The Swedish pharma and life sciences litigation newsletter

PHARMA

Biogen v Glenmark over dimethyl fumarate product

Biogen secures preliminary injunction against Glenmark in Sweden.

Biogen has long enjoyed exclusivity for Tecfidera, an oral therapy containing the active substance dimethyl fumarate (DMF) for the treatment of relapsing-remitting multiple sclerosis (RRMS). Here in Europe, disputes have been reported between Biogen and generic manufacturers in, inter alia, France, the Netherlands and Germany, with varying outcomes.

The dispute has also reached Sweden, where it centres on Biogen’s patent EP 2 653 873 B1 (EP 873). The patent claims a pharmaceutical composition comprising the active ingredient DMF or monomethyl fumarate (MMF), administered orally in a daily dose of 480 mg, for the treatment of multiple sclerosis (or, specifically, RRMS, see below).

In December 2024, Glenmark brought proceedings before the Swedish Patent and Market Court (PMC) seeking revocation of EP 873 in order to clear the way for its generic DMF product. In April 2025, Biogen responded by initiating infringement proceedings against Glenmark.

In parallel, opposition proceedings concerning EP 873 were ongoing before the EPO. In autumn 2024, the Opposition Division upheld the patent in amended form on the basis of an auxiliary request. That decision has been appealed to a Technical Board of Appeal, which has not yet issued its decision.

Biogen quickly succeeded with its infringement action. In June 2025, the PMC granted a preliminary injunction preventing Glenmark’s launch.

Glenmark appealed to the Patent and Market Court of Appeal (PMCA), pointing in particular to a Danish court’s decision in parallel national infringement proceedings. The Danish court had considered it likely that the Opposition Division’s ruling was incorrect and that EP 873 would ultimately be revoked.

The appeal was unsuccessful and the PMCA dismissed it. In its reasoning, the Court discussed in detail the presumption of validity attaching to granted patents, how that presumption operates when a patent has been upheld in amended form, and how to approach situations where opposition decisions have been taken but not yet become final due to appeal.

The PMCA took as its starting point the CJEU’s judgment in Phoenix Contact (C-44/21), where the CJEU emphasised that European patents are presumed valid from the date of grant, and noted that Swedish case law reflects this principle. At the same time, the Court noted that Swedish practice also recognises that a granted patent no longer enjoys such a presumption once it has been revoked for example in opposition, even if the decision is under appeal (and the patent formally remains in force).

On this basis, the PMCA held that EP 873 could no longer be presumed valid in its granted form, but the presumption applied to the patent as amended, as maintained by the Opposition Division – namely limited to the treatment of RRMS.

The Court then turned to the question of whether Glenmark had succeeded in rebutting that presumption and shown that the amended patent was unlikely to withstand scrutiny. Glenmark relied first on evidence concerning differences between DMF and MMF, which it said the Opposition Division had not taken into account. Secondly, Glenmark pointed to the Danish court’s ruling, which – unlike the Opposition Division – interpreted the Enlarged Board of Appeal’s decision G 2/21 to mean that certain post-published evidence could not be considered.

The PMCA was not persuaded. The Court noted that, even if the Opposition Division had not had access to Glenmark’s specific evidence, it had nonetheless considered the differences between DMF and MMF. The fact that the Danish court adopted a different view of G 2/21 and the treatment of post-published evidence was also not given decisive weight – the Opposition Division had in any event addressed that particular issue.

The appeal was therefore dismissed, and the preliminary injunction against Glenmark remains in place

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SPC ELIGIBILITY

AstraZeneca regarding SPC for dapagliflozin and metformin

Background

In June this year, the Swedish Patent and Market Court of Appeal (PMCA) rejected an application from AstraZeneca concerning SPC protection for a combination of the substances dapagliflozin and metformin. The case concerned the product Xigduo, used in the treatment of diabetes.

The decision is of particular interest as it is one of the first in which a national court has interpreted the CJEU’s statements in cases C-119/22 and C-149/22 (Teva Finland) concerning the application of article 3(a) of the SPC Regulation. To our knowledge, there is currently only one other reported case (Cour d’appel de Paris, 16 May 2025, Janssen, rilpivirine and tenofovir alafenamide), where the interpretation was in fact the opposite, despite similar underlying circumstances.

In an earlier decision in the same matter, the PMCA had concluded that article 3(c) of the SPC Regulation constituted an obstacle to the granting of an SPC. The PMCA had reached this conclusion without seeking a preliminary ruling from the CJEU, which in turn led the Swedish Supreme Court to set aside the decision and remit the case to the PMCA due to a procedural error. The PMCA subsequently stayed the proceedings pending the outcome of Teva Finland. After the CJEU delivered its decision in Teva Finland, the PMCA resumed its handling of the case and issued a new decision.

