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 - 16 August 2024 - is below:

INDIA

Supreme Court sets aside Court of Appeal Order.

On 2 August 2024, the Supreme Court of India issued an Order in Novartis AG & Anr (Novartis) v Natco Pharma Limited (Natco) which set aside the judgment of 24 April 2024 rendered by a Division Bench of the High Court of Delhi.

The judgment of the Division Bench arose in an appeal against a judgment of Single Judge Hari Shankar dated 13 December 2021. By his order at first instance, which was impugned in appeal, the Single Judge had granted an interim injunction against Natco for prima facie infringing Novartis’ patent to eltrombopag olamine (IN 233161), the salt form of eltrombopag found in Novartis’ commercial product (Revolade®). It is believed that this was one of the first PIs ever granted on a salt patent in India.

On appeal, the Division Bench had set aside parts of the Single Judge’s Order. Natco had challenged the basis of the order on a number of grounds, including (i) an allegation that the olamine salt was not eligible for patent protection under the notorious section 3(d) of the Indian Patents Act and (ii) an allegation that the earlier eltrombopag compound patent, by covering the olamine salt within its scope had prior disclosed it. The Division Bench heard the appeal over multiple hearings between February and July 2022 but did not deliver a judgment in a timely manner. On 21 May 2023, IN 233161 expired, upon which the still pending appeal proceedings became infructuous. Nevertheless, in November 2023, Natco pressed for a re-hearing, citing new case law which had arisen in the interim and the re-hearing took place over a number of occasions between November 2023 and March 2024. The Division Bench finally rendered its decision on 24 April 2024, overturning the PI.

As the patent had expired while the matter was pending before the Division Bench, the Supreme Court concluded that it had been unnecessary for the Division Bench to enter upon a detailed review on merits, since the injunction which had been issued by the Single Judge was no longer in force. Accordingly, the Supreme Court set aside both the judgment of the Division Bench dated 24 April 2024 as well as the judgment of the Single Judge dated 13 December 2021. It also stated that both the orders cannot be used as precedents. The main proceedings between the parties will now continue, notwithstanding the patent’s expiry, in order to assess potential damages.

UPC

Vienna Local Division denies access to documents.

In contrast to the order of The Hague Local Division we recently reported on (see Irides Weekly Update 31 2024), on 12 August 2024, the Vienna Local Division denied a third party’s request for access to documents in UPC_CFI_33/2024, prioritising the protection of ongoing proceedings and personal data under Art. 45 UPCA over transparency. The applicant was a competitor of the claimant, and its products were alleged to infringe the Slovenian part of the claimant’s European Patent. Due to a similarity between the applicant’s products and the defendant in these UPC proceedings, it argued it had a direct interest in access to information relating to the validity of the patent in suit.

The Court held that, unlike decisions and orders, written pleadings and evidence are protected by GDPR and can only be viewed upon a reasoned request. The Court deemed there to be a higher threshold for access to documents prior to a decision being reached in proceedings. In this situation, the applicant must have a legal interest in the information that requires access in order to protect their interests. However, the request for access may fail due to the balancing of interests under data protection law and also due to the protection of the integrity of the proceedings if the protected confidentiality interests are to be considered more important than such research by the applicant. In this case, the Court held that the applicant did not need to access the statement of claim to assess whether its product fulfilled the features of the patent in suit, and that the applicant did not assert a legal interest in the access to documents. Therefore, its application was denied.

This decision can be seen as a further instance of the Local Divisions of the UPC being influenced by their national traditions.

UPC

Court of Appeal rejects 10x Genomics’ application to reopen proceedings in 10x Genomics v NanoString.

On 6 August 2024, the Court of Appeal issued its judgment in relation to 10x Genomics’ application for a retrial of proceedings in 10x Genomics v NanoString (UPC_CoA_335/2024). 10x Genomics contested the Order of the Court of Appeal on 26 February 2024 on the basis of serious procedural errors, based on an alleged fundamental violation of the right to be heard in the proceedings. The Court of First Instance issued an Order in the preliminary injunction proceedings that Nanostring must refrain from any infringement of EP 4108782 (EP 782). Nanostring appealed against this and the Court of Appeal set aside the Order on 26 February 2024. On 24 April 2024, 10x Genomics filed a motion to reopen the proceedings.

10x Genomics argued that there had been a violation of the principle of a fair trial because the Court of Appeal had ignored the basic procedural requirements regarding the burden of presentation and proof. It argued that although the Court of Appeal relied on its own expertise and a party expert opinion, the expertise of individual members of the panel is not evidence provided for by the RoP. In doing so, 10x Genomics contended that the Court of Appeal had based its decision on facts which were neither submitted by the parties nor introduced into the proceedings by order of the court. 10x Genomics contended that this constituted a fundamental violation of Art. 76(2) UPCA. Further, it argued that the Court of Appeal had deviated from the basic requirements of the RoP for the provision and collection of evidence in its decision-making and disregarded the mandatory rules on the burden of presentation and proof. They submitted that this also constituted a violation of the principle of a fair trial (Art. 6 of ECHR). 10x Genomics further submitted that the Court of Appeal had inappropriately made an assessment of costs as neither the UPCA nor the RoP contain a legal basis for making a ruling on costs in summary proceedings. As the question of costs in summary proceedings had never been addressed by the Court of Appeal, nor had it been discussed by the parties in the written pleadings, there was a violation of Art. 6 ECHR. Nanostring argued that there was no violation of any regulations on the burden of proof and the gathering of evidence. Further, the costs award made by the Court of Appeal was not objectionable and was in accordance with r.242.1 RoP.

