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    Key takeaways from the EPO’s study “Standards and the European patent system”

    On 14 May, the EPO published the study Standards and the European patent system. The study seeks to improve transparency in the relationship between standards and patents in Europe, by providing insights from an EPO dataset linking patents and standards. The study also provides early observations into SEP litigation under the UPC. I will very briefly highlight the most interesting aspects of the first part of the study before I will focus on the UPC SEP litigation part. Linking European patents and standards The EPO has an prior art collection of over 5.5 million documents from standard development organizations (SDOs). Examiner citations to these documents create a link between European patents and standards. The EPO used this to create a new dataset: the EPO Cited SDO Documents dataset, which is available for download here. The study inter alia shows that 17.4% of patents citing SDO documents are declared SEPs (Figure 3.3.1). According to the EPO, the positive correlation between citations of SDO documents and SEP declarations suggests that the link between patents and SDO documents as made in the dataset could serve as a useful indicator for assessing essentiality. The top 50 authors of standard documents cited in patent applications are shown in Figure 3.1.3. The top five are Huawei, Ericsson, Qualcomm, Nokia and Samsung. The study further shows that there is large variety between SEP holders’ practice in citing SDO documents in their declared SEPs. Vivo and Sun Patent Trust rank at the top, citing SDO documents in close to 70% of its declared SEPs, while others cite SDO documents in (way) less than 5% of their declared SEPs (Figure 3.3.2). The study also notes that the data suggests that well-known SEP holders such a Qualcomm, Ericsson, Nokia and Huawei take a selective approach to declaring patents SEPs, possibly declaring only patents they regard as truly essential (p. 48). Key takeaways from the statistics on UPC SEP litigation The chapter on UPC SEP litigation provides some interesting statistics as well. The study looked at SEP-related commercial disputes (not individual proceedings) between 2015 and 2025. A total of 101 SEP related disputes were identified, the majority (59) relating to mobile telecommunications. Since its opening, the UPC has been involved in 23 SEP related disputes. These 23 SEP related disputes make up 12% of the total 194 disputes (again: not proceedings) at the UPC. Because oftentimes multiple infringement actions are filed in a single SEP dispute, declared SEPs make up 27% of the UPC’s infringement actions. The data also evidences to some degree the complex nature and associated need for active case management in SEP cases. The 23 SEP related disputes gave rise to 123 orders and decisions, which is an average of 5.35 orders/decisions per SEP-related dispute. The average for non SEP related disputes is 4.51 orders/decisions. The data shows that the UPC has been involved in all recent multi-jurisdictional SEP related disputes, taking the place of the UPC contracting MS’ national courts. Over 95% of SEP related orders and decisions are from the German Local Divisions, compared to approximately 50% of non-SEP related ones. This shows that the German LDs are even more popular when it comes to SEP disputes than the general trend already illustrates. This is hardly surprising. German national courts have granted the vast majority of injunction requests in SEP cases since 2018 (as is also noted in the study). It is not strange for SEP holders to assume that the German judges will carry on their tradition with their UPC hat on. Although there have only been three substantive decisions in SEP cases by the UPC, two wherein a FRAND defense was raised (Panasonic v Oppo, Huawei v Netgear) and one wherein no FRAND defense was raised (Philips v Belkin), I would say these SEP holders are not entirely wrong in their assumption. The study further suggests that the UPC may reduce fragmentation of SEP-related disputes as current disputes are dealt with in only two European venues: the UPC and UK. But the study also acknowledges that it is too early to observe whether the UPC will be leading to a decrease in the number of disputes that result in decisions from different courts in different jurisdictions. In my view, the relevant question is not whether we will see less fragmentation in Europe (very likely: yes), but where the disputes will go. The UPC may get competition from a UPC Contracting MS’s national court if that court proves to be willing to impose cross-border injunctions after the recent CJEU’s BSH v Electrolux decision. Naturally, this also depends on the national courts’ approach to assuming jurisdiction vis-à-vis the claims against defendants not domiciled in their jurisdiction based on the close connection of those claims with claims against a home court “anchor” defendant. For foreign EU MS and Lugano Convention based defendants, this approach is harmonized (Art. 8 (1) Brussels I-bis recast Regulation and Art. 6 (1) Lugano Convention) and therefore – at least in theory – claimants cannot really forum shop. As for assuming jurisdiction against other foreign defendants, national jurisdictional rules will generally apply (note that this is different in the UPC, see Art. 71b(2) Brussels I- bis recast Regulation). Some national civil codes, such as the Dutch one, have a national provision that is (almost) identical to Art. 8 Brussels I- bis recast, others, and I understand Germany to be such a jurisdiction, have not. If national courts prove to be eager to go cross-border post BSH v Electrolux, the UPC’s appeal may need to be derived from something else than its ability to impose a multi-territorial injunction by means of one decision. This appeal may potentially lie in the UPC’s willingness to determine FRAND rates. Until now, no continental European court has set a FRAND rate. Although Dutch and French national courts have assumed jurisdiction to hear FRAND determination claims, these disputes were settled before any substantive decision was rendered (more on the NL case here, and on the FR case here). Last year, the LD Mannheim ruled that the UPC is competent to hear a FRAND counterclaim (in Panasonic v Oppo). At the launch event of the study (recording can be found here), UPC Court of Appeal judge Rian Kalden stated that she sees two ways to obtain a FRAND determination from the UPC. A SEP holder may request for an injunction conditional on the defendant (implementer) not accepting a court determined FRAND rate (FRAND injunction). An implementer may start a DNI action arguing that it does not infringe, because it will pay the FRAND rate that will be set by the court. It is now waiting for a party to start one of these two types of actions and advance the UPC’s case law in doing so. 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

    Visser’s Annotated EPC 2025 – major updates at a glance

    As spring turns to summer and the days grow longer across EPC Member States (and, in some cases, banish darkness entirely with the midnight sun!), many of us in the IP community eagerly await the release of the new Visser, now in its 33rd iteration! As always, this version includes numerous updates reflecting changes in the law, formal procedures and case law, as well as improvements to the book’s content (or so the authors hope). What can you expect this year? Below is a brief summary of some updates, presented in no particular order. At long last – a beginner’s guide to the EPC! This year’s edition includes an “Introduction to the EPC” section. The authors recommend that newcomers to the IP profession—whether candidates aiming to become European Patent Attorneys, paralegals, or students—begin their exploration of Visser with this section, conveniently located near the beginning of the book. It provides a brief overview of the EPC, traces the journey of a European patent application through its framework, and covers some key formal matters. Revamped patentability section This year brings an exciting and long-awaited update for readers: a reworked section on patentability, covering Articles 52-57. The update includes an expanded discussion on exclusions from patentability, a detailed and structured description of the problem-solution approach, and insights into specific topics such as computer-implemented inventions and biotechnology inventions. Harsher IP Sanctions The EPC rules have been updated to incorporate the latest amendments to the EU’s regulations on sanctions against Russia. Specifically, Regulation (EU) No 833/2014, amended in February 2025, stipulates that Russian nationals, residents, and entities are barred from obtaining new patents (among other types of intellectual property and with some exceptions) in EU Member States. The newly introduced Rule 39(2a) implements this regulation, while Rules 36(5) and 160(3) further clarify its impact on divisional and Euro-PCT applications. Equality in IP language Here is a little experiment – ask your favorite generative language model to create an image of a patent attorney (many now include image generation, which has led to some mild misuse of AI-generated images on social media). Chances are, it will depict a white man in a suit (I tested this with ChatGPT and Mistral’s Le Chat). Since these models are trained on the texts and images they receive, the language we use is crucial in addressing biases within our profession and the field of intellectual property. Therefore, amending the default masculine language of the EPC to be gender-neutral is both timely and essential. Fifty of the EPC rules have been updated to remove the default “he”, primarily referring to the applicant and the representative. Laos joins the validation party Welcome, Lao People’s Democratic Republic, now a new validation state of the EPC as of 01.04.2025. Details under Art.79. Goodbye, anachronystic tech! Last year marked the end of an era for two older (dare I say, “retro”?) technologies used by the EPO: fax and smartcards. The online tools and portals offered by the EPO have also been evolving. Online Filing using OLF is set to be retired by the end of the year, Online Filing 2.0 is up and running, and the role of MyEPO is expanding. Further details can be found in the notes to Rule 2. Awaiting EboA’s verdict Last year, two new cases were referred to the Enlarged Board of Appeal: G1/24 and G2/24. The former addresses claim construction in light of the description, while the latter pertains to the status of an intervener at the appeal stage if all other appeals are withdrawn. Both cases are now included in the case law table preceding the index in Visser. One patent to rule them all – Infringement under UPCA The notes under Article 64 have been expanded to include an overview of infringement under the Unified Patent Court Agreement. This section now covers the UPC opt-out option for European Patents, direct and indirect infringement, exceptions to infringement, prior use, and the exhaustion of patent rights. Legal practitioners enjoy reduced bureaucratic burden European patent attorneys, or “professional representatives” as referred to in the EPC, already enjoyed the presumed right to act before the EPO without the need to file authorizations. Now, legal practitioners will also be exempt from filing such authorizations by default, placing them on equal footing with EPAs in this regard. Additionally, the EPO has expanded its acceptance of electronic signatures on authorizations. For more details, see the notes to Rule 152. 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

