In the second of a series of articles for IBI Journal, Mathys & Squire partner Anna Gregson, who specialises in biotechnology, provides an overview of some of the key applications of cell therapies as well as a closer look at the challenges facing the evolution of this field.

The achievements of cell-based therapeutics over the last decades have bolstered efforts in recent years to bring more of these products to market and across an ever more diverse range of applications. These advanced therapeutics offer promising potential to treat conditions which, to date, have defied traditional treatment modalities. Interest and investment in this sector is at an all-time high and whilst many are hopeful of a boom in the number of approved therapies in the coming years, the industry still faces significant challenges, particularly with regard to the manufacture and regulation of these cell-based products.

To date, the applications of cell therapies have largely fallen into two broad categories; tissue regeneration and immuno-modulation. With regard to the former, cell therapy has been viewed as one of the most promising techniques for the repair of damaged tissue, with applications in cardiovascular disease, neurodegenerative disease (for example, Parkinson’s and Alzheimer’s), musculoskeletal injury or degeneration and endocrine dysfunction (for example, type I diabetes).

Cell therapies have proven particularly effective in the repair of articular cartilage, for which the intrinsic capacity for repair is low. The most established of these therapies have employed the patient’s own cells, i.e. autologous cells. In brief, harvested chondrocytes are expanded ex vivo, seeded into a collagen matrix and then re-implanted into cartilage defects in joints. Such products have been available for around a decade now (ChondroCelect, developed by TiGenix was first approved in the EU in 2009) and have shown considerable efficacy, although use of these advanced options is still low when compared to traditional treatment modalities (for example, joint replacement and analgesics). Whilst cartilage repair applications have tended to employ the terminally differentiated chondrocyte, bone repair applications have made use of the regenerative capacity of stem and progenitor cells.  Bone marrow derived mesenchymal stem cells (MSCs) have been proven in a range of orthopaedic applications over recent decades, including in the treatment of infants with osteogenesis imperfecta and in the repair of non-union fractures. Unfortunately, obtaining sufficient yields of pure MSC populations from bone marrow has proven difficult and there has been a switch in recent years to utilise MSCs derived from other sources, such as adipose tissue.

Autologous cell therapies like those discussed above all depend on obtaining sufficient cell numbers from the donor patient and the ability to expand functional cells ex vivo. Off-the-shelf cell therapies, which clinicians can employ for a range of patients, as and when needed, without concerns over yield or expansion protocols, are likely to represent the future of cell therapy. UK based biotech, ReNeuron is one such company forging ahead with allogeneic cell therapies. Interestingly, ReNeuron’s neural stem cell line for the treatment of the disabling effects of stroke were cryopreserved prior to utilisation in the PISCES I (phase I) clinical trial. Cryopreservation is just one of a number of advancements which will be necessary to bring off-the-shelf cell products to reality.

Whilst the regenerative applications of cell therapies have, at the very least, been researched for some time now, the immuno-modulatory applications of cell therapy, in particular, chimeric antigen receptor (CAR) T cells, is a more recent development. Indeed, it was only in the early 90s when first generation CAR T cells (which contained an antibody/T cell receptor fusion molecule) were developed and around the same time researchers were investigating adoptive transfer of patient derived virus-specific T cells. Since these early days, significant leaps forward have been made. In 2017, Novartis’ Kymriah (tisagenlecleucel) became the first CAR T cell therapy to be approved by the FDA, with Kite Pharma’s Yescarta (axicabtagene ciloleucel) following shortly thereafter. Data from the UK’s Cell and Gene Therapy Catapult clinical trials database indicates that there were around 22 clinical trials investigating the safety and efficacy of CAR T cells in the UK alone in 2018. The success of CAR T cells to date has largely been shown for haematological malignancies (indeed, Kymriah and Yescarta are approved for the treatment of acute lymphoblastic leukaemia and large B-cell lymphoma respectively). In contrast, despite extensive research, CAR T cell therapy for solid tumours hasn’t had the same impact, not least because of the challenges of targeting solid tumours including identifying a suitable target antigen and homing the cells to the hostile, tumour microenvironment. Nonetheless, strides are being made by combining CAR T cell therapy with other biologic agents, specifically checkpoint inhibitors such as pembrolizumab and nivolumab which target programmed cell death protein 1 (PD-1) a key regulatory protein found on T cells. The University of Pennsylvania, for example, is recruiting for a phase I clinical trial assessing the safety of a CAR T cell/pembrolizumab combination therapy for the treatment of glioblastoma. This follows preliminary evidence from the Memorial Sloan Kettering Cancer Center that showed both safety and efficacy of a mesothelin targeting CAR T cell and pembrolizumab combination therapy in patients with malignant pleural disease. Thus, the use of CAR T cells for the treatment of solid tumours appears to be progressing.

