Sunday Surprises
Rose Hughes
August is supposed to be the quiet month. Somebody ought to tell the courts of Europe. In recent weeks, the same heart failure drug has had its SPC upheld in two jurisdictions on two quite different grounds of attack, the UPC has declined to wait for a French court, and a Dutch pharmacy has found where the compounding exemption stops.
Entresto twice over: UK and Greece arrive at the same place
In the first of 2 cases relating to the Novartis drug Entresto, on 8 July the Multi-Member Court of First Instance dismissed ELPEN's attack on the Greek SPC under Articles 3(a) and 3(b) of Regulation 469/2009. ELPEN argued that Novartis' product is a sodium salt complex of sacubitril and valsartan, whereas ELPEN's is a physical mixture of the two sodium salts, so the authorised and marketed products were not, on its case, the same. The court held that the product, for SPC purposes, is the active ingredients themselves, not the solid-state form in which they are delivered.
In the UK, Meade J upheld both EP (UK) 1467728 and SPC/GB16/025 in Accord Healthcare Limited v Novartis AG [2026] EWHC 2127 (Pat) on 13 August. Accord ran obviousness, lack of plausibility and collocation, and challenged the SPC separately. None of it succeeded, infringement was established, and UK generic entry is blocked until at least January 2028.
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The UPC would rather not wait (Merz v Viatris)
The Paris Local Division has declined to halt an infringement action over Merz's French SPC 13C0033, based on EP 2377536 and covering a fampridine dosing regimen marketed as Fampyra for multiple sclerosis. Viatris Santé had revocation, non-infringement and compulsory licence claims before the Paris judicial court. Rather than stay its own proceedings, the Local Division has effectively split the dispute. The national claims stay where they are and the infringement action at the UPC. Exercising its discretion under Article 30 of the Brussels I Recast Regulation, it reasoned that because the UPC aims to decide within twelve months, it would rule first anyway, so a stay served no purpose.
The statement of defence is due on 11 September 2026, with an oral hearing anticipated at the end of May 2027. The SPC expired on 25 July 2026, so what is really in play is damages.
The pharmacy exemption has edges (Novo Nordisk v Ceban)
On 5 August the District Court of The Hague granted Novo Nordisk a preliminary injunction against Ceban Ziekenhuisfarmacie over a compounded semaglutide nasal spray sold as Semanova. Ceban relied on the pharmacy exemption in Article 54c(e) of the Dutch Patent Act, covering preparation for immediate use in individual cases pursuant to a prescription, and said it supplied no more than fifty patients a month. The court was not persuaded. Ceban had imported 600 grams of semaglutide, branded the preparation, registered it in the G-Standard, held stock and resold to other pharmacies, all pointing to structural, potentially large-scale use rather than individual preparation. The court kept the regulatory and patent law exemptions apart, and read the patent exemption narrowly so as not to undermine the exclusive right. Distribution must cease, on penalties of up to €500,000.
A patient information form is a publication (Xarelto)
Finally, the Court of Appeal of The Hague revoked Bayer's EP 1845961 on a rivaroxaban dosage regimen, on Sandoz's application. Crucially, the court accepted patient information forms from a phase II trial as prior art, holding them publicly available and not confidential, and that the skilled person would have arrived at the claimed subject matter without inventive effort. Bayer may take the point to the Dutch Supreme Court, and damages proceedings from earlier preliminary injunctions remain on foot in the UK.
Posthumous IP rights in art: what the artist leaves behind
The Competition Law Association's rescheduled evening on posthumous IP rights in art will be held on Thursday 3 September, 6.00pm to 9.00pm, at Boodle Hatfield LLP, 240 Blackfriars Road, London SE1 8NW. Michael Edenborough KC and Stefano Theodoli-Braschi of Serle Court Chambers will speak on protecting creative legacies whilst enabling access. Administering an artist's estate involves far more than the physical works and the copyright in them. A statutory regime transfers economic and moral rights on death, and common law rights such as goodwill are often overlooked. The panel will also cover the pitfalls of dealing with artists' estates.
Attendance is free for CLA members, £50 for non-members, £35 for academic and public sector employees and £10 for students, trainees and pupil barristers. Registration closes on Wednesday 2 September. Anyone registered for the original April date will be re-registered automatically.
Litigation rights courses at Nottingham
Nottingham Law School has flagged the start dates of its two courses leading to litigation rights for patent and trade mark attorneys. The Intellectual Property Litigation Certificate course starts on 19 November this year. The Basic Litigation Skills course starts on 2 June 2027. Details of both are on the Nottingham Trent website.