Regeneron Pharmaceuticals, Inc. & Anor v Alvotech HF & Anor

In so far as they are relied on for making for export outside the UK and EU, both notifications failed to provide marketing authorisation (“MA”) reference number(s) for the intended territory of export (Japan). This is the “Export Issue”. No Japanese MA number was publicly available at the date of either Notification, and, by the time it was available, there was less than three months left to SPC expiry. This objection applies to both Notifications, and it was not argued that the Second Notification remedied it; and

The First Notification was not made in the name of a “maker” that is “established in the United Kingdom”: the “Maker Issue”. This alleged shortcoming, which the Defendants did not accept to be correct, is accepted by the Claimants to have been remedied by the Second Notification.

Manufacturers outside the EU located in a country where there was no SPC (or similar exclusive right) could make a drug and export it to another country (I will call this the “export country”) where again there was no SPC or similar exclusive right (or at least no valid exclusive right that would be infringed – see below). Manufacturers inside the EU could not do that because the SPC (in EU member states where there was one) would be infringed. So, EU companies were at risk of being disadvantaged when it came to competing for sales in the export country.

On the expiry of an SPC in the EU, manufacturers in the EU could not start to sell effectively on “day 1” (the first day after expiry) because they would not have had a chance to make any stock, as to do so would have infringed the SPC during its life. Manufacturers outside the EU could stockpile, by contrast, and import freely and effectively into the EU on day 1. So again, EU companies were at risk of being disadvantaged.

The general principles of European interpretation were set out in Srl Cilfit v Minister of HealthCase 283/81 [1982] ECR 3415, where the Court of Justice gave the following guidance on the interpretation of directives:

“20.

Finally, every provision of Community law must be placed in its context and interpreted in the light of the provisions of Community law as a whole, regard being had to the objectives thereof and to its state of evolution at the date on which the provision in question is to be applied.”

In IDT Card Services [2006] EWCA Civ 29, the Court of Appeal considered the principles of interpreting of domestic legislation implementing European directives. Having cited the above paragraphs from Cilfit at [69] of its judgment, it explained the significance of the travaux and the objectives of the statute at [70]-[71]:

“70.

When European Union legislation has to be examined, the courts often have no difficulty in finding that the meaning is clear on any basis. The English courts have with practice also become accustomed to looking at the travaux préparatoires and asking advocates to produce them. They are also becoming more accustomed to looking at a few of the different language versions of directives. However, the guidance in the Cilfit case is not always easy to apply. The number of different language versions that the court can examine is limited. The court also rarely has the benefit of decisions on European Union legislation in other member states […]

71.

On the other hand, the Cilfit case makes a point that is of particular importance on this appeal, and that is that the court should have regard to the objectives of the legislation. English statutes rarely contain statements of their objectives because they are often found not to be reliable guides to the detailed points of interpretation that tend to arise on English statutes. However European Union directives frequently have long preambles setting out the purposes or reasons for the measures and what it is intended to achieve. This point is an indication that the objectives of a measure have a greater normative force under Community law than they would under English law.”

Tools to aid the purposive interpretation of European legislation include the terms of the legislation, including its preamble, the preparatory documents, the usual meaning of expressions used, comparison of different language texts of the instrument, and the purpose and general scheme of the legislation (RTL Television v NLM [2004] 1 CMLR 5 at [97]-[99]).

If a local marketing authorisation, or the equivalent of such authorisation, in a specific third country, for a given medicinal product, is published after the authority is notified, the notification should be promptly updated to include the reference number of that marketing authorisation, or the equivalent of such authorisation, as soon as it is publicly available. If the reference number of that marketing authorisation, or the equivalent of such authorisation, is pending publication, the maker should be required to provide, in the notification, that reference number as soon as it is publicly available.

For reasons of proportionality, failure to comply with the requirement regarding a third country should only affect exports to that country, and exports to that country should, thus, not benefit from the exception provided for in this Regulation. It should be the responsibility of the maker established in the Union to verify that protection does not exist or has expired in a country of export, or whether that protection is subject to any limitations or exemptions in that country.

Since the adoption in 1992 of the predecessor to Regulation (EC) No 469/2009, markets have evolved significantly and there has been huge growth in the making of generics and especially of biosimilars, and in the making of their active ingredients, in particular in countries outside the Union (‘third countries’) in which protection does not exist or has expired.

The absence in Regulation (EC) No 469/2009 of any exception to the protection conferred by the certificate has had the unintended consequence of preventing makers of generics and biosimilars established in the Union from making generics and biosimilars in the Union, even for the purpose of export to third-country markets in which protection does not exist or has expired. Likewise, makers are prevented from making generics and biosimilars for the purpose of storing them for a limited period before the expiry of the certificate. Those circumstances make it more difficult for those makers, in contrast to makers located in third countries where protection does not exist or has expired, to enter the Union market immediately after expiry of the certificate, given that they are not in a position to build up production capacity for the purpose of export or for the purpose of entering the market of a Member State until the protection provided by that certificate has expired.

Those circumstances put makers of generics and biosimilars established in the Union at a significant competitive disadvantage in comparison with makers based in third countries that offer less or no protection. The Union should strike a balance between restoring a level playing field between those makers and ensuring that the essence of the exclusive rights of holders of certificates (‘certificate holders’) is guaranteed in relation to the Union market.

The timely entry of generics and biosimilars into the Union market is important, particularly in order to increase competition, to reduce prices and to ensure that national healthcare systems are sustainable and that patients in the Union have better access to affordable medicines. The importance of such timely entry was underlined by the Council in its conclusions of 17 June 2016 on strengthening the balance in the pharmaceutical systems in the Union and its Member States. Regulation (EC) No 469/2009 should, therefore, be amended so as to allow the making of generics and biosimilars for export and storing, while bearing in mind that intellectual property rights remain one of the cornerstones of innovation, competitiveness and growth in the internal market.

