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 - 25 August 2023 - is below:
Court of Appeal grants BMS preliminary injunction on apixaban compound patent
Court of Appeal grants BMS preliminary injunction on apixaban compound patent. On 15 August 2023, the Court of Appeal of the Hague granted BMS’ request for a preliminary injunction against Sandoz, Stada, and Teva on the basis of EP 1 427 415 ("EP 415") and its associated SPC, which protects the compound apixaban, used in the treatment of thromboembolic disorders. In doing so, the Court of Appeal overturned the decision of the first instance court which had refused the preliminary injunction. The merits proceedings are due to be heard by the Court of the Hague on 13 October 2023.
BMS started preliminary relief proceedings against Sandoz in April 2022. On 10 May 2022, the Court of the Hague refused the preliminary injunction on the basis that there was a substantial chance that validity of EP 415 would not be upheld on the merits because the invention had not been made plausible, and thus there was no inventive step. BMS did not appeal this decision.
Subsequently, the Enlarged Board of Appeal of the EPO issued its decision in G2/21, which concerned plausibility, on 23 March 2023. Stada and Teva announced that they intended to launch their generic apixaban product on 1 May 2023 and 1 June 2023 respectively. BMS then started preliminary relief proceedings against Stada and Teva. It also started new preliminary relief proceedings against Sandoz arguing that the decision in G2/21 represented a change in the law that was of fundamental importance. The first instance court again refused the preliminary relief against Sandoz and Stada on 17 May 2023, and against Teva on 31 May 2021. BMS appealed those decisions.
The Court of Appeal characterised BMS’ appeal as arguing that the first instance court’s interpretation of G2/21 was incorrect. It therefore carried out its own analysis of G2/21. It found that the only requirement imposed by G2/21 for being allowed to take into account a technical effect when assessing inventive step, was whether the skilled person can derive from the patent application that the claimed technical effect is encompassed by the technical teaching, and embodies the same invention disclosed in the patent application. This requirement does not mean that the patent application must already include evidence that the claimed technical effect actually occurs. The Court of Appeal also noted that the test for sufficiency, which applies when the technical effect is explicitly claimed, does require evidence of the claimed effect, and therefore the test for inventive step cannot be subject to the same condition.
The Court of Appeal then applied this analysis to EP 415; if the skilled person could derive from the application that apixaban was a promising inhibitor of the enzyme factor Xa then that would constitute a technical effect that could be considered for inventive step. The patent application that granted as EP 415 sets out its objective as the improved inhibition of factor Xa, provides details of assays for testing this, and includes apixaban as an example (which was made in the greatest quantity). It does not contain any information on the activity of apixaban, instead reporting that some compounds had been tested in the described assays and had an activity at or below a particular level. Based on this disclosure and the common general knowledge, the Court of Appeal found that the skilled person would consider apixaban a promising candidate, and therefore there was a technical effect for the purposes of assessing inventive step. The Court of Appeal therefore reached the preliminary opinion that the defence of Sandoz, Stada and Teva that there would be a substantial chance that EP 415 is deemed invalid by the Dutch court hearing the case on the merits due to a lack of inventive step must be dismissed.
The Court of Appeal also rejected the argument that BMS did not have any urgent interest, and therefore awarded the preliminary injunction.
The Delhi High Court on July 24, 2023 considers 'product-by-process' patent claims in Vifor International Ltd. Vs MSN Laboratories Pvt. Ltd
The Delhi High Court on July 24, 2023 considers “product-by-process” patent claims in Vifor International Ltd. Vs MSN Laboratories Pvt. Ltd. On 24 July 2023, the Delhi High Court issued a decision relating to Vifor’s “product-by-process” patent claims following an application for an interim injunction by Vifor and Emcure against MSN Labs, Dr Reddy Labs and Corona Remedies Pvt. Ltd. (a separate suit was filed by Virchow Biotech against Vifor). The Court held that that the defendants’ variants of Ferric Carboxymaltose (FCM) (used for treating iron-deficiency) did not infringe the claimant’s patent since they derived the same compound through different processes. Accordingly, the defendants are able to launch their versions of the drug.
Having first dismissed the claimant’s argument that there were no “product-by-process” claims under Indian law, the Court moved on to consider the issues in this case. The claimant’s patent contained claims for “water-soluble iron carbohydrate complexes” which were “obtainable from” a particular process. The claimant argued that this was a product claim since the language “obtainable from” simply served to highlight that the claimed process was just one of the many ways through which the “water-soluble iron carbohydrate complexes” could be produced. The Court disagreed, considering that to be categorised as a product claim, a product must be described by its composition and structure and not limited by a process. The limitations on obtaining FCM by a specified process defined in the said claim aligns it with a “product-by-process” claim. In particular, the process was a characteristic property of the claims that was used to distinguish the patent from the prior art. The Court referred to the previous positions the claimant had taken where it relied on the novelty of the process to obtain its iron carbohydrate complexes during prosecution in response to oppositions filed by various third parties.
Accordingly, Vifor’s claims were characterised as product-by-process claims with the process terms held to be limitations to, and not additional features of, the rights granted to it.
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