Focus of the decision

The PMCA’s decision turns largely on its application of a statement made by the CJEU in Teva Finland concerning article 3(a). Before addressing that point, however, the Court first reconsidered article 3(c).

Article 3(c)

In light of the CJEU’s ruling in Teva Finland, the PMCA carried out a renewed examination of article 3(c). The Court noted that the CJEU had stated that the content of the basic patent is irrelevant in the context of this provision. To assess whether the requirement of article 3(c) is fulfilled, it is therefore sufficient to identify the product covered by the SPC application and verify whether it had already been the subject of an SPC in the Member State concerned at the time of the application.

The PMCA found that the combination of dapagliflozin and metformin was clearly identifiable in the SPC application and that no SPC had previously been granted in Sweden for this combination. The Court therefore held that the requirement of article 3(c) was satisfied.

Article 3(a)

The PMCA then turned to article 3(a), which requires that the product be “protected” by the basic patent. Here too, the assessment depended on the CJEU’s statements in Teva Finland.

Importantly, the Court focused on the existence of a synergistic effect of the substances in a combination product. The Court found that a mere assumption in the specification of the basic patent was not sufficient to establish such an effect.

In reaching this conclusion, the PMCA firstly referred to the CJEU’s reasoning on combination products in Teva (C-121/17) and the two-step test set out there, as well as Royalty Pharma (C-650/17), concerning the requirement that the product must necessarily fall within the invention protected by the basic patent.

The PMCA emphasised that the CJEU in Teva Finland had made clear that an explicit mention of the two active ingredients in the claims of the basic patent is not sufficient to meet article 3(a). Such an explicit mention suffices only for the second step of the Teva test; and the first step must also be satisfied.

For the first step, it is not enough that the patent merely states that an active ingredient claimed in the patent may be combined with another known active ingredient in the public domain. The patent must also disclose how the combination constitutes a necessary component in solving the technical problem. If so, the first step can be satisfied even if one of the active ingredients was previously known or belonged to the public domain. In particular, if the patent discloses that the combination has an effect going beyond a mere aggregation of the ingredients, and that it contributes to solving the technical problem, the conclusion may be drawn that the combination necessarily falls within the invention protected by the patent.

Against this background, the PMCA noted that claim 1 of the basic patent specifically mentions dapagliflozin and that claim 7 refers to the combination of dapagliflozin and metformin. The second step of the Teva test was therefore satisfied.

However, as regards the first step, the PMCA focused on whether the basic patent disclosed that the combination had a combined and synergistic effect. The specification suggested that dapagliflozin in combination with other antidiabetics would produce greater antihyperglycaemic effects than each substance individually, and greater than the additive effects of the two combined. It also stated that metformin was the preferred second agent. Nevertheless, the PMCA found this insufficient.

Conclusion

The PMCA required more from the basic patent than a mere assertion of synergy to conclude that the first step of the Teva test was satisfied. The Court characterised the specification’s disclosure of a combined effect as an “assumption” and considered that it was not “substantiated”. The Court specifically noted the wording in the specification (“[i]t is believed that…[there is a synergy]”). It may be that the Court meant that a more conclusive statement would have sufficed, but in that case it would essentially be a matter of phrasing or drafting. Our interpretation is therefore that the Court most likely envisaged that some form of experimental data or the like would be required.

This interpretation of Teva Finland is very interesting, not least because the CJEU itself did not reason in terms of experimental data or the like, but rather in terms of “mention in the claims” and “disclosure” in the specification. This language may suggest textual explanations rather than concrete test data. The Court’s interpretation also raises the question of whether an SPC applicant can remedy this type of deficiency with supplementary data (post-published evidence).

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MEDTECH

Novus Scientific (previously Radi Medical Systems) v Poly-Med over surgical mesh products

In a long-running and complex dispute, an interesting Appeal Court decision has now emerged. The dispute is centred around a material sale and patent and know-how licence agreement between the US based licensor Poly-Med and the Swedish based licensee Novus. These kinds of disputes very rarely end up in Swedish courts, as they are instead resolved in (confidential) arbitration. Accordingly, the case is a true treasure trove when it comes to addressing legal controversies related to sophisticated licence agreements. The presentation below will be limited to covering issues that fall within the scope of this newsletter.

The background of the dispute is that Novus around 2005 developed and patented the basic concept for a surgical mesh for use in treatment of hernia. Novus turned to Poly-Med to help with further development and selection of a suitable bioabsorbable polymer for the mesh. The polymers were already patented by Poly-Med. The parties concluded a “Sale of Material and License Agreement” which, among other things, gave Novus the right to purchase materials but also to manufacture the selected materials. After the agreement was concluded and the development of the mesh continued, Novus filed further patents covering their developed surgical mesh. The mesh was offered by Novus under the trademark TIGR Matrix.

