In this article for Open Access Government, Mathys & Squire Partner Andrew White argues that widespread adoption of electric vehicles is key to achieving net-zero carbon emissions.
If the UK Government is to meet its target of net-zero carbon emissions by 2050, then the widespread adoption of electric vehicles is key. When combined with a wider shift in how electricity is generated in the UK, electric vehicles truly do offer a more efficient alternative, with a lower carbon footprint than conventional internal combustion engines. To date, drivers who have adopted electric vehicles are those with the ability to charge their vehicles either off-street, at home, and/or at work.
However, if the UK is to see more widespread adoption of electric vehicles, then the issue of providing sufficient access to electric charging points for those who do not have the luxury of off-street parking needs to be addressed. Indeed, with a growing recognition of the problems associated with poor urban air quality, the need for electric vehicle adoption to foster net-zero carbon emissions would appear to be greatest in locations that pose challenges in providing sufficient charge points.
Ameliorating any real (or perceived) barriers that drivers may have about getting access to an electric vehicle charge point and/or ‘range anxiety’ is crucial. One solution may be to provide charge points in public car parks, transport nodes, shopping centres, etc., allowing drivers to use their leisure time to fully recharge their vehicles. Providing enough residential on-street charge points will also be important. If sufficient charge points are provided, drivers would not be concerned about the ability to guarantee a space to re-charge when they return home after a journey, which may be the case at present due to relatively sparse charge points in towns and cities.
If there is to be a wider uptake in electric vehicles in the UK, then drivers need to perceive charge points as (i) accessible; (ii) in a good state of repair; and (iii) that a database of their locations (e.g. for use via a smartphone app or similar) is accurate and up to date so that a charge point can always be found when needed.
The government’s recent announcement to double residential street charge point funding and increase access to real-time information can, therefore, only be welcomed, but it may not be a silver bullet. Typically, residential charge points work based on delivering a slow charge over the course of the night (e.g. over nine hours) so that the vehicle is charged and ready to go in the morning. While this may be suitable for the ‘normal’ commute for many drivers, those taking ‘out of the ordinary’ journeys – or deviating from their normal routine – may still have concerns.
One way in which Britain can bounce-back from COVID-19 is evidenced by the UK Government’s ambition to build “a network of rapid charging stations for electric cars,” said Transport Secretary, The Rt Hon Grant Shapps MP during May 2020. The UK Government had a vision that each motorway service area will have no less than six ultra-rapid charge points by 2023. In the future, it is anticipated that drivers can charge their cars in around 15 minutes, which is three times quicker than they can today.
The Transport Secretary recently remarked that while the car industry has of been very badly hit during the COVID-19 crisis, sales figures for April 2020 tell us that for the first time, “the two biggest selling models were both electric vehicles.” Shapps added that to keep the momentum of the “quiet, clean car revolution going”, £10 million of funding will be allocated to support extra car-charging points. The Transport Secretary provided some additional thoughts that follow on from this ambition. “The car will remain the mainstay for many families and, as well as backing electric infrastructure, we’re going to accelerate the filling of pot-holes that plague so many road users,” he commented.
It is interesting to note as part of tough new standards for cycling infrastructure, the UK Government is aiming for “at least one ‘zero-emission city,’ with its centre restricted to bikes and electric vehicles,” the Transport Secretary added. Finally, a comment by the Transport Secretary sums up well the UK Government’s ambition for making electric vehicles the “new normal” of the future. “We want to make electric cars the new normal, and ensuring drivers have convenient places to charge is key to that,” Shapps said.
As an expert in the field of battery technology, Mathys & Squire client Stephen Irish, Commercial Director at Hyperdrive Innovation, comments that a solution to this issue may be the provision of ‘fast charge’ points. If a number of these are distributed in the community at accessible locations amongst slower ‘normal’ charge points, then drivers can opt to charge their vehicle with a fast charge point when they are going to make such a journey.
Stephen notes that there are downsides, however. Fast charge points work by delivering much higher power to electric vehicle batteries, which can create excess heat and result in the batteries and charging circuitry becoming extremely hot. Not only is this much more inefficient, but in some cases, it may also require some degree of active cooling. Moreover, if repeated frequently, the use of fast charging can rapidly degrade the car’s battery.
He adds that the battery’s on-board management system (known as the battery management system or BMS) is key to managing and mitigating this degradation and is critical to how the batteries interface with the charge point.
