Since the UK voted to leave the EU in the referendum in 2016, Japanese owners of intellectual property rights in Europe have been concerned about the consequences for their rights, and the increased cost and complexity of obtaining protection in both the UK and the remaining EU countries (the so-called “EU27” countries that remain after the UK has left) in the future. In this article we examine the process by which the UK leaves the EU, and the consequences for registered design protection in Europe during the Brexit process and afterwards.
2. Process of the UK leaving the EU – the transition period
Legally, the UK has ceased to be a member of the EU since 31 January 2020. However, because a Withdrawal Agreement was concluded between the UK and the EU, EU law continues to apply in the UK during a transition period, which is scheduled to expire on 31 December 2020. During that period, the UK remains a full participant in the EU intellectual property systems, and Registered Community Designs continue to have effect in the UK.
According to the Withdrawal Agreement, the transition period can be extended by up to two years, but any such extension must be agreed before 1 July 2020. The UK Government has stated that it will not extend the transition period. Nevertheless the UK policy on this could change. It is advisable to plan on the basis that the transition period will expire on 31 December 2020, but in July this will be known with reasonable certainty.
3. After the UK has left the EU – the end of the transition period
Once the transition period ends, EU law will cease to apply in the UK. The UK will no longer be a participant in EU intellectual property systems, and Registered Community Designs will cease to have effect in the UK.
The UK IPO has published guidance about what will happen at that time, which is updated from time to time:
The required legislation has been made as “The Designs and International Trade Marks (Amendment etc.) (EU Exit) Regulations 2019”, and can be read here:
Basically, if a design is protected as a Registered Community Design, or an EU designation in an international design, then the UK will automatically and free of charge provide a corresponding UK national design registration, with the same subject matter and effective filing and priority dates. No action is required from the right holder, but the right holder can opt out of receiving the UK registration if they wish. Renewal fees must be paid to the UK IPO, on the same schedule as the Registered Community Design, in order to maintain protection in the UK.
The numbering system for these automatically granted rights has been decided, and it corresponds to the existing Registered Community Design (RCD) number (including the 4-digit suffix identifying the design number within a registration) prefixed by “9”. Thus RCD 004048098-0004 will give rise to UK registered design number 90040480980004. (The numbering system for the corresponding UK registration from an International design registration designating the EU has not yet been announced.)
In the case of pending applications, however, a corresponding UK application or registration is not given automatically or free of charge. Instead, the applicant will have the right to file a corresponding UK design application within 9 months from the end of the transition period, that is by 1 October 2021, while retaining the earlier filing and priority dates of the Registered Community Design or International application. The usual application fees in respect of such applications must be paid to the UK IPO. In this context, “pending” applications include, in addition to applications which have not been registered by the EU IPO or WIPO:
1)Registered Community Designs where deferment of publication was requested and which remain unpublished at the end of the transition period; and
2)International design registrations designating the EU less than 6 months from the publication date by WIPO in respect of which the EU IPO has not communicated to WIPO that protection has been granted.
Clearly, it is much more advantageous to the rights holder to have by the end of the transition period a registered EU right, whereby a UK right is obtained automatically and free of charge, compared with a pending EU application, which involves significant cost and effort to obtain the corresponding UK protection. This is the main consideration that informs the recommended strategy during the transition period, as set out later in this article.
4. Deferred publication
The UK system for registered designs is similar to the EU IPO system in many respects. For example, there is no substantive examination, online filing is possible, and multiple design applications are permitted. One important difference however is deferment of publication. The EU IPO permits the registration of designs with deferment of publication for up to 30 months from the priority date. The UK IPO however has a different system, wherein registration itself can be deferred, but only for 12 months from the filing date. Since publication occurs at registration, this effectively allows deferment of publication for up to 12 months from the filing date.
If in the 9 month period from the end of the transition period a UK design application is filed (according to the procedure set out in the previous section of this article) with a request for deferment of registration based on a Registered Community Design that is subject to deferred publication, registration and publication of the UK design application will happen at the earlier of (a) the expiry of the deferment period at the EU IPO or (b) 12 months from the actual date of filing of the corresponding UK design application.
5. Strategy during and after the transition period
The recommended strategy to be employed by current users of the Registered Community Design system, such as those based in Japan, is a little different depending on whether currently those users prefer to use the International Registration system under the Hague agreement, or whether it is preferred to file direct applications at the EU IPO (possibly claiming priority from an earlier filing under the Paris Convention).