In 2015, Poly-Med terminated the agreement based on material breach of contract. In Poly-Med’s view, Novus had violated the agreement by marketing and selling their mesh for other purposes than hernia treatment. In addition, Poly-Med asserted that Novus had included licensed know-how in Novus’ subsequent patents, which now therefore rightfully belonged to Poly-Med. Novus disputed the allegation and sued for damages caused by wrongful termination. Poly-Med counter-sued requesting injunctions, damages and patent ownership.

The outcome before the District Court was Solomonic: Poly-Med’s termination because of material breach of contract was justified and effective but the Court found no evidence that Novus’ continued manufacture and sale of their product would infringe Poly-Med’s trade secrets or licensed know-how. (Poly-Med’s patent rights were not an issue in the dispute, if not for other reasons, simply because the Court did not have jurisdiction to try patent infringement claims.) Nor did the Court find that Novus had included licensed know-how in their patents in violation of the agreement.

The Appeal Court only partially agreed with the District Court. It agreed that the licence contained a restriction to treatment of hernia and that Novus had violated the restriction over many years. The fact that a subsequent FDA approval of the mesh permitted a broader use – which was Novus main defence line besides the wording of the agreement – did not alter the original content of the agreement.

However, the Appeal Court also noted that Poly-Med already in 2010 had notified Novus about the overbroad marketing of the mesh stating that this was “a serious issue” but over the next five years did nothing further. On the contrary, Poly-Med collected royalty payment from sales that were not for treatment of hernia. Under these circumstances, and even though the agreement contained “no-waiver” terms and the like, the violations could not be considered material, and the termination was unjustified. Same as the District Court, the Appeal Court did not award Poly-Med ownership of Novus’ patents since Poly-Med’s know-how had not been used.

The Supreme Court has recently granted a narrow leave for appeal covering only the question whether Novus’ overstepping of the restriction to hernia treatment was material or not (and thus permitting immediate termination).

We think that most lawyers intuitively would say that a field of use restriction in a licence agreement is an important provision and that, as is the case here, a continuous and intentional violation would amount to a material breach of contract. The Supreme Court will now have the final say. We should have an answer within a year or so.

As a final note. The parties appear to have litigated essentially the same issues in the US in parallel and Poly-Med has also faced legal issues related to its relaxed attitude to Novus’ violation of the restriction to treatment of hernia.

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News from the UPC
Nordic-Baltic Regional Division

MEDTECH

Edwards Lifesciences v Meril Life Sciences et al over transcatheter heart valves

The Nordic-Baltic Regional Division (NBRD) has issued a decision in one of the numerous disputes between Edwards and Meril concerning transcatheter heart valve systems for TAVI procedures.

As reported in previous editions of our newsletter, Edwards initiated infringement proceedings against Meril and co-defendants based on EP 3 769 722, entitled “Low Profile Delivery System for Transcatheter Heart Valve”, with the aim of stopping one of the products in Meril’s Myval System – namely, the Navigator THV balloon catheter delivery system. Meril responded with a counterclaim for revocation.

Following an oral hearing in January, the NBRD has now delivered its first substantive judgment, a decision that was highly anticipated. The decision provides a detailed analysis of many intricate aspects of the patent’s validity and infringement, and in doing so reveals the Court’s approach to a number of issues of wider principle. A summary of the decision is set out below.

Jurisdiction

The first issue before the Court was whether it had competence in respect of Meril Germany, one of the named defendants.

The Court found that sufficient connections existed between Meril Germany and the alleged infringements in Estonia and Lithuania. While the Navigator is manufactured by Meril’s Germany’s parent company, Meril Germany is described as the group’s European headquarters, was listed as exporter of record for shipments, and featured in Meril’s marketing materials as the contact point for availability of the Navigator in Europe. Together with evidence that the Navigator had been offered for sale, and even sold, in Estonia and Lithuania, these facts were sufficient to establish that the NBRD had jurisdiction over Meril Germany.

Claim construction

The Court then undertook a detailed analysis of EP 722 and certain key features.

It began by emphasising that interpretation of a patent must not lead to an unjustifiably narrow scope of protection. Referring to decisions of the Düsseldorf and Munich Local Divisions, the Court stressed that a narrowing construction that departs from the broader understanding of the claim wording by the skilled person can only be permitted in exceptional cases.

The parties’ main disagreement concerned the construction of the term “elongated shaft”. Meril argued that the term must be understood as relating to a guide catheter (or guide tube), to be distinguished from a balloon catheter. Edwards, on the other hand, submitted that an elongated shaft need not be limited in this way and could equally be part of other types of catheters.

