A piece by Managing Associate Laura Clews has been featured in Volume 2 of the Sustainable Food Digest by Food Matters Live, giving an insight into patents related to environmentally friendly food packaging.
An extended version of the press release is available below.
Due to their low cost of manufacture, versatility and durability, plastics quickly became an established material for packaging food and drink products. However, there has been a growing concern around the disposal of these non-biodegradable materials. Food and drink packaging formed 83% of household plastic waste produced in the UK in 2022, and of the 2.5 million metric tons of plastic waste generated in 2021, only 44% was recycled. The remainder is typically sent to incinerators and controlled landfills, which do not provide a long-term solution for ever increasing amounts of waste.
Consumers are therefore calling for the use of more environmentally friendly packaging which can degrade without releasing toxins. Manufacturers must ensure that packaging material has sufficient strength to contain and protect the product through its transport, storage and distribution. In the food and drink industry, it is also imperative that materials do not leach any undesirable chemicals into/onto the product. Additionally, packaging must provide a suitable water vapour transmission rate (WVTR) and oxygen permeability coefficient as the amount of moisture and oxygen present can affect the shelf life of the product. Producing cost-effective packaging is also important as most consumers are only willing to pay a small premium for environmentally friendly products.
Fortunately, the food and drink industry has risen to this challenge and many new and innovative packaging materials have been developed in recent years.
Edible Packaging
The concept of edible packaging and containers is not new – Italo Marchiony’s patent directed to a mould for ice cream cups was granted in 1903. However, many of the latest developments in edible packaging have centred around nutritious seaweed. At the London Marathon 2019, runners were offered “Oohho” by Notpla, edible seaweed pouches filled with a sports drink, in a bid to replace 200,000 single use plastic bottles. The capsules can be bitten to release the liquid inside and if the consumer prefers not to eat the seaweed film, it will naturally break down within 4 to 6 weeks once discarded.
Notpla’s patent application (GB 2,612,816) teaches that the edible membranes are produced by extracting a cellulose polymer from seaweed which is then pumped through a die to create two ribbons or films. The desired liquid is then injected between the two ribbons/films which are subsequently sealed.
Evoware have also utilised seaweed to produce edible packaging, creating containers, straws, cutlery, and even edible Ello Jello cups. These are formed by hydrating seaweed to create a slurry which is then cast and dried in the required form (WO 2014/108887).
As an alternative approach to edible containers, Italian designer Enrique Luis Sardi produced a new coffee cup for Lavazza in 2003. The design comprised a pastry dough molded into the form of a cup and a patented icing sugar coating on the inner surface, creating a waterproof barrier whilst also sweetening the coffee it contained. The cookie cup can be consumed after use, which could eliminate some of the 2.5 billion disposable coffee cups used each year in the UK, and provide a delightful snack.
Other Food-Based Packaging
For most adults, coffee is not simply a drink choice, but an essential for day-to-day life. It has been reported that in the UK, 500,000 tonnes of used coffee grounds are produced every year, most of which ends up on landfill sites. Fortunately, Kaffeeform, has found a way to repurpose this waste, creating durable cups formed from recycled coffee grounds and other plant-based resources that are hardened with biopolymers.
Thermoplastic Cellulose
Some companies have turned to plant power to create environmentally friendly packaging materials similar to plastics, including VTT Technical Research Centre of Finland Ltd, who have developed a thermoplastic cellulose material.
As the most abundant renewable organic polymer, the use of cellulose as a packaging material is highly desirable. However, it cannot be thermally processed and is virtually insoluble in traditional solvents. In order to impart thermoplastic properties, modification of cellulose is required. In the patent application filed by VTT (WO 2016/193542), the physical and chemical properties of a thermoplastic cellulose material are achieved by decreasing the molar mass of raw cellulose using a hydrolysis process and a long chain fatty acid modification. The material formed can reportedly be moulded to a desired shape using heat and processed using traditional plastic treatment processes. These materials are reported to be mechanically strong, provide excellent WVTR properties, and good heat-sealability.
Polyhydroxyalkanoates (PHAs)
PHAs are a class of bio-derived, biodegradable polymers which have tuneable properties ranging from rigid-brittle to rubber. They are compostable thermoplastics, and include natural polyesters produced by bacterial fermentation of sugar, glucose, or vegetable oil feedstock. The versatility of PHAs makes them a suitable candidate for a wide range of applications, providing a viable alternative to fossil fuel-derived plastics. Cambridge Consultants have developed a range of food and drink containers and utensils formed from PHAs.