By spotting pinch points between current technology and future commercial need, innovative technology can be turned into commercially valuable intellectual property.
A version of this article was published by Open Access Government in June 2020.
In the ruling of the Düsseldorf Higher Regional Court (2 U 31/16), the limitations of the scope of protection of an SEP arising from a FRAND declaration, as well as existing licence agreements in the case of transfers of rights of the SEP, are examined in more detail.
As an SEP owner, Unwired Planet claimed for information and damages from a granted European SEP with effect in Germany from Huawei (SEP user). The SEP was transferred earlier from Ericsson to Unwired Planet for reasons of better licence generation.
However, Ericsson had already started to conclude its own (old) licence agreements before the transfer. The key procedure points to be considered were therefore:
For the SEP, Ericson had filed a FRAND declaration, and since such a declaration limits the effect of the SEP, it automatically follows the SEP in the event of a transfer and is transferred to the new SEP owner. In this case, Unwired Planet itself had also issued a corresponding FRAND declaration.
Due to the transfer of the effect of an existing FRAND declaration from the first SEP owner to the new SEP owner, the Higher Regional Court of Düsseldorf decided that the existing old licence agreements remain important for the assessment of whether a licence offer meets the FRAND criteria. For the court, the very first licence agreement is decisive here, since no examination for discrimination can be made at that point in time. Rather, only the criteria ‘fair’ and ‘reasonable’ must be met.
From the point of view of the Düsseldorf judges, this must be interpreted as a commitment to a licensing concept which may only be deviated from at a later point in time in limited and justified cases. This concept also continues to exist not only ‘on the merits’ but also concerning ‘amount and content’ for the transfer of the SEP, so that the new SEP owner is also bound by this concept.
In the event of transferring an SEP to a new owner, the existence of a licensing concept established by old licence agreements, in addition to a FRAND declaration, also constitutes a restriction on the new owner’s use of the SEP.
From the Higher Regional Court of Düsseldorf’s perspective, the content and conditions of existing old licence agreements are therefore decisive for the assessment of the amount of a FRAND licence. Thus, the new SEP owner must ensure that he has access to such old licence agreements if he is interested in exploiting the SEP, including judicial enforcement. Confidentiality obligations in such old licence agreements cannot release the new SEP owner from this obligation under the Düsseldorf Higher Regional Court per se.
As the owner of an SEP, special attention should be paid to the very first licence agreement. Its conditions must meet the criteria of ‘fair’ and ‘reasonable’ and sets the standard values for the licence rate and reference value for all future licence agreements.
As the purchaser of an SEP, the restriction of the SEP’s effect by the automatic transfer of the FRAND declaration and by the licensing concept already established from old licence agreements must be considered. When drafting the transfer agreement, it should also be ensured that the new SEP owner has a right to access and a right of presentation for old licence agreements in legal disputes in order to enable the SEP to be exploited.
As employers contemplate the grim possibility that redundancies might be unavoidable during this time of uncertainty, the rigorous governance of commercially sensitive secret information and intellectual property (IP) becomes more vital than ever.
For most technology and engineering businesses, the most valuable IP is its people – and the knowledge each of them carries around in their heads, that which they will carry into any future employment if they move on.
Employers often assume that everything confidential that an employee cannot disclose during their employment is a trade secret, which, if the employee left the company they could not use in employment by a competitor or in their own competing startup. This is not the case.
There is a distinction between trade secrets and the employee’s own know-how. An ex-employer can take legal action against an ex-employee or his/her new employer to restrain use of trade secrets, but unless they have taken the proper steps, the ex-employer cannot do anything about the ex-employee making use of their own know-how.
The boundary between these two types of confidential information can be unclear. It is possible for something which starts out as a trade secret to cease to be treated as such, because of the way it is handled in a business. Thus, in some circumstances, information handling practices can cause control of a valuable once proprietary secret to be lost when employment ends.
The law recognises that employees may use different types of information in their employment. Firstly, there is information which is not confidential. Secondly, there is information in the form of the employee’s knowledge which the employee must treat as confidential during the period of his employment, but which they are not restrained from using or disclosing after the employment has ended. Thirdly, there are trade secrets.
Even prior to the adoption of the Trade Secrets Directive in 2018, this third class of information had its own definition and required different treatment. The second class of information necessarily remains in the employee’s head and becomes part of his or her own skill and knowledge. Significantly – there is generally no restriction on the employee using or disclosing this second class of information, their own knowledge, after termination of the employment.
