Crafting IP Strategies for Innovative Biotechs

Following his conversation with John Joson Ng for Nucleate Singapore Pulse, we speak to Adam Gregory about crafting effective IP strategies for biotech ventures, avoiding common pitfalls, and adapting to growth and emerging technologies.

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How do you go about devising an IP strategy for a biotech venture?

Devising an IP strategy for a biotech venture is never a ‘one-size-fits-all’ process. Each company has its own unique profile of technology, resources, and commercial ambitions, and its strategy must be carefully crafted to help it carve out a competitive position in the ever-evolving biotech landscape.

In my view, the foundation of an effective IP strategy lies in truly understanding the company’s core technology, its development trajectory, and long-term business objectives. This isn’t a one-time exercise – it requires ongoing engagement to ensure the strategy remains aligned with the company’s evolving goals, scientific progress, and market opportunities. A well-designed IP strategy should be a dynamic, ‘living’ plan that adapts as the venture grows.

A crucial starting point for any biotech is to ask: What do we have that’s special, and how do we protect it? Answering this question helps define the core innovations that need safeguarding and sets the direction for the broader IP strategy. While filing patent applications is often a key component, other approaches – such as maintaining certain aspects of the technology as trade secrets – can also be strategically valuable. The choice between patents and trade secrets depends on factors such as the nature of the technology, the competitive landscape, and the venture’s long-term commercialisation plans.

Beyond securing protection, an effective IP strategy must also consider enforcement and competitive positioning. A biotech company must anticipate how its IP will be leveraged in partnerships, licensing agreements, or potential acquisitions. Additionally, freedom-to-operate (FTO) assessments are important to ensure that the company is not infringing on patents held by third-parties.

Ultimately, a strong IP strategy does more than just protect innovation – it serves as a cornerstone of the venture’s commercial success.

How important is a biotech company's IP position, and how does impact its appeal to potential investors?

The IP position of a biotech company is often central to its commercial success, particularly in the early stages when revenue generation from product sales is still years away. Unlike other industries where companies can quickly bring products or services to market, biotechs – especially those developing new therapeutics – must navigate long and costly development and regulatory pathways before seeing any return on investment.

As a result, a biotech’s primary commercial assets are typically its proprietary technologies – whether novel drugs, platforms, or methodologies – arising from its research and development activities. The company’s value is directly tied to how well these technologies are protected. Investors, potential partners, and licensees will scrutinise the company’s IP position, asking fundamental questions: What technology does this venture have that’s special, and what’s preventing a competitor from replicating it? The due diligence process will assess whether the core innovations have been properly protected through strong patent filings and other IP safeguards.

If a company has developed a groundbreaking therapeutic but has disclosed critical details before securing patent protection, it risks undermining its commercial viability. Without enforceable IP rights, there’s little incentive for investors to fund further development, as competitors could freely exploit the same technology. Similarly, large biopharma companies seeking to acquire or license early-stage assets will hesitate to proceed if they cannot secure a competitive advantage through IP exclusivity.

Ultimately, the strength of the IP position significantly influences investment and partnering decisions. It determines not just whether a company secures funding or collaboration opportunities, but also the scale of investment and the terms of agreements. A robust IP position can mean the difference between a biotech’s success and failure, shaping its ability to attract capital, forge strategic alliances, and bring innovative technologies to market.

What is a common strategic mistake you often see from early-stage biotech ventures?

A common pitfall in early-stage patent strategy is filing a weak initial patent application, followed by a full disclosure of the technology before a properly drafted PCT application is filed. This misstep can have serious consequences.

Patents are granted only for claims that are novel and inventive over prior disclosures made before their effective filing date. However, due to financial constraints, early filings – especially from start-ups and academic spin-outs – are often minimally drafted, lacking sufficient technical detail, fallback positions, and well-structured claim language. When a comprehensive PCT application is filed a year later, much of its content is only entitled to this later filing date, rather than the priority date of the initial filing.

This becomes particularly problematic during examination when amendments to the claims are necessary. If the required claim amendments rely on content introduced in the PCT application, those claims are only entitled to the later PCT filing date. In academic and start-up settings, where researchers frequently publish their work in journals or present at investor meetings between the initial filing and the PCT stage, these disclosures can then be cited as prior art against the patent application. As a result, what could have been a strong patent might ultimately be rejected due to a lack of novelty or inventive step.

