Helen Henderson is a senior associate and Kate Manson is an associate at European intellectual property firm, Withers & Rogers. They are both patent attorneys who specialise in the life sciences and medtech sectors respectively.
Innovating to improve IVF outcomes is a fast-developing segment of the thriving femtech market, as it seeks new solutions to infertility.
In May, the first births achieved through ground-breaking IVF technology, one involving the use of innovative mitochondrial donation treatment (MDT) and another using a sperm-injecting robot, have underlined just how far this field of research science has come. However, assisted reproductive technologies (ART) still only lead to around one third of patients being able to have a baby, so femtech innovators know that there is still plenty of room for improvement.
Automating IVF
Advancements in robotics and microfluidics, and the desire for greater efficiency when delivering IVF treatments, have led to an increased interest in the use of automation. Accuracy is essential to the success of IVF procedures and the precision provided by automated systems removes the risk of human error. Oocyte cryopreservation, the process of freezing egg cells, is an example of where automation is hugely beneficial. This process ensures eggs are frozen in a controlled and consistent manner, increasing the likelihood that they will develop into an embryo once fertilised.
The shift from manual to automated systems is also evident in early-stage hormone treatments. In Japan, the development of an algorithm, which measures precisely the dosage of recombinant follicle-stimulating hormone (rFSH) needed to stimulate egg production in IVF patients, has been found to reduce the risk of ovarian hyperstimulation syndrome (OHSS). OHSS is a complication that can occur in patients receiving rFSH, causing abdominal swelling, vomiting and dehydration.
Along with increased automation, AI is increasingly finding use in improving outcomes for patients receiving IVF treatment in the area of embryo selection. Based in Israel, Fairtility has developed an AI-based decision support system, which is able to predict an embryo’s viability. With a patent pending at the World Intellectual Property Office (WO 2022/259028), the system uses artificial neural networks to analyse time-lapsed images of a developing embryo looking for visual indicators, such as size, area, shape, proportion and symmetry. In methods where a single static image is analysed, it can be difficult to identify clear distinctions between states; whereas this system analyses the development of an embryo over a given time frame (e.g. from fertilisation to blastulation) to give a more reliable prediction of its viability. Similarly, the system is able to analyse minute features that a clinician analysing a static image would not be able to detect.
IVF at home
The rapid growth of the femtech market, which is estimated to reach $20.59 billion by2030, has given rise to a number of apps and digital platforms that offer patients more autonomy over their fertility and IVF journey. Some allow patients to track their reproductive health by inputting personal data, which can lead to a more personalised treatment plan. Their data can also be collated with that of others to inform a better understanding of infertility. Other platforms facilitate virtual consultations between patients and fertility specialists, helping to improve clinical efficiency and boost accessibility to specialist services.
Alternative technologies
The recent surge in femtech apps has occurred in tandem with the development of advanced IVF technologies, such as MDT, where nuclear DNA from the mother’s fertilised egg is substituted for nuclear DNA from the donor’s fertilised egg as part of a treatment for mitochondrial disease, a genetic mutation which affects over 14,000 people in the UK.
In vitro gametogenesis (IVG) further illustrates the headway gained by IVF innovators; specialists can genetically programme non-reproductive cells into induced pluripotent stem cells to be manipulated into gametes for use in IVF treatments. From a patient perspective, this technique eliminates the need for hormonal treatment and invasive transvaginal oocyte retrieval. In vitro maturation, the process of maturing an egg in a laboratory before it is fertilised through intracytoplasmic sperm injection (ICSI), also mitigates the risk of OHSS as there is no need to administer drugs to stimulate egg production. Given the many factors that cause infertility, the development of a diverse range of IVF technologies is likely to improve patient outcomes.
IVF in space
Predictions that IVG could one day be responsible for almost all human births sounds far-fetched enough, but it’s nothing compared to the changes that could be yet to come as a result of human procreation in space. R&D company, SpaceBorn United, is leading the way with the development of an unmanned bio-satellite that will carry out the first human IVF procedure in Earth’s orbit. The research initiative, dubbed the Assisted Reproductive Technology In Space (ARTIS) programme, will involve a series of missions before attempting the conception and development of a human embryo in a low gravity environment in 2028. Learnings from this programme could have a significant impact on the future of human civilisation; as well as the advancement of IVF technologies on Earth, the findings could also provide critical knowledge to support human life during the colonisation of other planets.
Patenting IVF technology
Early developments in IVF technology were done largely without IP protection, however, this trend is changing. Predictions that the market is set to grow to $1,280.61 million by 2029 make it all the more important that innovators understand the intellectual property (IP) landscape.
One of the challenges to protecting IP in the IVF market is that not all aspects of the technology are eligible for patent protection and different rules apply in different countries. For example, the European Patent Office (EPO) does not permit patenting of methods that involve the destruction of embryos or use of human embryos for industrial or commercial purposes. Processes for modifying the germline genetic identity of human beings are also excluded from patent eligibility. At the United States Patent and Trademark Office (USPTO), some processes involving the visual monitoring of embryo development have been considered to relate to natural phenomena, which cannot be patented.
Innovators should therefore engage early with specialist IP advisors who can assist with the development of a holistic, commercial strategy. Due diligence is paramount and knowledge of the patent landscape and regulations in different countries will be key to bringing a new product to market. Above all else though, innovators must stay focused on finding new solutions for infertility and improving patient outcomes in this life-affirming area of research science.