As London Climate Action Week gets underway, the conversations dominating the agenda tend to involve renewable energy, carbon markets and sustainable infrastructure. Weight management medication is rarely on the list. Yet the rapid rise of GLP-1 receptor agonists, the class of drugs that includes semaglutide, sold as Ozempic and Wegovy, is beginning to redefine the eating habits of millions of people, and society’s eating habits have profound implications for the planet.

The recent approval of the first oral GLP-1 tablet in the UK removes one of the biggest practical barriers to uptake. With injectable GLP-1s already used by nearly 1.9 million adults in Great Britain, a figure that has nearly tripled in two years, oral formulations are likely to drive adoption to an entirely new scale. As these drugs become more accessible, their wider effects on the food system come into sharper focus.

Eating less, eating differently

It is well established that the most immediate effect of GLP-1 drugs is that users significantly reduce their food intake. A 2024 study from Cornell University found that households with at least one GLP-1 user reduced grocery spending by 5.3% within six months of adoption, rising to 8.2% in higher income households.

However, GLP-1 users are not simply eating less, they appear to be eating differently. The study also showed that the largest spending reductions were concentrated in calorie-dense, processed food categories, including a 10.1% decline in savoury snacks. A 2026 Guardian investigation found that more than half of GLP-1 users described their approach to eating as ‘mindful’, guided by hunger rather than habit. Three-quarters ate less chocolate, and 72% reduced their consumption of crisps. A Danish study analysing over 1.9 million supermarket receipts confirmed the broader pattern: after starting GLP-1 therapy, participants spent a larger share of their shopping on unprocessed foods and a smaller share on ultra-processed foods. Yoghurt was the only food category to record a statistically significant increase in spending.

There is, of course, a legitimate question about cause and effect. People who use GLP-1s are, by definition, engaged in active weight management, and some of the observed dietary improvements may reflect that broader motivation rather than the pharmacological effects of the drug itself. Nevertheless, there is a plausible biological mechanism. GLP-1 drugs have been found to slow gastric emptying and dampen hunger signals in ways that appear to alter the neurological drivers of cravings, particularly for high-fat and high-sugar foods, in a manner that willpower and dietary advice have historically struggled to replicate.

Why ultra-processed foods are a climate concern

The environmental significance of a shift away from ultra-processed foods (UPFs) is considerable. UPFs now account for over 70% of food sold in grocery stores in the UK and US, and represent more than half of total calorie consumption. Research published in Nature Sustainability found that, although UPFs represented just 19% of participants’ diets by weight, they contributed disproportionately to environmental pressures: 24% of diet-related greenhouse gas emissions, 23% of water use, 23% of land use, and 26% of energy demand.

This outsized footprint reflects the full lifecycle of ultra-processing: from extensive monoculture agriculture and high-energy manufacturing to long-distance supply chains and excessive packaging. A longitudinal study published in Science of the Total Environment found that participants who made substantial reductions in UPF consumption reduced their carbon footprint by 0.6 kg of CO₂ equivalent over the study period.

It is also worth noting that UPFs are, to a degree, engineered to undermine the very satiety signals that GLP-1 drugs seek to restore. Ultra-processed foods are known to suppress the effectiveness of key gut hormones — including the body’s own endogenous GLP-1 — that signal fullness, making overconsumption an almost predictable outcome. In that respect, GLP-1 drugs do not merely suppress appetite, they may be partially correcting a cycle of overconsumption that certain food products have, by design, helped to entrench.

The protein question

Were the story simply one of reduced consumption of calorie-dense, processed foods, the environmental case would be relatively straightforward. However, the picture is complicated by a concurrent shift in protein demand.

GLP-1 drugs produce significant weight loss, but a significant proportion of that loss, estimated at between 40% and 50%, can come from lean muscle mass rather than fat. To mitigate this, clinical guidance strongly recommends that GLP-1 users substantially increase their protein intake, typically to between 1.2 and 2.0 grams per kilogram of body weight per day, well above the standard dietary recommendation. The commercial consequences are already being felt. For example, the price of whey protein, derived from dairy, has risen fivefold in recent months as global demand has outpaced supply.

The environmental impact of this protein surge depends heavily on which protein sources consumers are actually turning to. On this point, the available evidence is somewhat reassuring. Multiple consumer surveys and market datasets suggest that GLP-1 users are gravitating away from red and processed meats and towards leaner alternatives: fresh poultry, fish, eggs, legumes, and lighter dairy products such as yoghurt. A study published in Food Quality and Preferences, surveying nearly 2,000 consumers, found that 45% of GLP-1 users reported eating less beef than before starting the medication. The likely mechanism is consistent with the drug’s known effects. By amplifying satiety signals and slowing gastric emptying, GLP-1s appear to make heavy, fatty foods — red meat, cold cuts, hard cheeses — less appealing.

From an environmental perspective, this directional shift is meaningful. Producing a kilogram of beef generates approximately 60 kg of greenhouse gas emissions; a kilogram of poultry generates around 6 kg. Dairy products sit at an intermediate level, though lighter formats such as yoghurt carry considerably lower footprints per unit of protein than hard cheese. Research published in Nature Climate Change has estimated that the worldwide adoption of a diet aligned with the EAT-Lancet planetary health diet, characterised by a shift from red meat towards legumes and nuts as principal protein sources, could reduce global annual dietary emissions by 17%. The dietary changes seen as a result of GLP-1 use appear to be moving in that more environmentally favourable direction.