Firstly, there is no ‘bright-line test’ to separate one type of information from the other[1], and there is no magic way to make legitimate employee knowledge be deemed a trade secret. Proper management of sensitive information is needed however to ensure that valuable trade secrets do not inadvertently become, through mishandling, information which an ex-employer can no longer control when employment ends.
Secondly, the ex-employer must be able to identify the particular secret information at issue, and preferably to define it in a way which is broad enough to protect the ex-employer’s legitimate interests but without being so broad as to go beyond the enforceable scope of the ex-employee’s obligations.
For further information about managing your business’ sensitive and confidential information, distinguishing between trade secrets and employee know-how, get in touch with one of our IP experts.
[1] The Trade Secrets Directive (also known as the Trade Secrets (Enforcement, etc.) Regulations 2018) provides its own definition of a trade secret.
In this article for Compare the Cloud, we discuss the improved energy efficiency of Tiny AI, as well as the commercial benefit for companies in capitalising on the advancements they bring in giving AI more widespread and sustainable applications, through a developed IP strategy.
Advances in AI have changed the world in the last decade, whether indirect consumer-facing services like Amazon’s ‘Alexa’ or Apple’s ‘Siri’ which have become widespread, or behind the scenes with image processing; less glamorous inference; data processing; or control applications.
Whilst large scale necessarily cloud anchored applications will be here for the foreseeable future, cloud processing of AI requests places heavy demands on communications networks. Regardless of how communication technology advances, there will always be some issues of latency and reliability of connection. In a mobile world and for real-time safety-critical applications – with autonomous vehicles being one notable application – this can still be an important practical barrier to greater adoption.
The world is, unfortunately, experiencing the effects of the Covid-19 crisis at the time of writing, which has, among other things, greatly reduced human travel and transport energy demands. Data still travels, increasingly so, and a rising concern is the proportion of energy consumed by computing and communications. Although data obviously costs a lot less energy to transport than a person, it still has a finite energy and infrastructure cost. Rapidly growing individual streams of individual raw data from myriad mobile consumer applications of AI to and from data centres will hit bottlenecks. ‘Locally sourced’ intelligence can mitigate this.
The historical shift between cloud versus local or edge and mixed processing in other areas of computing will be familiar to most readers. You wouldn’t sensibly post a letter from the UK to California just to ask a question that the person at the post office counter could easily have answered for you. Using a data centre a thousand miles away to identify a smile could be compared to using a sledgehammer to crack a nut – even if you still need to use a cloud solution for part of the application. For many AI applications, an acceptable result can be obtained without needing the resources of a data centre, if a suitably trained processor is used locally. This can avoid, or at least reduce, communication demands and data centre processing demands – thereby making more applications more widely available.
A lot has been said and written about patent protection for AI. Speaking from my personal perspective as a patent attorney working in this area, I have frankly seen disproportionate hype around not much more than application of known techniques to a new data set, whereas some of the more interesting development (to me personally at least) is not really protectable for various reasons outside the scope of this article. That is not to say there is no scope for valuable innovation in the area of ‘conventional’ AI, but do not expect every application to be protectable, and be prepared to engage creatively with someone to root out what is commercially worthwhile protecting.
That being said, I do see plenty of scope for interesting and protectable development in making tiny AI work well. There are of course numerous applications which do work locally, but AI feeds on data. Having plenty of data to train on is important, so gathering available new input to grow that dataset is an important part of bootstrapping knowledge and effectiveness. This does not readily lend itself to individual smaller processors working on their own datasets.
Taking the right aspects of what can be done in the cloud and choosing to do them locally and then managing the interactions between local and cloud components still has a lot of unsolved problems. Getting the most out of all the data available to the local device’s eyes or ears without simply shipping all of it back to base, and keeping distributed processors efficiently up to date with the latest intelligence, is likely to play an important part in next-generation consumer AI applications.
I see AI as just following the cycle of other industrial developments a step or two behind other industries: we are now looking at improving energy efficiency; miniaturisation; data supply chain logistics; and security (which will be an issue – e.g. rogue data corrupting training). There is plenty of scope for innovation here as in other industries.
