Marleen van den Horst

On 11 February 2025, the Court of Appeal of The Hague (“CoA”) rendered its decision in the PI proceedings between Janssen Biotech Inc (“Janssen”) and Samsung Bioepis NL B.V. (“Samsung”). The CoA upholds the decision of the Provisions Judge in first instance and denies the PI claimed by Janssen. Samsung can benefit from the SPC Manufacturing Waiver for production and stockpiling for export of its biosimilar product containing ustekinumab. This case is of particular interest as it is one of the few decisions on the application of the SPC Manufacturing Waiver and, more generally, provides clear answers to various questions raised on when a manufacturer can benefit from said waiver. What preceded In our Pharma Update of 31 January 2024 we have reported on the decision of the Provisions Judge of the District Court of 23 January 2024. In said decision the PI claimed by Janssen was denied as the Provisions Judge was of the preliminary opinion that Samsung could benefit from the production-for-export and stockpiling- for-export exemptions of the SPC Manufacturing Waiver. Facts Janssen holds EP 1 309 692 B1 (“EP 692”) for “ANTI-IL-12 Antibodies, compositions, methods and uses”. The medicinal product of Janssen is marketed under the brand name ‘Stelara’ and contains the active ingredient ustekinumab. EP 692 was granted on 13 May 2009 in, among others, Italy and Denmark. The patent expired on 7 August 2021. After expiration, Janssen was granted an SPC in Italy, Denmark and the United Kingdom (UK – ending on 19 January 2024). Similar Stelara patents in Canada and South Korea have also expired. However, Jansen has filed patent(s) (applications) in these countries that protect the treatment regimen approved for Stelara for ulcerative colitis disease. Samsung has developed a biosimilar of ustekinumab with Stelara as reference called SB17. The Dutch Samsung entity (the defendant) issued a notice to the Danish and Italian authorities respectively that it intended to manufacture and stock its biosimilar in Denmark and Italy for the purpose of exporting it to the UK, Canada and South Korea based on Regulation 2019/933 regarding the SPC Manufacturing Waiver “MW Regulation”) and to market the product in the European Union after expiration of the SPC (stockpile exemption). Samsung mentioned that it would submit the reference numbers of its market authorisations in said countries as soon as publicly available. Samsung additionally undertook towards Janssen that it would not manufacture its biosimilar products for the EU-market until 24 January 2024 in order to avoid discussion on the stockpile exemption in the PI proceedings. Assessment of the CoA In its decision, the CoA considers the full range of arguments put forward by the parties. In general, the CoA considers that the purpose of the SPC Manufacturing Waiver is to create a level playing field for generic and biosimilar manufacturers in the EU vis-à-vis competitors in third countries in order to promote EU competitiveness in global markets where protection expired, while at the same time ensuring protection for SPC holders in the EU. In particular, the CoA answers three legal questions: 1. Does a valid reliance on the production-for-export exemption require that the manufacturer has a MA for the intended country of export at the time of notification, or at least before production commences? The CoA answers this question by first analysing the wording of the MW Regulation and finds that article 5(5)(e) of the MW Regulation only requires that the reference number of an MA is provided in relation to the notice of the SPC Manufacturing Waiver once this is available. There is no obligation for the manufacturer to wait with giving notice or with starting production until the MA for the intended country of export is granted and a reference number is provided. 2. Does a valid reliance on the production-for-export exemption require that at the time of the notification, or at least before the start of production, there are no IP rights in force in the intended exporting countries that could oppose entry into that country’s market? The CoA is of the opinion that the MW Regulation does not contain a requirement that the manufacturer must wait with the production under the waiver until the IP rights have expired in the intended export country. Starting production before those rights have expired is not considered unlawful because manufacturing in the EU under the waiver does not automatically infringe an IP right in the country intended for export. This would only be the case if IP rights still exist when the product is imported into that country’s market. 3. Does a manufacturer have the right to stockpile for the intended export? The CoA considers that under article 5(2)(a)(ii) MW Regulation the EU manufacturer is also entitled to stockpile its products as this is strictly necessary for export to third countries in order to achieve Day 1 entry and for the manufacturer to benefit from the “first mover” effect. The CoA considers that this is in line with the intention of the Union legislator and that Day 1 entry is not only intended for the EU but also for Day 1 entry in third countries, giving the EU manufacturer a first mover effect. The CoA rejects Janssen’s concerns that stockpiling could create a risk that products destined for third countries would eventually enter the EU market. According to the CoA there are sufficient safeguards in the MW Regulation to prevent such products from entering the EU market.

