Introduction
In April 2023 the EU published draft legislation which, if enacted, would represent a major shift in the regulatory and IP framework for pharmaceutical products in Europe.[1] As well as establishing a unitary SPC (to complement the recently-introduced unitary patent), the proposed legislation alters the regulatory exclusivity periods available for innovative products, and changes the Bolar exemptions. Overall, the proposed legislation strongly favours the generics industry and undercut the rewards available to pharmaceutical innovators.
Recently, the EU Parliament has approved some significant changes to the provisions which deal with regulatory exclusivities and the Bolar exemption.[2] [3] These changes reduce the negative impact of the legislation on the period of exclusivity, and they reduce the burden on innovators to obtain regulatory exclusivity. The changes do, however, significantly extend the scope of the safe harbour available to generics manufacturers under the Bolar exemption. It also raises a serious question of whether the proposed Bolar provisions are compliant with the EU’s obligations under TRIPS.
Changes to the Proposed EU Pharmaceutical Legislation for Medicinal Products
Changes to Regulatory Protection Periods
The initial proposal for the new Directive would have reduced the duration of data exclusivity for innovative medicinal products from 8 years to 6 years, whilst retaining the additional 2 years of market protection as at present (to a total of 8 years of regulatory exclusivity, as compared to 10 years at present). However, to “encourage innovation” the initial proposal provided various options for extending the exclusivity period, with the longest of these being an extra +2 years of data exclusivity available to certain innovators if the medicinal product is launched in all 27 EU member states. This seemed like an onerous requirement to restore the level of regulatory exclusivity to that which is currently provided.
In the latest changes, the period of data exclusivity for innovative medicinal products is increased to 7.5 years from the date of grant of the MA, and there is no longer any exclusivity benefit from launching in all EU member states.[4], [5] There are also additional periods of data exclusivity available for:
The total period of regulatory data exclusivity may not exceed 8.5 years,[9] which means that not all of the above extensions may be applied simultaneously.
In addition to the extra data exclusivity which is available, the amended Directive allows an additional +1 year of market protection to be obtained (i.e., in addition to the 2 years which is already provided) where an additional therapeutic indication is authorised which provides a “significant clinical benefit” over existing therapies.[10] This extension may only be granted once.
Overall, the changes to the regulatory exclusivity periods in the proposed new Directive seem broadly in favour of pharmaceutical innovators – they largely restore the extent of regulatory protection and they remove what would have been very onerous requirements to obtain additional protection (for those entities who were eligible to apply for the longest extensions to the periods of data exclusivity). Seen in this light, the changes which have been approved by the EU Parliament may be seen as balancing what would otherwise have been a heavily generics-friendly shift in EU law.
It may be noted that the latest changes do not alter the situation as regards orphan medicinal products, which are handled under a proposed new medicinal products Regulation.[11] For orphan drugs, the standard period of market exclusivity is to be reduced from 10 years to 9 years, and the existing 2 years of additional exclusivity for completing pediatric studies is to be abolished. However, options for extending the period of exclusivity are available, where the product addresses a high unmet medical need (+1 year) and/or is launched in all 27 EU member states (+1 year). An additional +1 year is also available for each new MA obtained for a new orphan indication of the product (up to an extra +2 years). It remains to be seen whether any further changes are made to these proposals, e.g. whether the reward for launching in all EU states is removed (as it has been in the new Directive).
Changes to the Bolar Exemption
The Bolar exemption available under existing EU legislation provides a limited safe harbour against infringement of patent or SPC rights in connection with conducting “necessary studies and trials” for seeking authorisation of a generic medicinal product.[12] There are, however, significant differences in the implementation of the current Bolar exemption across Europe. The uncertainty caused by the different interpretations currently adopted by the national courts could be resolved through judicial harmonisation, e.g. through rulings by the UPC or the CJEU, rather than by further regulation. Nevertheless, the proposed new Directive, in its initial version, seeks to clarify and expand the scope of the exemption. Thus, the proposed Bolar exemption references “biosimilar, hybrid or bio-hybrid medicinal products” explicitly alongside “generic” products.[13] This appears to clarify that the exemption should not apply to innovative medicinal products. The initial proposal also provides security for Third Party entities that supply the MA applicant with a patented product for use in trials, or who carried out such trials on behalf of the MA applicant (at least within Europe).
In the latest amendments, the EU Parliament has approved some major changes to the proposed Bolar provisions which are weighted heavily in favour of the generics industry. In doing this, they have apparently rejected alternative amendments which would seek to address concerns from pharmaceutical innovators about the initial version of the new Directive. In an Opinion on the new Directive, published in November 2023, the EU Committee on Industry, Research and Energy sets out reasons why the new Bolar provisions as originally proposed could weaken IP protection across Europe and damage confidence in the European IP framework.[14] In particular, that Opinion recommends limiting the Bolar exemption to activities solely related to obtaining MAs.[15] It appears that those proposals were purposefully rejected in the version approved by the EU Parliament.
As amended, the proposed Bolar provision of the new Directive reads:[16]
“Patent rights, or supplementary protection certificates … shall not be regarded as infringed when necessary studies, trials and other activities are conducted for the purpose of:
The activities conducted exclusively for the purposes set out in the first paragraph, shall cover as relevant the submission of the application for a marketing authorisation and the offer, manufacture, sale, supply, storage, import, use and purchase of patented medicinal products or processes, including by third party suppliers and service providers.
This exception shall not cover the placing on the market of the medicinal products resulting from such activities.”
References to biosimilar, hybrid and biohybrid products are removed from Article 85, thus potentially opening the exemption to innovative products which happen to fall within the scope of pending patents. This appears to be consistent with the amended Article 85 not mentioning a “reference medicinal product” which is a term used in the current legislation. This would also be consistent with an amendment made to one of the Recitals in the proposed new Directive which relates to the Bolar exemption, whereby the Recital no longer refers to “the market entry of generics and biosimilars” but instead to “the timely market entry of medicinal products, in particular the market entry of generics and biosimilars”.[17]
The proposed Bolar exemption does not adopt the amendment recommended by the EU Committee on Industry, Research and Energy, namely to state in the preamble that the product is used for the exclusive purpose of performing actions in pursuit of a MA. Whilst the second paragraph of the Bolar exemption characterizes what is covered by “activities conducted exclusively for the purposes set out in the first paragraph”, it is not apparent that this statement necessarily limits the scope of the exemption to activities carried out exclusively for the aforementioned purposes. It is unclear, therefore, which other commercial activities might fall under the Bolar exemption. Given the concerns raised by the EU Committee on Industry, Research and Energy, it is perplexing that the amended Directive does not state in its preamble that the exempted activities must be conducted exclusively for the purposes set out in points (i) to (iiia) of paragraph 1, or otherwise make this point explicit in paragraph 2.