The global biodegradable packaging market reached over $440 billion in 2021 and is expected to continue to increase. In addition, the global consumable packaging market was valued at $697 million in 2016 and is on track to reach $1.10 billion in 2023. As the development of more environmentally friendly packaging materials has the potential to create significant revenue for manufacturers, it is unsurprising that companies at the forefront of this research are looking to protect their intellectual property in advance of any product launch.
The United Nations’ 28th Framework Convention on Climate Change (UNFCCC) Conference of the Parties (COP28) will run from 30 November – 12 December 2023 at Expo City, Dubai, United Arab Emirates (UAE). The conference brings together politicians, activists, citizens, and business representatives from over 190 countries to set the course for the future of the green economy.
According to the United Nations (UN), “climate change is the defining crisis of our time and it is happening even more quickly than we feared.” Therefore, it is no surprise that COP28 is set to be one of the largest and most important international gatherings of 2023, with over 70,000 delegates expected to attend, including heads of state and leaders from 197 countries around the world.
Since the inception of the Paris Agreement at COP21 in 2015, UN member countries have been committed to keeping average global temperature rises around 1.5°C compared to pre-industrial levels and strengthening the world’s ability to adapt to the effects of climate change.
COP28 will present an opportunity to achieve further progress towards the goals of the Paris Agreement. The COP28 agenda will also be focused on four additional ‘paradigm shifts.’
COP28 aims to significantly reduces emissions and builds on the progress made during previous summits. In particular, COP28 aims to accelerate mitigation efforts to develop decarbonisation strategies aligned with the Paris Agreement, implement carbon market and non-market approaches to attract investments, ensuring a faster transition towards a fossil-free energy system.
The COP28 Presidency, in partnership with global state and industry collaborators, is advancing a comprehensive energy plan in alignment with scientific recommendations. This plan includes a focus on tripling renewable energy capacity, reducing oil and gas emissions, transitioning high-emission sectors to low-carbon technologies, promoting fossil-free transportation, and accelerating the phaseout of unabated coal power, while encouraging action, transparency, and accountability from companies and countries in line with global standards.
According to the COP28 Presidency, finance is essential for climate action, especially in developing countries, but the current financial system is inadequate to achieve the Paris Agreement goals, as those will require over $2.4 trillion annually by 2030. COP28 will urge the leaders of the developed countries to fund the Green Climate Fund, double adaptation finance by 2025, and scaleup adaptation efforts.
COP28 will aim to establish a new financial architecture, promoting dialogue on finance principles and reforming international financial institutions. This approach also seeks innovative solutions to mobilise private capital through regulatory reforms and voluntary carbon markets, accelerating climate progress in developing nations.
COP28 will focus on addressing the impacts of climate change by prioritising adaptation, enhancing adaptation finance and ensuring support for those facing severe climate impacts. The conference emphasises a Global Goal on Adaptation (GGA) framework, which aims to promote efforts on nature, food, health, water, and relief, and champions conservation and adaptation, highlighting the roles of women and indigenous peoples, while addressing climate-related humanitarian and security challenges through initiatives like Early Warnings for All and the Risk-informed Early Action Partnership.
COP28 will prioritise inclusivity, collaborating with diverse groups for active participation, emphasising gender balance, and promoting indigenous peoples’ access to finance. The Youth Climate Champion, Minister Shamma Al Mazrui, strengthens youth engagement through initiatives like the International Youth Delegates program, calling for continued support. The COP28 program embraces innovation and inclusivity, addressing various topics, and urges commitment to multilevel partnerships.
COP28 will set the course for the future of the green economy, and the four paradigm shifts will serve as a blueprint for the immediate action that might expect from the leaders attending the conference. We also expect governments to continue to implement local policies to support innovation in cleantech. All solutions and innovative concepts helping to fulfil the green agenda and mitigate climate change should be protected, and the best way to do so is with help of intellectual property rights.
At Mathys & Squire, we work with many cleantech clients on green technology breakthroughs and sustainable solutions. We are pleased to partner with companies and inventors who are addressing climate change and whose initiatives further the objectives set forth by COP28.
We eagerly await the results of the COP28 summit to see how they will influence the future of the green economy.
