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Inventive step

    The approach to the assessment of inventive step of antibodies at the EPO – is there an artificial barrier and should it be brok

    On 9 January 2025 I reported on Parts 1 and 2 of a three-part article in EPI Information by Tamaris Bucher, a Principal Patent Attorney at Novartis Pharma AG, on the current approach to antibody patents at the EPO. In Parts 1 and 2, Bucher argued that Part G.II.6.2 of the EPO Guidelines, which starts with a presumption that antibodies are prima facie non-inventive, creates an artificial barrier to obtaining patent protection for antibody inventions and sets a higher standard for the assessment of antibody claims that does not have clear basis in Art. 56 EPC or EPO case law. Bucher’s submission in Part 3 of the article is that the EPO Guidelines on inventive step for antibody patents are based on an unfounded prejudice that antibody generation work is routine and do not reflect the fact that antibody development and engineering for diagnostic or therapeutic purposes is a highly complex art requiring inventive skill. Scientists do not simply vaccinate an animal with the target and apply the product of the Köhler-Milstein hybridoma technique in a diagnostic or therapeutic context. Rather, the development of commercially relevant antibodies follows an unpredictable path and involves the combination of multiple techniques with the goal of obtaining an antibody with appropriate affinity, biological activity, selectivity, cross-reactivity, immunogenicity, stability, solubility, viscosity, aggregation, purity and biophysical criteria and the absence of undesirable post-translational modifications. Therapeutic and diagnostic antibodies are not simply products of nature, as the EPO appears to view them. Part 3 presents a proposed solution. The starting point, according to Bucher, is to bring the Guidelines on antibodies into consistency with the principles applied to small molecule compounds and to step back from the use of the term “antibody” in the formulation of the objective technical problem. Typically, the objective technical problem for antibody claims is formulated as (i) the provision of an antibody to the target X that exhibits the relevant improvement (where there is an improvement in a particular property) or (ii) the provision of an alternative antibody to the target or for use in the same purpose (where no improvement is identified). However, in Bucher’s view the use of the term “antibody” may have the inadvertent effect of causing EPO examiners to overlook the variability in antibody complementarity-determining regions (CDRs, the regions of antibodies that are responsible for binding to the target). Unlike small molecule compounds, for which structures are claimed as graphical representations, antibodies are represented by seemingly generic terms (“SEQ ID No. Z” or “SEQ ID No. ZZ”, which each represent a series of amino acids) so differences between 3D structures are less apparent. This makes it easier for examiners to overlook the different structures in the paratope (the part of the antibody involved in binding to the target) in claims defined by specific CDR or VH/VL sequences. The issue is further compounded by the discouragement of the assessment of structural information in Part G.II.6.2 of the Guidelines. Bucher suggests reformulating the objective technical problem as the provision of a specific alternative molecular structure (or sequence) for use in achieving the functional activity Y to reflect the complex and varying structures that can be represented by sequences in different SEQ IDs. For the final step of the problem-solution approach – in which it is considered whether or not the claimed solution, starting from the closest prior art and in light of the objective technical problem, would have been obvious to the skilled person – Bucher argues that the correct question should be whether the claimed antibody with its specific amino acid sequences would have been made by the skilled person by following the prior art and with a reasonable expectation of success of achieving the desired activity, not whether it could have been made using unlimited time and resources. The key question that arises is what the impact would be of such a change of approach in relation to antibody claims. Bucher argues that it would be limited: claims to antibodies defined by SEQ ID are relatively narrow in scope so the grant of additional antibody patents would not be problematic for the antibody field or detrimental to the public in general. Whether readers agree or not it is clear that this is an area ripe for consideration given the importance of biologics in modern healthcare. Bucher’s article series has already generated significant discussion amongst patent practitioners so there is clearly momentum for further debate – and potentially a change in approach – in this critical area. Ms Bucher’s article can be found at the following link: epi Information | The Barrier Around Antibody Inventions at the European Patent Office More from our authors: Vissers Annotated European Patent Convention 2024 Edition by Kaisa Suominen, Nina Ferara, Peter de Lange, Andrew Rudge € 105 Annotated PCT by Malte Köllner € 160 AI Governance and Liability in Europe: A Primer by Ceyhun Necati Pehlivan, Nikolaus Forgó, Peggy Valcke € 150

    Never Too Late: If you missed the IPKat last week!

    Here is the weekly recap of what you might have missed! Patents Rose Hughes explained cell therapies and their unique challenges in the pharmaceutical marketplace. She also provided insights regarding loss of exclusivity. Katfriend Adanna Onah analyzed the decision of the Court of Appeal of England and Wales in Ensygnia IP Ltd v Shell UK Oil Products Ltd & Ors [2024] EWCA Civ 1490. The case concerned Ensygnia’s patent for QR code-based authentication and payment systems. Rose Hughes outlined T 1865/22 concerning the inventive step of a composition where the only distinguishing feature was a lower concentration of a component compared to the closest prior art. The Board of Appeal questioned whether the claimed composition involved an inventive step. Plant Varieties Jocelyn Bosse reported on a recent decision of the Supreme People’s Court concerning compensation for the unauthorised plantings and sale of an apple variety called 'Scilate'. The Court awarded RMB 3.3 million (£319,000) in damages, recording the largest award for a civil claim for PVR infringement. Copyright and AIEleonora Rosati reviewed the US Court of Appeal decision in A Recent Entrance to Paradise which is an artistic work that is claimed to have been entirely generated by Dr Stephen Thaler’s Creativity Machine. The Court of Appeal has confirmed that “the Copyright Act of 1976 requires all eligible work to be authored in the first instance by a human being.” Trade Marks Söğüt Atilla discussed the EUIPO Fifth Board of Appeal's decision to refuse to register a colour combination for “agricultural machines and implements, namely field sprayers” in Class 7 of the Nice Classification due to the absence of sufficient evidence demonstrating acquired distinctiveness through use under Article 7(3) EU Trade Mark Regulation. Designs Marcel Pemsel looked into the latest decision of the General Court concerning the design of a light bulb and the interpretation of Art. 7(2) Community Design Regulation. IP events and opportunities Oliver Fairhurst informed the Readers of upcoming events from Italy, the UK, Poland, and USA. Several opportunities include a Senior Research Associate recruitment from the Faculty of Law at the University of Cambridge. The Cambridge Faculty of Law is also recruiting a Senior Research Associate to work on the challenges of innovation and advanced medical computing. Be sure to check out our post and Events page for more details.

    Excluding a technical feature is not inventive without evidence of a technical effect (T 1865/22)