The proposed wording does clearly permit commercial, or at least pre-commercial, activities relating to inter alia manufacture, storage and offer for sale of patented products in the context of authorization and pricing approval. The final paragraph of the Bolar provision clarifies that the exemption “shall not cover the placing on the market of the medicinal products resulting from such activities” but it neither expressly forbids a party from offering to sell medicinal products during the term of a patent or SPC nor expressly prevents a party placing medicinal products on the market after patent or SPC expiry where those products have been made, stored and/or offered for sale during the lawful term of the patent or SPC.
All of the above observations indicate that the scope of the Bolar exemption will be significantly wider under the new Directive.
Is the Bolar Exemption of the New Directive Compliant with TRIPS?
The apparent breadth of the proposed new Bolar exemption, in particular as regards commercial or pre-commercial activities, raises a serious question of whether the EU will comply with its legal obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights (the “TRIPS Agreement”) if it enacts the new Directive.
Article 30 of the TRIPS Agreement provides signatories with limited powers to implement an exception to the exclusive rights conferred by a patent, where such an exception “do[es] not unreasonably conflict with a normal exploitation of the patent”. The lawful extent of such an exception was addressed by the WTO panel in Canada – Patent Protection of Pharmaceutical Products, a complaint brought by the European Communities and their member states against proposed legislation from the Canadian government.[18] In that case, the WTO panel systematically reviewed the wording of Article 30 and the intention of the legislature, and held that a Bolar exemption which exempted acts carried out solely for the purpose of seeking regulatory authorisation would be permitted[19], but that the exemption of commercial acts would run contrary to Article 30. In particular, the WTO panel expressly disapproved of the notion that Article 30 would permit the exemption of commercial acts carried out in anticipation of a large-scale pharmaceutical product launch immediately after patent expiry, e.g. an act such as stockpiling.[20] The WTO panel held that a gradual process of market entry after patent expiry is part of the normal patent framework under TRIPS, and that a Bolar exemption cannot be used to flood the market with generic product immediately after patent expiry.
It is precisely such acts which the new Directive appears to endorse. Looking first to the Recitals of the new Directive, whilst Recital 63 states that “[t]he exemption must be confined to conduct studies and trials and other activities needed for the regulatory approval process, health technology assessment and pricing reimbursement request” and that “there can be no commercial use of the resulting final medicinal products obtained for the purposes of the regulatory approval process”, the indication in Recital 64 that the Bolar exemption “will allow all necessary steps to support timely access to generic medicinal products, inter alia, to conduct studies to support pricing and reimbursement as well as the manufacture or purchase of patent protected active substances for the purpose of seeking marketing authorisations during that period” calls into question how the term “commercial use” is being used. Indeed, Recital 64 goes on to state that the Directive will contribute to “the timely market entry of medicinal products, in particular the market entry of generics and biosimilars on day one of loss of the patent or SPC protection”.[21] In order to enter the market on “day one”, a generic or biosimilar manufacturer must not only have completed all of the regulatory requirements, and sought agreement on pricing or completed offers for tender in at least some countries, but must also have manufactured and stockpiled the product ready to distribute and sell. These acts are clearly considered as being “commercial use” within the ruling of the WTO panel in Canada v EC.
Looking to the language of Article 85 of the new Directive, this may (as noted above) permit aspects of manufacture and storage of a medicinal product which is then placed on the market in large scale immediately on patent expiry. Such a situation is expressly identified in Canada v EC as failing to be compliant with Article 30 of the TRIPS Agreement. The new Directive goes further than this, however, and also permits tenders or offers for sale that may occur during the pricing and reimbursement approval process. Obtaining pricing and reimbursement approval at least represents an implicit offer to sell a medicinal product in many countries, and in some other countries it can involve an explicit offer to sell or even sale of the product. “Offering for sale” and “selling” are two fundamental patent rights protected under Article 28 of the TRIPS Agreement and the reasoning set out by the WTO panel in connection with stockpiling arguably applies equally to any commercial or pre-commercial offer for sale. As such, the exception under part (iii) of Article 85, and the recital of “offer” and “sale” in paragraph 2 of Article 85 (insofar as it relates to pricing and reimbursement approval), would also fail to be compliant with Article 30 of the TRIPS Agreement.
Summary
The initial version of the proposed new Directive significantly reduced the amount of data exclusivity available and set onerous requirements for innovators to extend the exclusivity period. In the latest changes, the EU Parliament has approved a version which relaxes those requirements and largely restores the amount of regulatory exclusivity which is available. In this respect, it dials back the heavily pro-generic stance which was apparent in the initial version.
The changes made to the proposed Bolar exemption, however, provide for a wider exclusion from infringement which appears to swing the pendulum back in favour of the generics industry. Not only are new products arguably within the scope of the safe harbour, but there is also a lack of clarity around which other activities, including commercial activities, would be permitted during the term of patent or SPC protection. In particular, the wording of the new Directive does not expressly forbid that products manufactured or stored under the Bolar exemption are placed on the market on “day one” after patent or SPC expiry. Furthermore, the extension of the safe harbour to activities conducted in the process of seeking pricing approval undercuts another commercial activity (offer for sale) which would otherwise be protected by a patent or SPC. Absent an EU-wide mechanism to adjudicate when any given medicinal product comes off-patent (i.e., a mechanism to help promptly and finally determine “day one” before it occurs – thereby providing well-needed certainty not only to the pharmaceutical industry, but also to patients, stakeholders and the public at large), the proposed pricing and reimbursement exemption may encourage generics manufacturers to offer a product for sale at an early stage when patent or SPC protection is still pending – this would be contrary to the interests of rights holders, of member states and of patients. The proposed Bolar exemption may thus be unworkable and fail to achieve its intended aims.
Finally, the extent to which the Bolar exemption has been widened merits an investigation of its compliance with Article 30 of the TRIPS Agreement. The jurisprudence which the EU itself (in an earlier guise) helped to develop sets limits on the extent to which Bolar exemptions may be defined; those limits are arguably exceeded by the new Directive as regards both the potential for stockpiling and the proposed pricing and reimbursement exemption.