    When May Ex Parte Injunctions Be Granted in Patent Cases in Denmark? – A Case Comment on BS-19037/2025 from the Danish Maritime

    Article 9(4) of Directive 2004/48/EC obliges Member States to ensure that courts may issue provisional measures, including injunctions, without giving prior notice to the defendant in certain circumstances. This applies, in particular, when a delay is likely to result in irreparable harm to the rights holder, or when there may be a real risk that evidence may be concealed or destroyed by the defendant. Although effective enforcement is a central aim of the Directive, the provision also recognises the exceptional nature of ex parte measures, which must be applied with due regard to fundamental procedural rights. Under the corresponding rule in Danish procedural law, the court may dispense with notifying the opposing party whene it is deemed unobjectionable (ubetænkeligt), or where prior notice would undermine the purpose of the injunction. In a – rare – recent decision (BS-19037/2025) from the Danish Maritime and Commercial High Court (Sø- og Handelsretten) these rules were applied in practice. The dispute evolved over several rounds of litigation between Biogen and Sandoz on patents relating to the use of dimethyl fumarate in the treatment of multiple sclerosis. Biogen obtained its first preliminary injunction against Sandoz on 3 February 2023, following proceedings initiated in August 2022. That injunction was upheld both by the Commercial Court and, later, by the Eastern High Court in December 2023. A second injunction was granted in February 2025 on the basis of a patent claim that had been limited to cover only relapsing-remitting multiple sclerosis (RRMS). Both injunctions remain in force. Nevertheless, Sandoz was awarded a public procurement contract by Amgros in February 2025 for the product “Dimethyl fumarate 1a Farma.” According to Biogen, the tender offer infringed its patent rights, as the active substance and its approved therapeutic use remained within the scope of the earlier injunctions. In response, Biogen initiated new injunction proceedings, this time seeking an ex parte decision. The court, however, declined the application. The court held that—despite the parties’ previous legal history—it would not be unobjectionable to exclude Sandoz from the hearing. Moreover, the purpose of the injunction would not be undermined by notifying Sandoz, since the supply period under the Amgros tender would not commence until 1st of August 2025, providing ample time for a hearing and a decision. The decision illustrates the cautious approach taken by Danish courts in relation to ex parte measures in patent cases. Even in cases involving repeated infringement claims and enforceable injunctions, the threshold for excluding the defendant from proceedings remains very high. 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

    Various Artists -- DOWNTOWN (Happy 50th Anniversary to "SONGS")

      Y'know, the other day, I saw this adorable little teaser from Sony Music Japan's YouTube channel. Cartoon cutouts of the members of the legendary New Music band Sugar Babe(シュガー・ベイブ)appear and do some minimalistic moving around while their "Downtown" track is playing. Then the announcement comes out that their one and only "SONGS" album from April 25th 1975 is getting its special 50th anniversary release today. Well, there was no way that I could let this one slide by KKP, especially on Urban Contemporary Friday. I did get my own special version of "SONGS" years ago at the old Shibuya RecoFan...I think it was the 30th anniversary edition and I wrote about the album way back in 2013, so that's all said and done. Plus, I had even written about the arguably most famous track "Downtown" more than a year previously in the first few weeks of the blog's existence. However, as I said above, I'm not about to ignore the significance of this opportunity. Therefore, I've opted to provide as many of the cover versions of "Downtown" as created by composer Tatsuro Yamashita(山下達郎)and lyricist Ginji Ito(伊藤銀次)that I've known and written about here including one that I discovered only last night. As for why "Downtown" has been popular among listeners and musicians alike, I mentioned in the original article for the song that my favourite version among the covers has been EPO's 1980 City Pop take since it was not only the first version that I had ever heard, but also because it was just a bright and happy and welcoming song about enjoying a Saturday night in the big city, aka Tokyo. And I think despite all of the different arrangements that "Downtown" has undergone depending on the band or singer, that feeling of optimism and fun hasn't been diminished. Starting with Sugar Babe, the song dares listeners to come to the metropolis. Imagine what it must have been like back in 1975 or 1980 with the Sugar Babe original and then the EPO cover respectively when Tokyo and Japan were further going up in the world and the economy. Sugar Babe (1975) I have to admit that the original by this band took a while to grow on me since I was so attached to the EPO cover version. However, I can say that Tatsuro's take is also some rollicking rock n' roll fun which sounds like the gang busking about in Shibuya or Shinjuku. EPO (1980) EPO's EPO-tastic version is something that I will always put up alongside Mariya's "Plastic Love" and Miki's "Mayonaka no Door" as a City Pop anthem. Whenever I listen to it, I get those images of West Shinjuku and its skyscrapers at sunset and how they eventually got me to come over to Japan finally. Haruko Kuwana (1982) Another City Pop Queen, Haruko Kuwana's(桑名晴子)cover of "Downtown" is available on her 1982 album "Moonlight Island". Compared to Sugar Babe's rollicking original and EPO's groovy cover, Kuwana's take goes into a funkier and just-as-fun direction but it is no less City Pop. YMCK and DE DE MOUSE (2008) Apologies to DE DE MOUSE that I couldn't include him in Labels but I got the warning from Blogger that I reached my 20-label limit; I'll compensate on the original article since until today, I hadn't known that the chip tune band YMCK had collaborated with DE DE MOUSE on this cute-as-all-heck techno cover. Maaya Sakamoto (2010) Maaya Sakamoto's(坂本真綾)"Downtown" was a pretty cool take because it incorporated a couple of genres into one cover: ska and jazz. Plus, the fact that it was being used as the opening song of an anime brought me lots of joy since it would mean a new generation of folks were getting their share of this song. Juice=Juice (2021) Heck, even the contemporary aidoru group Juice=Juice was having their fun with "Downtown". Sounding like a spacy version of EPO's "Downtown", I wouldn't mind visiting Odaiba in Tokyo Bay while listening to this one as accompaniment. Nice oomphy percussion! the band apart (2024) And we come full circle with the latest version that I've gotten to know. the band apart has actually been around since 1998 and in July 2024, they came up with their "Downtown ep". Their take is more along the lines of Sugar Babe's original, and the bright and glossy music video above signifies what I've always imagined about the song vis a vis Tokyo. I'll see if I can find another song to cover by the band soon. Strangely enough, April 25th is also an anniversary for another City Pop classic.

    Use versus process patents: Implications for novelty and scope (T 1913/21)