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Immuno-modulatory cell therapies other than CAR T cells are also being investigated in the clinics. By way of example, Fate Therapeutics is currently assessing the safety of its off-the-shelf Natural Killer (NK) cell therapy. Unlike traditional CAR T cells, Fate’s NK cell therapies are derived from an induced pluripotent stem cell (iPSC) line allowing the production of large numbers of well-defined cells without relying on a patient’s own immune cells (which are often depleted in many cancers). Preclinical studies showed the efficacy of these cells in the treatment of checkpoint inhibitor resistance tumours. At present, Fate has a pipeline of at least five different NK cell therapies.

As well as the immuno-oncology applications, cell therapies are also being trialled for immuno-regulatory applications such as for in the treatment of autoimmune disease and graft versus host disease. These trials have largely involved the use of autologous, expanded, regulatory T cells (Treg cells) which, through a range of mechanisms, are able suppress a variety of immune cells. Treg cells used in studies to date have been isolated from both umbilical-cord blood and peripheral blood. A variety of phase I studies have been completed or are in the process of assessing the safety of Treg cells for the treatment of type I diabetes. Although in the early stages of development, data to date is showing that Treg cells are well tolerated in patients and the ex vivo expansion methods are capable of generating sufficient numbers of stable and functional Treg cells. Future phase II/III trials will of course be needed to reveal the true potential of these cells.

Global investment in cell-based therapies increased to US$7.6 billion in 2018, a 64% increase from the previous year. In spite of this, the sector still faces a number of significant challenges before these advanced therapeutics become widely used.

Research and development in this sector is undeniably booming, though difficulties in expanding, manufacturing and transporting cell products may be hampering the commercial viability and ultimate availability of these products. Achieving the quantity of cells needed with current production methods, especially if uptake of these therapies becomes more widespread, is one of the major hurdles facing the industry. By way of example, the recommended dose of ChondroCelect is 1 million cells/cm2 of cartilage defect. CAR T cell therapy Yescarta is dosed at a staggering 2 million cells per kg (around 140 million cells for an average adult male). The issue is magnified somewhat by the focus of today’s research on the cell product per se; emerging biotech companies with innovative cell therapies should, at an early stage, consider the processes that will be necessary to achieve the desired cell numbers for later phase II/III trials and beyond. These challenges also bring opportunities however, and there are now a number of innovative companies seeking to develop solutions for the industry, to simplify, accelerate and improve cell therapy manufacturing and supply.

Automation of the manufacturing processes is currently of significant interest to the community. At present, the manufacturing processes employed in the generation of cell therapies largely resemble those utilised in other biopharmaceutical areas (for example therapeutic antibodies). Unlike therapeutic antibodies production however, cell therapies (especially those relying on patient or donor cells) vary significantly from batch to batch, requiring complex and adaptive processes to generate consistent products within the regulatory confines. Through the implementation and training of a variety of mechanisms, e.g. sensors, robotics and image acquisition as well as processing software, researchers believe variability and reliability of current manufacturing processes can be improved.

Whilst improvements in the manufacturing processes will hopefully lead to a reduction in the costs associated with the production of cell therapies, it should be noted that, unlike traditional therapeutic modalities, cell therapies are often a one-off treatment option for patients. Biotech companies must bear this in mind when attempting to recoup their research and development costs and, as such, costs are always likely to be higher than traditional biologics. As it stands, the high costs associated with these therapies is proving challenging for healthcare providers to justify.

The cost of these therapies is at least in part due to the convoluted path from bench to bedside. Cell therapies are considered differently to the conventional biopharmaceutical agents and have to undergo even more rigorous regulatory and quality assessments. This of course ensures public safety, but has also put the brakes on the number of cell therapies actually being approved (despite the ample number of trials). As is so often the case, the regulatory frameworks in place have not been able to keep up with the unprecedented scientific advances in this field. What’s more, the absence of harmonisation across jurisdictions has placed undue burden on the smaller players in this field. The lengthy timescales involved in obtaining regulatory approval (even after showing clinical efficacy) are exemplified by Holclar, an autologous cell therapy (comprising human corneal epithelial cells and limbal stem cells) for the repair of damaged cornea, which despite having shown clinical efficacy as early as 1997, only obtained regulatory approval in 2015.