If the Bolar exemption is considered as a ‘grand bargain’ between innovators and generics, under which generics can perform studies necessary for regulatory approval in advance of patent expiry, and in exchange for which innovators are provided additional term of exclusivity (e.g. by way of SPC protection), then the proposed new Directive rewrites that bargain in favour of an earlier market entry of generics without offering any compensation for innovators. This is particularly problematic in a regulatory environment where there is no clear determination of “day one” before it occurs. Overall, therefore, while the balance has shifted, the new legislation still looks to represent an erosion of the protections currently afforded to the innovator pharmaceutical industry and it raises serious questions of non-compliance with the EU’s international legal obligations.
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[1] The main changes are summarized by Creemer et al., Pharm Pat Anal (2023) 12(6):249-252
[2] The initially proposed Directive is COM(2023)192, “Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC”, published 26 April 2023.
[3] The adopted text of the amendments to the Directive has reference T9-0220/2024 and is dated 10 April 2024.
[4] Article 81(1) of the new Directive as amended (Amendment 199 of T9-0220/2024).
[5] Articles 81(2)(a) and 82 of the new Directive are deleted (Amendments 200 and 207 of T9-0220/2024).
[6] Article 81(2)(b) of the new Directive as amended (Amendment 201 of T9-0220/2024).
[7] Article 81(2)(c) of the new Directive (not amended).
[8] Article 81(2)(ca) of the new Directive (newly added by Amendment 202 of T9-0220/2024).
[9] Article 81(3)(a) of the new Directive (newly added in Amendment 206 of T9-0220/2024).
[10] Article 80(2)(a) of the new Directive (newly added in Amendment 196 of T9-0220/2024). Note that the initial version of the new Directive provided a +1 year extension to the period of data exclusivity in these same circumstances (former Article 81(2)(d) of the new Directive, as deleted by Amendment 203 of T9-0220/2024).
[11] COM(2023)193, dated 26 April 2023. See especially Articles 71 and 72.
[12] Article 10(6) of Directive 2001/83/EC (in its current form).
[13] Article 85(a)(i) of the new Directive (newly added in Amendment 211 of T9-0220/2024).
[14] 2023/0132(COD): “DRAFT OPINION of the Committee on Industry, Research and Energy for the Committee on the Environment, Public Health and Food Safety on the proposal for a directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC (COM(2023)0192 – C9-0143/2023 – 2023/0132(COD))”.
[15] 2023/0132(COD) at Amendments 13 and 14, and their corresponding “Justifications”.
[16] Article 85 of the new Directive, as amended by Amendments 209-215 of T9-0220/2024.
[17] Recital 64 of the new Directive (Amendment 47 of T9-0220/2024, emphasis added).
[18] See the decision of the panel in WT/DS114/R, 17 March 2000 (“Canada v EC”).
[19] See Canada v EC, sections 7.45-7.50.
[20] See Canada v EC, sections 7.35-7.36.
[21] Recital 64 of the new Directive (Amendment 47 of T9-0220/2024 with emphasis added), noting that the definition of “day one of loss of patent or SPC protection” is undefined in the new Directive.
Mathys & Squire attorneys: David Hobson, Martin MacLean and Nicholas Fox have filed a Petition for Review on behalf of Ipsen Bioinnovation asking the European Patent Office’s (EPO) Enlarged Board of Appeal to set aside a decision which resulted in the revocation of Ipsen Bioinnovation’s patent EP 2677029.
A Petition for Review is an exceptional remedy which enables a party to overturn a decision of an EPO Board of Appeal. The success rate for Petitions for Review is notoriously low, with fewer than 5% being successful. This is because Petitions for Review can only be based on very specific grounds and there is an obligation on parties to bring issues to a Board’s attention at a hearing. Failing to do so renders a Petition for Review inadmissible unless the circumstances are such that an objection could not have been raised during the appeal proceedings.
Unusually, valid grounds for a Petition for Review appear to have been made out in the present case.
Background to the case
EP 2677029 was opposed as allegedly being invalid on the grounds of added matter, lack of sufficiency and lack of inventive step. At first instance, the added matter objection was rejected. However, the allegation of lack of sufficiency was upheld. No ruling was made on inventive step.
Ipsen Bioinnovation appealed.
When responding to the Grounds of Appeal, in addition to asking the Board of Appeal to uphold the Opposition Division’s finding of lack of sufficiency, the respondent also asked the Board to overturn the Opposition Division’s decision that the claims of Ipsen Bioinnovation’s Main Request did not add matter. This argument gained traction with the Board of Appeal, and in a Preliminary Opinion, issued by the Board a few weeks before a hearing was scheduled, the Board indicated that they were of a preliminary view that three of the dependent claims in the Main Request contained added matter.
Mathys & Squire responded by filing arguments to the contrary and in addition, submitted two additional auxiliary requests into the proceedings which deleted these dependent claims, noting that such claims could not have been filed with the original appeal because the Opposition Division had previously found in Ipsen Bioinnovation’s favour. Mathys & Squire further noted that the deletion dealt fully with the added matter objections, did not raise any new issues, and did not in any way shift the focus of the appeal which, from the beginning of the case, had been the issue of sufficiency.
Fundamental violation of the right to be heard
At Oral Proceedings, after initially rejecting an added matter attack against claims 1 and 3 of the Main Request, the Board ruled that dependent claims 2 and 4 of the Request added matter. The Board then proceeded to refuse to admit the requests deleting these claims into the proceedings and revoked the patent. No explanation for the refusal to admit the auxiliary requests which deleted the dependent claims alleged to add matter was given at the oral hearing itself.
When the Board’s written decision was issued, it became apparent that the Board had departed from previous EPO case law which would have admitted the requests deleting the relevant dependent claims into the proceedings.
Starting with the decision in T1480/16, many Boards[1] have ruled that deleting dependent claims (particularly when such a deletion does not result in a shift of the focus of a case) is merely a restriction of the scope of an appeal and as such does not constitute an amendment of an appellant’s case. Under such an interpretation of the law, such a request can be made at any time during appeal proceedings and a Board does not have a discretion to refuse the request merely because it is submitted after parties have been summoned to Oral Proceedings.