    The recent decision T 1913/21 highlights a crucial differentiation between second non-medical use claims and process claims. The Board of Appeal found that, according to the established case law, claims in which the technical effect of the invention occurs only as part of a process for producing a product, must be regarded as a process claim and not second non-medical use claims. This distinction has significant implications for the novelty and scope of protection of the claims. Legal background: The novelty of non-medical use claims versus process claims The distinction between second non-medical use claims and process claims is crucial for the assessment of novelty. Use claims, e.g. use of compound X for use in a (non-medical) use Y, are an acceptable claim format in Europe. However, specific case law applies to novelty assessment of such claims, as compared to process claims (IPKat). Second medical use claims are dealt with by different provisions.  Antibody manufactureFor second non-medical use claims, the principles established in decisions G 2/88 and G 6/88 of the Enlarged Board of Appeal (EBA) apply. According to these decisions, a claim to a new use of a known compound for a particular non-medical purpose, which is based on newly identified technical effect should be interpreted as including that technical effect as a functional feature of the claim. Accordingly, such a claim is novel provided that the technical feature has not previously been disclosed (see also Case Law of the Boards of Appeal, I.C.8.1.3).  In other words, according to G 2/88 and G 6/88, a new use based on a newly discovered technical effect of a known compound can be novel even if the physical activity required to carry out the use was already known. For example, the use of compound as e.g. a fungicidal plant spray, may be considered novel even if the use of the compound as a general spray for plants was already known. Whilst the fungicidal use and effect of the compound could be considered inherent in the previous use of spraying plants, the new use is considered to include the fungicidal technical effect as a technical feature of the claim, rendering the claim novel (T 231/85). Non-medical use claims do not permit patent protection for known products The EBA in G 2/88 made it clear that its findings on second non-medical use claims applied specifically to use claims that do not result in a product (r. 5.1). For process claims, Article 64(2) EPC states that "[i]f the subject-matter of the European patent is a process, the protection conferred by the patent shall extend to the products directly obtained by such process". Given that, according to G 2/88, the use considered therein are not those resulting in a product, they should also not fall within the scope of Article 64(2) EPC. As such, second non-medical use claims cannot be used as a back-door method for achieving patent protection for an already known product, even if a new functional feature of the product has been identified.  Case background: Antibody manufacture T 1913/21 related to Biogen's European patent EP 2707383 for methods of preventing and eliminating the formation of trisulfide bonds in proteins, e.g. antibodies, during manufacture. Unwanted trisulfide bonds in antibodies are generally undesirable modifications that may inadvertently affect the antibody's desired function. Claim 1 on appeal was as follows: "Use of an inhibitor of cysteine degradation for reducing the formation of trisulfide bonds in proteins, wherein the inhibitor of cysteine degradation is selected from pyruvate [...], wherein the use comprises: culturing cells expressing said proteins in the presence of an effective amount of the inhibitor of cysteine degradation, whereby trisulfide linkage formation in said proteins is reduced [...]" Claim construction: Use claim or process claim? Following opposition by Roche, the patent was found to be novel and inventive. The Opposition Division construed claim 1 as a second non-medical use claim directed to e.g. pyruvate for reducing trisulfide bond formation in proteins, wherein the technical effect of pyruvate in reducing trisulfide linkage formation was considered a limiting functional feature of the claim. On appeal, the central issue was whether the claim should be construed as a second non-medical use claim (as argued by the Patentee) or as a process claim for the production of proteins (as argued by the Opponents). On appeal, the Board of Appeal disagreed with OD's analysis. The Board of Appeal particularly found that the claim should be regarded as a process claim for the production of proteins, not as a non-medical use claim in the sense of G 2/88 and G 6/88. The Board noted that: "[T]he claimed subject-matter comprises carrying out process steps, which result in the production of a product. Following the principles laid down in G 2/88 and G 6/88 [...] the claimed subject-matter must be regarded as a process for the production of proteins with a 'reduced' number of trisulfide linkages, regardless of the fact that the claim is drafted as the 'use' of a chemical compound." (r. 20) The Board noted that the technical effect stated in the claim ("reducing the formation of trisulfide bonds in proteins") could not occur except as part of a process for producing proteins: "[W]here an invention relates to a new technical effect of a physical entity that can only occur as part of a process for the production or manufacture of a product, such that this effect is inextricably linked to and cannot occur in isolation from the production process, a claim directed to that 'use' of the physical entity to achieve that effect must be regarded as directed to the production process per se." (r. 23) Having construed the claim as a process claim, the Board of Appeal assessed the claims novelty accordingly. The prior art documents disclosed processes for the production of recombinant proteins in which cells were cultured in the presence of pyruvate. The technical effect of "reducing the formation of trisulfide bonds" was not explicitly mentioned in these documents. However, the Board found that because the claimed subject-matter was a process for the production of a product, the stated purpose or effect was not a limiting feature. As a result, the Board concluded that claim 1 lacked novelty. Conflicting case law? The Patentee requested a referral to the EBA, arguing that the Board of Appeal's approach to claim construction represented a deviation from G 2/88. However, the Board of Appeal rejected this request on the basis that the teaching of G 2/88 was limited to true use claims, and that it had therefore properly applied the decision. The Board of Appeal also cited a number of previous decisions, including T 1855/06, T 304/08, T 1179/07, T 684/02, that had also highlighted the limited applicability of G 2/88 and G 6/88.  Interestingly, the Board of Appeal nonetheless acknowledged divergent case law on the issue. In its reasoning, the Board of Appeal explicitly disagreed with decisions T 0062/02 and T 1011/04, which had interpreted similar claims in the sense of G 2/88. Addressing this disagreement head-on, the Board of Appeal in the present case explained that T 0062/02 and T 1011/04 contradicted the established case law. A critical failing of these earlier decisions, according to the Board of Appeal, was their lack of reasoning regarding the distinction between use claims and process claims under Article 64(2) EPC. For the Board of Appeal, these previous decisions did not address why the technical effect recited in the claims should be considered a functional feature when that effect related to a property of the product rather than to the use itself.  Final thoughts The decision in T 1913/21 provides further clarification on the distinction in the novelty assessment between non-medical use claims and process claims. In its decision, the Board of Appeal made it clear that the format of a claim, and particularly whether or not it includes the word "use", is not determinative. What matters is the technical subject-matter claimed. This case thus confirms that the mere drafting of a claim as a "use" claim cannot circumvent the fact that when the claim defines a production process for a product, the claim will be considered a process claim. Therefore, even when a technical effect of a compound is inextricably linked to a production process, the EPO is still likely to treat such a claim as a process claim and not a use claim, regardless of the claim format. Antibody manufacturing patents can be valuable if they protect a generally applicable method that is adopted by the industry. However, process patents also have significant drawbacks, given that competitors may be able to easily design around process claims or use the method without this being readily apparent to the patentee. The patentee in the present case faced the even more fundamental problem that the antibody manufacturing process they were seeking to protect involved a compound already commonly used in antibody manufacture. The method was therefore considered inherently disclosed by the prior art methods, despite the identification of a new technical effect of the compound and the "use" format of the claim. Further reading How do you determine the novelty of a second (non-medical) use claim? (T 1395/15) (Feb 2020) The benefits and pitfalls of drug manufacturing IP (T 2543/22) (Feb 2025) Beyond the process: Securing robust IP protection for cell therapies (March 2025)

    G1/24 hearing: primacy of the claims vs. the diamond test

    G 1/24 addresses the extent to which the description can be used to interpret the claims. As previously discussed, it looks set to be one of the most consequential EPO decisions of the decade. The hearing in G 1/24 took place on 28 March, with the opponent advocating a new “diamond standard” that the “description and drawings should be used to interpret the claims“, while patentee favoured the primacy of the claims approach. In case you missed it, here is a brief (and non-exhaustive) summary of some of the main points raised. Questions The following questions were referred: 1. Is Article 69 (1), second sentence EPC and Article 1 of the Protocol on the Interpretation of Article 69 EPC to be applied to the interpretation of patent claims when assessing the patentability of an invention under Articles 52 to 57 EPC? 2.May the description and figures be consulted when interpreting the claims to assess patentability and, if so, may this be done generally or only if the person skilled in the art finds a claim to be unclear or ambiguous when read in isolation? 3. May a definition or similar information on a term used in the claims which is explicitly given in the description be disregarded when interpreting the claims to assess patentability and, if so, under what conditions? Admissibility of the questions The preliminary opinion of the Enlarged Board tended to find questions 1 and 2 admissible, placing the ball in patentee’s court. Their main argument was that this issue has already been decided by the Enlarged Board. Reference was made in particular to G 2/12: A distinction needs to be made between, on the one hand, the aspects of patentability and, on the other hand, the (protective) effects of European patents or patent applications. The EPC clearly provides for such a clear division, as the requirements for patentability are governed by Articles 52 to 57, 76, 83, 84 and 123 EPC whereas the extent of protection and the rights conferred by European patents or patent applications are specified in Articles 64(2) and 69 EPC in particular… As a consequence, whether a product claim or a product-by-process claim is patentable is to be examined irrespective of the extent of protection that is conferred by it after grant. While certainly relevant to the present case, we’re not convinced that specifically the issue of claim interpretation has been decided. Add to this the fact that an earlier decision of the Enlarged Board does not preclude a later (even contradictory) one, and it seems likely that the preliminary opinion on this point will be maintained. As for the third question, the preliminary opinion of the Enlarged Board tended to find this inadmissible. This wasn’t heavily challenged by the opponent or the EPO President. Perhaps because, as the EPO President put it, this third question is a subset of the second. Regardless of whether the decision explicitly addresses this point, we hope that it provides a clear basis to determine whether definitions of claim terms can be disregarded. Questions 1 and 2 As question 3 looks less likely to be relevant, in the following we will focus on the discussion on questions 1 and 2. The Enlarged Board’s preliminary opinion doesn’t come to a clear conclusion for question 1. However, they generally “recognise the interest in uniform application of the principles of claim interpretation both in patent grant proceedings… and also in post grant revocation and infringement proceedings“. And for question 2 they preliminarily concluded that “the description and the figures can be referred to in the course of claim interpretation“. This places the burden on patentee to explain why Article 69, which undoubtedly deals with claim interpretation for infringement, should not be relied on. Patentee Paraphrasing George Orwell, patentee responded that “[all parts of the application are equal, but] some parts of the application are more equal than others“. Picture of George Orwell which appears in an old accreditation for the BNUJ. Namely, the patent is an “asymmetric legal document“, in which the claims have primacy. Legal basis for this is to be found in the first line of Article 84 EPC “The claims shall define the matter for which protection is sought“. Leading decisions such as T 56/21 discussed here were cited in support of these arguments. As for using Article 69 EPC, patentee warned of Donald Rumsfeld’s “unknown unknowns” following any change to EPO practice on claim interpretation, decreasing legal certainty. Article 2 of the protocol raises the spectre of equivalents being brought into claim interpretation along with Article 69, which would undermine the famous EPO gold standard. While this is an unappealing prospect, it may not be enough to dissuade the Enlarged Board from at least adopting the principles of Article 69 EPC for claim interpretation. It was also interesting that patentee accepted that the description can be used to interpret the claims, if the claims are unclear. This is based on a well-established line of EPO case law, and is consistent with their position in the opposition case. But it does raise the question of where exactly this principle can be found in the Convention, especially if Article 69 EPC is not relevant. In our view the second sentence of Article 84 EPC doesn’t read very easily onto this scenario. Opponent Opponent meanwhile advocated a new “diamond standard” that the “description and drawings should be used to interpret the claims“, to complement the existing gold standard. Legal basis for this can be found in Article 69 EPC, it being the only article to expressly address claim interpretation. They argued that this is critical to avoid the “angora cat” problem: where patentee adopts a broad claim interpretation for infringement but a narrow one for validity. It was also pointed out that Articles 100 and 138 EPC require the assessment of “the subject matter of the European patent”, a broader concept already encompassing the description. If this did not provide appropriate basis, Article 125 EPC would kick in, meaning that the same principles would be adopted anyway in view of the principles applied in the contracting states. This last point is somewhat controversial, as Article 125 EPC is restricted to procedural law, while interpretation is arguably substantive. Otherwise, as discussed here, their fundamental point seems sound, that the same approach should be taken for both validity and extent of protection in all European forums. EPO President The EPO president referred to Article 1 EPC and the goal of creating a “system of law, common to the contracting states“, and argued for the same interpretation pre-and post grant. In their view, multiple sources in the EPC including Articles 84 and 69 EPC suggest that the claims should be interpreted based on the description. The description has a secondary role, but a role nonetheless.   Interestingly, they also made a plea that the issue of adaptation of the description also be settled in G 1/24. It will be interesting to see if the Enlarged Board takes this up. A decision on this would certainly be welcome. If not, it looks likely that another referral on this issue will be made in T 697/22 later this year. Enlarged Board Meanwhile, the Enlarged Board did not give much away. The only question came from legal member D. Rogers, who asked whether Article 1 of the protocol goes beyond Article 69 EPC first sentence. The relationship between these elements of the EPC might be relevant for the decision, and in particular whether reasoning based on Article 69 also requires the protocol. The Chairman concluded the oral proceedings stating that their “real work” now begins, suggesting that there is much for them still to form an opinion on. That said, although the pleading from all parties was of a high standard, it seemed that no significant new points emerged in the hearing. At this stage then, it seems likely that the preliminary opinion will be maintained, i.e. that at least the principles of Article 69 EPC can be applied, such that the description and figures can be referred to. 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

