European patent update – key decisions at the EPO and Dutch Court

We cover some recent key decisions in European patent disputes, this time in the EPO and Dutch Court.

Part 1 – T 1252/20 – Compounds falling under Art. 54 (4)(5) EPC

Relevance of the Decision

Art. 54 (4)(5) EPC allows a protection for compounds for the use in methods falling under Art. 53 (c) EPC, i.e. treatment, diagnostic and surgical methods. However, such second medical use claims are, according to standard EPC practice, not available for devices. T 1252/20 now provides further insights into the definition of such compounds, and makes clear that only the nature of the respective compound itself and not its mode of action defines whether or not second medical use protection is available. This is very relevant to the MedTech field as to the patentability and novelty of certain compositions by way of second medical use.

Decision

In T 1252/20 (decision of February 6, 2024), the Board of Appeal (BoA) ruled that question of whether a material or an object is a "substance or composition" in the sense of Articles 53(c) and 54(4) or (5) EPC should be decided, in the first place, on the basis of the claimed material or object as such. If this analysis leads to the conclusion that indeed a “substance or composition” is present, this requirement of Article 54(4) or (5) EPC is fulfilled. No additional restrictions relating to its mode of action are derivable from the EPC (reasoning, point 12, see Catchword)

In this case, the BoA overturned the decision of the Examining Division which had refused grant on the basis of lack of novelty. To the contrary, the BoA was convinced that the composition in question did qualify for a “substance or composition” and so was novel under Art. 54 (4)(5) EPC. The case will now be remitted for further prosecution on other patentability requirements.

Reasons

In the case underlying the decision, Applicant sought protection for a composition for use in reducing or eliminating cancerous cells in a subject by forming at least a partial blockage, lodging, occlusion or embolism in a blood vessel to deprive a tumor in the subject of blood supply. The “composition” in question comprised a solution comprising an amphiphilic peptide, which are applied as an aqueous solution via a catheter into a blood vessel and aggregate to form a hydrogel upon contact with body fluid. This hydrogel then blocks the blood vessel which induces necrosis of the tissue.

The Examining Division had rejected the application because the peptide solution did not qualify as a “substance or composition” in the sense of Art. 54 (5) EPC, their mode of action being purely mechanical. Accordingly, the use defined in the claim was not a limiting feature and the claim lacked novelty over the prior art (from which the hydrogels were undisputedly known).

By analysing in detail Art. 54 (4)(5) EPC and the relevant case law (especially G 5/83, T 2003/08 and T 1758/15), the BoA came to the conclusion that there is no legal basis for the mode of action as a criterion for qualifying a material or object as a substance or composition under Art. 54 (5) EPC (Item 9 of the Reasons). Interestingly, the BoA stated that the driving force behind G 5/83 was not the identification of subject-matter that had to be excluded from possible protection, but on the contrary, to confirm availability of a special protection form for such subject-matter that was seen as deserving protection but appeared to be unpatentable under the explicit provisions of the EPC 1973. Therefore, the BoA explicitly addresses the right of the Applicant if the requirements of the EPC are fulfilled, a principle which appears often to be forgotten in the current EPO practice.

In addition, the BoA also found that the use of the mode of action as the decisive criterion seems problematic for several other reasons, especially because the mode of action is often not known or may change after the substance has been administered to the body (Item 10 of the Reasons). The BoA concluded that only the nature of the material as such can be the decisive force for deciding whether it is open for protection under Art. 54 (4)(5) EPC (Item 12 of the Reasons). In this context, the BoA made also clear that protection of devices is not available under Art. 54 (4)(5) EPC.

Take home messages

Although protection of devices is still not available under Art. 54 (4)(5) EPC, this decision opens the door for second medical use claims covering the use of substances which have no chemical or biological mode of action, like surgical adhesives or fillers.

Careful claim drafting will still be required to ensure a maximal scope of protection. But this is a significant decision, especially for applicants in the MedTech field.

Part 2 – Dutch Court (Hague): SPC waiver notification was compliant and PI refused.

Relevance of the Decision

Now in its 5th year and after transitioning into force during 2022, there has been a growing number of notifications seeking to exploit Europe’s new “SPC waivers”, which enable drug manufacturing in the EU notwithstanding patent protection ongoing via supplementary protection certificate (SPCs)¹.

There are two waivers: one for manufacture for export ex-EU; and one for manufacture for stockpiling to facilitate ‘Day 1’ post expiry launch in the EU. Now the transition period is over, the former applies throughout the term of affected SPCs, but the latter applies only during the final 6 months.

