Mathys & Squire and RSM are pleased to be co-hosting ‘An introduction to AI’ during London Tech Week. The event will be held on Monday, June 10th 2019 at 25 Farringdon Street, London, EC4A 4AB.

We will be providing an overview on artificial intelligence (AI) and how it is and will continue to change business operations across a range of functions and industries; what are the challenges when it comes to implementing and utilising AI; as well as the opportunities that can arise in this brave new world.

Schedule

4pm: Registration

4.30pm: Welcome from David Blacher, Head of Media & Technology at RSM

4.35pm: Introduction to AI presented by Neil Sharples, Partner at RSM

5.05pm: IP in relation to AI – challenges and opportunities (presented by Andrew White, Managing Associate at Mathys & Squire)

5.30pm: Drinks and canapés

To register for the event, please RSVP to Saba Ismail.

We talk to Phil Staunton, Managing Director of D2M Innovation Ltd, a design consultancy that helps turn great ideas into brilliant newly manufactured products that sell.

Manufacturing is the stage at which a product finally comes to life and, after many months or even years of planning, designing and re-designing, this is an exciting time in the journey from concept to market. That said, it can also be a daunting stage and one in which speed to market remains key.

Phil Staunton, who founded D2M Innovation in 2010, has over 10 years’ experience of supporting start-up businesses and SMEs develop and launch innovative, new products onto the market. He now specialises in strategic planning of product development to minimise risk and therefore maximise the chances of success.

Phil explains that there are up to 18 main stages of work you are likely to progress through, and his advice is: “Do not compromise on shortcuts that may create bigger issues further down the line. Bear in mind that, often, you will have to choose between quality, cost and time to completion, so make sure you know which are most important to you.

“Make sure that you inform the manufacturer of any particular standards or certification that your product needs to comply with and, ideally, select a manufacturer that is used to working to the standards of the countries where you plan to sell your product.

“The right manufacturing partner is the key to the success of your product, and before you embark on the process of selecting your manufacturer, you will need to have a manufacturing specification for your product, which is a complete representation of the product which provides any suitable manufacturer with the right information for production.”

Phil recommends using a checklist, like the one below, to make sure you don’t miss anything important.

Another thing worth considering before the manufacturing specification is completed, is whether or not to consider registered design protection for the product in its final form. This can provide powerful protection for the appearance of your product, and unlike patents, can be put in place quite quickly to guard against copies of your product entering the market very shortly after yours. Not only can this severely affect your own sales, but if the copies are of poor quality your brand can also be badly damaged.

Ultimately, though, Phil adds: “You are not the first entrepreneur following this path. You will probably make mistakes during this process. Learn from these, be reactive, and don’t give up!”

This article was first published in Business & Innovation Magazine in May 2019.

One of the most common issues faced when securing protection in China is the earlier registration of third-party rights, which are then cited against the later application. However, there are various tactics that can be adopted to overcome this hurdle.

Many articles are written about various aspects of the trade mark system in China: the risks of the first-to-file system, the development of the law in recent years, the behaviour of trade mark squatters and the production of counterfeit goods. However, fewer focus on the obstacles encountered when filing in China or offer practical guidance on how to overcome or address these.

For foreign businesses attempting to protect their marks in China, objections throughout the prosecution process are reasonably commonplace for various reasons, including significant differences between China’s legal system and those of other countries. However, in our experience, one of the most common issues is the earlier registration of third-party rights that are then cited against the later application and form a block to its progress. Under the Chinese system, the onus is on the applicant to overcome the possibility of confusion with earlier rights, as compared to it being up to the earlier rights holder to actively object to a later application.

Having assisted many clients over the years that face this exact problem, we have had to consider and develop
several potential strategies and solutions for tackling the issue. Below are a handful of the methods we regularly
use to try to obtain protection.

Pre-filing

Anyone filing in China should be aware that the classification system is unique and that a specification drafted for elsewhere in the world is unlikely to pass the Chinese examination process without some form
of query or objection being raised. Where possible, it is therefore advisable to obtain a full list of the terms included within each relevant sub-class from a Chinese attorney and to consider creating a separate or adapted specification for use in China that either utilises those terms in place of the specification employed in the jurisdiction where the mark was first registered or lists them alongside, to assist with later adaptations.

