiry. Because many prescribing lists use brand names, a branded medicine may remain the default option; if the generic name is not listed, it cannot be prescribed. As a result, a strong trademark can help maintain market share even once exclusivity on the underlying drug has lapsed.
Regulatory Protections: Data Exclusivity and SPCs
Not all protection comes from patents or trade secrets. In life sciences, regulatory frameworks themselves create extra layers of exclusivity:
- Data exclusivity: In the pharmaceutical sector, clinical trial data submitted to regulators benefits from exclusivity periods. This follows the “8+2+1” rule: 8 years of data exclusivity during which competitors cannot rely on the data, plus 2 years of market protection, with the possibility of a further 1-year extension for a new indication providing significant clinical benefit. This applies only to authorised medicinal products, not to medical devices, diagnostics, or agricultural biotech.
- Supplementary Protection Certificates (SPCs): Even after a 20-year patent term, many biotech products face delays due to lengthy regulatory approval. SPCs compensate by adding up to 5 years of additional protection for medicinal and plant protection products.
Patents or Trade Secrets? A Strategic Balancing Act
Biotech innovators must weigh whether to patent a discovery or keep it a trade secret, and each has distinct trade-offs.
Patents deliver enforceable exclusivity for up to 20 years, provide proof of innovation, and give confidence to investors and partners. They can be licensed, used defensively, and layered with data exclusivity and SPCs. However, the trade-off is disclosure: competitors can not only learn from the invention but may use it to develop competing generics and biosimilars. Patents are also expensive to secure and maintain, and their protection is ultimately finite.
Trade secrets, by contrast, can last indefinitely if confidentiality is preserved. In biologics, for example, keeping manufacturing know-how secret can make it harder for biosimilar developers to replicate the product. But protection is fragile: once secrecy is lost, it cannot be regained. Enforcement is difficult, and investors may regard trade secrets as less visible and secure.
In practice, the strongest biotech IP strategies use both. Crown-jewel inventions, such as therapeutic molecules, platforms, or engineered cells, are typically patented to secure enforceability and market visibility. While critical know-how such as culture conditions, machine learning models and proprietary datasets can be safeguarded as trade secrets, giving the company an enduring competitive edge.
Think Like a Scientist, Strategise Like a Lawyer
Protecting IP is both art and science. It requires the creativity to identify what is truly innovative, and the discipline to protect it properly.
In biotech, the true measure of success is not just the discovery itself, but the exclusivity that allows it to change the world. Or, to borrow from WD-40: sometimes the most powerful ingredient in innovation is knowing what to share and what to keep secret.
For advice on exploiting and protecting your IP portfolio, please contact our Commercial and Technology team.