5.1 Obtaining protection in Europe using direct applications
Users of the Registered Community Design system who currently apply for registration directly at the EU IPO are recommended to continue to apply in the EU only until the end of the transition period. There is no real advantage to applying for separate UK registrations in the meantime (so-called “double filing”) – the EU registration will cover the UK until the end of the transition period, and a UK right will be given immediately after that. The EU IPO registers applications extremely quickly, and so an application filed well before the end of the transition period will almost certainly be registered by the end of the transition period. Some applicants have been “double filing” already, but this involves significant extra cost for no real benefit, and so it is not recommended.
The main source of delay in registration of applications is delay by the applicant in filing a certified copy of the priority application, if priority is claimed. The time limit for filling the certified copy is 3 months from the filing date. For applications filed close to the end of the transition period, applicants will need to provide the certified copies sooner than this in order to secure registration before the end of the transition period. Ideally, the certified copy should be submitted on filing – it can conveniently be filed as a scan of the paper document.
Even very close to the end of the transition period, it is probably more convenient to file the EU application alone, and then file a UK application, if needed, during the nine-month period following the end of the transition period. So double filing of EU and UK applications at the same time should rarely if ever be required.
In the case of Registered Community Designs that will be under deferred publication at the end of the transition period, if it is desired to maintain the secrecy of the design, then again it is better to file a corresponding UK application during the 9-month period following the transition period, because that will maximise the possible period before the UK application is registered and published.
On the other hand, it may be that there are some Registered Community Designs under deferred publication where the owner no longer needs to keep the design secret, for example because the design has been made public by another route in the meantime. It is recommended to review any portfolio of designs under deferred publication so that publication is requested in advance of the end of the transition period where secrecy is no longer required. Thus, the automatic corresponding UK right can be obtained.
After the end of the transition period, applicants will need to file separate EU and UK applications in order to secure design protection in each jurisdiction.
5.2 Obtaining protection in Europe using the Hague system
In the case of applicants who currently use the Hague system for obtaining registered design protection in Europe, the recommendation is quite different. It is suggested NOT to rely on obtaining the corresponding automatic UK right, as this will be a national registration, not a designation within the Hague registration. (The advice mentioned above in Section 3 from the UK IPO states “The IPO and WIPO are discussing options that will ensure rights holders do not lose protection in the UK for their internationally protected EU designations on 1 January 2021” and it is conceivable that an agreement might be reached to make the UK right a designation in the Hague registration, but it is doubtful that a legally and technically operable system could be achieved by WIPO in time. In any case, the 2019 Regulations provide for a UK national right). So the UK right must be renewed separately, it cannot be renewed within the international registration.
Applicants use the Hague system in order to obtain protection in multiple territories that can be maintained with a single renewal fee payable to WIPO. The corresponding UK registration arising at the end of the transition period from an International registration designating the EU will lie outside this system, so the proprietor will have an International registration protecting many jurisdictions, and then a separate UK national registration that will need to be maintained by paying renewal fees separately to the UK IPO. This runs contrary to the rationale for using the Hague system, and is quite inconvenient for the proprietor.
The UK has been an independent member of the Hague system for international registration of designs since 13 June 2018. It is recommended that users of this system who wish protection in Europe designate the UK in addition to the EU (which we may call “double designation”), starting immediately (if they are not already doing so). The additional fee involved is very small, and a separate UK designation ensures continued protection in the UK as part of the International registration even after the end of the transition period, that can be maintained in force by payment of renewal fees for the International registration only.
When an International registration designates the EU, a corresponding UK national right will arise at the end of the transition period, even if the International registration designates the UK as well. Thus, in principle, if the International registration designates the EU and the UK, at the end of the transition period the proprietor will have two essentially identical rights covering the UK – the UK designation of the International registration and a UK national right. In this situation, the UK national right will not be needed, and users can either opt out of receiving this, or can allow it to lapse at the time of payment of the first renewal fee by non-payment of the fee.
It is stressed that if users of the Hague system do not designate the UK separately from the EU in International design applications at the present time during the transition period, the proprietor of the International design application or registration designating the EU only can still obtain protection in the UK at the end of the transition period according to the procedures set out above in Section 3 (either a corresponding UK registration is given or the applicant has the right to file a corresponding UK application), but the proprietor cannot obtain this protection as part of the International registration. The recommendation for “double designation” is a matter of convenience for the proprietor, not a danger of loss of protection in the UK.