    The recent Board of Appeal decision in T 1865/22 considered the inventive step of a composition where the only distinguishing feature was a lower concentration of a component compared to the closest prior art. The prior art taught that higher concentrations of this component were advantageous. The Board of Appeal found that simply excluding a technical feature disclosed as essential or advantageous in the prior art cannot in itself establish inventive step in absence of evidence showing that a comparable technical effect to the prior art can still be achieved. G 2/21 was mentioned but not directly applied in the case given that the patentee's evidence of the invention's technical effects was considered late-filed.  Inventive step at the EPO: The problem-solution approach and technical effects  The assessment of inventive step at the EPO follows the problem-solution approach, which requires identification of the closest prior art, the objective technical problem to be solved, and an assessment of whether the claimed solution would have been obvious to the skilled person. The problem-solution places heavy emphasis on the problem to be solved by the invention in view of the closest prior art. The identity of the closest prior art, and the technical effect of the invention view of the closest prior art, are therefore be highly influential to the outcome of an EPO inventive step analysis.  In need of paint removal The Enlarged Board of Appeal (EBA) decision in G 2/21 considered the question of whether post-filed evidence can be used to support a technical effect of an invention view of the closest prior art. The EBA ordered that: "A patent applicant or proprietor may rely upon a technical effect for inventive step if the skilled person, having the common general knowledge in mind, and based on the application as originally filed, would derive said effect as being encompassed by the technical teaching and embodied by the same originally disclosed invention." Since G 2/21, the Boards of Appeal have generally interpreted the EBA order to mean that the application as filed does not need to explicitly mention the technical effect of the invention in view of the closest prior art, or to provide experimental evidence of it. As interpreted by T 0116/18, G 2/21 merely requires the purported technical effect to be "conceptually comprised by the broadest technical teaching of the application as filed" (T 0116/18, r.11.10). Accordingly, it may be "sufficient that the skilled person, having the common general knowledge in mind, and based on the application as filed, recognises that said effect is necessarily relevant to the claimed subject-matter." (T 0116/18, r.11.10). However, as clarified in later decisions such as T 1994/22, mere broad sweeping statements about providing "a quality product" are not sufficient to encompass and embody specific undisclosed technical effects. Case Background The case in T 1865/22 related to EP 3374443, owned by Atotech GmbH. The patent was directed to a non-aqueous stripping composition for removing organic coatings, such as epoxy resin and paint, from surfaces. The patent was opposed by Chemetall GmbH. The Opposition Division (OD) maintained the patent in amended form, and the Opponent appealed this decision. On appeal, the claimed stripping composition was specified as comprising three components: a  solvent, co-solvent and a pH-active agent. The parties accepted that the only difference between the claimed composition and the composition disclosed by the closest prior art was the concentration of the co-solvent component. In the prior art, the co-solvent was described as 25% by weight. The claimed composition specified a co-solvent 2-20% by weight. The central question for the Board of Appeal was whether the claimed composition, differing only from the prior art by its lower co-solvent concentration, involved an inventive step. Evidence of a technical effect?  Critically, the application as filed did not mention any technical effects associated with the lower concentration of solvent. In the absence of any established technical effect for the distinguishing feature, the Board of Appeal thus formulated the objective technical problem as "to provide an alternative stripping composition" (r.4.3). The Patentee argued that the skilled person would not have reduced the amount of the coupling agent (monoethylene glycol) in the prior art example because, according to the prior art disclosure, high concentrations of this component were essential for appropriate tolerance to water. In other words, the Patentee argued that the prior art taught away from the claimed invention. This argument had convinced the Opposition Division to acknowledge inventive step. In contrast to the OD, however, the Board of Appeal did not find the Patentee's argument convincing. The Board of Appeal particularly found that arbitrarily varying the concentrations of components in a composition, including changing the concentration of one component in favour or to the detriment of others, is routine for the skilled person and does not involve an inventive step (r.5.1). The Board of Appeal concluded that "[t]he mere fact that claimed subject-matter excludes a technical feature [...] disclosed in the closest prior art as being essential or advantageous for a technical effect [...] cannot in itself establish the existence of an inventive step. Rather [...] it must be shown that the claimed subject-matter achieves said technical effect to an extent comparable to that of the closest prior art, even without this feature. Without such proof, the claimed subject-matter merely results in an obvious deterioration of the technical effect described in the closest prior art." (r.5.3).  Following this reasoning, the Board of Appeal concluded that the claimed subject-matter lacked inventive step over the prior art and revoked the patent.  Late filed evidence and G 2/21 At oral proceedings, the Patentee attempted to argued that the lower concentration of co-solvent specified in the claim was a distinguishing feature that resulted in a number of technical effects, such as a lower viscosity. Importantly, however, these submissions were not admitted to proceedings. The Board of Appeal considered the submissions to be amendments to the Patentee's appeal case and that allowing the submissions would be contrary to procedural economy (Articles 13(1) and 13(2) RPBA).  Consequently, the way in which G 2/21 should be applied to the facts of the case was not considered by the Board of Appeal. The decision made only a brief reference to G 2/21, with the Board of Appeal merely noting that the application as filed did not mention anything about a reduction in viscosity. For the Board of Appeal, this raised the issue of "whether the respondent can rely on these effects at all for the assessment of inventive step" (r.9.2). Final thoughts The decision in T 1865/22 highlights the importance of providing evidence to support inventive step when claiming compositions or devices that omit features previously described as essential in the prior art. T 1865/22 also aligns with the established case law on arbitrarily selecting parameter ranges, reinforcing that merely changing the concentration of components without an associated technical effect will generally be considered obvious. As the Board of Appeal emphasised, the problem-solution approach requires that the distinction between the claimed invention and the prior art leads to a non-obvious technical effect. Interestedly, the patent in question in the present case was a European originating case. One might have expected the lack of focus on the technical problem in the application as filed to be a consequence of US-style drafting.  In cases where the claimed invention might involve excluding a feature described as advantageous in the prior art, T 1865/22 thus serves as a reminder to establish clear technical effects associated with this exclusion at an early stage in the proceedings, and to provide adequate support for such effects in the application as filed. The challenge for establishing inventive step in the European patent system is anticipating which features of the invention will be those necessary to distinguish from the closest prior art, given that the closest prior art may not become known until after the application has been filed. In some cases, the closest prior art may not be known to the patentee until the granted patent is challenged by a third party. Whilst G 2/21 provides patentees with some leeway in these situations, T 1865/22 is a reminder that the earlier you can identify and provide evidence of your technical effect, the better. 

    The description of a patent should "always" be used to interpret the claims (DexCom vs. Abbott, UPC_CFI_230/2023)

    The Paris Local Division of the Unified Patent Court (UPC) first substantive decision on patent validity in DexCom v Abbott (UPC_CFI_230/2023), provides some interesting commentary on how much the description should be taken into account when interpreting the claims. Claim interpretation is the subject of the highly anticipated referral to the EPO's Enlarged Board of Appeal, G1/24 (IPKat). In DexCom v Abbott, the Paris Local Division followed the approach taken in previous UPC decisions, namely finding that the description should always be consulted when interpreting the claims.   Case Background The case involved DexCom, a US company specialising in continuous glucose monitoring systems, and Abbott, a global healthcare group. DexCom's European patent EP3435866 related to an analyte monitoring system for measuring glucose levels in diabetes patients. The patent claimed a system comprising a sensor configured to take analyte measurements, a sensor electronics unit, and a display device. A key feature of the system was the use of two different communication protocols, a Bluetooth/BLE for transmitting a first portion of measurement data, and NFC/RFID for transmitting a second portion in response to a data request command. DexCom alleged infringement by Abbott's FreeStyle Libre 2 products. Abbott challenged the validity of the patent through a counterclaim for revocation, whilst the main validity dispute focused on whether the claimed dual-protocol system was obvious over the prior art. Overlapping portions The patent in question had previously been opposed, and the opposition rejected with on appeal filed.  Claim interpretation: The description and drawings must always be considered The Local Division first addressed the issue of claim interpretation, adopting the standard set by the UPC Court of Appeal that "the patent claim is not only the starting point, but the decisive basis for determining the protective scope of the European patent" (para. 4.2). The Local Division adopted the claim interpretation standard set by two previous UPC Court of Appeal decisions, establishing five key principles for balancing patent protection with legal certainty. As noted by the Local Division, the Court of Appeal had previously found that: "The patent claim is not only the starting point, but the decisive basis for determining the protective scope of the European patent." (para. 4.2).  Following this lead, the Local Division agreed that interpretation of the claims also "does not depend solely on the strict, literal meaning of the wording used" as "the description and the drawings must always be used as explanatory aids" (paragraph 4.2, quoting UPC_CoA_335/2023). In other words, for the Local Division it is necessary to examine both the claim language and the description in order to interpret the claims. The Local Division also emphasises that the principles of claim interpretation apply uniformly to infringement and validity assessments.  Applying these principles to the case in question, the Local Division addressed the specific disputes over claim interpretation, particularly regarding the meaning of what constituted "first" and "second" portions of the measurement data. Abbott had argued during EPO opposition proceedings that Dexcom had adopted a narrow interpretation of "portion" requiring: (1) two distinct portions of data using different protocols, and (2) neither portion could contain all the data. Abbott claimed Dexcom was now taking a broader view in litigation because Abbott's Freestyle Libre 2 transmitted "the same analyte measurement data" using both protocols, resulting in "total overlap" (para. 4.6). Applying its principles of claim interpretation, the Division looked to the description to understand the terms used in the claims. The Division agreed with Abbott that "portions of data are not comparable to parts of a book or portions of a cake" (para. 4.7). In contrast to cake, the Local Division found that while "portions" of data could overlap and contain some of the same data, they also could not be identical. For the Local Division, this would contradict both the usual distinction between "first" and "second" portions and the description's reference to "a portion of the analyte data... and another portion." The Local Division's interpretation therefore relied on both the ordinary meaning of "portion" and the distinction made in the description of the patent between "a portion" and "all" data.  Inventive step On inventive step, the Local Division found that the prior art disclosed most features of the claimed system, with the only difference being that it did not expressly specify using NFC/RFID as the second protocol. Critically, the Division's definition of portions as being able to overlap but not be identical, meant that the prior art was interpreted as possessing this feature. The Local Division instead determined the core inventive concept as being assessed whether using NFC as the second protocol was obvious. The Local Division concluded the choice of NFC would have been an obvious to a skilled person, noting that the prior art "expressly discloses that the device 120 already uses NFC for the request command initiating the transmission of the second portion, meaning that the user has already brought the device 120 into close proximity with the device 102. It would therefore be obvious for the skilled person to continue using the same protocol, namely the second near-field communication protocol NFC, to transmit the data and achieve the effects commonly ascribed to this protocol." (para. 23.7) The Local Division was unconvinced by DexCom's arguments regarding technical difficulties or synergistic effects. It found that selecting NFC as the second protocol would have been a routine choice given its well-known advantages of low power consumption and security due to limited range. The Local Division therefore revoked the patent in its entirety across all designated UPC states, also dismissing DexCom's infringement claims and auxiliary requests to amend the patent. DexCom was ordered to bear the costs of the proceedings. Final thoughts The Paris Division in UPC_CFI_230/2023 follows the lead of other divisions and the Court of Appeal of the UPC in finding that the claims of a patent should be understood in the context of the patent as a whole. In UPC_CoA_335/2023, for example, Court of Appeal similarly found that the description "must always be used as explanatory aids for the interpretation of the patent claim and not only to resolve any ambiguities in the patent claim" (IPKat). By contrast, EBA has indicated in its preliminary opinion that it believes the description "can" be referred to for the purposes of claim interpretation (IPKat). It will be interesting to see how and if any divergence emerges between the EBA and the UPC on this highly contentious issue, and whether the EBA takes the decisions of the UPC into account when tackling the questions of G1/24.  Further reading EBA's preliminary opinion in G1/24: "the description and the figures can be referred to in the course of claim interpretation" (Feb 2025) UPC Munich Local Division takes a novel approach to claim interpretation (SES vs Hanshow, UPC-CFI-292/2023) (Jan 2024) First substantive decision of the UPC Court of Appeal overturns preliminary injunction in NanoString v 10x Genomics (UPC_CoA_335/2023) (March 2024)

