These activities are best undertaken with the support of your technology transfer office or those individuals responsible for commercialisation within your host institution.
Working with your technology transfer office
Technology transfer offices seek to support the protection and commercialisation of IP and engagement with industry. Your host institution will have policy frameworks that govern what you can and cannot do in this domain. Technology transfer offices have experience in both academia and industry that can add value to a researcher’s endeavour to commercialise IP, and can help you navigate the process.
This site also links to other websites.
The NHMRC takes no responsibility in relation to the information provided. Users are expected to undertake their own due diligence.
Principles of commercialisation
The commercialisation process is based on five key principles:
- Identifying an unmet need*
- Demonstrating proof of concept
- Protecting the asset
- Establishing strategic partners
- Creating impact.
*Unmet need implies that there is a product or service that has been shown to be absent in the sector for which there is a significant need. It is assumed that, in identifying the unmet need, the researcher has comprehensively reviewed and validated existing and emerging competition, identified the context in which the new product or service will be offered, and has interviewed end-users (e.g. clinicians, regulators, patients) to obtain independent, experienced views on use.
Examples of an asset include:
- A molecule or vaccine
- A formulation
- A substance for targeted drug delivery (a “vehicle”)
- An off-label use for a drug
- A medical device
- A diagnostic
- A public health intervention
- An algorithm or piece of software.
It is important to note that an asset may not necessarily provide a financial return, but still have a substantial impact on human health and well-being.
Intellectual property and patents
Intellectual property (IP) can be defined as a novel creation of the mind – a new idea or invention – that is commercially (or artistically) useful. There are several different types of IP, such as an invention, trade mark, design, brand, or even the application of an idea. Commercialisation of IP means extracting value from the IP by marketing a new product, production method, or service based at least partly on the IP.
IP has been created if an idea/invention fulfils three basic criteria:
- It is novel and has not been previously published or reported (e.g. in a trade journal, in a current or expired patent, or via social media)
- It has utility (a benefit or practical use)
- It can be reduced to practice (there is experimental evidence to show that it works).
Novelty also means showing that an idea or invention cannot easily be conceived by someone “skilled in the art”. If a combination of existing ideas clearly and logically leads to an idea or invention, then it is not novel. However, if the process by which an idea or invention is conceived is not obvious, it is likely to be considered novel.
Intellectual property arising from biomedical research is generally in the form of a patent and occasionally as copyright material. A patent is an exclusive right granted for an invention. Copyright is a legal term used to describe the rights that creators have over their literary and artistic works. Copyright is not specifically covered here.
For an invention to be patented it must have utility, so inventing something that has a practical use is key. The invention cannot remain a purely theoretical concept, no matter how novel it is.
For further guidance on this topic, it may be useful to seek an opinion from a patent attorney or technology transfer office.
Ownership of IP
Intellectual property created in the course of employment will generally be owned by the employer, unless the employee has a specific right to ownership.
Ownership is normally set out in an employment contract signed by both parties, or by the policy of the employer’s institution. Students own their IP unless they have assigned it to the host institution as a condition of their candidacy. A technology transfer office will be able to clarify the rules of IP ownership.
Patenting IP will require an inventorship determination by the host institution or an external service provider so that the identity and contribution of each inventor can be determined. Note that inventorship does not automatically follow from authorship or ownership.
Commercial returns generally come to the owner of the IP. However some host institutions have policies that require owners to share commercial returns on the basis of each person’s contribution to the “inventive steps” in the commercialisation process. This may include members of teams who helped transfer the invention to practice. It is not restricted to the named inventors on the patent(s).
In the first instance, it is important to record the creation of IP by filing within an appropriate recording system. This is called an invention disclosure record. An invention disclosure record should match the supporting notes and experimental procedures, results, and conclusions initially recorded in hard copy form. It must be signed and dated by the researcher and counter-signed by another person who is familiar with the work but did not conduct it. This signed and dated record may be required to substantiate a patent during prosecution of the patent filing.
