The Swedish pharma and life sciences litigation newsletter

PHARMA

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

In our September 2024 issue, we reported on the ongoing and intense litigation in Sweden between Bayer and several generic pharmaceutical companies concerning Bayer’s blockbuster anticoagulant product, Xarelto, which is used to prevent and treat blood clots.

The litigation was initiated by Sandoz, which filed a lawsuit against Bayer seeking to invalidate Bayer’s patent, EP 1 845 961. However, the Swedish Patent and Market Court (PMC) ruled in Bayer’s favour, upholding the validity of the patent. Sandoz has since appealed this decision, and the case is currently pending before the Swedish Patent and Market Court of Appeal.

In response, Bayer has filed lawsuits against Sandoz and other generic manufacturers, including STADA, Teva, Glenmark, and Viatris, alleging patent infringement. Each of these companies, in turn, has launched proceedings to invalidate the patent. The PMC has issued preliminary injunctions preventing the sale of the generic versions of Xarelto in Sweden, with one notable exception: a capsule product that was not considered to infringe a claim directed at a tablet product under the doctrine of equivalence.

Disclosure of internal documents

A noteworthy development in these proceedings occurred when the PMC, at the request of Teva, ordered Bayer to disclose certain internal documents. These included notes and participant lists from an expert meeting held during the development of Xarelto. The court determined that these documents could serve as evidence in the case, and this outweighed Bayer’s interest in maintaining their confidentiality. In reaching its decision, the court gave weight to the fact that these notes had been used as evidence in parallel litigation in South Africa and were therefore deemed potentially relevant to the Swedish proceedings.

Managing complex multi-party proceedings

These legal disputes have become highly complex and extensive. The PMC is currently working on developing a plan to manage and progress the cases towards a final resolution involving all parties.

We will continue to monitor and report on this fascinating cluster of litigation surrounding Xarelto.

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PHARMA

STADA and Sandoz v Takeda over the validity of lisdexamfetamine SPC and lisdexamfetamine product

As previously reported in our September 2024 newsletter, disputes are ongoing in Sweden concerning the supplementary protection certificate (SPC) protection for Takeda’s product Elvanse (lisdexamfetamine), a medication used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

In proceedings before the Swedish Patent and Market Court (PMC), STADA has challenged the validity of Takeda’s SPC which is based on EP 1 644 019 (the basic patent).

STADA has presented a range of arguments, contending, in essence, that the only active ingredient in lisdexamfetamine is dexamfetamine. Consequently, under the SPC Regulation, the product (ie the active ingredient) should be considered dexamfetamine. Marketing authorisations (MAs) for dexamfetamine products were already granted prior to the MA for Elvanse, which served as the basis for the SPC. STADA asserts that the MA for Elvanse therefore does not constitute the first authorisation to place the product on the market under Article 3(d) of the SPC Regulation.

STADA further argues that the basic patent does not cover the product (dexamfetamine), thereby failing to satisfy the requirements of Article 3(a) of the SPC Regulation. Additionally, STADA claims that the prior existence of products containing dexamfetamine on the market places lisdexamfetamine outside the scope of the SPC Regulation, contravening Article 2 of the Regulation.

Finally, STADA contends that the SPC lifetime must be calculated based on the earlier MAs for dexamfetamine products. This results in a negative lifetime by such a margin that it is impossible to arrive at a positive lifetime even with a paediatric extension.

For all of these reasons, the SPC is invalid, STADA claims.

The PMC has just recently issued its decision in this case. The court started out by noting that the core of STADA’s argument was that the “product” covered by the SPC under Article 1(b) of the SPC Regulation (ie the active ingredient) should be considered dexamfetamine, not lisdexamfetamine.

This argument required the PMC to address a key question what constitutes the active ingredient in Elvanse under the SPC Regulation. The Court approached this matter in two stages.

The PMC’s reasoning

According to the PMC, case law from the ECJ establishes that the term “active ingredient” under the SPC Regulation must align with the definition of “active substance” in Article 1(3)(a) of the Medicinal Products Directive. Consequently, the starting point was how the substance was defined with regard to its function in the medicinal product during the marketing authorisation process for Elvanse. The regulatory authorities had assessed the active substance lisdexamfetamine based on clinical trial data submitted by Takeda, in compliance with the Directive’s pharmacological efficacy requirements.

