Materials are important. They are the stuff that new things can be made of. Whether that’s a functionally coated medical implant, a particularly clear and comfortable ocular device or as part of a system for filtering blood, materials underpin many inventions in the healthcare sector. Within the innovation-driven medical device industry, new materials can significantly enhance device performance, patient safety, and treatment outcomes, leading to competitive advantages. Protecting materials-related inventions is therefore of high importance.

There are a number of requirements for a patent to be granted, not least that the invention to be protected must be novel and inventive. Assuming those hurdles have been met, consideration needs to be given as to how to best claim the invention. Claims determine the extent of protection conferred by the patent and must be clear and concise and supported by the description. They need to adequately define the material(s) that forms the basis of the technology. A patent application must also provide sufficient teaching to enable the skilled person to perform the invention (the invention must be sufficiently disclosed). A thought should also be given to the types of claims in the application – obvious contenders are product/apparatus claims and process (manufacture) claims, but may there also be scope for a method of use claim?

This article will discuss factors to consider when drafting an application protecting materials used in medical devices, with a few examples to highlight some specific challenges.

Claim language

Claims might include functional language, provided that a person skilled in the art would have no difficulty in providing some means of performing the function without exercising inventive skill. That is, they must be able to provide one or more materials that achieve such a function. The claim may specify that a medical device includes a surface layer “for the prevention of microbe growth”, where the skilled person understands this could broadly cover coatings containing, for example, antimicrobial materials such as zinc pyrithione, silver, isothiazolinone treatments, and quaternary ammonium compounds. Specifying the exact materials, or even the class of materials, might be unduly limiting on the scope of protection, whereas functional language can provide broader coverage and can be harder for potential infringers to design around.

However, extremely broad-brush functional language or attempts to define the invention by a result to be achieved are generally not allowed, in particular if they only amount to claiming the technical problem underlying the application. An independent claim should indicate all the essential features of the object of the invention in order to comply with the requirements of Article 84 EPC (G 2/88 and G 1/04).  The extent of the monopoly conferred by a patent, as defined in the claims, must correspond to the technical contribution to the art. If the essential features necessary to achieve the result are not claimed, then third parties are unable to assess whether they are infringing the patent – the claim is unclear. Nevertheless, claims encompassing a result to be achieved may be allowed in certain circumstances[1]. For example, a claim directed to an “effective amount” of an antimicrobial agent “sufficient to substantially inhibit microbial growth”, may be allowed if further defining the amount of the agent would unduly restrict the scope of the claim and the skilled person would be able to directly and positively verify the degree of inhibition of microbial growth.

Alongside functional language, claims typically include structural limitations, defining characteristics that are critical to the material’s functionality or properties. Devices encompassing certain materials may benefit from the specific properties of that material, leading to improved performance and innovation. The mechanisms underpinning that performance might be better understood via advanced characterisation techniques, and parameters derived from those techniques can be used to define the invention. Whilst parameters might give the illusion of precision when compared to functional language, a parameter with an unclear or missing measurement method can be open to different interpretations, making it difficult for a third party to determine whether they are infringing the claim. European Patent Office (EPO) Guidelines require that a measurement method for a parameter is included in the claim itself[2], unless it can be convincingly shown that[3]:

•    the measurement method to be employed belongs to the skilled person’s common general knowledge (e.g., because there is only one method, or because a particular method is commonly used); or

•    all the measurement methodologies known in the relevant technical field for determining this parameter yield the same result within the appropriate limit of measurement accuracy.

Thus, for any parameter that might be measured in different ways, giving rise to different results, caution must be exercised when using the parameter to define the material.

Examiners frequently raise clarity objections to parameters such as “viscosity”, “glass transition temperature”, “molecular weight”, “porosity” and “particle size”, as well as more “unusual parameters” (which might make a comparison with the prior art difficult). Since clarity is not a ground for opposition, opponents typically attempt to show that the unclear term makes the claim so broad as to be anticipated by the prior art, or that the parameter renders the claim insufficient due to an absence of detailed information as to how it is measured.

The description

Sufficiency at the EPO requires that there is enough information in the specification to allow the person skilled in the art, using common general knowledge, to perform the invention over the whole area claimed without undue burden and without needing inventive skill. That is, regardless of whether or not the claim defines the material using parameters, the best practice would be to include a detailed description of the material’s composition, structure, and manufacturing process. Details such as the chemical, physical, mechanical or electrical properties that are critical to the material’s functionality are also important, as well as the conditions that are essential for performance and/or manufacture. Examples can help to demonstrate the features essential for carrying out the invention such that it is apparent to the skilled person how to put the invention into practice[4].

As discussed above, if the measurement method is part of the skilled person’s common general knowledge, it might be possible to omit the technique from the description. For example, in certain subject areas, such as powder technology, the measurement technique for an average pore size or diameter of particles may be extremely common such that the skilled person could put a suitable method into practice. However, even for very well-known parameters, there are limits to the extent that common general knowledge can be relied upon to overcome any deficiencies in the disclosure of the measuring method. A level of uncertainty in the limits of protection might affect the clarity of the claim, but a greater level of uncertainty might make it impossible for the skilled person to carry out the invention and thus compromise the sufficiency of the disclosure.