IP negotiation and licensing
Assistance from a technology transfer office or equivalent individuals at the host institution will likely be needed. External service providers can also supplement the skills and experience of the host institution when negotiating a license to IP.
IP Australia’s Understanding IP is a valuable resource that provides information to researchers about IP and how it can be protected.
Timing of filing a patent application
A patent application must be filed prior to publication of any manuscript or conference abstract, or any other public disclosure. Furthermore, it may be a condition of employment that any discoveries are made known to a technology transfer office prior to public disclosure. If an invention is not protected by filing a patent application, novelty will be lost. In a competitive landscape, people often come up with similar ideas in the same timeframe. Previously filed patent applications may have priority if the ideas and claims overlap.
As a strategy, filing early should be balanced with the need to “reduce the invention to practice” (i.e. produce supporting evidence) and support broad claims in a patent application. It is good practice to file as early as practicable, but ensure that data generation to support the patent claims and commercialisation/partnering plans is on track, as patent application costs increase significantly after 30 months.
Stages of filing a patent application
A detailed guide to the patent application process can be found on the IP Australia website.
Stage 1: Provisional patent application
The first step is filing a provisional patent application through a patent attorney within a single geographical jurisdiction such as Australia or the US.
Stage 2: Patent Co-operation Treaty (PCT) application
A Patent Co-operation Treaty (PCT) application is filed 12 months after the provisional application. This 12-month period allows time to generate additional data that might be needed to support the broad claims in a patent application. The PCT assists applicants seeking patent protection internationally for their inventions. Through filing one international patent application under the PCT, applicants can simultaneously seek protection for an invention in a large number of countries.
Stage 3: National phase of the patent application
At 30 months (or 31 months depending on the country), the national phase of the patent application is made. The cost is dependent on the total number of countries in which the IP is being protected, and the filing and translation costs in each.
Aboriginal and Torres Strait Islander knowledge within the IP system
Aboriginal and Torres Strait Islander traditional knowledge is encompassed in a broad definition of intellectual property. IP Australia has several case studies that can be linked to traditional knowledge and traditional cultural expressions of Indigenous peoples, including stories, dance, languages, symbols, crafts, cosmology, and medicinal and environmental knowledge.
The true value of IP is best determined by how much a company is prepared to pay to use the IP or what the market would pay for a product or service derived from the IP. IP Australia’s Commercialise Your IP resource provides information to researchers about how IP can be commercialised.
Start-up companies are very useful vehicles for the commercialisation of research that has a commercial application. They are particularly useful in the development of an idea beyond the proof of concept stage into a practical “reduction to practice” (i.e. produce supporting evidence), for example as a service, technology and/or product. However, establishing a business to commercialise an idea is a resource and time-intensive process compared to licensing, which allows someone to use IP on agreed terms and conditions.
When planning a licence agreement or start-up, it is a good idea to get the basics ready and continually ask questions of the data, market research, clinicians, patients, and mentors:
- What is the value proposition (why would an investor put money into the licence or start-up, how much return would they expect, and over what timeframe)?
- What is the route to market or licensing income (what path will be taken to make money as quickly as possible, or achieve a substantial increase in valuation of the IP and supporting data)?
- What is the unmet market need (medical researchers should also consider the unmet clinical need)?
- How secure is the IP? Who owns it? Is there a clear “chain of title”? Investors need to know that the IP can be cleanly transferred to a prospective spin-off, subsidiary company, or licensee.
- Has freedom to operate (FTO) been obtained, or are other patents or copyright being infringed?
- Who is the team (the founders, their track record, and the early recruits)?
Finally, think about investors’ expectations and how they may impact on an “exit strategy” (being bought out early in a trade sale, floating on the public market etc.).
Commercialising a device
Commercialisation of a medical device requires knowledge of the project planning, technical, marketing development, and regulatory approval processes required for success. External service providers can supplement the skill sets and experience of the host institution in commercialising a device.
