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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 - 02 February 2024 - is below:


Hague District Court rejects preliminary injunction sought following SPC Manufacturing Waiver notification

As mentioned in our Weekly Update 4/2024, on 23 January 2024, the Court of The Hague handed down a decision addressing the application of the SPC manufacturing waiver. Janssen had sought a preliminary injunction (PI) to prevent Samsung Bioepis (SB) from manufacturing a biosimilar ustekinumab medicine in Denmark and Italy for export outside the EU (Janssen’s Stelara being the reference product). Janssen has relevant SPCs in Denmark in Italy. The Court examined the meaning of art. 5(2)(b) of the SPC Regulation and refused Janssen’s application on the basis that SB’s export notification had been validly made. 

By way of background, SB submitted a notification under art. 5(2)(b) of the SPC Regulation to Janssen and the Danish and Italian authorities in October 2023. SB sought to rely on the notification in relation to its intention to: (1) manufacture for export to a country outside the EU; and (2) stockpile for selling within the EU following expiry of the SPCs. Janssen’s case only related to the manufacture for export aspect of the notification.

Unlike in the recent decision from the Munich Court in a case brought by Janssen against Formycon, SB specified the countries to which it intended to export (for Denmark: the UK and for Italy: Canada, South Korea and the UK), but did not provide the MA numbers, and suggested that these would follow once publicly available. Janssen disputed SB’s ability to rely on the manufacturing waiver in circumstances where the MA numbers had not been provided.  Janssen therefore sought an unrestricted injunction, or an injunction which would prevent SB from manufacturing until 3 months after the date on which SB notified the authorities and Janssen of the specific MA numbers.

The Dutch Court considered the purpose of the Regulation, namely to put European manufacturers of generic and biosimilar products on a “level playing field” with non-EU manufacturers. In relation to the failure to supply the MA numbers, the Court held that the Regulation does not require provision of the MA number at the time of the notification. The Court relied on the purpose of the Regulation as well as the literal wording of the Regulation, in both art. 5(5)(e) and recital 17, which refer to providing the MA number as soon as it is publicly available. The Court further pointed out that the Regulation recognises that time is of the essence in respect of the stockpiling exemption and the importance of generics/biosimilars companies being able to launch on day 1 after SPC expiry, and that it would not make sense if this recognition did not also apply to the manufacturing waiver for export to third countries. The Dutch Court thus disagreed with the German Court’s basis for its restrictive approach. Whereas the German Court considered that the Regulation had taken shape out of a desire by the legislators to simplify the notification procedure, the Dutch Court held that it was more properly explained by an appreciation of the need to avoid manufacturers having to disclose trade secrets.

In relation to an argument that Janssen had other relevant IP rights in the third countries which would be infringed by the sale of SB’s ustekinumab, the Court held this was not relevant under the Regulation. Were there to be infringement in such a third country, that would be a matter for resolution via proceedings in that country, if necessary. The Court was satisfied in this case, given the imminent expiry date of the SPCs and the fact that SB had started proceedings to clear the way in other territories that it was right to refuse the injunction. Furthermore, in relation to products intended for export to third countries being stored within the EU before export, the Court held that given the wording of art. 5(2)(a)(ii), products manufactured for export to outside the EU did not need to be exported immediately. It held that exactly how long would be a period as per normal business practices which would not disadvantage European manufacturers.

On this basis, the application for an preliminary injunction was refused.


The High Court of Delhi clarifies the rights of pre-grant opponents in the patent examination process

On 9 January 2024, the Division Bench, High Court of Delhi handed down its judgment holding that patent examination and pre-grant opposition processes are independent and separate.  An opponent in a pre-grant opposition does not have a right to intervene in the examination process. This judgment overturned an earlier Single Judge Bench order.

Novartis AG (“Novartis”), the appellant, was the applicant for Indian Patent Application No. IN4145184 filed before the Controller on 8 June 2007.  Natco Pharma Limited (“Natco”) among others was a pre-grant opponent.  Hearings on all pre-grant oppositions were concluded on 3 November 2022.  Subsequently, the Controller gave directions for Novartis to make certain amendments to the patent application.  The patent was then granted on 14 December 2022.  Natco complained that the order for grant was made without it being heard on the amendments, submitting that a pre-grant opponent should have the right to be represented at a hearing against both voluntary amendments and those that may have been directed by the Controller. These submissions were accepted by the Single Judge, leading to the appeal by Novartis. On appeal, Novartis argued that the opponents had filed a series of oppositions leading to the grant being delayed by more than 16 years and the Single Judge had erred in failing to bear in mind the statutory distinction between the examination procedure and pre-grant opposition.  Novartis also argued that the right to a hearing should not extend to a right to participate in proceedings originating from decisions made by the Controller to amend the application.  

In its decision, the High Court of Delhi found itself unable to support the “theory of merger” advocated for by Natco and favoured by the Single Judge, being of the opinion that the Controller must be independently satisfied that the application merits acceptance. The Court noted that both the Patent Act 1970 and the Patent Rules 2003 clearly envisage a separation between the examination process and pre-grant opposition process.  Merging the two processes would “render the entire system unwieldly and counterproductive”. The Court held that the statutory scheme is in accordance with the principles of natural justice and the rights of interested persons are sufficiently safeguarded and preserved by section 25(2) of the Act which relates to post-grant oppositions. Further, Natco’s assertions disregard the nature and extent of the pre-grant opposition process. In contrast to an adversarial process, the pre-grant opposition merely contributes to the overall assessment of the patent application and the opponent is not entitled to intervene in the broader examination process.  The Court also opined that the Controller, as well as courts, would be well advised to ensure that the examination process is not inordinately delayed or derailed by the filing of serial objections in abuse of the pre-grant opposition process.  

The examination and opposition processes, though statutorily structured to proceed in parallel, are therefore independent and separate.


Opponent files petition for review in relation to post filed data

The opposing party in T116/18 has submitted a petition for review on the basis that its right to a fair hearing has been fundamentally violated, as per art. 112a (2)(c) of the European Patent Convention (EPC). In the petition for review, the opponent in T116/18 has submitted that it was not given a chance to respond to the TBA’s version of the new plausibility test from the EBA in G2/21, as the test was introduced for the first time in the TBA's written decision, preventing the opponent from presenting its views on the test during the appeal process.  The request can be found here


Milan and UPC sign an agreement on third seat

On 26 January 2024, the Headquarters Agreement was finalised establishing the third seat of the Central Division in Milan, Italy. The seat will have responsibility for human necessities, comprising amongst other industries, the pharmaceutical and medical device industries, the agricultural industry, and the food industry.  More detail can be found here.


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