Historically, women’s health has been greatly underfunded and under-researched. Nowhere is this gender-biased neglect more evident than in the research and clinical management of menopause symptoms. In response, World Menopause Day, held every year on 18 October, aims to raise awareness of the symptoms and impact of menopause and highlight the options available for supporting those going through the menopause transition.
The World Health Organisation (WHO) defines menopause as “the permanent cessation of menstruation resulting from loss of ovarian follicular activity”.
In the UK, the average age for menopause is 51. However, spontaneous (natural) early menopause affects approximately 5% of the population before the age of 45 whilst premature menopause, defined as menopause before the age of 40, occurs in approximately 1% of women. It has been estimated that over one billion women globally will be perimenopausal or postmenopausal by 2030 and nearly 50 million people are expected to reach menopause each year.
Whilst a natural part of ageing, menopause often has a significant impact on personal, social and professional quality of life. Alarmingly, research from the Fawcett Society indicates that 10% of women have left the workplace due to the symptoms of menopause whilst a 2019 survey found that three in five menopausal people were negatively affected at work.
Classic symptoms of menopause include hot flushes (vasomotor symptoms), mood changes such as anxiety and depressive symptoms, urogenital symptoms including sexual dysfunction, incontinence and urinary tract infections, disturbed sleep, impaired verbal memory and musculoskeletal pain. For many, these symptoms are severe and debilitating. Even those who do not experience severe symptoms are at risk of long-term effects including increased risk of cardiometabolic disease, diabetes, bone loss and cancers associated with increased abdominal fat (e.g., breast, colon and endometrial cancer).
Symptoms are likely underdiagnosed and undertreated. For many, hot flushes are the only symptom they attribute to menopause, meaning that other symptoms are left inadequately managed. Many are hesitant to ask for help in case their symptoms are dismissed by medical professionals as a normal part of ageing.
Nevertheless, pharmacological treatments are available. The gold standard treatment for menopause symptoms is hormone replacement therapy (HRT), which aims to replace hormones lost during the menopause transition (i.e., oestrogen and progesterone). However, patient confidence in the safety of HRT was severely damaged following the publication of the 2002 Women’s Health Initiative (WHI) study and the 2003 UK Million Women Study (MWS) which first linked HRT to increased risk of blood clots and stroke and a small absolute increased risk of breast cancer respectively. The resultant decline in HRT prescribing cast doubt over the commercial returns within the women’s health sector. As such, pharmacological innovation for menopause treatment has largely been limited to novel combinations of oestrogen and progesterone (e.g. synthetic or bioidentical forms) and formulations optimised for different routes of administration (e.g., oral tablets, patches, suppositories, gels or sprays).
More recently, interest in the menopause market has been piqued by the success of novel nonhormonal therapies such as fezolinetant. This next generation of therapeutics stems from the research of neuropathologist Prof Naomi Rance, who identified a specific group of neurons in the hypothalamus (a part of the brain that controls body temperature) that become overactive and enlarged in the brains of menopausal people. However, whilst fezolinetant has been approved by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) and is currently available via private prescription, it is not yet available via the National Health Service (NHS).
Faced with “medical gaslighting” and a dearth of suitable therapeutics, tech-savvy women are increasingly taking matters into their own hands and turning to technology to ease their menopause symptoms; the result being a boom in the FemTech (“female technology”) industry and rich pickings for innovators.
A notable example is Vira Health’s Stella app, which aims to provide a personalised treatment plan (for example, cognitive behavioural therapy, sleep scheduling, pelvic floor exercises) based on specific symptoms, machine learning, and lifestyle preferences. Devices aimed at relieving the symptoms of hot flushes include the Menopod, which was featured on an episode of Canadian Dragons Den, and the Thermaband Zone.
In such a rapidly growing market, innovators would be wise to develop a strategy for protecting and exploiting their intellectual property at an early stage. If in doubt, your patent attorney will be able to guide you.
Mathys & Squire have ranked in the 2025 Chambers and Partners UK Legal Guide, which acknowledges some of the top ranked law firms and lawyers each year. The research analysts obtain information through one-to-one interviews and investigation.