Effective drafting of the description not only ensures the requirements of sufficiency of disclosure are met, but also that there is a sound basis for future amendment as well as an adequate description of key features to minimise the chance for interpretation disputes in opposition and appeal proceedings. As to the latter, there is a degree of divergence in the case law over the extent to which the description and drawings should be used to interpret claims and a decision on this is being referred to the Enlarged Board of Appeal. The referring Board in T 439/22 stated that “a narrow interpretation of the claim language ignoring a definition giving [sic] in the description would also conflict with a broader interpretation by national courts or the UPC when having to deal with the granted claim later during the live [sic] of the parent”[5]. Given the current different approaches to claim interpretation by EPO Boards, careful thought should be given to the detailed description and how it may be used to interpret the claims (particularly in view of its use by national courts as an explanatory aid for the interpretation of the claims).

Claim types

In addition to claims seeking protection for the new product/material and method of manufacture, claims directed to the method of using the product might be included. If a medical device is applied in a novel and inventive way, it may be possible to patent the new method of using the device alongside patenting any enhancements or modifications of the device itself. Use claims provide an additional layer of protection for novel medical devices and can offer valuable protection when a new use of a known product has been identified. Use claims might cover both non-therapeutic methods as well as therapeutic methods, although care must be taken for medical device-related inventions as Article 53(c) EPC excludes methods for treatment of the human or animal body by therapy or surgery from being patented. The exclusion does not, however, apply to products, in particular substances or compositions, for use in said methods.

The legal framework of the EPO differentiates between chemical/pharmaceutical inventions and medical devices, but the dividing line between what is a substance or composition and what is a device is not entirely clear. In T 2003/08, the Board considered that the “substance” or “composition” must achieve the medical effect and that the terms “substance” or “composition” referred at least to products which were chemical entities or compositions of chemical entities. According to T 1758/15, products that have a chemical “mode of action” are “substances or compositions”. However, the recent Board of Appeal decision in T 1252/20 proposed to define the product in terms of its own characteristics instead of the interactions it may have with the body: a “substance or composition” should include any product that may be defined by its chemical composition, regardless of the mechanism of action of the product in the body.

Following T 1252/20, a broader category of products may be permissible as the subject of second medical use claims. For medical devices comprising novel materials, creative claim drafting might enable protection in the form of a medical use claim directed to the material defined by its chemical composition (avoiding the use of device-like features such as shape or pore-size). Whether a product is a substance or composition, or a medical device will still require a case-by-case assessment. Therefore, it may be prudent to include use claims for products that might previously have been considered medical devices, even if there is a question over whether the material used is a “substance or composition”. The description should include details of the product delivery and its mode of action by chemical means in order to follow the reasoning in this decision, particularly since this area of law remains unclear.

The following case studies look at some examples of challenges that can be faced when claiming materials in medical devices.

Case Study 1 – supporting experimental data/evidence for sufficiency of disclosure

Chemical formulae are infrequently used in the medical device sector, with a preference given to more functional language which may allow for a broader claim.  Nevertheless, a material which may be defined by its chemical formula, can provide a simple and elegant claim:

“A medical implant comprising a biodegradable magnesium-based alloy with a surface layer comprising a magnesium carbonate, characterized in that, the magnesium carbonate has the formula Mg2[(OH)2(CO3)] · 3 H2O.”

The specification provided a detailed description of the experimental conditions required to achieve a magnesium carbonate coating on the magnesium-based medical implant. The specification indicated that different types of magnesium carbonates could form depending on the atmospheric conditions, and included an example with the conditions required to achieve the specific formula claimed (Mg2[(OH)2(CO3)] · 3 H2O). The example allegedly confirmed the presence of the specific magnesium carbonate via an infrared spectrum identifying the coating material.

However, during an opposition, prior art was found to demonstrate that the depicted spectrum did not in fact correlate with that of the claimed chemical formula. The Opposition Division considered that the spectrum did not allow the conclusion that the claimed material was actually obtained in the example, raising the question of sufficiency of disclosure, since the skilled person would be faced with having to perform more experiments to determine how to obtain the claimed formula, a “research program”.

It is thus key, that the specification provides sufficient experimental details required to achieve the claimed chemical formula defining the material and any examples and/or data support this. Patent attorneys and inventors must work closely together to ensure that any examples contain all the conditions needed to achieve the claimed product, and that any data presented in the application confirms the materials are achieved.

Case Study 2 – details and definitions for functional features

Functional language is frequently used to define a material, but difficulties can arise when insufficiency and/or lack of clarity objections are raised, and there are a lack of amendment options in the description.

Packaging material for an ophthalmic lens was defined as absorbing less than a certain amount of the therapeutic agent comprised within the lens it was intended to package:

A blister pack for packaging an ophthalmic lens comprising therapeutic agents, wherein said blister pack comprises a polymeric material that absorbs less than 10% of said therapeutic agents.

Experimental data was provided in the application testing the percentage absorption of a solution of a specific therapeutic agent by specific polymeric materials, defined by their tradenames[6]. The data showed that certain polymeric materials were not suitable. The Examining Division objected that the invention was not sufficiently disclosed across the scope of the claim since the experimental data could not be deemed representative of any therapeutic agent or any class/group of polymeric materials. The Division also objected that the conditions under which absorption of the therapeutic agent was tested, such as concentration of the therapeutic agent, duration of exposure to the solution/material and test temperature, were not specified and no standard test was referred to. Since the test method affected the technical effect underlying the present invention, the absorption of the agent, this further contributed to lack of sufficiency of disclosure. It was objected that the person skilled in the art, using their common general knowledge, was unable to perform the invention over the whole area claimed without undue burden and without needing inventive skill.

