Developing an inhaled RNA therapy requires a company to bring several technologies together: the therapeutic RNA, its carrier, the formulation, the manufacturing process and the delivery device. As these elements become a defined product, they also create a connected set of IP dependencies. Decisions about technical performance, development investment and future partnerships therefore need a clear understanding of the company’s freedom to operate.

This becomes particularly important when a young biotechnology company moves from laboratory research towards preclinical development, manufacturing scale-up and clinical preparation. Formulations are refined, production methods become more specific, and development partners contribute additional technology and know-how. Each step can change which third-party rights are relevant and which technical or commercial options remain available.

For a company developing both its own therapeutic candidates and a reusable delivery platform, these decisions have consequences across several programmes. A formulation choice may influence future applications. A manufacturing partnership may determine access to essential process knowledge. An agreement for one indication may shape how the platform can be used with other partners. IP management must connect these individual commitments with the company’s longer-term development and licensing strategy.

Continuous, product-centric Freedom-to-Operate management provides a framework for addressing this challenge. It connects the evolving product architecture with relevant patent rights, defined review points and clear responsibilities. Its practical value lies in helping management recognise when a technical change, a licensing discussion or a different development route should be considered while meaningful options remain open.

The CEIPI IP Business Academy brings such practical management challenges into its teaching through questions contributed by industry representatives. Students learn to connect IP analysis with the decisions faced by research teams, company founders, manufacturing specialists and business development managers.

We are therefore pleased to include this practical question with Dr. Benjamin Winkeljann, Co-Founder and CEO of RNhale. The case explores how an inhaled RNA platform company can organise FTO management throughout development while preserving the platform’s value for future applications and partnerships. It asks students to consider the scope of the analysis, the development decisions it should inform and the collaboration arrangements needed to support long-term platform reuse.

Mini case study

A young life-sciences company is developing a platform for the local delivery of RNA therapeutics to the lung. Its technology combines RNA cargo, lipid-based nanocarriers, an embedding process that converts the formulation into an inhalable dry powder, and a manufacturing approach designed for stability and scale. The platform can be adapted to different RNA sequences and pulmonary indications.

The company has entered a decisive translational phase. Substantial public funding is supporting the preclinical development of a first therapeutic candidate for a severe respiratory disease, the scale-up of the dry-powder manufacturing process, new equipment, and the preparation of the programme for clinical development. Technical choices that were previously experimental are therefore becoming product and process commitments.

Its commercial strategy has two connected paths. The company intends to advance selected drug candidates itself and to make the delivery and formulation platform available through collaborative R&D and later licensing relationships. Each programme may involve different RNA payloads, carrier compositions, formulations, devices, manufacturing partners, target indications, territories, and development responsibilities.

The relevant patent landscape is equally layered. Third-party rights may concern RNA constructs, lipid components, particle architectures, pulmonary formulations, powder-processing methods, inhaler devices, dosing concepts, manufacturing steps, and indication-specific uses. New applications can be filed, claims can change during examination, and partner contributions can introduce further dependencies while the company is refining its own product architecture.

Management now needs a repeatable way to connect changes in the product and the patent landscape with concrete decisions. The company must determine which technical layers and variants require an FTO baseline, when reviews should be repeated, which developments should trigger escalation, and how findings should influence design choices, licensing discussions, partner selection, indication priorities, and market sequencing. The system must support the first drug programme while preserving the platform’s value for additional programmes and partners.

Question

How should such a company build continuous, product-centric Freedom-to-Operate management that keeps its first therapeutic programme, its reusable delivery platform, and future partner programmes commercially actionable as the technology and patent landscape evolve?

Product scope. Which product, platform, manufacturing, device, and use-related layers should be represented in a Product FTO Risk Map, and how should variants and target markets be prioritised?

Decision gates. At which development gates should the FTO position be updated, and which changes in the product or the patent landscape should trigger a design-around, licensing, validity, partnership, or market-prioritisation decision?

Partner governance. How should background IP, partner contributions, improvement rights, data access, and manufacturing know-how be governed so that collaborative programmes strengthen the platform’s long-term reusability and licensing readiness?

Why this is a highly practice relevant question

RNA therapeutics and advanced drug-delivery platforms create dense and rapidly changing patent landscapes. Commercial freedom can depend on the interaction of several technical layers, even when no single third-party patent covers the complete product. A product-centred analysis must therefore connect claims with the actual payload, formulation, process, device, use, and jurisdiction.

The timing of the analysis has direct economic consequences. Early findings preserve technical and commercial options while formulations, processes, and indications can still be changed. Late findings can affect preclinical investment, manufacturing scale-up, clinical planning, fundraising, and negotiations with development or licensing partners. Continuous monitoring becomes valuable when it is linked to defined decision gates, responsibilities, and escalation rules.

A dual model combining proprietary drug development with platform partnerships adds another layer of complexity. The company needs sufficient freedom for its own candidate and a credible explanation of dependencies for future partners. Collaboration agreements must also preserve access to improvements, data, materials, and manufacturing knowledge that determine whether the platform remains reusable across several programmes.

Future IP managers will increasingly have to translate patent information into choices for R&D, business development, manufacturing, clinical strategy, and market entry. This case requires them to design an operating model for FTO management: a structured baseline, a Product FTO Risk Map, monitoring fields, review gates, escalation triggers, documented options, and clear interfaces with partnership and portfolio decisions.

Dr. Benjamin Winkeljann

Dr. Benjamin Winkeljann is Co-Founder and CEO of RNhale, a biotechnology company developing inhaled RNA therapeutics and a platform for pulmonary RNA delivery. His background combines mechanical engineering, bioengineering and pharmaceutical research. He studied mechanical engineering at the Technical University of Munich, where he completed his doctorate in 2020, before continuing his research at TUM and subsequently joining the Department of Pharmacy at Ludwig-Maximilians-Universität München in 2021. Academic profile at LMU

Since 2023, Benjamin has served as a group leader at LMU’s Department of Pharmacy and as Co-Founder and CEO of RNhale. In 2024, he also became a Principal Investigator at the Comprehensive Pneumology Center Munich within Helmholtz Munich and the German Center for Lung Research. His work connects academic research with the development of inhalable RNA medicines, bringing an interdisciplinary perspective to the scientific, technical and commercial decisions involved in translating a delivery platform into therapeutic applications. Academic profile at LMU · RNhale research and development