Data and commentary provided by Mathys & Squire has featured in an article by The Trademark Lawyer and Solicitors Journal, giving an insight into the issues that companies face amidst the recent surge in AI legal cases.
An extended version of the press release is available below.
The surge in new artificial intelligence (AI) legal cases to decide if infringements arise when copyrighted data is used to train AI systems, suggests that intellectual property law will struggle to keep pace with the speed of AI developments, says leading intellectual property law firm, Mathys & Squire.
Companies are increasingly concerned about both the risks of intellectual property infringements and confidentiality issues when using AI. Companies are even urging their advisors, such as law firms and professional services firms, not to input any of their information into AI systems such as large language models (LLMs) amid fears of data leaks.
Lack of clarity on AI related copyright breaches
Mathys & Squire says that, as with the growth of the internet, AI is going to see both the courts and legislation struggle to provide businesses clear direction on rapidly developing law relating to AI.
Clear infringements occur if generative AI systems are directly reproducing copyrighted information. However, it is unclear whether copyright infringements arise when the AI system producing them has been trained on this copyrighted information.
AI LLMs are fed massive amounts of data so that the model can automatically return results, which could be copyrighted material. This is creating confusion for owners of copyrighted material who want to protect their intellectual property rights.
Andrew White, Partner at Mathys & Squire says, “AI is creating a multitude of new challenges and questions in relation to intellectual property. Many legal cases are ongoing as individuals seek clarification on what their rights and responsibilities are. Companies with copyrighted material and AI companies themselves are in urgent need of clarification.”
Recent legal cases regarding AI copyright disputes include:
Some tech firms themselves have already taken action to provide clarity on the issue. Microsoft said it will take legal responsibility if customers get sued for copyright breaches while using its AI Copilot platform. Google has also reassured users of its AI tools on Cloud and Workspace platforms that it will defend them from copyright claims.
Companies fearful of AI data leaks
AI also presents serious potential confidentiality risks to companies. As data is stored in the cloud, data leaks can occur even if companies use their own private AI systems to safeguard against information being shared outside of their organisation.
Italy had previously banned ChatGPT over data protection concerns in April 2023 before reversing its ban later that month. Apple has restricted its employees from using AI tools over fears that confidential data could be leaked to outside sources.
Adds Andrew White, “It is important to have safeguards in place to ensure that confidential information is not input into these AI systems. Given the enormous risks, companies have made formal requests to their professional advisors like law firms and management consultants not to enter any of their information into AI systems.”
High-profile examples show that the entering confidential information into AI can have serious consequences. These include:
Leading intellectual property law firm Mathys & Squire has confirmed a round of promotions for equity Partners, Partners, and Managing Associates. The commentary provided by Mathys & Squire has featured in an article by The Patent Lawyer and The Solicitors Journal.
An extended version of the press release is available below.
Max Thoma and Andrea McShane have been promoted to Partner from Managing Associate.
Caroline Warren, Craig Titmus, Stephen Garner and Juliet Redhouse have all been promoted within the partnership.
Alan MacDougall, HR Partner at Mathys & Squire, says: “These promotions are part of our strategy to recognise and reward the array of talent that we have at the firm.”
“All those promoted have played a crucial role in our growth and we are delighted they will become an even more integral part of Mathys & Squire in the future.”
These promotions together with our recent senior hires of Helen Cawley, to head our trade mark practice, and solicitor Nicholas Fox, to strengthen our litigation practice, demonstrate the continued growth and development of our senior leadership team.
Data and commentary provided by Mathys & Squire has featured in an article by The Patent Lawyer and Solicitors Journal, giving an insight into the system’s growth since its introduction.
An extended version of the press release is available below.
100 days on from the launch of Europe’s new patent courts system, 10,976 Unitary Patents have now been registered, says leading intellectual property law firm Mathys & Squire. This shows just how quickly the new system has grown in just a matter of weeks since its introduction.
Under the Unified Patent Court (UPC), patent holders can obtain a single patent covering 17 European countries and enforce such patents and existing European patents in participating countries by filing a single claim under the regime of the UPC. Previously, organisations had to maintain separate patents in each individual country and could only enforce a patent in the country where that patent was registered. The new system significantly reduces this complexity making enforcing and maintaining patents in Europe easier.