(The parties’ differing positions stemmed from the fact that Meril’s Navigator is constructed differently from the system primarily illustrated in EP 722. The patent discloses a system in which a guide catheter and a balloon catheter are separate but cooperating components: the guide catheter providing support and steering (with a steerable distal end), and the balloon catheter being advanced through it and used for expansion and deployment of the valve. By contrast, the Navigator consists solely of a balloon catheter that combines the balloon portion with a steerable distal section, with no separate guide catheter.)

On this point, the Court sided with Edwards. It held that claim 1 is directed to an apparatus for indicating flex of a distal end of a catheter, and that nothing in the claim wording limits this to a particular type of catheter. The underlying technical problem addressed by EP 722 is that, when steering a catheter through a patient’s vasculature, it can be difficult to determine the degree of flexion at any given time. Effective steering requires such information, and this is true regardless of catheter construction. The patent discloses multiple embodiments and it is clear that different types of catheters may comprise an elongated shaft. The elongated shaft in claim 1 may, but need not, be the guide shaft of a guide catheter.

Validity

The Court then turned to validity. Meril alleged that the patent was invalid as a whole for added subject matter, lack of inventive step, and insufficiency of disclosure.

Added matter

On added matter, Meril argued that Edwards’ claim amendments amounted to unallowable intermediate generalisations, extracting features from their original context and omitting essential elements. For example, since the parent and grandparent applications both concerned a flex indicating device of a delivery system comprising both a guide catheter and a balloon catheter, Meril contended that EP 722 must also be so limited. The Court, however, did not accept this argument, siding with Edwards and emphasising that the specification disclosed a number of different inventions. Nonetheless, Meril did succeed in persuading the Court that several dependent claims contained added subject matter.

Sufficiency of disclosure

On sufficiency, Meril argued that claim 1 was not sufficiently disclosed because it omitted a longitudinal slot required to enable movement of the flex indicating member. Edwards maintained this was at most a clarity issue, and that the specification and figures disclosed at least one workable embodiment. The Court agreed with Edwards and held that claim 1 was sufficiently disclosed.

Claim 9, however, presented greater difficulty for Edwards. It referred to an inner sleeve with external threads mating with the flex indicating member, which Meril said conflicted with the teaching of the patent. Edwards argued this was an obvious drafting error, but the Court noted that the specification provided literal support for the granted wording and did not clearly guide the skilled person on how to implement such an arrangement. It therefore concluded that claim 9 was insufficiently disclosed.

Inventive step

The Court then considered inventive step. It first reiterated the applicable legal standard: the problem–solution approach is the EPO’s established method, applied by most national courts, while some other jurisdictions use slightly different standards but often reach the same result. The UPC has applied the problem–solution approach in several cases, and here too the Court saw no reason to deviate.

Meril relied on a large number of prior art references and combinations, but the Court rejected these attacks. In summary, it found that the prior art cited was structurally too different for the combinations proposed by Meril to be obvious. It stressed that the objective technical problem must not be formulated in a way that points towards the solution, so as to avoid hindsight. The Court noted that its conclusions were consistent with the EPO’s Opposition Division in the ongoing opposition proceedings, and also referred to certain findings of the UK High Court as relevant to its assessment.

Conclusion on validity

The Court thus maintained EP 722 in amended form, with the same wording of claim 1 as upheld by the Opposition Division, but with the dependent claims deleted.

Infringement

Having addressed validity, the Court turned to infringement.

Meril’s non-infringement case focused mainly on the interpretation of the term elongated shaft (see above), namely that it referred specifically to a guide catheter, and that the Navigator does not include such a component. The Court referred back to its earlier claim construction, confirming that the term was not limited to guide catheters but applied to catheters generally, including balloon catheters. On that basis, the Court held that the Navigator, constructed as a balloon catheter with inner and outer shafts, satisfied this requirement. The device also had a handle with a rotatable activation knob connected to a pull wire, enabling flex of the distal shaft. The Court therefore concluded that the Navigator literally infringed amended claim 1.

Infringing acts and liability

Finally, the Court considered whether Meril Germany was implicated in the infringing acts alongside its parent company and the distributors. Edwards highlighted that Meril Germany, a wholly owned subsidiary of the parent company, was described in materials as “Meril European Headquarters”, listed as the EU contact for customers, and shown as exporter of record for shipments. These marketing materials indicated the Navigator was available across most UPC states, with Meril Germany as the only EU contact point, amounting to an offer for sale. The Court also noted the close commercial interdependence of Meril Germany and the parent company. It therefore held Meril Germany jointly and severally liable with the parent company and the distributors in for the infringing acts in those states and, more broadly, throughout the territory of unitary effect.

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