5.3 Further considerations on using the Hague system
Some applicants are reluctant to use the Hague system at all, and this is understandable. It is difficult to produce a set of representations of a design that will be accepted by every Office, and it may result in suboptimal protection in some countries, and refusal of protection in others. Even if objections in a notification of refusal of protection are overcome, the need to respond to objections raised by national offices involves worry and expense, which rather defeats the purpose of using the international registration system at all.
Both the UK IPO and the EU IPO are very strict about the concept that all the representations relate to the SAME design. This means that if the international registration contains, for example, reference views that show features differently from the main views, objections are likely to be encountered. The Hague system may not be suitable in all cases.
In summary, therefore, the advice is:
·Users of the Hague system should designate the UK in addition to the EU starting immediately, and it is suggested that they opt out of receiving the corresponding automatic UK national right.
·Direct filers at the EU IPO should file in the EU only until the end of the transition period. After the end of the transition period it will be necessary to file in the UK separately for new applications and in respect of any Registered Community Designs that were not registered (or on which publication was deferred) when the transition period ended.
It is regrettable that users of the EU design system are faced with additional concerns as a result of Brexit. However, the action to be taken in respect of design protection is not complex, and it is hoped that applicants will not be worried unnecessarily.
Mental Health Awareness Week 2020 has been timely encouragement to talk about mental health during the current pandemic. To promote good mental wellbeing, EIP last year established a Mental Health initiative, in which ten staff across the four UK offices qualified as Mental Health First Aiders (MHFAs). MHFAs are trained to look for signs that someone is struggling with their mental health and provide appropriate support.
For this year’s Mental Health Awareness Week, five MFHAs shared their experiences while living in lockdown, recording a video blog each for every working day of the week. The blogs covered a variety of experiences such as working from home with a young family in central London and exploring the open green spaces around Bath to break up the working day.
One way EIP staff have been staying in touch since working from home is through a virtual tea break; a daily video call, open to everyone at EIP to chat with people from around the firm. Each day this week, someone from the MHFA team joined the virtual tea break to talk about mental health and the importance of ending the stigma.
Sharon St. Louis, a former Samaritan and leader of the EIP MHFA team, was pleased with the way the MHFA team continued to provide support during the lockdown. Sharon said: “Mental Health Awareness Week has been fully embraced by EIP thanks to the vlogs that have been shared from our amazing MHFAs. It has allowed us to get an insight into how their mental health has been holding up during this very strange time, enabling the viewer to reflect on how they are being similarly affected and share what they have experienced. One of the themes that came out of the vlogs is the importance of actively listening to someone that would like to be heard. We can all manage that small act of kindness which can help to improve all of our mental health”.
The Enlarged Board of Appeal at the European Patent Office has now provided its opinion in G3/19 abandoning the interpretation of Article 53 (b) EPC given in previous decision G2/12. In light of Rule 28 (2) EPC, the Enlarged Board held that the term “essentially biological processes for the production of plants or animals” in Article 53 (b) EPC is to be understood and applied as extending to products exclusively obtained by means of an essentially biological process.
G3/19 represents a major shift in what constitutes patentable subject matter in the agriculture sector. This shift was certainly not a foregone conclusion as the Enlarged Board had previously held, only a couple of years ago in G2/12, that Article 53(b) EPC excluding “plants or animal varieties or essentially biological processes for the production of plants or animals” from patentability did not have a negative effect on the allowability of a product claim directed to plants or plant material. The fact that Article 53(b) EPC does not explicitly exclude patentability of plants and the general principle that exceptions to patentability should be construed narrowly played a part in these decisions.
Rule 28 (2) EPC introduced in the implementing regulations in July 2017 to clarify the interpretation of Article 53 (b) EPC prohibits the grant of patents for plants obtained exclusively by essentially biological processes. This change in the EPC in conflict with previous Board decisions was considered by many as changing law by the back door. In T1063/18, the Technical Board of Appeal held that, for claims directed to a plant product obtained by an essentially biological process, the interpretation given in G2/12 must prevail over Rule 28 (2) EPC. The Technical Board also raised questions on the competence of the EPO Administrative Council to clarify (and perhaps change) the meaning of the prohibition set out in Article 53 EPC by means of implementing regulations. This conflict between a Technical Board upholding patentability of subject matter stated as excluded from patentability in Rule 28 (2) EPC led to the EPO President seeking resolution by the Enlarged Board.
The status of EPO as an international organisation separate to the EU and the chequered history of Rule 28 (2) EPC, which was introduced in response to a European Commission Notice relating to the EU Biotech directive, also led many to expect that the Enlarged Board will continue to consider plants exclusively obtained by essentially biological processes to be patentable. However, the Enlarged Board has performed a U turn relying on a “dynamic interpretation” of Article 53(b) EPC.