    Never Too Late: If you missed the IPKat last week!

    As this Kat (and possibly several other IPKat Readers based there) starts the week with Korea’s Lunar New Year holiday, take a moment to catch up on what you might have missed from the past week on The IPKat! Trade Marks Jocelyn Bosse looked into the latest decision of the US District Court for the District of Arizona in VIP Products LLC v. Jack Daniel's Properties concerning likelihood of confusion. The Court found that VIP's intent was to create a parody product rather than to confuse the public. However, after evaluating the evidence from a consumer psychology expert, the Court decided that there was a likelihood of dilution of the famous mark. Artificial IntelligenceEleonora Rosati outlined the new Vatican AI Guidelines regarding the development and use of AI models. The Guidelines were released by the Pontifical Commission have been in force within the Vatican City State since 1 January 2025. They touch upon key emerging issues in AI, including development/training, output generation, transparency obligation, and the authorship and ownership of AI outputs. PatentsA Kat enjoying SeollalRose Hughes analysed a Board of Appeal decision (T 0816/22) concerning whether post-published phase III clinical trial data showing a lack of efficacy can invalidate a second medical use patent that appears plausible based on the data in the application as filed. Our Kat reflects on whether this decision raises questions about the current sufficiency/enablement standard for therapeutic use inventions and the prior art that may be cited against them.  Rose Hughes also explained the Board of Appeal's decision in T 2130/22 regarding the inventive step of a pharmaceutical formulation. The Board rejected the Opponent's argument that the technical effect had not been shown across the scope of the claim. Katfriend Konstantin Voropaev (Elbert, Nazaretsky, Rakov & Co) explored how two recent decisions from opposite sides of the Atlantic, the US Federal Circuit decision in Janssen Pharmaceuticals v. Teva and the UPC decision in 10x Genomics, signal a potential convergence in the patent obviousness analysis. These rulings highlight a shift from the traditional approach of prior art towards more flexible and context-sensitive assessments. IP events and opportunities Eleonora Rosati informed the Readers of upcoming events and opportunities. She began by reminding the IPKat Book of the Year Awards 2024, as voting ends on 31 January 2025. Durham Law School will host a conference on IP and AI in the age of technology race, taking place in Durham, UK, on 19-20 May 2025. Moreover, the fifth biennial International Conference REDA 2025 will be held on 26-27 May 2025, focusing on regulation and enforcement in the digital era, with a special emphasis on emerging technologies and recent EU legislative developments. The University of Antwerp is also recruiting a teaching and research assistant. The successful candidate will join the academic assistant staff and contribute to teaching, research, and service activities. Key recent developments from Australia, Europe, and US are as follows. Australia has established a First Nations Expert Working Group on Indigenous Cultural and Intellectual Property. The European Commission has launched a targeted consultation to gather input from stakeholders on the efficiency and effectiveness of the International IP SME Helpdesk activities in China, South-East Asia, Latin America, and India. The USPTO is seeking public comments on whether the United States should sign and implement the WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge by March.

    Never Too Late: If you missed the IPKat last week!

    Another eventful week in the world of IP, and this Kat is here to keep you updated with the latest from The IPKat. Trade marks and Plant Varieties Marcel Pemsel reviewed a recent decision of the General Court concerning the visual similarity between Armani’s well-known eagle-shaped logo and a sign that also consisted of eight horizontal stripes. The Court decided to annul the BoA’s decision that had found a low degree of visual similarity. The judges also considered the General Court judgments cited by the BoA in its contested decision to be inapplicable in the case at hand. Jocelyn Bosse discussed a word mark application for a new plant variety of the University of Georgia. Several conflicts arose after the USPTO granted the trade mark for the name SEABREEZE, due to a failure to conduct a proper search of the plant variety protection register before proceeding with the trade mark application. Marcel Pemsel reported on a recent decision from the Higher Regional Court of Hamburg concerning the use of a bleeding red cross on a book cover criticizing the German healthcare system. The Court ruled that the use of the bleeding red cross infringed the plaintiff’s well-known trade mark for the Red Cross (Sec. 14(1) sentence 1 no. 3 German Trade Mark Act). CopyrightSöğüt Atilla continued her exploration of the European Copyright Society’s Opinion on Pelham II. In part two, she focused on the features that pastiche works should exhibit according to the European Copyright Society. PatentsKatfriend Ian Jones (GJE) analysed the European Patent Office referral concerning third-party interveners. The Enlarged Board is expected to provide comments by 17 April 2025. Guest UPCKats William Mooney and his team members (Carpmaels) reported on i-mop v Arcora (UPC CFI 193/2024) concerning decisions by default. Jocelyn Bosse explained T 0425/23 concerning issues of insufficiency of disclosure, novelty, and inventive step. The disputes centred around a European patent filed by Impossible Foods Inc., claiming a meat substitute that acquires the taste and smell of meat during cooking.  Book ReviewAnastasiia Kyrylenko reviewed the book “Research Handbook on Intellectual Property Rights and Arbitration,” edited by Simon Klopschinski and Mary-Rosy McGuire (Edward Elgar, 2024). The book targets a broad audience interested in the arbitration of intellectual property disputes. IP events and opportunities Eleonora Rosati informed the Readers of the Global IP Exchange Europe Exchange event. This invitation-only event will take place in Berlin on 11-12 March 2025.Eligibility requirements to receive an invitation are as follows:•Controlling where the IP, Patent, Trademark, Brand Protection, or Anti-Counterfeiting budget is spent•Holding a position as the Head of IP or Head of Patent, Trademark, Brand Protection, or Anti-Counterfeiting•Having a personal annual budget of £500,000 or above•Having an active requirement for IP solutions within the next 6 - 12 monthsTo learn more and request an invitation, click here. She also reminded the Readers of upcoming events and opportunities. Applications for GuestKat and InternKat positions are open until 20 January. The 7th edition of the IPKat Book of the Year Awards will recognize and celebrate the best IP books published in 2024. Do not forget to vote your preferences until 31 January. Moreover, ASEAN Geographical Indications Webinars will start on 21 January. Sir Richard Arnold will deliver his 9th Annual Lecture at Westminster Law School on 18 February. Additional opportunities include the WIPO International Patent Drafting Training Program, the 2024 4iP Council Research Awards, and ATRIP's Call for Papers on IP and Justice.