Regulation is of course paramount to ensure the safety of patients receiving advanced therapeutics (including cell and gene therapies) which have long been shrouded in safety concerns. These concerns are not without basis. Indeed, safety has been a major sticking point for stem cell therapies. The primary concern regarding stem cell therapies is unwanted differentiation, as has been shown in the cardiovascular setting, where calcifications have been identified in the myocardium of patients treated with MSCs following infarction (MSCs, of course, give rise to cells of bone and cartilage as well as muscle). Tumorigenesis has also been a concern for stem cell therapies, although this appears to have been unwarranted based on current data. In the immuno-oncology field, CAR T cells have also been associated with safety concerns including the development of cytokine release syndrome in patients receiving CAR T cell therapies, the engagement of target antigens on non-pathogenic tissues and host immune response to the specific recombinant proteins found in these cells. Pleasingly, the industry is seeking solutions to these problems and research is ongoing to improve the safety profile of these therapies. In the CAR T cell space, the incorporation of suicide or elimination genes into delivered cells is being investigated as a means to selectively deplete these cells in the body when necessary. The approved cell therapies are largely still in their infancy and data from future phase IV clinical trials will be indispensable in assessing the long-term safety of these therapies.

The number of cell therapies actually approved for clinical use remains small. This highlights that, despite the significant scientific advances and investment, the sector is largely still at the research and development stage. Having said that, the industry appears to have reached a critical mass and with the number of clinical trials in this field growing steadily, we can only assume that we will be seeing more and more of these therapies in the clinics. The industry seems to have clicked and more emphasis is now being placed on the challenges of efficiently, yet safely, manufacturing these products. Improvements in this key area could pave the way for wider implementation and access to these therapies. A multidisciplinary approach will be essential in the coming years to increase the number of approved therapies whilst still ensuring affordability and, importantly, patient safety.

This article was first published in the Winter 2019 edition of IBI Journal (pp. 6-9).

In this article for Food Manufacture, managing associate Laura Clews considers some examples of innovation in alternatives to single-use plastics.

For decades, many countries around the world simply exported recyclable materials, including plastics, to China for reuse in their recycling programs; in fact almost half of the world’s recycling was exported to China as this was more economical than developing national recycling programs. However, in 2018, China announced a ban on importing waste, including plastics, citing environmental reasons for this change. Accordingly, many countries around the world must either develop economical recycling facilities or turn to the use of landfill sites (which could not be used indefinitely!).

Through the actions of many people in the media spotlight, such as David Attenborough and Greta Thunberg, the environmental impact of day-to-day life has also been brought to the forefront of consumers’ concerns. In particular, consumers are looking to more environmentally friendly alternatives to single use plastics within the food and drink industry.

Thus, endeavouring to meet these needs, many companies within this industry have funded intensive research to find environmentally friendly and economically viable methods of recycling plastic and/or suitable alternative packaging materials.

Recycling plastics

One company looking to find more effective and environmentally friendly methods of recycling plastics is Green Lizard Technologies. The method of recycling waste polyethylene terephthalate (PET) developed by this company uses proprietary catalyst systems to break down the PET polymer chain to its raw materials (BHET – bis(hydroxyethyl)terephthalate). It has been reported that this new method is highly effective, producing yields of BHET of up to 61% from the reaction mixture. Once PET has been broken down to BHET it can then be reused to form other plastics or alternative polymeric materials.

It has been reported that this process produces recycled materials which are essentially free from contaminants, and therefore can be reused to produce food and drink packaging, such as PET recycled water bottles.

This new recycling method has caught the eye of major players within the industry, and it was announced on 14 November 2019 that Poseidon Plastics Ltd., a joint venture between Green Lizard Technologies, Panima Capital & Abundia Industries, signed an agreement with the world’s leading differentiated producer of PET and PEN polyester films, DuPoint Teijin Films (DTF) in order to develop this unique polyester recycling technology.

Is replacing single use plastics with alternative materials really the answer?