Nicholas Fox, Partner at Mathys & Squire, says that the Unitary Patent system, which includes the new UPC, has already been successful in positioning itself as the new system of patent protection in Europe.
As well as the growing number of patents registered under the unitary system, the number of patent disputes heard in the new UPC is also gaining pace. 60 cases have already been filed in the court since it opened in June.
In comparison, only 33 patent cases have been filed so far this year in the High Court in London indicating that the total number of High Court patent cases is likely to be similar to the 35 filed in 2022, and significantly down on the 50 or so a year normally seen in recent years (52 cases in 2019, 51 cases 2020, 49 cases in 2021).
The UPC is Europe’s new system for patent enforcement, launched in June 2023 after being in planning for many years. The UPC is intended to introduce a uniform and more efficient patent litigation framework across the European Union and significantly reduce the cost and complexity involved in IP proceedings.
Says Nicholas Fox: “The launch of the UPC seems to be accelerating a trend that was already underway – the move of patent litigation away from the UK and towards Europe.”
“Brexit created the risk that the UK is becoming a secondary location for patent enforcement rather than a primary one.”
UK patent attorneys and the Unified Patent Court
Mathys & Squire explains that the UK is not part of the UPC system after leaving the European Union. However, almost all UK patent attorneys are also qualified as European patent attorneys and roughly a third of those have been able to register to have a right to conduct litigation before the new Court. This means that UK nationals constitute the second largest group of individuals with the right to practice before the UPC. This is despite Brexit having excluded UK solicitors from practising before the Court.
Only Germany (399 lawyers and 2,139 patent attorneys) has more IP professionals qualified to practise before the UPC than the UK (971 patent attorneys). The UK is significantly ahead of other similarly sized European countries such as France (93 lawyers, 446 patent attorneys) and Italy (124 lawyers, 322 patent attorneys) by this metric.
Owners opt 535,000 European patents out of the UPC
By default, all existing European patents granted by the European Patent Office are subject to the jurisdiction of the UPC. This potentially leaves such patents subject to revocation across multiple jurisdictions in a single revocation action. To address this, the UPC gives patent proprietors the right to opt such patents out of the jurisdiction of the new court.
Mathys & Squire says that owners have chosen to opt 535,000 patents out of the jurisdiction of the UPC. This represents approximately half of the total number of European patents in existence. Rates of opt-out have varied across technologies, reflecting the extent to which different industries consider central revocation to be a threat.
The areas with highest opt-out rates include pharmaceuticals (64% of patents opted out), textiles (64%) and organic chemistry (63%). Whereas the lowest opt-out rates are in respect of patents for engines (32%), semiconductors (34%) and mechanical elements (34%).
Despite many existing patents having been opted out from the UPC, that has not prevented revocation actions having been filed with the new court with 15 of the 60 cases filed to date being independent revocation actions against existing European patents.
As previously reported, the EPO’s ‘10-day rule’ will cease to exist from 1 November 2023.
From that date, EPO communications will be deemed to be delivered on the same date which they show, rather than 10 days later (as occurs at present). Thus, the date of a communication will be considered the date of notification and be decisive for determining the expiry of an applicable deadline.
Please note this only applies to EPO communications dated on or after 1 November 2023.
As a safeguard against late delivery of communications, the EPO has introduced measures to extend deadlines in cases where delivery of a document is disputed, and it can be established that a document was delivered to the addressee more than seven days after the date it bears. The burden will be on the EPO to establish when the document was actually delivered. In addition, if the EPO is unable to prove that a document has been delivered, the document in question will be reissued with a new date, and that new date will be used to determine the expiry of an applicable deadline.
Those receiving reports of EPO communications from Mathys & Squire from 1 November onwards may notice our correspondence emphasises that the ‘10-day rule’ no longer applies.
The ‘10-day rule’ originated as a ‘buffer’ to take into account delays in receiving documents by post. The abolition of this rule is part of a wider strategy to support digital transformation in the patent grant procedure at the EPO.
If you have any questions about these changes, please don’t hesitate to get in touch with your Mathys & Squire contact, or reach out to our team using our contact form here.
We are pleased to announce the appointment of new Partner Nicholas Fox.
Nicholas joins after four years in the London office of US IP specialist law firm Finnegan. Nicholas spent the previous eight years with Top 20 UK law firm Simmons & Simmons, where his primary focus was multi-jurisdictional patent litigation.
