Piercing The Limits | Patenting In The Age Of Needle-free Vaccines

For more than a century, the needle and syringe have been the standard tools of immunisation. Now, advances in engineering and formulation are driving a shift toward needle-free vaccine delivery systems, reshaping both global health and patent strategy.

Valued for their simplicity, the needle and syringe method has been limited by cold-chain storage requirements, the need for medical supervision, the safe disposal of sharps waste, and the fear and anxiety they frequently evoke, particularly in children and those with needle-phobia.

Needle-free systems are no longer experimental; they are progressing into late-stage development and commercial adoption. By improving patient access and simplifying vaccine distribution, these technologies help overcome both clinical and logistical barriers, while at the same time opening fertile ground for building strong, commercially valuable patent portfolios.

As patent activity increasingly extends beyond formulations to include devices, coatings and delivery mechanisms, we review some of the delivery systems currently in development and outline key IP protection areas for strategic innovators.

Microneedle and microarray patches

Microarray patches (MAPs) use microscopic projections to deliver vaccine into the outer skin layers, where immune cells are concentrated. The approach is painless, efficient, and often more stable than traditional injections.

Brisbane-based Vaxxas has emerged as a global leader. Its High-Density Microarray Patch (HD-MAP) platform has entered late-stage clinical development with support from the Coalition for Epidemic Preparedness Innovations (CEPI) and the Biomedical Advanced Research and Development Authority (BARDA).

Earlier this year, the company secured a new US patent covering its precision print-head coating process, expanding its portfolio to more than 40 issued patents worldwide spanning patch/applicator design, coating and loading processes, and vaccine formulations, demonstrating how process and materials innovation can be just as strategically important as the device itself.

Internationally, US-based Micron Biomedical is developing a CEPI-supported dissolvable microarray "button" for pandemic preparedness. The skin-applied patch delivers vaccine through microscopic projections that dissolve within minutes, offering a needle-free, thermostable, and self-administered alternative to injections.

Micron is also exploring applications of the technology beyond vaccines, including its use for injectable therapies such as those for obesity and diabetes. Their patent filings focus on dissolvable microarray structures, fabrication methods, and applicators, together with scale-up and clinical translation.

Collectively, these efforts show how patch platforms are evolving into modular, multi-antigen systems with broad commercial and patent potential.

Mucosal delivery systems

Mucosal vaccines, delivered through the nose or mouth, aim to trigger immunity where many infections start. Nasal sprays, inhalable powders, and oral films are all in development as painless, self-administered alternatives to injections.

FluMist®, a live-attenuated intranasal influenza vaccine (LAIV), was developed in the late 1990s by Aviron and later acquired by MedImmune. It became the first FDA-approved intranasal LAIV in 2003 and moved to a quadrivalent formulation in 2012 using cold-adapted, temperature-sensitive attenuated strains. This platform has been protected by patents, now held by MedImmune/AstraZeneca, encompassing strains, intranasal formulations, and methods. More recently, it has been announced that FluMist® will be added to several Australian state immunisation programs from 2026, marking the first large-scale public rollout of a mucosal vaccine in Australia.

Several other products have recently received regulatory authorisation. In India, Bharat Biotech's iNCOVACC®, an adenovirus-vectored intranasal COVID-19 vaccine, received emergency-use authorisation in September 2022. In China, CanSino's Convidecia Air®, an aerosolised booster version of its Ad5-nCoV vaccine, received emergency-use authorisation that same month, supported by patent filings dating back to 2020 covering the inhaled formulation and nebuliser-based delivery.

The journal Science also recently profiled a proof-of-concept "floss vaccine", studied at North Carolina State University, where tape-style dental floss coated with vaccine was applied at the gumline's junctional epithelium. The approach produced strong mucosal and systemic responses in mice, with early human feasibility studies indicating that oral-gingival targeting may be achievable, pointing to a potential new needle-free route.

From a patent perspective, mucosal delivery is an interdisciplinary space where formulation, aerosol physics, and device engineering meet. Patent filings often couple composition with device parameters such as nozzle geometry, plume characteristics, particle size, and mucoadhesive chemistry, signalling a shift toward protecting the integrated system rather than isolated parts.

Jet injectors

Jet injectors deliver vaccines through a fine, high-pressure liquid stream that penetrates the skin within milliseconds. These systems, powered by either a spring or compressed gas, deliver intradermal or intramuscular doses within milliseconds. The approach reduces sharps waste, eliminates the risk of needle-stick injuries, and simplifies large-scale immunisation campaigns by allowing faster administration with minimal training.