    [GuestPost] G1/24: Tuning in! A take on the state of proceedings before oral proceedings

    Today is the day of the highly anticipated oral proceedings on G 1/24. The referral relates to a highly fundamental question of patent law, namely how the claims of a patent should be interpreted. KatFriend, Greg Corcoran, takes us through the background to the referral, details of the latest flurry of submission and suggests the key points to look out for in the hearing today. Over to Greg!  "Today, Friday 28th March, the Enlarged Board of Appeal (EBA) will hear representations from the parties to the proceedings and the European Patent Office (EPO) for the Referral G 1/24 relating to use of the description in claim interpretation, as first reported here. This Referral has received an unusually high-level of interest, not least because the decision could impact the practice of all European patent practitioners. Over thirty Amicus Briefs were received, including two late filed and two from the same party (the epi). The President filed Comments, which some may consider controversial. The Preliminary Opinion of the EBA was unusually brief, with many commentator reports having a greater word count than that of the Opinion itself. In preparation of the hearing today, here are some highlights of the proceedings so far.  Background to the case The Referral derives from an opposition to a Phillip Morris patent (EP 3076804) for a smoking article. The Opposition decision was appealed, asking the Board of Appeal if a definition in the description of the patent could be used for a broader interpretation of the claim-term "gathered" than would be known to a person skilled in the art.  The divided case law The Referring Board noted in its Interlocutory Decision, T 439/22, that split case law existed for interpreting claims in view of the description, which refer to both Arts 84 and 69 EPC.  Tuning in to G 1/24, IPKat is all ears! The first line of case law, e.g. T 223/05, advocates that Art 84 EPC, not Art 69 EPC, applies in EPO proceedings: a patent claim should essentially be read and interpreted on its own merits rather than with the aid of the description and drawings. If the claim wording is clear to a person skilled in the art in view of the common general knowledge, reference to the description is unnecessary. Exceptionally, reference to the description and drawings may be made when a claim lacks clarity. A particular meaning present only in the description (and not the claims) cannot be used to interpret an apparently broad term of a granted claim to have narrow scope. Limiting reference to the claims on their own, or with the description, if necessary, is alleged to ensure that for a person skilled in the art the claims would be clear and unambiguous (Art 84 EPC). This ensures a proprietor cannot adopt a narrower interpretation during prosecution than after grant, preventing the ‘Angora cat’ phenomenon. In the second line of case law e.g. T 1473/19, “Article 69 EPC and the Protocol are the only provisions in the EPC containing rules for the interpretation of patent claims” and the “claims must satisfy the requirements under Article 84 EPC so that they can fulfil their purpose of enabling the protection conferred by the patent to be determined under Article 69 EPC (cf. G 2/88, Reasons 2.5)”. The description is generally taken into account for claim interpretation, unlike in the first established line of case law. Although account should be taken of the description and drawings when interpreting a claim (Art 69(1) EPC), the claims have primacy for determining the extent of protection. This recognises that features cannot be read in claims that are only present in the description.  Some commentators note that the Referring Board cites the UPC Court of Appeal decision Nanostring v 10x Genomics when referring to G 2/88 and G 6/88 (which it argues applies Art 69 EPC to patentability). Nanostring is now leading UPC case on claim interpretation. Could it be that the Referring Board is suggesting that the EPO follow the UPC or at least take note of developments in UPC practice?  What lies at the heart of the split case law is how Arts 84 and 69 EPC are applied by the EPO for claim interpretation, i.e. prior to grant and opposition.  The referral questions and provisional answers Thus, the Referring Board decided that a referral was required in view of the divergence in case law to determine the relevance of cited prior art should the claim be broadened by referring to “gathered” in the description. The Referral Questions, simplified for brevity, are:  Question 1) Is Art 69 (1) EPC and the Protocol of Interpretation legal basis for claim interpretation? Question 2) Should reference be made to the description and the drawings when interpreting claims? Question 3) Can a specification be a dictionary of definitions for the patent? Amicus Briefs, The President’ Comments and Pegram’s Third Party Observations Twenty-eight amicus briefs were filed, which is an unusually high number, by parties with interests over the full range of technical fields. In response to the Referral Questions, most briefs gave positive replies to the first Question; all but one were positive in response to the second Question; and, for the third Question, most stated a definition of a claim term in the description may not be disregarded. It should be noted that over a third of the Briefs cited T 56/21 which was decided shortly before the deadline for filing the briefs. A referral about the practice of amendment of the description had been expected from this case; yet the Board of that case decided amendment of the description on allowance was inappropriate and a referral was unnecessary, as reported here.  The President of the EPO filed his Comments at the same time as the amicus briefs. His arguments differed from any of the briefs, arguing the EBA should account for the established EPO practice under Art 84 EPC of amending the description in compliance with the allowed claims prior to grant. He considers this practice as essential for ensuring consistent claim interpretation. He cites T 438/22 that affirms the practice of amendment of the description (as reported here) and which is divergent case law relative to T 56/21. The President could be asking the EBA to check the impact of its decision against the established EPO practice. Yet others interpret the President’s Comments as asking the EBA to extend the Referral Questions to encompass the practice of amending the description.  Noting the deadline for filing amicus briefs had elapsed, John B Pegram filed third party observations, arguing, if the EBA were to extend the Referral Questions in view of the President’s arguments, interested third parties should be given the right to be heard.  Preliminary Opinion  The EBA published its Preliminary Opinion on 6 February 2025, (see IPKat). Of the three Referral Questions, the EBA appears most interested in the first Question. Simplifying the provisional answers for brevity:  Provisional Answer 1: The EBA recognises the interest in uniform claim interpretation in EPO and Board of Appeal proceedings (including pre-grant) and in post-grant national court proceedings, including the UPC. The EBA identifies two sub-questions:     A. Should the principles of claim interpretation of Art 69(1) second sentence EPC and Article 1 of the Protocol be applied for claim interpretation when assessing patentability (Articles 52 to 57 EPC);      B. Are Article 69(1) EPC and Article 1 of the Protocol the legal bases for the principles referred to in question A)?  Provisional Answer 2: The EBA views the description, and figures can be used for claim interpretation.  Provisional Answer 3: This question is inadmissible. An answer is not required for the underlying case. Through his support of the practice of amendment of the description, Art 84 EPC, the President seeks uniform claim interpretation. The President is one of the parties with such an interest that the EBA acknowledges this in the introduction to its first answer. Therefore, if the EBA has decided to ignore the President’s Comments, this is not communicated in the Preliminary Opinion. The EBA may still respond to the President's arguments. Later Filings  Normally the next filing in proceedings would be the final pleadings of the parties. Yet there are three further third-party filings:  a. Further Third-Party Observations: of 13 February present the development of Art 69 EPC evidenced by the travaux préparatoires of the EPC. Art 69 EPC is inapplicable pre-grant because the article was developed exclusively for infringement post-grant, and the reference to ‘applications’ is for ‘provisional protection’ i.e. rights conferred after publication but before grant. This appears to support the Respondent’s arguments. b. The epi filed their Second Amicus Brief on 18 February 2025 in response to the President’s Comments, noting: the Referral Questions does not directly address the adaption of the description, Art 84 EPC. The epi notes Art 84 EPC does not stipulate that the description must only contain subject matter which supports the claims. Yet it considers it is not necessary to address the question of amendment of the description in order to answer the Referral Questions.  Despite taking a position inconsistent with that of the President, the epi observes that in practice there are strongly held views for and against the practice of amendment of the description.  The epi criticises a rigid application of EPO practice as advocated by the President, noting that the patent from which the Referral derived, despite having clear claims (Art 84 EPC) during assessment of patentability, demonstrates a problem can exist when interpreting claims applying Art 69 (1) EPC and the Protocol. Such interpretation might lead to an extent of protection deviating from the subject matter for which protection is sought, and which is assessed for patentability relative to the prior art.  It presents examples that demonstrate retaining the description unrelated to the claimed invention would not be detrimental to claim interpretation post-grant, but would even assist a person skilled in the art to understand the context of the invention. Retaining such non-supporting disclosure would not automatically result in a lack of clarity, because a person skilled in the art would not rely on such disclosure for claim interpretation. If such disclosure later broadened claim scope, applying Art 69(1) EPC second sentence during patentability would ensure such broader scope would need to be patentable.  The epi repeats Pegram’s arguments and argues interested third parties had not made representations about the question of amendment of the description because this question is extraneous to the Referral. Without pleadings from all sides and views, the epi takes the position that a decision in the present proceedings on the question of amendment of the description would be premature.  c. Amicus Brief of 20 February 2025 from Mewburn Ellis (Mewburn). Mewburn represented Hoffman-La Roche in the appeal T 56/21 from which a referral on amendment of the description had been expected. As explained earlier, that Board finally decided that a referral was not necessary because adaption of the description had negative consequences post grant. The President explicitly criticised this decision at para 72 and 73 of his Comments, citing T 438/22 to affirm EPO practice.  The President’s own Comments appear to undermine the argument that the EPO practice of amending the description has sure footing, by highlighting that the practice relies on one limb of divergent EPO case law. Mewburn arguably shows that T 56/21 serves not to demonstrate that a referral on the question of amendment of description is unnecessary, but that a new referral would be appropriate.  Mewburn observes that the Preliminary Opinion is silent whether the EBA will consider the question of amendment of description.  They ask that, if the EBA decides to consider the President’s question, third parties are given the opportunity to file Amicus Briefs before the EBA’s consideration of the President’s question.  Final Arguments of the Parties  The Respondent builds on earlier arguments that the Referral is inadmissible, and the first Question really relates established practice for clarity (Art 84 EPC). The Respondent proposes to reformulate the first Question to refer to the full Protocol, including Art 2 on equivalence. They reason then that Art 69 EPC may only apply post grant. T56/21 features the same argumentation that Art 69 is inapplicable in the EPO proceedings for patentability. However, the Respondent asks that the President’s request (to consider amendment of the description) is not considered in the proceedings.  The Appellant argues that Art 69 EPC applies for patentability (see G 6/88 cited in the Referral, T439/22) so that how the EPO, Courts and public interpret the claims results in the same understanding of the claimed subject matter. Art 69 EPC is the only provision of the EPC that specifically addresses claim interpretation, and this provision explicitly states that the description and drawings must be used to interpret the claims, without condition. The Appellant supports Pegram’s arguments that amendment of the description is not part of the Referral (paragraph 157), yet it positively supports amendment of the description, noting that sometimes the practice may be ‘insufficient’ (paragraph 21). Curiously, the Appellant seems not to support Pegram’s argument that third parties should be given the right to be heard if the EBA decides to consider the President’s arguments (paragraph 156). The Appellant applies the general principles of EU Administrative Procedural law (paragraphs 24 to 43) which is applicable in most but not all EPC contracting states, as a guide for the legal principles on interpretation (Art 125 EPC) to support its arguments for harmonised claim interpretation, in applying Art 69 EPC.  It observes such an approach: would increase certainty in court decisions; is enabled by the commencement of the UPC; and would result in higher quality granted patents, which is in-line with the interests of the EPO. Points to Note for the Hearing There are many points at play in these proceedings. In view of the Preliminary Opinion, it is likely that the proceedings will focus on the first Referral Question: if the principles of Art 69 (1) EPC and its Protocol are applied to claim interpretation for patentability and if these provisions provide legal basis. The parties to the proceedings and the EPO (which will also participate in the hearing today) appear to have differing views.  Some key issues appear to be:  Will the EBA decide that the principles of Art 69 EPC and its Protocol (or even as legal basis) should be applied pre-grant for claim interpretation to assess patentability in place of Art 84 EPC? Will the EBA accept the Appellant’s arguments that the EPO should harmonise its approach to claim interpretation with the UPC? This appears to be the legal issue upon which this Referral appears to turn, and it is only supported by the Appellant.   Will the Respondent’s efforts to reformulate the first Referral Question to incorporate Art 2 of the Protocol succeed? Should the EBA accept this argument, the Referral could be swiftly concluded but given the Preliminary Opinion’s acknowledgement of the interest in consistent interpretation before the EPO and the Courts, this outcome is perhaps unlikely. How will the EBA respond to the President’s argument that the decision should account for the practice of amendment of the description? The parties to the proceedings, the two late filed Amicus Briefs and Pegram in his Observations argue that the EBA should not account for this practice when answering the Referral Questions. If the EBA does consider the President’s argument, would third parties be able to file new Amicus Briefs? There is no precedent so that outcome appears unlikely and third parties appear not have attempted to add substantial arguments, as such, in response to the President’s argument; rather the two late filed amicus briefs mainly argued against the EBA considering Amendment of the Description when answering the Referral Questions. In any event, the EBA will answer the Referral Questions as is necessary to address the issues from the originating appeal: which is unrelated to amendment of the description. It will be interesting to see the EBA’s approach on this point.  Is reference to amendment of the description completely avoidable? It is unclear if the decision can avoid reference to the amendment of the description entirely because the decision is highly likely to refer to Art 84 EPC. Further the Appellant explicitly refers to EPO practice in its arguments (paragraph 21). If the EBA decides not to consider the question of amendment of the description, it will be interesting to see how it formulates its decision in view of the Appellant’s arguments without consequences for the practice of amendment of the description. Summary These and other questions will be considered by the Enlarged Board of Appeal in the hearing today at 10am CET. The hearing can be followed by livestream using the link supplied here: Oral proceedings in case G1/24 ("Heated aerosol"). The decision is expected later this year."  Related IPKat Articles BREAKING: Referral to the Enlarged Board of Appeal on claim interpretation confirmed (G1/24) - The IPKat Deletion of claim-like clauses: Board of Appeal finds legal basis for adaptation of the description from "the EPC as a whole" (T 0438/22) - The IPKat Board of Appeal back-pedals on referral in view of "unequivocal" lack of legal basis for the description amendment requirement (T 56/21) - The IPKat GuestPost: A referral broadened? To have one’s cake, to eat it...or not yet to get it (G 1/24) - The IPKat

