The Swedish pharma and life sciences litigation newsletter

PHARMA

Bayer v Sandoz, STADA, Teva, Glenmark and Viatris regarding rivaroxaban products

Patent and Market Court of Appeal Revokes Xarelto Dosing Patent

We have previously reported on the extensive Swedish litigation concerning rivaroxaban and Bayer’s dosing patent EP 1 845 961, protecting once-daily administration of rivaroxaban for the treatment of thromboembolic disorders. The first instance court upheld the patent in invalidity proceedings brought by Sandoz, and Bayer obtained preliminary injunctions against Sandoz and several other generic companies. The proceedings have attracted considerable attention given the commercial importance of Xarelto (rivaroxaban) and the parallel disputes ongoing in numerous other jurisdictions.

The dispute has now taken a decisive turn. Recent developments in Germany — where the Federal Patent Court in Munich revoked the German part of EP 961 for lack of inventive step — demonstrate that the position is evolving across Europe. The German decision was reportedly influenced by material from the so-called “Einstein” clinical study. Sweden has now also reached a similar outcome.

PMCA Reverses Course and Revokes EP 961 in Sweden

In a recent and significant ruling, the Swedish Patent and Market Court of Appeal (PMCA) has overturned the first instance judgment in Sandoz’s revocation action and declared EP 961 invalid in Sweden.

Admission of the Einstein Material on Appeal

A central procedural and substantive issue concerned material from Bayer’s above-mentioned Phase II “Einstein” study. This documentation — including a patient information and consent form, as well as a decision by a Swedish ethics review board approving the study — had not formed part of the record at first instance.

On appeal, however, Sandoz succeeded in having this material admitted, despite the general restriction against introducing new facts and evidence at the appellate stage. This constituted an important procedural victory for Sandoz.

The PMCA first examined whether the Einstein documents formed part of the prior art. Bayer argued, inter alia, that patients who received the consent form were in a special relationship with Bayer in its capacity as study sponsor and therefore did not constitute members of the public. The Court found no support for the view that the patients were bound by confidentiality or otherwise subject to obligations restricting disclosure. As regards the ethics approval decision, the Court held that it became publicly available when it was formally issued. The PMCA therefore dismissed Bayer’s objections and concluded that the Einstein documentation formed part of the prior art.

Novelty: “Works Quickly” and Rapid-Release Tablets

On novelty, the PMCA held that the claimed invention was not directly and unambiguously disclosed by the Einstein material. Although the documents disclosed most features of the claimed once-daily dosing regimen, the key issue was whether they disclosed the use of a rapid-release tablet.

The consent form stated that the medicine “works quickly”, but did not expressly refer to a rapid-release formulation. The PMCA observed that it would appear somewhat strained to describe a prolonged-release tablet as one that “works quickly”, and that the expression would most naturally be understood as referring to a rapid-release tablet. At the same time, the documentation left some room for interpretation, not least because it did not specify whether the tablet had to be swallowed whole. The Court therefore concluded that the Einstein material did not disclose the claimed subject-matter in a novelty-destroying manner. The same applied to the ethics approval decision.

Inventive Step: A Broad Assessment of the Clinical Evidence

The decisive issue was inventive step. In its analysis, the PMCA adopted a broad and inclusive approach to the prior art, rather than limiting itself to a strict single-document starting point.

Importantly, the Court did not treat the Einstein material as the closest prior art. Instead, it started from an earlier multiple-dose study conducted by Bayer and published before the priority date (the “Kubitza” study), in combination with a scientific poster (the “Harder poster”) summarising results from another rivaroxaban study. The inventive step assessment was then carried out against that background, taking into account additional prior art, in particular the Einstein documents.

Against this overall framework of clinical findings, the PMCA assessed the expectations of the skilled person. Rivaroxaban had been tested in various doses administered once and twice daily. Therapeutic effects had been observed at lower doses, and higher doses had not resulted in bleeding complications. Data on half-life and residual pharmacodynamic effects were also available.

According to the PMCA, these results indicated that rivaroxaban had a relatively broad therapeutic window and that its anticoagulant effect persisted for a considerable time, despite what had initially been regarded as a relatively short half-life. Data concerning thrombin generation — reflecting the anticoagulant effect of rivaroxaban — also pointed towards suitability for once-daily administration.

Although some of the measurement methods underlying the Harder poster data were not yet fully established, the PMCA held that the skilled person would not have disregarded the reported conclusions, particularly given that the study had been conducted by leading researchers in the field.

The Harder poster reported a half-life approximately twice as long as that stated in the Kubitza study and concluded that certain parameters indicated a prolonged pharmacodynamic effect, supporting once-daily dosing. The Court considered these findings highly relevant to the skilled person’s assessment of dosing frequency.

The Einstein material reinforced this assessment. Through the ethics approval decision, the skilled person would have been aware that Bayer had progressed to a Phase II study investigating once-daily dosing. The consent form expressly stated that the purpose of the study was to determine the optimal dose for once-daily administration. It also referred to another study identifying an optimal dose for thrombosis prevention following hip surgery.