US-based medical technology company PharmaJet offers two needle-free platforms: Tropis® for intradermal delivery and Stratis® for intramuscular/subcutaneous delivery. The Tropis® device is the only WHO-prequalified needle-free injector and was used in Pakistan's 2025 polio campaign, reaching more than 1.5 million children. The same platform has been adopted for both DNA and mRNA vaccines, demonstrating compatibility with next-generation vaccine formats. PharmaJet's patent portfolio covers nozzle design, cartridge systems, and pressure regulation, illustrating how mechanical engineering can secure durable protection.

In India, innovation in needle-free delivery is accelerating. In May 2024, the Serum Institute of India (SII) acquired a 20% stake in IntegriMedical to advance its spring-powered jet injector technology. The device uses a high-pressure piston to deliver medication through a micro-orifice in the skin, reducing pain and needle-related hazards. Following local approval in 2022 and commercial launch in 2024, adoption has grown among clinicians treating children and needle-phobic patients. The system is also currently in trials comparing COVID-19 booster delivery with conventional needles.

Solid-dose injectors

Solid-dose vaccine delivery systems replace liquid injections with dry, thermostable formulations administered through compact, needle-free devices. These systems deliver a small solid pellet or tablet into or onto the skin, where it dissolves and elicits an immune response.

Solid-dose injectors, such as the aVaxziPen® system developed in the UK, take a different path by delivering thermostable vaccine pellets through a reusable pen-type device. Supported by CEPI, the technology eliminates cold storage and sharps waste. Recent patent filings from aVaxziPen cover solid-dose compositions and cassette/applicator mechanisms, reflecting a comprehensive protection strategy around both product and device.

Other emerging methods

Researchers are also exploring other physical approaches to improve vaccine uptake. These approaches include:

• Electroporation (Inovio's CELLECTRA®), which uses short electrical pulses to create temporary pores in cell membranes, improving uptake of DNA or RNA vaccines;
• Skin-stretch applies mechanical tension, which creates transient microchannels, activates immune cells, and enhances vaccine uptake;
• Thermal and optical ablation, which uses heat or light to remove the outer cellular barrier to allow vaccine delivery; and
• Ultrasound delivery, which uses sound waves to propel vaccines through the skin by acoustic cavitation, creating microchannels that allow molecules to reach immune-rich tissues.

Each modality opens a different technical and patent space, covering device architecture, control parameters, and energy modulation, where cross-disciplinary innovation often drives the most valuable IP.

Patents and IP strategy

The shift toward device-based vaccination is also reshaping IP strategy. Traditionally, vaccine portfolios were built around antigen design, adjuvants, and formulation chemistry.

In the emerging landscape, however, competitive advantage increasingly lies in the delivery platform itself and in how biological and mechanical innovations interact to achieve immunogenicity, stability, and scalability.

With innovations increasingly bridging biology, engineering, and manufacturing, effective protection demands a layered and cross-disciplinary patent strategy.

Key areas of protection now include:

• Device architecture: encompassing applicators, nozzles, cartridges, and coating systems. Small variations in geometry or pressure regulation can materially affect dose precision and patient outcomes, giving rise to strong, defendable claims.
• Formulation-device interfaces: where the performance of the vaccine depends on how it interacts with a polymer matrix, microneedle coating, or dissolvable film. These hybrid innovations often yield valuable process or composition claims that sit alongside device patents.
• Manufacturing and loading processes: especially those that improve scalability, thermostability, or uniformity of dosing. Process patents in this space can extend exclusivity even when product claims are narrow.
• Combination and method claims: linking a defined vaccine type to a particular delivery mechanism or dosing approach, ensuring protection for the integrated platform rather than its individual parts.

As delivery technologies become more sophisticated, the IP landscape is also becoming more complex. Overlaps between biologic and device patents increasingly demand close collaboration between R&D teams and patent counsel from the earliest stages of development.

The strongest portfolios are those that recognise the delivery technology not as an accessory but as a core component of the vaccine's inventive concept, one that shapes both its clinical performance and its commercial life cycle.

Freedom-to-operate analyses are also evolving. The convergence of medical device and biopharmaceutical patent spaces means that overlapping ownership, licensing structures, and regulatory classifications can create hidden barriers to market entry. A coordinated strategy that aligns patent drafting, regulatory planning, and design-around considerations is now essential to avoid downstream bottlenecks.

How we can help

Developing and protecting innovation in vaccine delivery requires a strategic and cross-disciplinary approach. Our team advises on all aspects of IP protection for emerging delivery platforms, from early design and proof-of-concept through to clinical translation and commercialisation.

If you are working on needle-free or alternative vaccine technologies and would like to discuss how best to protect your innovation in Australia or globally, we would be happy to assist.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.