This will not always be possible (e.g. if filing via the Madrid Protocol or where a priority claim means that a previously drafted specification must be used). However, in instances where the strategy may be employed, it is advisable to consider doing so.

It will be useful from a wider prosecution perspective but can also help to avoid the unnecessary citation of earlier rights. For example, it can often be the inclusion of one term in one sub-class that prompts a citation from the China Trademark Office (CTMO). When, for example, a UK specification has been used, this may be an unnecessarily wide-reaching term that could have been removed or limited prior to examination in order to avoid the citation.

Conduct Searches as Soon as Possible

Pre-empt Objections
Despite the propaganda, the trade mark system in China no longer lives up to its Wild West reputation; there is a wider acknowledgement of the value of intellectual property and the authorities are adapting the law in an attempt to stamp out the dishonest practices that gave rise to the reputation in the first place. However, trade mark squatting is still present and there will always be individuals and businesses that see the financial opportunity presented by the first-tofile system.

For this reason, you will often find that a client’s brand is illegitimately registered in China even before that client has decided to protect the mark itself.

Because of this, as well as the potential existence of legitimately registered earlier rights, it is strongly advisable to conduct searches as soon as there is any indication that the client has an interest in the Chinese
market. Where no obstacles are found, early filing is also strongly recommended to prevent interim disruptive filings by third parties.

Searches and Non-use Actions
One of the most common methods of overcoming the citation of an earlier right is to file a cancellation action against the earlier right on the basis of non-use (i.e. where it has been registered for more than three years and no obvious use can be identified). This is a useful way of removing the citation from the register and thus clearing the way for the client’s application.

However, the process is not always straightforward; if the non-use action has been prompted by an official objection to a trade mark application, the CTMO will not generally agree to suspend examination of the application pending the outcome of the non-use action, thereby leaving the client with no option but to file the non-use action, abandon the application and re-file in the hope that by the time the new application is examined, the non-use action is close to being concluded.

This is why pre-filing searches are so important in China; it is much more beneficial to know about potential citations in advance of filing so that you can instigate those actions early, rather than wait 18 months until you receive a refusal and then potentially have to start from scratch. Indeed, in circumstances where nonuse actions are instigated before either the filing or the provisional refusal is issued, the CTMO is more likely to agree to a suspension pending the outcome of the cancellation action.

Thus, discovering potential citations before filing could lead to the development of a more informed strategy that reduces the time and cost involved in obtaining protection.

Invalidate Earlier Registrations

Where a non-use action is not possible (either because the registration is too young or use is being made in China), clients can also look at pursuing an invalidation action against the cited right.

These can be based upon a number of grounds, including earlier proprietary rights or bad faith; the latter of which is more likely to succeed when there is evidence of squatting and dishonest intentions.

However, such actions are generally difficult to support in the absence of good evidence, a copyright registration or prior use/protection of the mark in relation to virtually identical goods to those included within the cited registration.

Indeed, a handful of our clients have discovered identical logo marks registered in China in classes in which they have no protection and have not previously used their marks. In these circumstances, invalidation
actions failed despite the logo being clearly identical due to the lack of pertinent evidence of use or ownership in relation to the contentious goods or services.

Wait

Sometimes, despite all one’s best efforts, none of these options are viable and it is difficult to identify a route forward. In these circumstances, the client may need to accept that it has to play the long game. Generally if the application was filed by a squatter, there will be no real intention to use it and so you could choose to diarise the three-year non-use date and then pursue non-use proceedings as soon as possible,
while simultaneously re-filing for the client’s mark in the hope of achieving the above-mentioned stay of proceedings, if necessary.

Consider Copyright Protection

In the interim, or even as a defensive mechanism alongside an initial trade mark filing, copyright registration in China can provide a useful addition to a client’s portfolio and additional armour against trade mark
misuse or misappropriation. Indeed, it provides the client with a registered right protecting its stylised mark and it is not limited by the same classification system.