We are delighted to announce that Mathys & Squire have maintained our ranking in the Chambers and Partners 2025 guide.
Chambers state:
“The Mathys & Squire team are able to handle complex and sophisticated matters with extreme competence and professionalism in a timely manner.”
“Mathys & Squire are always responsive and apply very high standards to get to the final product. They are nothing short of outstanding.”
“Mathys & Squire combines good technical patent work with pragmatism and successfully leverages technical and industry knowledge.”
Amongst the team, Partner Martin Maclean has also been ranked as a Band 1 Patent Attorney, acknowledged for his work as an “outstanding patent attorney.”
For more information on the Mathys & Squire rankings, visit the Chambers and Partners website here.
In a much-anticipated decision, Technical Board of Appeal 3.3.04 has held that there is no requirement under the EPC for an applicant to amend the description of a patent application before grant (T 56/21). This case is the latest in a developing line of decisions from the EPO’s Technical Boards of Appeal to go against the Office’s long-standing practice of requiring amendments to the description before grant for consistency with the claims.
Of particular interest, the Board declines to refer questions to the Enlarged Board of Appeal which could help resolve this issue, despite having indicated its intention to do so earlier in appeal proceedings. In a detailed decision (running to 90 pages), the Board concludes that a referral is unnecessary, among other things because of recent developments from the Court of Appeal of the UPC and because it views the EPO case law as “evolving” rather than divergent. Ultimately, the Technical Board takes the view that “[t]he wording of Article 84 EPC as well as its context leave no room for requiring, in examination, that the description be adapted to allowable claims to match their subject-matter.” The Board takes the clear view that Article 84 is a requirement to be met by the claims and cannot impose any conditions on the content of the description. Rules 42, 43 and 48, which have previously been suggested by some as a legal basis for requiring description amendments, are also dismissed.
A notable feature of the decision is that the Board sees a clear separation between the assessment of claims for compliance with the clarity and support requirements under Article 84 EPC on the one hand, and on the other hand the principles governing the interpretation of those claims post-grant under Article 69 EPC to determine of the extent of protection which they confer. The Board concludes that Article 69 EPC has no relevance in grant proceedings, and criticises the EPO’s current practice as “encroach[ing] on the competence of national courts and legislators” in seeking to use description amendments to “reduce the variability in the determination of the extent of protection of a patent … and to arrive at a more “harmonised” determination of the extent of protection”. Given that the relevance of Article 69 is already the subject of a pending referral to the Enlarged Board (G 1/24), it seems surprising that the Board in this instance has reached such an unequivocal conclusion. This suggests that the Board in the present instance might be seeking to influence that debate, and raises a question as to whether its view on description amendments might change if the Enlarged Board does not see such a clear separation between the rules for claim interpretation pre- and post-grant.
This decision provides applicants with further legal support for refusing an order to amend a description before grant, but it seems unlikely that the EPO will change its Guidelines or its practice unless and until a referral to the Enlarged Board is eventually made on this topic.
In a surprise move, the representatives acting on behalf of UC Berkley defending CRISPR patents in appeal proceedings before the EPO have withdrawn their approval of the texts of the patents thereby revoking them and bringing the appeal proceedings to an end. When doing so, the representatives justified the withdrawal referencing “serious procedural concerns” arising from the Board of Appeal handling of appeal T2229/19, a decision Mathys & Squire are seeking to reverse through an application for Petition for Review.
In T2229/19 a Board held as inadmissible a request to delete two dependent claims solely on the grounds that although the deletion would have addressed all the objections considered so far, the deletion would not prima facie overcome the Board’s preliminary opinion on a different, yet to be discussed issue, namely sufficiency of disclosure.
In the CRISPR appeal, UC Berkely’s representatives concluded that given that the chairperson and rapporteur in their appeal were also members of the Board in T2229/19, the risk that the Board would adopt a similar approach in their appeal was such that the Patentees could not “be expected to expose the Nobel-prize winning invention protected by the … patent[s] to the repercussions of a decision handed down under such circumstances, when other members [of the patent family were] still at a stage where the Patentees [could] ensure that they [would] ultimately be fully heard on all substantive issues.”
