03/11/2023
The introduction of the contraceptive pill in 1960 gave women economic freedom, sexual liberation and unprecedented autonomy over their bodies. However, over 60 years after this milestone, and given the adverse side effects of hormonal contraception, there is a considerable way to go to improve methods of contraception.
The pitfalls of the pill are well documented; use of hormonal contraceptives increases a woman’s rate of taking antidepressants by 22-25%[1] (80-120% for teenagers), increases female suicide rates by 308%[2], and increases the risk of developing breast cancer by 9% to 38% depending on length of use[3].
A heightened awareness of these risks, coupled with numerous other side effects (migraines, vaginal infections and mood swings to name but a few) is driving women away from hormonal contraceptives. Worryingly, we lack similarly effective, convenient and non-invasive alternatives.
The above analysis reveals an exciting opportunity for innovators to provide non-hormonal contraceptive technologies and upend the contraceptive market. Last year, the UNFPA reported, “nearly half of all pregnancies, totalling 121 million each year worldwide, are unintended”[4]. There is clearly a captive audience and a demand for technologies that provide efficacy comparable to hormonal contraceptives without the hormone-related side effects.
Although investment within the women’s health tech sector has been laggard, the last few years have witnessed considerable growth. As a result of this, the significant opportunities for innovation mentioned above have led to a development boom within contraceptive technology. In such a competitive market driven principally by technological innovation, 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.
In this article, we provide a brief overview of some current innovation in the non-hormonal and male contraceptive spaces.
Cervical Mucus Engineering – Cirqle Biomedical
Cirqle Biomedical is a Danish start-up pioneering cervical mucus engineering as an alternative to hormonal birth control.
Since one of the roles of cervical mucus is to prevent infection, it is impenetrable to foreign cells, including sperm cells, throughout the month. However, around ovulation, hormonal changes trigger a loosening of the mucus, allowing sperm to pass through the cervix and fertilise an egg.
Cirqle have discovered small biopolymers that can alter the microstructure of cervical mucus to make it temporarily impenetrable to sperm, preventing fertilisation. These mucoadhesive polymers were shown to be a 100% effective barrier in efficacy trials in large animals. This was the first demonstration of a novel mechanism of action in female contraception in 60 years.
Cirqle Biomedical have three PCT applications with filings in major jurisdictions worldwide.
Beyond contraception, Cirqle believe that many unmet needs in women’s health could be addressed with a mucus engineering approach. These include infertility, vaginal infections and sexually transmitted diseases.
On-demand Contraceptive Gel – Evofem Biosciences
Evofem Biosciences is a biotechnology company providing over-the-counter products in the feminine health and hygiene space. They have a particular focus on sexually transmitted infections and contraception.
Evofem Biosciences’ main contraceptive product, Phexxi, is a gel which works by maintaining an acidic vaginal pH to decrease sperm motility and prevent pregnancy. It is an on-demand method of contraception, so can be used only when needed.
Vaginal pH levels normally vary between 3.5 and 4.5. The entry of sperm raises the pH, allowing sperm to travel to the uterus. Application of a vaginal pH modulator such as Phexxi, whose active ingredients are lactic acid, citric acid and potassium bitartrate, keeps vaginal pH within the range of 3.5 and 4.5, hindering sperm motility and reducing the chance of fertilisation.
Evofem Biosciences have several granted patents and pending applications towards acid-buffering contraceptive compositions, their manufacture, and an application device. They also have patents and pending applications towards antimicrobial compositions for the prevention and treatment of bacterial vaginosis (BV) and sexually transmitted infections such as HPV.
Male Contraceptives
In recent years there has been noticeable interest in developing male contraceptives. Involving men in the use of contraception allows contraceptive responsibility to be shared, reducing the pressure on women to bear the financial and health-related burdens that typically come with birth control. Furthermore, for some women, health reasons restrict their use of hormonal contraceptives. Clearly, the male contraceptive space is ripe for innovation.
In March 2022, a team of scientists revealed a new non-hormonal male contraceptive that prevents pregnancy in mice, with high efficacy and no obvious side effects. The pill selectively inhibits a protein called retinoic acid receptor alpha (RAR-α). This blocks the effects of retinoic acid, a form of vitamin A that plays important roles in the growth and differentiation of sperm cells. In male mice, daily dosing resulted in sterilisation which was, promisingly, reversible – after stopping the compound, the mice were fertile again after 4 to 6 weeks. Human trials are being planned.
Summary
The social discourse around female health is changing. This is owed in part to the normalisation of conversations surrounding female health and wellbeing, as well as responses to abortion laws in the wake of the Roe vs Wade case. There are notable efforts being made to improve all aspects of birth control, but we must maintain this momentum in the hope that in the next 60 years we can innovate improved methods of contraception.
Inventions can be protected through different aspects. Patent claims can be drafted, for example, towards particular devices, components, methods of production, or methods of use. Having a patent portfolio covering different aspects of a central idea adds significant value and could deter competitors from operating in the same technological area.
Reddie & Grose has a wide breadth of cross-disciplinary experience in drafting and prosecuting patent applications relating to medical devices and digital healthcare related inventions. If you have products in these spaces or particularly the FemTech space, and are looking to obtain patent protection, or would like to discuss this or any of the content of this blog, please reach out to us.
Sources
[1] Skovlund CW, Mørch LS, Kessing LV, Lidegaard Ø. Association of Hormonal Contraception With Depression. JAMA Psychiatry. 2016;73(11):1154–1162.
[2] Skovlund CW, Mørch LS, Kessing LV, Lange T, Lidegaard Ø. Association of Hormonal Contraception With Suicide Attempts and Suicides. Am J Psychiatry. 2018 Apr 1;175(4):336-342
[3] Lina S. Mørch, Ph.D., Charlotte W. Skovlund, M.Sc., Philip C. Hannaford, M.D., Lisa Iversen, Ph.D., et al. Contemporary Hormonal Contraception and the Risk of Breast Cancer. N Engl J Med 2017; 377:2228-2239
[4] “Seeing the Unseen: The case for action in the neglected crisis of unintended pregnancy” (United Nations Population Fund, UNFPA), March 2022.
This article is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking any action in reliance on it.