Notwithstanding the challenges faced as a result of the lack of experimental details, the application also did not provide basis to define polymeric materials more generally. The definition provided for the general class/group of polymers relied on the glass transition temperature – a parameter, which was not further defined, and no measurement method was supplied.

The functional feature was in the claim as filed and could not be removed without contravening Article 123(2) EPC. However, there was no basis for an amendment to clearly define the class or group of polymeric materials and the application did not contain sufficient detail to enable the skilled person to measure the therapeutic agent absorption. As such, these problems were terminal for the application.

The inclusion of progressive amendment options in the description (e.g., general polymeric material, general class/group of polymers, specific polymers, tradenames) as well as complete details of experimental conditions is therefore important.

Case Study 3 – medical use claims and consideration as to the “substance or composition”

An invention may reside in a new filter apparatus comprising a material for removing a chemotherapeutic agent from blood. Whilst claims directed to a method of using the filter apparatus (below) may be allowable in some jurisdictions, such as the US, they are not in a format permitted at the EPO.

“A method of treating a subject with cancer of the liver comprising:

isolating blood flow out of a vein,

administering a chemotherapeutic agent,

collecting blood laden with the chemotherapeutic agent, and

filtering the blood laden with the chemotherapeutic agent with a filter apparatus comprising an extraction medium comprising activated carbon.”

These types of claims need reformulation before the EPO. Use of the apparatus in filtering blood encompasses therapeutic and surgical aspects, falling under the exclusion of Article 53(c) EPC. One claim format might focus on claiming the chemotherapeutic agent, a “substance or composition”, in a format corresponding to Article 54(5) EPC:

“A chemotherapeutic agent for use in a method of treating a subject with cancer of the liver, said method comprising:

isolating blood flow out of a vein,

administering said chemotherapeutic agent,

collecting blood laden with the chemotherapeutic agent, and

filtering the blood laden with the chemotherapeutic agent with a filter apparatus comprising an extraction medium comprising activated carbon.”

The Examining Division questioned whether the use of the chemotherapeutic agent was novel over the prior art. The Division considered that the difference over the prior art resided primarily in the new filter apparatus, and the use of the chemotherapeutic agent (in treating cancer of the liver) was not necessarily modified or adapted in connection with the subsequent filtering of the blood. As such, the use of the chemotherapeutic agent as claimed was deemed not to be novel or inventive over the prior art: it involved neither a new compound, nor a new therapeutic agent, nor a new treatment regimen[7].

It can be difficult in these circumstances to reformulate such a use claim to capture the medical device. Alternative claim “reformulations” might focus on a claim to the specific use of the new material, the activated carbon:

“Activated carbon for use in a method of treating a subject, said method comprising:

isolating blood flow out of a vein,

administering a chemotherapeutic agent,

collecting blood laden with the chemotherapeutic agent, and

filtering the blood laden with the chemotherapeutic agent with a filter apparatus comprising an extraction medium comprising the activated carbon.”

A question arises as to whether the activated carbon is a “substance or composition” within the meaning of Article 54(5) EPC. It may be possible to completely define the activated carbon in terms of its chemical composition, following the decision in T 1252/20, or even assert that the “mode of action” is a chemical interaction (in line with T 1758/15) between the activated carbon and the chemotherapeutic agent so as to remove cancer cells from the blood of patients. However, if the invention lies in device-like features of the activated carbon, such as shape or pore-size, then it is unlikely that this claim format will meet the requirement for second medical use claims to be patentable.

Key takeaways

A balance has to be struck between providing an adequate and often detailed definition of a material (for clarity and novelty purposes), and retaining a breadth of claim that is harder for potential infringers to design around. For materials-related inventions, this often involves the use of functional claim language alongside structural language, including parameters, to define the material/device. The functional language should relate to clear and easy to measure functional properties so that any alleged infringement can be proven.

Together with ensuring that the patent application provides sufficient disclosure of the invention, the inclusion of detailed definitions, measurement methods and enabling examples in the description can provide options for incremental amendments. This not only gives reassurance at the drafting stage and is critical for obtaining a granted patent, but also provides a patent which can be enforced and defended against challenges.

A patent attorney who specialises in the field of materials science can be invaluable in obtaining a clear, enabled and robust patent capturing inventions relating to materials used in the healthcare sector.

[1] If the invention can only be defined in terms of a result to be achieved, or if defining more precisely would unduly restrict the scope of protection and if the result can be directly and positively verified by tests or procedures adequately specified in the description or known to the skilled person and which do not require undue experimentation (T 68/85).

[2] If the description of the measurement method is so long that inclusion makes the claim unclear or difficult to understand then a reference to the description can be included in the claim instead.

[3] The applicant might submit an expert declaration or experimental data to prove one of these exceptions applies.

[4] A single example may suffice, but where the claims cover a broad field, the application is not usually regarded as satisfying the requirements of Article 83 unless the description gives a number of examples or describes alternative embodiments or variations extending over the area protected by the claims. (Guidelines Part F-III, 1)

[5] Point 6 of the communication of 5th December 2023.

[6] Under the EPO Guidelines Part F-IV, 4.8, the use of trademarks in the claims is not allowed as it does not guarantee that the product referred to is not modified while maintaining its name during the term of the patent. 