As an electronics, telecommunications and software expert, Nicholas has represented clients such as smartphone manufacturers, global software companies and pharmaceutical majors spanning multiple jurisdictions including Europe and Asia.
Nicholas is a respected voice in the intellectual property sector previously as a member of the Intellectual Property Regulation Board and currently as a member of the Joint Disciplinary Panel where he oversees complaints on breaches of the Patent and Trade Mark Attorney Code of Conduct.
Nicholas has also contributed to and written in many publications on patentability. He is a regular contributor to European Intellectual Property Review and most recently contributed to the Cambridge University Press’ The Cambridge Handbook of Artificial Intelligence: Global Perspectives on Law and Ethics.
Alan MacDougall, Partner at Mathys & Squire says: “We are delighted to welcome Nicholas to the team. His addition will expand our intellectual property litigation offering and continue to help deliver quality and impactful work for our clients. We are confident that his extensive knowledge and experience will prove a long-term asset to us and our clients.”
Nicholas Fox says: “I am excited to be joining the Mathys & Squire team. The firm is renowned for its contentious IP work and I’m looking forward to adding my experience to what is already a strong practice.”
Nicholas is qualified as a solicitor in England, Wales and Ireland as well as an Attorney-at-Law in New York State, adding significant strength to Mathys & Squire’s IP litigation team.
This release has been published in the World Intellectual Property Review, JUVE Patent and the Solicitors Journal.
According to the 2017 UK Commission for Employment and Skills Report, there is an annual shortfall of 40,000 skilled STEM workers, with the number of technical jobs expected to increase in the future.
Whilst some students receive guidance and support from their families, friends, and schools that help nurture them into this field, the barriers to entry, that poverty and social backgrounds can create, restrict many others. Founded in 2010 by Dr. Rebecca McKelvey, In2ScienceUK is a socioeconomic charity that strives to tackle this issue by providing young people from disadvantaged backgrounds with exciting opportunities to gain invaluable experience of STEM careers and research.
Mathys & Squire is proud to announce that we have recently partnered with In2Science in order to support their mission and will be sponsoring two students to go through the 2024 In2STEM programme.
By boosting diversity and inclusion across STEM sectors, In2Science looks to ensure that the UK remains at the forefront of science, technology, engineering, and maths-based industries whilst helping young people to obtain high earning jobs and economic stability. Data shows that STEM workers typically earn 20% more than employees in other fields do. By exposing students from low-income backgrounds to these opportunities, In2Science leads the fight against economic inequality within this sector.
In2Science allows students to work with, and learn directly from, STEM professionals and researchers, benefitting from their skills, expertise, and passion. They do so by offering work placements, information skills sessions and careers workshops, and offer access to expert advice from leading STEM professionals and researchers, including guidance on further education and beyond.
The 2024 In2STEM programme connects disadvantaged students with experienced STEM professionals from different fields. Taking place during the summer holidays, Year 12 and 13 students will be able to access in-person and online opportunities such as work placements, skills and careers workshops, and interactive events.
The In2STEM programme team will collaborate closely with the host professionals to ensure an engaging and beneficial placement that allows students of all abilities and backgrounds to explore STEM beyond the classroom, develop crucial skills, and boost their applications for further education. To round off the programme, In2Science will host celebration events to recognise the hard work and success of the students and volunteers.
At Mathys & Squire, we believe giving back to the community is incredibly important, and the mission of In2Science is one that resonates with every member of our team. Our decision to sponsor two students to take part in the programme is done with the goal to help foster the development of disadvantaged students into the innovators of the future, so that they can achieve success in their chosen field and become pioneers themselves. We are thrilled to help shape the next generation of scientists, engineers and technicians, who will stand at the forefront of innovation and research.
The Enlarged Board of Appeal has just issued its decision in consolidated cases G 1/22 and G 2/22 concerning the EPO’s competence to determine ‘same applicant’ priority issues and the assessment of priority in a PCT application (see our earlier coverage here and here). The decision seems to mark a dramatic relaxation of the EPO’s approach to same-applicant priority, and thus it is strongly pro-applicant/patentee.
First question
The Enlarged Board was asked to answer two questions, the first of which it rephrased thus:
“Is the EPO competent to assess whether a party is entitled to claim priority under Article 87(1) EPC?”
The question was answered as follows:
“The European Patent Office is competent to assess whether a party is entitled to claim priority under Article 87(1) EPC.