The aim of this Regulation is to promote the competitiveness of the Union, thereby enhancing growth and job creation in the internal market and contributing to a wider supply of products under uniform conditions, by allowing makers of generics and biosimilars established in the Union to make in the Union products, or medicinal products containing those products, for the purpose of export to third-country markets in which protection does not exist or has expired, thereby also helping those makers to compete effectively in those third- country markets. This Regulation should also allow such makers to make and store products, or medicinal products containing those products, in a Member State for a defined period pending the expiry of the certificate, for the purpose of entering the market of any Member State upon expiry of the corresponding certificate, thereby helping those makers to compete effectively in the Union immediately after protection has expired (‘EU day-one entry’). This Regulation should also complement the efforts of the Union's trade policy to ensure open markets for makers of products, or medicinal products containing those products, established in the Union. Over time, this Regulation should benefit the entire pharmaceutical sector in the Union, by allowing all players, including newcomers, to reap the benefits of the new opportunities opening up in the fast-changing global pharmaceutical market. Furthermore, the general interest of the Union would be promoted given that, by reinforcing Union- based supply chains for medicines and by allowing storing with a view to entry into the Union market upon expiry of the certificate, medicines would become more accessible to patients in the Union after the expiry of the certificate.

In those specific and limited circumstances, and in order to create a level playing field between makers established in the Union and third-country makers, it is appropriate to provide for an exception to the protection conferred by a certificate so as to allow the making of a product, or a medicinal product containing that product, for the purpose of export to third countries or of storing, and any related acts in the Union strictly necessary for that making or for the actual export or the actual storing, where such acts would otherwise require the consent of a certificate holder (‘related acts’). For instance, such related acts could include: possessing; offering to supply; supplying; importing; using or synthesising an active ingredient for the purpose of making a medicinal product; or temporary storing or advertising for the exclusive purpose of export to third-country destinations. That exception should also apply to related acts performed by third parties who are in a contractual relationship with the maker.

By limiting the scope of the exception to making for the purpose of export outside the Union or to making for the purpose of storing, and to acts strictly necessary for such making or for the actual export or the actual storing, the exception provided for in this Regulation should not conflict with the normal exploitation of the product, or the medicinal product containing that product, in the Member State in which the certificate is in force, namely with the core exclusive right of the certificate holder to make that product for the purpose of placing it on the Union market during the term of the certificate. In addition, that exception should not unreasonably prejudice the legitimate interests of the certificate holder, whilst taking account of the legitimate interests of third parties.

Effective and proportionate safeguards should apply in relation to the exception in order to increase transparency, to help the holder of a certificate enforce its protection in the Union and check compliance with the conditions set out in this Regulation, and to reduce the risk of illicit diversion onto the Union market during the term of the certificate.

This Regulation should impose an information obligation on the maker, namely the person established in the Union, on whose behalf the making of a product, or a medicinal product containing that product, for the purpose of export or storing, is carried out. It is possible that the maker directly carries out the making. That information obligation should consist of requiring the maker to provide certain information to the competent industrial property office, or another designated authority, which granted the certificate (‘the authority’) in the Member State where the making is to take place. A standard form for notification should be provided for this purpose. The information should be provided before the making of a product, or a medicinal product containing that product, starts for the first time in that Member State, or before any related act prior to that making, whichever is the earlier. The information should be updated as and when appropriate. The making of a product, or a medicinal product containing that product, and the related acts, including those performed in Member States other than the one of making in cases where the product is also protected by a certificate in those other Member States, should only fall within the scope of the exception where the maker has sent the notification to the authority of the Member State of making, and where the maker has informed the holder of the certificate granted in that Member State. Where making takes place in more than one Member State, a notification should be required in each of those Member States. In the interests of transparency, the authority should be required to publish, as soon as possible, the information received, together with the date of notification of that information. Member States should be allowed to require that notifications, and updates to notifications, be subject to the payment of a one-off fee. That fee should be set at a level which does not exceed the administrative cost of processing notifications and updates.

The maker should also inform the certificate holder, through appropriate and documented means, of the intention to make a product, or a medicinal product containing that product, pursuant to the exception, by providing the certificate holder with the same information as notified to the authority. That information should be limited to what is necessary and appropriate for the certificate holder to assess whether the rights conferred by the certificate are being respected, and should not include confidential or commercially sensitive information. The standard form for notification could also be used to inform the certificate holder, and the information provided should be updated as and when appropriate.

This Regulation is without prejudice to other intellectual property rights that could protect other aspects of a product, or a medicinal product containing that product. This Regulation does not affect the application of Union acts that aim to prevent infringements, and facilitate enforcement, of intellectual property rights, including Directive 2004/48/EC and Regulation (EU) No 608/2013 of the European Parliament and of the Council.

Since the objective of this Regulation, namely to promote the competitiveness of the Union, in a manner that creates a level playing field for makers of generics and biosimilars in relation to their competitors in third- country markets in which protection does not exist or has expired, by laying down rules enabling the making of a product, or a medicinal product containing that product, during the term of the corresponding certificate, and also by providing for certain information, labelling and due diligence obligations for makers that use those rules, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

Although this is not expressly stated in the wording of the Regulation, according to the spirit and purpose of the Amendment Regulation 2019/933, which is intended to allow the export to third-country markets where there is no protection or protection has expired (recital 8), the making of a product or a medicinal product containing this product for the purpose of export to a third country that is not without protection is to be regarded not only as an infringement of the patent or certificate protection effective in that third country, but also as an infringement of the relevant protection certificate according to Regulation 469/2009 (v. Czettritz/Kau GRUR-Prax 2018, 396 (397).

If the maker, when making for third countries of export, does not provide to the authority and the certificate holder the reference number of the marketing authorisation, or the equivalent of such authorisation, for one or more third countries of export, as soon as this is available, the privilege of making can not be claimed with respect to these third countries of export, Art. 5 (7) of Regulation 469/2009. Conversely, a violation of the information obligation according to Art. 5 (5) a)-d) of Regulation 469/2009 does not result in the loss of the privilege of making. Yet the certificate holder can assert this obligation in court, and if adjudicated, can enforce it by compulsory execution according to Sec. 888 ZPO [German Code of Civil Procedure].