    The Approach to the Assessment of Inventive Step of Antibodies at the EPO – a Critical Analysis

    The festive period normally leads to a slight slow-down in work in Europe and as such, it can provide the opportunity to catch up on wider reading as well as to grab a little rest. In between the years 2024/5, I read Parts 1 and 2 of an interesting three-part article in EPI Information by Tamaris Bucher, a Principal Patent Attorney at Novartis Pharma AG, on the issue of the granting of patents to antibody inventions at the EPO. Ms Bucher, who possesses over 20 years of experience in practice as a patent attorney, takes issue with the EPO Guidelines concerning the assessment of the inventive step for claims to new antibodies and argues that they are inconsistent with the EPO’s approach to inventive step in other areas, such as those for small molecules in which predictability of the structure-activity is considered. Part 3 – to be published early in 2025 – will provide a proposal solution to the issue. Following a brief introduction, Part 1 of Bucher’s article points the spotlight directly on Part G.II.6.2 of the EPO Guidelines (2024 version) (“the Guidelines”) which state: “The subject-matter of a claim defining a novel antibody binding to a known antigen does not involve an inventive step unless a surprising technical effect is shown in the application or unless there was no reasonable expectation of success of obtaining antibodies having the required properties (cf G-VII, 13). Examples of surprising technical effects include an unexpected improvement over prior-art antibodies in one or more properties, such as therapeutic activity, stability or immunogenicity, or an unexpected property not exhibited by prior-art antibodies.” Further, at the end of the Guidelines, two further exceptions are identified which could permit the recognition of an inventive step: “Nevertheless, antibodies can be inventive if the application overcomes technical difficulties in generating or manufacturing the claimed antibodies. A novel type of functional antibody format may also be considered inventive.” As Bucher observes, the general wording of the Guidelines is both negative and unequivocal (“does not”) and seems to go against Art 56 EPC itself which does not contain such a presumption. Bucher considers the explanations given by the EPO for their Guidelines but is not convinced by them as she explains in her detailed analysis of the case-law cited by the EPO. Part 2 of Bucher’s article drills down into two of the exceptions (cited above) which are prescribed by the Guidelines to the premise that a novel antibody binding to a known antigen is prima facie obvious, namely: (i) a surprising technical effect; and (ii) a claim to a novel type of functional antibody format. In relation to (i), among other things, Bucher revisits the TBA decision in T645/02 – which was the original antibody case upon which the later cases cited in the Guidelines rely upon as authority for the proposition that a surprising technical effect is required – and concludes, from an analysis of the original German text, as well as the English translation, that this decision did not refer to a “surprising technical effect” but rather that the provision of a particular antibody with certain precisely defined properties had the elements of surprise, rather than the surprising technical effect per se being surprising. She posits that what was being recognised was the non-obviousness of the manner in which that improved technical effect was achieved i.e. essentially the unpredictability in the structure-activity relationship. As regards the second exception, namely a novel type of functional antibody format, Bucher notes that this permits EPO Examiners to consider at a high level of resolution the structural configuration of a claimed antibody against the prior art. However, the particular amino acid sequences, for instance within a variable region, are discouraged from being taken into account. The devil – or should it be the angel? – is often in the detailed information and when it comes to the functionality of antibodies, Bucher finds that the approach in the Guidelines discouraging the assessment of the predictability of detailed amino acid sequence information is “simply not justified”. I’m looking forward to reviewing Part 3 of the article which, as noted above, promises to outline a new proposal for the formulation of the objective technical problem for antibody inventions. Although I am a patent litigation lawyer and hence not involved directly day-to-day in the prosecution of patent applications at the EPO, it seems to me that this is an important issue worthy of wider consideration. Ms Bucher’s article can be found on the following link: epi Information | The Barrier Around Antibody Inventions at the European Patent Office More from our authors: Vissers Annotated European Patent Convention 2024 Edition by Kaisa Suominen, Nina Ferara, Peter de Lange, Andrew Rudge € 105 Annotated PCT by Malte Köllner € 160 AI Governance and Liability in Europe: A Primer by Ceyhun Necati Pehlivan, Nikolaus Forgó, Peggy Valcke € 150

    Dutch District Court upholds BMS’s apixaban patent

    On 30 October 2024, the District Court of the Hague handed down two merits decisions on the widely litigated apixaban patent of Bristol-Myers Squibb (see here and here – Dutch language versions). EP 1 427 415 B1 (EP 415), which lapsed in 2022, and the corresponding supplementary protection certificates (SPCs) have been subject to litigation throughout Europe (see e.g. the previous posts on the UK, France and Spain). In 2023 the Dutch Court of Appeal already granted preliminary injunctions against Sandoz and Teva and Stada as it found that there was not a serious chance that the apixaban patent and SPC would be held invalid in merits proceedings. Both Sandoz and Teva appealed this decision to the Supreme Court. In these merits proceedings Sandoz and Teva had filed invalidity claims to pave the way for generic apixaban in the Netherlands. The Dutch court found the patent and SPC (no 300500) to be valid and granted an injunction against Sandoz. In its decisions the Dutch court addressed two pivotal aspects: (formal) priority of the patent in light of the G 1/22 and G 2/22 decisions of the Enlarged Board of Appeal (EBA); and inventive step in light of the EBA’s G 2/21 decision to determine whether BMS could rely on the purported technical effect. Priority Teva had argued that BMS Company, applicant of the patent, was not entitled to the priority right when it filed the application. The inventors had initially transferred the priority document to BMS Pharma, but the subsequent PCT application, from which EP 415 stems, named BMS Company as applicant. Only after the application was filed, the priority document was transferred from BMS Pharma to BMS Company. The court dismisses the argument. As was held by the EBA in G 1/22 and G 2/22 and now repeated by the court, there is a rebuttable presumption that the subsequent applicant is entitled to the priority right. The presumption can only be rebutted in exceptional cases. It is for the party challenging the entitlement to priority to prove that this entitlement is missing; merely raising speculative doubts is not sufficient. BMS Company is therefore presumed to have been entitled to the priority right, which presumption was not rebutted by Teva. According to the court, there can be no doubt that the intention within the BMS group was to file the application with a valid priority claim. Referencing the EBA in G 1/22, the court considers that the applicant should be protected from the situation like the one at hand, where their own intermediate prior art is published under the assumption of the applicant’s entitlement to the priority right. The court further considers that the validity of the priority claim is confirmed by the nunc pro tunc transfer (i.e. a later, confirmatory transfer) of the priority document from BMS Pharma to BMS Company, which transfer is deemed effective as of the moment of the PCT application. Inventive step and G2/21 To determine if the patent is inventive, the court applies the EPO’s problem-solution approach. Parties agree that apixaban is a so-called selection invention in which case an inventive step may be accepted only if the selection is connected to a particular technical effect and if no hints existed which lead the skilled person to the selection. Thus, the selection of apixaban from the compounds disclosed in the closest prior art should be coupled to a particular (new or improved) technical effect. Parties assume that this effect (in any case) is that of Factor Xa inhibition. Since the same effect is attained by the compounds disclosed in the prior art, the effect must be present to an unexpected degree. Consequently, the question that lies before the court is whether BMS can rely on the purported technical effect of improved Factor Xa inhibition. The court thereto recalls the standard set out by the EBA in G 2/21: the patentee may rely upon a technical effect for inventive step if the skilled person, having the common general knowledge in mind, and based on the application as originally filed, would derive said effect as being encompassed by the technical teaching and embodied by the same originally disclosed invention. If the G2/21 test is met, the patentee may still present evidence during the examination that the alleged technical effect actually occurs, i.e. post-filed evidence can be taken into account. An assessment of the patent application and the common general knowledge leads the court to conclude that the technical effect on which BMS wishes to rely for inventive step, namely improved Factor Xa inhibition, will be considered by the skilled person as encompassed by the technical teaching. According to the court, the skilled person would derive from the application that it not only aims to provide new compounds as Factor Xa inhibitors, but also improved Factor Xa inhibitors over those in the prior art. The specific technical means that the application provides to solve this problem comprise at least the synthesized compounds disclosed in the examples of the application (among which apixaban). Moreover, the skilled person will assume that these compounds have been tested but they will also be able to synthesize the compounds themselves and easily test the compounds for their efficacy as Factor Xa inhibitors. It is then not required for the application to contain test results or other evidence, nor is it required that the application explicitly mentions the technical effect that is relied on. What is relevant is that the effect does not change the nature of the claimed invention. According to the court, BMS’s post-filed evidence demonstrates that apixaban is a better inhibitor of Factor Xa than the compounds disclosed in the prior art. The court concludes that apixaban would not be obvious to the skilled person. Foreign rulings The court notes that its assessment of the inventive step aligns with that of the French, Norwegian and Swedish courts. In contrast, the English High Court of Justice and Court of Appeal came to a different finding, which the Dutch court says is the result of the application of the test formulated by the Supreme Court in Warner-Lambert v Generics [2018] UKSC 56. The Irish court applied a test similar to that of the English court, resulting in a different outcome there as well. The District Court follows the reasoning of the Dutch Court of Appeal in 2023 (see this earlier post here). The Court of Appeal at the time considered the Warner-Lambert test, applied by the English courts, to be developed specifically for sufficiency of disclosure and not for assessing inventive step. The District Court – like the Court of Appeal – emphasizes that the G2/21 threshold for inventive step is distinct from and easier to meet than the standard for sufficiency. Accordingly, both the Court of Appeal and the District Court could justify the differing outcomes. A clear Dutch approach thus appears to be emerging. More from our authors: Vissers Annotated European Patent Convention 2024 Edition by Kaisa Suominen, Nina Ferara, Peter de Lange, Andrew Rudge € 105 Annotated PCT by Malte Köllner € 160 AI Governance and Liability in Europe: A Primer by Ceyhun Necati Pehlivan, Nikolaus Forgó, Peggy Valcke € 150