Conflict of interest management
The commercialisation of intellectual property may result in a financial return to the IP contributors and inventors and the host organisation. This may result in the researcher having a conflict of interest. Real or perceived conflicts of interest are common amongst entrepreneurs, and are best managed by full disclosure when they are first recognised. Host institutions usually have policies to help researchers identify, report, and manage conflicts of interest.
The first step in engagement is getting the story right. A thorough understanding of the technology, the related product/service, the competition, the development pathway and the profile of an ideal partner is essential. Such a dossier can be developed with professionals (either consultants or business development specialists) in a technology transfer office. Preferably, more than one target company will be identified and engaged at the same time prior to deciding on the best deal.
Establishing connections in the health and medical research sector
The health and medical research sector is very broad, encompassing academic and industry-based research, service providers, entrepreneurs and small start-up companies through to multi-national device and pharmaceutical companies. Investors in the sector range from high net worth individuals and angel investment groups to venture capital funds.
Further information and examples can be found at http://www.ausbiotech.org/ and https://www.bio.org/
Establishing connections with the industry sector
Engaging with industry is often facilitated by attendance at conferences. There, industry-based researchers and managers interact directly. Many conferences have trade exhibitions where there is a greater likelihood of such interactions occurring. It may be possible to arrange an initial consultancy, for example, within a company. This may then lead to a “research contract” being put in place where fee-for-service research is undertaken for the company.
Establishing connections with end users
Relationships with end users are best achieved by active engagement either through attendance at conferences and trade shows or by inviting industry partners to review relevant research through the host institution. Discussion of an invention will often require signing a confidentiality agreement to prevent disclosure.
Establishing connections with Small and Medium Enterprises (SMEs)
Small and Medium Enterprises (SMEs) are typically grouped as device, diagnostic, or biotech companies, and are valuable resources for engaging and commercialising research. Besides conferences and trade shows, contacts are generally identified through a technology transfer office or equivalent individuals at the host institution. Many can also be identified by web searches.
Establishing connections with large and/or global companies
Large and global companies generally operate through a network of talent scouts in business development roles. Some of these scouts may be based in Australia and some will be located at a head office in the Asia-Pacific region, Europe, or the USA.
As above, the identity and contact information for business development scouts may be available through a technology transfer office or equivalent individuals at the host institution, or via web searches.
Working with mentors
Scientific entrepreneurs have most often learnt through experience and making mistakes. It is a good idea to reach out to people who have started a company, filed patents, or licensed IP. There are also national conferences where entrepreneurs meet to “swap notes”. Information on upcoming conferences and other events can be found at www.ausbiotech.org.
Existing support mechanisms
The Department of Industry, Innovation and Science IP toolkit contains guides and tools to help researchers and businesses use and manage IP in collaborations.
The Therapeutic Goods Administration (TGA) protects the health and wellbeing of the community by regulating and monitoring all therapeutic goods that are distributed in Australia. The TGA provides the dedicated service SME Assist to help researchers, small to medium enterprises (SMEs) and start-ups developing new medicines and medical devices understand their regulatory and legislative obligations. The SME Assist email list allows subscribers to stay up to date with the latest researcher and SME information from TGA.
MTP Connect is a not-for-profit organisation that aims to boost the innovation, productivity, and competitiveness of Australia’s medical technology, biotechnology, and pharmaceutical (MTP) sector by facilitating collaboration between existing industry associations, research bodies, investors, funders, and government agencies and departments in Australia.
AusBiotech is an Australian not-for-profit biotechnology organisation that provides representation and services to promote the global growth of the Australian life sciences industry. It consists of a national network of members in the therapeutics, medical technology (devices and diagnostics), digital health, food technology, agricultural, environmental and industrial sectors, and provides initiatives to drive sustainability and growth, outreach and access to markets, and representation and support for members.