All the courts, including the German court, held that the ordinary meaning of Art. 5 is not what the Claimants say. I agree with this.

The German court said that the purposes of the Amendment Regulation nonetheless led to a conclusion in line with what the Claimants argued before me.

The relevant purpose relied on by the German court was the ability of the SPC owner to enforce its exclusive right in the export territory. The Dutch and Belgian courts disagreed with this, and I also disagree, for reasons given above.

The Defendants said that the German court made a mistake about the legislative history/intent of the Amendment Regulation, in that the court thought that the requirement for the maker to notify the SPC owner of the countries of intended export was removed from the legislation only for simplicity and that such information was not really confidential. The Claimants accepted that was a mistake. Below, I conclude that it was a material mistake which vitiates the reasoning appreciably.

The Claimants retaliated by arguing that the reasoning of the other courts consistently muddled up the export waiver with the storage waiver. In my analysis below I reject that.

According to the wording of Article 5(2)(b) of Regulation (EC) No. 469/2009, it is not necessary for the number of the marketing authorisation to be available for each third country of export when the information is conveyed. According to the intention and purpose of the Regulation, however, derogation in Art. 5 of the Regulation must be interpreted restrictively to the effect that the manufacturer cannot invoke this if it has not conveyed the authorisation number for at least one country and has not declared to which third country an export is to take place. (marginal note 17) (key point of judgement)

It is true that the wording of Article 5 of Regulation (EC) No. 469/2009 makes no distinction between third countries with and without existing intellectual property rights. Instead, only third countries are mentioned, in general terms. From the recitals of the Regulation, however, the objective arises that an export should only take place to third countries without conflicting property rights. (marginal note 20) (key point of judgement)

[…]

The manufacturer cannot benefit from the privilege of Art. 5 of Regulation (EC) No 469/2009 if an authorisation number has not been conveyed for any third country and it has not been declared to which third country the export is to be made. (marginal note 26) (key point of judgement)

3 In a notification to the Applicant and the German Patent and Trade Mark Office dated 31/05/2023, received by the Applicant on 07/06/2023, the Defendant stated its intention to produce a biosimilar of ... in Germany for export to third countries. The Defendant did not provide an authorisation number, nor did it explain to which third countries the export was to take place. No application has been made for marketing authorisation in a third country. The Applicant then made its request in the proceedings. (the file for which has been consulted by the Chamber) by letter dated 30/06/2023, for the issuance of an interim injunction, whereby the Defendant shall be prohibited from producing.... ... The Defendant then sent a further notification dated 27/07/2023 to the German Patent and Trade Mark Office and the Applicant and changed the production purpose from "export and storage" to "storage" with regard to the original notification dated 31/05/2023. Subsequently, the parties unanimously declared procedure ... to be completed.

4 In a notification to the Applicant and the German Patent and Trade Mark Office dated 23/08/2023 (Annex PM1), the Defendant again stated its intention to produce a biosimilar of ... in Germany for export to third countries. In turn, the Defendant did not provide an authorisation number, nor did it explain to which third countries the export is to take place. No third-country authorisation has thus far been applied for.

15 2. The Defendant cannot validly make use of the manufacturing privilege under Article 5(2)(a(i) and (ii) of Regulation (EC) No 469/2009 on supplementary protection certificates for medicinal products (as amended by Regulation (EU) 2019/933 amending Regulation (EC) No 469/2009) because it has neither conveyed an authorisation number nor has it declared to which third country the export is to be made.

[…]

17 Pursuant to Article 5(5)(e) of the Regulation, it is a prerequisite that the manufacturer convey the number of the marketing authorisation or something equivalent to this authorisation in each third country of export as soon as it becomes publicly available. It is true that, according to the wording of the provision, it is not necessary for the authorisation number to be available at the time the information is conveyed, in accordance with Article 5(2)(b) of the Regulation. According to the intention and purpose of the Regulation, however, derogation from Article 5 of the Regulation must be interpreted restrictively to the effect that the manufacturer cannot invoke this if it has not conveyed the authorisation number for at least one country and has not declared to which third country an export is to take place.

19 The aim of amending Regulation 2019/933 (hereinafter also referred to as the Regulation) is to promote the competitiveness of the European Union by allowing manufacturers of generics and biosimilars to manufacture - in the EU - medicinal products and products for export to the markets of third countries in which there is no protection or in which protection has expired (Recital 8 of the Regulation). Contrary to the opinion of the defendant, the purpose of the Regulation is not to fully equate manufacturers within the EU with manufacturers in third countries and that European manufacturers should at all times be able to produce biosimilars and generics that infringe a protective right, largely without restriction. Looking at the Regulation as a whole, its aim is rather to achieve an appropriate balance between the conflicting interests of the IPR holder and the manufacturer and to allow only a selective exception in the event of export to third countries free of intellectual property rights.

20 In particular, the Regulation seeks only to enable exports to those third countries without protective rights. Although the wording of Article 5 of the Regulation, as the Defendant rightly notes (Reply, marginal note E.2.2), is makes no distinction between third countries with and without existing property rights. Rather, the only reference made is to third countries in general. However, recitals 3, 4, 8, 29 and 30 each state the objective that exports should only take place to third countries without conflicting property rights. Recital 18 further clarifies that the manufacturer should make sure that there is no protection in an export destination country. Finally, it follows from recitals 4 and 5 of the amending Regulation that the derogation in Article 5 of the Regulation is intended to eliminate competitive disadvantages for manufacturers in the EU with respect to manufacturers in third countries where no protection exists. However, this competitive disadvantage exists only with regard to third countries in which there are no conflicting intellectual property rights. In third countries, however, in which intellectual property rights are opposed, manufacturers may not act in any case, so that there is no threat of discrimination against manufacturers in the European Union in this respect.

