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 BMS, Pfizer 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 of ‘IP 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’ 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?
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.
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.
At a packed hearing in Munich, Board 3.3.8 in five-member form upheld the decision of the Opposition Division revoking EP-B-2771468 – an important CRISPR patent belonging to the Broad Institute, MIT and Harvard – for lack of novelty over intervening art due to loss of priority. The appeal in case T 844/18 was of significance not only to the CRISPR community, but also to users of the European patent system more generally due to the questions of law it raised.
The case turned on the issue of legal entitlement to priority. The PCT request for the application from which the patent derived had not included all of the applicants for the US provisional applications from which priority was claimed, or their successors in title. The proprietors argued that this did not matter, for three innovative reasons, any of which would, if accepted, mark a radical shift in European practice.
Firstly, the proprietors argued that the EPO is not empowered to assess legal entitlement to priority, in the same way that the EPO cannot determine entitlement disputes.
A second line of argument, which only became relevant if the first did not succeed, was that the EPO was wrong to assess legal entitlement to priority on the basis of the ‘all applicants’ approach, according to which all of the applicants named on a priority application, or their successors in title, must be named on the later European filing in order to introduce priority rights. The proprietors argued that the approach limited access to international protection and was therefore contrary to the object and purpose of the Paris Convention. They advocated an approach requiring only one applicant / successor in title in common.
A third line of argument, which only became relevant if the second did not succeed, was that the EPO should determine the person who ‘duly filed’ a priority application under the national law of the state in which the priority application was filed. According to the proprietors, the omitted applicants were not, under US law, persons who had duly filed the provisional applications with respect to the subject matter claimed in the PCT application, or successors in title thereto, because they had not contributed to that subject matter or derived rights from an inventor who had contributed to that subject matter.
The opponents, one of which was represented by James Wilding and Alex Elder of Mathys & Squire, argued that EPO practice in assessing legal entitlement to priority aligns with the object and purpose of the Paris Convention, finds support in the wording of the legislation and in the established case law, and should therefore continue.
Events took an interesting turn at the start of day three of the hearing when, having heard the parties on only the second argument, the Board indicated that it was minded to seek guidance by referring questions to the Enlarged Board of Appeal in relation to all three arguments. The opponents protested that they should be heard on the first and third arguments before a decision to refer was taken, and so the hearing continued with a discussion of the remaining arguments.
After hearing the parties, the Board concluded on the fourth day that it could decide the case without the need for a referral. The Board went on to reject all three of the proprietors’ arguments. In upholding the decision of the first instance, the Board opted to follow established EPO practice. Whilst that did not work to the proprietors’ advantage, it does help maintain certainty within the European patent system.
In this article for Business & Innovation Magazine, we talk to TBAT Innovation about R&D Tax Credits.
Research & Development (R&D) Tax Credits are a UK tax incentive, designed to encourage investment in R&D, which enable businesses to reduce their tax bill, or claim payable cash credits as a proportion of their R&D expenditure.
R&D Tax Credits can be a hugely effective way to inject additional finance into a business, and in recent years, there has been a steady increase in the number of businesses claiming them. However, there is still a large proportion not taking advantage of the scheme and for those that are, they may not be claiming all they’re entitled to, as qualifying R&D is potentially being overlooked.
Business Development Manager, Vincent Seddon, from TBAT Innovation, who provides business support for SMEs and, in particular, R&D advice nationwide, tells me: “There seems to be a lack of understanding in relation to what R&D means when it comes to making R&D Tax Relief claims, and consequently, what can and cannot be claimed.”
He goes on: “It can be difficult to navigate areas of the HMRC guidelines, and it’s important for an R&D Tax Consultant to take the time to fully consider and understand your business’s technical projects to identify all eligible activities. In many cases, making an R&D Tax Credit claim is left to the company’s accountancy firm, but do they have the experience, the time and the technical expertise to build a robust and maximised claim on your behalf?”
Some of the definitions below can be a little ambiguous, but if you and your business have said ‘yes’ to any of them, then you may be able to claim back some of your R&D spend.
Your project may result in a new process, product or service, or improve on an existing one.
To make an R&D Tax Relief claim, it’s important to invest time gathering relevant information in relation to your spend, as this can have an impact on the claim value. It is also crucial to include technical reports to demonstrate that R&D has been completed, focusing on the technical uncertainty faced.
Vincent goes on to explain, “It’s a long process to follow and can be quite time consuming if it’s done in-house. Important elements can be perceived not to be R&D, and potentially be omitted, or even worse, overlooked. Using a specialist R&D Tax Credit consultant can help avoid this from happening and serve as a fresh pair of eyes overseeing the claim.”
When working with businesses, it is always a sensible approach to ensure that there is a robust IP strategy in place which takes R&D into account. Quite often R&D is focused on crowded technical areas and it is important to work with an IP firm to help you uncover any prior art or patents from other businesses where R&D efforts may provide limited scope.
At Mathys & Squire, we work directly with R&D teams and technical directors, and can provide advice such as patent searching and identification of any prior art which could be used to help companies ensure they do not embark or invest time in developing new technologies which may, or may not be eligible for R&D claims.
In summary, if you are not claiming R&D Tax Credits, or are claiming, but are unsure whether you are including all your eligible spend, get in touch with an R&D Tax Relief expert.
This article was first published in Business & Innovation Magazine in January 2020.