Addressing this challenge is not straightforward. Investing more in initial filings to ensure stronger priority applications is one option, but early-stage budgets are often constrained, and the commercial potential of a technology may still be uncertain. Alternatively, public disclosures could be delayed until after a robust patent filing, but this is difficult in practice. Academics face significant pressure to publish, while start-ups need to generate interest, attract investment, and establish credibility – often requiring them to publicly discuss their innovations.

The key to avoiding these pitfalls is strong communication between the technical team and those responsible for IP strategy. By aligning publication plans with a well-thought-out patent filing strategy, companies can better balance competing pressures and ensure their innovations are properly protected from the outset.

Do IP strategies change as biotechs grow, e.g. from launch to exit via acquisition, merger, or IPO?  How might a strategy for a biotech start-up differ from a large multinational corporation?

IP strategies for biotech companies evolve significantly as they grow, typically shifting from a disclosure-driven approach in the early stages to a more strategic, long-term focus as the company matures. The needs of a start-up or spin-out differ greatly from those of a large multinational biopharma company, with financial constraints, business objectives, and regulatory considerations all playing a role.

For early-stage biotechs, patent filings are often dictated by the immediate need to disclose details of the technology externally. This can arise from the necessity to present at conferences, generate interest from potential investors, or satisfy academic pressures to publish. Even when discussions with investors or potential licensees occur under non-disclosure agreements (NDAs), securing patent protection beforehand is often advisable to safeguard the company’s competitive position.

As the company progresses, its IP strategy becomes more proactive rather than reactive. Instead of filing patents primarily to preempt disclosures, the focus shifts to ensuring strong and strategically timed protection. Since patent terms are limited to 20 years, delaying filings for novel technologies – where feasible – can help extend exclusivity further into the future. For example, large biopharma companies, often wait until a product is well into clinical development before filing patents, maximising the prospects of strong commercial protection during its peak revenue years.

Resource allocation is another key difference between start-ups and large corporations. Early-stage companies are often selective in their filings due to financial constraints, prioritising core technologies with clear commercial potential. In contrast, multinational biopharma companies often have the resources to pursue broad patent coverage, filing multiple applications across various aspects of a single technology.

Beyond patents, as a biotech approaches major milestones such as acquisition, merger, or IPO, its IP strategy must be aligned with these objectives. Investors and potential buyers will scrutinise the strength, breadth, and freedom-to-operate aspects of the company’s IP portfolio. Ensuring that patents are robust, enforceable, and positioned to support future market exclusivity is critical to maximising valuation of the programme or venture.

Ultimately, a well-designed IP strategy should adapt to the company’s growth stage, financial position, and long-term business goals.

How do you envision biotech patent strategies evolving in the future, especially with the rise of frontier technologies like artificial intelligence and next generation therapeutics?

As biotechnology continues to evolve, patent strategies must adapt to keep pace. Traditional approaches to IP protection may no longer be sufficient, as new technologies present novel challenges and opportunities for securing exclusivity.

It’s key to understand how an invention will be applied in the real world, and the most effective protection strategies vary depending on the nature of the technology. For instance, in antibody development, composition-of-matter claims are often the gold standard, as they provide the strongest protection for a new therapeutic. By contrast, in autologous cell therapies – where each treatment is tailored to an individual patient – method claims can be particularly valuable, as the uniqueness of the process itself is a critical aspect of the technology.

Timing is another crucial factor. In rapidly evolving fields like AI-driven drug discovery, where the technology may become obsolete in just a few years, companies must carefully consider whether traditional patent filings are the best approach. In some cases, maintaining certain innovations as trade secrets or selectively filing patents to maximize short-term competitive advantage may be more effective. Similarly, industries such as cellular agriculture, which are subject to different regulatory timelines than pharmaceuticals, require tailored IP strategies that align with both scientific progress and commercial viability.

Another major shift in biotech patenting is the increasingly decentralised nature of innovation. Cutting-edge research and development is no longer confined to large institutions – collaborations between academia, start-ups, and multinational corporations are becoming more common, often spanning multiple jurisdictions. However, the patent system remains largely national/regional, creating complexities in securing global protection. Future IP strategies will need to navigate this increasingly fragmented landscape.

Ultimately, the future of biotech patent strategy will require a more nuanced, flexible approach – one that not only protects core innovations but also accounts for rapid technological advancements, regulatory shifts, and the increasingly interconnected nature of the industry.