Where the picture becomes more complicated

The food industry’s response to GLP-1 users has seen the proliferation of ‘GLP-1 friendly’ products, protein bars, fortified shakes, high-protein ready meals, which represents, in many cases, a new category of highly processed food. If users are substituting one form of processed consumption for another, the environmental benefit may be more limited than the headline shift away from snacks would suggest. The sustainability outcome appears to depend critically on whether increased protein density is genuinely replacing excess calorie consumption, or simply creating an additional category of demand.

It is important to position GLP-1-related dietary changes within a broader cultural context. The emphasis on protein consumption has become well established. Notably, the new US Dietary Guidelines, published in January 2026, have inverted the traditional food pyramid to place protein at its base, reflecting a wider societal shift in nutritional priorities. Separating the specific contribution of GLP-1 use from this wider trend is difficult. It should also be noted that most of the available evidence on what GLP-1 users actually eat is derived from consumer surveys and supermarket receipt data, rather than controlled clinical trials, and should be interpreted with the appropriate caution.

A disruption to the food system, not a climate intervention?

It would be overreaching to present GLP-1 drugs as a climate intervention. However, GLP-1 drugs are proving to be an undeniable disruptor of the food system, and one that is growing in scale and likely to grow further as oral formulations reduce the barriers to access. Meanwhile, research published in Nature Climate Change suggests that diet shifts represent one of the most powerful demand-side mechanisms available for reducing food-system emissions. It is clear that the food industry is already responding to the shift in consumer preferences, although whether that translates to a net positive environmental impact remains uncertain.

GLP-1 medications will not, on their own, deliver the scale of dietary transition that climate targets require. However, by reducing appetite for the food products most associated with overconsumption and environmental pressure — and by nudging both consumers and producers towards a greater emphasis on nutritional quality — they may be contributing to a more sustainable direction of travel.

Whether the shift in consumer habits is durable – particularly beyond the period of active medication use – and whether the commercial response from the food industry reinforces or diminishes the potential environmental benefit, remains to be seen. Nevertheless, particularly during London Climate Action Week when there have been numerous extreme heat weather warnings in the capital, it seems that the impact of GLP-1s on society’s eating habits and its wider environmental implications should form a part of the broader climate conversation.

The use of AI across every sector, public and private, is now undeniable – and the CleanTech sector is no exception. However, AI’s growth comes with a big issue. As the International Energy Agency (IEA) put it in its 2025 Energy and AI report, “there is no AI without energy.” Data centre electricity demand rose 17% in 2025 alone, far outpacing the 3% growth in global electricity demand overall, and AI-focused demand specifically is projected to triple by 2030 (IEA, 2026).

Whilst this is a real cost, it is not the whole story. The IEA’s 2025 Energy and AI report is equally clear that, if used well, AI can meaningfully accelerate the search for climate solutions through faster R&D, cheaper experimentation, and more efficient data analysis across energy, industry, and the built environment. The question for the CleanTech sector is not whether to use AI, but how to use it for applications with genuine, measurable climate impact.

This Climate Action Week, we take a look at where AI is already being used for good by spotlighting some of the startups doing exactly that with the support of The Greenhouse, Undaunted’s 12-month CleanTech accelerator, which has supported 180 startups since 2012 and helped its alumni raise over $1.33bn in investment. We’ll also look at why, as AI-driven CleanTech innovation accelerates, a clear IP strategy is becoming essential to turning a good idea into a defensible, fundable business.

AI Innovation in Practice

Utilities and the built environment

In the UK, the energy required to maintain buildings accounts for almost a quarter of the country’s carbon footprint. At the same time, demand for sustainable office space is rising as ESG credentials become a bigger driver of commercial property value. This leaves building owners and facilities teams with a difficult issue: how to retrofit and manage existing stock sustainably, cost-effectively, and at scale.

Carbon Shift, a Greenhouse graduate, is tackling this with AI software that improves decision-making around sustainable retrofits to help building owners identify the most cost-effective and environmentally impactful interventions before committing capital. Cosy Sense, another graduate, has developed a management system (GB2701612A) that gives facilities teams in retail, office, and hospitality settings a single platform for monitoring energy use, with automated controls that let managers act on that data directly to reduce emissions.

Both are examples of AI applied to a hard, high-impact problem. AI isn’t being used as an add on feature but as the mechanism that makes sustainability decisions faster, cheaper, and more confidently taken.

Manufacturing, engineering, and maritime

The maritime sector faces a similar challenge at a larger scale. Shipping is responsible for 3-4% of the EU’s overall carbon dioxide emissions, and although the International Maritime Organisation considers it the least environmentally damaging mode of transport, its sulphur, nitrogen oxide, and carbon dioxide emissions remain firmly in regulators’ sights. The UK’s own Maritime Decarbonisation Strategy targets net zero for the domestic maritime sector by 2050, adding commercial pressure to an already complex engineering problem.

BlueNose, another Greenhouse alumnus, addresses this with AI-driven software that models the cost and emissions impact of retrofitting existing cargo ships, then designs aerodynamic retrofit structures (US2025382031A1) that can be fitted to vessels already in service. BlueNose estimates that, if rolled out fleet-wide across active container ships, its retrofits could cut emissions by 11 million tonnes of CO₂ a year.