For clients with distinctive logos, a copyright registration can provide a strong alternative right for enforcement purposes. For example, the client can obtain a registered right to record with Customs, and potentially a broader-reaching right to enforce against squatters filing to protect the client’s logo in different classes of goods or services. It is therefore well worth considering.

Purchase Earlier Rights

It is no secret that trade mark squatters will often request huge sums of money in return for the transfer of an earlier trade mark registration for the client’s brand (or something similar). Often the figure put forward is far in excess of the value of that registration, particularly in view of the fact that squatters rarely take the steps to enforce those rights against the rightful owner.

However, in certain circumstances, the purchase of an earlier right may be worth considering – for example, if the value is reasonable in comparison to the cost of pursuing actions at the CTMO, potentially having to re-file and being forced to stall enforcement action in the interim.

Moreover, this could be an option worth considering where a mark is already within the non-use period or very close to that period and thus more vulnerable, or where there was actually a genuine intent to use but it has fallen out of use, or perhaps if there are overseas rights that can be used as leverage in negotiating a commercial relationship that could benefit both parties.

However, do consider who is best to begin those negotiations, as an initial approach from a lawyer is not always looked upon favourably from a cultural perspective.

This article was first published in the June/July 2019 edition of World Trademark Review.

For more information, contact Margaret Arnott or Laura West.

The food and drink industry is one of Europe’s largest manufacturing sectors, with, according to FoodDrinkEurope, an annual turnover of €1,109bn. However, in order to capitalise on this lucrative industry, manufacturers must follow (or more ideally stimulate) changing consumer demands and government initiatives. 

One of the most significant recent consumer trends has been the increased demand for healthier foods and drinks. Consumers have become much more conscious of maintaining a healthy and balanced diet and are looking more critically at the ingredients contained within their food and drink.

In recent years there has also been an increased awareness of the methods of manufacture, the inclusion of additives and the sourcing of food and drink ingredients. The desire to live healthier lifestyles has resulted in, among others, an increased demand for new vegetarian and vegan options, nutritionally improved and ‘gut healthy’ foods. 

This change in consumer purchasing is reflected in the given drivers for innovation in the food and drink industry, with health food trends (natural, medical and vegetal) reported as showing the greatest increase in 2017, particularly in the soft drink sector, which was recorded as the most innovative sector in 2017.

No doubt this change in manufacturing drivers is, at least partly, related to the new national guidelines, such as those published by Public Health England (PHE), which aim to reduce the amount of sugar in children’s food by 20% by the year 2020, and the general EU benchmark of reducing added sugars in food products by a minimum of 10% by 2020, with respect to the baseline levels of member states at the end of 2015. 

But what if consumers grow tired of this healthy lifestyle trend and want to give in to ‘naughty’ urges once again? Is it possible to maintain a healthier lifestyle and continue to eat the comfort foods that we all know and love? Essentially, is it possible for us to have our cake and (quite literally) eat it too? 

Fortunately, many food and drink manufacturers have committed extensive time and resources to looking at this exact issue. In recent years, research and innovation in the food and drink industry has not been solely focused on providing new healthy, micronutrient filled foods for us to try. It has also looked at how to make the food and drink products traditionally associated with higher calories and increased amounts of fat, salt and sugar healthier, while maintaining the texture, taste and appearance we have come to expect and enjoy. 

Reduced Fat Fish and Chips

Fish and chips is quintessentially British fare, using a batter formed from a slurry of wheat flour and water. However, deep-fried foods
such as these absorb large amounts of oil during cooking, which significantly increases their calorific content and reduces the nutritional value.

Fortunately, VA Whitley & Co Ltd, a UK supplier to the Fish and Chip and Fast Food Trade, has perfected a healthier batter which comprises fava bean flour (from the Vicia faba bean) in place of the traditional wheat flour. The fava bean flour has been found to reduce fat/oil uptake during cooking, while importantly maintaining the familiar colour, texture and taste of traditional fish batter.