[7] The Division specifically considered whether differences arose in: a new group of patients (T 19/86, T 233/96), a new mode of administration (T 51/93), a new dosage (T 56/97, T 230/01) or a new clinical situation (T 384/03, T 1229/03). Differences were found only to relate to the apparatus features.

World Intellectual Property (IP) Day takes place on the 26th of April every year, allowing us to reflect upon the importance of intellectual property in driving innovation and the future of technology.

Each year, a relevant theme is chosen by the World Intellectual Property Organisation (WIPO) as a focus for the celebrations that take place on World IP Day. This year, WIPO announced the theme as IP and the Sustainable Development Goals (SDGs): building our common future with innovation and creativity.

The 2030 Agenda for Sustainable Development was adopted internationally back in 2015, providing shared guidelines on peace and prosperity for people and the planet, now and into the future. The United Nations states that the 17 SDGs are an urgent call for action by all countries globally.  World IP Day 2024 presented the perfect opportunity to highlight the crucial role that IP plays in protecting the innovation and creation that drives us towards the achievement of the 17 SDGs, for the benefit of everyone.

To celebrate, Mathys & Squire hosted a drinks reception in our Shard offices, which involved a fascinating panel discussion on green technology and IP with Martin Atkins (CEO and Co-Founder of Green Lizard Technology), Jim Shaikh (Head of the Greenhouse Climate Innovation start-up accelerator at Undaunted), Jordan Berkowitz (Head of Strategy for Biophilica) and Chris Hamer (Partner), moderated by Michael Stott (Partner). Our panellists discussed various topics related to the green technology sector, including the key challenges in protecting IP rights, effective strategies for commercialising innovations while ensuring sustainability and scalability, investment and partnerships, IP licensing agreements and emerging trends and technologies.

We closed the evening with networking and IP-themed cocktails.

Our team look forward to hosting another event next year!

We are delighted to welcome a new Partner into our Munich office, Dr. Matthias Brittinger.

Matthias brings with him 20 years of experience in the IP field. He joins from Müller Hoffmann & Partner, a boutique IP law firm in Munich. He has a breadth of expertise working across various technologies, including significant experience working on standard essential patents (SEPs) related to telecommunications, processor, and codec technology.

As well experience in SEPs, Matthias has expertise in litigation across various technical fields. He has earned recognition as one of the most reputable Patent Attorneys in GermanyTop of Form in leading German business magazine Wirtschaftswoche.

Andreas Wietzke, Partner in Mathys & Squire’s Munich practice says: “We are very excited to welcome Matthias to Munich team. Bringing in Matthias as a new partner highlights the success and continuity of our Pan-European concept since our Munich office was founded 5 years ago.”

Matthias Brittinger says: “After 10 years as a partner at a German boutique firm, I am happy to be joining a global player in IP.  In particular, I was convinced by the fact that Mathys & Squire can provide IP advice all over Europe as a one stop shop. At Mathys & Squire I’m looking forward to contributing to the firm’s litigation practice and acquisition work.”

Matthias is a German & European Patent and Trade Mark attorney, and a European Design Attorney. He is a member of VPP, the association of IP professionals, and FICPI, the NGO promoting common solutions and advocacy for private IP practitioners. He is also admitted to practice before the German Supreme Court for nullity proceedings.

This release has been published in JUVE Patent, The Patent Lawyer and Solicitors Journal.

In a display of the importance of the biotechnology industry to the European economy, the European Commission (EC) last week announced actions being taken within the EC’s strategy for boosting this industry across the continent. Details are outlined in the official EC Communication on “Building the future with nature”, linked here.

The Communication acknowledges that biotechnology is “a critical technology from the economic security perspective” and is key component to the EU’s strategy toward autonomy and resilience. Thus, the importance of supporting biotech companies is outlined in detail, with welcome acknowledgment that a “supportive” regulatory framework and more financing opportunities are needed for the industry to thrive. The EC discusses a wide range of challenges they wish to work toward addressing, ranging for the complexity of the regulatory framework and associated costs, to expertise/skill access, and even the importance of promoting public acceptance of ‘bio-manufactured’ products.

Streamlining regulatory pathways, including permitting and authorisation

Those interested in the regulatory framework will be interested to note that the Communication includes a dedicated section directed to discussing the “streamlining” of regulatory pathways. The EC recognises the need to improve conditions for moving R&D from the lab to the market, and notes “The Commission will assess how EU legislation and its implementation could be further streamlined to reduce any fragmentation, explore potential simplification, and shorten the time for biotech innovations to reach the market; as well as regulatory obstacles that arise at national or other governance levels which impede an effective single market.”  It is particularly interesting to note that “the Commission will launch a study that will map key current industrial bio-based value chains, analyse the regulatory framework and the impact of relevant legislation, and thereby lay the foundations for a possible EU Biotech Act.”

There is emphasis placed on “targeted simplifications to the regulatory framework”, as well as “streamlining/simplifying approval processes for certain product categories.”

It is helpful to note that the EC has already put some thought into how such reforms could actually be explored/tested, outlining the intention to “promote the establishment of regulatory sandboxes that allow to test novel solutions in a controlled environment for a limited amount of time under the supervision of regulators as a way of bringing more of them quickly to the market”, consistent with the observation that is has already been proposed for “breakthrough therapies under the reform of the pharmaceutical legislation.”