What connects Carbon Shift, Cosysense, and BlueNose is that each uses AI as the engine behind a specific, well-defined climate outcome – lower retrofit costs, lower energy waste, lower fuel burn. That specificity matters, both for genuine climate impact and, as we explore below, for what can actually be protected as IP.

Why This Matters for IP Strategy

Despite the potential, AI adoption in the energy sector remains surprisingly low. The IEA’s 2025 Energy and AI report found that only 2.3% of energy start-ups have an AI-related value proposition, compared with 7% in life sciences and 4.3% in agriculture, and roughly only 1% of energy-related patents reference AI as part of the claimed innovation. The Greenhouse alumni therefore seem to be the exception, not the rule.

That gap is an opportunity but it is also exactly the situation in which IP strategy matters most. When a sector is under-exploited, the startups that move first have the clearest run at building a defensible position. As more capital and attention flow into AI-driven CleanTech, that window narrows, and clear, well-drafted protection becomes the difference between a startup that can defend its market position and one that cannot.

AI-driven inventions also raise distinct patentability questions that founders should consider early, including:

None of the above considerations need to slow a startup down. If done early, a review of your IP considerations can be a relatively light-touch process that runs alongside fundraising and product development rather than competing with it. It is also the kind of groundwork that investors expect to see in place before they commit capital.

Climate Action Week is a good moment to look at how far AI-driven CleanTech has come – and Carbon Shift, Cosysense, and BlueNose are a small sample of what’s possible when AI is pointed at a specific, well-defined climate problem. As more startups follow their lead, the firms that protect their innovation early will be best placed to turn that progress into a lasting commercial advantage.


At Mathys & Squire, our team has deep expertise in AI, machine learning, and CleanTech and can assist you with your IP Portfolio. For advice or any questions related to your UK and European patent or design rights, please contact Charlotte Penney, Andrew White, or your usual Mathys & Squire patent advisor.

Partner Claire Breheny has been featured in World IP Review and Retail Times offering insight into the rise in trade mark disputes involving influencer brands and “dupe” products.

Her commentary highlights how growth in the cosmetics sector has led to an influx of new companies and products entering the market. At the same time, the growing appeal of alternative “dupe” products among younger consumers has created additional challenges for brand owners. Claire emphasises the importance of securing appropriate trade mark protection to help prevent and take action against imitations.

Read the extended press release below.


The boom in investment in beauty product sales has helped drive a 31% jump in UK trade mark disputes over cosmetics brands in the last year, jumping to 55 disputes up from 42 in the previous 12 months, shows new research by leading intellectual property law firm Mathys & Squire*.

The sector is a fertile ground for trade mark disputes as major beauty companies launch new products and new cosmetic companies, often backed by social media influencers, proliferate.

Some of the disputes centre around the growth in dupes i.e. cheaper imitations of expensive cosmetics products.

Trade marks give businesses and influencers intellectual property rights over distinctive elements of their brands, such as their name or logo. This helps them take legal action against copycats trying to encroach on their product area.

Actions brought last year include one against an online beauty brand accused of copying Anomaly, the vegan haircare brand founded by influencer Priyanka Chopra Jonas**. Another case brought in the UKIPO was against L’Oreal for applying to register “LUMI SKIN GLOW TINT” based on earlier LUMI formative trade marks.

Claire Breheny, Partner at Mathys & Squire, says: “The growth of the sector has created a very competitive environment with both claims been launched by innovative new brands and by the big cosmetics houses.”

“Many small businesses are selling beauty products on social media that imitate the names, logos or packaging of well-established brands. Fighting against them is much harder without trade mark protection.

“One of the problems that large companies now face is the enthusiasm that younger consumers have for “dupes” which are products that are often deliberate copies of, or at best “inspired by” best-selling products.”

The global beauty market is worth $450 billion and has grown by around 7% annually over the past three years***. Cosmetic products are often seen as resilient as demand for them holds up even during downturns – the so-called “lipstick effect”.

Disputes concerning skincare brands accounted for 24% of cases (13) while those involving make-up brands made up 13% (7). These sectors have attracted growing business interest as viral tutorials on social media boost consumer demand.

Claire Breheny says: “Some small businesses are taking advantage of the boom in interest in skincare to launch copycat brands. Skincare is much bigger category than it was just a decade ago.”

Generally, when demand for specific products rises rapidly and businesses rush to launch new brands, the door is left open for trade mark disputes.”

Disputes concerning haircare products accounted for 20% of cases in the last year (11) while fragrances made up 16% (9). Other categories included body care (4 cases or 7%), nail products (3 cases or 5%) and dental products (3 cases, or 5%).


* Year end 31 October 2025

** The action was brought by Maesa LLC, a beauty brand incubator that partnered with Priyanka Chopra Jonas to develop Anomaly

*** Source: McKinsey – The State of Fashion: Beauty report

In honour of Cervical Screening Awareness Week in the UK, which takes place from 15th to 21st June, we will be talking cervical tests, challenges facing development in women’s health and some practical solutions.

What is a cervical screening test?

Cervical screening, which used to be called a smear test, is a test to check the health of the cervix and help minimise the risks of cervical cancer. All women aged 25 to 64 are invited for cervical screening every 5 years and everyone with a cervix should be offered screening.