Not only does this batter reduce the overall calorific content of the resulting food product, but it also meets many of the other consumer-driven demands of today. For example, the use of fava bean flour provides additional health benefits over wheat flour as it is higher in protein, fibre, and trace minerals. Fava bean flour is also gluten-free, and so is suitable for those among us who are either intolerant to or just prefer to opt for gluten-free alternatives.

Patents provide an alternative and interesting source of information for identifying emerging technology trends. One such recently observed trend supports a growing interest in the use of indirect biomarkers in diagnostic assays. This article describes the key differences between direct and indirect biomarkers, and illustrates two examples to show how indirect biomarkers are providing new clinical diagnostic opportunities, namely to improve initial triaging of patients in accident and emergency scenarios and to allow rapid and accurate screening of patients carrying a latent tuberculosis infection.

Classical diagnosis of disease-causing agents relies on identification (i.e. direct detection) of a key biomarker that is characteristic of said agent. Examples of such biomarkers include: nucleic acids (detection via polymerase chain reaction hybridisation, sequencing, isothermal amplification); antibodies (detection via ELISA, immunofluorescence (IF)); antigens/ proteins (detection via ELISA, IF); and agent isolation (detection via differential cell culture means). This, in turn, requires knowledge of the infectious agent in question (table 1), and goes together with constant refinement pressures to ensure all newly-emerging variants are also captured. The high specificity typically demonstrated by such biomarkers, however, unfortunately presents an Achilles’ heel when a negative diagnostic outcome is reached such that further intelligence (other than subtractive analysis of the targeted agent per se) can be gleaned.

It should also be noted that the different biomarker types demonstrate their own strengths and weaknesses when assessed in terms of, for example, minimum diagnosis time requirements, transportability, relevant detection window timeframe, and sensitivity (table 2).

By way of example, the following Ebola case study (figure 1) nicely illustrates the potential criticality of detection window factors that impact both polymerase chain reaction and antibody detection. In more detail, premature use of polymerase chain reaction detection during either the ‘incubation’ or early ‘pre-haemorrhagic’ phases will likely result in a false negative. Similarly, premature use of a diagnostic for IgM up to and including the mid ‘pre-haemorrhagic’ phase would also likely yield a false negative.

Figure 1: Multiple Biomarkers – Ebola case study (source: Prof Nigel Silman, PHE Porton, Salisbury SP4 0JG)

While significant advances have been made with classical biomarker diagnostics, there remains a variety of notable unmet clinical needs:

• rapid, accurate biomarker tests for differential diagnosis;
• biobanks of well characterised clinical

  samples;

• requisite materials to construct immune-assays and

  molecular diagnostics;

• true point of care platforms for diagnostic

  assays; and

• robustness to permit field use.

Is now the time for an alternative (potentially supplementary) approach?

Recent developments with the use of indirect biomarkers (e.g. differential gene expression or metabolism profiles) have attracted significant interest. The use of carefully selected biomarker sets in combination with robust algorithms provide important assay flexibility and allow specificity and/or sensitivity levels to be dialled-up or down as appropriate to achieve an optimal read-out. Moreover, this flexibility provides the means for further interrogation of a clinical scenario where initial diagnosis has failed to identify a positive outcome, and thereby addressing one of the major weaknesses associated with classical biomarkers weaknesses.

By way of example, WO2018/060739 teaches use of a variety of different marker sets can be employed to distinguish between septic inflammatory response syndrome (SIRS) and sepsis, and subsequently to differentiate between important subsets thereof. In more detail, a simple triage diagnostic of this type would find immediate value, for example when assessing a patient who has presented in any emergency scenario. Rapid point of care confirmation that the patient has SIRS would negate the need to administer antibiotics, and potentially represents a huge step forward in improving current antibiotic husbandry.

Similarly, for a patient presenting with sepsis, being able to differentiate between abdominal sepsis and pulmonary sepsis would permit a more informed decision to be made with regard to the type of antibiotic administered (e.g. to target gram positive, or gram negative bacteria). Another interesting biomarker set described allows one to monitor patient recovery and hence to determine more accurately the correct time point for appropriate patient discharge from hospital. This would, of course, help to address current bed capacity problems without compromising patient safety.

