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 - 13 October 2023 - is below:

EPO

EBA hands down decision on priority entitlement by joint applicants

On 10 October 2023, the Enlarged Board of Appeal issued its decision in consolidated cases G 1/22 and G 2/22. The EBA determined that the EPO has the authority to evaluate priority claims and generally assumes that an applicant claiming priority in line with the EPC's formal requirements is entitled to do so, but this presumption can be challenged. Decision here.

By way of background, TBA Board 3.3.04 referred two questions in consolidated cases T 1513/17 and T 2719/19 to the EBA, namely:

1. Does the EPC confer jurisdiction on the EPO to determine whether a party validly claims to be a successor in title as referred to in Article 87(1)(b) EPC?
    
2. If question 1 is answered to the affirmative, can a party B validly rely on the priority right claimed in a PCT-application for the purpose of claiming priority rights under Article 87(1) EPC in the case where 1) a PCT-application designates party A as applicant for the US only and party B as applicant for other designated States, including regional European patent protection and 2) the PCT-application claims priority from an earlier patent application that designates party A as the applicant and 3) the priority claimed in the PCT-application is in compliance with Article 4 of the Paris Convention?

Under art. 87(1) EPC “[a]ny person who has duly filed […] an application for a patent […] or his successor in title, shall enjoy, for the purpose of filing a European patent application in respect of the same invention, a right of priority during a period of twelve months from the date of filing of the first application”.

In the reasons for its decision, the EBA differentiated between the right to file a European patent application and the right to claim a priority date. The EPO can assess an applicant's entitlement to a priority date, as it falls under the independent law of the EPC. The presumption of entitlement exists when formal requirements for claiming priority are met, and it is justified due to the interests of the involved parties in seeking protection, the absence of formal transfer requirements in many countries under the EPC, and the support provided by the priority applicant to a subsequent applicant. This presumption would apply even when the priority applicant differs from the subsequent applicant and is not limited to PCT applications.

Additionally, the EBA deemed that the joint filing of a PCT application serves as evidence of an implied agreement between the parties involved that each should be entitled to rely on the priority deriving from an earlier application filed by only one of them, unless substantial indications suggest otherwise.

On this basis, in relation to the first question, the EBA confirmed that the EPO has the authority to evaluate priority claims and generally assumes that an applicant claiming priority in line with the EPC's formal requirements is entitled to do so, but this presumption can be challenged.

With respect to the second question, the EBA held that the rebuttable presumption extends to cases where a European patent application derives from a PCT application and when the priority applicants differ from the subsequent applicants. In the situation where a PCT application is jointly filed by parties A and B (i) designating party A for one or more designated States and party B for one or more other designated States, and (ii) claiming priority from an earlier patent application designating party A as the applicant, the joint filing implies an agreement between parties A and B allowing party B to rely on the priority claim, unless there are substantial factual indications to the contrary.

By using rebuttable presumptions that priority claims are valid, the EBA seeks to promote the interests of applicants and move away from an overly formalistic approach that may inadvertently deprive applicants of protection. Paragraph 101 of the EBA’s reasons puts it in these terms:

“Low standards for a valid transfer of priority rights not only serve the purpose of harmonisation with national laws that could be applicable instead of the autonomous law of the EPC. They serve the purpose of priority rights, namely to facilitate international patent protection, by reducing the risk that the inventors’ (or their legal successors’) interest in obtaining patent protection in multiple jurisdictions is jeopardised by formal requirements they may inadvertently fail to meet.”

NETHERLANDS

Dutch court grants preliminary injunction in respect of Nebido® drug

On 3 October 2023, the District Court of The Hague granted Grünenthal’s request for a preliminary injunction in respect of its testosterone undecanoate drug Nebido®.

Nebido® was developed by Bayer AG and is protected by EP 1 457 208 (the “Patent”) which Grünenthal acquired in 2022. The Patent relates to a formulation of testosterone undecanoate (“TU”) with castor oil and benzyl benzoate for the long-term treatment of hypogonadism (testosterone deficiency in men), and its administration in 10-to-14-week intervals via intramuscular injection. Teva was granted a marketing authorisation for a generic version of Nebido® in December 2022 (“Testosterone Teva”). Like Nebido®, Testosterone Teva is indicated for injection via a 4ml solution containing 1000mg TU in a vehicle of castor oil and benzyl benzoate at 500mg/ml. Following MA grant, Grünenthal informed Teva that launch of Testosterone Teva prior to patent expiry on 14 March 2024 would infringe the Patent, and requested confirmation that Teva would not launch during the patent term or an explanation why Testosterone Teva considered that it did not infringe.