The test involves a tube-shaped tool, known as a speculum, being inserted into the vagina, which opens to allow the doctor to see the cervix and collect a sample of cells. Cervical screening checks for a virus called high-risk Human Papillomavirus (HPV). If high-risk HPV is present, then the sample will be checked for cervical cell changes.

Cervical screening is estimated to save around 5000 lives a year in the UK due to early diagnosis of cancerous cells enabling more effective treatment. Despite this, the NHS website states that currently around one third of eligible people do not come forward for their screening.

Why are 1 in 3 women turning down potentially life-saving treatment?

Sânziana Foia, founder of Papcup, for whom we have recently filed a patent application, has spoken  about the historical lack of innovation in certain areas of women’s health which can make life-saving treatment an unnecessarily scary or unpleasant experience for women. After her first cervical screening, she began to wonder if there could be a less invasive alternative to sampling with speculums.

In response, she created Papcup, a self-testing device that detects HPV.  Unlike the tests offered by the NHS today, Papcup is designed to spot high-risk HPV in menstrual blood using bio-sensor technology. The device does not require vaginal insertion and you do not even need to leave the comfort of your own home in order to perform the test. Papcup could provide a viable alternative for women who have suffered sexual trauma, or who are virgins or for any other reason feel uncomfortable about inserting something into their vagina.

Beyond the literal physical discomfort of cervical screening, many women may feel a general discomfort around their sexual and vaginal health. Taboo does not just stop women helping themselves but also prevents the health system and innovation landscape advancing, so that women face barriers accessing the help they need.

Is women’s health taboo?

Historically, the healthcare system has not been inclusive. Men have frequently been treated as the default patient in clinical practice and medical research, and women’s health and healthcare needs have often been marginalised. 

In 1977, the Food and Drug Administration (FDA) created a policy to exclude women of reproductive potential from Phase 1 and 2 clinical trials unless they had a life-threatening condition. It wasn’t until 1993 that the US Congress passed a law requiring the inclusion of women in clinical research.

As recently as 2019, a study by Harvard Medical School showed that women accounted for roughly 40% of participants in clinical trials for three of the diseases that most affect women — cancer, cardiovascular disease, and psychiatric disorders — despite representing 51% of the U.S. population.

Another recent study of the funding of 18 different types of cancers by the National Cancer Institute found that gynaecologic cancers (ovarian, cervical, uterine) ranked 10th, 12th and 14th, respectively, in funding normalized to years of life lost, whereas prostate cancer ranked 1st.

Women of colour face even greater underrepresentation in clinical trials and medical research, which often does not report the intersection of biological sex and race.

Even as technology advances, we see these gender discrepancies prevail. Modern digital health trackers and AI symptom checkers are frequently calibrated against baseline male physiology (heart rates, temperatures). This leaves women at risk of misdiagnoses or inaccurate fitness, heart, and fertility metrics when they are tracked via consumer apps.

This is why digital femtech tools specifically designed to monitor women’s health are so vital. Innovators in femtech are striving to undo centuries of neglect, finally collecting and analysing the data which could give us the answers on how to transform women’s lives.

Problems facing innovators in Femtech and how we solve them

Ignorance and taboo in relation to women’s health penetrates not only the health system, but the investment landscape too. We have seen the potential which femtech has to do what doctors have failed to do for years, but there are barriers to widespread deployment beyond regulatory medical approval.

Femtech investment struggles partly because venture capital is predominantly male. This creates demographic disproportionality, where investors struggle to understand or empathize with female-specific health needs. Additionally, the lack of historical exits in femtech means that, with no precedents to point to, many VCs hesitate to take early-stage risks.

Taboo also seeps into social media and online platforms, negatively impacting investment opportunities. These platforms frequently miscategorise women’s reproductive health content as inappropriate, creating marketing barriers that heavily deter risk-averse investors.

Overall, this leads to a severe lack of funding, with investment in Femtech making up for only around one to two percent of total health tech investment in 2025.

This lack of funding means that treatment in women’s health often lags behind other treatment and as a result women’s treatment is unnecessarily antiquated, invasive and ineffective.

Intellectual property for femtech

At Mathys and Squire, we are excited to work with intellectual property (IP) targeting Femtech and to support the inventors who are making progress in this area. This technology will combat problems facing women’s health, such as the physical and mental discomfort surrounding cervical screening.

In sectors with high rates of innovation, IP is essential for protecting inventions, attracting investment and supporting commercial security. A robust IP portfolio can assist Femtech innovators in obtaining funding by demonstrating concrete assets and the potential for market dominance without the risk of being copied by competitors.


For more information relating to patentability and managing intellectual property, please reach out to a member of our team.

Partner Rebecca Tew has been featured in The Times and World IP Review providing commentary on the increase in trade mark applications that are associated with popular sports game Padel.

The commentary highlights the growth of investment in padel-related brands and the importance of IP protection to help stay ahead in an increasingly competitive market, which has already been demonstrated in a range of categories including raquets, clubs, clothing and more.

Read the extended press release below.


Trade marks filings to register new padel brands in the UK rose 148% to 270 in the year to 31 March 2025, up from 109 the previous year, shows new research by leading intellectual property law firm Mathys & Squire*.

In comparison, only 23 new brands related to tennis were registered over the same period.