On 22 January 2025, the District Court of The Hague handed down its judgement in the final relief proceedings initiated by Biogen against Sandoz, Polpharm, Neuraxpharm and Mylan (collectively referred to as “the Generics”). It ruled that EP 2653873 (“EP 873”) of Biogen on dimethyl fumerate (DMF, marketed as Tecfidera®), is invalid. EP873 protects the use of an orally administered pharmaceutical composition containing the active ingredient DMF for treating multiple sclerosis (MS) with an effective daily dose of 480 mg DMF. DMF has been known since the 1990s as a drug for treating psoriasis. Inventive step Shortly after the Generics listed their generic 480 mg DMF products in the G-Standard (pricelist) for October 2022 and after health insurers designated some of these products as preferential in NL, Biogen sued  the Generics for infringement of EP 873. The Generics counterclaimed for revocation of Biogen’s patent, inter alia arguing that EP 837 lacked inventive step or sufficiency of disclosure (G2/21). The Generics relied on a clinical study that demonstrated the efficacy of 720 mg DMF per day and the potential for a lower dose to also be effective for the treatment of MS. The clinical study became part of the prior art through two pre-priority date presentations called ‘Kappos I’ and ‘Kappos II’. In the proceedings, both Biogen and the Generics acknowledge that Kappos I and II are full prior art and disclose the use of DMF as an effective drug for the treatment of MS. Starting from Kappos I or II, the Court found that the only difference between Kappos I or II and EP 837 relates to the 480 mg per day dosage set forth in claim 1. During the oral hearing it was established that both parties found that the administration of DMF to treat MS at a dose of 480 mg per day is as effective as administration of 720 mg per day. Therefore, the Court considered that the objective technical problem that the patent tries to resolve is to find an alternative treatment for MS that is as effective as the state of the art, namely the administration of DMF of a dose of 720 mg per day. Biogen argued that the objective problem was to find an improvement in the oral treatment of MS, but the Court rejected this argument and held that – unlike the apixaban case – the patent application (parent patent) of EP 837 did not describe an improved treatment. In addition, the Court found that the purpose of the patent application was not to find the best dose of DMF, but to screen for potentially MS-active substances similar to DMF. Agreeing with the Generics, the Court is of the opinion (5.39) that the skilled person, starting from Kappos I and/or Kappos II, and the general common knowledge,  knows that the efficacy (and therefore the effectiveness) of DMF is dose-dependent and that lower doses are also effective for the treatment of psoriasis. The skilled person would therefore have a reasonable expectation of success that this problem for an alternative dose could be solved in an obvious way by testing lower doses of DMF. Contrary to Biogen’s argument, the skilled person would then carry out those tests. In this way, with routine testing and thus without inventive effort, the skilled person would find that a dose of 480 mg per day has a therapeutic effect. Therefore, claim 1 of EP 837 is obvious. The two auxiliary requests filed by Biogen are also dismissed by the Court. Sufficiency of disclosure The Court also addresses the ‘squeeze’ that the Generics identified, namely that in case EP 873 would be found inventive (quod non), it lacks sufficiency of disclosure and is (also) invalid for that reason. The Court held that the patent or application must sufficiently disclose the subject matter allowing the skilled person to apply the invention over the whole range claimed by the patent without undue burden. Second medical use claims bring about that it must be tested whether the therapeutic effect of the composition and dosage regimen for the claimed medical indication (in this case MS) is disclosed in the application/patent or, in the absence thereof, is credible. In relation to