The backbone technology of AI is potentially valuable, and I predict numerous new companies will emerge to capitalise on niche areas, intellectual property (IP) being a key aspect of their strategy in order to maximise value and avoid simply being swallowed up or bypassed (and they may well be acquired based on that value). Companies working in AI often have a lot of smart people working on getting the product working well as a priority (for understandable reasons), but some give a lower priority to looking ahead to actively maximising ultimate value realisation. Creatively approaching the IP strategy is one component. It is always satisfying to see a company that has developed a great product do well, and frustrating to see one who did ok but could have done better. The key here would be for more companies to capitalise fully on the advancements they bring in giving AI more widespread and sustainable applications.
This article was originally published by Compare the Cloud in June 2020.
For more information on our IP expertise relating to artificial intelligence and machine learning, visit our page here.
Since the Court of Justice of the European Union (CJEU)’s decision in the case of Huawei v ZTE (July 2015) regarding competition law implications for FRAND-based standard essential patents (SEPs), various national courts have sought to clarify the scope of what can be considered ‘appropriate behaviour’.
In a recent SEP ruling, the Higher Regional Court of Karlsruhe comments on the interpretation of the four steps defined by the CJEU in 2015, and in particular, addresses the following key points:
Based on an SEP, the SEP user was sentenced in the first instance at the Mannheim District Court to cease and desist; to provide information; to destroy; to recall; and to pay damages. The SEP user appealed against this decision and was directed to the Higher Regional Court of Karlsruhe.
In this judgment, the Higher Regional Court of Karlsruhe confirmed that transmission of the infringement notice to the defendant is not absolutely necessary in order to fulfil the obligation under Step I of the CJEU decision. Instead, it is sufficient to send the notice of infringement to a group company which is responsible for licence negotiations and licensing within the group.
At the courts in Düsseldorf, a very high standard has been applied so far to the content of the notice of infringement. From the point of view of the Higher Regional Court of Karlsruhe however, it is sufficient that the SEP user is able to get a basic picture of the infringement allegation. For this purpose, contrary to the opinion of the Düsseldorf courts, no specific claim charts are necessary in Karlsruhe. Instead, reference to the SEP and the corresponding sections in the standard are adequate.
The Higher Regional Court of Karlsruhe’s deadline to reply to the infringement notice is considered to be two months. This relatively short period is justified by the fact that only an overview of the infringement notification is necessary for the first reply. A detailed examination of the merits of the infringement allegation is regularly conducted in the subsequent licence negotiations. However, if this deadline is missed, it is possible to make up for the failure to reply, even if the infringement proceedings are already underway. The same applies to the commencement of licence negotiations, provided that a pressure-free negotiation situation exists between the parties. In this aspect, a harmonised opinion emerged between the relevant courts in Germany.
The Higher Regional Court of Karlsruhe sets a lower standard than the courts in Düsseldorf for an assessment of whether a licence offer of the SEP holder meets the FRAND criteria. According to the present judgment, it is enough to hand over and explain the content of existing licence agreements regarding the FRAND assessment. In the present case, these reduced criteria were not taken into account, so the court considered the claims for injunction and recall to be abusive. In Düsseldorf courts, it is usually expected that full copies of these agreements must be submitted.
The Higher Regional Court of Karlsruhe also has a different opinion to the courts in Düsseldorf when it comes to the scope of accounting. Thus, in the present case, the SEP user must provide information on profit and costs in addition to the accounting regarding the FRAND license.
While the German infringement courts further clarify the CJEU requirements for SEPs, the courts in Düsseldorf, Munich and Karlsruhe/Mannheim all appear to apply the judgment differently on some key points.
For an SEP holder, this means that the choice of jurisdiction should be made with caution at this stage. In particular, the court in Mannheim/Karlsruhe seems to offer itself as comparatively friendly for an SEP holder, as the claims for infringement notification are lower, the scope of disclosure of existing license agreements is more limited, and the scope of the information that can be obtained through accounting is broader.
In this article for Open Access Government, Mathys & Squire partner Craig Titmus turns the spotlight on genomics and public health from a patent attorney’s perspective.
A genome contains the entire genetic code required to build and sustain an organism, and genomics is the study of that genetic code and its function. The essence of genomic research has long been a source of ethical debate, and yet it undoubtedly provides a hugely powerful tool for the understanding and improvement of public health.