The Enlarged Board refrained from answering the general question as to whether the EPO Administrative Council has the power to interpret primary legislation by introducing new implementing regulations on the basis that answering this general question could give the Administrative Council “carte blanche to deviate from established case law and give a particular meaning to an Article of the EPC by means of the Rules of the implementing regulations. This would open the door to the possibility of circumventing the statutory procedures for amending the Convention itself, namely by way of a diplomatic conference pursuant to Article 172 EPC or by unanimous vote in the Administrative Council”.
The Enlarged Board then considered the specific issue of Article 53 (b) EPC applying the grammatical, systematic and teleological methods of interpretation and stated that “The Enlarged Board endorses the conclusions which were reached in decision G2/12 on the basis of each of these methods.” The Enlarged Board recognised that “the systematic interpretation of Article 53 (b) EPC does not support giving the process exclusion a broad meaning to the effect that it also excludes product claims or product-by-process claim from patentability”.
The Enlarged Board also considered that subsequent agreement or practice between parties to a treaty, as required in Article 31 (3) (a) and (b) of the Vienna Convention on the interpretation of treaties, required agreement between all parties. Hence, even agreement by a majority of EPC Contracting States is not sufficient for changing the interpretation of Article 53(b) EPC.
Furthermore, the Enlarged Board did not consider the existence of Rule26 EPC, which requires interpretation of relevant EPC provisions by reference to the EU Biotech directive as a supplementary means of interpretation, as sufficient reason to deviate from the conclusion in G2/12 as that Rule did not have the effect of incorporating the Biotech directive into the EPC. It also confirmed the EPO’s status as an independent international organisation with its own autonomous legal order which is not directly bound by EU law or impacted by the EU Commission Notice on the interpretation of the EU Biotech directive.
However, in the end the Enlarged Board deviated from the decision in G2/12 on the basis of “Dynamic interpretation in light of Rule 28 (2) EPC”. The Board held that a particular interpretation which has been given to a legal provision can never be taken as carved in stone because the meaning of a provision may evolve over time and that Rule 28(2) EPC and the travaux preparatoires for that Rule establish the EPC legislator’s intention that plants or animals obtained exclusively by means of an essentially biological process are excluded from patentability. The Enlarged Board here also relied on the intention and aims of Contracting States with regard to Article 53(b) EPC as having evolved since its previous decision in G2 /12 (35 contracting states voted in favour of introducing Rule 28 (2) EPC and a number of them have aligned national provisions). The Enlarged Board thus concluded that this “clear legislative intent” of the Contracting States “allows and indeed calls for a dynamic interpretation of Article 53 (b) EPC” thereby abandoning the interpretation of this Article as set out in G2/12.
It is surprising that even though the Enlarged Board wanted to a) avoid general pronouncements that risk opening the door to the possibility of circumventing the statutory procedures for amending the European Patent Convention and b) considered that agreement by a majority of Contracting States was not enough to change an EPC Article’s interpretation under Article 31 (3) (a) and (b) of the Vienna Convention, it eventually decided that an amendment to European Patent Convention was not required in this case and considered the fact that most Contracting States had voted in favour of adoption of Rule 28(2) EPC in the EPO Administrative Council to be sufficient to change the interpretation of Article 53 (b) EPC.
As a consequence of this Enlarged Board Opinion, claims directed to products exclusively obtained by means of an essentially biological process will not be allowed by the EPO in cases with an effective date (filing or priority date as the case may be) on or after 1 July 2017 (the date when Rule 28 (2) EPC came into effect).
This will have significant consequences for intellectual property protection in the agriculture sector and is likely to increase the prominence of plant variety rights, the so far less favoured sui generis intellectual property system.
Article 83 EPC (Sufficiency) requires a European patent to disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art. Case law regarding the sufficiency of medical use claims has developed over the years through several EPO Board of Appeal decisions and has held that a claim to a second medical use is sufficiently disclosed if there is evidence that the claimed therapeutic effect can be achieved. This evidence of a therapeutic effect can be in the application or can be derivable from common general knowledge, meaning that experimental results in the application, although strongly desirable, are not always required to establish sufficiency. The standard to be met for this has traditionally not been considered too burdensome by Patentees, because the onus of proving lack of sufficiency has been placed on the examiner or opponent raising the objection, who must provide “serious doubt substantiated by verifiable fact”.