[…]

22 According to the stated protective purpose of the Regulation, the three-month period referred to in Article 5(2 (b) of the Regulation is to be applied, contrary to the opinion of the Defendant (Reply to application, marginal note 10.2), not only for the purpose of enabling the IPR holder to check whether the requirements of the Regulation have been complied with and, in particular, whether there is a risk of the products being diverted to the EU market. However, in the opinion of the Chamber, the three-month period is also intended to make it possible for the IPR holder to check whether a market authorisation has been granted in the intended third country of export and whether export to the designated third country is authorised. Otherwise, it would be incomprehensible why Article 5(4)(e) of the Regulation requires that the authorisation number be conveyed at all. This understanding is also supported by recital 15, in which the following is expressly stated.

"This information should be limited to what is necessary and appropriate to enable the certificate holder to assess whether the rights conferred by the certificate are being complied with (...)"•

[…]

25 Contrary to the opinion of the Defendant, it does not follow from recital 18 that the manufacturer alone is responsible for compliance with intellectual property rights in the third country. All that is clarified is that the manufacturer is responsible for ensuring that there is no conflicting protection in the third country. Thus does not mean however that the IPR holder's legal protection options are limited. The Defendant has not demonstrated and it is also not clear why the IPR holder would have to accept the generally prohibited production of the product and should only be referred to a claim for legal protection in the third country concerned. In particular, the IPR holder would hardly have the option of obtaining a ban on production within the European Union by resorting to the courts in a third country. In this respect, the right to effective legal protection (Article 47 of the Charter of the Fundamental Rights of the European Union) also requires that the IPR holder must in principle be able to defend itself, within the EU, against the potential infringement of an IPR by the production of a product, even if it is intended for export to a third country.

26 cc) It follows from this that the manufacturer cannot claim the privilege of Article 5 of the Regulation if an authorisation number has not been conveyed for any third country and no explanation has been given as to which third country the export is to take place, as this is the only way for the IPR holder to check whether the export to the third country is contrary to an IPR. Whether - in accordance with the opinion of the claimant (Reply, marginal note 40) - it is imperative that the manufacturer has provided an authorisation number for at least one third country, or that it is sufficient to state to which third country the export is intended, can be omitted, because the Defendant has not provided any further information on the intended export.

27 If it were sufficient for the manufacturer, as in the present case, to merely convey the intention to manufacture without any information on the intended country of export, the purpose of the three-month period would be (too) easily undermined. The manufacturer could commence manufacturing after the three-month period and submit the application in the third country. Since there is no explicit obligation to give notice of the application in the third country, it could convey the authorisation number at a later date, after receiving the authorisation, and enter the third country’s market directly. Under certain circumstances, the IPR holder would only be informed of this at the time it entered the market and would not have sufficient opportunity to examine whether the imminent market entry in the third country precludes IPRs. It would also be deprived of the possibility of effective legal protection, because it would only be able to take action against production and export as well as distribution in the third country after market entry if it were not a third country free of intellectual property rights. At this point, however, the risk that already completed facts would have been created by production and distribution would have been realised and the damage (usually difficult to repair) would have occurred. According to the Defendant's understanding, the mere announcement of the production for the purpose of export would ultimately be sufficient to claim the manufacturing privilege. However, this contradicts Article 5(5)(e) of the Regulation, which as a rule provides for the notification of the authorisation number.

28 The Chamber’s view is also supported by the comparison with Article 5(2)(a)(i) of the Regulation. In Article 5(2)(a), the Regulation distinguishes between two cases in which, in exceptional circumstances, use is permitted despite the existing intellectual property right: on the one hand, in (a)(i) and (ii) production for the purpose of export or related actions, and on the other hand, in (a)(iii) and (iv) production of products in order to place them on the market in the Member States following expiry of the certificate (day 1 market entry), or related actions. In principle, storage of the products is only permitted at the earliest six months before the expiry of the protection certificate in accordance with Article 5(2)(a)(iii) if the intention is to place the products on the market in a Member State following expiry of the protection certificate. In the case of production for the purpose of export, however, storage is permitted only in accordance with Article 5(2)(a)(i) and (ii) insofar as this is absolutely necessary for the actual export. Even if a specific time frame is not mentioned in this respect, this means - contrary to the opinion of the Defendant (Reply to marginal note 21.3.1) - unlike lit. a) iii), that, in any event, longer-term storage is not permissible. Production for long-term storage in stock is therefore not covered by the manufacturing privilege if the manufacturer only has the general intention of exporting the products to a third country, but it has not even been determined to which specific third country the export is to take place. On the other hand, such long-term storage would be at risk were the manufacturer to commence production three months after notification without knowing and/or having made appropriate (regulatory) arrangements as to the specific third country to which the export is to take place.

29 The Chamber does not overlook the fact that Article 5(5)(e) of the Regulation only provides for notification of the authorisation number "as soon as it is publicly available". Moreover, in the legislative procedure, the obligation provided for in the fourth revised proposal of the Council, 15777/18, to designate the third country of export in the absence of an authorisation (see Annex rop13 in the procedure ... P. 21), no longer included in the final text of the amending regulation. Further, in contrast to the original amendment proposed by the Commission, COM(2018) 317 final, the text of the Regulation no longer provides for notification of a provisional list of the third countries to which the product is to be exported (see Annex ROP10 in the procedure . p. 19). However, in the Chamber’s view, the aim of the amendments made within the framework of the legislative procedure was to simplify the obligation to notify the national patent authority, but not to impair the examination rights of the IPR holder. It follows from the legislation that identification of the country of export is essential in order to assess whether the conditions for effective use of the derogation are met (as stated in the fifth revised Council proposal, 5130/19, Annex ROP14 in the procedure ... p. 5). Although the consideration of trade secrets of the manufacturer that are worthy of protection is also one of the objectives of the Regulation to be observed (cf. recital 15; first revised proposal of the Council, 12514/18, Annex rop11 in the procedure ... P. 3; fourth revised Council proposal, 15777/18, Annex rop13 in the procedure ... P. 4) As a rule, however, no sensitive trade secrets are disclosed through the mere notification of the intended third country of export. In addition, in accordance with Article 5(4)(e), the Regulation generally provides for the notification of the authorisation number. This also follows from Annex I of the Regulation, which contains a standard notification form in accordance with Article 5(2)(b) and (c) of the Regulation and provides for the notification of the authorisation number under (e). The Regulation itself therefore assumes that the implicit notification of the export destination country is a prerequisite for use of the manufacturer's privilege and, in this respect, attaches greater importance to the interests of the IPR holder in the knowledge of the export destination country than to the interest of the manufacturer in the confidentiality of the country of export.

