Benjamin Niemeijer

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 15 August 2023, the Court of Appeal of The Hague (”CoA”) rendered its decision in the PI proceedings between Bristol-Myers Squibb Holdings Ireland Unlimited Company (“BMS’’) and Sandoz B.V. (“Sandoz’’), Centrafarm B.V. et al. (“Centrafarm”) & Teva B.V. et al. (“Teva’’). The CoA is of the preliminary opinion that EP 1 427 415 B1 (“EP 415”) makes the technical effect plausible, allowing post-published evidence to be taken into account. The CoA comes to its finding after the Enlarged Board of Appeal (“EBA’’) handed down its decision in G2/21. The likelihood of EP 415 being held valid in the pending final relief proceedings is high and therefore a PI against the generic companies is granted. Making this case of particular interest is that two out of the three CoA Judges are also Appeal Judges in the UPC. This case may show the position the UPC may take on plausibility. BMS is the owner of EP 415 and of SPC no. 300500 based on this patent (“SPC”). EP 415 was in force in the Netherlands until 16 September 2022. The SPC relates to apixaban or pharmaceutically acceptable salt forms thereof (marketed by BMS as Eliquis®) and is in effect from 17 September 2022 until 19 May 2026. What preceded  The first apixaban case in the Netherlands was the PI proceedings between BMS and Sandoz. The Provisions Judge of the District Court of The Hague (“PI Judge” rendered his decision on 10 May 2022. According to the PI Judge, there is no inventive step due to lack of plausibility and therefore a good chance that the patent (and the SPC) will be held invalid in final relief proceedings. A PI against the sale of generic apixaban by Sandoz was denied. No appeal was filed. On 23 March 2023 the EBA decided case G2/21 on plausibility. It considered three questions about the circumstances in which it is permissible to rely on post-published evidence of a technical effect in support of inventive step. The EBA provides guidelines on whether or not to consider post-filed evidence. The new PI proceedings After the EBA ruling, BMS filed another interim relief proceedings against Sandoz and against Centrafarm. BMS requested the PI Judge to grant a PI against both generic companies, alleging infringement of the NL part of EP 415 and the related SPC. The key question was whether the G2/21 decision changed the position taken in the earlier preliminary judgement given on 10 May 2022 and what the standard of plausibility should be in the Netherlands for taking into account post-published evidence. According to the Provisions Judge, the G2/21 decision does not change the application of the concept of plausibility, as the EBA embraces the consistent line of case law of the Technical Boards of Appeal. Therefore, the PI request of BMS is dismissed. BMS also filed interim relief proceedings against Teva before the same Provisions Judge, requesting a PI against Teva. In this case the Parties agreed that a judgement should be rendered identical to the judgment of 17 May 2023, so that all cases could subsequently be heard in the same appeal proceedings. The Provisions Judge rejected the PI against Teva on the same grounds as expressed in his  decision of 17 May 2023. The main considerations of the CoA The key question in the interim relief appeal proceedings is which criteria should be applied in order to decide whether or not post-published evidence can be accepted to hold a patent claim inventive (ab initio plausibility or ab initio implausibility) in light of the decision of the EBA in G2/21. Unlike the Provisions Judge, the CoA holds the patent inventive. It finds that the post-published evidence can be taken into account. According to the CoA, the sole criterion in G2/21 for taking into account a technical effect when applying the PSA is 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. This entails that it is not obliged that the patent application always needs to provide ‘’proof’’ or needs to make plausible that the technical claimed effect actually occurs. This needs to be filled in on a case-by-case basis. The CoA refers to par. 77 of G2/21 to stress that the admission of post-published evidence is different in assessing inventive step when compared to assessing sufficiency of disclosure. The circumstances of the apixaban case imply that on the priority date the average person skilled in the art could derive from the application, WO 652, that apixaban has the most advantageous effect as an fXa inhibitor. Therefore, the criterion as described in G2/21 has been met. The patent application disclosed more than a mere verbal statement of the technical effect so there is no reason for the skilled person in the art to doubt that the function of apixaban (an improved fXa inhibitor) could not be achieved (ab initio implausibility). There is no requirement that any evidence to that effect should be included in the application. The CoA stated that in the final relief proceedings in France and Norway, the Courts came to a similar conclusion based on the same reasoning. It is remarkable that the CoA explicitly considers the decisions of these countries as highly persuasive to the detriment of the UK High Court and Appeal Court decisions, which it distinguishes as being made on the basis of assessing sufficiency of disclosure. The CoA points out (sections 3.21-3.24) that in many countries invalidity proceedings have been instituted, some of which have been decided, others are pending, two of which in NL.