More than 40 years have passed since Maxam & Gilbert first published their seminal paper on DNA sequencing (1), and today’s genetic sequencing capabilities are simply staggering. The genetic code is made up of ‘bases’ and there are more than three billion bases in the human genome. Viruses occupy the other end of the spectrum, with genomes around four-six orders of magnitude smaller than humans. It now takes roughly a day to sequence a human genome and costs are heading towards $100. With such high speed and low cost, whole genome sequencing is rapidly becoming the go-to technique for many types of genetic analysis, even when investigators are interested only in a specific region of a genome. Indeed, our overwhelming wealth of genomics information has become a challenge in itself and has been propelled into the world of big data.
As patent attorneys, we are responsible for a considerable number of inventions that rely upon genomic information, and the ever-increasing number of patent applications in this field is a testament to the advances in genetic research.
A major application of genomics has been in the identification of disease ‘markers’, which include genetic changes, or mutations, that cause or correlate with disease. One such example is the ‘BRCA1’ and ‘BRCA2’ (BReast CAncer) genes which normally function in repairing DNA and suppressing tumours. Changes in a BRCA gene can impair its normal function, and so people with a BRCA mutation are more likely to develop breast cancer. There is also a chance that the carrier of a mutated BRCA gene will pass the mutation on to their children. Analysis of the BRCA1 and BRCA2 genes is, therefore, a powerful tool in diagnosing increased risk of breast cancer and tracking the mutation through families.
Curiously, the Supreme Court of the United States held that a patent relating to the BRCA1 and BRCA2 genes was not eligible for patent protection in the U.S. because it relates to a product of nature (2). This was one of several landmark Supreme Court decisions that fundamentally re-wrote the rules of patentability in the U.S, particularly in the life sciences, and the effects of these changes are being felt in other patent jurisdictions such as Canada and Australia. Understandably, these legal changes have reduced the general commercial appetite for diagnostics research and for filing U.S. patent applications, but we would urge innovators not to be dissuaded – we have developed a number of strategies to navigate these rule changes, and continue to secure valuable patent protection for diagnostics inventions across the globe.
Genomics also plays a central role in personalised/precision medicine, which is frequently defined as providing ‘the right treatment, for the right patient, at the right time’. A patient’s genetic background can impact greatly on how well they will respond to a particular therapy, and ‘companion diagnostics’ make use of this information to tailor treatments to meet individual patient requirements. This type of genetic information is also being used to inform clinical trial design, because enrolling the most suitable patients into a trial helps to maximise the chances of success, whilst minimising the risk of poor patient outcomes.
Filing patents to protect companion diagnostics inventions can be an extremely effective way of extending the scope of protection for a given therapy, because the diagnostics patent may remain in force long after the corresponding therapeutics patent has expired.
Genomic research is also critical in the fight against COVID-19, where whole genome sequencing is already being applied on an unprecedented scale to help understand the epidemiology and spread of COVID-19. Governments across the world have recognised the importance of genomics by providing additional funding, and inter-institutional consortia have been established to share expertise and fast-track research. One such initiative is the new ‘COVID-19 Genomics UK consortium’, which received £20 million investment and is supported by the UK Government, the UK’s National Health Service (NHS), Public Health England, UK Research and Innovation (UKRI), and the Wellcome Sanger Institute, and involves numerous academic institutions.
Genomic research is also vital in the design of vaccines and therapeutics, including against COVID-19. Most vaccines work by mimicking a structure on the outside of a pathogenic virus or bacteria, and these so-called ‘antigens’ enable the body’s immune system to ready itself against future encounters with the same structure, such as when it is on the outside of the pathogen. The shape of these structures is written into the pathogen’s genetic code, and researchers are using this genomic information as a blueprint in the design of new vaccines against COVID-19.
These really are exciting times, at least from a genomics perspective. It is inevitable that our abundance of genomics data, coupled with increased collaboration and capacity to analyse those data, will continue to accelerate innovation and advancements in public health.
This article was first published by Open Access Government in May 2020.
References
In this article by IT Pro, considering what Tiny AI is, and how this emerging technology might develop, Mathys & Squire managing associate Andrew White provides his expert commentary.
Listed as one of MIT Technology Review’s 10 Breakthrough Technologies of 2020, this version of AI is set to make a real difference in solving important problems. But what exactly is it and what will its impact be?