G2/21, the Court states that if the desired technical effect is part of the claim, but the patent does not prove or at least make plausible that this technical effect is achieved by the teachings of the patent, nor does the person skilled in the art assumes this on the basis of the common general knowledge or the cited literature, then there is insufficient disclosure. The Court found that that the application says nothing about the efficacy of the claimed dosage of DMF in treating MS. Since the Court does not consider any experimental data other than Kappos I and II, EP 873 is lacks sufficiency of disclosure. Parallel proceedings  The decision handed down by the District Court of The Hague is the first decision in final relief proceedings to hold (the NL part of) EP 873 invalid. To date, only Sweden has ruled in final relief proceedings on (the validity of) EP 873. The Swedish Court found EP 873 valid and imposed an injunction on the generic companies. Earlier Biogen commenced several PI proceedings in various European countries. In the Czech Republic, Denmark, Latvia, Slovakia, Estonia, Ireland and Sweden, PI’s were granted. In contrast, in Austria, Belgium, Portugal, Slovenia, Italy, France, Spain, Estonia, Germany, Norway and Hungary, PI’s were rejected because the patent was found invalid on a preliminary basis. Conclusion It remains to be seen if the NL judgement on the invalidity of EP 873 is going to be followed by other European jurisdictions.

On 30 October 2024, the District Court of The Hague ruled in two separate final relief proceedings that EP 1 427 415 B1 (“EP 415”) and the SPC of Bristol-Myers Squibb (“BMS”) on apixaban are valid and, in the case of Sandoz infringed (BMS/Sandoz and Teva/BMS). With these rulings, the NL District Court allows post-published evidence. G2/21 (plausibility) and G1/22 and G2/22 (priority) are taken into account. What preceded: interim relief (PI) proceedings The first PI decision on apixaban in the Netherlands goes back to 10 May 2022 when the Provisions Judge of the District Court of The Hague denied a PI, requested by BMS against the sale of generic apixaban by Sandoz. After the decision in G2/21 of 23 March 2023, BMS started new PI proceedings against Sandoz and STADA/Centrafarm, later also against Teva. In separate decisions of 17 May 2023 and 31 May 2023, the Provisions Judge again ruled in favour of the generic companies and denied the requested PI, stating that G2/21 did not change the position regarding the rejection of post-published evidence. The Provisions Judge assessed it as likely that the claims of EP 415 would not be considered inventive due to lack of plausibility in final relief proceedings. All decisions were appealed by BMS. Contrary to the Provisions Judge, the Court of Appeal (CoA) held EP 415 inventive and found that the post-published evidence could be taken into account when assessing inventive step. Reference is made to our Pharma Update of 25 August 2023. Two NL final relief (invalidity) proceedings The final relief proceedings which have now been decided, were initiated well before the PI proceedings, but delayed in view of G2/21. Priority in view of G1/22 and G2/22 The Court first considers the attack on priority. The generic companies argued that BMS cannot rely on priority document US 165 because, at the date of filing of the EP 415 application, the applicant (BMS Company, the predecessor of BMS) was not the holder of priority document US 165. The transfer of US 165 from the holder of the priority document to the applicant of EP 415 did not take place until several years after the filing of the EP 415 application. In its judgment, the District Court refers to G1/22 and G2/22, in which the EBA stated that, under the EPC, the holder claiming priority is presumed to be entitled to rely on the priority document claimed. This presumption also applies where the European patent is derived from an international (PCT) application and/or where the applicants of the priority document are different from the applicant of the subsequent application. The burden of proof to rebut this presumption