Artificial intelligence and use of data

Those interested in the EC’s response to growing adoption of AI tools across different industries will be interested to note that the Communication includes a dedicated section directed to discussing AI and its use in innovation within the biotech sector. After discussing advances contributed to by AI to-date, the EC goes on to outline “actions to foster the application of big data and AI in biotech and biomanufacturing companies.”   This includes discussion of the GenAI4EU initiative, and how the EC intends on supporting the accelerated “uptake” of AI.

Intellectual property

Although the Communication is not intended to be a focus-piece on biotech patents, (or IP more broadly), the EC do take the initiative to specifically point out the important of IP in the industry, including to new entrants by providing a reminder that IP is “a critical asset which emerging biotech start-up companies can offer to secure financing”. 

As part of the actions discussed in ‘stimulating’ the market, the Communication also recognises that providing “a stable, predictable, and balanced IP framework for protecting and valorising biotech innovation and facilitating access to it, especially to smaller actors across the value chain such as primary producers and SMEs, is crucial for ensuring a vibrant biotech ecosystem in the EU.”

Recognition of changes/additions with the patent system is provided: “The launch of the unitary patent (‘UP’) system in 2023, as well as the upgrade of the current EU regime for supplementary protection certificates (SPCs), proposed in the context of the Commission’s ‘patent package’ of 2023, will support ground-breaking innovation in biotechnology. Innovators across the EU, including in biotech, need to reap the full benefits of these initiatives, therefore the swift adoption of the ‘patent package’ is essential.”

The Commission provides a brief comparison of the leading territories in terms of ‘biotech patent’ filings (USA>EU>CN), indicating that the EC keeps a view on the importance of patent filings in maintaining the EU’s international competitiveness, when compared with other key international players in the biotech space.


It is encouraging to note the EC sees the continued importance in updating its biotech policy, and how important this industry is to society.  Policy makers in adjacent, yet important nations within biotech, (notably the UK and Switzerland), will doubtless wish to keep abreast of the EC’s plans.

Clarivate has issued its list for the Top 100 Global Innovators, 2024, which highlights the companies and research institutions that invest heavily into innovation, allowing them to act as a driving force in shaping their industries.

There are two qualifying hurdles based on inventive activity that entities must pass in order to be recognised in the top 100 list. Innovating organisations must have filed more than 500 patent applications since 2000 and be issued more than 100 granted patents within a five-year evaluation window of 2024. Institutions are then ranked by their international presence and the strength of their invention.

Samsung Electronics tops the list of global innovators

Samsung Electronics leads the list, one of 18 all-time recipients that have retained Top 100 Global Status for the last 13 years. Three companies re-entered the top 100 after a period of absence: Tencent (China), Daikin Industries (Japan), and ZEISS (Germany). Two companies have been awarded Top 100 status for the first time: Coretronic (Taiwan), and Disco (Japan).

Japan maintains its position as the biggest contributor to the top 100 (38 entities), with more than half of those that made the top 10 coming from Japan, operating in sectors such as electronics, computing equipment and automotives. Whilst Japan’s presence is strong, the representation of Japanese companies has not increased since last year. Entities from Mainland China, however, have made marginal gains in this year’s edition. 

Electronics and computer equipment the largest industry sector

Industry segments have also seen an increase in the variety of representation in this edition of the list, following the trend seen in last year’s report. Electronics and computing equipment is the largest industry sector, made up of 26 innovating organisations. Industrial systems saw an increase of 4 representatives, whilst semiconductors (+2), and software, media and fintech (+1), all saw small gains. Representation in the field of chemicals and materials declined (-3), as did industrial conglomerates (-2).

High-tech sectors predicted to lead future innovator rankings

Within the report, it is forecasted that entities within high-tech sectors such as telecommunications and software, media and fintech are expected to improve their rankings within the Top 1,000 Global Innovators ranking. Based on predictions from the top 1,000 organisations, the government and academic research segment is expected to grow, following the inclusion of three institutions from the public sector in this year’s list.

Furthermore, South Korea, Taiwan, Japan, and Mainland China are forecast to improve dramatically in the average organisational Top 1,000 Global Innovators ranking by 2028, commanding the top 4 spots.

Smaller businesses changing the patent landscape

Based on an analysis of the global innovation ecosystem, focusing on the top 1,000, it is evident that the rapid rise of patent activity has seen increased competition, with more activity coming from smaller companies. Clarivate’s findings show that the share of global innovation attributable to the top 1,000 entities is decreasing, going from over 33% in 2016 to 17% today.

With smaller organisations contributing more to new innovation, the landscape is changing. Smaller innovators pose an ever-growing risk to the market share currently possessed by larger enterprises.

Our services

At Mathys & Squire, we work with both large and small enterprises, building close and longstanding relationships with our clients to establish robust defensive and offensive IP portfolios that generate and maximise commercial value in this ever-changing landscape.

Since June last year, patent proprietors have had the option of registering their European patents as Unitary Patents. Instead of having a bundle of national rights, proprietors have the option to maintain a single Unitary Patent right extending across the member states participating in the Unified Patent Court (UPC).

The primary attraction of such Unitary Patents is the lower cost for patent protection, as protection can be maintained across 17 participating member states by filing a single translation with the European Patent Office (EPO) and paying maintenance fees similar to the costs of maintaining protection in four of those countries. The major downside of such Unitary Patents is that they are always subject to revocation in a single court action, whereas if opted-out from the jurisdiction of the UPC, individual national patents can only be revoked on a country-by- country basis.