The rise in padel brands comes as entrepreneurs and investors move quickly to tap into the sport’s booming growth. The number of people in the UK who played padel at least once in 2025 more than doubled to 860,000, up from 400,000 in 2024**.

Brands that registered padel related trade marks in the past year span a wide range of products and services. These include padel clubs and academies, padel racquet manufacturers, specialist padel clothing brands, a professional padel championship, and even drinks and restaurants with padel-inspired branding.

Rebecca Tew, Partner at Mathys & Squire, says “UK businesses are moving fast to establish brands that stand out in a fast-growing and increasingly competitive market. Securing registered trade mark protection can help them build long-term value into the brands they create.”

“Having a trade mark can help companies protect against competitors trying to encroach on the brand that they have developed and invested in.

“For these businesses securing their name and logo through a trade mark is key, as these are what customers recognise, trust and return to.”

“As the number of padel players continues to grow and spending increases, counterfeiters or competitors might seek to exploit successful brands. Having a trade mark allows businesses to act against these attempts quickly and effectively.”

Businesses are drawn to the higher-income demographic that padel attracts. The sport tends to appeal to urban professionals in major cities, as it can be played in compact spaces in busy areas and matches can be completed in a short time.

Padel has received increasing media attention in recent years, with famous tennis players like Andy Murray and high-profile figures such as Shakira and Cristiano Ronaldo all declaring themselves big fans of the sport.

Trade mark filings for padel have surged in recent years, leaving tennis behind


* Research based on data from the Intellectual Property Office

** Source: LTA Padel, the UK’s National Governing Body for tennis and padel

We are delighted to have been named as one of Europe’s Leading Patent Law Firms by the Financial Times in their 2026 report.

The list highlights IP firms that demonstrate excellence in patent strategy, consultation, drafting, filing and prosecution, and marks the eighth consecutive year that our firm has been included in this prestigious ranking. Featuring in the report reflects our continued commitment to delivering exceptional patent services to clients across a wide range of industries.

In addition to our overall recognition, we are proud to have been recommended in four specialist areas of expertise:

The research process is conducted by Statista on behalf of the Financial Times, gathering recommendations from clients, patent attorneys, in-house counsel and other IP professionals throughout Europe.

We would like to extend our gratitude to all of our clients and contacts who took the time to highlight our firm as part of this year’s research.

To access the full report and rankings tables, please visit the FT website here.

Mathys & Squire is delighted to announce a series of senior promotions across our UK offices.

The promotions reflect our continued dedication to strategic growth as a firm, as well as the value we place on career progression.

In recognition of their hard work, the following have now been appointed as Partners:

In our London office, the below have been promoted to Managing Associate:

In our Cambridge office, two of our Associates have been promoted to Managing Associate:

Martin MacLean says, “It was with great pleasure that we announce these promotions and recognise the achievements and talent of our new Partners and Managing Associates. Their commitment to delivering excellence and dedication to their clients has shone through during their time with us, and we look forward to seeing how they will continue contributing to the success of the firm. At Mathys & Squire, we are passionate about supporting career progression and rewarding hard work, and this is an important step in the firm’s strategic growth.”


These promotions have been covered in Law360 and NewLaw Journal.

Skinny labels are a powerful tool for generic drug companies to avoid infringement of method of treatment/ ‘medical use’ patents after the original drug patent expires, by allowing a ‘carve out’ of the still-patented medical indications. However, as a generic drug is identical to the originator’s branded drug, physicians may prescribe it ‘off-label’ for the carved-out indication. The originator company may then try to sue the generic manufacturer for patent infringement.

The US Supreme Court’s recent decision in Hikma Pharmaceuticals v Amarin Pharma Inc., ruled that generic manufacturer Hikma did not induce infringement of Amarin’s patent.

Read more to learn what this could mean for enforcement of pharmaceutical patents against generics in the US, and how this compares to the approach taken by the UK courts.

Skinny Labels

Pharmaceutical companies can apply for method of treatment/ medical use patents to maintain patent protection for their drug (limited to the claimed medical indications) for years beyond the original drug patent’s expiry date. 

Legal systems aim to create a fair balance between IP protection and market competition; and health systems are motivated to bring down the cost of medicines when possible. 

To try and achieve this balance, generic drugs are allowed to carry a ‘skinny label’ that omits patented medical indications. This ‘carve out’ of patented uses may allow the generic manufacturer to enter the market for off-patent indications before all of the drug’s patents expire.

Hikma v Amarin 2026 – Summary of the facts:

Amarin Pharma developed the drug Vascepa®, which was initially approved by the FDA to treat severe hypertriglyceridemia (SH). Later, Amarin obtained FDA approval and patents for a new method of use of Vascepa®: reducing cardiovascular risk (CV). 

In 2020, Hikma Pharmaceuticals obtained FDA approval to sell its ‘generic Vascepa’ under a skinny label carving out the patented use in CV. Despite Hikma’s skinny label, Amarin alleged that Hikma’s website statements, press releases, and references to its product as ‘a generic version of Vascepa’ effectively encouraged physicians to prescribe the drug for the patented CV indication – i.e., Amarin alleged that Hikma induced patent infringement under 35 U.S Code § 271(b). 

The question discussed before the US Supreme Court became:

Can a generic manufacturer be liable for induced infringement when it uses a skinny label that excludes the patented indication, but other communications allegedly encourage the patented use?