By way of further example, WO 2015/170108 teaches use of a variety of biomarker sets for identifying M tuberculosis infection. This infectious cycle of this agent includes an intracellular ‘latency’ phase during which bacilli do not circulate freely within the body, and are therefore particularly difficult to detect. A further setback with the use of classical biomarkers for detecting M tuberculosis is skin testing may be compromised by BCG vaccination and by exposure to environmental mycobacteria. The presence of a large reservoir of asymptomatic individuals latently-infected with mycobacteria presents a major problem for global control of M tuberculosis infections. This is indeed a key priority for many health and immigration authorities, particularly at the ‘point of entry’ for developed countries where the majority of TB cases are imported. The indirect biomarker sets described achieve both accurate and timely diagnosis of early-stage infection where conventional biomarker detection (via cell culture or PCR) is not possible. Possibly of most significant interest, the authors describe use of unique marker sets that provide robust diagnosis of latent M tuberculosis at sensitivity and specificity levels far superior than have been hitherto reported.

These two brief case studies illustrate the huge opportunities indirect biomarkers present for rapid bio-sensing technologies for both the control and prevention of infectious diseases, and related heath- or life-threatening management scenarios.

We urgently need to start moving away from sole reliance on classical biomarkers (noting in particular the impotence of these markers in negative diagnostic output scenarios) and start embracing the new world of indirect biomarkers to detect and characterise important host signature profiles.

This article was first published in the April 2019 edition of Intellectual Property Magazine.

Nobody can fail to notice the ever-increasing presence of the internet in almost all aspects of daily life, with seemingly everything now having some level of connectivity. Medtech is clearly no exception and in fact, is one of the technology sectors to most embrace the opportunities that Internet of Things (IoT) brings – with the interconnection of devices and systems via the internet (IoMT). However, innovating in the IoMT world may involve stepping into other areas of technology that are different to those with which the medtech community are familiar, bringing new challenges, new competitors, and the need for a new way of thinking, especially with regards to your intellectual property (IP) strategy.

In recent years, medtech companies have been developing ways to enhance products using the IoT. Just a few examples are wearable monitors that send data to a connected device or to a healthcare provider; smart medications that record how and when they are used and provide feedback for improving efficacy; data tags in manufacturing and packaging to monitor batch quality, shelflife, shipping and returns, etc. Each of these, and the many other applications being developed, requires transfer of data between devices.

A mistake I have often seen made in the medtech sector, even by otherwise IP savvy companies, is incorporating known communications technologies into devices without checking whether this is covered by existing IP. Whilst it may seem surprising, there is often problematic IP held not only by known competitors (whose own IP strategy you may be comfortable with), but more frequently by companies with whom you previously did not compete, since many big-name IT companies are now moving into the medtech space, and they may have a very different approach to IP. Should they enforce their IP rights, it can be very costly and damaging to a business, to the point you may have to remove your product from the market, and the accompanying compensation payable to them may be significant.

Therefore, it is important to rethink and modify your IP strategy if you want to take advantage of the IoT. One of the biggest changes I recommend is to consider the IP landscape at the earliest stage in development and as frequently as possible, since the technology sector is very fastpaced (compared with MedTech) and new IP can arise even when you think you have cleared a product. Tech companies are extremely prolific when filing IP, so it can often seem like there is a huge amount of IP covering what you want to do and no way through it. However, much of this IP is speculative and unlikely to be valid in broad terms, so its existence does not necessarily prevent you from doing what you want, but you will need clear, practical advice to help you make strategic decisions.

Another aspect that is quite often neglected by medtech companies is filing your own IP. Medtech is generally a very innovative sector, with developments that stand out as being inventions. Therefore, it’s common for medtech companies to see communications technologies as not adding anything particularly innovative to a product and to not seek protection for the new IoMT device. You are missing out on valuable protection that not only can be used to stop competing products, but can also be a bargaining and commercial tool should you find yourself within the IP protection of another company and in need of a licence for example.