It is highly unusual for a patentee to withdraw their approval of the text of a patent during appeal proceedings and accompany such a withdrawal with an expansive statement as to why a patent is valid and why the patentees have concerns about the expected handling of a case by a Board of Appeal.
It could well be that UC Berkley were merely providing cover for a withdrawal which will significantly delay the EPO making a final ruling on the validity of a patent. Certainly, that was the view of the representatives of the opponents who described the withdrawal as “a transparent move to avoid any possibility of an adverse decision” which they claimed was “justified by a (spurious and hypothetical) concern about the future conduct of the Board.”
However, if UC Berkley’s concerns are to be taken at face value, they raise serious questions about the EPO Boards of Appeal and in particular the Rules of Procedure which were introduced in 2020.
Those Rules of Procedure sought to emphasise that EPO Appeals should be restricted to a review of the proceedings at first instance and reduce the extent to which new matters might be raised on appeal. However, it is evident, that in some areas this has led to inconsistencies in approach. In our Petition for Review we noted that two distinct approaches [1] to the deletion of dependent claims during appeal proceedings (neither of which had been followed by the Board in that case) had arisen.
UC Berkely noted that our Petition for Review against T2229/19 could be pending for quite some time. Although the Petition for Review procedure was intended to be as simple and short as possible and prior to 2020, Petitions for Review were typically resolved in around 10 months, evidently that is no longer the case as was clearly demonstrated with the four-and-a-half year time period taken to resolve the Petition for Review in R1/20 which was finally resolved in July this year.
In the meantime, even though a Petition for Review is pending against it, T2229/19 serves as a potential precedent to be followed in other EPO Appeals and indeed recently another EPO Board of Appeal in T172/22 referred to T2229/19 as a precedent for refusing to allow claims to be deleted during appeal proceedings.
When Board of Appeal decisions result in the filing of Petitions for Review and cause the withdrawal of high-profile appeals, the apparent inability of the EPO to rule on such Petitions in a timely manner is very concerning.
[1] T1480/16 vs T1224/15
We are delighted to announce that Mathys & Squire has upheld its position in the 2025 edition of The Legal 500 for both PATMA: Patent Attorneys and PATMA: Trade Mark Attorneys categories.
Patent Partners Chris Hamer, Alan MacDougall, Martin MacLean, Jane Clark, Paul Cozens, Dani Kramer, Philippa Griffin, James Wilding, Sean Leach, James Pitchford, as well as Alexander Robinson, Peter Arch, Laura Clews, who are newly ranked, are all featured in the 2025 edition of the directory.
Mathys & Squire’s trade mark team has also received recognition in the directory. From our trade mark practice, Partners Margaret Arnott, Rebecca Tew and Gary Johnston, and Helen Cawley who is listed, and Managing Associate Harry Rowe, have been ranked.
The firm received glowing testimonials for its patent and trade mark practices:
”M&S have a very deep technical and legal experience that covers areas very relevant for green carbon sequestration technologies. They also have representation in key markets in Germany and the UK, which makes it very relevant. The team work very well together and drafted in a quick time period our patent application.”
”M&S team of IP experts provides unparalleled knowledge and experience in all areas of intellectual property, including patents, trademarks, design protection, and litigation. The firm’s versatile team of attorneys, scientists, and strategists possesses deep experience navigating complex IP landscapes for high-growth, technology-driven industries.”
”The Mathys & Squire team have been excellent in providing focused and pertinent advice on tricky issues and have shown considerable technical and commercial ability in fintech patent issues.”
”From my first call till today, I have seen a kind and professional approach from Mathys & Squire. Despite my language barriers, their patience and understanding makes me feel comfortable and confident through the communication process. I have worked on two patent applications with them in the last year.”
“The entire team at Mathys & Squire is very professional, welcoming and very patient. We pose some difficult issues sometimes and we always get a prompt, detailed response which enables us to take a final decision with the client. We are very pleased both professionally and administratively.”
“I’ve worked with Mathys & Squire for the last 15 years. They mostly deal with our patent work and some design registration. I’m impressed with the way they deal with all our patent office issues. On a personal level, they are easy to work with and, when we write new patents, they make the process straightforward and painless.”