A ‘sheer possibility’ or ‘plausibility’ of inducing infringement?

The US Court considered the relevant legal question to be whether Hikma actively encouraged infringing use for CV – it was not enough for Amarin to assert that Hikma’s marketing material might, ‘passively’ encourage physicians to use the generic drug off-label for this patented indication. In the Court’s view, Amarin failed to plausibly show that Hikma – even implicitly – took the kind of ‘active steps’ to encourage infringement that are required for induced infringement liability.  

This decision is a victory for generic drug manufacturers by confirming the high standard of proof required for originators to pursue induced-infringement claims in the US. Although a skinny label  does not guarantee ‘safe harbour’, a generic manufacturer may be more confident of avoiding induced infringement in the US if they do not ‘actively encourage’ use of the generic drug in patented indications.

How does this compare to UK law?

The current position in the UK is somewhat less clear.

In the UK, the Supreme Court in Warner-Lambert Company LLC v Generics (UK) Ltd 2018 was asked to consider direct infringement of a ‘Swiss form’ 2nd medical use patent. As they found the patent to be invalid, the Court did not need to decide on infringement: the judges made revealing ‘obiter’ (non-binding) comments but did not provide a definitive test for assessing infringement by a skinny-labelled generic drug.

Warner-Lambert v Generics

The 5 UK Supreme Court judges were split between two different proposed legal tests: 1) based on outward presentation of the generic product – including packaging and labelling – whereby a skinny label would avoid a finding of infringement; and 2) based on subjective intent – whereby other factors such as “words, conduct and even inactivity” are assessed to determine whether the generic manufacturer intended to target the patent-protected market.

Therefore, uncertainty remains as to what a generic manufacturer must do to avoid infringement of a patented medical indication in the UK and any future decision is likely to be highly fact-specific. A test based on outward presentation would certainly favour the generics industry but may be unfair to originators where off-label use is widespread. A test based on subjective intent – or even a US-style assessment of ‘active encouragement’ – places a high evidentiary burden on originators but this more ‘holistic’ approach may better reflect some ‘real world’ practices.

Whichever test is applied, it seems that a properly executed skinny label may offer protection from infringement of pharma patents in the US and UK, so long as the generic manufacturer’s conduct does not – even implicitly, or by omission – encourage off-label use of the generic drug for a patented indication.

In honour of Diabetes Awareness Week in the UK, which takes place from 8th to 15th June, we will be taking a closer look at the innovations which are revolutionising treatment.

This article will also discuss the role of intellectual property in the development of medicine and medical devices designed for people living with diabetes, and how companies can ensure they maintain a strong position in the market through their patent strategy.

What is diabetes?

Diabetes is a condition where the body cannot properly regulate the amount of glucose in the blood, leading to high blood glucose (hyperglycaemia) which can harm blood vessels, and limit the flow of oxygen and nutrient-rich blood to the body’s organs and nerves.

The level of glucose in the blood is regulated through the actions of two opposing hormones, glucagon and insulin, which are produced in the pancreas by alpha- and beta- cells, respectively. These cells are found in discrete clusters within the pancreas known as islets. Insulin triggers the absorption of glucose from the bloodstream into cells of many tissues throughout the body including fat, liver, and muscle cells.

Diabetes occurs when the body cannot properly make or respond to insulin. Type 1 diabetes (T1D) is a complex chronic autoimmune disease where the immune system destroys insulin-producing beta cells in the pancreas. In comparison, type 2 diabetes (T2D) is a metabolic disorder, often developing later in life, where the body becomes resistant to insulin or does not produce enough.

How do you treat diabetes?

The number of people with diabetes worldwide is rising and is expected to reach over 850 million by 2050, but tackling the disease remains a challenge.

Diabetes can be managed through insulin therapy, which involves daily insulin injections or use of insulin pumps to continuously deliver insulin to the patient. In 1922, Frederick Banting and Charles Best treated a teenager with T1D for the first time by injecting insulin isolated from dog pancreas. They famously sold the patents on insulin and the method of making it to the University of Toronto for $1 each in 1923. Since these early days of insulin therapy, scientific advances have included the creation of artificial insulin molecules such as short-acting insulin analogues (e.g. Lispro and Glulisine) and long-acting analogues (e.g. Glargine and Degludec) to more closely mimic the actions of normal insulin.

Nevertheless, insulin therapy is not curative and must be combined with the constant monitoring of blood glucose levels to avoid complications such as hypoglycaemia, (a dangerous low blood glucose episode). The need to constantly manage blood sugar can place a serious strain on a person’s daily life, as well as on their mental health.

However, in recent years, research into diabetes has reached a turning point. Scientists are exploring new treatments which tackle the root cause of type 1 and 2 diabetes and fully restore insulin production, leading to a future where people suffering with diabetes may no longer reliant on insulin therapy. Solutions are also emerging which make monitoring and management a lot easier, such as holistic approaches to overall health, and “med tech” device ecosystems integrated with digital AI tools to streamline and automate insulin delivery.

Key focus areas in innovation

The rise of medtech

Advancements in medtech and the digitalisation of healthcare has allowed for more accurate tracking of blood glucose levels in both T1D and T2D patients, as well as the possibility of automatic insulin injections.