    Notes on the EPO Boards of Appeal Case Law Conference 2024

    In case you missed it, here are the main points from the EPO Boards of Appeal Case Law Conference 2024. As ever, this was a really interesting event with lots of high quality presentations. Above all, it is great to hear at first hand what the Board members themselves think of the hot topics at the EPO. Update on Board of Appeal Timelines – Carl Josefsson As usual, the President of the Boards of Appeal was first up. He highlighted the improvements in statistics on timeliness: As of June 2024, less than 10% of cases are older than 30 months. By the end of 2025, they predict that there will be no more than 10% of cases older than 24 months. Although no detailed statistics were presented, these figures generally seem in line with the trend in figure 1 of the 2023 Annual Report of the Boards of Appeal: These are of course welcome developments, it is only a shame they are not accompanied by similar statistics relating to quality. Highlights of Recent BoA Case Law – Karel Peirs Sufficiency: Over the Whole Range Comes to Mechanics This presentation looked at various aspects of claim construction. Mr Peirs highlighted that the debate continues on whether sufficiency requires that the skilled person is able to carry out the invention “Over the Whole Range”, or if showing “at least one way” suffices. While traditionally applied in chemistry (see e.g. T 500/20 r 3.6), recent decisions (e.g., T149/21, T553/23) suggest that the requirement to demonstrate sufficiency across the whole claim scope (i.e. in all technically viable contexts, but not including unusual circumstances like a nuclear strike) is increasingly being applied for mechanical inventions. No doubt music to the ears of opponents in this field. Adaptation of the Description: Should It Stay or Should It Go? Adaptation of the description was also touched upon by Mr Peirs, with both T56/21 and T438/22 briefly discussed. He didn’t go further than accepting that there is a divergence, which is more than can be said of T56/21 itself! See our earlier post on this: Kluwer Blog Article: La Zizanie de l’OEB sur l’Adaptation de la Description). G2/21 – Marcus Müller The meaning of G 2/21 continues to confound many practitioners. As such, Mr Müller’s detailed explanations of the key points in several recent decisions applying G 2/21 were welcome. First several decisions were presented that applied the G2/21 test and allowed post-published evidence when assessing inventive step (T1525/19, T1989/19, T840/22, T2716/19, and T681/21 AR4). Then, several decisions in which post-published evidence could not be relied upon were discussed (T681/21 (MR), T887/21, T1994/22), with T681/21 acting as a useful bridge, as it permitted the evidence for some requests not others. We have commented on some of these before, see e.g. – Trying to Make Sense of the Oracle of G2/21: T116/18 vs. T681/21. Particularly interesting were the cases dealing with a very common scenario – where post-published evidence is filed to show that a first alternative disclosed as part of the original invention delivers an improved technical effect relative to a second alternative also disclosed as part of the original invention. T840/22 held that this was “precisely what regularly occurs in patents/patent applications in the field of chemistry” and allowed the reliance on the new data. On the other hand, T852/20 didn’t permit reliance on new data in what seemed from Mr Müller’s presentation to be a similar scenario. We are also grateful to Mr Müller for providing his own “personal summary” on how to understand the seemingly divergent cases following G2/21. Based on our understanding from the lecture, it is his view that: There is no true divergence in decisions; apparent inconsistencies are due to differences in the details of the cases; It is important that it is clear that the effect is essential to the invention and tied to the claimed subject matter; If 2 is met, post-published data can generally be used for inventive step unless there are legitimate doubts; If an effect can be relied upon, the improvement can be relied on too; There is no need for verbatim basis for the effect; Sweeping statements of effects may be not be enough though in themselves; Patentee will struggle if there is an inconsistency between the teaching of the application as filed and the mechanism of the effect they later rely on. Of course, the first thought when analysing these is to question whether they are entirely consistent, emphasising on the one hand the lack of need for verbatim effect but criticizing sweeping statements on the other. Presumably though this comes down to the context-dependent first point, and particularly the role the different common general knowledge may play in leading to different decisions in similar scenarios. While these points may therefore be difficult to use to reliably predict the outcome of any specific case, it is very useful to know which are considered to be the key elements. Image taken from commons.wikimedia.org Rules of Procedure of the BoA (Four Points of Divergence) – Kemal Bengi-Akyürek and Jeannine Hoppe This was another tour de force of a presentation – with a wide variety of points of divergence in application of the RPBA identified by the speakers. The points where different boards have applied these strict rules in different ways were as follows: Pre-emptive Strikes Should an opponent already comment in the grounds of appeal on requests filed in the first instance that were not part of the opposition division decision? Divergent decisions T2035/16 and T664/20 were discussed (on this topic, see also the HE Quarterly of September 2024: Inconsistencies in the Application of the EPO Rules of Procedure of the Boards of Appeal Concerning Case Amendments). Carryover Requests These are requests on appeal that were filed before the first instance but no decision on admissibility was reached in the first instance decision. Mr Bengi-Akyürek discussed these at length. It was first highlighted that Rule 12.4 RPBA gives the applicant the burden to show that these were “admissibly raised and maintained” in the first instance. Three different approaches to how the boards deal with such requests were identified. T364/20: the board steps into the Opposition Division’s shoes to evaluate admissibility, and has no discretion not to admit if the OD should have admitted (r.7 of the decision) (on this point see also: The meaning of “admissibly raised” in Article 12(4) RPBA). T1800/20 headnote: this applies a similar approach, but in reaching the decision weighs up different factors such as timing, suitability to overcome objections, convergence, and whether new issues are raised. T246/22: again applying different factors to reach the decision, by suggesting a “minimal test” of whether the request and the purpose of the request were filed in due time in the first instance. If so, admissibility on appeal can be addressed using the RPBA to decide whether they are admitted. Contrary to T 364/20, T246/22 advises against stepping into the Opposition Division’s shoes (r. 4.13). While different factors are applied when deciding on these carryover requests, it seems clear that filing requests without due substantiation is a risky business, regardless of the stage of the proceedings. The third stage of appeal proceedings Two different aspects of divergence were identified concerning the third, strictest stage of the appeal proceedings. Concerning Rule 13.2 RPBA, it was accepted that there is divergence as to whether procedural requests can even be held inadmissible (On this point, see also: Kluwer Blog Article: T1006/21). Meanwhile, two different approaches for assessing the Rule 13.2 “exceptional circumstances” test were discussed: it seems that some decisions take a more lenient approach (T2295/19, T339/19, T2604/18), as they don’t require the amendment to have been caused by the exceptional circumstances, just that exceptional circumstances are generally present in the case. Meanwhile, we understood that other decisions – like T2482/22 or T1558/22 – take a stricter view and require a causal link between the exceptional circumstances and the amendments. A final word As many of the cases above point to some degree of divergence between the Boards, we found the general discussion of the Board Members Kemal Bengi-Akyürek and Jeannine Hoppe in the questions section particularly interesting. The perennial issue of divergence between boards had been raised in a question, with a comparison between Boards of Appeal decisions and a “lottery” being drawn. As expected, the Board members strongly defended their decision-making process on several points, not least that the decisions in the end are generally well-reasoned and not entirely arbitrary like a lottery. They also took the view that some divergence is a normal step on the way to adopting a uniform application of the law, and is even something that arises from the EPC referring to a plurality of Boards. We have some sympathy with these explanations and the difficulty of ensuring complete consistency across the large number of decisions issued each year. But they will be cold comfort to parties who have had the bitter experience of losing patents or oppositions due to the interpretation of the RPBA adopted by the particular Board they find themselves before. But, as Bengi-Akyürek put it, “that’s life”, calling to mind the lyrics to Frank Sinatra’s famous song…   More from our authors: Vissers Annotated European Patent Convention 2024 Edition by Kaisa Suominen, Nina Ferara, Peter de Lange, Andrew Rudge € 105 International Handbook of Blockchain Law: A Guide to Navigating Legal and Regulatory Challenges of Blockchain Technology and Crypto Assets, Second Edition by Matthias Artzt & Thomas Richter € 190 The Unitary Patent and the Unified Patent Court, Second Edition by Pieter Callens & Sam Granata € 176