    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

    G 2/21 applied to software inventions (T 0687/22)

    The EPO Board of Appeal decision in T 0687/22 confirms beyond doubt the relevance of G 2/21 to software inventions. The decision in T 0687/22 links the case law from G 1/19 and G 2/21 to highlight the importance of establishing a credible technical effect of software invention. The Patentee in the case made several attempts to formulate an objective technical problem solved by the invention based on several suggested technical effects. The Board of Appeal, citing both G 2/21 and G 1/19, was not convinced that the necessary criteria for relying on these purported technical effects were met.   Disclosure of a technical effect (G 2/21) In G 2/21 the EBA found that post-filed evidence for technical effects can be used 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." (Headnote II). Subsequent Board of Appeal decisions have found that, following G 2/21, it is not necessary for applications to explicitly mention the technical effect relied on for inventive step or to provide experimental evidence in support of a technical effect. The broad applicability of G 2/21 According to T 0116/18, the technical effect relied on for inventive step only needs to be "conceptually comprised by the broadest technical teaching" and recognisable as "necessarily relevant to the claimed subject-matter." T 2465/19 found that “the technical effect of an invention over the closest prior art need not be explicitly stated in the application, as long as it is derivable from the original application, in particular since the closest prior art may not have been known to the applicant when drafting it”. T 1994/22 nonetheless clarified that vague statements like providing "a quality product" are insufficient to support specific undisclosed technical effects (IPKat).  The applicability of G 2/21 to software inventions Many of the Board of Appeal decisions to apply G 2/21 have been in biotech and chemistry field, including cases relating to a second medical use (T 0258/21, IPKat),  polymorphs (T 1994/22, IPKat), and cheese (T 0629/22, IPKat). However, G 2/21 has also been applied to other fields, including semiconductors (T 2465/19, IPKat). Indeed, G 2/21 is relevant in any case for which there is a question about the disclosure of a technical effect relied on for inventive step in the application as filed (IPKat).  There is a clear connection between G 2/21 and one of the central issues for software inventions, that of establishing features of the claimed invention that contribute a technical effect. According to the established case law in the software field, a feature may be only be relied on as contributing a technical solution to the objective problem to be solved in view of the closest prior art if the features provides a technical effect (see Case Law of the Boards of Appeal, I-D-9.2.8), see also the EBA decision in G 1/19). Given the importance of identifying a technical effect for the patentability of software inventions, the guidance from G 2/21 on the disclosure and evidence requirements for technical effects relied on for inventive step is highly relevant to the field.  Establishing a technical effect of a software invention (T 0687/22) The patent at issue in T 0687/22 related to active occlusion cancellation in hearing devices (EP 3340653). T 0687/22 related to an appeal of the opposition division (OD) decision to maintain the patent in amended form. The Opponent appealed the OD decision, requesting that the patent be revoked.  The central issue in the case was whether the distinguishing features of the invention compared to the closest prior art provided a credible technical effect that solved an objective technical problem. Despite numerous attempts by the Patentee to identify a technical problem solved by the invention, including improved energy efficiency, circuit stability and flexibility, the Board of Appeal could not "identify any technical effect that can be credibly associated" with the distinguishing features (r. 2.3).  The Patentee submitted the alternative argument that the objective technical problem could be formulated as merely "providing for an alternative modification of the resulting signal based on the signal from the ear-canal microphone." However, the Board of Appeal rejected this effect for being too broad, noting that "a modification introduced solely for the sake of differentiation from the prior art simply means that, at most, the novelty requirement of Article 54 EPC is met" but does not guarantee compliance with Article 56 EPC (r. 2.3.4).  Given the absence of a credible technical effect that could be associated with the distinguishing features of the claimed invention, the Board of Appeal concluded that none of the requests were allowable under Article 56 EPC. As a result, the patent was revoked. Relevance of G 2/21 to software inventions  Interestingly, in its reasoning in T 0687/22, the Board of Appeal made a direct reference to both G 2/21 and G 1/19: [w]hen following the problem-solution approach to assess inventive step in the case in hand, a technical effect associated with the distinguishing feature(s) of the invention must be identified on the basis of the claim wording to establish a credible objective technical problem (see e.g. G 1/19, Reasons 82 and 124 as well as G 2/21, Reasons 25). If no such technical effect can be identified, there is not necessarily any technical problem to be solved (see e.g. G 1/19, Reasons 49).  In reason 25 of G 2/21, cited by the Board of Appeal, the EBA noted:  The technical problem must be derived from effects directly and causally related to the technical features of the claimed invention. An effect could not be validly used in the formulation of the technical problem if the effect required additional information not at the disposal of the skilled person even after taking into account the content of the application in question. T 0687/22 thus confirms the clear relevance of G 2/21 to software inventions, and specifically to the criteria for establishing a technical effect of the distinguishing features of the invention in the application as filed.  A possible avenue for the Patentee to rescue the case might have been to provide some post-published evidence of their purported technical effects. The Board of Appeal would then have had to assess whether the criteria of G 2/21 were met, namely whether the technical effect relied on was encompassed and embodied by the application as filed. However, no post-published evidence was submitted, and so this issue was not considered.  Final thoughts While the focus of commentary about G 2/21 has been on its relevance to biotech and chemistry cases, its principles are equally applicable to software inventions. T 0687/22 confirms the relevance of G 2/21 to software inventions, and particularly the need to both establish a credible technical effect for your invention that is identifiable from the application as filed. G 2/21 was not focused on the concept of plausibility, given that it was primarily concerned with the disclosure requirements for a technical effect relied on for inventive step. However, the focus of the decision in T 0687/22 on the credibility of the alleged effects is also a reminder that the concept of plausibility/credibility in inventive step is highly applicable to software inventions. More on this to follow!  Further reading The relevance of G 2/21 to machine learning inventions (T 2803/18) (Aug 2023)