2.8. On 24 October 2023, Samsung Bioepis submitted a notification within the meaning of Article 5(2)(b) of the SPC Regulation to the Danish and the Italian authority respectively in copy to Janssen, in which Samsung Bioepis announces that it intends to manufacture and stockpile its biosimilar in Denmark and Italy, respectively:

- for exports to third countries (the manufacturing-for-export waiver ex Art. 5(2)(a), under i and ii, SPC Regulation);

Janssen first argues that Samsung Bioepis in its notifications must mention the reference number of the marketing authorisations granted in the export countries in order to obtain a valid manufacturing waiver. However, it does not follow from the Manufacturing Waiver Regulation [i.e., the Amendment Regulation] that at the time the manufacturer makes the notification ex Art. 5(2)(b) Manufacturing Waiver Regulation, it must already be granted a marketing authorisation in the country to which it wants to export. According to the text of the regulation, the manufacturer only has to provide the reference number of the marketing authorisation or the equivalent of such authorisation in each third country of export, as soon as it is publicly available. This means, in the preliminary opinion, that if this number is not yet publicly available, the manufacturer has the option to supplement the notification with the reference number of the marketing authorisation as soon as that is publicly available, as evidenced by Article 5(5)(e) Manufacturing Waiver Regulation.

The European legislator thereby gave the manufacturer the opportunity to make the notification at the time that it does not yet have a marketing authorisation and to provide the reference number later as soon as it has obtained this number, which in practice is equal to the time when the licence was granted to it. This is also stated in so many words in the recitals under no. 17:

"If a local marketing authorisation, or the equivalent of such authorisation, in a specific third country, for a given medicinal product, is published after the authority is notified, the notification should be promptly updated to include the reference number of that marketing authorisation, or the equivalent of such authorisation, as soon as it is publicly available. If the reference number of that marketing authorisation, or the equivalent of such authorisation, is pending publication, the maker should be required to provide, in the notification, that reference number as soon as it is publicly available.”

The establishment history shows that this has been deliberately chosen with the aim of allowing manufacturers located in the EU to compete fairly with manufacturers located outside the EU who can (also) start manufacturing biosimilars before a marketing authorisation has been granted. It also opted for a clearly defined information obligation whereby manufacturers do not have to provide certificate holders with company confidential or commercially sensitive information.

In addition to the fact that it follows from the literal wording of the Manufacturing Waiver Regulation that the marketing authorisation does not yet have to be granted at the time of the notification, this is also not necessary, contrary to what Janssen argues, to be able to determine the properties of the biosimilar in order to determine whether it falls under the scope of protection of a patent/SPC in a third country. After all, these properties are often already known after phase III clinical trials and it follows from the legal requirements for biosimilars that the Summary of Product Characteristics (SmPC) must largely correspond to the reference medicinal product in question.

The fact that the manufacturer can only submit a notification as referred to in Article 5(2)(b) Manufacturing Waiver Regulation after the marketing authorisation has been granted, as Janssen argues, (and thus can only start manufacturing three months after that) does not follow from the regulation and also does not relate to the purpose of the regulation, namely the creation of a level playing field so that manufacturers located in the European Union can effectively compete with manufacturers outside the European Union. In this context, the Preliminary Relief Judge notes that the European legislator with regard to the EU stockpile waiver acknowledges that the possibility of day-one entry is important in order to be able to compete effectively (recitals under 8). It is not clear why this would be different in order to compete effectively in countries outside the EU. In this context, it is also important that Samsung Bioepis, by stating the intended export countries, enables Janssen to check whether patent or SPC rights still apply in the respective country and whether it can initiate proceedings about this, as can be explained below.

The Landgericht München considered that the manufacturing-for-export waiver should be interpreted restrictively in the sense that the notification must give the reference number of a market authorisation before the manufacturing-for-export waiver can be invoked. In this context, the Landgericht found:

[…]

In the English translation:

“The Chamber does not fail to recognize that Article 5 para. 5 lit. e) of the Regulation only provides for the notification of the marketing authorization number "as soon as it is publicly available". Furthermore, in the legislative procedure the obligation to name the third country of export in the absence of a marketing authorization, which was still provided for in the fourth revised Proposal of the Council, 15777 /18 (see exhibit rop13 in proceedings 21 O 8059/23, p. 21), was not included in the final text of the Amending Regulation. Also, in contrast to the Commission's original Amending Proposal, COM(2018) 317 final, the wording of the Regulation no longer provides for the notification of a provisional list of third countries to which the product is to be ex-ported (see exhibit rop10 in proceedings 21 O 8059/23, p. 19). However, in the view of the Chamber, the amendments made during the legislative procedure were intended to simplify the notification obligation towards the national patent authority, but not to impair the examination rights of the property right holder.”