A report by Green Alliance published in January 2020, ‘Plastic promises: What the grocery sector is really doing about packaging’, looks at the kneejerk reaction by many retailers and suppliers to replace single use plastics with other materials which are considered to be “more environmentally friendly” in response to the increased media attention and growing pressures from the public.

The report comments that many retailers and suppliers are simply replacing single use plastic packaging with alternative single use materials, such as glass, paper, wood and biodegradable materials, without undertaking a rigorous analysis of the environmental impact of such materials compared to single use plastics.

Worryingly, many reports have found that due to the manufacturing process, number of times consumers are likely to reuse these materials and the availability of recycling schemes, these alternative materials can be more damaging to the environment than single use plastics. For example, a study for the Northern Ireland Assembly in 2011 found that paper bags generally require four times more energy to manufacture compared to plastic bags.

Alternative materials

Accordingly, there is a drive within the food and drink industry to source alternative materials which are more environmentally friendly and also meet the common requirements of the food and drink industry (such as preserving the packaged consumable).

For most adults (and particularly those who work in big cities and/or have children) coffee not simply a drink choice, but an essential for day-to-day life. In fact, it has been reported that in the UK 95 million cups of coffee are consumed a day, which produces around 500,000 tonnes of used coffee grounds every year, most of which simply ends up on landfill sites (see ‘Put Your Coffee Waste to Work’, by Bio-bean). Fortunately, Berlin based company, Kaffeeform, has found a way to repurpose this waste product, turning coffee grounds into durable cups. Kaffeeform states that these alternative cups are formed from recycled coffee grounds and other plant-based resources that are hardened with biopolymers.

In addition, New York based biotech company, Ecovative Design, has also produced a new environmentally friendly material based on mushrooms. The material has been used to form surfboard blanks to replace those previously used formed from expanded polystyrene or polyurethane foam with a fibreglass coating.

The blanks, which are entirely biodegradable, are made from a material called Myco foam which is formed from mycelium (the white, glue-like, branching part of fungus referred to as hyphae) and organic farm waste, such as corn husks, straw and lentil pods. During manufacture the mycelium grows, feeding on the organic waste, and forms long entangled fibres. This new material has been an immediate success, and not only in the surfing world. Ecovatve Design has now branched out into making faux-leather materials, packaging and skincare products, forming partnerships with well-known companies such as Bolt Threads, IKEA and DELL.

This article was first published in Food Manufacture Magazine in February 2020.

Today, 31 January 2020, the UK exits the European Union (EU). This however has no impact in practical terms on European IP rights for the time being, because after today the UK enters a transition period which is scheduled to last until 31 December 2020.

During the transition period, EU trade mark and registered design filings will continue to cover the UK. 

European patents are in any case unaffected by Brexit (even after the transition period). 

Mathys & Squire’s ability to represent its clients in the UK and Europe is not affected by Brexit (even after 31 December 2020). As a firm, we remain a European business with offices in the UK, Germany, Luxembourg and France, and we will continue to represent our clients across Europe. 

Visit our Brexit page for more details on the long-term implications of Brexit on IP rights.

As a European firm, Mathys & Squire, with offices in the UK and Europe, we are in a strong position to be able to handle both UK trade marks and designs, as well as EU Trade Mark Registrations and Registered Community Designs, and we have been working with our clients on cost-effective strategies for doing so. 

If you have any questions, please contact your usual Mathys & Squire adviser or for more information on this topic, email [email protected].

In this opinion piece for Raconteur’s Intellectual Property report, we consider how inventors will be impacted as AI develops.

A lot has been said about how artificial intelligence (AI) might revolutionise the world of intellectual property (IP), perhaps replacing humans as inventors or taking over existing IP systems. Let’s cut through the hype and consider what we can realistically expect.

The term AI is often used loosely. I use it to mean machine-learning, whether guided or loosely constrained, to detect patterns or produce inferences or outputs based on what the machine has “studied” rather than its original programmer. Machine-learning usually needs lots of data to learn and the line with data analytics is often blurred.

Starting with the basics, there are undoubtedly advances in the way machine-learning operates or can be computationally implemented efficiently and these advances may be patentable, just as for other inventions.

However, many commercial applications of AI involve taking generally known AI techniques and applying them to a data-crunching problem and this alone is unlikely to be considered inventive.