For example, implantable continuous glucose monitors (CGMs) enable real-time tracking of glucose levels and can help patients understand how food, physical activity and daily routines affect their blood sugar levels, and make small self‑management changes. Recent innovations in the CGM field focus on sensor chemistry as well as improving sensor accuracy, lifespan and user comfort.

A particularly active area of patenting concerns the integration of CGMs with digital health platforms and automated insulin delivery systems to allow accurate 24/7 control. Entire device ecosystems, known as an “artificial pancreas” or a closed-loop system, may reduce the burden on people with diabetes. These systems combine a CGM in communication with an insulin pump, and a control algorithm to enable the devices to predict and respond to glucose fluctuations without user input. Such systems can also be integrated with machine learning and AI to facilitate the analysis of data and offer predictive insights.

The UK is a global leader in the rollout of hybrid closed-loop systems for people living with T1D. Following years of research and advocacy, the treatment has been offered on the NHS over the last few years and has contributed to the reduction of ethnic and socioeconomic inequality in access to diabetes treatment.

The intersection of integrated digital solutions with drugs has significantly influenced patent strategy, with innovators seeking protection for medical devices, software, predictive AI algorithms, methods for data sensing, calibration, integration and cloud storage, and user interfaces, for example, alongside next-generation therapeutic drugs to cure or modify diabetes.

A curative breakthrough for type 1 diabetes

There is currently no cure for diabetes, but the future may look different. We are seeing a movement beyond insulin therapy towards curative or disease-modifying therapies.

Immunotherapies are a new kind of T1D treatment. In 2025, the drug Teplizumab (also known as Tzield®), was approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for people aged 8 and over. Teplizumab is a monoclonal antibody which modifies the immune system to prevent it from attacking insulin-producing beta cells, and is the world’s first immunotherapy for T1D. It delays the progression of stage 2 T1D into stage 3 T1D, when the diabetes becomes clinical and individuals require insulin therapy; however, it does not prevent its onset forever.

Immunotherapies such as these could be used alongside regenerative medicine, which, in the case of T1D, would repair or replace the beta cells which have been destroyed. This has been shown to be a highly promising pathway towards a cure, but there are still obstacles to overcome.

Islet transplants, involving the transplantation of islets from donor pancreas into the liver of someone with T1D, have been available in the UK since 2008, but are only used for a very small number of people. Donor islets are limited, their quality differs, and patients usually require more than one transplant. Protecting the transplanted cells from the body’s immune system in order to keep them alive and working is a major challenge; transplant patients must receive strong immunosuppressants which increase infection risk and put strain on the kidneys.

Scientists are now working to solve these issues. For example, a recent first in human study showed that gene-edited “hypoimmune” donor islet cells can successfully evade detection by the immune system and continue to produce insulin for over a year post-transplant.

 Stem cell and biomaterials engineering approaches are also being harnessed to produce insulin-producing cells from stem cells, and to protect implanted cells from attack. An ongoing clinical trial in T1D patients is investigating the function of lab-grown, human stem-cell derived beta cells, and has shown promising results with patients restoring natural insulin production following transplantation.

The move to stem cell therapies will reduce the need for organ donors and enable treatments to be more scalable, and preliminary studies are underway to investigate the possibility of using autologous stem cells from the patient themselves to bypass the need for immunosuppressants.

Cell therapies are becoming one of the most important strategic areas in diabetes IP. Patent activity is increasing across the board, covering the engineered cells themselves, methods for genetic engineering and manufacturing of the cells, and devices or compositions for encapsulation and delivery. As the environment becomes more crowded, cell therapies for diabetes could become the next major patent battleground.

A holistic health approach for type 2 diabetes

One evolving class of drugs for T2D work by mimicking hormones that the body releases after eating. For example, GLP-1 is a gut hormone which binds to receptors on beta cells and tells them to release insulin. GLP-1 receptor agonists are a class of medications that mimic the gut hormone GLP-1, enhancing insulin secretion, suppressing glucagon, slowing digestion and reducing appetite. They can help people with T2D reduce blood sugar levels and lose weight, which enhances insulin sensitivity.

The success of GLP-1 therapies has made them a major focus of pharmaceutical innovation and commercial investment. The intellectual property landscape has become highly competitive in recent years, with protection expanding beyond the underlying core molecular chemical structures to encompass delivery devices, dosing regimens, manufacturing processes and combination therapies. Recent commercial successes have further intensified innovation and competition with companies seeking protection for specialised oral formulations and multi-target therapies.

While most GLP-1 therapies require regular and systemic administration through injections or oral dosing, emerging gene therapies aim to provide long-lasting benefits from a single treatment. In a significant milestone, the first-ever clinical trial of a gene therapy for T2D has recently received regulatory approval in Europe. The therapy uses adeno-associated virus (AAV)-based gene therapy to deliver instructions for making GLP-1 directly to beta cells in the pancreas. Unlike conventional GLP-1 therapies, patent protection in this area has focused on vector design, tissue-specific expression systems and promoter technologies, scalable manufacturing processes and methods of delivery.

The benefits of GLP-1 therapies extend beyond blood glucose management. Growing evidence supports that a more holistic treatment approach for T2D by integrating GLP-1 therapy with overall health management, rather than focusing on blood glucose control, leads to 8% fewer cardiovascular events, 7% fewer hospitalisations and 7% fewer bed days, putting less pressure on the healthcare system.