“I have not found any scientific area of focus where [the] team aren’t comfortable. The Mathys & Squire team do excellent legal work for us and are always on the lookout for information that will help further our understanding of European legal issues.”
”Paul Cozens demonstrates a masterful grasp of the subject area and is solution driven to problem solving.”
”Alan MacDougall has been my trusted business partner for more than 10 years. Alan is diligent person who provides helpful, accurate, and timely answers to questions that are unclear for us. Alan has a wealth of knowledge and experience in the intellectual property field and his useful and appropriate advices has always been of great help to us. We look forward to working with him to further expand our business.”
“If intellectual property is or could be important to your business, and you want to be assured of the best possible advice, then look no further than Mathys & Squire and Dani Kramer in particular, you will be hard pressed to find any better.”
”Sean Leach is technically and legally competent, approachable and responsive.”
“The trade mark team is supportive, available, and interested in supporting the business to grow.”
”Gary Johnston has oodles of experience and is sensible and commercial.’
”Harry Rowe is fantastic and really helps us to secure trade marks and to pursue other IP protections. Harry has integrity and is genuinely interested in our business, which is a tech-start with ambition for global growth and societal change. He gets the importance of the latter also. He helps us to map a pathway forward to support our business to grow.”
”Harry Rowe has excellent communication skills, often having to translate complicated legal agreements for me in a way that I will understand them. He makes sure to get a very clear understanding of what’s unique about our business and can think laterally to identify issues that might become an issue for us in the future.”
For full details of our rankings in The Legal 500 2025 guide, please click here.
We extend our gratitude to all our clients and connections who participated in the research, and we extend our congratulations to our individual attorneys who have earned rankings in this year’s guide.
Managing IP have released their guide for the 2024 IP Rising Stars, which recognises the best up-and-coming practitioners across several IP areas and more than 50 jurisdictions. Each year, the research analysts obtain information through firm submissions, research data and feedback to identify the IP Rising Stars.
We are delighted to announce that Partners Edd Cavanna and Max Thoma and Managing Associate Harry Rowe have been named as 2024 IP Rising Stars.
Alongside IP STARS, Managing IP annually identifies professionals who have demonstrated excellent practice on behalf of their firm, making it a commendable award.
For more information on the Mathys & Squire rankings, visit the IP Stars website here.
Partner Nicholas Fox has been featured in the ‘’This is a big problem’: The CRISPR controversy and the ‘mess’ at the heart of the EPO’s appeals boards’’ article by Sarah Speight published by WIPR and LSIPR discussing a request by CRISPR scientists to withdraw their patents over allegations of mishandling by the EPO’s Board of Appeals has thrust a ‘’fundamentally unfair, uncertain system’ into sharp focus.
Here is a short extract from the articles:
‘’…It’s seriously unusual for one set of patent attorneys in another set of proceedings to refer to another case in the way that they have done,” says Mathys & Squire partner Nicholas Fox, who filed the Ipsen complaint…
….”The fundamental issue here is discretion,” he adds. “It’s the discretion of the board, and it’s causing [problems], particularly for amendments or later amendments’’…
This article was first written for and published in WIPR and LSIPR on 27 September 2024. Please visit WIPR and LSIPR to read the full articles.
The UK remains highly ranked in terms of global innovation, but is the UK’s science and technology scene missing a trick when it comes to optimizing value for their innovations through international patent protection?
The World Intellectual Property Organization (WIPO) recently published the 2024 edition of its annual report of the Global Innovation Index, ranking world economies on various metrics considered pertinent to fostering innovation. Although the UK was overtaken by Singapore in this year’s edition, it remains highly innovative at a respectably 5th overall rank. Switzerland, Sweden and the United States maintain their top three overall ranks of the 2023 edition.