Another area that must be considered is data protection, especially with the recent legislation changes such as the EU General Data Protection Regulation (GDPR) which came into force in 2018. How you implement GDPR may lead to IP opportunities and again, commercial opportunities with regards to licensing.

Timely and appropriate IP advice throughout your development cycle is essential. You can spend large amounts and still not avoid the pitfalls, whereas getting it right from the very start can save costs over time. As you are moving into another sector, with big name players that are typically more aggressive with their IP, and whilst it can be daunting, the rewards can be significant. As Facebook’s Mark Zuckerberg said: “In a world that’s changing really quickly, the only strategy that is guaranteed to fail is not taking risks”.

This article was first published in the March/April 2019 edition of Med-Tech Innovation Magazine.

Mathys & Squire will be exhibiting on stand F58 at the Med-Tech Innovation Expo on 15-16th May.

Why is Facebook Suing Over Trade Mark Infringement and Cybersquatting?

Legal action and Facebook is nothing new, but why – and who – is the social media giant suing over trademark infringement and cybersquatting? At the start of this month, Facebook released a short blog post confirming it was taking legal action against a small cluster of Chinese websites. This legal move was prompted by the fact that these websites were selling fake accounts, followers and likes on Facebook and its sister company Instagram.

In the blog post entitled Cracking Down on the Sale of Fake Accounts, Likes and Followers, the company said it was enforcing its “rights under US intellectual property law” based on the websites “illegal use” of its trade marks and brand. It concluded by saying: “Inauthentic activity has no place on our platform. That’s why we devote significant resources to detecting and stopping this behaviour, including disabling millions of fake accounts every day. Today’s lawsuit is one more step in our ongoing efforts to protect people on Facebook and Instagram.”

What is Trade Mark Infringement?

Trade Mark infringement is the unauthorised use of a trade mark by a company offering a related or competing service or product. That being said, it’s important to know that a trade mark need not be identical to constitute an infringement. It comes down to whether the use of the trade mark is likely to confuse consumers. In this case, the explicit use of the word ‘Facebook’ in the domain names, along with the fact that the sites were offering fake accounts, likes and followers (a breach of Facebook’s terms of service) was deemed sufficient for the company to decide to take action.

What is Cybersquatting?

Cybersquatting is defined under US federal law as the practice of registering, selling or using a domain name with the intention of profiting from a trade mark belonging to someone else. In the case of this particular lawsuit, Facebook is alleging that the companies in question are using its trade marks by using web addresses such as ‘facebook88.net’, ‘myfacebook.cc’ and ‘infacebook.cc’. By using the ‘Facebook’ name, these sites are attempting to profit from the goodwill and reputation that has been built up in the brand.

The Facebook Lawsuit

The lawsuit that Facebook has filed alleges that four Chinese companies and three individuals based in China have been operating a number of websites since 2017, and that by promoting the sale of bogus accounts it is infringing Facebook’s trade marks and terms of service. The companies implicated are Xiu Network (Shenzhen) Science and Technology Company, Xiu Feishu Science and Technology Company, Xiufei Book Technology Co. and Home Network (Fujian) Technology Co. Ltd.

Facebook is asking for the companies to be banned from creating misleading sites and fake accounts, and for the profits derived from the activity to be awarded to Facebook along with $100,000 for every infringing domain name.

The lawsuit is an unusual move for the company, which already purges millions of fake accounts every day; 2.1billion were disabled between January and September 2018 by its own account. So, the move to file a lawsuit is likely due to the extent of infringement in this particular instance. Regardless of the outcome, other companies operating in the same manner would be wise to keep a close eye on the verdict. In issuing of the lawsuit, Facebook is sending a clear message that illegal activity will not be tolerated.

Mathys & Squire is one of Europe’s most highly regarded intellectual property firms. Contact us to find out how we can help ensure your business grows legally, and how we can help enforce your intellectual property rights.