The Preliminary Relief Judge does not find any support in the history of the Manufacturing Waiver Regulation for the consideration that the requirement to mention the export countries in the notification was removed with the aim of simplifying the notification obligation. In this context, reference is made to the comments to the Third revised proposal, which states:

“Information to the SPC holder aims to provide the latter with the information needed to enforce its SPC. It should not contain commercially sensitive information relating, for example, to export countries, as this could potentially have the unwanted effect of negatively affecting competition.”

and the Fourth revised proposal, which states:

“Most diverging views have been expressed on the requirement to notify third country export destinations (point (f) of Article 5(3)). This point, therefore, has now been re-engineered, to essentially remove confidential and sensitive details of future export intentions. Instead, the maker must now provide the reference number of the corresponding market authorization (or equivalent) obtained in the third country of export in respect of a given medicinal product, so that the country in question is identifiable.”

The removal of the requirement to mention the export countries in the notification appears to be motivated by concerns about having trade secret information provided by manufacturers and not by the wish to simplify the notification procedure.

In addition, Janssen argues that Samsung Bioepis may not manufacture a biosimilar under the manufacturing-for-export waiver because the countries to which it wants to export them are not “rights free”. However, no requirement follows from the Manufacturing Waiver Regulation that no relevant patent rights apply in the intended export countries and/or that the manufacturer must demonstrate this in advance. For the question whether manufacture is permitted under the manufacturing waiver, this is not necessary for the time being. If the manufacturer subsequently opts to market the biosimilar in a third country where patent rights apply, it is up to the patent/certificate holder to file infringement proceedings in that country if necessary.

Although Janssen rightly argues that in the considerations (3, 4 and 8) of the DCCP, reference is made to “biosimilars intended for export to third countries where there is no protection or where said protection has expired”, the Preliminary Relief Judge does not infer from that that the intention of the European legislator was that manufacturing under this waiver would only be permitted if no relevant (patent) rights apply in the export countries. After all, the literal wording of the provisions of the DCCP does not include such a requirement. Moreover, it would be contrary to the objective of the Manufacturing Waiver Regulation to achieve a level playing field with global competition, if manufacturers based in the EU could only manufacture for export to countries that are “rights-free”, because they are then seriously disadvantaged compared to competitors based outside the EU who are not bound by such restrictions. After all, this would mean that the European manufacturer, unlike a competitor in a country where there is no (or no longer) protection, could only start manufacturing the medicinal product concerned after the patents in the export country have expired or been revoked. The manufacturing of medicinal products, and certainly biosimilars, as Samsung Bioepis has argued undisputedly, takes considerable time (six months or more). The explanation proposed by Janssen would effectively make day-one entry impossible and thus undermine the purpose of the Manufacturing Waiver Regulation.

According to SB, this requirement does not imply more or less than that a reference number must be communicated at the time that this is publicly available, and it is not clear anywhere that the manufacturer must already have a marketing authorisation in the intended country of export at the time of the notification, or at the start of the manufacturing. According to Janssen, it is evident, on the other hand, that the manufacturer must already have a marketing authorisation at the time of the notification, or at the latest at the start of the manufacturing. With reference to Article 5(2)(b), 4 and 7 of the SPC Regulation, recitals 17 and 18 of the MW Regulation [i.e., the Amendment Regulation] and the establishment history and objective of the MW Regulation, Janssen argues that the three-month period of Article 5(2)(b) of the SPC Regulation is intended to enable the SPC holder to check whether the requirements for the waiver have been met and whether the intended country of export is free of rights before the start of manufacturing, so that the SPC holder can start proceedings if necessary. According to Janssen, this objective would not be achieved if the notification is made long before a marketing authorisation is issued, manufacturing is started and a stock is created, since the SPC holder can only assess based on the marketing authorisation whether the maker actually intends to enter the market in the export country and whether in the export country there is a risk of an infringement of the exclusive rights of the SPC holder. The risk of diversion of products to the Union market would be enormous without a marketing authorisation. According to Janssen, the provision that the reference number of the marketing authorisation must be specified “as soon as this is publicly available” is therefore only included in case a marketing authorisation has already been granted, but the reference number has not yet been published. Janssen also points out that manufacturing for export before a marketing authorisation is obtained requires stockpiling. The latter is not permitted under the manufacturing-for-export waiver. It also sees an indication in this that a marketing authorisation must be obtained for a valid reliance on the manufacturing-for-export waiver.

The Court of Appeal does not follow Janssen in its argument. First, the interpretation of Janssen does not find support in the wording of Article 5 of the SPC Regulation. Only Article 5(5)(e) of the SPC Regulation mentions the marketing authorisation. The only requirement of this provision is that the reference number is communicated as soon as it is publicly available. If the reference number is not yet publicly available, according to the literal wording of Article 5(5)(e) of the SPC Regulation, this does not prevent reliance on the manufacturing-for-export waiver. The wording does not provide grounds for the opinion that this is different if the reference number is not yet publicly available because a marketing authorisation has not yet been obtained.

[…]

Secondly, Janssen’s interpretation is not supported in the considerations of the MW Regulation. The requirement to provide the marketing authorisation reference number is only discussed in recital 17 of the MW Regulation. This recital states, insofar as relevant:

[omitted]

This does not show that that manufacturing may not take place if the reference number has not been provided because there is no marketing authorisation yet. This consideration also does not show that the reference number, in the eyes of the legislator, plays an essential role in the conditions for the waiver. All of this is also not apparent from any other consideration.

Thirdly, an interpretation of Article 5(5)(e) which means that at the time of the notification, at least no later than before the start of manufacturing, there must already be a marketing authorisation, is not in accordance with the purpose of the obligation to notify and the purpose of the MW Regulation. The purpose of the notification is shown from recital 15 of the MW Regulation (underlining Court of Appeal):

[omitted]

The purpose of the notification is therefore only to enable the SPC holder to verify that its rights granted by the SPC are guaranteed for the Union market, and not to verify that IP rights in force in third countries are respected. This is in line with the purpose of the MW Regulation (see recitals 6.4 and 6.5). The purpose of the 3-month period is to enable the control of those rights (and, if necessary, their enforcement). The argument of Janssen that the marketing authorisation must already have been granted before notification, or at least manufacturing, because the SPC holder can only assess based on the marketing authorisation or if the export country threatens to infringe the exclusive rights of the SPC holder that apply there, therefore fails.