Taken together, the PMCA considered that the skilled person would have viewed once-daily administration as a realistic and promising approach. Starting from the Kubitza study in combination with the Harder poster, and considering the Einstein consent form and ethics decision, the skilled person would have had a reasonable expectation of success that once-daily administration of rivaroxaban in a rapid-release formulation would constitute a safe and effective treatment for thromboembolic disorders.

On that basis, the PMCA concluded that the claimed dosing regimen lacked inventive step. The patent was therefore declared invalid in Sweden.

---

PHARMA

Biogen v Sandoz, Viatris, Neuraxpharm and Glenmark over dimethyl fumarate products

EPO Board of Appeal revokes Biogen’s dimethyl fumarate dosage patent

We have previously reported in this newsletter on Biogen’s successful enforcement of its patent against dimethyl fumarate (DMF) products marketed by Sandoz, Viatris and Neuraxpharm in Sweden. Biogen obtained preliminary injunctions against all three companies, thereby preventing generic competition with the originator product Tecfidera, an oral therapy containing DMF for the treatment of relapsing-remitting multiple sclerosis (RRMS).

The injunctions were based on European patent EP 2 653 873, which concerns the dosage regimen of the product. The patent claims a pharmaceutical composition comprising DMF or monomethyl fumarate (MMF), administered orally in a daily dose of 480 mg, for the treatment of multiple sclerosis, in particular RRMS.

We have also reported on the Swedish court’s dismissal of attempts by the generics to clear the way through a revocation action.

Most recently, in our September 2025 issue, we noted that Biogen had secured a preliminary injunction against Glenmark as well. This was achieved notwithstanding that the patent had been limited in ongoing opposition proceedings before the EPO. The Opposition Division upheld the patent in amended form on the basis of an auxiliary request, limiting it to the treatment of RRMS. The Swedish court held that Biogen was entitled to rely on a presumption of validity for the patent as amended and maintained by the Opposition Division.

The dispute has now taken a different turn. In November 2025, a Board of Appeal of the EPO revoked the patent in its entirety. As a matter of substantive patent law, the Swedish preliminary injunctions were therefore wrongly issued and based on a patent that has now been found invalid.

Although the Board has not yet issued its written reasons, the minutes of the oral proceedings indicate that the patent was revoked for added matter. This is of particular interest, as the issue appears to concern a question that had previously been examined – and rejected – by the Swedish Patent and Market Court (PMC).

Before the PMC, the claimants argued that the patent contained impermissible claim amendments resulting from selections made from multiple separate lists in the application as filed. The alleged selections concerned the specific daily dose (480 mg/day), the active substance (DMF), and the medical condition (multiple sclerosis, MS). According to the claimants, the combination of these features was not directly and unambiguously disclosed in the original application.

The PMC did not accept that analysis. On the contrary, it held that most of the amendments identified by the claimants could not be regarded as selections at all, and concluded that the amendment was, in essence, based on a selection from a single list relating to the daily dose. On that basis, the Court found that the claimed subject-matter could be derived from the application as filed.

The issue before the Board of Appeal appears to have been framed in similar terms. The minutes suggest that the Board focused on the combination of three central features: treatment of MS, use of DMF or MMF, and a daily dose of 480 mg. In contrast to the Swedish court, however, the Board appears to have concluded that there was no explicit disclosure of that specific combination, and that no implicit disclosure could be identified that constituted a direct and unambiguous consequence of an explicit disclosure in the application as filed when read with the eyes of the skilled person.

It would probably go too far to draw any general conclusion from this case that Swedish courts apply a systematically more patentee-friendly approach to added-matter assessments than the EPO Boards of Appeal. Nevertheless, the case illustrates that even where the same legal standard – direct and unambiguous disclosure – is applied, different tribunals may reach different conclusions as to whether a particular combination of features is clearly and unambiguously derivable from the original filing.

---

PHARMA (Regulatory)

Novartis v STADA over nilotinib SmPC carve-out and marketing authorisation

Swedish court addresses nilotinib “apple sauce” carve-out

A number of recent cases in Europe have addressed nilotinib and the so-called “apple sauce patent” (EP 2 501 384), relating to a method of administering nilotinib to patients with swallowing difficulties. Now, a Swedish judgment from late last year provides further guidance on how the carve-out mechanism may apply to patented methods of administration.

Nilotinib, marketed by Novartis as Tasigna, is an anti-cancer medicinal product primarily used in the treatment of chronic myelogenous leukaemia (CML). It is supplied in capsule form and should be taken on an empty stomach, as food intake may increase the risk of adverse effects. The patent in question covers, in essence, dispersion of capsule contents in apple sauce for patients who are unable to swallow capsules.

Administrative Court of Uppsala: carve-out accepted

In November 2025, the Administrative Court in Uppsala ruled on the marketing authorisation for Nilotinib STADA in Sweden.

The Swedish Medical Products Agency had granted marketing authorisation for Nilotinib STADA with Tasigna as the reference medicinal product. The summary of product characteristics (SmPC) for Tasigna includes information on an alternative method of administration: patients with swallowing difficulties may open the capsules and disperse the contents in apple sauce.