Chimeric antigen receptors (CARs) are artificial proteins that are used to redirect immune system cells to attack targets that are normally invisible to them, such as cancer cells. CARs are typically made by fusing the antigen binding domain of an antibody specific to a target of interest to the transmembrane and intracellular signalling domains of receptors normally found on the surface of immune cells. When a T-cell or other immune cell expressing the CAR encounters the target, the CAR binds it and stimulates the cell to attack.

Interest in CARs has rocketed following reports a few years ago that patients with refractory blood cancers were achieving complete remission after CAR cell therapy. Even a single dose of CAR cells can be highly effective, and for a very long period of time, because unlike conventional drugs, CAR cells are able to live on and patrol inside the body, much like normal immune cells. Due to its impressive effects in treating blood cancers, an anti-CD19 CAR-T therapy called Kymriah (tisagenlecleucel) became, in 2017, the first genetically modified cell therapy approved by the FDA. The Kymriah approval was shortly followed by FDA approval of a second anti-CD19 CAR-T therapy called Yescarta (axicabtagene ciloleucel). Both drugs gained approval in Europe in 2018, and it is likely that more CAR cell therapies will be approved, particularly in relation to blood cancers.

Current Challenges
One of the main challenges of CAR cell therapy is manufacture. ‘Foreign’ cells are normally rejected by the host immune system, so it is important to manufacture CAR cells that are a suitable match to the recipient. In the case of Kymriah and Yescarta, this is achieved by using the patient’s own T-cells to engineer the CAR cell therapy they are going to receive. Both drugs are thus a form of ‘personalised medicine’, the manufacture of which for patients in different countries presents a logistical challenge that increases the cost of therapy. In the US, for example, the list price of Yescarta is reported to be $373,000.

Patent Landscape
The growing interest in CAR-T therapy has been accompanied by massive growth in the number of CAR-related patent filings, see figure 1.

The biggest PCT filers by applicant name include Cellectis, Juno Therapeutics, Novartis, the University of Pennsylvania, and the US Department of Health and Human Services. Juno, which has been acquired by Celgene, has a candidate anti-CD19 CAR-T therapy called JCAR017, and Celgene has a candidate anti-BCMA CAR-T therapy called bb2121 (developed in collaboration with Bluebird Bio), both of which are in clinical testing against blood cancers. Novartis owns the Kymriah product, which it developed in collaboration with The University of Pennsylvania. Other significant players include Kite Pharma, now part of Gilead, which owns the Yescarta product. Both Kite and Novartis also have candidate anti-BCMA CAR-T therapies that are undergoing clinical evaluation.

The patentability of CAR cases is often based on aspects of CAR design. The choice of target antigen or binding domain may give rise to patentability, much like in conventional antibody cases. Other design aspects include the choice or combination of transmembrane and intracellular signalling domains, and the format of the CAR, which may be presented e.g, as a single molecule or as a split structure in which the target binding and intracellular signalling functions are partitioned into separate molecules that can associate.

Patent protection can also be sought for aspects of CAR cell manufacture. For example, Gilead highlights Kite’s European and US manufacturing patent applications as relevant to its Yescarta product. Particular medical applications of CAR cells may also form the basis of patentability.

With an increasingly crowded patent landscape comes litigation. Kite has already tried – unsuccessfully – to invalidate a US patent relating to Sloan-Kettering’s CAR technology, and further disputes seem inevitable.

The Future
It is likely that approval will soon be given for the treatment of further forms of blood cancer using CAR cell therapy, and it is hoped that this new class of drugs will also prove effective at treating solid tumours. Much research effort is also going into the development of ‘universal’ CAR cells – an off-the-shelf product that does not require personalised manufacturing. Cellectis and Celyad both have universal CAR-T therapy candidates in clinical testing.

This article was first published in the March 2019 edition of Intellectual Property Magazine.

In 2016, a group from academia, industry, funding agencies, and scholarly publishers produced a paper on how the infrastructure supporting the reuse of scholarly data could be improved, with the underlying objective of extracting the maximum benefit from research investment. 

The paper outlined the FAIR guiding principles for scientific data management and stewardship: findability, accessibility, interoperability and reusability. The principles aim to bring clarity to the goals of good data management and stewardship, and to define simple guideposts to inform those who publish or preserve scholarly data.