lies with the party contesting the right to priority. With regard to G1/22 and G2/22, the Court finds that implicit consent to the transfer of priority rights is sufficient. As the EBA considers the possibility of a nunc pro tunc transfer of priority rights, the Court concludes that, in this case, the deed of transfer after the filing date can be relied on to claim priority and the generic companies failed to provide sufficient evidence to rebut the presumption of priority. Plausibility in view of G2/21 In light of the inventive step attack brought by the generic companies, the main issue in the final relief proceedings is whether BMS can rely on a claimed technical effect for inventive step. The Court first applies the PSA as set forth in G2/21 and then analyses if for the skilled person, having the common general knowledge in mind, and based on the application as originally filed, said technical effect is derivable as being encompassed by the technical teaching and embodied by the same originally disclosed invention. Like the CoA, the District Court considers that, in view of the decision in G2/21, there is no obligation that the patent application must always “prove” or make plausible that the claimed technical effect actually occurs. The District Court concludes that the claimed technical effect is disclosed, inter alia, in one of the preferred embodiments mentioned in the patent application. It therefore admits BMS’s post-published evidence and finds that the post-published evidence shows an improvement in the technical effect. Other jurisdictions The Court further notes that also in France, Norway and Sweden EP 415 was held valid, albeit following a different line of reasoning. The English High Court ruled differently because – according to the Dutch Court – it applied a different test (plausibility in the context of sufficiency) as set forth the Supreme Court’s decision in Warner- Lambert. Likewise the Irish Court. Multiple invalidity proceedings on EP 415 are still pending, e.g. in Bulgaria, Czech Republic, Denmark, Finland, Hungary, Italy, Croatia, Poland, Portugal, Slovakia, Spain and Switzerland. Conclusion The decisions show that depending on the circumstances, post-published evidence may be admissible if the technical effect is derivable for the skilled person from the application as filled and is part of its overall technical teaching. Earlier, in Insud Pharma / Galenicum, the Court of Appeal of The Hague had decided that post-published evidence may be rejected if the technical effect is not derivable from the application. The decisions also show that the rebuttal of the presumption of priority as presented in G1- and G2/21, along with the subsequent decisions of the Court of The Hague, remains a very challenging proposition in practice.

On 23 January 2024, the Provisions Judge of the District Court of The Hague handed down a decision in the PI proceedings initiated by Janssen Biotech Inc. (“Janssen”) against Samsung Bioepis NL B.V. (“Samsung NL”). Janssen claimed that Samsung NL infringed its Stelara SPCs granted in Italy and Denmark. The Provisions Judge denied the PI as according to his preliminary assessment Samsung NL can benefit from the SPC Manufacturing Waiver. Janssen’s SPC- Stelara Janssen holds European patent EP 1 309 692 B1 (“EP 692”) for “ANTI-IL-12 Antibodies, compositions, methods and uses“. The medicinal product of Janssen is marketed under the brand name ‘Stelara’ and contains the active ingredient ustekinumab. EP 692 was granted on 13 May 2009 in, among others, Italy and Denmark. The patent expired on 7 August 2021. After expiration, Janssen was granted a SPC in Italy, Denmark and the United Kingdom (UK – ending on 19 January 2024). Similar Stelara patents in Canada and South Korea have also expired. However, Jansen has filed patent(s) (applications) in these countries that protect the treatment regimen approved for Stelara for ulcerative colitis disease. SPC Manufacturing Waiver Samsung has developed a biosimilar of ustekinumab with Stelara as reference called SB17. Samsung NL issued a notice to the Danish and Italian