    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. 

    To infinity and beyond! The sufficiency requirements for open-ended ranges (T 1977/22)

    The recent Board of Appeal decision in T 1977/22 related to the patentability of claims defining subject matter with open-ended parameter ranges. The question before the Board of Appeal was whether a claimed open range, and its numerically infinite scope, could ever be said to be sufficiently disclosed (Article 83 EPC). The Board of Appeal rejected the argument that all open-ended ranges are inherently insufficient. Instead, the Board of Appeal suggested criteria for assessing whether an open-ended range is sufficiently disclosed, based on an assessment of whether there is sufficient practical guidance enabling a skilled person to work within the range without undue burden.  Legal Background: Open-ended ranges According to Article 83 EPC, European patents should "disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art." For numerical ranges, this requirement is typically interpreted as meaning that the skilled person must be able to reproduce the invention across the entire claimed range (IPKat: Plausibility demystified - a review of EPO case law before G 2/21). This test is applied to all types of invention, including those in the mechanical field (IPKat).  Unlimited Kats The sufficiency test for ranges raises an important question for claims specifying an open-ended range for a particular parameter. An open-ended range specifies only one boundary, thereby potentially extending infinitely in one direction. Can such ranges ever satisfy the requirement of reproducibility across the entire scope, given that an infinite range would by definition include parameter values that would not be achievable by a skilled person? The case at issue in T 1977/22 related to Rhodia Operations' patent EP 3086872, which was opposed by Neo Chemicals & Oxides (Europe) Ltd. The patent related to a thermally stable inorganic composite oxide material comprising specific amounts of metal oxides. The invention proposed to solve the problem of thermal aging in catalytic converters, where traditional materials lose their specific surface area and catalytic efficiency when exposed to high temperatures during operation. By creating a composite oxide that maintained an exceptionally high surface area even after severe calcination conditions, the invention aimed to provide improved catalysts with superior durability. Claim 1 as granted (and on appeal) specified an inorganic composite oxide material comprising specified amounts of particular metal oxides. Crucially, the claim specified that the material exhibited a surface area defined by one of three open-ranges: >150 m²/g after calcining at 900°C for 2 hours; >85 m²/g after calcining at 1000°C for 4 hours; or >40 m²/g after calcining at 1100°C for 5 hours. In other words, there was no upper limit to the indicated surface areas specified by the claims. The Opposition Division had revoked the patent for insufficiency in view of the specified open ranges (Article 83 EPC).  Open-ended ranges and the "reproducibility over the whole scope" standard The Opponent argued that the claimed invention was insufficiently disclosed because it was impossible to reproduce the invention across the entire scope of the open-ended ranges. Since the specific surface area defined by each of the three open ranges could theoretically extend to infinity, the Opponent submitted that the claim inevitably included non-working embodiments that could not possibly be achieved. The Patentee argued in response that the patent provided detailed teachings in the examples that would enable a skilled person to manufacture the claimed material through routine trial and error experimentation. The Patentee also pointed out that the Opponent had not attempted to rework any examples or identified specific information gaps that would prevent reproduction. Instead, the Opponent had merely made general allegations about irreproducible embodiments without providing evidence. Criteria for sufficient disclosure of open-ended range The Board of Appeal rejected both extreme interpretations of the case law on open ranges. For the Board of Appeal, a literal interpretation requiring enablement of every conceivable value in the upward direction would impose an impossible burden on applicants and patentees. On the other hand, simply disclosing in the specification a few isolated examples falling within the claimed range could not always be said to be providing a sufficient disclosure. Instead, the Board of Appeal proposed that, in order to satisfy the sufficiency requirement for open ranges, the patent should provide "teachings demonstrating that, by operating within the scope of specific (essential) structural and/or process features, the skilled person would be in a position to achieve multiple variants of the invention without undue effort i.e. embodiments with different parametric values falling within the open-ended range." (r.4.13) Applying this general principle, the Board of Appeal identified two distinct situations that may arise with respect to claims comprising parameters defined by an open range. First, there would be cases where the defined parameter was not restricted by any structural or process features. For the Board of Appeal, such claims would generally not be enabled unless the range was directly or indirectly limited by closing the range or by defining interrelated parameters imposing an upper boundary (r.4.6.7(a)).  In contrast, there would also be cases in which the claimed subject matter defined by an open-ended range was further restricted by structural and/or process features. For the Board of Appeal, such claims may be sufficiently disclosed if the teachings indicate that the skilled person could achieve different parametric values within the claimed range by making trivial adjustments within the scope of these features (r.4.6.7(b)). Application to the case at hand In applying its proposed criteria to the patent in question, the Board of Appeal noted that the specification provided detailed disclosure of how to manufacture the claimed material. The examples in the patent pertained to two distinct composite oxides with components and concentrations falling within the scope of claim 1, including the specified open-ended ranges (r. 6.6.6). The evidence provided in the patent indicated that the components and concentrations of the metal oxides were the essential parameters for adjusting and enhancing the specific surface area (r. 6.6.7).  Therefore, for the Board of Appeal, the claims defined not only the open-ended range parameters but also the essential structural features (the metal oxide components and their amounts) required to achieve those parameters (r.6.6.9). Based on this analysis, the Board of Appeal concluded that the open-ended ranges were enabled by the teachings in the patent, and the invention was reproducible over the whole scope of the claim, and that the requirements of Article 83 EPC were therefore met. The decision under appeal was therefore set aside, and the case was remitted to the Opposition Division for consideration of novelty and inventive step.  Consistency with existing case law (and no referral to the EBA) Both parties had requested a referral to the Enlarged Board of Appeal (EBA) on the question of the correct approach to the sufficiency of open ranges. However, in its decision, the Board of Appeal took pains to demonstrate that its approach was consistent with previous decisions concerning open-ended ranges, and concluded that there was also no divergence in the case. The Board of Appeal particularly argued that the differing outcomes in previous cases were primarily due to case-specific factors rather than fundamental divergences in legal principles. The Board of Appeal was thus of the view that the previous decision on the issue could be reconciled with its own approach.  In cases where open-ended ranges were found reproducible (such as T 487/89, T 624/08, T 2213/08, and T 398/19), the Board of Appeal argued that the claims in question were defined by structural and/or process features that enabled adjustment of the parameter. In cases where open-ended ranges were found irreproducible (such as T 1008/02, T 1942/21, and T 2344/12), the Board of Appeal argued that this was because the claims in question did not define features shown to enable achievement of high parametric values. In T 1008/02, for example, the claim defined a product (a superabsorbent material) in terms of an open-ended range for liquid absorbing capacity without specifying any structural or process features that would enable achieving this property. The Board of Appeal concluded that there was therefore no justification for a referral to the EBA. Importantly, the case law on the novelty and inventive step of selection inventions also applies to open ranges (IPKat). As the Board of Appeal confirmed in this decision, claims specifying selected higher parameter values falling within an open range will be novel, and potentially inventive, in view of the prior disclosure of the open range (r.4.12.3).  Final thoughts The decision in T 1977/22 provides some useful guidance for the assessment of open-range sufficiency. In this Kat's view, the approach taken by the Board of Appeal in this case is pragmatic and thankfully avoids setting unrealistic standards that would effectively prevent the use of open-ended ranges altogether, and the consequent enforced introduction of entirely arbitrary limits.  On the other hand, including an open range in a claim is a risky strategy that should be avoided if it is not strictly necessary for capturing the full scope of the invention.  As the Board of Appeal pointed out in this case, whilst the criteria for open range sufficiency "avoids setting unrealistic goals [...] the burden is higher than [for] a closed range", i.e. which may be satisfied by the provision of one example of a working embodiment within the claimed range. The Board of Appeal also noted that, whilst the approach taken by Boards of Appeal have been consistent on the fundamental principles of the disclosure required for open ranges, some Boards of Appeal have required a slightly higher standard than others (r. 4.10). For example, some Boards of Appeal have required the specification to enable the skilled person to work the invention outside of the range embodied by the examples. Consequently, whilst the use of open range parameters will provide a broader scope of protection, they will also open you up to a higher disclosure standard. The strategic approach is therefore to establish what claim scope is necessary for commercially relevant protection and to limit the claims accordingly. In most cases, the commercially relevant scope (even one that protects against design-around) is likely definable using a closed range.  Further reading Gold Standard test for novelty reigns supreme, even for subranges (T 1688/20) (Jan 2023) Plausibility demystified - a review of EPO case law before G 2/21 (Feb 2023) Chocolate teapots and nuclear bombs: Whole range sufficiency of mechanical inventions (T 0149/21) (July 2023)