A second line of case law has taken a different view, holding that the deletion of dependent claims does constitute an amendment of a party’s case. This means that a party has to establish “exceptional circumstances” that justify the admission of a request. However, invariably this has been held to satisfy the “exceptional circumstances” test for admission whenever a request has related solely to the deletion of dependent claims which:
In the present written decision, it became apparent that the Board had declined to follow either of these approaches and instead had decided to refuse to admit the amendments on the ground that they did not address the Board’s concerns relating to sufficiency of disclosure; a ground that had never been discussed at the Oral Proceedings.
Basing a decision on a ground on which a party has not had the opportunity to present comments is a clear breach of a party’s right to be heard under Article 113 EPC and constitutes grounds for a Petition for Review. Further, as there was no prior indication that the Board would depart from the previous case law and that the Board required arguments on sufficiency to be presented, it was not possible to bring this breach to the attention of the Board at the hearing itself.
David Hobson, commented: “Our client Ipsen clearly suffered an injustice here. I recall my surprise at the hearing that our claim requests were not admitted given that: (i) they unquestionably addressed the added matter issue; and (ii) our position was supported by well-established EPO case law. It was only upon receipt of the decision that the underlying reasoning of the Board of Appeal became clear. I could not have guessed at the time that Ipsen’s right to be heard had been violated and that a consideration of sufficiency was central to the Board of Appeal’s refusal to admit the claim requests. We are hopeful that the Petition for Review will put right this wrong.”
Martin MacLean commented: “The post-grant proceedings in relation to this patent have been as unconventional as I have experienced in 25 years of practicing as a European Patent Attorney. The whole purpose of Oral Proceedings is to give patentees the opportunity to be heard prior to a Board of Appeal ruling on the validity of a patent. When issuing their decision to revoke this patent, the Board must have been aware that questions of sufficiency had not been discussed. The Board’s decision to revoke this patent is therefore clearly unsafe and should be overturned.”
The case is proceeding as case number R14/24.
[1] For example in: T914/18, T995/18, T1857/19, T884/18, T565/16, T981/17, T1792/19 and T2201/19.
[2] See for example T853/17, T306/18, T682/16, T1224/15, T853/17, T306/18, T884/18, T494/18 and T2920/18.
Mathys & Squire is pleased to be ranked as a leading European patent law firm by the Financial Times (FT) in their 2024 report.
Mathys & Squire has also been highlighted in five specialised areas of industry expertise: ‘Biotechnology, Food & Healthcare‘, ‘Chemistry & Pharmacy‘, ‘Electrical Engineering & Physics’, ‘IT & Software‘, and ‘Mechanical Engineering.’
This annual ranking is based on client and peer recommendations, compiled by the FT’s research partner, Statista. We would like to extend our thanks to all our clients and contacts who took the time to recommend our firm.
To access the full report and rankings tables, please visit the FT website here.
Mathys & Squire is thrilled to be ranked in the 2024 edition of IAM Patent 1000: The World’s Leading Patent Professionals . IAM is known for being the definitive resource outlining word-class private practice patent expertise, and conducts extensive qualitative research to identify leading firms and individuals based on their abilities, market presence, and the complexity of their work. Only those with exceptional skills and deep insights into patent matters are featured in the directory.
In addition to our firm ranking, a record number of Mathys & Squire attorneys have been recognised as ‘Recommended Individuals’. Partners Paul Cozens, Stephen Garner, Anna Gregson, Chris Hamer, Dani Kramer, Alan MacDougall, Martin MacLean, James Pitchford, Juliet Redhouse, Michael Stott, Craig Titmus, Andrew White and Consultant Partner Jane Clark have all maintained their rankings. We are also pleased to see Partners Philippa Griffin and Nicholas Fox ranked for the first time.
Mathys & Squire has been recognised as a ” real industry leader that provides a very high level of service and support. It has a real breadth and depth of technical understanding paired with European legal expertise and experience dealing with legal systems elsewhere.” Our team have also been praised for their ability to “collaborate and communicate effectively with clients and each other to efficiently manage global portfolios, coordinate patent strategies, advise on FTO matters and represent patrons in proceedings at the EPO. They keep up to date with commercial developments to provide proactive and cost-effective advice, and always make themselves available to answer questions, providing clear and concise summaries.”
Commentary by Partner Nicholas Fox has been featured in Law Society Gazette, Law Society of Ireland Gazette, World IP Review, Life Sciences Intellectual Property Review, The Canadian Lawyer and The Australian Lawyer, looking back at one year of the Unified Patent Court (UPC) and discussing how national courts still dominate patent litigation in Europe.
Read the extended press release below.
One year in, the jury is still out on the new UPC as its caseload is still dwarfed by national courts, say leading intellectual property law firm Mathys & Squire.
The UPC opened on June 1, 2023 with the aim of becoming Europe’s primary patent court. In its first year of operation, 205 cases were filed at the court (134 infringement cases, 39 revocation actions and 32 provisional measures actions). This represents around 15% of the total number of patent cases filed in Europe in 2021, when a total of 1,275 patent law cases were heard in the UK, Germany, France, Italy and the Netherlands combined.
Although 205 cases in an initial year is an impressive total, the UPC still has a long way to go before it becomes Europe’s primary court for patent litigation. The UPC’s caseload places it slightly ahead of the French courts, which heard 174 patent cases in 2021, and a long way behind Germany, which heard 841 patent cases that year.
Most important of all, very few UPC cases have yet to reach any form of conclusion. That is not unexpected. Under the UPC’s court rules, cases are expected to reach a final hearing in 12 months with decisions issued shortly thereafter. It is only now that the Court has been running for a full 12 months that we can start to expect the Court to begin issuing substantive decisions. Up until now, the Court has only ruled on a handful of cases, primarily on procedural issues.
It is likely to be quite some time before the jurisprudence of the UPC resembles anything approaching a settled state. Although there should be a steady stream of substantive decisions over the next 12 months, such decisions will only be decisions at first instance. It will not be until settled practice begins to develop through a substantial body of decided cases or cases are referred to the UPC Court of Appeal that the approach of the new court to substantive patent law is likely to become clear.
UPC case numbers dwarfed by other courts
A slow start for the UPC was baked-in by design.
The UPC has no jurisdiction over patents granted by national patent offices. However, a significant proportion of European patent disputes relate to such national patents rather than to patents granted by the European Patent Office, over which the UPC does have jurisdiction.