The EPO has been tracking the uptake of Unitary Patents and according to the EPO  website patent proprietors are choosing to convert around 18% of European patents into Unitary Patents.  The EPO also reports both the technology fields where the greatest numbers of Unitary Patents have been granted and the patent proprietors owning the greatest numbers of Unitary Patents.

As of 1 March 2024, the EPO reported the following as the top ten fields for Unitary Patents and the top ten proprietors of Unitary Patents.

Technology FieldUPs
1Medical Technology2524
2Civil Engineering1267
4Other machines1142
6Digital Communications1095
7Electrical Machinery1022
8Computer Technology919
Technology FieldUPs
1Johnson & Johnson364
2Siemens AG340
3Qualcomm Inc.264
5L M Ericsson241
7Becton, Dickinson & Co.143
9Fraunhofer Gesellschaft122

From the raw numbers, it would appear that the Unitary Patent System has been enthusiastically embraced by tech giants such as Siemens, Qualcomm, Samsung and Ericsson which has led to digital communications being the 6th most common field of technology for Unitary Patents. However, such raw numbers do not take account of the fact that there are far higher numbers of patent applications in some fields than others. When this is considered, a very different picture appears.

Take up of Unitary Patents by field of technology

Scaled by numbers of patent applications in each field of technology, the take up of Unitary Patents in different fields to date are as follows:

Technology fields where Unitary Patents are most popular

Technology fields where Unitary Patents are least popular

(%) Unitary
1Civil Engineering40.0%
3Machine Tools27.7%
5Other Machines25.9%
6Thermal Processes24.5%
7Medical Technology24.4%
8Mechanical Elements23.5%
9Environmental Technology23.5%
10Chemical Engineering23.3%
(%) Unitary
1IT methods6.4%
4Audio visual9.2%
7Digital Communications10.9%
8Electrical Machinery12.4%
9Materials Chemistry12.9%
10Organic Chemistry12.9%

Similarly, when compared with the numbers of patent applications various proprietors filed in 2021 (a reasonable indicator of the numbers of patent applications filed by an applicant each year), the extent to which some of the top Unitary Patent proprietors have embraced Unitary Patents is more tempered as is shown in the table below. As can be seen, in reality, Samsung and Huawei are actually converting a relatively small proportion of their patent applications into Unitary Patents.

ProprietorUnitary Patents2021 ApplicationsRatio
1Johnson & Johnson36486142%
2Siemens AG340172020%
3Qualcomm Inc.264153417%
5L M Ericsson241188413%
7Becton, Dickinson & Co.14329449%
9Fraunhofer Gesellschaft12256422%

Rather, when considering the numbers of patent applications different applicants file, the most enthusiastic users of the Unitary Patent System relative to patent filings appearing in the EPOs top users list, are Align Technology, followed by Pirelli and Vestas (see below).

ProprietorUnitary Patents2021 ApplicationsRatio
1Align Technology5016313%
4Becton, Dickinson & Co.14329449%
6Johnson & Johnson36486142%
8Tata Group9522842%
9Philip Morris10627139%

Notable also are the major patent filers who appear on the EPOs top filers lists, but who have made very little or no engagement with the Unitary Patent System as are listed below.

ProprietorUnitary Patents2021 ApplicationsRatio
4Robert Bosch2212892%
6OPPO Mobile1210571%
9General Electric28710%

Other, notable opt-outs appearing in the EPO’s top 50 patent filers for 2021, who appear yet to have engaged with the Unitary Patent system include: Baidu, 3M, CEA, Dow Chemical, HP and NTT Docomo, all of whom filed between 691 and 461 European patent applications in 2021 and all of whom are yet to register any Unitary Patents.


The picture these numbers paint is a nuanced one.

Historically, around 50% of European patent applications (most typically electronics patent applications) were validated and maintained in UK, Germany and France. A further 40% (often mechanical patents) were maintained in between 4-6 jurisdictions (often UK, Germany and France and along with a selection from Italy, Spain, and the Netherlands) with the remaining 10% of European patents (typically pharmaceutical patents) being maintained more broadly, sometimes (around 2% of patents) much more broadly.

That the fields of technology where proprietors most frequently choose Unitary Patents (e.g. civil engineering, furniture, machine tools, handling & other machines) are predominately in the mechanics field, suggests that to date, the success of the Unitary Patent has been replacing European patents which previously would have been maintained moderately broadly. Presumably, patent proprietors in such fields have been attracted by the potentially lower maintenance costs for such patents.

It is, however, also clear that different patent proprietors, even in the same areas of technology have very different approaches. Some (e.g. Volvo and Pirelli in the automotive field) are enthusiastic users of the new system. In contrast other major filers in the same field (e.g. Volkswagen who filed 459 European patent applications in 2021 and currently have 13 Unitary Patents) have barely used it.

Moving on to the electronics fields, the numbers suggest that some proprietors (e.g. Siemens and Ericsson) are choosing to covert around 15-20% of their European patents into Unitary Patents. However, many others (e.g. Samsung, Huawei & Nokia) are choosing to obtain Unitary Patents at a far lower rate or (e.g. Sony, Microsoft, NTT Docomo) not at all.