There is a rebuttable presumption under the autonomous law of the EPC that the applicant claiming priority in accordance with Article 88(1) EPC and the corresponding Implementing Regulations is entitled to claim priority.”
The first part of the answer does not change current practice: the EPO can continue to assess all aspects of the right of priority. The Enlarged Board held that priority rights are autonomous and that their creation, existence and effects are governed only by the EPC and Paris Convention. A contrast was drawn in this regard with entitlement to a European application, which is governed by national laws and assessed by national courts. The Enlarged Board further recognised the importance of comprehensively assessing patentability, which would only be possible if the EPO has the power to assess priority entitlement.
The second part of the answer signals a major change in the EPO’s approach to assessing priority entitlement. Under the autonomous law of the EPC, it is apparently now enough for the priority applicant to have consented to a priority claim in a subsequent application, there being no formal requirements laid down in this regard (“the EPO should … accept informal or tacit transfers of priority rights”), and the presumption being that consent was given. The presumption of entitlement is rebuttable because “in rare exceptional cases the priority applicant may have legitimate reasons not to allow the subsequent applicant to rely on the priority.” However, the rebuttable presumption is also “strong … under normal circumstances”, and thus a party challenging entitlement to priority “can … not just raise speculative doubts but must demonstrate that specific facts support doubts about the subsequent applicant’s entitlement to priority”.
Support for the rebuttable presumption is said to be found “taking into account (i) that the priority applicant or its legal predecessor must under normal circumstances be presumed to accept the subsequent applicant’s reliance on the priority right, (ii) the lack of formal requirements for the transfer of priority rights and (iii) the necessary cooperation of the priority applicant with the subsequent applicant in order to allow the latter to rely on the priority right.” A priority-claiming application is of course often filed before the priority application is published, thus implying a degree of cooperation between the priority applicant and subsequent applicant.
On the face of it, the new rebuttable presumption approach could put an end to many attacks on same-applicant priority in EPO opposition proceedings – an opponent may have to prove that the applicant for a subsequent application did not obtain consent from the priority applicant in order to claim priority, e.g. the subsequent applicant acted in bad faith. Indeed, the Enlarged Board envisages that the approach “substantially limits the possibility of third parties, including opponents, to successfully challenge priority entitlement.”
In further good news for applicants and patentees, the Enlarged Board also suggests that it should now be possible to fix those rare chain of title priority issues that do arise retroactively: “If there are jurisdictions that allow an ex post (‘nunc pro tunc’) transfer of priority rights …, the EPC should not apply higher standards.”
Second question
The second question, which applied if the Enlarged Board found that the EPO has jurisdiction to determine same-applicant priority, reads thus:
“Can a party B validly rely on the priority right claimed in a PCT-application for the purpose of claiming priority rights under Article 87(1) EPC in the case where
1) a PCT-application designates party A as applicant for the US only and party B as applicant for other designated States, including regional European patent protection and
2) the PCT-application claims priority from an earlier patent application that designates party A as the applicant and
3) the priority claimed in the PCT-application is in compliance with Article 4 of the Paris Convention?”
The Enlarged Board answered the question as follows:
“The rebuttable presumption also applies in situations where the European patent application derives from a PCT application and/or where the priority applicant(s) are not identical with the subsequent applicant(s).
In a situation where a PCT application is jointly filed by parties A and B, (i) designating party A for one or more designated States and party B for one or more other designated States, and (ii) claiming priority from an earlier patent application designating party A as the applicant, the joint filing implies an agreement between parties A and B allowing party B to rely on the priority, unless there are substantial factual indications to the contrary.”
The answer is not surprising in view of the answer to the first question. The threshold for disputing such an agreement between parties A and B is again high: “factual indications … of a substantial nature” are needed, e.g. evidence that “an agreement on the use of the priority right has not been reached or is fundamentally flawed”.
Conclusion
Many patents have been revoked by the EPO based on intervening art deemed relevant because priority entitlement was challenged and the patentee could not provide sufficient proof that the applicant for the European application (or international application designating Europe) was the successor in title to the priority applicant when the European application was filed. It seems likely that in many of these cases, the priority claim would be deemed valid under the rebuttable presumption approach. The Enlarged Board’s decision thus seems to mark a major relaxation of the EPO’s approach to same-applicant priority.