Nor does the UPC jurisdiction extend over all European countries. The UK was forced to withdraw from the UPC following Brexit and many significant European countries, notably Spain and Poland have chosen not to join the new system.
Additionally, patent holders have the choice to opt patents out of the jurisdiction of the court and around two-thirds of European patents in existence when the court opened were opted-out. This will have included the vast majority of patents which patent holders thought might have been the subject of third-party revocations actions before the UPC.
The 39 stand-alone revocation actions brought before the UPC in its first year is in stark comparison with the thousands of oppositions filed annually at the European Patent Office (EPO). Although the total number of UPC revocation actions will be bolstered by counterclaims for invalidity brought against patents which are sought to be enforced in the UPC, such numbers are dwarfed by the 3,775 oppositions filed in the EPO in 2022 and are likely to continue to be so for the foreseeable future.
Says Nicholas Fox: “The success of the UPC in attracting work to date is significant – but that shouldn’t be overstated. When we compare the UPC to other national patent courts we see that the UPC is still just one of many courts developing European patent case law.”
“Currently, most businesses tend to focus on bringing patent cases at a national level. If the UPC wants to become Europe’s hub for patent litigation it has to convince patent holders that litigating continent-wide is worthwhile.”
“Both corporates and lawyers will also need to become more comfortable that the UPC will deliver predictable and very robust judgments. At the moment, most of the very big ticket patent litigation, for example in pharmaceuticals, is staying within the national court systems.”
Managing IP has released its 2024 guide of the IP STARS legal directory, which recognises the most outstanding practitioners covering several IP practice areas and more than 50 jurisdictions. Each year, the research analysts obtain information through firm submissions, client interviews, as well as online surveys, to identify the leading IP STARS.
We are delighted to announce that Partners Jane Clark, Hazel Ford and Paul Cozens have been named as ‘Patent Stars’ and Partners Gary Johnston, Rebecca Tew as well as Consultant Margaret Arnott have been recognised as ‘Trade Mark Stars.’ Additionally, Partners Philippa Griffin, Nicholas Fox, David Hobson, Martin MacLean and Andrew White have been featured as ‘Notable Practitioners’ in the latest guide. The 2024 Rising Star rankings are due to be released in September 2024.
The firm is also pleased to have maintained its rankings for ‘Patent prosecution’ and ‘Trade mark prosecution’ in the 2024 directory.
For more information, and to view the rankings in full, visit the IP STARS website here.
In recent EPO decision T 293/19 a Technical Board of Appeal has suggested that claims to products that could be envisaged as obvious improvements over the prior art, but which could not be produced using methods known in the art, may not be deemed inventive. This decision departs from a long-standing line of previous case law.
The case at issue included claims to both a process and products that were obtainable using that process. The Board decided that the process was both novel and inventive, and then went on to consider the patentability of the product claims. In one request, the product (an IgM antibody preparation) was defined by a specific property (a proteolytic activity of less than 8U/l) that was not disclosed in the closest prior art document. The Board had doubts over whether this feature was sufficient to distinguish the closest prior art but gave the proprietor the benefit of the doubt for the sake of argument.
Whilst it was undisputed that a low proteolytic activity was considered a desirable property in the prior art, the proprietor argued that there were no processes in the prior art that could lead to a product having a proteolytic activity below the claimed threshold and that the product should thus be considered inventive. In support, the proprietor referred to earlier decision T 595/90 which states that “an otherwise obvious entity… may become nevertheless non-obvious and claimable as such if there is no known way or applicable… method in the art to make it and the claimed methods for its preparation are therefore the first to achieve this in an inventive manner”. The reasoning of that decision has subsequently been followed in a number of cases and until now seemed to be a well-established principle of EPO case law.
The Board had doubts over whether known processes could produce the claimed composition, but again assumed in favour of the proprietor. However the Board did not accept the proprietor’s argument that the product claim should thus be held inventive, stating that the EPO’s problem-solution approach for assessing inventive step “[a]t no point…includes the question of whether a product could or could not be obtained by a process known from the art for it to be inventive” and that “an obvious improvement…is not necessarily inventive for the reason alone that it cannot be prepared by methods available at the filing date”. The product claim was thus found obvious, with the Board of the view that the invention lay in the development of the process to produce the product and not the product itself.
This conclusion is in some ways difficult to understand. The EPO’s problem-solution approach does only ask whether the invention was “obvious” to the skilled person without explicitly addressing whether this means that the skilled person should merely be able to envisage the invention or actually produce it. However, in order to destroy novelty, an enabling disclosure of a product is required in the prior art (i.e. the skilled person must be able to make the product based on its disclosure in the art), and so it is not clear why this should not also be a consideration when assessing inventive step. If somebody produces a product for the first time using inventive skill, why should they not be entitled to a claim to that product in addition to the process used to make it?
The Board’s conclusion thus seems to represent a significant departure from the principles established by T 595/90. The Board in T 293/19 states that its conclusion would depend on the facts of the case and the claim wording but provides minimal additional guidance, and so it will be interesting to see if any other Boards follow this decision.
Leading intellectual property (IP) law firm Mathys & Squire is pleased to announce the promotion of Laura Clews, Samantha Moodie and Edd Cavanna to Partners at the firm.
An extended version of the press release is available below.
Laura Clews has been appointed to Partner in Mathys & Squire’s life sciences & chemistry team, continuing a 13 year-career with the firm. Laura holds a doctorate in liquid chromatography and is a highly skilled patent lawyer with global knowledge of drafting and litigating patent applications, particularly in the fields of ionic liquids, composite materials, polymer chemistry, solar cells, medical stents and oil and gas technologies.
Samantha Moodie has also been promoted to Partner at Mathys & Squire, having joined the firm’s life sciences & chemistry team in 2011. A specialist in molecular biology and biotechnology and holding a doctorate in molecular virology, Samantha has extensive experience managing complex worldwide patent portfolios. Areas of particular focus for Samantha include antibody-based therapeutics, nucleic acid-based diagnostics and stem cell and regenerative technologies.
Edd Cavanna too has been appointed Partner in Mathys & Squire’s IT & engineering team. With a PhD in Physics, Edd joined the firm in 2015 and specialises in the IP and technology areas of mechanical, electronic, software and energy. Edd’s promotion will strengthen the firm’s services across all technology fields, especially semiconductor devices and applied superconductivity.