The relatively low take up of Unitary Patents in the electronics field relative to the total numbers of patent applications filed in that field suggests that the additional translation costs involved in registering a Unitary Patent compared with maintaining rights solely in UK, Germany and France (where protection can be obtained without filing a translation of a patent) is causing proprietors in those fields to delay embracing the Unitary Patent.

For large companies, a selective approach is entirely sensible. Typical translation costs for a Unitary Patent are expected to be around €5,000 per patent and translation costs will mount up to a considerable sum when a patent proprietor is filing thousands of applications each year.

As the present analysis focuses on the most active users of the Unitary Patent System and the largest filers of European patent applications, the behaviour of smaller companies is harder to discern. However, there are hints that at least some smaller companies are actively embracing the Unitary Patent System. Many of the fields of technology where Unitary Patents are proving popular (e.g. civil engineering, furniture, machine tools, handling & other machines) are fields which tend not to be dominated by exceptionally large filers of patent applications. It is also notable that it is the two smallest patent filers (Align Technology and Pirelli) covered by this study, both of whom filed less than 50 patent applications in 2021, who appear to be converting the greatest proportions of their patent portfolios into Unitary Patents.

Finally, the relatively low take up of Unitary Patents in the chemical and life science fields, would seem to confirm the reluctance of patent proprietors or at least the most frequent patent applicants, in those fields to expose potentially very valuable individual patent rights to the risk of revocation in a single court action. In most cases, this reluctance would appear to outweigh the potentially significant cost savings which the Unitary Patent route affords rights which are broadly maintained across Europe. However, even then, patent proprietors in those fields are converting around 10-15% of their granted European patents into Unitary Patents. 

This year for International Women’s Day, we asked a few of our partners to highlight inspiring female inventors and pioneers that have had a lasting impact on intellectual property (IP). Partners Jane Clark, Helen Cawley, Caroline Warren and Dani Kramer outline the incredible careers and legacies of Sheila Lesley, Kathi Vidal, Anna Connelly and Grace Hopper.

Partner Jane Clark recounts her experience with Sheila Lesley

Partner Jane Clark recounts her experience with Sheila Lesley OBE, one of the ground-breaking examples in the UK of women in IP and the first female President of CITMA, The Chartered Institute of Trade Mark Attorneys.

“My female role model in IP, well there weren’t many around in the UK back then, but in any event it has to be the incomparable Sheila Lesley. Sheila was a pioneer for women in the UK IP profession.”

As set out in the linked obituary, Sheila attended Girton College, Cambridge, specialising in Natural Sciences and Law but decided not to pursue a career in chemical research after being inspired by seeing John Logie Baird, the inventor of television, walking across the golf course in Bude. Instead, Sheila joined Forrester Ketley & Co. (now Forresters IP) qualifying as a UK Chartered Patent Agent (as UK Patent attorneys were then known) in 1953.

“Ours was then a male-dominated profession, so much so that Sheila was the first woman in 29 years to qualify as a UK Chartered Patent Agent (as UK Patent attorneys were then known)!”

Sheila went on to become the first female president of The Chartered Institute of Trade Mark Attorneys and her contributions were recognized with an OBE in 1988.

“I started work as a trainee patent attorney at what was then Forrester Ketley & Co. when Miss Lesley (as we were expected to call her) was already a senior partner. As a senior partner of the firm, she was employing far more women trainees than any other patent attorney firm in the UK at that time.”

“Despite the fact that Miss Lesley focused on trade marks, she always found time to support the female trainee patent attorneys. Indeed, I vividly recall taking a general inquiry call from a “gentleman” who said to me he didn’t want to talk to a girl and would I put him through to a man. I was polite but obviously offended, explained to the “gentleman” that I would transfer the call to one of our senior partners and transferred the call to Miss Lesley explaining before I transferred the call exactly what the “gentleman” had said. Miss Lesley told me later that she had politely told the “gentleman” concerned that we did not want his business. I would still love to know exactly what Miss Lesley said to him!”

Partner Helen Cawley showcases the work of Kathi Vidal

Partner and Head of Trade Marks, Helen Cawley, wanted to highlight Kathi Vidal, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office (USPTO).

“Kathi is clearly a very intelligent lady who is at the top of her profession.  At the same time as being a role model she invests time in others to help them reach their full potential.”

As chief executive of the USPTO, Kathi Vidal heads one of the largest Intellectual Property (IP) offices in the world, with an annual budget of $4 billion and over 13,000 public servants. Kathi was named as one of Managing IP’s top 50 most influential people in IP in 2022.

Attending Binghamton University at the age of 16, Kathi received a bachelor’s in electrical engineering and accepted a position at General Electric Aerospace, (now Lockheed Martin), prior to graduating. During this time her time at General Electric Aerospace, she designed one of the first A.I. intelligence systems for aircraft, as well as aircraft engine-control systems that are still used today.

She has helped to protect intellectual property rights, representing a broad spectrum of companies from start-ups with limited resources to some of the world’s most well-known companies.

Throughout her career, Kathi has shone a light on the importance of mentoring and creating opportunities for women from diverse backgrounds.  She continues this important work today.

Partner Caroline Warren outlines Anna Connelly’s lasting impact on public safety

Partner Caroline Warren wanted to celebrate Anna Connelly, a famous innovator that developed an external metal staircase in 1887, which is considered to be one of the earliest systems specifically designed as a fire escape.