Whether European national courts and the Unified Patent Court also now adopt the rebuttable presumption approach remains to be seen. However, it seems unlikely that the Enlarged Board’s decision will be ignored in these other jurisdictions.
This decision relates to an unusual case of added matter and how considerations typically relevant to sufficiency of disclosure impacted its assessment.
In this case, basis for an amended claim deriving (only) from an example was considered to be undermined by the apparent failure of the medical treatment described in the example to achieve the technical effect required by the main claim. In short, a second medical use claim cannot find basis in an example which does not successfully achieve the therapeutic effect set out in the claims.
The claim in question included the following features:
Example 3 of the application as filed included, amongst other things, two groups of animal subjects (piglets) which were injected intramuscularly with the triple vaccine combination product of Claim 1. One group was injected only once – as per the dosage regimen of Claim 1 – and another group was injected with a booster shot, thus receiving two doses of the combination vaccine and therefore falling outside of the dosage regimen of Claim 1. The example reported that a detectable level of antibodies for Mycoplasma hyopneumoniae was present only in the booster shot group and not in the single dose group (nor in a control group receiving no vaccine). Example 3 thus made clear that the single administration of the vaccine, as claimed, was not successful.
The patent in question was initially opposed on the grounds of added matter (Art. 123(2) EPC) and sufficiency of disclosure (Art 83 EPC) and was revoked at first instance for failing to meet the requirements of sufficiency of disclosure only. The Opposition Division held that: “achieving the purpose recited in the claim was only a matter of sufficiency of disclosure, not of added subject matter” (see T 2593/11, Reasons 3.4).
However, during the appeal against this decision by the proprietor, the Board of Appeal took the view that the technical feature of protection against all three pathogens using the claimed (single administration) dosage regime was not in fact adequately disclosed in the application as filed. At the hearing, the Board considered added matter (Article 123(2) EPC) first and ultimately revoked the patent on that ground without needing to consider sufficiency of disclosure, in contrast with the first instance proceedings.
Whilst it may seem strange for the particular result of an example to be decisive in whether or not a claim to a medical use can be considered to have basis in the application as filed, the Board’s decision makes more sense in light of established case law on novelty of second medical use claims.
“Mere statements that a particular therapy is being explored do not amount to a novelty-destroying disclosure of a second medical use claim which includes the achievement of this therapy as a technical feature” (T 1859/08, Reasons 13).
“A document that describes the administration of a compound to diseased subjects but neither explicitly nor implicitly discloses an effective treatment of the disease by this compound does not directly and unambiguously disclose this treatment” (T 239/16, Reasons 5.2 and 5.3).
Although these earlier decisions relate to novelty, the Board held the view that “the concept of disclosure must be the same for the purposes of Articles 54 and 123 EPC (in view of G 2/10, G 1/03).” In other words, a disclosure that would not be enabling in the sense of novelty, would also not be able to provide basis for an amendment.
When these decisions are considered, it seems clear that an example lacking any positive results cannot, in and of itself, be considered to disclose a medical use, where a positive outcome or improvement/benefit is normally considered implicit in a claim to the treatment or prevention of a disease or condition. This is clearly the case even if the intent or purpose of the example was to evidence that particular claimed treatment.
Nevertheless, it is clear that this decision applies only to the scenario where the example alone is being assessed for basis and not alongside other disclosures in the specification as filed which might normally be expected to be present. As many readers will know, using a specific example as basis for an amendment to a claim under European Patent Office (EPO) practice can often fall foul of added matter issues, particularly when only certain features are extracted (‘cherry picked’) from the example and imported into a claim and other features are left behind (as in the case of an ‘intermediate generalisation’).
In this particular case, the Board could seemingly have further justified the finding of added matter on the basis that there is an inextricable link in Example 3 of the claimed (single administration) dosage regime and a failure to inoculate against Mycoplasma hyopneumoniae. Importing the dosage regime from the example, without also the failed result reported therein, could therefore also be characterised as an unallowable intermediate generalisation under EPO practice.
This decision reaffirms the importance of providing disclosure of technical effects in the description, and not just confining them to discussion in the context of a specific example, in order for such disclosures to potentially serve as basis for a claim amendment under EPO practice. It also potentially adds further to an opponent’s toolkit in objecting to scenarios in which a claimed technical effect is based only on disclosures taken from examples, particularly where there is any ambiguity over the results achieved in those examples.