    Logical Fallacy in Patent Law: Analysing Abolkheir’s Challenge to the Soundness of Non-obviousness Test

    In his recent work published in the Journal of Intellectual Property Law and Practice, Dr. Mo Abolkheir argues that the prevailing interpretation of ‘inventive steps’ places emphasis on the inventor’s imaginative capacity rather than the invention itself. Bhuwan Sarine discusses and analyzes this perspective, offering his thoughts on Dr. Abolkheir’s approach. Bhuwan is a third year B.A., LL.B. (Hons.) student at National Law School of India University, Bengaluru. He is interested in Intellectual Property Laws and the dynamic intersection of law and technology, and seeks to pursue a career in academia and research. His previous posts are available here. An illustration to explain an ad hominem argument. Dr. Abolkheir labels the inherent fallacy within patent law as “inventio ad hominem” fallacy. Image from here Logical Fallacy in Patent Law: Analysing Abolkheir’s Challenge to the Soundness of Non-obviousness Test By Bhuwan Sarine In a recently published editorial in the Journal of Intellectual Property Law and Practice, Bristol-based philosopher Dr. Mo Abolkheir made a big claim about there being an (unnoticed) logical fallacy at the core of patent law. Questioning the logical foundations of patent laws, he argues that defining ‘inventive step’ in terms of ‘non-obviousness’ shifts the focus of inquiry to the inventor, rather than the invention itself. This happens when the invention is assessed for non-obviousness with respect to the standard of ‘person skilled in the art.’ Abolkheir has an issue with this because what ends up being examined is not the invention, but the inventor’s imaginative and cognitive skills. He even goes so far to call this inventio ad hominem fallacy, a variant of the well-known ad hominem fallacy (for the uninitiated, ad hominem is a logical fallacy in which someone’s argument is sought to be rebutted using personal attacks on his/her character, instead of addressing the argument itself). In this post, I will reflect upon the claim made by Dr. Abolkheir. After laying the ground, I will assess the strength of his claim by addressing points for and against it. I will finally conclude with the questions this claim gives rise to. The Argument Across jurisdictions, ‘inventive step’ is assessed on the basis of the inventive concept’s non-obviousness, i.e., whether or not the core inventive concept is obvious to a person skilled in the art. This, as Dr. Abolkheir argues, gives rise to a logical fallacy since the focus is on the imaginative capacity of the inventor, rather than the invention itself. It confuses ‘invention’ with ‘person.’ His argument proceeds thus: for being patentable, (i) the core inventive concept must be beyond the grasp of those with average imaginative powers (person skilled in the art), (ii) the inventor has grasped the core concept of invention, and therefore (iii) the inventor’s powers of imagination are above average. Illustration of the ‘non-obviousness’ test using India’s case: Under s. 2(1)(ja) of the Patents Act, 1970, ‘inventive step’ is defined in terms of three main components, i.e., technical advance, and/ or economic significance, and non-obviousness. Judicial dicta has laid down the test for non-obviousness. In Hoffman-La Roche Ltd. v. Cipla Ltd., the Delhi HC held that if the invention is obvious to a skilled worker, in the field concerned, in the state of knowledge concerning at the date of patent to be found in the literature available to him, patent cannot be granted. It has to be seen if the differences between the claimed invention and the prior art are such that the claimed invention would have been obvious. Now, who is this ‘skilled worker’ or ‘person skilled in the art?’ Recently, in Rhodia Operations v. Assistant Controller of Patents and Designs, the Madras HC elaborated on this expression. It held that this is a hypothetical person created by law, and possesses a skill level which is greater/good than an average person. Because most disciplines/arts require a range of skills or skill set, this person needs to possess the skill set to do the job well. Outstanding imaginative skill, however, is not required. Coming back to Abolkheir’s claim To sum up from India’s example, the question to be asked is whether, on using the literature (prior art), the person skilled in the art is able to arrive at the claimed invention. If the answer is yes, the threshold of ‘inventive step’ is not met. In his piece, Abolkheir points to this very comparison between the imaginative capacities of the inventor and the person skilled in the art. He says that an invention is patentable only if the former’s imaginative powers are above average, i.e., beyond that of a person skilled in the art. In his words, this analysis (focusing on the inventor instead of the invention) falls prey to the inventio ad hominem fallacy. He calls it a variation of the well-known ad hominem fallacy.  What is the Consequence of this Fallacy? Abolkheir suggests that patent laws have been indirectly testing the inventor’s powers of imagination indirectly for all these years. According to him, patent laws are not dual examination systems to assess both invention and inventor, but are designed for the former only. They end up examining the latter unintentionally. This has given rise to a system of second-hand examination, which according to him is similar to assessing the parents of a student by examining his/her homework. Another, and perhaps bigger, consequence is that this kind of assessment has led to an increased amount of subjectivity in the system. This causes differing assessments of patentability by controllers and judges at different levels. As a result, while getting patents becomes increasingly difficult, granted patents also become vulnerable to post-grant invalidation and revocation. Strengths of the Piece Abolkheir is correct in saying that analysis goes beyond the objective assessment of the invention alone while assessing non-obviousness. He therefore suggests limiting it to compare the invention and the relevant prior art. This is also because unlike schools and universities, patent offices have limited expertise to be able to go into cognitive assessments of this kind. Another strength of his piece is that it highlights the issue with this kind of assessment with the increasing use of AI. Presently, there is a lot of indeterminacy around the non-obviousness analysis. In his article, Gregory Mandel notes the factors producing indeterminacy. One of them is the failure to define the baseline level of ordinary skill against which an invention would be assessed. With the increasing use and huge potential of AI to combine information from completely different sources, the threshold of ‘person skilled in the art’ will inevitably increase in the future. Patent applicants are therefore going to find it very difficult to judge and satisfy this indeterminate threshold. The present non-obviousness test was conceived in a completely different era. If the same is continued to assess applications in the present (and future), it will double the burden for the applicants. Abolkheir’s piece does well to highlight the desirability of a reform. Evaluating Abolkheir’s Claim: Is there a Logical Fallacy? A major criticism of Abolkheir’s piece is that when looked at closely, the claim of this analysis being similar to ad hominem fallacy is far-fetched. Under ad hominem, the response (of a personal nature) is irrelevant to the argument made/question asked. But under non-obviousness test, the analysis is still limited and relevant. There is no broad examination of the person’s overall cognitive abilities. What is examined is his/her imaginative skills with respect to the particular invention. One of the points that Abolkheir seems to have missed is that a number of actors are involved in the entire patenting process. It is not limited to the invention in isolation. Keeping actors aside, the analysis also has to look at novelty, utility, public interest and pre-grant opposition, amongst other aspects. Because of the nature of inquiry being such, different people will feature at different stages, and it might not be practicable to examine the invention solely for these aspects. While advocating a restricted mode of assessment for non-obviousness, he overlooks the fact that the entire process otherwise is inherently multifaceted.  Another argument against this piece is that the inventor and his invention are not so distinct and separable as Abolkheir makes it look like. The latter is an expression of the former’s abilities, and both are not strictly two entities. His example “examining the parents of a student by examining his/her homework” appears to be a misfit to the case at hand because a student and his parents are two distinct entities. Abolkheir highlights and criticises the subjectivity introduced into the system by this kind of analysis and even hints that an objective mechanism is missing. However, he fails to point out why objectivity is desirable and how it would solve the problem of differing assessments by controllers and judges, in the backdrop of growing use of AI.  Issues to Ponder Over With the increase in AI usage, the threshold of ‘person skilled in the art’ is going to increase. This piece has underscored the necessity of a different sort of analysis, keeping in mind the changed circumstances. The question arises, what are the alternatives available? How would an objective mechanism be arrived at and how the same would address the challenge posed by AI? A related issue to think over is the possibility and feasibility of adopting different systems of assessment for AI and non-AI related patents.  Among alternatives, Abolkheir talks about the half-causation framework which he devised in 2019. However, it is highly technical in nature and would require specialised training. In addition to a rigorous examination of the invention in question, it entails dividing the entire process of working out the invention into phases. But such strict compartmentalisation might not be feasible for all inventions. If we extend the expertise argument here, it would not be practicable to expect the patent offices or Courts to apply half-causation. While it addresses the logical flaw highlighted, it is hit by lack of expertise.   Conclusion Even though there are some missing pieces in his argument, Dr. Abolkheir has stirred a discussion on the possibility of reform in patent law. Towards the end, he hinted at coming up with a follow up paper presenting his alternatives to the logical fallacy including the half-causation framework. It would be interesting to see what he comes up with, since he claimed it to offer more objectivity as well as control the AI risk. The overall question still looms, are the foundations of the non-obviousness test as solid as has been assumed till date? Further research is required to answer this.  [Thanks to Swaraj for asking me to look at the paper, and the discussion session attended by Swaraj, Praharsh, Sunidhi Das, Samridhi Chugh and Yukta Chordia for the comments and questions which helped frame and write this post.]

