Earlier this year, biopharmaceutical company Stablepharma announced a proposed distribution agreement with AFT Pharmaceuticals covering several international markets for its lead fridge-free tetanus-diphtheria vaccine candidate. The announcement followed positive clinical and stability data and reflects a broader shift taking place within the thermostable vaccine sector. Increasingly, the discussion is moving beyond proof of concept and towards the challenges of commercialisation, manufacturing and market access.
For many years, thermostable vaccines have been discussed as a potential solution to the challenges associated with cold-chain distribution. The underlying scientific principles are not new, and approaches such as lyophilization have long been used within the pharmaceutical industry.
The challenge, however, has been translating thermostability from an interesting technical capability into a commercially scalable healthcare solution. Demonstrating stability is one hurdle. Demonstrating clinical performance, scalable manufacture, regulatory acceptance and commercial adoption is another altogether.
While approaches such as lypholisation have been used within the pharmaceutical sector for many years, relatively few technologies have successfully navigated the combined hurdles of formulation development, clinical validation, large-scale manufacture and commercial deployment.
As the sector matures and companies seek to bring thermostable products to increasingly large markets, attention is turning towards a different question: how can innovators build, protect and extract long-term value from their intellectual property (IP) and proprietary technologies?
How can thermostable vaccine developers protect a platform technology rather than a single product?
For many developers of thermostable vaccines, the greatest long-term opportunity may not reside in any individual vaccine candidate. Instead, it may lie in a broader technology platform that can be applied across multiple products, indications and markets.
This creates an important strategic challenge. Individual products generate the clinical milestones and commercial traction that validate a technology. However, much of the value can sit within the underlying platform and its future applications. Investors, commercial partners and acquirers are often just as interested in the scalability of the platform as they are in the success of the lead product.
The challenge is therefore to ensure that an organisation’s IP protection strategy supports both the current product opportunity and the longer-term platform strategy.
Three considerations stand out:
- Understanding where the value really sits. Is the key asset a particular vaccine formulation, a stabilisation process, a manufacturing capability or a platform that can be applied across multiple products? The answer should influence how IP resources are prioritised
- Building IP protection that can evolve alongside the technology. Platform technologies rarely stand still. New products, new formulations and new applications can all create opportunities to strengthen and extend IP protection over time.
- Recognising that patents and know-how serve different purposes. Patents can help protect technological advances and support commercial discussions, while manufacturing expertise and process optimization may be more valuable when retained as confidential know-how.
How should IP strategy be aligned with commercial goals for thermostable vaccines?
As technologies move towards commercialisation, IP decisions increasingly become business decisions. Questions surrounding where to seek protection are closely linked to future manufacturing plans, partnering strategies and target markets. The challenge is ensuring that investment in IP rights supports commercial objectives rather than simply increasing the size of the IP portfolio.
When resources are finite, strategic focus becomes particularly important. The strongest IP portfolios are not necessarily the largest. They are the IP portfolios that provide the greatest support for the organisation’s commercial ambitions.
Three areas frequently deserve particular attention:
- Prioritising strategically important markets. Not every territory will justify significant investment. Patent filings and broader IP protection should support markets where meaningful commercial opportunities are expected to emerge.
- Consider the wider supply chain. Future manufacturing locations, key partners and distribution hubs may be just as important as end markets when determining where patent protection and other IP rights will create value.
- Aligning IP investment with business objectives. Patent filings and other IP rights should support the organisation’s route-to-market, partnering strategy and long-term growth plans, rather than being pursued as an objective in their own right
How can thermostable vaccine developers manage IP risks and opportunities in partnerships?
Few healthcare innovations reach patients without collaboration. Manufacturing partners, distributors, contract development organisations and other collaborators all play important roles in helping innovative technologies reach the market. Recent developments within the thermostable vaccines sector illustrate the growing importance of these relationships as companies look to accelerate commercial deployment.
Partnerships create significant opportunities, but they also introduce questions around ownership, control and commercialisation of IP. What begins as a commercial discussion can quickly become an IP discussion. The most successful collaborations are built on clarity, particularly when it comes to ownership and use of IP rights, proprietary know-how and future developments arising from the collaboration.