Nonetheless there may be protectable IP in the detail of how this is done effectively in a given case. An expert can advise on whether there is likely to be commercially worthwhile protection to seek in a particular application or if simply keeping the data is the key.

More colourful debate has involved whether a machine can itself be an inventor or an author, or speculation about one AI filing its own patent applications and another “official” AI examining them. I participated in a public debate with the UK Intellectual Property Office and AI evangelists on the practical, legal and moral implications of this.

Patent applications have been filed for an invention naming an AI as inventor, with a notion that this was deliberately done to test boundaries. The UK and European patent offices have both ruled that an AI cannot be an inventor. Academic debate may continue on such questions as how do you determine the term of copyright which depends on the life of an author, if the author is a machine. But for now, at least for businesses, the issues are thankfully clear.

The real impact of AI will take place behind the scenes; companies will use AI in design and competitor analysis, but let the human directing the AI take the credit. There is a close parallel with the issues when a semi-autonomous vehicle has a collision: the driver is responsible. To a pilot these issues are nothing new; the captain is ultimately in command and responsible whether or not he or she chooses to rely on autopilot or other systems to assist in navigation or control.

In one sense this is just normal use of technology, in the same way computer-aided design and computer-aided manufacturing simplified getting from concept to product or word processors and spreadsheets and databases assisted document production and accounting and filing.

A new issue is that AI may make it easier for what I term “artificial inventing” based on analysing apparent gaps in the prior art; it is often more productive to task smart humans to make positive inventions whereas an AI can work 24/7 just looking for gaps. There are also so-called AI tools for searching and assisting with preparing patent applications which I have seen; AI will creep into the field of analysing, selecting, examining and even writing patent applications from all directions.

Some balance to this is that machine-learning works well with a training dataset to spot patterns in “what is”; good examples being image processing or identifying anomalous behaviour. However, inventions must be unique and it is less straightforward for AI to deal helpfully with an open-ended “what isn’t”.

We should embrace AI tools where they can help, but don’t expect them to replace expert strategic human insight or fundamentally change IP in the next few years.

This article was first published in Raconteur ‘s Intellectual Property report in January 2020 (page 7).

On 29 January 2020, the Court of Justice of the European Union (CJEU) handed down its judgment in the Sky v SkyKick C-371/18 case, on which there has been a wealth of commentary and speculation (in particular in the wake of the EU Advocate General’s (AG) non-binding opinion delivered on 16 October 2019).

The judgment follows a referral from the High Court of England and Wales in trade mark infringement proceeding brought by Sky against SkyKick. SkyKick counterclaimed by attacking the validity of Sky’s trade marks on the grounds that: a) Sky’s trade mark specifications lacked the required clarity and precision; and b) the specifications covered by Sky’s trade marks covered terms for which Sky had no reasonable rationale for seeking registration and, therefore, the registrations were filed in bad faith.

SkyKick’s counterclaim raised several questions in the proceedings which required clarification. Mr Justice Arnold therefore referred the following questions to the CJEU:

(1) Can an EU trade mark or a national trade mark registered in a Member State be declared wholly or partially invalid on the ground that some or all of the terms in the specification of goods and services are lacking in sufficient clarity and precision to enable the competent authorities and third parties to determine on the basis of those terms alone the extent of the protection conferred by the trade mark?

(2) If the answer to question (1) is yes, is a term such as “computer software” too general and covers goods which are too variable to be compatible with the trade mark’s function as an indication of origin for that term to be sufficiently clear and precise to enable the competent authorities and third parties to determine on the basis of that term alone the extent of the protection conferred by the trade mark?

(3) Can it constitute bad faith simply to apply to register a trade mark without any intention to use it in relation to the specified goods or services?

(4) If the answer to question (3) is yes, is it possible to conclude that the applicant made the application partly in good faith and partly in bad faith if and to the extent that the applicant had an intention to use the trade mark in relation to some of the specified goods or services, but no intention to use the trade mark in relation to other specified goods or services?

(5) Is section 32(3) of the UK Trade Marks Act 1994 compatible with [Directive 2015/2436] and its predecessors?”