One of the key benefits in increasing the availability of data is that it helps improve its accuracy. For instance, data from different studies may be combined to create large data sets for analysis by the scientific community. It will also be subject to greater levels of peer review thereby allowing any assumptions used in creating the data, or conclusions that are drawn from it, to be informedly challenged.

While an increase in the accuracy of data is undoubtedly a good thing for the scientific community, there is a question of whether improvements in the availability of data will inevitably lead to innovators losing control of their intellectual property.

What Are the FAIR Principles?
The original 2016 paper elaborates on what is meant by findability, accessibility, interoperability and reusability. However, one of the clearest interpretations has been set out by the Association of European Research Libraries (LIBER), an early endorser of the principles. According to LIBER:

• findability requires that data and supplementary materials have sufficiently rich metadata and a unique and persistent identifier;
• accessibility requires that data and metadata are understandable to humans and machines. Data is deposited in a trusted repository;
• interoperability requires that metadata use a formal, accessible, shared, and broadly applicable language for knowledge representation; and
• reusability requires that data and collections have clear usage licences and provide accurate information on provenance.

What is absolutely clear from the original 2016 paper is that the FAIR principles are intended to apply not only to ‘data’ in the conventional sense, but also to the algorithms, tools, and workflows that led to that data. 

And What Is Their Impact?
The FAIR principles reflect the movement in recent times towards open science values. Many of the FAIR principles had already been adopted in the scientific community.

In the original 2016 paper, the following initiatives were highlighted as examples of systems in which at least some of the FAIR principles were already being implemented: Dataverse (an open-source data repository software), FAIRDOM (integrating the SEEK14 and openBIS15 platforms in a FAIR data and model management facility for systems biology), ISA16 (a metadata tracking framework to facilitate collection, curation, management and reuse of life science datasets), Open PHACTS (a data integration platform for information pertaining to drug discovery), wwPDB (an intensively-curated data archive about experimentally-determined 3D structures of proteins and nucleic acids) and UniProt (a comprehensive resource for protein sequence and annotation data).

In Actavis Group PTC EHF and others v ICOS Corporation and another [2019] UKSC 15, the Supreme Court had to consider whether claims directed to a new dosage regime of a drug were obvious. The patent (EP 1173181) was owned by ICOS Corporation and was the subject of an exclusive licence to Eli Lilly & Co. Its claims (including second medical indication claims in both the ‘Swiss-style’ and the newer ‘EPC 2000’ format) covered a dosage regimen of up to 5 mg per day for the compound tadalafil, sold under the brand name Cialis for the treatment of erectile dysfunction. Actavis sought to invalidate the patent on the basis of ‘Daugan’, which was the first medical use patent for tadalafil.

At first instance the judge had held that the dosage regime was non-obvious, but this was overturned on appeal. ICOS now sought to reverse the decision of the Court of Appeal.

The Supreme Court upheld the Court of Appeal’s finding of obviousness. In reaching this conclusion, the court listed 10 factors which were ‘relevant considerations’, including whether at the priority date something was ‘obvious to try’ and whether the research leading to the invention was of a ‘routine nature’, as well as whether the results of the research were surprising.

Although ICOS had argued that it was surprising to find that a dosage of 5 mg was effective and associated with reduced side-effects, the court nevertheless agreed with the Court of Appeal that this merely lay “at the end of the familiar path through the routine pre-clinical and clinical trials’ process” given the context of the routine Phase IIb dose-ranging studies in which the dosage had first been tested. Once the dosage had been identified via routine studies, any ‘surprising’ effects associated with it were merely an ‘added benefit’ and not sufficient to confer an inventive step. The court did not provide any guidance as to how the various ‘relevant considerations’ should be weighted, stressing that this would depend on the facts of any particular case. It also explicitly recognised that, in principle, valid dosage regime patents may exist. However, it seems that in many cases dosage regime patents may now be found invalid in the UK unless (for example) there is something unusual or non-routine about the circumstances surrounding identification of the dosage.