Roberta Sher, technical assistant at intellectual property law firm Reddie & Grose LLP discusses the innovation gap in women’s healthcare, and the important IP considerations for start-ups.
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Women are at the forefront of healthcare. They control 80% of all healthcare decisions, and spend 29% more per capita on healthcare than men. However, despite their pivotal role in the healthcare system as consumers, medical professionals, caregivers and decision makers, health issues unique to women have historically been overlooked.
Endometriosis is one such condition that illustrates a clear innovation gap. It occurs when tissue similar to the endometrium – the inner lining of the womb – grows in other places, such as the ovaries and fallopian tubes. Endometriosis affects 1 in 10 women of reproductive age, most of whom will experience chronic, debilitating pain, and carry a greater risk of infertility and certain cancers.
Although it affects roughly the same number of people worldwide as diabetes, endometriosis received just 5% of the funding in 2018. As a result, the past four decades have shown little innovation in the endometriosis field. There is no known cause or cure, and diagnosis takes an average of eight years in the UK, largely because the symptoms, though severe, are non-specific, and endometriotic lesions in the pelvis are not detected on ultrasound. Until now, surgical removal and analysis of the lesions has been required to diagnose endometriosis with certainty.
Reddie & Grose
Roberta Sher
Thankfully, the landscape is changing. Several companies are developing non-invasive diagnostic tests based on endometriosis-specific biomarkers. There have been over 1,100 new patent filings specifically directed towards endometriosis in the last five years, which serves as an indication of rising investment.
Through over a decade of peer-reviewed scientific research, female-led company Dot Laboratories have found that the dysregulation of certain single-stranded, non-coding RNA fragments called microRNAs are associated with endometriosis. Their product, DotEndo, is a blood test that analyses the expression of these miRNAs to reliably and accurately identify endometriosis.
DotLab have a growing patent portfolio that includes three granted US patents, as well as several patent applications pending worldwide. Their granted patents provide commercial protection for methods of preparing the miRNA sample for analysis, and methods of detecting endometriosis based on the expression level of the specific panel of miRNAs by applying a machine learning algorithm to the miRNA expression profile.
French company Endodiag are conducting validation studies on another blood test, EndoDTect, which analyses changes in the expression levels of a combination of biomarkers to detect endometriosis. Their patent portfolio focuses on the in vitro use of anti-CD71 antibodies to identify and eliminate endometriotic cells. CD71 is a receptor present on the surface of all human cells, in numbers that increase with the cell’s proliferative capacity. By binding the CD71 receptor, anti-CD71 antibodies can identify endometriotic cells, which behave a little like cancer cells in the way they proliferate. Endodiag have one granted patent in France, and pending applications in Europe, Japan, and the US.
And it doesn’t end at blood tests – another French company, Ziwig, have built upon microRNA research to develop the first saliva-based diagnostic device for endometriosis. From a saliva sample, the Ziwig Endotest can detect endometriosis based on the analysis of 109 different salivary microRNAs via NGS (Next Generation Sequencing) and AI. It has been validated by one of the largest endometriosis clinical trials, in collaboration with 15 French specialist endometriosis centres.
Filing patents is of paramount importance to protect inventions from being commercially exploited. This is particularly the case for start-ups, where one idea or product often forms the core of the business. Having a granted patent, especially in major markets such as Europe and the US, can also be attractive to potential investors.
As seen above, start-ups can protect their core invention in different ways depending on its nature. Claims can be drafted towards particular components, methods of production, or methods of use. Having a patent portfolio covering different aspects of the central idea can add significant value and make it more difficult for competitors to operate in the same technological area. If a start-up only has one patent, a competitor could successfully challenge its validity and clear the way for their own operations.
DotLab, Endodiag and Ziwig, amongst others, are driving a long overdue paradigm shift in the way we approach and manage endometriosis. In doing so, they play into femtech’s wider mission; to provide actionable technologies that empower women to self-manage aspects of their health and make informed decisions about their bodies.