 

Whilst it was expected that the CJEU would follow the AG’s opinion, the CJEU has instead handed down a somewhat conservative judgment which may be summarised as follows:

Importantly, the judgment confirms that under EU law an EU/national trade mark registration cannot be invalidated on the grounds that the specified goods and services lack clarity or precision. This will come as a relief to brand owners with trade mark registrations covering broad terms such as “computer software”, who may otherwise have faced invalidity actions had the CJEU followed the tone of the AG’s opinion. The judgment is therefore likely to be seen as a ‘big win’ for brand owners.

As far as broad specifications are concerned, the judgment maintains the status quo and does not change the approach followed previously by UK practitioners and the UK Courts. The position with respect to the bad faith question may be somewhat different, and we will have to see how national courts interpret the CJEU’s clarification of what constitutes a finding of bad faith.

The Sky v SkyKick case will now return to the High Court, and it will be interesting to see how the High Court addresses the CJEU’s judgment in its decision.

For more information about the implications of the judgment or for trade mark advice more generally, brand owners are encouraged to get in touch with our trade mark team.

In the final article of our ‘IP trends for 2020’ series, we look at how developments in artificial intelligence will impact and disrupt the tech sector.

2019 marked another year of continued venture in the fields of AI, ML and Big Data, with standout developments such as the first anniversary of the UK Government’s AI Sector Deal, with an updated policy paper and the appointment of an AI Council (see here), and the UK Health Secretary’s announcement of a £250 million investment in AI to create a new National Artificial Intelligence Lab “to improve health and lives of patients” (click here).

Looking to the year ahead, AI continues to dominate the horizon for blue-sky businesses, notably, as touched on in our previous IP trends article on personalised medicine, with the use of AI in the provision of healthcare and development of health tech.

In particular, AI in health tech, bioinformatics and the development of technology that brings powerful AI algorithms to bear in diagnosis and treatment, is a particular trend that we at Mathys & Squire are seeing and expect to see more of as 2020 progresses.

As evidence of this, and at the time of writing, BBC News has recently published an article entitled: ‘AI “outperforms” doctors diagnosing breast cancer’, which describes a study conducted by Google Health and Imperial College London, published in the journal Nature, which evaluates the use of an AI system in breast cancer screening and found it to be just as effective as clinicians in spotting the disease (see study here).

Of course the use of AI is not limited solely to health tech. AI seems to be disrupting all fields of technology. Other AI trends we expect to see in 2020 include AI’s increasing role in the development and proliferation of autonomous vehicles and self-driving cars (e.g. Toyota’s recent announcement of its 175 acre ‘fully connected ecosystem’ to be built at the base of Mount Fuji, titled the ‘city of the future’ – read more here); the use of AI in emerging and evolving 5G networks; and the continuation of AI augmenting the human workforce – not by replacing humans altogether, but by developing human intelligence and enabling employees to carry out their roles more optimally.

The application and adoption of AI technologies typically involves an amalgamation of a number of different technical fields – whether it be the combination of computer algorithms with bioinformatics, or neural networks and telecommunication networks. As such, careful drafting will be required, not only to navigate the various overlapping exclusions relating to software, mathematical models, but also to ensure that patent protection of a commercially valuable scope is obtained. However, if a carefully planned and executed IP strategy is developed and executed, then in times of disruption such as these (as noted in our article published here) there is scope for commercially significant key strategic IP protection to be obtained.

The third article in our ‘IP trends for 2020′ series focuses on personalised medicine in the pharmaceutical and biotech sectors, and how this will be impacted by developments in AI.

Following the recent excitement surrounding technologies such as CAR-T therapy and CRISPR, the focus on targeted therapeutics looks set to progress in 2020. This year is likely to witness a continued drive towards personalised medicine within the pharmaceutical and biotech sectors, together with an increased focus on developing the data capture and analytics capabilities necessary for these new therapies to realise their full potential.

To maximise impact across areas such as drug discovery, diagnostics, patient selection and treatment optimisation, there is a growing interest in new ways of acquiring and analysing patient data. Recent developments in fields such as artificial intelligence (AI) and machine learning (ML) are also playing an increasingly influential role in the biotech space, with FDA approvals of AI algorithms increasing exponentially over the past few years, and the AI healthcare market predicted to reach $6.6 billion by 2021.

This has led to the formation of new partnerships between the tech and healthcare industries: AI startup Concerto HealthAI is currently working with BMSPfizer and Astellas to support their precision oncology initiatives, while Roche’s acquisition of Flatiron Health and Foundation Medicine recently provided proof-of-concept that clinically meaningful insights can be generated through large-scale analysis of genomic and clinical data.