    OK Computer: the EPO’s New Generative AI Legal Interactive platform

    One critical factor in developing generative AI is access to a large amount of well-structured data. As such, the EPO is sitting on a goldmine when it comes to AI tools for patent law. I was therefore excited to hear about the recent launch of the EPO’s “legal interactive platform“, which provides information about patent law and procedures at the EPO. My initial impressions were positive – the platform mostly provides accurate answers to general questions, and seems to outperform ChatGPT-4o and Perplexity on these specific tasks. That said, it wasn’t entirely reliable or overly useful at digging out legal points from individual decisions. Introducing the legal interactive platform The legal interactive platform is a chatbot available through “MyEPO Portfolio“. To access it, you need to set up an account with the EPO, go through two-factor authentication each time you want to logon, and select the icon shown below. It is therefore more difficult to access than ChatGPT and Perplexity, but worth the effort. The platform answers questions based on its knowledge which includes the EPC, EPC and PCT Guidelines, decisions of the Boards of Appeal, Case Law book, OJ, and the most important legal texts relating to the Unitary Patent system. Normally, it provides links to the sources when answering your questions. It is possible to select different sources of information for answering your questions: “legal text”, “case law” or “legal text and case law”. The source chosen is quite important as conflicting answers are provided depending on the mode used. Answering general legal questions In my experience, the platform gave reasonable answers to general questions. For example, I asked: Does an examining division in a divisional application have power to stay proceedings pending the outcome of a board of appeal decision concerning opposition proceedings against the parent? Pending opposition or appeal proceedings concerning the parent application (or any member of that family of applications) do not constitute grounds for staying the examination proceedings for a divisional application, either by the EPO on its own initiative or on request. Reasons for a stay or interruption of proceedings are set out in E‐VII, 1 (1. Interruption) to E‐VII, 3 (3. Stay of proceedings when a referral to the Enlarged Board of Appeal is pending) as detailed in the EPO Guidelines for Examination. Furthermore, if a party requests a stay of opposition proceedings for the sole reason of pending appeal or opposition proceedings of a patent family member (e.g., a parent application), the request will not be granted. The party will receive a communication from the opposition division indicating the reasons for its intention not to grant the request. This communication does not constitute an appealable decision under Article 106(2) (EPO Guidelines for Examination). Therefore, an examining division in a divisional application does not have the power to stay proceedings pending the outcome of a board of appeal decision concerning opposition proceedings against the parent. While the second paragraph is not particularly relevant, the first paragraph does correctly cite the Guidelines on this point. ChatGPT-4o answered this question incorrectly, while Perplexity got the answer right, but didn’t provide such useful references. Other general questions on the burden of proof in EPO prosecution, missing the Rule 58 EPC deadline and requesting PACE were also answered correctly. Note though that the platform can get it catastrophically wrong even when the answer is in the Guidelines: Can I still validly file a divisional application during the further processing period for the parent application, even if I do not pay the further processing fee? Yes, you can still validly file a divisional application during the further processing period for the parent application, even if you do not pay the further processing fee. It is unclear why Guidelines A-IV, 1.1.1 was overlooked. ChatGPT-4o and Perplexity also failed this one. Answering legal questions on specific scenarios Despite having access to the decisions of the Boards of Appeal, the platform seemed to struggle to find decisions addressing specific scenarios. For example: Is there an epo decision stating that a prior art value of Y% is novelty destroying for a claim to >Y%? The European Patent Office (EPO) case law does not provide a direct answer to the question of whether a prior art value of Y% is novelty-destroying for a claim to >Y%. However, the principles of novelty assessment as outlined in the EPO case law can be applied to such a scenario. According to the case law… The platform failed to identify the catchword of T 594/01 which answers this when in the “case law” mode. Interestingly, a better answer was given which did identify a relevant passage of the case law book citing this decision when the “case law” and “legal text” modes were used together. It seems then that the platform may sometimes struggle to find points made in decisions if they are not flagged in the case law book. This was confirmed by the following question, which to our knowledge is not answered in the case law book, but is discussed at reason 7.6 of T 523/14: If a claim specifies some numbered steps, is there a case which held that such a claim is not restricted to the numerical order of the steps, i.e. also covers any order of the steps? Here too, the platform did not provide case law support. I had similar experiences with other cases, e.g. admissibility of inadmissibility requests discussed here. Concerning questions which the platform couldn’t answer, I noticed a tendency to answer with related but not relevant decisions. For example, asking “Are there any cases confirming entitlement to partial priority where the range in the application is narrower than the range in the priority application?” gave a long answer on G 1/15, which concerned the opposite scenario in which the range in the application was broader. Conclusion The EPO is to be commended for developing this impressive tool, which certainly seems to offer a marked improvement over existing tools for searching at least the Guidelines and the Case Law Book. That said, as the platform freely admits, the results suffer from a lack of accuracy, making it very important to carefully check everything it says. I also wondered whether having the different “legal text”, “case law” or “legal text and case law” modes is really helpful. Given that they sometimes gave contradictory results, it seemed to me that it may be better simply to have a single mode which automatically selects the source of information based on the question asked. Of course, it wouldn’t be polite to conclude my review of the platform without asking the platform to review me: As a legal assistant, I don’t have the capability to review or evaluate your use of my services directly. My primary function is to assist you by providing information related to the European Patent System, including details about the European Patent Convention, Unitary Patent, case law, and decisions of the Boards of Appeal, among other topics. To ensure you’re getting the most out of my assistance: Be Specific: Providing detailed and specific queries helps me retrieve the most relevant information for you. Use Keywords: Including keywords related to your query can improve the accuracy of the information I provide. Clarify Acronyms: If you use acronyms, you might want to clarify them or ask me to resolve them to ensure accuracy. Follow-Up Questions: If the information provided isn’t exactly what you were looking for, feel free to ask follow-up questions for clarification or additional details. Feedback: While I can’t review your use directly, your feedback on the responses can help guide future interactions for better assistance. It seems we both have something to work on. 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

    The benefits and pitfalls of drug manufacturing IP (T 2543/22)