authorities respectively that it intended to manufacture and stock its biosimilar in Denmark and Italy for the purpose of exporting it to the UK, Canada and South Korea based on Regulation 2019/933 regarding the SPC Manufacturing Waiver “MW Regulation”) and to market the product in the European Union after expiration of the SPC (stockpile exemption). Samsung NL mentioned that it would submit the reference numbers of its market authorisations in said countries as soon as publicly available. Samsung NL additionally undertook towards Janssen that it would not manufacture its biosimilar products for the EU-market until 24 January 2024 in order to avoid discussion on the stockpile exemption in the PI proceedings. The PI Judge’s assessment of infringement According to Janssen Samsung NL infringes its SPCs in Denmark and Italy and cannot benefit from the SPC Manufacturing Waiver because Samsung NL (i) did not specify the reference numbers of the marketing authorisations in the exporting countries, (ii) Janssen’s patent rights are in force in the countries to which Samsung NL intends to export its biosimilar, and (iii) Samsung NL is not allowed under the SPC Manufacturing Waiver to store the biosimilar products. The PI Judge finds that according to the text of MW Regulation the manufacturer is obliged to provide the reference number of market authorisation, or the equivalent of such authorisation in each exporting third country, only as soon as it is publicly available. This entails, according to the preliminary view of the Provisions Judge, that if this number is not yet publicly available, the manufacturer has the possibility to supplement the notification with the reference number of the marketing authorisation as soon as it is publicly available, as reflected in Article 5(5)(e) MW Regulation. The Provisions Judge considers that the MW Regulation is sufficiently clear on this item. It is taken into account that the nature and the content of the provisions in question were extensively debated during the revision of the earlier SPC Regulation. The Provisions Judge is therefore of the opinion that it is not necessary to raise preliminary questions to the Court of Justice of the EU on the application of the SPC Manufacturing Waiver, as suggested by Janssen. The fact that the District Court of Munich in the matter Janssen vs Formycon ruled differently on this matter does alter his view, especially because the Provisions Judge finds the reasoning of the District Court of Munich in said decision not convincing. Janssen further argued that Samsung NL may not manufacture a biosimilar under the waiver because in the countries to which Samsung NL intendeds to export its product, patent rights are existing. The Provisions Judge considers that there is no requirement under the MW Regulation that the intended exporting countries are free of patent rights and/or that the manufacturer must prove this in advance. Such requirement would be contrary to the objective of the MW Regulation of ensuring a level playing field with global competition. If EU based manufacturers were only allowed to manufacture for export to countries that are ‘free of patents’ they would be put in a serious disadvantage compared to non-EU based competitors not subject to such restrictions. In relation to the storage of the products the Provisions Judge states that it follows from the wording of Article 5(a)(a)(ii) of the MW Regulation that under the export exemption, ‘temporary storage’ is allowed. The MW Regulation does not specify a maximum period for such ‘temporary storage’ other than that it must be strictly necessary for the actual export. Conclusion The Provisions Judge is of the preliminary opinion that – contrary to the Janssen vs Formycon decision – a manufacturer of a biosimilar can rely on the SPC Manufacturing Waiver a) even if the market authorisation reference number is not yet publicly available, b) there are possible patents rights in the countries to which the product is exported and c) temporary storage of the products is possible when strictly necessary for the actual export.