Meanwhile, major tech players such as Google, IBM and Microsoft have all taken steps into the biotech space. Among other developments, 2019 saw the announcement of several new healthcare-related collaborations by Alphabet-owned Verily, and a partnership between Microsoft and Novartis aimed at integrating AI across clinical development and commercialisation.

While these partnerships have the potential to drive significant technological progress, they also give rise to a new set of legal, ethical and regulatory issues. In addition, healthcare and tech partners will need to consider how to align their IP strategies in order to maximise licensing opportunities across fields which may have historically taken different approaches to issues such as the extent of protection they choose to obtain, and which jurisdictions they choose to obtain it in.

These new approaches are also likely to lead to a shift in IP strategy within biotech. As therapeutic interventions target ever-smaller patient populations with increasingly specific treatment regimens, we are likely to see a greater emphasis on ensuring that value is captured not only within final therapeutic products and protocols, but across the entirety of the clinical development process. In particular, obtaining appropriate protection for the processes which contribute to drug discovery, patient selection and treatment optimisation, as well as for the data capture and analytics tools underpinning them, is likely to become increasingly important.

Furthermore, the EPO’s approach to patentability in this area is still evolving. In 2018, the EPO updated their Guidelines for Examination to include, for the first time, specific guidance on how the patentability requirements for algorithms and computer programs should be understood in the context of AI and ML. Meanwhile, in decision T 0694/16, the EPO’s Technical Board of Appeal acknowledged that a claim directed to the use of a known drug in a purposively selected patient subgroup could be considered novel, even where the identified subgroup overlapped with the previously treated patient group.

In view of the complexities of this subject matter, careful drafting will be required to navigate overlapping exclusions relating to software, mathematical models and methods of diagnosis and treatment. In addition, addressing these issues surrounding the role of data and AI within the biotech field will be fundamental to realising the full potential of personalised medicine, and will require specialist advice. Mathys & Squire’s multidisciplinary team, with experts in biotech, pharmaceuticals, vaccines, diagnostics, medical devices and healthcare products / services, can assist clients in this sector with the complete range of intellectual property services, including devising an IP strategy in order to identify and maximise the value of their intellectual property.

For more information, and to get in touch with one of our experts, click here.

For the second in our series ofIP trends for 2020′ articles, we’re looking at designs and how they are likely to be affected by both Brexit and a push for sustainability in the coming 12 months.

The election result at the end of 2019 appears to resolve some of the uncertainty around the UK’s exit of the EU, not least with regards to IP matters such as registered designs.

The UK is now set to leave on 31 January 2020, and the UK government’s current withdrawal agreement provides for a ‘transition period’ lasting until 31 December 2020. EU trade mark and registered design filings made during this time will continue to cover the UK. At the end of the transition period, granted EU registered designs will be ‘cloned’ into corresponding UK registered designs at no cost to their owners. This means that design-focused businesses can continue to file EU registered design applications in 2020 and these will continue to provide protection in the UK even beyond the transition period (if granted before the 31 December).

Only EU registered design applications which are still pending at the end of the transition period will need to be re-filed as UK registered design applications (which will necessitate the payment of further official fees). Since it typically only takes a few weeks for EU registered design applications to register, there is no need for applicants to consider a change to their design filing practice until December 2020. We therefore anticipate a trend of companies taking advantage of this transition period to obtain registered design protection across the UK and the EU via a single application.

Another major design trend we expect to see in 2020 is an increase in product packaging innovations. As touched on in our first 2020 trends article (here), consumers are more aware than ever of the impact of their consumption habits on the environment. This has resulted in a focus on sustainability – the use of reusable coffee cups has risen dramatically, and major supermarkets are starting to respond to demand to offer alternatives to disposable packaging for food products, produce and other consumer goods.

Designers now face the challenge of creating packaging which provides reliable and effective protection for goods at a reduced cost to the environment. After all, the disposal of goods spoiled as a result of inadequate and ineffective packaging is just as wasteful and environmentally damaging as the disposal of the packaging. With this in mind, we wonder whether in 2020 we might see increasing innovation in packaging design, construction and materials in order to overcome these challenges in a sustainable manner.