A recent report by the Chartered Institute of Patent Attorneys (CIPA), based on the 2023 edition of the Global Innovation Index, has however highlighted the UK’s relatively lower ranking on metrics related to international patenting activities. The UK ranks 19th and 20th in the number of multi-jurisdictional patent family filings and in the number of PCT application filings, adjusted for purchasing power parity GDP, respectively. This is well below the economies ranked higher overall in the Global Innovation Index (i.e. Switzerland, Sweden, the United States and Singapore), and is also behind comparable economies such as Germany, France, the Netherland, South Korea or Japan.
The benefits of geographical diversification over a patent strategy focussing only on a single country can be significant. Protection in several key jurisdictions allows increased value to be derived from a patent portfolio, be it in the form of a competitive edge in a larger overall market or in the form of increased revenue obtained by licensing patent rights across different regions. Competitors are deterred more effectively from challenging a patent in view of the increased potential costs and legal risks of multi-jurisdictional litigation. In addition, investors may place increasing value on multi-jurisdictional patent families, thus elevating the valuation of a business.
Why British businesses, despite their high capacity for innovation, pursue international patent protection at a lower rate than businesses in competitive economies remains an open question. CIPA’s analysis shows that the lower number of overseas filings by UK applicants may well be attributed to lower rates of filing at the European Patent Office (EPO) and in China. Given that EPO member states and China make up a significant proportion of British export markets, these lower rates of filings are surprising.
Ultimately, the number of jurisdictions in which to pursue patent protection remains a business decision. While it is not pragmatic in most technology areas to file in tens of jurisdictions, a focus on several key jurisdictions may elevate the value derived from innovation and ensure that business interests are well protected in an increasingly globalized economy.
An article by Partner Andrew White and Associate Jessie Harrison has been published in IAM Magazine giving insight on why the UK patent system needs an overhaul to better accommodate AI-related innovations and foster a more conducive environment for technological progress.
Artificial Intelligence (AI) is driving innovation across a host of industries, from healthcare and finance to transportation and entertainment. However, the UK’s patent system seems to be struggling to keep pace with these rapid advancements. As the innovation landscape changes, this article will explore why the UK patent system requires an overhaul to better accommodate AI-related innovations and promote a more conducive environment for technological advancement.
The global artificial intelligence market size is expected to grow twentyfold between 2021 and 2030, from about USD 100 billion in 2021 to nearly USD 2,000 billion in 2030 (Statista 2023). In order to position the UK as a global centre for AI and data-driven innovation, it is important to ensure that the UK can provide the best environment for developing and commercialising AI technologies.
This article, first written for and published in IAM Magazine on 31 August 2024, considers the current ambiguity in UK patent law and its competitive disadvantage from a global perspective. To read the full article, click here.
Commentary by Partner Nicholas Fox has been featured in Law360, Global Legal Post, World Intellectual Property Review, Managing Intellectual Property, Commercial Dispute Resolution, Solicitors Journal, discussing the Unified Patent Court’s (UPC) decision to grant Mathys & Squire’s access to evidence in a Unified Patent Court case between Astellas and Healios.
Read the extended press release below.
Background
Mathys & Squire, the intellectual property law firm, had brought a test case to try and improve the transparency of the operations of the UPC. Previously commented on the following articles:
In recent decisions the UPC had been restricting the access of third parties to pleadings and evidence in UPC cases that should have been accessible on request.
The principles of openness and transparency in Court proceedings and the rights of third parties to access public documents are well established principles in International and European law.
The UPC is a new court system (just over a year old) which will have the power to enforce patents across much of the European Union.
Comments from Nicholas Fox, Partner at Intellectual Property Law firm Mathys & Squire: “We are delighted that the Unified Patent Court has finally granted our request to access the pleadings in this case.”
“However, the way in which our request has been processed still raises significant concerns about the UPC commitment to transparency and open justice.”
“It has taken more than 8 months for the court to process our request. The exceptionally slow processing of the request has delayed our access until after the underlying case was settled.”
“The Judge-Rapporteur has previously stated an intent that the access request would be processed “expeditiously” as soon as an appeal relating to another document access request had been concluded. Those appeal proceedings concluded on 10 April and yet the Court has taken more than 4 months to process our application and issue a decision granting our access request.”
“So far, the UPC has yet to grant access to written pleadings and evidence in a case prior to an underlying matter being concluded.”