In this article for Open Access Government, Laura Clews, managing associate at Mathys & Squire, analyses the protection for innovative new products in the medical cannabis & CBD sector.
In recent years, ongoing medical research into the use of CBD (cannabidiol, a non-psychoactive compound found in the flower of the cannabis plant), for the treatment of conditions, such as epilepsy, stress, arthritis and Alzheimer’s disease, has become more widely publicised. This has, at least partly, contributed to the notable change in consumer perception of CBD and CBD-based products. Consumers have become more aware of the potential health benefits associated with CBD-based products and the distinction between CBD and other cannabis extracts, such as THC (tetrahydrocannabinol), which induce a ‘high’ upon consumption and so the demand for CBD-based products continues to rise.
It has been predicted that the value of the global legal cannabis market is expected to reach $66.3 billion by the end of 2025 (reported by Grand View Research, Inc.) and so it is no surprise that medical manufacturing companies have committed more funding into the research of new CBD-based drugs. In addition, the relaxation of legislation surrounding the use of CBD-based products in many countries has surely incentivised further research and innovation in this field.
Successful companies know that in order to secure a competitive advantage in rapidly developing markets, early protection of intellectual property (IP) rights is essential. However, as this market is fairly new, there is still some uncertainty as to how different patent systems across the world will approach the assessment of, for example, novelty and inventive step for CBD-based products, extraction methods and their uses.
Although it is not possible to protect a CBD compound per se, given that this compound occurs in nature, it is still possible to protect CBD-based products. For example, companies may be able to obtain valuable protection in the form of:
Also, at least under European practice, if a naturally occurring compound can be shown to have a specific technical effect, this compound may be patentable for particular use as a result of that effect. For example, the use of CBD or a medicament comprising CBD in the treatment of new diseases/ailments.
As with all patent applications, the applicant would still need to demonstrate that the claimed invention is novel and inventive in view of the prior art, as well as being industrially applicable.
As cannabis-based products were, until recently, illegal in most countries, there appear to be far fewer publicly available disclosures on methods of producing cannabis-/CBD-based products, compared to other types of medicinal compounds or food and drink products, enabling those quickest off the mark to obtain broad protection. However, as cannabis has been used for thousands of years in medicine and textiles, the validity of the broadest patent claims on file may be uncertain in view of this prior use.
The validity of broad CBD-based claims has recently been assessed in the US. On 30 July 2018, United Cannabis filed an action against Pure Hemp Collective LLC in Colorado, alleging that products made by the Collective fell within claims 10, 12, 14, 20 to 22, 25, 27, 28, 31 and 33 of their U.S. Patent US 9, 730,911. As an example, Claim 10 of this patent states:
“A liquid cannabinoid formulation, wherein at least 95% of the total cannabinoids is cannabidiol (CBD)”.
In response, Pure Hemp filed an Early Motion for Partial Summary Judgment, arguing that the asserted claims of U.S. Patent No. 9,730,911 were invalid.
The arguments presented by United Cannabis as to the validity of the claims were based on two main points, (i) the liquid formulation itself, was purported as being novel; and (ii) alleged “markedly different physiological characteristics” of the liquid. However, the court was able to form a decision based on the first point alone.
In the decision by Judge Martinez, it was set out that: “Pure Hemp has failed to establish beyond genuine dispute that a liquefied version of cannabinoids and related chemicals at the concentrations specified in the 911 Patent is anything like a natural phenomenon. It may be true, as Pure Hemp insists, that cannabinoids in nature can take the form of a resin; that a resin can be highly viscous; that a highly viscous substance may at times be considered a liquid; and therefore it is logically possible that cannabinoids in nature might appear in a form that could, in some sense, be deemed a “liquid.”…Even accepting as much, the 911 Patent specifies threshold concentrations of cannabinoids and related chemicals. Pure Hemp nowhere claims that these precise concentrations, or anything close to them, occur in liquid form in nature.”
Whilst this case provides some certainty on patentable subject-matter in the US, it is not clear that the same approach would be followed in other countries. Indeed, under European practice, a known compound is not considered novel purely on the basis of the compound being provided in a purified form, as long as the degree of purity can be achieved by conventional means. In this way, the above claim may not be considered novel over any previous methods of extracting CBD (regardless of how effective these methods are).
Although the use of cannabis-based products for medical purposes is legal in many US states, to date, the US Food and Drug Administration (FDA) has only approved one CBD-based drug, Epidiolex, for treating a rare, severe form of epilepsy. It has been reported that further drugs have not yet been approved due to the limited information available about CBD, including about its effects on the body.
Similarly, in the UK only two CBD-based drugs have been awarded approval by the Medicines and Healthcare Products Regulatory Agency (MHRA) – Epidiolex and Sativex (which is a mouth spray that contains a mixture of THC and CBD for treating muscle stiffness and spasms in patients with multiple sclerosis).
The House of Commons Health and Social Care Committee published a report on 18 June 2019 – “Drugs policy: medicinal cannabis – Sixteenth Report of Session 2017-19” discussing that whilst medicinal cannabis was changed from Schedule 1 to Schedule 2 of the Misuse of Drugs Regulation 2001 in November 2018, allowing specialist doctors to prescribe it and for products to be available for further research to be conducted, the committee believes that further robust clinical trials are necessary in order to test the efficacy and safety of such medical products before the approval of further drugs can be granted.
This article was first published in Open Access Government in January 2020.
