Irides: Weekly patent litigation update

The Irides Weekly Update is our round-up of patent litigation news highlights from around the world. Taking its name from the plural of “iris” - a nod to the ability of Irides to see what’s happening around the world.

Our latest edition - 26 January 2024 - is below:
 

GERMANY

Munich Regional Court Rules on Biosimilar SPC Infringement

On 20 October 2023 (in a decision that has recently become available), the Munich Regional Court decided in favour of granting an interim injunction against an alleged infringement of a Supplementary Protection Certificate (SPC) whilst considering the SPC manufacturing waiver.

By way of background, Janssen holds an SPC which protects its product Stelara until 20 July 2024. Formycon has created FYB202, a biosimilar version of Stelara, and plans to manufacture in Germany. The SPC Regulation allow for manufacturing in the EU within the SPC term,subject to specific conditions. This provision is part of Reg. (EU) 2019/933, implemented in 2019, which amends the earlier SPC Regulation (Reg. EC/469/2009). Formycon notified Janssen and the German Patent and Trade Mark Office (GPTMO) of its intention to manufacture the biosimilar product in Germany for export to a non-EU Member State during the term of the SPC. Formycon did not provide a marketing authorisation number for that third country, or specify to which country the export was to take place.

Janssen sought an interim injunction on the basis that Formycon could not rely on the SPC manufacturing waiver because it had not provided an authorisation number for the country of export. Formycon argued that this was not a requirement of the SPC Regulation.

The German Court held that Formycon could not rely on the manufacturing waiver because it had neither provided an authorisation number nor declared the third country to which export was to be made.

The court held that whilst the purpose of the SPC Regulation is to promote the competitiveness of the EU as a manufacturing hub, it is not intended to put EU manufacturers on a completely equal footing with non-EU manufacturers.

Subsequently, a correction issued on 19 December 2023 aimed to rectify clerical and factual errors in the original judgment.
 

STOP PRESS | NETHERLANDS

Hague District Court also rules on PI for Stelera

We understand that on 24 January 2024, the District Court handed down its decision following a hearing in December refusing the interim injunction to Janssen in relation to Samsung Bioepis’ biosimilar product. More details to follow in a future edition of Irides.
 

MALAYSIA

The Intellectual Property Corporation of Malaysia launches IPR Marketplace

On 18 January 2024, the Intellectual Property Office (MyIPO) launched a platform where inventors can list their inventions for the purposes of being viewed by prospective collaborators. The platform aims to bridge the gap between the latest inventions and commercialisation. IP owners can list patents for licensing and sale.
 

SPAIN

Barcelona Court interprets the EBA decision in G2/21 to invalidate apixaban compound patent

On 15 January 2024, the first instance Commercial Court of Barcelona found ES 2 329 881 (“ES 881”) invalid for lack of inventive step and lack of sufficiency.  ES 881 protects the factor Xa inhibitor apixaban, sold by Bristol-Myers Squibb and Pfizer as Eliquis®, and is the Spanish validated part of EP 1 427 415.  In EPC contracting states, this places Spain in line with the United Kingdom where the patent has been held invalid up to the Court of Appeal, but contrary to Sweden, Norway and France, where the patent has been found valid.

Teva challenged the validity of ES 881 on three grounds: i) that ES 881 was not entitled to priority as BMS was not the successor in title of the priority document, and that there was novelty-destroying intervening prior art; ii) that ES 881 was insufficient; and iii) that ES 881 lacked inventive step.  The Barcelona Court did not address the first ground given it had invalidated ES 881 on the second and third grounds.

The court first considered the allegation of insufficiency, and followed the comments of the EBA in G2/21 on second medical use claims. The EBA stated that for second medical use claims, proof of the claimed therapeutic effect must be provided in the application as filed.  BMS argued that these comments were obiter dicta, but the court disagreed in the sense that this conclusion was well supported by TBA case law.  Given the application as filed (“WO 652”) lacked any proof of the technical effect for apixaban, any second medical use claims would be invalid.  Claims 7 to 29 were formulated as Swiss form claims, and were therefore invalidated. However, the compound per se claims and first medical use claims were not insufficient.

The court addressed the lack of inventive step allegation against the remaining claims via the problem-solution approach. The parties were agreed that the closest prior art was a patent application (“WO 131”) which disclosed a class of compounds including apixaban, but without an individual disclosure.  The court then sought to determine the technical effect of this difference. BMS argued that this technical effect was a new factor Xa inhibitor with improved pharmacological properties.  Applying G2/21, the court formulated the question as whether the skilled person would consider this technical effect covered by the technical teaching and embodied by the same invention as WO 652.

The court carefully reviewed WO 652 to discern its teachings.  It found that there was no clear indication of apixaban being the preferred compound, no disclosure that it had been tested in a factor Xa assay, and that even if it had been, that it met the potency criteria set by WO 652.  Accordingly, it concluded that the skilled person would not consider BMS’ proposed technical effect to be covered by the technical teaching and embodied by the same invention as WO 652.  Given this, it found the objective technical problem to be the provision of an alternative factor Xa inhibitor.

The court then followed the well-established line of TBA case law that there is no invention in simply choosing a different compound (see for example T 488/16 Dasatinib), and so found there to be no inventive step.
 

UPC

Irish UPC Referendum to be held June 2024

On 23 January 2024, Irish Enterprise Minister Simon Coveney gained Cabinet permission to draft the bill for the Unified Patent Court referendum, and wording of the proposed referendum can now be prepared. The Government plans to hold this referendum at the same time as local and European elections between the 6th and 9th June 2024. More information can be found here.