Tiny AI, also known as Tiny ML in reference to machine learning (ML), is currently a big focus for AI researchers. The aim is to reduce the size of artificial intelligence (AI) algorithms; especially those that use large quantities of data and computational power, for example natural language processing (NLP) models like Google’s BERT. According to the MIT Technology Review, the larger version of BERT has 340 million data parameters and training it just once costs enough electricity to power a US household for 50 days.
“Tiny AI involves building algorithms into hardware at the periphery of a network, such as the sensors themselves,” explains Andrew White, a UK and European patent attorney at IP firm Mathys & Squire. “The idea is that they can be integrated into hardware to perform data analytics at low power, avoiding the need to send data back to the cloud for processing.” This improves latency as well as power consumption and enables Tiny AI to run on devices like our mobile phones, increasing their functionality but also improving our privacy as the data stays on the device.
Click here to read the full article, written by IT Pro in May 2020.
For further information on how our IP experts can help your business in the rapidly developing field of artificial intelligence and machine learning, click here.
Mathys & Squire and two of its clients – Wootzano and Imperial College London – featured in an article written by The Guardian on the increased demand for intellectual property legal services during the Covid-19 crisis, as innovators work to have their ideas patented.
A snippet of the article is available below:
Christopher Hamer, a partner at intellectual property specialists Mathys & Squire, agrees: “In terms of the volume of new work [since the crisis began], it was a striking amount, and I know other firms have seen this as well.
“A lot of it has been people coming and saying, ‘we have talked about this in the past and I would like to progress it.’ They are looking at their long-term future and trying to understand where they are going to be when things go back to normal.”
Although precise figures will not be available until next year, according to a spokeswoman for the Intellectual Property Office where British applications are filed, “early indicators suggest that input this year is up on the January to April period last year”.
[One] innovator who has done that is Atif Syed, CEO and founder of a firm called Wootzano. From a unit in Sedgefield, county Durham, the small company has developed what it describes as “electronic skin”, a highly stretchable polymer that Syed says can detect sensations “the way you and I would, understanding touch, pressure, temperature, humidity”.
While it could have many applications, the lockdown has underlined its potential use for robots picking soft fruit, where packing facilities faced with post-coronavirus labour shortages are increasingly looking at automation. The firm has been working on the skin for some time, but the crisis has driven the response from potential customers.
“Whenever situations like this happen, there will always be new applications [for the product],” says Syed.
One innovation with a very clear potential benefit has been developed at Imperial College, London, where a team of product designers and behavioural scientists have come up with a new product to encourage handwashing in developing countries.
“Everyone in the world knows about hand-washing, pretty much,” says project leader Weston Baxter, but research by the team in Tanzania showed that bars of soap were viewed by many as items for laundry and dish-washing, not for washing their hands after using the toilet.
In response, they developed a cheap and easily produced soap “tab” and dispenser system which, trials in the country show, dramatically increased rates of hand-washing.
In a time of immense new challenges, Baxter says, the opportunities for new ideas are enormous. “Whenever there is a lot of friction like this, it means there is a lot of opportunity for innovation. There has been a lot of very fast trial and error, certainly faster than we have seen in a normal time.”
A version of this article was published by The Guardian in May 2020 – click here to read the piece in full.
In this article by JUVE Patent, Mathys & Squire associate Alexander Robinson provides his comments regarding the Enlarged Board of Appeal ruling that plants and animals obtained from essentially biological processes are not patentable – contrary to earlier decisions by the European Patent Office (EPO).
The past decade has seen a huge battle on the patentability of plants. Encompassing tomato, broccoli and now chilli pepper, varying decisions have led to complex ethical debates. But now a conclusion is within reach. In case G 3/19, the Enlarged Board of Appeal at the European Patent Office has decided that plants, or animals, obtained via an ‘essentially biological process’ are not patentable. This upholds Article 53(b) EPC: “European patents shall not be granted in respect of plant or animal varieties or essentially biological processes for the production of plants or animals; this provision shall not apply to microbiological processes or the products thereof.”
The board describes the decision as a “dynamic interpretation of the exception to patentability.”
Alex Robinson, associate at IP attorney firm Mathys & Squire, says “The decision represents a complete reversal of a policy that the same body put in place only five years ago, and will come as a major blow to the agri-tech industry. This decision was widely unexpected and will be seen as politically controversial.”