As has commonly arisen and been said about Europe’s overarching laws governing SPCs, there has been considerable commentary and lobbying with respect to lack of clarity in the SPC waiver legislation, including calls (in particular by generic/biosimilar industry organisations) to reduce the burden on the manufacturers who seek to exploit the waivers. While such debates continue, and some notifications appear to have progressed without litigation, others have been more hotly disputed.

In terms of disputes, Janssen has commenced proceedings in Germany and the Netherlands claiming preliminary injunctions (PI) following notifications made by (different) biosimilar manufacturers seeking to invoke the waivers for biosimilars of Stelara®/ustekinumab.

In October 2023, the Munich District Court awarded Janssen a PI against Formycon on bases including that Formycon’s waiver notification was deficient as it did not indicate any authorisation number and/or the export country, thereby depriving Janssen of the ability of check whether such export would conflict with its other property rights.

Parallel proceedings in the Netherlands between Janssen and Samsung Bioepis (SB) - covering similar issues - were heard before the Hague Court at the end of December 2023. The Dutch court therefore was able to consider the Munich judgment in reaching its decision. SB’s notification concerned the manufacture of biosimilar ustekinumab in Denmark and Italy for export ex-EU (to UK, Canada and South Korea). Janssen’s claim in the Hague was accordingly based on the domicile of the relevant SB entity (in the Netherlands) and not the location of any activities in the Netherlands per se. This decision therefore also shows the prominence of the Dutch court as a jurisdiction in which patentees seek to pursue preliminary cross border relief in respect of acts of alleged patent infringement undertaken in other EU countries.

Decision

The Hague Court handed down judgment on 23 January 2024 and rejected Janssen’s claim for a PI; finding SB’s waiver notification to be compliant with the legislation.

This is a significant development, both for biosimilar manufacturers seeking clarity on how to make such notifications and patentees seeking to scrutinise them, in particular given its contrast to the outcome before the German courts (also now under appeal).

Reasons

The judgment summarises that Janssen had 3 main complaints with respect to SB’s waiver notification:

(1) There was no reference number for a marketing authorization granted in the export countries when the notification was made.

(2) Janssen had ongoing patent rights for ustekinumab/Stelara in the export countries, which would be infringed by import into those countries.

(3) The making-for-export waiver does not allow products destined for export to third countries to be stored in the EU before being exported.

Accordingly, as a result of these purported breaches, Janssen claimed that SB’s activities in Denmark and Italy would not qualify for the waiver and risked infringement of its SPC rights.

The Hague court rejected all of these arguments. Taking each in turn:

(1) The Hague court held that the European legislator had given manufacturers the option of making the notification at the time when it does not yet have a marketing authorization and transmitting the reference number later, once it was obtained. The court held this was clear and deliberate on the face of the legislation and its drafting history. It noted that such a requirement would also not be line with the purpose of the waiver, which was to create a level playing field so that manufacturers EU can compete effectively with manufacturers outside the EU. So on this issue in particular, it reached a different conclusion to the German court, as the Dutch judge acknowledged; mostly but not only due to variations in the facts, but also due to a wrong interpretation of the law.

(2) In relation to Janssen’s purported patent rights in the export countries, the Hague court held it was up to the patentee to bring infringement proceedings in that country (or countries) if necessary, but that the existence of such rights did not invalidate the waiver notification in the meantime. The court noted the appearance of statements to the contrary in the recitals to the legislation, but emphasised the lack of such wording in the literal wording of the operative provisions.

(3) The Dutch court accepted the arguments that the two waivers are different, but that the making-for-export waiver permitted “related acts”, including temporary storage. It noted that the Regulation did not specify a maximum period for such storage, but considered in light of the purpose of the waiver it allowed a period customary within normal business operations, which will not put the manufacture at a disadvantage compared to non-EU-based competitors. In this way, the court held that this waiver did not require export “almost immediately” as it considered Janssen to have contended.

Take Home Messages

This case, including in particular the contrasting outcome to German proceedings, shows the potential complexity in successfully interpreting and invoking the EU SPC waiver legislation, including the significant interim remedies that might otherwise be sought where parties are not aligned.

With significant reforms to EU SPC legislation already well advanced before the European Parliament, it seems unlikely that any further amendments will be introduced in the short term that might impact on the provisions of the SPC waivers. In the meantime, parties in this field should continue to monitor these cases for developments to see how national courts are interpreting the legislation as to what is and what is not acceptable. This naturally raises the questions of whether any CJEU referrals may also be expected to arise with a view to seeking clarity.

¹ Europe’s form of patent term extension to compensate patentees for loss of protection due to adherence with EU regulatory frameworks, in particular those governing human medicinal products.