Meanwhile, decisions were handed down by the German Federal Patent Court in February 2023, and the English Patents Court in July 2023, invalidating the Patent on the grounds of obviousness and insufficiency respectively. Following these decisions, in August 2023 Teva informed Grünenthal of its intention to advertise Testosterone Teva in the G-Standaard of October 2023 (to be published on 19 September 2023) and put it on the market shortly after.

Grünenthal applied to the court for a preliminary injunction to prohibit Teva’s launch of Testosterone Teva, on the grounds that Testosterone Teva infringed claims 1, 2, and 5-7 of the Dutch designation of the Patent. In response, Teva submitted the Patent was invalid due to lack of novelty and/or inventive step over the prior art Von Eckardstein, or lack of sufficiency across the scope of the claims, citing the judgments from the German and English courts. In interim proceedings on 13 September 2023 the Judge ordered Teva to remove Testosterone Teva from the October 2023 G-Standaard with immediate effect.

In considering the application, the Dutch court acknowledged that whilst foreign judgments should be given due respect, it would form its own judgment on validity, especially in summary proceedings. The court also noted that a different claim set was in issue in the Dutch proceedings whereby composition claim 1 was more limited, and that the test on plausibility is different in the Netherlands following the case law to date applying the EPO’s Enlarged Board of Appeal (EBA) decision in G2/21. The Dutch Court held that it does not follow from G2/21 that the patent application must contain proof that the claimed technical effect actually occurs or is rendered plausible in the application itself. The relevant question is what is required for the average skilled person to deduce from the application that the claimed technical effect was included in the technical teaching concerning that effect, and this depends on the facts.

In its provisional judgment, the court found there was no substantial chance that claim 1 of the Patent would be found invalid in proceedings on the merits of the case, and consequently ordered a PI against Teva to cease infringing activities with immediate effect.

INDIA 

Delhi High Court underscores importance of strict adherence to procedural rules in post-grant oppositions

On 4 October 2023, the High Court handed down a decision concerning the procedure for post-grant oppositions under the Patents Act, 1970, and the Patents Rules, 2003 and highlighted the significance of adhering strictly to the rules and procedures.

In September 2017, the Patent Office granted to Akebia Therapeutics Inc., a patent to an invention titled "HIF-1α prolyl hydroxylase inhibitor compounds". During post-grant opposition proceedings, Akebia contended that the Controller of Patents had not followed the proper procedure as the documents submitted by the opponent along with their post-grant opposition were not accompanied by supporting affidavits, making them inadmissible as evidence.

The Court agreed that there were procedural irregularities. Setting aside the Opposition Board’s recommendations, it allowed the documents filed by the opponent in September 2018 to be treated as evidence, provided they were supported by an affidavit that had been filed in February 2019. It also permitted Akebia to introduce additional evidence and directed that there should be a fresh review of the case by the Opposition Board, taking all evidence into account. Decision here.

COLOMBIA

Colombia issues its first pharmaceutical compulsory license

On 2 October 2023, the Ministry of Health in Colombia officially adopted the recommendation of the Inter-institutional Technical Committee and instructed the Superintendence of Industry and Commerce to begin the process for granting the first compulsory license for a pharmaceutical patent.

Available details are relatively few, but it appears that on 2 June 2023, the Colombian Ministry of Health initiated a procedure to declare public interest in patents related to the HIV/AIDS treatment drug Dolutegravir. A committee recommended the Ministry to issue a compulsory license owing to the increasing HIV/AIDS cases in Colombia and the difficulty in obtaining licenses from the relevant patent holders. However, the recommendation did not provide any evidence that patients experienced problems accessing Dolutegravir in Colombia.

The decision to issue the license appears to be based on the number of rising HIV/AIDS cases, the need for standardised treatment, and reducing treatment costs. It is still possible for the relevant patent holders to take action against this decision, such as appeals or non-compliance actions.