On 1 November 2023, the District Court of The Hague handed down a decision in the invalidity proceedings instituted by Sandoz B.V. (“Sandoz’’) against Bayer Intellectual Property GmbH. (“Bayer’’). The Court held the once-daily dosing regimen of rivaroxaban, claimed in EP 1 845 961 B1 (“EP 961”), inventive. The use of rivaroxaban and the anticipated launch of Sandoz’s generic product Rivaroxaban is used as an anticoagulant for the treatment of thromboembolic disorders (TEDs). Bayer markets its rivaroxaban product under the name Xeralto. Bayer was the owner of EP 1 261 606 B1 that protects the active ingredient rivaroxaban. Based on said patent, Bayer was granted SPC no. 300370 that will expire on 1 April 2024. Sandoz is planning to launch a generic product containing rivaroxaban in the Netherlands after expiration of the SPC. Sandoz started invalidity proceedings claiming that EP 961 is invalid due to lack of inventive step. Bayer instituted a counterclaim requesting: 1) an injunction against Sandoz for (likely) future infringement of the NL part of EP 961 and 2) a declaration that any offering or placing on the market of Sandoz’ product (e.g. listing the product in the ‘G-Standaard’), or importing or storing the product for those purposes, is an infringing act. What preceded EP 961 was granted on 22 April 2015. Opposition was filed by fifteen parties. In 2018 the Opposition Division revoked EP 961 for lack of inventive step. In appeal, the Technical Board of Appeal (“TBA’’) maintained the patent as granted. Since then, multiple national suits have been filed to invalidate EP 961 e.g. in Germany, Norway and in the United Kingdom. In its decision of 9 June 2023 the Court of Oslo concluded that the patent was inventive. Difference between the TBA and NL proceedings The main difference is that the TBA found EP 961 inventive based on Kubitza I & II and the Harder Abstract, whereas in the Dutch (and Norwegian) proceedings Sandoz introduced the ‘’Harder Poster’’ as new prior art, which was not introduced in the opposition. The Harder Poster reveals parameters in the pharmaco-dynamics that suggest suitability for a once-daily dosing. After summarising the reasoning of the TBA, the District Court of The Hague discusses the Norwegian decision in the parallel proceedings, where the Harder Poster has been taken into account in assessing inventive step. The District Court’s assessment of inventive step Following the parties, the District Court applies the PSA and takes the Harder Poster as the closest prior art. The difference between the Harder Poster and the claimed invention is that the latter concerns the medical use of rivaroxaban in the claimed dosage regimen. Harder is a phase I study on the pharmacodynamic effects of rivaroxaban on eight healthy subjects, but not a study on what the effects and therapeutic efficacy are in patients. The technical effect of the distinguishing feature is that rivaroxaban in the dosage regimen (once daily for at least five days with a rapid release dosage form) is effective and safe in TED patients. According to the Court the objective technical problem is: “finding an oral dosage regimen of rivaroxaban that is safe and effective against TEDs”. This is almost the same as defined by the TBA, albeit that the Court does not concur with the TBA’s (additional) objective of finding a ‘convenient’ dosage regimen as part of the problem to be solved. To assess inventive step, it must be assessed whether, based on the technical problem, the invention was obvious for the average skilled person on the priority date. According to the Court an inventive step is lacking if the person skilled in the art, based on the relevant state of the art, would have solved the problem as claimed in the patent. As the invention is the result of further research, the invention is not only obvious if the skilled person had carried out that research and the results are clearly predictable, but also if there is an incentive in the state of the art that there is a reasonable expectation of success. This means that the skilled person is able to predict a reasonable successful outcome of the research project within an acceptable time period. The hope to succeed is insufficient. The Court points out that the Harder Poster does not provide a reasonable prediction that rivaroxaban would be safe and effective in patients in a once-daily dose. It does not provide convincing results to support this, as the study was conducted in only eight healthy subjects, lacks data on half-life time, whereas the type of tests used were of an experimental nature. Moreover, the skilled person would not have a reasonable expectation of success, because of numerous negative pointers, like 1) the high (and life-threatening) risk of over- and under-dosing patients in anticoagulant research would make him cautious to extrapolate results in phase I studies to a phase II study, 2) Harder does not provide half-time data, which is an important indicator for determining dosing frequency, 3) the negative research experience with a comparable Xa inhibitor, razaxaban, leading to severe bleeding in patients and 4) some medical-ethics committees rejected Bayer’s proposal to test once daily dosing of rivaroxaban in clinical trials. The District Court also assesses Sandoz’ argument that the skilled person, starting to test two- or three-day doses in a phase II study would, through routine steps, ultimately end up with a once-daily dosing regimen. But the Court rejects this view as Sandoz failed to describe how the skilled person would have overcome the negative pointers and would endeavor to also try a once-daily doses with a reasonable expectation of success. Conclusion Based on its own assessment and with reference to the Norwegian judgment and the TBA decision, the District Court rejects Sandoz’ claim for invalidity and holds EP 961 inventive. Both counterclaims of Bayer are granted.