Janssen’s argument that the notification becomes pointless if the maker can start manufacturing and stockpiling without it being clear whether the maker actually intends to enter the market in the intended export country, also fails. With this argument, Janssen disregards the fact that based on Article 5(5) of the SPC Regulation other information must also be provided to the SPC holder than the reference number of the marketing authorisation. This information informs the SPC holder which maker intends to manufacture in which countries under the waiver. Janssen also disregards the fact that the manufacturer must ensure, based on Article 5(8) of the SPC Regulation, that the products do not have an active unique identifier within the meaning of Delegated Regulation (EU) 2016/1617, and that the manufacturer must apply a logo on the products intended for export based on Article 5(9) of the SPC Regulation. These measures aim to prevent the diversion of the products and their entry into the Union market. According to Article 5(5) MW Regulation, the notification of Article 5(4) MW Regulation also has the purpose of enabling the SPC holder to check whether these obligations are met (see recital 6.12).

[…]

Moreover, the proposal for the MW Regulation was further amended because the European Parliament (EP) considered that mentioning an export country before the marketing authorisation reference number was publicly available was undesirable because it concerns commercially valuable confidential information. The explanation to the revised proposal for the MW Regulation of 18 February 2019 states about this: “Lengthy discussions at technical meetings were needed to convince the EP of the Councils approach of having symmetry between the information notified to the competent patent office and the information provided to the SPC holder and to explain to the EP that under the Council approach no confidential or commercially sensitive information would be disclosed and that the publication of all information given to the patent office would be in the interest of fair competition and would avoid any burden on or liability of the national offices. At the end, the EP was willing to accept the Council’s approach. However, as part of the overall compromise, one adaptation in the information to be made in the notification as regards export countries needed to be made, as a concession to the EP (). The reference to the third country of export was dropped, as the EP insisted that this would be commercially sensitive information and the EP, although it had moved a long way from its initial mandate, would not accept to include it.”

[Emphasis added by the Dutch Court in the original]

This shows that the EU legislator no longer required that the maker, if he did not already have a reference number, must provide the intended export country. This information was considered too confidential. The requirement was therefore replaced by the requirement to provide the reference number as soon as it was publicly available.

In Janssen’s explanation, the maker could only rely on the manufacturing-for-export waiver if he possesses an export license at the time of notification. SB rightly argues that this does not align with the intention of the EU legislator mentioned in the citation to reach a compromise between the desire to provide the authority and the SPC holder with equal information and the desire not to share confidential information with the SPC holder in the interest of fair competition.

After all, it would force the maker to apply for a marketing authorisation at an earlier stage (Janssen argues that SB should have done so), so that it can start manufacturing after granting it. Applying for this earlier and subsequently specifying the marketing authorisation reference number would have the same effect as the removed obligation to specify the intended export countries in the absence of a marketing authorisation reference number: competitors would become familiar with the maker’s plans at an early stage. This is contrary to the interest of fair competition explicitly mentioned by the EU legislator and the purpose of the MW Regulation to create a level playing field with competitors of third countries, who can already start manufacturing before they have a marketing authorisation (see recital 6.4) and who do not have to disclose their market strategy at an early stage. Furthermore, Janssen acknowledges that the marketing authorisation reference number usually becomes publicly available a few days and no more than a few weeks after the date it was obtained. It is not clear that the debate of the Union legislator on the confidentiality of data pertained to this short period between granting the marketing authorisation and the reference number becoming public. This is also, as SB rightly argues, an indication that the EU legislator was concerned with finding a solution to the conflicting interests of the SPC holder and the generic pharmaceutical companies in the period between the notification and the granting of the marketing authorisation.

[…]

Janssen states that the manufacturing-for-export waiver does not allow a stockpile to be created for export. In this context, it argues the following, in summary:

­ The creation of a fully level playing field as such is not an objective of the MW Regulation. The aim is to strike a fair balance between the importance of a more level playing field and the exclusive rights of the SPC holders.

­ A legal basis to allow the creation a stockpile for export is missing. Article 5(2) of the SPC Regulation permits stockpiling only for a “Day-1 entry” in the EU. Article 5(2)(a) under ii of the SPC Regulation only exempts the strictly necessary actions for actual export. This does not include stockpiling for “Day-1 entry” in third countries.

­ Recital 9 of the MW Regulation shows that temporary stockpiling necessary for actual export is permitted. This means, for example, temporary stockpiling until a container is loaded or until a carrier picks up the container. Storage until a trade permit is obtained or the intended export countries are free of rights, is not necessary for actual export.

­ Recital 11 of the MW Regulation stipulates that the manufacturing-for-export waiver may not apply to keeping products in stock for purposes other than those mentioned in the MW Regulation.

­ The Union legislator, according to the establishment history of the MW Regulation, was against keeping products in stock, due to the risk that these products would be diverted to the Union market. The Union legislator ultimately allowed stockpiling only for “Day-1 entry” in the EU. No basis can be found in the legislative history for a (wider) waiver for stockpiling for “Day-1 entry” outside the EU.

­ A “Day-1 entry” outside the EU does not exist; a maker can export as soon as they have a marketing authorisation.

­ Allowing manufacturing by SB on a larger scale than foreseen by the EU legislator is contrary to Article 52 of the EU Charter, since the (constitutional) right of the SPC holder is too limited. After all, this restriction does not meet the public interest objectives recognised by the Union and is also not proportionate, even though exceptions should in fact be interpreted in a limited manner.