    The Board of Appeal decision in T 2543/22 relates to a manufacturing method for preparing a therapeutic peptide. The Board of Appeal found that whilst various methods were known, the skilled person would not have had a reasonable expectation of success in applying them to produce the specific claimed peptide. The case highlights some interesting aspects of pharma IP strategy, particularly as related to manufacturing IP and whether this is best protected with patents or trade secrets.  Benefits and pitfalls of drug manufacturing IP Patents to the drug substance itself will always be the preferred IP strategy for protecting a therapeutic drug product. However, there are some cases where product IP is not possible, for example because the product is well known or difficult to define, or has limited useful patent term if clinical development has taken a long time. In these circumstances, manufacturing IP is another way of protecting return of investment in the drug. However, manufacturing patents bring with them a number of risks and potential pitfalls.  In many cases, manufacturing IP may be easy for any potential competitor, generic or biosimilar company to design around. It is challenging for generics and biosimilars to design around a drug substance patent, given that regulatory approvals are tied to the drug substance itself. By contrast regulatory approvals will generally not specify that any one particular manufacturing process must be used to make the drug. Generic and biosimilar companies are thus free to develop their own manufacturing processes to avoid any manufacturing IP owned by the innovator company.  Drug manufacturing Added to the problem of the potential design-around by competitors is the issue of the limited term of protection afforded by patents. There are a number of drug products on the market for which the innovator has retained exclusively far longer than would have been possible with a patent, solely through the process of manufacturing trade secrets. One notable example is the hormonal replacement therapy (HRT) Premarin. Pfizer has retained market exclusivity for Premarin since its introduction in 1942 solely through retaining secrecy of its complex manufacturing process. If a patent had been filed for the manufacturing process it would have likely long expired, leaving generics to copy the method disclosed in the patent. Therefore, if manufacturing a drug is particularly hard, trade secrets may be a better approach for retaining market share without competition as they are not limited to a 20 year term like patents.  Another problem with manufacturing patents is the challenge of detecting and proving infringement. Just as the innovator of a drug can keep their manufacturing process secret, so too can the competitors (see also IPKat on how this issue also applies to AI-assisted drug discovery). It may not be until litigation discovery that infringement can be proven. Without access to the competitor's facilities or detailed manufacturing records, gathering evidence of infringement or a manufacturing process could be extremely difficult.  Amgen's therapeutic peptide manufacturing IP  The patent at issue was EP3126373, owned by Amgen, covering a manufacturing method for Amgen's peptide drug AMG 416, marketed as Parsabiv for use in decreasing parathyroid hormone levels to treat various conditions. The manufacturing patent expires 4 years after the SPC for Parsabiv, based on the composition of matter (CoM) patent (EP2459208). Interestingly, unlike the opposition for Amgen's other patents relating to Parsabiv, the oppposition in this case was filed anonymously. The appeal was from the Opposition Division's decision to reject the opposition and maintain the patent as granted. AMG 416 contains a disulfide bond between a D-cysteine and L-cysteine residue. The key feature of the claimed manufacturing method for AMG 416 was the formation of this disulfide bond between the specific cysteine residues. The claimed method particularly involved using an intermediate peptide containing a 2-pyridinesulfenyl (SPy) activating group on the D-cysteine residue.  Inventive step of manufacturing  The main issue on appeal was whether the use of SPy intermediate was obvious. The closest prior art identified for inventive step by the Board of Appeal was the composition of matter (CoM) case for AMG 416 (WO 2011/014707). CoM patent disclosed the structure and sequence of AMG 416, but only provided general information about peptide synthesis methods.  On appeal, the Opponent argued that the invention was obvious because forming disulfide bonds using the methods described in the patent activation was well-known in peptide chemistry. The Opponent submitted that it would thus have been obvious to use these methods to prepare the intermediate specified in the claim and use this intermediate to prepare AMG 416. The Patentee argued in response that whilst individual elements or the method were known, the skilled person faced multiple choices in designing a synthetic route to AMG 416.  The Board of Appeal agreed with the Patentee, and found that the skilled person would have needed to divert from the explicit teaching in the closet prior art to perform the entire synthesis process (r.6.3.1). The Board of Appeal concluded that starting from the closest prior art, "the skilled person would not have had a reasonable expectation of producing AMG 416 in an alternative way " (r. 6.4). The Board of Appeal concluded that the claimed method was not obvious in view of the closest prior art in combination with either common general knowledge or any of the other documents cited. The appeal was therefore dismissed and the patent maintained as granted.  Final thoughts Amgen was therefore successful in retaining its manufacturing patent for Parsabiv. However, the question remains whether generics will need to use the claimed process for manufacturing their own versions of Parsabiv, and whether it will be clear whether or not they have done so. It is notable that the opposition in this case was filed anonymously, indicating that whoever challenged the patent does not want to alert Amgen to the possibility that they are thinking of using the method. There is also the question of how easy the patent would be to design around. The patent indicates that the claimed invention improves the yield, which may be critical to commercial viability. However, there may be other methods for improving yield. Finally, it is interesting that Amgen chose to patent their manufacturing process in this case instead of preserving the method a trade secret. Possibly Amgen took that view that, whilst the method should be considered inventive by EPO standards, it was not so non-obvious that other companies would not think of using it themselves.   Further reading More on pharma IP strategy:  IP strategy for AI-assisted drug discovery (Oct 2024) Functional claims for pharmaceutical formulations: Validity versus enforcement (T 2130/22) (Jan 2025) Plausibility as a moving target: Phase III clinical trial results sink second medical use patent (T 0816/22) (Jan 2025) Insilico Medicine: Lessons in IP strategy from a front-runner in AI-drug discovery (Feb 2025)

    EBA's preliminary opinion in G1/24: "the description and the figures can be referred to in the course of claim interpretation"

    The Enlarged Board of Appeal (EBA) has issued its preliminary opinion in the closely watched referral G1/24 relating to the role of the description in claim interpretation. The preliminary opinion provides the EBA's initial view on the three referred questions ahead of oral proceedings scheduled for 28 March 2025. The EBA's thoughts on the three questions are very brief, and only Questions 1 and 2 are considered admissible.  Legal background: Claim interpretation The referral in G1/24 originated from T 0439/22 and relates to fundamental questions regarding claim interpretation at the EPO. The question at the heart of the referral in G1/24 is whether, and to what extent, the description should be taken into account when interpreting the claims. The referred questions particularly seek clarity on the relationship between Article 69(1) EPC and Article 84 EPC. Article 69(1) EPC states that "the extent of protection conferred by a European patent or a European patent application shall be determined by the claims" whilst "the description and drawings shall be used to interpret the claims". Article 84 EPC states that "the claims shall define the matter for which protection is sought" and "shall be clear and concise and be supported by the description". The Board of Appeal in T 0439/22 found disparity in the case law on how and if the provisions of Articles 69 and 84 should be applied to claim interpretation.  And then there were two Case background: G1/24 - spiralled or gathered? The referral stems from pending appeal T 0439/22  concerning Philip Morris' European patent EP3076804. The patent, which survived opposition at first instance, relates to a cartridge for a "heat-not-burn" smoking device where tobacco is heated rather than burnt. The central issue in the appeal is whether the claims lack novelty. The dispute hinges on the interpretation of the term 'gathered' in the claims, which specify that the cartridge comprises 'gathered' smoking material. The prior art discloses a cartridge comprising 'spirally wound' smoking material. The description provides an unusually broad definition of 'gathered'. The Board of Appeal noted that this definition appeared to conflict with the normally narrower meaning of the term in the tobacco industry. The Opposition Division had applied what the Board of Appeal termed the "classical approach" to claim interpretation, following the principle that the description should only be consulted to construe unclear claim terms. Under this approach, recourse to the description is prohibited when interpreting otherwise clear claim language. Nonetheless, the Board of Appeal identified a divergent line of case law, exemplified by T 1473/19, which holds that definitions provided in the description "cannot be left unconsidered". The outcome of the appeal turns on this point of claim interpretation. Considering the description's broad definition would favour the Opponent's novelty attack, whilst interpreting the claim term 'gathered' according to its normal meaning without reference to the description would support the Patentee's case for novelty.  The questions referred to the EBA are as follows:  Question 1: Application of Article 69(1) EPC during examination The first referred question asks: "Is Article 69(1), second sentence, EPC and Article 1 of the Protocol on the Interpretation of Article 69 EPC to be applied to the interpretation of patent claims when assessing the patentability of an invention under Articles 52 to 57 EPC?". In other words, Question 1 asks whether Article 69(1) EPC is relevant during pre-grant examination and opposition.  Question 2: Role of description and drawings The second question asks: "May the description and figures be consulted when interpreting the claims to assess patentability and, if so, may this be done generally or only if the person skilled in the art finds a claim to be unclear or ambiguous when read in isolation?". In other words, Question 2 asks whether the description should be used to interpret the claims, and if so, whether this should only be to resolve otherwise unclear claim language. There is a significant body of Board of Appeal case law finding that the description should only be consulted if the claim language would be unclear to a skilled person.  Question 3: Definitions in the description The third question asks: "May a definition or similar information on a term used in the claims which is explicitly given in the description be disregarded when interpreting the claims to assess patentability and, if so, under what conditions?" The EBA's preliminary opinion The EBA's initial view is that Questions 1 and 2 are admissible, whilst Question 3 is deemed inadmissible.  On Question 1, the EBA notes the interest in the "uniform application of the principles of claim interpretation both in patent grant proceedings [...] and also in post-grant revocation and infringement proceedings before the courts of the EPC contracting states, including the Unified Patent Court". So far, the UPC has taken the approach of considering the patent as a whole such that the description should always be used to interpret the claims. The EBA considers Question 1 to raise at least two issues that need addressing. First, whether the principles of Article 69 EPC and the Protocol should be applied during examination, and second, whether they provide the legal basis for the principles to be applied the interpretation of the claims.  For Question 2, regarding whether the description and figures may be consulted when interpreting claims, the EBA's preliminary view is that "the description and the figures can be referred to in the course of claim interpretation" (r. 2). The EBA's thoughts on this question are very brief and so we await the final decision for the EBA's analysis.  The EBA's preliminary view is that Question 3 is inadmissible. Again, the EBA's reasoning is very brief. The EBA merely notes that "an answer to it is not required for the referring Board to reach a decision on the case before it" (r. 3). Final thoughts The EBA in its preliminary opinion has also chosen to so-far ignore the intervention of the President of the EPO that the referral should be broadened to consider the question of description amendments (IPKat). Instead of the referral being broadened, from the preliminary opinion of the EBA, it appears that it may in fact be narrowed. However, the normal note of caution that this is only the preliminary view of the EBA applies, and we await the final decision following the March hearing.  Further reading GuestPost: A referral broadened? To have one's cake, to eat it...or not yet to get it (G 1/24) (Jan 2025) BREAKING: Referral to the Enlarged Board of Appeal on claim interpretation confirmed (G1/24) (July 2024) Will we have a referral on using the description for claim interpretation or is the Board of Appeal jumping the gun? (T 439/22) (Jan 2024) EPO tries to have its cake and eat it on claim interpretation (T 0169/20) (March 2023)

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