Says Alan MacDougall, HR Partner at Mathys & Squire: “It’s a great pleasure to see Laura, Samantha and Edd continue very successful careers with Mathys & Squire and welcome them to our partnership. After joining Mathys & Squire as Technical Assistants, all three have grown into highly regarded specialists in their respective fields. Their wealth of expertise will make a vital contribution to the exceptional services we deliver to our clients.”
Mathys & Squire has also promoted five lawyers to Managing Associates – Alex Elder, Adam Gilbertson, Lionel Newton, Oliver Parish and Leonard Wright.
Says Alan MacDougall: “Congratulations to Alex, Adam, Lionel, Leonard and Oliver are also due, whose promotions are another reflection of the remarkable talent within our firm. Our talented new Managing Associates will deliver valued support to our partners across all service lines and sectors.”
Commentary by Partner Andrew White has been featured in The Independent and The Patent Lawyer, discussing how R&D in defence, alongside agriculture and logistics, is driving innovation in drone technology.
Read the extended press release below.
The number of global patents filed for drone technology has increased 16% from 16,800 in 2022 to 19,700 in 2023* (includes patents for drone countermeasures), shows new research from leading intellectual property (IP) law firm Mathys & Squire.
Increased innovation in drone technologies has been driven by greater research and development (R&D) spending in the defence sector, the ongoing integration of AI into drone technology as well as drones that can better handle countermeasures. This reflects the growing usage of drones in military conflicts.
Russia is now in the top five countries for filing drone patents. 333 drone-related patents were filed by Russian entities in 2022 and 2023. Ukraine only filed 4 patents relating to drone technology over the same period.
Andrew White, Partner at Mathys & Squire, says: “Military applications now make up a significant proportion of R&D in drone technology. We’re seeing more investment in drone research from defence businesses as governments realise that they are in a literal arms race within this field.”
Industrial and commercial applications continue to drive drone innovation
Commercial applications of drone technology also continue to expand rapidly, with some emerging applications including:
China remains at the forefront of drone innovation, with 82% of all global drone patents filed since 2015 originating from Chinese companies. During 2023 this rose to 87%, accounting for 17,285 patent filings. Drone manufacturer DJI of China was the most frequent filer of drone patents – filing 88 in the last year. The US was the second largest filer of drone patents, filing 858 in 2023.
With the global drone market estimated to be worth over $100 billion**, Mathys & Squire emphasises the importance of proactive patent strategies for businesses looking to capitalise on the opportunities presented by drone technology.
White concludes, “As drones continue to be adopted across more industries, it’s crucial for businesses to safeguard their IP in this competitive space through patent protection.”
* Source: World Intellectual Property Organisation. Year end December 31 2023
** Source: Goldman Sachs
Materials are important. They are the stuff that new things can be made of. Whether that’s a functionally coated medical implant, a particularly clear and comfortable ocular device or as part of a system for filtering blood, materials underpin many inventions in the healthcare sector. Within the innovation-driven medical device industry, new materials can significantly enhance device performance, patient safety, and treatment outcomes, leading to competitive advantages. Protecting materials-related inventions is therefore of high importance.
There are a number of requirements for a patent to be granted, not least that the invention to be protected must be novel and inventive. Assuming those hurdles have been met, consideration needs to be given as to how to best claim the invention. Claims determine the extent of protection conferred by the patent and must be clear and concise and supported by the description. They need to adequately define the material(s) that forms the basis of the technology. A patent application must also provide sufficient teaching to enable the skilled person to perform the invention (the invention must be sufficiently disclosed). A thought should also be given to the types of claims in the application – obvious contenders are product/apparatus claims and process (manufacture) claims, but may there also be scope for a method of use claim?
This article will discuss factors to consider when drafting an application protecting materials used in medical devices, with a few examples to highlight some specific challenges.
Claim language
Claims might include functional language, provided that a person skilled in the art would have no difficulty in providing some means of performing the function without exercising inventive skill. That is, they must be able to provide one or more materials that achieve such a function. The claim may specify that a medical device includes a surface layer “for the prevention of microbe growth”, where the skilled person understands this could broadly cover coatings containing, for example, antimicrobial materials such as zinc pyrithione, silver, isothiazolinone treatments, and quaternary ammonium compounds. Specifying the exact materials, or even the class of materials, might be unduly limiting on the scope of protection, whereas functional language can provide broader coverage and can be harder for potential infringers to design around.
However, extremely broad-brush functional language or attempts to define the invention by a result to be achieved are generally not allowed, in particular if they only amount to claiming the technical problem underlying the application. An independent claim should indicate all the essential features of the object of the invention in order to comply with the requirements of Article 84 EPC (G 2/88 and G 1/04). The extent of the monopoly conferred by a patent, as defined in the claims, must correspond to the technical contribution to the art. If the essential features necessary to achieve the result are not claimed, then third parties are unable to assess whether they are infringing the patent – the claim is unclear. Nevertheless, claims encompassing a result to be achieved may be allowed in certain circumstances[1]. For example, a claim directed to an “effective amount” of an antimicrobial agent “sufficient to substantially inhibit microbial growth”, may be allowed if further defining the amount of the agent would unduly restrict the scope of the claim and the skilled person would be able to directly and positively verify the degree of inhibition of microbial growth.
Alongside functional language, claims typically include structural limitations, defining characteristics that are critical to the material’s functionality or properties. Devices encompassing certain materials may benefit from the specific properties of that material, leading to improved performance and innovation. The mechanisms underpinning that performance might be better understood via advanced characterisation techniques, and parameters derived from those techniques can be used to define the invention. Whilst parameters might give the illusion of precision when compared to functional language, a parameter with an unclear or missing measurement method can be open to different interpretations, making it difficult for a third party to determine whether they are infringing the claim. European Patent Office (EPO) Guidelines require that a measurement method for a parameter is included in the claim itself[2], unless it can be convincingly shown that[3]:
• the measurement method to be employed belongs to the skilled person’s common general knowledge (e.g., because there is only one method, or because a particular method is commonly used); or
• all the measurement methodologies known in the relevant technical field for determining this parameter yield the same result within the appropriate limit of measurement accuracy.
Thus, for any parameter that might be measured in different ways, giving rise to different results, caution must be exercised when using the parameter to define the material.