Key takeaways for patent strategy

Maintaining exclusivity and market control grows increasingly important as the diabetes treatment landscape evolves, with opportunities for innovation expanding and changing in nature as competition rises.

Pharmaceutical companies can no longer rely on “core molecule” protection and composition-of-matter patents alone.It is important to have a strong product pipeline with multidisciplinary patent portfolios in place to layer protection, as well as iterative strategies to ensure the protection lasts as long as possible. For example, protection can be extended through SPCs and secondary patents protecting devices, formulations, dosage regimes or additional medical indications. Secondary patents may be just as commercially valuable as the drug itself and secondary filing strategies should be considered early in patent strategy to maximise protection.

In addition, as innovation within diabetes becomes more collaborative, bringing together pharmaceuticals and biotech, freedom-to-operate (FTO) analyses and licensing agreements become more complex. There are many overlapping patent families to consider across a single treatment approach and it is vital to get an idea of the level of competition or any broad patents in the area. To avoid the risk of litigation, early FTO analysis at the very start of a research project and ongoing FTO surveillance is vital, and companies are increasingly leaning towards strategic licensing and acquisitions across key jurisdictions.


Whilst diabetes remains a significant health challenge, we are getting closer to a point where people living with diabetes can become independent from constant management, and from an external insulin source. Diabetes treatment is evolving from a “drug category” into a full metabolic health platform ecosystem, and patent strategy is evolving with it.

For many growing businesses, intellectual property is one of the most important sources of commercial value. It can protect technical differentiation, support brand strength, improve investor confidence and create leverage in licensing, partnership or exit discussions.

Yet, because IP is intangible and frequently misunderstood, it is often managed reactively. Innovations may be discussed publicly or commercialised before protection has been considered. Trade mark gaps may only become apparent once a competitor enters the market. Key contracts with employees, contractors, suppliers or collaborators may be missing, outdated, or signed without properly addressing IP ownership, access rights, and risk allocation.

To bridge this gap and align your commercial goals with legal protection, businesses must take a proactive approach. So, what is an IP audit, and what is the importance of an IP audit for companies looking to scale?

What is an IP audit?

At its core, an IP audit is a comprehensive, systematic review of a company’s intellectual property assets and how intellectual property is managed. It goes beyond a simple administrative list of registered rights. An effective audit assesses the legal validity, commercial alignment, and potential risks associated with your proprietary technology, brands, designs, and trade secrets.

A thorough assessment typically addresses:

Why is an IP audit important?

An IP audit is not just a case of housekeeping; it’s vital for risk management and value creation. The importance of an IP audit can be broken down into two main functions: a snapshot of your current IP position, and mapping out the steps to secure and enhance your IP strategy for the future.

Identifying and cataloguing existing assets

Many businesses do not realise they possess valuable IP until a formal audit brings it to light. For example, a specialised software script, a proprietary manufacturing process, or a proprietary formulation may contain highly protectable innovations. An audit helps you systematically identify and assess these assets, decide how they should be protected, and understand how they may support commercial value

Spotting the ownership and application gaps

Crucially, a robust audit uncovers what you don’t securely own or protect. This is where businesses face the highest risk. A successful audit can reveal gaps such as:

How do you conduct an IP audit?

Conducting an IP audit takes your business from a purely compliance-focused position to a commercial, growth-focused one. But if you’ve not engaged with the process before, you may not know where to start.

If you want your audit carried out to the highest possible standards, our experts can help. We work with businesses of all sizes to identify intangible assets and map out a prioritised IP strategy to help you grow.

As a general overview, the IP audit process looks like this:

Step 1 – Scope and Objectives: Start by defining what the audit aims to achieve. Is it preparing the company for an impending Series A funding round, evaluating a brand expansion into new geographical markets, or assessing a newly acquired technical asset?

Step 2 – Information Gathering: Collate internal information, including product plans, marketing collateral, trade secret records, and key IP agreements. We use digital tools to simplify this process for you.

Step 3 – Legal & Commercial Analysis: Evaluate whether your IP is adequately protected. Are your trade marks registered and in the correct classes? Is there technical evidence, such as comparative testing, prototype results, or performance data, that supports the claimed technical advantage of the invention? Are your trade secrets protected by appropriate confidentiality agreements and access controls?

Step 4 – The Audit Report: A well-run IP audit should produce more than a list of registered rights. It should result in a clear, prioritised report identifying the company’s key IP assets, ownership position, protection gaps, third-party risks, contract issues, confidentiality controls and recommended next steps. The most valuable output is usually a ranked action plan showing what should be fixed immediately, what should be monitored, and where future budget should be allocated.

Once these steps have been carried out, your IP audit should act as a useful reference that the business can maintain as new IP is created or acquired.

Your IP audit checklist

If you’re new to the IP auditing process, here’s a checklist that will help steer your thinking in the early stages of identifying, categorising, and managing your commercial IP:

Align your IP strategy with business growth

An IP audit shouldn’t exist in isolation. But for growing businesses, it’s not feasible to recruit a full in-house IP team.

We’re here to help. Our IP specialists can help you to identify your intangible assets, develop a sustainable strategy to gain market traction, and understand your current IP value to set a benchmark from which to grow.

If you want a clearer view of what IP your business owns, where the risks sit, and which actions should be prioritised, our team can help you carry out a practical, commercially focused IP audit.