“The decision should, for the most part, not affect the availability of patents relating to genetically modified organisms. Some comfort for agri-tech is also provided in that the decision will not affect all patents which were granted or filed under the previous rules.” With biotechnology patents increasingly encompassing high-end technology, this exception is especially important.
Click here to read the full JUVE Patent article, published in May 2020.
On 30 April 2020, the Court of Justice of the EU (CJEU) handed down the latest in a long line of decisions regarding the question of how precisely a product must be identified in a patent in order to be eligible to benefit from the further protection offered by an SPC. This latest decision will be welcomed for providing more clarity in some respects, but in others it raises new questions. These will doubtless be the subject of further debate and – most probably – further references to the CJEU in due course. In particular, the CJEU’s clarification of the level of disclosure required in the patent could potentially cause divergence in practice regarding small molecule pharmaceuticals and biologics, while its ruling that an SPC may not be granted for a product ‘developed’ after the filing date of the patent as the result of an ‘independent inventive step’ is certain to provoke controversy.
Royalty Pharma is the proprietor of a patent (EP 1084705) containing claims directed, in EPO-appropriate format, to the use of inhibitors of dipeptidylpeptidase IV (‘DPP-IV’) for the treatment of diabetes mellitus.
On the basis of the EP ’705 patent, Royalty Pharma applied to the German patent office (DPMA) for an SPC for the product sitagliptin. Sitagliptin is a DPP-IV inhibitor and therefore satisfies the functional definition provided in the patent. However, sitagliptin is not explicitly provided as an embodiment in the patent. In fact, sitagliptin was developed by a licensee of the patent after the patent was filed, and is itself the subject of a separate patent owned by the licensee.
The DPMA refused the SPC application on the grounds that, in the absence of a specific disclosure of sitagliptin in the patent, the requirements of Article 3(a) of the SPC Regulation (requiring that a product should be ‘protected by a basic patent in force’) were not met. Royalty Pharma appealed against this refusal and, on appeal, the German federal patent court turned to the CJEU in search of further clarification of Article 3(a). The questions which were referred to the CJEU concerned not only the necessary degree of specificity in the patent, but also a question regarding whether a product could be deemed ‘protected’ where, as in the underlying case, it had been developed only after the filing of the patent.
The requirement for a product to be ‘protected by’ a patent in order to be eligible for SPC protection appears, at first glance, to be a simple one. However, this has been the subject of controversy ever since the CJEU’s Medeva decision in 2011 introduced the requirement that a product should be ‘specified in the wording of the claims’ rather than merely falling within the extent of protection conferred by the claims with regard to infringement. National patent offices and courts have grappled with the question of the degree of specificity required, and repeated references to the CJEU on this point have failed to elucidate a clear and generally-applicable test.
As noted with some exasperation by the English courts, notably by Arnold J in Teva v Gilead [2017] EWHC 13 (Pat), it is clear in light of Medeva that ‘something more is required than the product falls within the scope of the basic patent’, but the ‘something more’ has remained elusive. CJEU decisions since Medeva seem to have clarified that an individual, explicit disclosure of the product is not necessarily required, but it remains uncertain what degree of abstraction is permitted.
Most recently, the CJEU’s 2019 decision in Teva v Gilead introduced a two-pronged test whereby a combination of active ingredients would be considered ‘protected’ by a patent if:
from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent:
Although this provided some further clarity, various questions remained open, including how an assessment of ‘fall[ing] under the invention’ was to be made, since the CJEU in Teva had not explicitly ruled out the idea (advanced in particular by the English courts, including in the case underlying the Teva decision) that the product should embody the ‘core inventive advance’ represented by the patent.
In Royalty Pharma (C-650/17), the CJEU held as follows (translated from the German version of the decision as no official English version has been made available at the time of writing):
1. Article 3(a) […] is to be interpreted as meaning that a product is protected by a basic patent in force […] if it corresponds to a general functional definition used in one of the claims of the basic patent and necessarily belongs to the invention protected by this patent, but without being individualized as a specific embodiment from the teaching of the patent, insofar as the product can be specifically identified, in the light of all information disclosed by the patent, by the skilled person on the basis of his general knowledge of the relevant area on the filing or priority date of the basic patent and taking into account the state of the art at that date.
2. Article 3(a) […] should be interpreted as meaning that a product is not protected by a basic patent in force […] if, though it falls under the functional definition given in the claims, it was developed after the filing of the basic patent after an independent inventive step.