Examiners frequently raise clarity objections to parameters such as “viscosity”, “glass transition temperature”, “molecular weight”, “porosity” and “particle size”, as well as more “unusual parameters” (which might make a comparison with the prior art difficult). Since clarity is not a ground for opposition, opponents typically attempt to show that the unclear term makes the claim so broad as to be anticipated by the prior art, or that the parameter renders the claim insufficient due to an absence of detailed information as to how it is measured.
The description
Sufficiency at the EPO requires that there is enough information in the specification to allow the person skilled in the art, using common general knowledge, to perform the invention over the whole area claimed without undue burden and without needing inventive skill. That is, regardless of whether or not the claim defines the material using parameters, the best practice would be to include a detailed description of the material’s composition, structure, and manufacturing process. Details such as the chemical, physical, mechanical or electrical properties that are critical to the material’s functionality are also important, as well as the conditions that are essential for performance and/or manufacture. Examples can help to demonstrate the features essential for carrying out the invention such that it is apparent to the skilled person how to put the invention into practice[4].
As discussed above, if the measurement method is part of the skilled person’s common general knowledge, it might be possible to omit the technique from the description. For example, in certain subject areas, such as powder technology, the measurement technique for an average pore size or diameter of particles may be extremely common such that the skilled person could put a suitable method into practice. However, even for very well-known parameters, there are limits to the extent that common general knowledge can be relied upon to overcome any deficiencies in the disclosure of the measuring method. A level of uncertainty in the limits of protection might affect the clarity of the claim, but a greater level of uncertainty might make it impossible for the skilled person to carry out the invention and thus compromise the sufficiency of the disclosure.
Effective drafting of the description not only ensures the requirements of sufficiency of disclosure are met, but also that there is a sound basis for future amendment as well as an adequate description of key features to minimise the chance for interpretation disputes in opposition and appeal proceedings. As to the latter, there is a degree of divergence in the case law over the extent to which the description and drawings should be used to interpret claims and a decision on this is being referred to the Enlarged Board of Appeal. The referring Board in T 439/22 stated that “a narrow interpretation of the claim language ignoring a definition giving [sic] in the description would also conflict with a broader interpretation by national courts or the UPC when having to deal with the granted claim later during the live [sic] of the parent”[5]. Given the current different approaches to claim interpretation by EPO Boards, careful thought should be given to the detailed description and how it may be used to interpret the claims (particularly in view of its use by national courts as an explanatory aid for the interpretation of the claims).
Claim types
In addition to claims seeking protection for the new product/material and method of manufacture, claims directed to the method of using the product might be included. If a medical device is applied in a novel and inventive way, it may be possible to patent the new method of using the device alongside patenting any enhancements or modifications of the device itself. Use claims provide an additional layer of protection for novel medical devices and can offer valuable protection when a new use of a known product has been identified. Use claims might cover both non-therapeutic methods as well as therapeutic methods, although care must be taken for medical device-related inventions as Article 53(c) EPC excludes methods for treatment of the human or animal body by therapy or surgery from being patented. The exclusion does not, however, apply to products, in particular substances or compositions, for use in said methods.
The legal framework of the EPO differentiates between chemical/pharmaceutical inventions and medical devices, but the dividing line between what is a substance or composition and what is a device is not entirely clear. In T 2003/08, the Board considered that the “substance” or “composition” must achieve the medical effect and that the terms “substance” or “composition” referred at least to products which were chemical entities or compositions of chemical entities. According to T 1758/15, products that have a chemical “mode of action” are “substances or compositions”. However, the recent Board of Appeal decision in T 1252/20 proposed to define the product in terms of its own characteristics instead of the interactions it may have with the body: a “substance or composition” should include any product that may be defined by its chemical composition, regardless of the mechanism of action of the product in the body.
Following T 1252/20, a broader category of products may be permissible as the subject of second medical use claims. For medical devices comprising novel materials, creative claim drafting might enable protection in the form of a medical use claim directed to the material defined by its chemical composition (avoiding the use of device-like features such as shape or pore-size). Whether a product is a substance or composition, or a medical device will still require a case-by-case assessment. Therefore, it may be prudent to include use claims for products that might previously have been considered medical devices, even if there is a question over whether the material used is a “substance or composition”. The description should include details of the product delivery and its mode of action by chemical means in order to follow the reasoning in this decision, particularly since this area of law remains unclear.
The following case studies look at some examples of challenges that can be faced when claiming materials in medical devices.
Case Study 1 – supporting experimental data/evidence for sufficiency of disclosure
Chemical formulae are infrequently used in the medical device sector, with a preference given to more functional language which may allow for a broader claim. Nevertheless, a material which may be defined by its chemical formula, can provide a simple and elegant claim:
“A medical implant comprising a biodegradable magnesium-based alloy with a surface layer comprising a magnesium carbonate, characterized in that, the magnesium carbonate has the formula Mg2[(OH)2(CO3)] · 3 H2O.”
The specification provided a detailed description of the experimental conditions required to achieve a magnesium carbonate coating on the magnesium-based medical implant. The specification indicated that different types of magnesium carbonates could form depending on the atmospheric conditions, and included an example with the conditions required to achieve the specific formula claimed (Mg2[(OH)2(CO3)] · 3 H2O). The example allegedly confirmed the presence of the specific magnesium carbonate via an infrared spectrum identifying the coating material.
However, during an opposition, prior art was found to demonstrate that the depicted spectrum did not in fact correlate with that of the claimed chemical formula. The Opposition Division considered that the spectrum did not allow the conclusion that the claimed material was actually obtained in the example, raising the question of sufficiency of disclosure, since the skilled person would be faced with having to perform more experiments to determine how to obtain the claimed formula, a “research program”.
It is thus key, that the specification provides sufficient experimental details required to achieve the claimed chemical formula defining the material and any examples and/or data support this. Patent attorneys and inventors must work closely together to ensure that any examples contain all the conditions needed to achieve the claimed product, and that any data presented in the application confirms the materials are achieved.
Case Study 2 – details and definitions for functional features
Functional language is frequently used to define a material, but difficulties can arise when insufficiency and/or lack of clarity objections are raised, and there are a lack of amendment options in the description.
Packaging material for an ophthalmic lens was defined as absorbing less than a certain amount of the therapeutic agent comprised within the lens it was intended to package:
A blister pack for packaging an ophthalmic lens comprising therapeutic agents, wherein said blister pack comprises a polymeric material that absorbs less than 10% of said therapeutic agents.
