IP strategies for FemTech start-ups

Female technology (FemTech) is becoming big business with health and wellness apps, software and diagnostic products promising to revolutionise women’s health. Asma Mejri sets out strategic IP advice for FemTech start-ups.

FemTech, short for female technology, is a catch-all term for all technologies that address a need in the women's health sector. The term was coined in 2016 by Danish entrepreneur Ida Tin, the creator of an app to track the menstrual cycle. 

FemTech includes innovative platforms, software, products, devices and services designed to improve women's health and daily lives, and detect or treat conditions or health problems related to, among others: fertility, female oncology, contraception, menstrual cycles, pregnancy, maternity, genital and pelvic health, sexual health, menopause, beauty and wellness, and longevity. 

Examples of these technologies include apps (such as fertility tracking apps), collaborative platforms, connected devices (such as remote-tracking sensors) and wearable technologies, such as clothing and accessories (such as connected watches for menstrual cycle tracking).

According to the FemTech analytics report, published in 2021, the global FemTech industry ecosystem today includes no less than 1,550 companies, 1,000 investment funds and 30 R&D centres. According to the same source, the global FemTech market, valued at US$18.7 billion in 2019, is expected to exceed US$60 billion by 2027. 

While the FemTech industry has long been considered a niche sector, experts predict that this industry will grow exponentially in the coming years. Indeed, with the massive digitalisation of healthcare, fostered by the COVID-19 pandemic, more and more technological tools are being developed to manage health problems digitally and remotely. 

In particular, with the development of artificial intelligence (AI), big data technologies and connected objects, more and more FemTech startups are integrating data into their value propositions and focusing their solutions around the processing of medical and/or personal data of patients/consumers in order to provide personalised and tailored solutions to each user.

Relevant IP rights for FemTech start-ups

Intellectual property (IP) rights protect innovation and creativity, and can help all businesses secure their investments. IP rights can also create new revenue streams (through royalties), add substantial value to a business and are very attractive to investors. For FemTech start-ups, the main types of IP rights to consider include:

• patents, which protect technical solutions implemented in the product, including algorithmic solutions and technical solutions implemented by software;
• trademarks, which protect the distinctive signs (name, logo, etc.) that identify the product;
• designs, which protect the aesthetic appearance of a product;
• copyright, which protects original works of any kind (literary, graphic, musical, audiovisual, software, etc); and
• the protection of business secrets, which provides a legal framework for the protection of know-how and undisclosed strategic (sensitive and/or confidential) information of companies (in particular know-how) against unlawful obtaining, use and disclosure.

Patents, trademarks and designs are all registrable rights. This means that you have to apply for them, but once they are granted, you have a monopoly right over what you have protected. Copyrights are generally unregistered rights that arise automatically as soon as a work is created. 

Registered rights are territorial, so as a first step it is necessary to identify the countries or territories where protection might be needed. It is possible to start by applying for protection in the domestic market, which gives you time to validate interest and develop a strategy for protection abroad (up to six months for trademarks and designs, and 12 months for patents). This approach also allows you to spread your expenses. The costs associated with the protection of IP can vary and be high in some cases. For most companies, especially start-ups, seeking registered IP protection often involves a balancing act between risk and budget. An IP attorney can advise you on how to obtain the most effective protection within your budget and provide detailed quotations.

For unregistered rights, it is recommended to keep detailed records of the creation of any work, including the identity of the author(s) and the date of creation. It is also advisable to keep records of your promotional activity in relation to the creation, press articles, details of sales and turnover, copies of invoices, examples of product packaging, advertisements and brochures etc. This evidence may be useful if you ever need to assert your rights. There are various ways to provide evidence of ownership and date of creation, speak to your IP attorney to find out more.

What to protect with which IP rights?

The first element of your business to be protected is of course your business name and trademark. These can be protected by registering trademarks, provided they do not reproduce an existing name or trademark. 

If your solution involves software (or an application or computer program), the source code, object code and preparatory design material is eligible for copyright protection in many jurisdictions (for example, in France under Article L112-2 of the IP Code). 

Source code is defined as a set of instructions at the source of a computer program expressed in a language that can be understood and modified by humans. Object code is obtained by compiling the source code and is expressed in machine-readable binary code. Preparatory design material is ‘preparatory design work leading to the development of the program such that a computer program can be produced at a later stage’. This preparatory work includes, for example, mock-ups, flowcharts, functional and organic analyses, and functional architecture.

Source code, object code and preparatory design material, considered as forms of expression of the computer program, are eligible to copyright protection in the same way as any literary work. However, this is a protection of the form of the program. The ideas and principles underlying the software remain free to be used. Copyright protection does not extend to the functionality of the program.

Instead, the functionalities and technical elements of the software, if they constitute a technical invention, may be protected by patent law. The usual patentability criteria apply. In particular, the technical invention must be new (it must not have been made available to the public, in particular the software must not have been commercialised) and it must involve an inventive step (it must not follow in an obvious way from existing solutions). 

If your solution includes a database, the structure of the database (its architecture or layout) may be protected by copyright provided it meets certain criteria. However, this protection does not extend to the data or content of the database. Depending on the jurisdiction, the content of a database may benefit from protection via a sui generis right (e.g. in France, under Article L341-1 of the IP Code). This protection ‘is independent of and without prejudice to that resulting from copyright or any other right in the database or any of its constituent elements’. This protection is essential for the security and confidentiality of the data which includes in particular the personal and medical data of the users of your FemTech product. Finally, the elements making up the website of your FemTech startup can be protected by copyright. 

Digging deeper

While all of the above criteria apply to any Tech solution, there are some specific aspects that need to be taken into consideration when developing a FemTech or more generally a HealthTech solution.

A first consideration concerns technical inventions that can be protected by patent law. In the field of health, methods for surgical or therapeutic treatment of the human body (e.g. medical or aesthetic) and diagnostic methods applied to the human body are excluded from patentability. Some claim wordings thus lead to a rejection of the patent application if they define methods excluded from patentability. It is therefore important to consult a specialised patent attorney to draft the patent application so that the proposed solution is not excluded from patentability and allows a patent to be granted.

The second consideration concerns the protection of private information, especially if your solution implements algorithms or AI models that exploit data from, for example, apps, wearables or medical devices. On the one hand, it is important to ensure transparency of data use and to strengthen users' rights over their data by giving them the possibility to authorise access, sharing, use or sale of their data. On the other hand, it is important to ensure the security and confidentiality of this data.

Novagraaf has patent attorneys specialised in the field of software and life sciences as well as trademark and copyright attorneys, who work as a multidisciplinary team to provide the best possible support to clients. Please get in touch with us today for targeted advice and support.

Asma Mejri is a Junior Patent Engineer at Novagraaf in France.