    Sanofi vs. Amgen: Successful first UPC revocation action and strict assessment of therapeutic antibodies patentability

    On 16 July 2024, the Munich Central Division revoked a patent for the first time in the litigation between Sanofi, Regeneron, and Amgen (UPC_CFI_1/2023). This decision is important not only because it is the first of its kind, but also because it establishes UPC’s position on the patentability of therapeutic antibody inventions. In this case, a revocation action was brought against EP 3,666,797, one of Amgen’s patents relating to PCSK9 antibodies. The first claim of this title related to an antibody used to treat or prevent hypercholesterolemia or arteriosclerotic disease, in which the antibody “binds to the catalytic domain of a PCSK9 protein of amino acid sequence SEQ ID NO: 1, and prevents or reduces binding of PCSK9 to LDLR”. Three Sanofi companies had filed a main action for revocation on 1 June 2023, the day the UPC came into force, before the Munich section of the UPC central division, while on the same day, a few minutes later, Amgen filed an infringement action against these three companies and Regeneron before the Munich local division. Regeneron then filed a counterclaim for revocation, which the Sanofi companies did not do. These were therefore parallel and similar revocation actions before the central and local divisions, so that all parties agreed that the revocation counterclaim should be referred to the central division. These actions come against a backdrop that is rich, to say the least. Amgen, Sanofi and Regeneron have been battling since 2014 over patents relating to Amgen’s PSK9 antibodies, which Amgen claims cover both its Repatha and the Praluent marketed by Sanofi and Regeneron. Initially, the litigations were brought before the European national courts, before being brought before the UPC. A case relating to the U.S. patent corresponding to EP’797 was also brought before the U.S. Supreme Court. The main contribution of the UPC decision lies in its teaching on the patentability of therapeutic antibodies. The Court first set about interpreting claim 1, and thus its method of interpretation. Firstly, the Court considers that a person skilled in the art who interprets a claim determines the technical meaning of the terms used with the aid of the description and drawings. Next, the Court examines the claim’s functional feature “links the catalytic domain of a PCSK9”. The focus here is on understanding the functional limitation of the claim. The Court considers that for the person skilled in the art, antibody binding serves a purpose, namely, to prevent or reduce PCSK9 binding to LDLR. However, in the absence of any indication in the claim or description that binding must take place exclusively, or only principally, in the catalytic domain for the technical function to be achieved, it follows that the person skilled in the art would not have understood this. In addition, the Court also held that the other functional limitation, the therapeutic effect of antibodies (i.e., cholesterol reduction), implied that the claim only concerned antibodies with a therapeutic effect (even if it is a “very small” one). Ultimately, the functional language of the claim should not be interpreted as covering “all antibodies capable of binding to the catalytic domain”. Such an interpretation shows that the Court seems to want to give more weight to the description than the EPO Boards of Appeal generally do (e.g., T 169/20, “the support of the description for interpreting the claims should only be resorted to in the exceptional cases where the subject-matter of the invention and/or its technical context needs to be clarified, and may only be applicable when the invention in the description corresponds to the invention as claimed”). Secondly, the Court develops its analysis of the of the inventive step requirement (EPC, art. 56). It is interesting to note here that the Court chose not to follow the problem-solution approach classically employed at the EPO, by not starting from the closest state of the art, i.e. the most promising (EPO Guideline G-VII-5.1), but only from a realistic starting point. The Central Division considered that there was in this case an explicit orientation of the prior art towards the development of antibodies capable of blocking the link between PCSK9 and LLDR, because a person skilled in the art would have understood from the prior art that blocking this link could be explored for the treatment of hypercholesterolemia. Accordingly, in view of this orientation, the skilled person would have had a reasonable chance of success in obtaining the antibodies defined by my claims without engaging in an inventive step, even though he would have realized that manufacturing the antibodies and setting up the screening methods could require considerable time and resources. Thus, the Court revoked the patent in its entirety (i.e., here for all UPC member States), finding that the person skilled in the art was motivated to develop therapeutic antibodies against PCSK9 and that he would have arrived at the claimed antibodies with a reasonable chance of success without an “undue burden” (in reference to the time and resources required). As we’ve already noted supra, The Munich Central Division deviates slightly from the EPO’s positions on claim interpretation and assessment of inventive step. Nonetheless, the result concerning the patentability of antibodies is close to that of the EPO, and thus also differs from the U.S. approach. The Court’s position is close to that of the EPO, which holds that “the subject matter of a claim defining a novel antibody that binds to a known antigen does not involve an inventive step unless a surprising technical effect is demonstrated in the claim or unless there was no reasonable expectation of success in obtaining antibodies with the required properties” (EPO Guideline G-II-5.6.2). Thus, in the words of the German local division, in the absence of particular difficulties, the development of antibodies for a known target is routine and therefore not inventive. This contrasts with the US revocation, based on enablement requirement, and where enablement was judged insufficient because, even from the description, the skilled person had to make an inventive effort to arrive at the millions of antibodies covered, according to the Supreme Court, by Amgen patents (21-757 Amgen Inc. v. Sanofi (05/18/23)). Eventually, UPC establishes a much higher threshold of antibodies patentability in Europe than in the United States. More from our authors: Vissers Annotated European Patent Convention 2024 Edition by Kaisa Suominen, Nina Ferara, Peter de Lange, Andrew Rudge € 105 The Unitary Patent and the Unified Patent Court, Second Edition by Pieter Callens & Sam Granata € 176 Artificial Intelligence and Patents: An International Perspective on Patenting AI-Related Inventions by Jonathan P. Osha € 174 Enforcement of Decisions of the Unified Patent Court: A Survey of Participating Member States by Christof Augenstein and Johanna Flythstrom € 123