Experimental data was provided in the application testing the percentage absorption of a solution of a specific therapeutic agent by specific polymeric materials, defined by their tradenames[6]. The data showed that certain polymeric materials were not suitable. The Examining Division objected that the invention was not sufficiently disclosed across the scope of the claim since the experimental data could not be deemed representative of any therapeutic agent or any class/group of polymeric materials. The Division also objected that the conditions under which absorption of the therapeutic agent was tested, such as concentration of the therapeutic agent, duration of exposure to the solution/material and test temperature, were not specified and no standard test was referred to. Since the test method affected the technical effect underlying the present invention, the absorption of the agent, this further contributed to lack of sufficiency of disclosure. It was objected that the person skilled in the art, using their common general knowledge, was unable to perform the invention over the whole area claimed without undue burden and without needing inventive skill.
Notwithstanding the challenges faced as a result of the lack of experimental details, the application also did not provide basis to define polymeric materials more generally. The definition provided for the general class/group of polymers relied on the glass transition temperature – a parameter, which was not further defined, and no measurement method was supplied.
The functional feature was in the claim as filed and could not be removed without contravening Article 123(2) EPC. However, there was no basis for an amendment to clearly define the class or group of polymeric materials and the application did not contain sufficient detail to enable the skilled person to measure the therapeutic agent absorption. As such, these problems were terminal for the application.
The inclusion of progressive amendment options in the description (e.g., general polymeric material, general class/group of polymers, specific polymers, tradenames) as well as complete details of experimental conditions is therefore important.
Case Study 3 – medical use claims and consideration as to the “substance or composition”
An invention may reside in a new filter apparatus comprising a material for removing a chemotherapeutic agent from blood. Whilst claims directed to a method of using the filter apparatus (below) may be allowable in some jurisdictions, such as the US, they are not in a format permitted at the EPO.
“A method of treating a subject with cancer of the liver comprising:
isolating blood flow out of a vein,
administering a chemotherapeutic agent,
collecting blood laden with the chemotherapeutic agent, and
filtering the blood laden with the chemotherapeutic agent with a filter apparatus comprising an extraction medium comprising activated carbon.”
These types of claims need reformulation before the EPO. Use of the apparatus in filtering blood encompasses therapeutic and surgical aspects, falling under the exclusion of Article 53(c) EPC. One claim format might focus on claiming the chemotherapeutic agent, a “substance or composition”, in a format corresponding to Article 54(5) EPC:
“A chemotherapeutic agent for use in a method of treating a subject with cancer of the liver, said method comprising:
isolating blood flow out of a vein,
administering said chemotherapeutic agent,
collecting blood laden with the chemotherapeutic agent, and
filtering the blood laden with the chemotherapeutic agent with a filter apparatus comprising an extraction medium comprising activated carbon.”
The Examining Division questioned whether the use of the chemotherapeutic agent was novel over the prior art. The Division considered that the difference over the prior art resided primarily in the new filter apparatus, and the use of the chemotherapeutic agent (in treating cancer of the liver) was not necessarily modified or adapted in connection with the subsequent filtering of the blood. As such, the use of the chemotherapeutic agent as claimed was deemed not to be novel or inventive over the prior art: it involved neither a new compound, nor a new therapeutic agent, nor a new treatment regimen[7].
It can be difficult in these circumstances to reformulate such a use claim to capture the medical device. Alternative claim “reformulations” might focus on a claim to the specific use of the new material, the activated carbon:
“Activated carbon for use in a method of treating a subject, said method comprising:
isolating blood flow out of a vein,
administering a chemotherapeutic agent,
collecting blood laden with the chemotherapeutic agent, and
filtering the blood laden with the chemotherapeutic agent with a filter apparatus comprising an extraction medium comprising the activated carbon.”
A question arises as to whether the activated carbon is a “substance or composition” within the meaning of Article 54(5) EPC. It may be possible to completely define the activated carbon in terms of its chemical composition, following the decision in T 1252/20, or even assert that the “mode of action” is a chemical interaction (in line with T 1758/15) between the activated carbon and the chemotherapeutic agent so as to remove cancer cells from the blood of patients. However, if the invention lies in device-like features of the activated carbon, such as shape or pore-size, then it is unlikely that this claim format will meet the requirement for second medical use claims to be patentable.
Key takeaways
A balance has to be struck between providing an adequate and often detailed definition of a material (for clarity and novelty purposes), and retaining a breadth of claim that is harder for potential infringers to design around. For materials-related inventions, this often involves the use of functional claim language alongside structural language, including parameters, to define the material/device. The functional language should relate to clear and easy to measure functional properties so that any alleged infringement can be proven.
Together with ensuring that the patent application provides sufficient disclosure of the invention, the inclusion of detailed definitions, measurement methods and enabling examples in the description can provide options for incremental amendments. This not only gives reassurance at the drafting stage and is critical for obtaining a granted patent, but also provides a patent which can be enforced and defended against challenges.
A patent attorney who specialises in the field of materials science can be invaluable in obtaining a clear, enabled and robust patent capturing inventions relating to materials used in the healthcare sector.
[1] If the invention can only be defined in terms of a result to be achieved, or if defining more precisely would unduly restrict the scope of protection and if the result can be directly and positively verified by tests or procedures adequately specified in the description or known to the skilled person and which do not require undue experimentation (T 68/85).
[2] If the description of the measurement method is so long that inclusion makes the claim unclear or difficult to understand then a reference to the description can be included in the claim instead.
[3] The applicant might submit an expert declaration or experimental data to prove one of these exceptions applies.
[4] A single example may suffice, but where the claims cover a broad field, the application is not usually regarded as satisfying the requirements of Article 83 unless the description gives a number of examples or describes alternative embodiments or variations extending over the area protected by the claims. (Guidelines Part F-III, 1)
[5] Point 6 of the communication of 5th December 2023.
[6] Under the EPO Guidelines Part F-IV, 4.8, the use of trademarks in the claims is not allowed as it does not guarantee that the product referred to is not modified while maintaining its name during the term of the patent.
[7] The Division specifically considered whether differences arose in: a new group of patients (T 19/86, T 233/96), a new mode of administration (T 51/93), a new dosage (T 56/97, T 230/01) or a new clinical situation (T 384/03, T 1229/03). Differences were found only to relate to the apparatus features.