One of America’s earliest female patentees, Anna Connelly’s contributions to public safety has seen her responsible for saving thousands of lives for over a century. She was one of the first women to be granted a patent for an invention after the American Civil War, and revolutionised building safety through her system of exterior metallic staircases and platforms that enabled people to escape a building in the case of a fire.

“Anna’s invention is one of those ideas that seems so obvious after it’s been thought of, but it was a real revolution at the time and has saved countless lives since.”

An extract from Anna Connelly’s original patent (US368816A) describes the logic behind her ingenious design:

“My invention relates to improvements in fire-escapes; and it consists of a bridge surrounded by a railing and having openings in the ends of the floor thereof, as herein described, the said bridge being adapted to be placed on the roofs of adjoining or adjacent buildings, thereby permitting the ready and safe passage from one roof to the other.”

Partner Dani Kramer highlights Grace Hopper’s legacy in computer programming

Partner Dani Kramer wanted to showcase the incredible work of Grace Hopper, a pioneer in computer programming.

“The trailblazing contributions that Grace Hopper made to the early development of computer programming languages and the compiler led to the computing industry as we now know it. “

In 1952, Hopper developed the first ‘compiler’, a computer program that allows written instructions to be translated into computer code.

“What I was after in beginning English language [programming] was to bring another whole group of people able to use the computer easily … I kept calling for more user-friendly languages. Most of the stuff we get from academicians, computer science people, is in no way adapted to people,” Hopper explained in a 1980 interview.

Born in 1906, Grace Hopper graduated from Vassar College with degrees in mathematics and physics, later joining the US Navy following the bombing of Pearl Harbour. She was assigned to the Bureau of Ships computation project at Harvard following an initial rejection due to her age and diminutive size, according to a Yale University biography. This project saw her work on the Mark I, the first US electromechanical computer, calculating rocket trajectories, anti-aircraft gun range tables and calibrating minesweepers.

After the war, she joined the Eckert-Mauchly Computer Corporation, later Sperry Rand, where she pioneered the idea of automatic programming. It was here that she developed the compiler.

Nvidia, the global market leader in computer chips used in AI applications, and CEO Jensen Huang, recognise the importance of Hopper to AI computing and named one of their latest chips after her – the GH200 Grace Hopper Superchip. The company’s H100 chips (H for Hopper) are specifically designed for AI applications, and power generative AI services like ChatGPT.  

A three-day hearing began on Monday 19th February to address an appeal against the initial judgment which concluded that Tesco had infringed Lidl’s trade marks and copyright. Additionally, Lidl has appealed the decision to revoke one of its trade marks.

The Court of Appeal is tasked with determining whether the High Court’s finding that Tesco’s ‘Clubcard Prices’ logo infringed upon Lidl’s logo, both featuring a yellow circle within a blue square (Fig.1), was correct.

Figure 1.

This case covers a range of intellectual property rights, including passing off, trade marks, and copyright. The anticipated decision of the Court is expected to provide clarity on various aspects, notably claims of ‘evergreening’ and issues of bad faith.

Should Tesco’s appeal prove unsuccessful, it will be required to remove the Clubcard logo which has become very familiar across its stores.

As the hearing has now concluded, we eagerly await the decision.

See our previous coverage of the case here.

Mathys & Squire is delighted to announce that our trade mark team has been recommended in the 2024 edition of the World Trademark Review (WTR) 1000 guide. Partners Gary Johnston and Margaret Arnott retain their position as Recommended Individuals, whilst Rebecca Tew features for the first time.

The WTR 1000 directory illustrates the depth of expertise available to clients, serving as the definitive tool for those seeking outstanding trade mark services worldwide. Now in its 14th year, the WTR 1000  has firmly established itself as the definitive ‘go-to’ resource for those seeking stellar trademark expertise and partners worldwide. Mathys & Squire has been recommended for its work in the trade mark field, specifically in the ‘prosecution and strategy’ category. Our “team of experts share their clients’ ambition, passion and entrepreneurial spirit, going above and beyond what is expected when it comes to service delivery.

Alongside our firm ranking, Partners Margaret (recommended in the categories of ‘Enforcement & Litigation’ and ‘Prosecution & Strategy’), Gary (recommended in the category of ‘Prosecution & Strategy’), and Rebecca (recommended in the category of ‘Prosecution & Strategy), have received the following testimonials:

“Margaret is a bright and responsive attorney whose team is very professional and extremely experienced, with expert knowledge of all trademark matters. They handle global trademark registrations with a deft touch and help to successfully resolve any international issues.”

“Gary is a well-respected IP practitioner who provides pragmatic and well-thought-out advice.”

“Rebecca is an impressive practitioner who successfully overcomes challenges and handles opposition proceedings through accurate strategic advice and strong arguments.”

We would like to thank each of our clients, contacts and peers who took the time to participate in the research. For more information and to see the full WTR 1000 rankings, please click here.

Following the Decision of the Administrative Council of 14 December 2023, the European Patent Office (EPO) has announced a general increase in official fees, a year after its last fee increase in 2023. A complete breakdown of the increases is available on the EPO website.

Whilst some fees have been left unchanged, others have undergone modest changes of only about 4%. Most notably the renewal fees for the 3rd to 5th year have jumped significantly, ranging from 8 to 30% increases. Interestingly, the 6th year renewal has actually been reduced (2%).

For more information about the fee increases and how they may affect you, as well as to discuss any potential cost savings, please get in touch with your usual Mathys & Squire attorney, or send us an enquiry.