STADA removed this information from its SmPC. Instead, the SmPC stated that patients with swallowing difficulties should use another nilotinib-containing medicinal product. The omission reflected the existence of the above-mentioned apple sauce patent.

The Medical Products Agency nevertheless granted the marketing authorisation. Novartis appealed the decision. Under Swedish case law, the holder of the marketing authorisation for the reference product has standing to challenge the approval of a generic product.

Public health assessment and interpretation of EU law

The main issue before the Court was whether the application for Nilotinib STADA met the regulatory requirements relating to the SmPC, given that it did not include the same alternative administration instructions as Tasigna.

The Court first examined whether the difference could give rise to a serious risk to public health. It found no basis for such a conclusion. The Court noted that the SmPC for Nilotinib STADA clearly stated that patients with swallowing difficulties should use another medicinal product. That information was considered sufficient.

The Court then considered whether the carve-out was compatible with EU pharmaceutical legislation, in particular Regulation (EC) 726/2004 and Directive 2001/83/EG.

As a general rule, the SmPC of a generic medicinal product must correspond to that of the reference product in all relevant respects. However, it is not necessary to include parts of the reference SmPC that relate to indications or dosage forms still protected by patent.

The Court observed that the instruction to mix capsule contents with apple sauce constitutes an alternative method of administration rather than a separate indication or dosage form. On a literal reading of the legislation, the carve-out exception would therefore not appear to apply.

The Court nevertheless emphasised that the purpose of the carve-out mechanism must be taken into account. According to the case law of the Court of Justice of the European Union (CJEU), the exception aims to ensure that market entry of generics is not delayed until all patents protecting different indications or dosage forms of the reference product have expired.

In the Court’s view, the same rationale applies where a patent protects an alternative method of administration. Disallowing a carve-out in such circumstances would not be consistent with the objectives of the regulatory framework, particularly where the patented feature is more limited than an indication or a dosage form.

The Court also noted that the European Commission had granted marketing authorisation for Nilotinib Accord with a corresponding SmPC excluding the apple sauce administration.

The Court therefore dismissed Novartis’ appeal. Novartis had requested that a referral be made to the CJEU, but the Court found that a reference was not necessary.

Novartis has appealed the decision to the Administrative Court of Appeal. We will continue to monitor and report on further developments.

---

PHARMA

Bayer v Mylan over sorafenib product

Patent and Market Court of Appeal Upholds Revocation of Bayer’s Sorafenib Patent

We previously reported, in our September 2024 issue, on the dispute between Bayer and Mylan concerning EP 2 305 255, titled “Aryl Urea Compounds in Combination with Other Cytostatic or Cytotoxic Agents for Treating Human Cancers”. The proceedings were brought before the Swedish Patent and Market Court (PMC) and concerned Mylan’s sorafenib product.

Bayer initiated infringement proceedings in October 2022. Mylan responded with a counterclaim for invalidity. Although the PMC granted a preliminary injunction against Mylan in November 2022, the injunction expired shortly thereafter when the patent term came to an end. The case therefore ultimately focused on validity and potential compensation for alleged infringement during the patent term.

The dispute centred on claim 12 of the patent, directed to the tosylate salt of sorafenib as such, without limitation as to administration route or therapeutic indication. Bayer also relied on amended claims limited to oral administration and use in cancer treatment. Mylan challenged the patent on the grounds of added matter and lack of inventive step.

At first instance, the PMC rejected the added matter objection. The Court found that the application as filed disclosed the tosylate salt in isolated form and not exclusively in the context of combination therapies. Claim 12 therefore did not constitute an impermissible intermediate generalisation. On inventive step, however, the PMC reached the opposite conclusion. The prior art disclosed sorafenib in free base form, and Bayer relied on post-published comparative data to demonstrate improved solubility and bioavailability of the tosylate salt. Applying the principles developed in EPO case law following T 116/18 (G 2/21), the PMC accepted that improved solubility could be taken into account. Nevertheless, the Court held that salt screening was standard practice and that the skilled person would have included tosylate among pharmaceutically acceptable salts to be tested. The claimed salt was therefore considered obvious. The amended claims did not alter that conclusion. Bayer appealed.

PMCA: No Change on Appeal

The Swedish Patent and Market Court of Appeal (PMCA) has now delivered its judgment — and the outcome remains unchanged.

The PMCA first addressed added matter. It made no different assessment from that of the PMC. As the appellate court observed, the isolated tosylate salt was disclosed in several passages of the description without being directly and inextricably linked to combination therapy. Claim 12 therefore did not constitute an impermissible generalisation.

As regards inventive step, the PMCA expressly endorsed the reasoning of the first instance court. Referring to the detailed analysis in the PMC’s judgment, the appellate court concluded that claim 12 of EP 255 lacks inventive step and that the patent, as granted, is invalid in Sweden.

Bayer’s auxiliary requests — limited to the tosylate salt for oral administration and to its use in cancer treatment by oral administration — did not alter the assessment. In short, Bayer was not able to overturn the first instance decision. The revocation of EP 2 305 255 in Sweden therefore stands.

---