In reacting its decision, the Court of Appeal examined whether the requirements laid down in Art. 81(1) UPCA and r. 245 - r. 249 RoP were met. It ruled that the application was not admissible as the contested order did not suffer from a fundamental procedural error. The essence of 10x Genomics' request for a retrial was that the phrase "In the judgement of the court with technical expertise" in the Court of Appeal's Order should be understood to mean that the Court of Appeal used the personal opinion of one (or more) of its judges as evidence of Nanostring's submission, for which Nanostring did not provide sufficient supporting evidence. The Court of Appeal disagreed with 10x Genomics’ position for the following reasons: (i) the opinion was based on an incorrect understanding of the phrase "In the judgement of the court with technical expertise". The Court had expressed that it was particularly equipped and qualified to assess the arguments and evidence presented in a technically complex matter; (ii) the Court of Appeal based its assessment of inventive step not only on the submissions of 10x Genomics and Nanostring, but also on the description of EP 782 and the evidence adduced by Nanostring; and (iii) the Court of Appeal did not base its reasoning on the personal opinion of one or more of its judges.

In relation to costs, it noted that r. 118.5 RoP does not preclude the Court of Appeal from deciding on the apportionment of costs in summary proceedings. Therefore, there was a legal basis for the costs award. The fact that 10x Genomics refrained from using the opportunity provided to make submissions on a costs order in its defence and at the hearing did not oblige the Court of Appeal to discuss the issue with the parties. Furthermore, the fact that it was not discussed in the absence of a response from 10x Genomics did not mean that 10x Genomics was not afforded a fair hearing.

UPC

Düsseldorf Local Division rules a confidentiality order can limit number of persons with access to protected information.

On 8 August 2024, the Düsseldorf Local Division issued a confidentiality order in 10x Genomics v Curio (UPC_CFI_140/2024). The parties had already faced each other in summary proceedings in which the Court had issued orders on 11 March 2024 and 22 March 2024 to protect the Curio’s confidential information. Curio then filed a statement of defence in the main proceedings and also sought the protection of information that it considers to be confidential. According to Curio, the Court of Appeal had held that a r. 262A RoP order continues to apply after the proceedings unless the order states otherwise. Curio submitted that the same reasoning applies to the infringement action. In the alternative, it asked that if the Court considered that a new r. 262A RoP order is necessary, a confidentiality order access to the statement of defence and exhibits to the same conditions as in the Order of the Düsseldorf Local Division of 11 March 2024 should be granted.

10X Genomics argued that the legal framework does not require that the access of 10x Genomics’ legal representatives and their internal assistants to be limited to a certain number of named persons. It sought access to the Statement of Defence and exhibits to be extended to the following persons: (i) its legal representatives, insofar as they are authorised UPC representatives, and their internal support staff, if they are actively working on the proceedings; and (ii) three natural persons working for the Claimant. Alternatively, the circle of persons already granted access to the Statement of Defence and exhibits, should be extended to 5 additional individuals. Curio did not respond to 10x Genomics’ submissions.

The Court ruled that Art. 9(1) and (2)(a) of Directive (EU) 2016/943 provides that access to documents submitted by the parties or third parties containing trade secrets may be restricted to a limited number of persons. The protection of confidential information is provided for in Art. 58 UPCA and implemented in r. 262A RoP. Further, the confidentiality orders issued in the previous summary proceedings do not preclude an order under r. 262A RoP in the main proceedings. It also noted that the orders already made in the summary proceedings continue to have effect even after the conclusion of those proceedings. It considered that the group of persons granted access must be selected in such a way that the party affected by the preliminary order for the protection of confidential information is fully able to work and is in a position to comment on the merits of each point raised by the opposing party, taking into account the confidentiality interests of the opposing party. Therefore, in summary proceedings, it may be necessary to widen the circle of persons who have access to confidential information from the outset and even before the confidentiality order is issued.

The Court stated that it is important to strike a balance in summary proceedings between the applicant’s interest in expediting the proceedings, the right to be heard and the confidentiality interest of the party applying for the order. This may lead to a different confidentiality order from that which would have to be made in the main proceedings. It considered that the Mannheim Local Division rightly pointed out that there is normally no reason to limit the access of claimant’s representatives to a certain number, or even to UPC representatives, and their internal assistants, who must also be named. Where the Düsseldorf Local Division had ordered such a restriction in the past, this was due to the specific situation in the summary proceedings. However, the teachings of r. 262A.6 RoP cannot be ignored. Therefore, the number of representatives granted access to the confidential information should not be "unlimited" or "indeterminable" and effective protection of confidential information requires clear accountability.

The Court ruled that access to the statement of defence and exhibits should be restricted to (i) two legal representatives and their teams, actively involved in these proceedings, including other attorneys-at-law, patent attorneys and support staff, and (ii) a list of employees of 10x Genomics. The Order also outlines the obligations of members of the confidentiality club, including restrictions on use and disclosure, and the potential for penalties in case of breaches.

EL SALVADOR

New IP Law approved.

On 8 August 2024, the Legislative Assembly of El Salvador approved the new "Law on Intellectual Property", which unites in a single body the current "Law on Trademarks and Other Distinctive Signs" and the 1993 "Law on Intellectual Property", and creates the Salvadoran Institute of IP.

Key updates for patents include an express prohibition on the patenting of new uses for already patented products or processes, and the inclusion of an expressly defined Bolar Exemption.