The first point of the decision essentially reiterates the Teva test, and thus confirms that this applies to mono products as well as to combination products (as was the case in Teva). Notably, in reaching this conclusion the CJEU explicitly stated that the concept of the ‘core inventive advance’ was of ‘no relevance’ in the application of Article 3(a), thus closing the loophole left by the court’s failure to explicitly address this point in the Teva decision.
The CJEU’s reasoning provides some further information on how to assess whether a product can be ‘specifically identified’. According to the CJEU’s reasoning, this should include determining whether the product can be ‘directly and unambiguously derive[d] from the patent specification’, taking into account the prior art and the common general knowledge of the skilled person at the filing or priority date. This appears to be a conscious echo of the test applied by the European Patent Office (EPO) when determining whether an amendment to a patent application is permissible. If applied strictly by national patent offices, this test could impose a requirement for a high degree of specificity in the disclosure of the patent in order for a product to be considered ‘protected’.
Although the CJEU explicitly states that an individualised disclosure of the product is not required, applying an EPO-style ‘added matter’ analysis to determine whether a product can be ‘identified’ in a patent may nevertheless have divergent effects in different technical fields. In the case of small molecules, which can usually be defined via a series of ever-narrower general formulae and lists of substituent groups, it may in practice be more straightforward to meet the Teva test than in the case of biologics, where even a narrowly-framed functional definition will often leave room for debate as to whether any particular, individual product is disclosed within that definition.
The second point of the decision is likely to provoke the most controversy. The wording employed here is very similar to that employed by the German court which referred the questions underlying the decision. The CJEU justifies its finding by reference to underlying policy considerations, stating that an SPC holder would gain ‘unjustifiable benefit’ if an SPC were to be awarded on the basis of the results of research carried out after the filing of the application. However, the CJEU provides no explanation of how the criterion of ‘developed […] after an independent inventive step’ is to be assessed in practice.
In particular, it is unclear what standard should be applied when assessing whether or not an ‘independent inventive step’ is involved. Furthermore, it is not yet clear how a satisfactory distinction can be drawn between determining, on the one hand, whether a product involves an ‘independent inventive step’ over the disclosure of the patent (a test which is explicitly required by the CJEU) while also, on the other hand, avoiding an assessment of whether a product shares the same ‘core inventive advance’ embodied by the patent (a test which is explicitly ruled out).
The question of when a product can be said to have been ‘developed’ is also bound to generate further discussion. For example, in the case of new chemical or biological entities, is the product ‘developed’ when it is first synthesised or isolated, or only after clinical trials have been carried out in connection with the authorised indication? Does drug screening carried out on a computational basis, e.g. using an AI to predict whether a candidate compound will bind to a particular receptor, count as ‘development’? If clinical trials are required, what stage must have been reached in order for a product to be deemed ‘developed’?
As a further point of controversy, it might be noted that, in the case of small molecules, it is common for patents to include “paper” examples of individual compounds falling within the claim scope, which may nevertheless not yet have been synthesised and/or subjected to any clinical testing as of the filing date. At first sight it appears that such compounds would be deemed to meet the requirements of Article 3(a) as they are disclosed in the patent, and would therefore not be subject to the test of whether they were ‘developed after the filing of the basic patent after an independent inventive step’. However, this is difficult to reconcile with the policy-based rationale underlying the second point of the Royalty Pharma decision, namely that the SPC should not provide a reward for the results of research carried out only after the filing of the patent. Further questions may therefore arise as to whether this standard is applicable to all SPCs, not just those where the product is not individualised in the patent.
Once again, therefore, in answering one set of questions the CJEU has opened up a range of new uncertainties in how the SPC Regulation should be applied. The introduction of an EPO-style requirement for products to be ‘directly and unambiguously’ derivable from a patent, alongside an assessment of whether a product is the result of an ‘independent inventive step’, raises the prospect of further divergence between different national patent offices in the application of such tests. SPC applicants should therefore bear in mind that, if a choice of patents is available as the ‘basic patent’ for a new SPC application, a patent having an individualised disclosure of the product in question – or, failing that, the narrowest available definition encompassing the product – is normally likely to be the safest option for getting over the Article 3(a) hurdle.
Our summary of an earlier stage of this Royalty Pharma case is available here (September 2019).
For further information on SPCs, visit our specialist page, or contact the author of this article, Alexander Robinson.