SB argues against this, in summary, that the intention of the EU legislator was in fact to enable “Day-1 entry” for outside the EU. In this context, it refers to the purpose of the MW Regulation to improve the global competitive position of manufacturers in the EU. In order to be able to compete effectively in the global markets, according to SB, it is necessary to enter those markets first (the first mover effect) with generic and biosimilar medicinal products. SB states that this is only possible if the manufacturers can build up a stock. According to SB it cannot be inferred from the fact that “Day-1 entry” for countries outside the EU is not explicitly mentioned that it was not the intention to enable “Day-1 entry” outside the EU. An explanation for this is that there is no uniform “Day-1” worldwide; the “Day-1 entry dates” can be different for all countries. SB also points out that the MW Regulation does not set a maximum period for the “temporarily in stock” made possible by Article 5(2)(a) under ii MW Regulation. According to SB, the Preliminary Injunction Judge rightly interpreted this concept as maintaining a stock for a period that is customary within a normal operation.

[…]

However, the Court of Appeal derives from the objective of the MW Regulation that under the manufacturing-for-export waiver it is permitted to create a stockpile for the export, more specifically for “Day-1 entry” on the market of the intended export country. The Court of Appeal explains this as follows.

[…]

For the time being, the Court of Appeal does not deem it plausible that real competition on the global market is possible if only stockpiling of a very temporary nature is permitted, as Janssen argues (for example, temporary stockpiling pending the filling of a container or pending the transporter). Only with a stockpile is it possible to achieve a “Day-1 entry” in the intended export country and thus to actually compete with manufacturers outside the EU. It is thus consistent with the intention of the EU legislator to allow manufacturers in the EU to also maintain such stockpile for export that they can enter the intended export market on ‘Day-1’.

In contrast to the above, Janssen’s argument that the term “Day-1 entry” and “stockpiling” was only used in the context of the EU stockpiling waiver in the establishment of the MW Regulation, is not convincing. It is not clear that the Union legislator considered the possibility of a ‘Day-1 entry’ for the competitive position of makers for the Union market important, but not for the markets in third countries. It is illogical that, in Janssen’s view, SB was already allowed to create a “stockpile” for “Day-1 entry” in the EU, but not for, for example, the UK.

Janssen’s argument that “Day-1 entry” does not exist in the global market, because there is no global “Day-1” or because the market in third countries is already freely accessible to any party that wants to sell its product there and has the relevant licence, also fails. IP rights may also exist in third countries that prevent market entry. If those rights expire, a “Day-1” applies to the market of the third country concerned.

The Court of Appeal also does not follow Janssen in its argument that it is not the prohibition to stockpile, but the own timing of SB leads to that it cannot use the “first mover effect”. According to Janssen, SB should have applied for a marketing authorisation earlier. This argument disregards the fact that a valid reliance on the manufacturing-for-export waiver does not require that a marketing authorisation has already been obtained (see recital 6.21). The present case also does not affect the systematic interpretation of the exception given above.

Recital 11 of the MW Regulation does not lead to a different opinion. This consideration determines, insofar as relevant here:

() In addition, the exception should not cover any storing of products, or medicinal products containing those products, for any purpose other than those specified in this Regulation.

In the above it has already been considered that stockpiling for a “Day-1 entry” is in accordance with the purposes of the MW Regulation. There is therefore no conflict with recital 11 of the MW Regulation. For the same reason, Janssen's argument that allowing a stock for export in violation of Article 52 of the EU Charter allows manufacturing on a larger scale than foreseen by the EU legislator fails.

Finally, the Court of Appeal rejects Janssen’s argument that maintaining a stockpile for export increases the risk that products manufactured for export are marketed in the EU. The MW Regulation provides for measures to overcome this risk. The Court of Appeal refers to recital 6.13.

The conclusion is that, in the preliminary opinion of the Court of Appeal under the manufacturing-for-export waiver, SB is permitted to stockpile for the export of its biosimilar of Ustekinumab, more specifically for the purpose of “Day-1 entry” on the market of the intended export country.

The acting president, seated as in preliminary relief proceedings, determines that:

-The wording of Art. 5 of the SPC Regulation is clear regarding the information that must be provided (i.e. the list under Art. 5(5), a) through e), of the SPC Regulation) and that SB by its notification of 13 March 2024 has provided the information as listed under Art. 5(5), a) through e), of the SPC Regulation:

- This (restrictive) interpretation is also confirmed by:

Third ground: "strict necessity for the actual export"

[…]

It follows from the wording of Art. 5(2)(a) SPC Regulation as amended by the Waiver Regulation that the waiver also allows for related actions that are strictly necessary for the actual export. Recital 9 of the Waiver Regulation shows that related acts, for example, may concern the holding, offering for supply, supplying, importing, using or synthesising an active substance for the manufacture of a medicinal product containing this product, or the temporary stockpiling or advertising activities aimed exclusively at exports to destinations in third countries. The Waiver Regulation also does not provide for a maximum period for the temporary stockpiling, other than it must be strictly necessary for the actual export. In view of the objectives of the Waiver Regulation, this will be subject to a period that is customary in the normal course of business (taking into account the specificity for the manufacture of biosimilars the supply chains), as a result of which the maker is not disadvantaged compared to makers outside the EU. The time for this stockpiling is covered by the permitted related act under the waiver.

The foreign decisions

The acting president, seated in preliminary relief proceedings, took note of the two foreign decisions which also ruled on the interpretation of the Waiver Regulation and more specifically the notification requirements (i.e. the decision of 20 October 2023 of the Regional Court of Munich and the decision of 23 January 2024 of the Court of The Hague).

The Regional Court of Munich considered that the manufacturing waiver for exports should be interpreted restrictively in that the maker must indicate the reference number of the market authorisation in the notification before he can invoke the waiver. The acting president does not agree with the opinion that the requirement to mention the exporting countries in the notification has been removed from the historical origin of the provision with a view to simplifying the notification procedure.

The District Court of The Hague correctly took into account the wording of the provision in the interpretation of the Waiver Regulation, but also in the context thereof and with the objectives of the scheme, taking into account the historical origin from which it can be established that the information regarding the identity of the third countries was intentionally omitted for export in order to avoid that commercially sensitive information should be provided before public disclosure.