Key considerations include:
- Clearly defining contributions. Understanding what each party contributes helps establish realistic expectations regarding IP ownership, access and value sharing.
- Addressing future improvements early. Collaborative relationships frequently generate new ideas, data and developments. Establishing expectations regarding ownership and use of future IP at the outset can help avoid disputes later.
- Balancing protection and collaboration. Effective partnerships require the sharing of information, but not all information should be shared equally. The challenge is enabling collaboration without weakening the organisation’s IP position or eroding competitive advantage.
How can thermostable vaccine companies maintain competitive advantage as the market evolves?
Success inevitably attracts competition, particularly where valuable IP and commercially attractive technologies are involved. As technologies gain traction, competitors will seek alternative approaches, adjacent technologies and potential workarounds. Securing IP rights is therefore only one part of the challenge. Maintaining differentiation over time is equally important.
Success inevitably attracts competition, particularly where valuable IP and commercially attractive technologies are involved. As technologies gain traction, competitors will seek alternative approaches, adjacent technologies and potential workarounds. Securing IP rights is therefore only one part of the challenge. Maintaining differentiation over time is equally important.
Competitive advantage is rarely static. It requires continual innovation and a clear understanding of how the market and technology landscape are evolving. Companies that view the creation, management and enforcement of IP rights as an ongoing strategic activity are generally better placed to adapt to changing competitive conditions than those that regard IP as a series of isolated filing exercises.
This requires sustained focus on:
- Continuing to innovate beyond the initial breakthrough. The first-generation product is rarely the end of the story. Incremental improvements that generate additional IP can be just as important in maintaining a competitive position.
- Understanding where barriers to entry really exist. Those barriers may arise from patents, know-how, manufacturing expertise, regulatory experience or a combination of factors.
- Treating IP as a long-term strategic activity. Competitive landscapes evolve, and IP protection strategies must evolve with them.
What forms of IP protection matter beyond patents?
Patents are often the most visible form of IP, but they are rarely the only IP assets that contribute to competitive advantage. For many companies, substantial value resides in manufacturing expertise, process optimisation, regulatory knowledge, quality systems and commercial experience. Some of these assets are well suited to patent protection. Others derive value precisely because they remain confidential and are protected as proprietary know-how.
Determining where to draw that line can be just as important as deciding what to patent. The answer will vary from business to business and from technology to technology. However, one principle remains consistent: protecting value starts by understanding what creates value.
This means:
- Identifying the activities that underpin competitive advantage. Not every valuable asset is found in a patent portfolio, and not every patent contributes equally to business success.
- Matching the appropriate form of IP protection to the asset. Some innovations benefit from patent protection, while others are better protected through confidentiality, contractual provisions or operational expertise.
- Focusing attention on what matters most. The objective is not to maximise the volume of IP, but to protect the assets that support long term value creation.
What IP strategies will help thermostable vaccine developers achieve long-term commercial success?
For many years, discussion of thermostable vaccines has focused on the underlying science, and that focus is entirely justified. Without scientific credibility, clinical validation and scalable manufacturing, commercial success was never going to follow.
As more thermostable technologies move towards commercial deployment, a different set of questions is beginning to emerge. Questions about market access, manufacturing, partnerships, competitive positioning and long-term value creation are becoming just as important as the underlying science itself.
Intellectual property has an important role to play in addressing those questions, but patents are only part of the picture. Competitive advantage is more likely to arise from the interaction of patents rights (and other IP rights), know-how, manufacturing capability and commercial execution.
The companies that ultimately shape this sector are unlikely to distinguish themselves through thermostability alone. Their success will depend on how effectively they build, manage and leverage IP rights and know-how to support commercial growth, market adoption and long-term value creation.
Securing protection for your IP with Secerna
At Secerna, we work with innovative companies to develop IP strategies that support commercial objectives, partnering activities and long-term growth.
If you would like to discuss any of the issues raised in this article, please get in touch.