On 3 October 2023, the Provisions Judge of the District Court of The Hague rendered its decision in the PI proceedings between Grünenthal GmbH. et al. (“Grünenthal’’) and Teva B.V. et al. (“Teva’’). The Provisions Judge (“PI Judge”) is of the preliminary opinion that EP 1 457 208 B9 (“EP 208”) makes the technical effect plausible and is inventive. The likelihood of EP 208 being held valid in final relief proceedings is high and therefore a PI against Teva is granted. Making this case particularly interesting is that in parallel final relief proceedings, courts in Germany and the United Kingdom have found EP 208 invalid. The PI Judge (who is also a Judge in the Dutch local division of the UPC) is of the preliminary opinion that the plausibility standard in the Netherlands is different from that in the UK, referring to the recent PI decision of the Court of Appeal in the Apixaban case. Grünenthal is since July 2022 the owner of the Dutch part of EP 208 that is in force in the Netherlands until 14 March 2024. It markets the patented drug, which is a long-acting testosterone drug, under the name ‘Nebido’. What preceded  After Teva received a Dutch marketing authorisation for its generic product called ‘Testosterone Teva’ in December 2022, Grünenthal sent warning letters to Teva in February and April 2023, Teva did not respond until 24 August 2023 when it notified Grünenthal that it planned to enter its generic product in the G-Standaard of October 2023. Grünenthal initiated PI proceedings against Teva before the District Court of The Hague, accusing Teva of infringing EP 208. The interim claim in the PI proceedings  A first, interim hearing was held on 12 September 2023 dealing with the incidental (provisional) claim of Grünenthal, requesting the PI Judge to order Teva to withdraw the listing of its generic product from the October G-standard in order to avoid it being published.  The PI Judge handed down its interim decision on 13 September 2023, ordering Teva to withdraw its product from the October 2023 G-Standaard. According to the PI Judge, Grünenthal has a profound interest in maintaining the status quo as Teva is not yet on the market (nor any other generic) nor listed in the G-Standard, so no price erosion has taken place yet. The fact that Teva chose to ignore the warning letters is explicitly taken into account in the ultimate balance of interest in favour of Grünenthal. The main claims in the PI proceedings  On 26 September, the second oral hearing on the main claims was held. Grünenthal claimed that EP 208 is (about to be) infringed and is seeking a PI prohibiting manufacturing and distributing the generic product and an injunction against unlawful conduct.  The PI Judge rendered its decision on the main claims on 3 October 2023, finding the Dutch part of EP 208 provisionally valid and infringed. According to the PI Judge the Dutch part of EP 208 and the Dutch PI proceedings differ from the German and English final relief proceedings because: i) the claims of Dutch part of EP 208 have been substantially limited by Grünenthal during the Dutch PI proceedings, ii) the statements presented, the expert evidence and substantive debate were not identical and iii) the Dutch plausibility standard in the light of inventive step, after G2/21, differs from the plausibility standard in the UK. In formulating the Dutch plausibility standard, the PI judge refers to the G2/21 decision and to the recent decision of the Court of Appeal in the Apixaban case (section 4.35-4.43). which we have discussed in our Pharma Update of 25 August. The PI judge mentions that the plausibility criterion formulated by the Enlarged Board of Appeal in G2/21 is an abstract criterion. It must be filled in based on the specific circumstances of the case. This leads the PI Judge in section 4.41 to consider: “In applying the G2/21 test when assessing the inventive step of a claim in which the technical effect is not included as a feature, unlike the referral from Teva to the TBA case Agrevo, it is not necessary for the patentee to provide proof, or make it plausible in PI proceedings, that the technical effect works with at least the majority of the claimed compositions.”  The PI Judge observes that the outcome could have been different if Teva had made it plausible that the person skilled in the art, based on the application, could not derive, or has reasons to question that the technical effect would occur over the full breadth of claim 1 as limited in the Dutch part of EP 208.