    Barcelona Appeal Court reverses first instance judgment that had found apixaban patent to be invalid

    This morning, the Barcelona Appeal Court has announced a judgment of 18 July 2024, reversing the judgment of 15 January 2024 from Commercial Court number 4 of Barcelona, which had found patent EP 1,427,415 (“EP ‘415”), protecting apixaban, to be invalid. The main highlights of the decision may be summarized as follows: The first interesting aspect is the finding in relation to the right to priority. As in other European countries, Teva had challenged BMS’s right to priority on the grounds that the right to priority had not been correctly assigned from the BMS entity that filed the priority patent application, to the BMS entity that filed the application that resulted in the granting of EP ‘415. In short, the Court has denied Teva’s locus standi to question the right to priority on this formalistic ground. In particular, it has found that it does not make sense for a third party to discuss the legal relationship between the first applicant and the second applicant when there is no conflict between them. So, without citing decisions G 1/22 and G 2/22, the Court has followed the same logic. The Court has added that, even if one were to accept a third party’s locus standi in the circumstances described, the nullity attack should likewise be rejected, as it would be based on an extremely formal and, therefore, abusive, argument based on the different legal personality of the two companies of the same group. Finally, the Court has noted that BMS filed two legal opinions from two U.S. law experts which, at least, cast doubts on the strength of Teva’s arguments on the merits (i.e. whether or not the assignment had taken place correctly under U.S. law). Taking into account that, according to Spanish procedural law, in case of doubt, the petition of the party having the burden of proof must be rejected, the Court concluded that Teva’s lack of right to priority attack should have been dismissed in any event. The second aspect addressed by the judgment is inventive step. As patent aficionados will no doubt be well aware, the main theme of Teva’s inventive step attack around Europe has been that the patent application, as filed, did not make it plausible that apixaban had the alleged technical effect (factor Xa inhibition, etc.). In particular, in Spain, Teva based its inventive step attack on T 488/16 (Dasatinib) which, as is well known, was a classic example of the “ab initio plausibility” test. The Barcelona Appeal Court has first considered whether, in contrast to the European Patent Office (“EPO”) Technical Boards of Appeal (“TBAs”), national courts must examine “plausibility” in the first place. In this regard, the Court has noted that, unlike the EPO’s administrative organs, the function of national courts is to review whether a granted patent falls within any of the nullity grounds enshrined in article 138 of the European Patent Convention (“EPC”). In particular, the Court has noted that when, as in the case at hand, during prosecution the patent application was limited to one compound only (i.e., apixaban), the only question to be answered is whether or not the claim as granted is affected by any of such nullity grounds. In this regard, the position followed by this judgment resembles the German position. The Court has then moved to consider a second reason for rejecting Teva’s inventive step attack. As mentioned earlier, in Spain, Teva mounted its lack of inventive step attack on T 488/16 (Dasatinib). After G 2/21 was published, Teva relied on par. 72 of G 2/21, where the Enlarged Board of Appeal tried to protect the EPO from the disarray brought by the three divergent lines of case law discussed in G 2/21 (“[…] the Enlarged Board is satisfied that the outcome in each particular case would not have been different from the actual finding of the respective board of appeal“), to allege that the “ab initio plausibility” test applied in T 488/16 continued to be good law (i.e. nothing had changed). The Barcelona Appeal Court has noted that, contrary to Teva’s position, one cannot extract from G 2/21 the teaching that “everything has changed so that everything remains the same.” The Court has added that, for this reason, it cannot embrace Teva’s argument in the sense that G 2/21 has not left behind the “ab initio plausibility” test applied in T 488/16. This has been relevant for reversing the first instance decision which, after discussing G 2/21, ultimately upheld the inventive step attack applying Dasatinib (i.e., the “ab initio plausibility” test). In short, the Barcelona Appeal Court has considered that the Enlarged Board of Appeal, in G 2/21, introduced a more nuanced test. According to par. 5.24 of the judgment, the patent owner may rely on a technical effect if the person skilled in the art, departing from the application as filed and the common general knowledge, first, may conclude that such technical effect derives from the original technical teaching and, second, represents an embodiment of the same, meaning by technical teaching the invention claimed in the application. Against this background, the Court has noted that, once the patent has been granted, in the context of litigation before a national Court, the burden of proving that the conditions laid down by G2/21 are not fulfilled lies with the third party questioning the validity of the patent granted. Building from here, the Court has noted that Teva’s case had been built on the premise that T 488/16 (Dasatinib) required the application as filed to include information that made the technical effect plausible. It has then added that the new test introduced by G 2/21 does not require this. To sum-up, the Court has concluded that the legal test on which Teva based its inventive step attack has been left behind by G 2/21. Finally, following the order of Teva’s complaint, the Court has dealt with sufficiency. In this context, it should be clarified that the arguments used by Teva to question sufficiency were exactly the same lack of “plausibility” arguments used to combat inventive step. Like in the case of inventive step, the Court started its analysis highlighting that, once the patent has been granted, a national Court must examine the sufficiency of the claim as granted. In particular, in par. 8.8 of the judgment, the Court has noted that, contrary to Teva’s assertion, one does not have to look for a needle in a haystack because during prosecution, to overcome the examiner’s objections, “[…] the applicant simply cleaned-up the haystack and kept the needle.” Also, in par. 8.15-8.16 of the judgment, the Court has walked a very fine line in drawing a very important distinction between the reflections developed by the Enlarged Board of Appeal in par. 73-77 of G 2/21, meant to apply to second medical use claims, and the claims of the case at hand, which are not second medical use claims but medical use claims contained in the patent that disclosed apixaban for the first time. In par. 8.15, the Court has noted that since, in the case of second medical use claims, the patentability can only be justified by having invented a new medical use of a compound that was already known, the test must be stricter than in the latter case. The Court has added that, in any event, even if one were to apply to the medical use claims of EP ‘415, the test applied to second medical use claims, Teva had not established that the person skilled in the art would not have considered the technical effect of apixaban credible. All in all, this important judgment has aligned Spanish case law on this lively area with the position on inventive step and sufficiency taken by all other Courts in Continental Europe in the same case. More from our authors: Vissers Annotated European Patent Convention 2024 Edition by Kaisa Suominen, Nina Ferara, Peter de Lange, Andrew Rudge € 105 The Unitary Patent and the Unified Patent Court, Second Edition by Pieter Callens & Sam Granata € 176 Artificial Intelligence and Patents: An International Perspective on Patenting AI-Related Inventions by Jonathan P. Osha € 174 Enforcement of Decisions of the Unified Patent Court: A Survey of Participating Member States by Christof Augenstein and Johanna Flythstrom € 123

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