Further information on what Brexit means for registered designs – and all other aspects of intellectual property – can be found via our Brexit page (here). For expert advice on design law, whether you’re a startup, established household name or overseas attorney, contact a member of our specialist designs team, who can help to secure strategic protection for your designs internationally.

In line with recent public appetite for healthier living and sustainability, the expected trends for 2020 focus mainly on foods that improve our health and help the planet. This article highlights some of these industry trends for the coming year.

Seacuterie

‘Seacuterie’ attracted significant media attention in the summer of 2019 and has steadily gained momentum ever since. For anyone who has yet to come across seacuterie, the trend is similar to charcuterie but involves pickling, fermenting, smoking and/or aging seafood, and the use of superfood sea vegetables (such as kelp, seaweed and algae). As this trend has become more popular, chefs around the world (and some supermarkets, such as Waitrose) have produced more interesting and innovative seafood creations, such as octopus salami/ ‘sea-lami’, scallop mortadella and seafood sausages. In addition, and in line with a more environmentally-friendly customer base, the seacuterie trend looks to reduce waste by using every part of the fish (‘gills-to-fin’ cooking). We look forward to seeing the new seafood creations which will emerge in 2020, but in the meantime, fish-eye chips anyone?

CBD-based foods

It has been difficult to miss the ever increasing variety of CBD-based products and their popularity with consumers. In recent years, the consumer perception of CBD (cannabidiol, a non-psychoactive compound found in the flower of the cannabis plant) has become more positive and is now viewed as a ‘trendy’ new superfood ingredient which could help to treat/relieve a number of medical ailments, such as Alzheimer’s, epilepsy, pain, stress and anxiety. This shift in consumer perception with respect to CBD-based products is due, at least in part, to the increasing amounts of medical research on the effects of CBD and the increased publicity of the health benefits associated with the compound.

Accordingly, many well-known companies across the globe have been quick to respond to this development, for example companies such as Nestlé, Diageo, Starbucks are either currently producing or researching CBD-based products for release in the food and drink market, even Ben & Jerry’s has announced that it has produced a CBD ice cream!

Whilst this trend is now reasonably well established, we would expect to see many more new and exciting CBD-based foods and drink products in the coming year.

Meat alternatives

2019 certainly was the ‘year of the vegan’, with numerous companies investing heavily in producing new and innovative vegan-friendly meat substitutes, which look and even taste like meat. In particular, Spanish company, Nova Meat, disclosed a method of 3D printing meat-free products in order to create a texture closer to that of unprocessed meat. In addition, 2019 saw meat-free burgers take over the fast-food restaurants, with Beyond Meat joining forces with McDonald’s and Impossible Burger teaming up with Burger King to provide vegan burgers to the masses. 

In view of the significant success of this trend in 2019, and the ever-increasing number of consumers looking to take on vegan/vegetarian lifestyles (with 300,000 people signed up to take part in Veganuary this year), we would expect companies to continue their research into improved and exciting vegan products throughout 2020. In fact, following the success of the vegan sausage roll, Greggs launched its new vegan Steak Bake on 2 January 2020, containing Quorn, onions and meat-free gravy – which has already received positive reviews!

This article was first published in Food & Drink Network UK’s Industry Insight journal in January 2020.

It was announced last week that total venture capital (VC) funding for London’s tech companies rose by an unprecedented 87% last year to reach $9.7bn, over double that raised in Berlin and triple that raised in Paris. 

The UK is now the fastest growing tech ecosystem in Europe, and the UK tech sector recently overtook the US for foreign investment per capita. The surge was primarily fuelled by investments in fin-tech, AI and clean energy, all areas in which the Mathys & Squire team has significant expertise and where we are seeing increasing numbers of patent applications being filed by clients.

In such fast-growing sectors, establishing a carefully thought out and commercially sensitive intellectual property (IP) strategy is key. Not only will this avoid costly mistakes occurring down the line (often only being spotted at the 11th hour before a deal or investment is about to go through), but an effective IP strategy should add value to the business and help drive revenue – whether it be through locking in supply chains or keeping competitors ‘off the grass’.

The team at Mathys & Squire has years of real-world, commercial experience in creating such IP strategies and can really help to increase the growth and value of such businesses by making their IP work harder for them.

Contact us to find out how we can help you to maximise the value of your business’ IP.

An extended version of this article, with advice for early-stage startups, was published in Startups Magazine in February 2020.