In recent years, various jurisdictions, including the EPO, have been increasing the standard of evidence required for second medical use claims; in particular, that a therapeutic effect is plausible and works for every indication claimed. The Technical Board of Appeal decision handed down in October 2019, T-713/15, is in line with this.
The patent under appeal in T-713/15 was EP1707215 (the vasculitis patent), which claimed the medical use of an IL-6 receptor antibody for preventing and/or treating vasculitis. A marketing authorisation was obtained for the antibody in question, and it is distributed under the name tocilizumab. During the appeal proceedings the BoA overturned the decision of the opposition division to uphold the patent and revoked it for lack of sufficiency.
At the time of filing, the vasculitis patent contained clinical data for two patients showing that their symptoms were reduced by the administration of an IL-6 receptor antibody. During prosecution and the subsequent opposition proceedings these case studies were considered adequate evidence that the antibody could treat vasculitis. However, in the appeal decision it was noted that little mechanistic explanation was provided in the patent to support applicability of the treatment to all forms of vasculitis.
During the opposition and appeal proceedings, the opponent/appellant cited two documents, each published almost 10 years after the filing date of the patent, which, they alleged, demonstrated that the anti-IL6 receptor antibody was not effective in treating a rare form of vasculitis caused by Beçhet’s syndrome. Each document described a patient who had an adverse reaction to tocilizumab, and speculated that the lack of efficacy was due to differing cytokine profiles between Beçhet’s syndrome and more well-known types of vasculitis. In their decision revoking the patent, the Board explained that it was this evidence which lead them to conclude that the patent lacked sufficiency.
It is not unusual for patents to be granted at the EPO based on minimal evidence in the form of case studies, although there are signs that this is changing. In a recent decision T-1045/13 by the same Board, a lack of sufficiency was found, since the examples provided in the application in question related to a single patient each and did not give rise to statistically significant data. The issue in T1045/13 seemed to be that the Board did not consider the claimed therapeutic effect to be plausibly disclosed in the patent. For the vasculitis patent, the Board appeared to consider the strength of evidence provided on filing to be inadequate to outweigh the later published findings of lack of efficacy in Beçhet’s syndrome. Hence, the issue in T-713/15 was not whether the threshold test of plausibility was met at the filing date, but that a therapeutic effect was not obtainable in every form of vasculitis.
What will be uncomfortable for patentees is that even with more substantial evidence at the time of filing, it is unlikely that the vasculitis patent would have been protected against this attack, which was based on evidence arising in a rare disease, and almost 10 years after the filing date. This is especially the case, because it is not uncommon for new insights to be gained into treatable populations well after a filing date, since a therapy is always tested more widely after being brought to market. The life sciences sector has, for a long time, faced the dilemma of striking a balance between filing an application early and delaying until full data is gathered. However, information arising many years later, as a result of the wider use of a drug, is challenging to account for.
With this in mind, what can patentees do to ensure that their medical use patents will not be revoked or invalidated as a result of research performed many years after filing? It will not always be possible to anticipate such events. However, if it is known that the disease group recited in a claim (vasculitis in this case) includes heterogenous subgroups with potentially different mechanisms at play, then it could help to include mechanistic rationale for why a therapeutic effect should be achieved across all disorders claimed. On the other hand, if there are concerns that the mechanistic explanation underlying the claimed medical use may not apply to all subgroups of the broader disease recited in the claims, drafting appropriate fallbacks directed to subsets of diseases, and especially to the subsets exemplified is always sensible. During the appeal proceedings in question, the patentee did request to narrow the claims to specific forms of vasculitis during the oral proceedings; however, this request was denied as late filed.
The biggest take home message from these proceedings is for opponents; Lack of Sufficiency has traditionally been a challenging ground to assert at the EPO for several reasons, including the burden of proof being on the opponent. Because of this, Sufficiency has often been seen as a subsidiary attack, to be included only once prior art and added matter grounds for opposition have been established. However, in cases where evidence of a lack of technical effect across the full claim scope can be identified, Lack of Sufficiency is becoming a much stronger attack against medical use claims, which can knock out entire patents or clear the path for certain indications.
This Wednesday, 20th May, EIP Life partners Andy Sharples and Monika Rai will speak at One Nucleus’ BioWednesday webinar on ‘Enabling Access to Medical Technologies - Compulsory Licensing, TRIPS and FRAND’.
Andy and Monika will be joined by University of Leeds Professor Graham Dutfield to talk about lifting the patent barrier to access medicines, including the principles of FRAND and compulsory licensing/ TRIPS Agreement. The discussion will also reference the current COVID-19 situation as an example of how licensing could work.
Further details of the event can be found here.