STADA contended that lisdexamfetamine lacks pharmacological, metabolic, or immunological activity of its own, as its therapeutic effect arises only after hydrolysis to dexamfetamine. However, the PMC deemed this argument irrelevant. The decisive factor was the identification of the active substance in the medicinal product itself, regardless of its metabolic transformation within the body.

The PMC noted that the evidence on file demonstrated that a prodrug, a chemical derivative requiring enzymatic or chemical activation in vivo to release its active moiety, could qualify as an active substance under EU pharmaceutical law.

In conclusion, the PMC determined that, under the regulatory framework governing marketing authorisations, dexamfetamine could not be regarded as the active ingredient of Elvanse. Instead, lisdexamfetamine was identified as the active substance in the medicinal product and was therefore the subject of the granted SPC. The regulatory authorities had already determined that lisdexamfetamine possesses a pharmacological, metabolic, or immunological effects of its own, and thus it was unnecessary to revisit this question. STADA’s evidence on pharmacokinetics and related aspects was deemed irrelevant.

ECJ case law considerations

The next phase of the PMC’s analysis involved whether existing ECJ case law on the definition of “active ingredient” necessitated a different conclusion. STADA had cited several precedents, including Forsgren (C-631/13), Santen (C 673/18), MIT (C-431/04), GSK (C-210/13), and Abraxis (C-443/17).

The PMC observed, however, that the Swedish Supreme Court had ruled in a 2022 case (dapagliflozin-metformin) that ECJ decisions should be interpreted cautiously, especially when they are restrictive towards individual patent holders. The cited cases involved different facts, and none dealt with an active substance in the form of a prodrug. None of the cases specifically addressed whether the active substance specified for a medicinal product (lisdexamfetamine mesylate) has a pharmacological effect of its own, and what this implies for determining whether it can be regarded as an active ingredient. The court thus found that the cited case law did not directly apply or support STADA’s position.

Conclusion

This means that the PMC sided with Takeda, ruling that the product according to the SPC was lisdexamfetamine and not dexamfetamine, and upheld the validity of the SPC.

Other lisdexamfetamine proceedings

We have also previously reported on legal proceedings brought by Sandoz against Takeda regarding the same SPC. Sandoz is seeking a declaration of non-infringement for its generic lisdexamfetamine product, which contains the diadipate form of lisdexamfetamine. The PMC, however, sided with Takeda and concluded that Sandoz’s product constituted an equivalent infringement of the SPC. Sandoz has appealed this decision, and the case is now pending before the Swedish Patent and Market Appeal Court.

We will continue to monitor and report on these complex disputes surrounding Elvanse.

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PHARMA

Glenmark v Biogen over the validity of dimethyl fumarate patent and regulatory exclusivity & Biogen v Neuraxpharm, Viatris, and Sandoz over dimethyl fumarate products

Glenmark has initiated legal proceedings before the Swedish Patent and Market Court (PMC) against Biogen, seeking to invalidate Biogen’s European Patent EP 2 653 873, titled “Compositions and uses for treating multiple sclerosis”. The patent pertains to a dosage regimen involving 480 mg per day of dimethyl fumarate for the treatment of multiple sclerosis. The original product is Tecfidera.

Glenmark argues that the patent is invalid on the grounds of added subject matter, insufficient disclosure, and lack of inventive step. In support of its claim, Glenmark has inter alia referenced opposition proceedings at the European Patent Office (EPO), where the Opposition Division upheld the patent only with amended claims, narrowing its scope to cover only RRMS, in the autumn of last year.

In parallel with its efforts to invalidate Biogen’s patent, Glenmark has also pursued legal proceedings against the Swedish authorities concerning Tecfidera’s regulatory exclusivity.

In March 2024, the Swedish Medical Products Agency (SPMA) prohibited Glenmark from marketing its generic dimethyl fumarate products, stating that Tecfidera benefits from market exclusivity under Article 14.11 of the EU Medicines Regulation.

Glenmark challenged this decision before the Administrative Court, raising several arguments. It contended that the prohibition constituted a change of the SMPA’s earlier decision granting marketing authorisation for Glenmark’s products, which, according to Glenmark, was impermissible as favourable administrative decisions cannot be altered to the detriment of the affected party. Glenmark further argued that the decision effectively revoked the marketing authorisation for its products.

The Administrative Court, however, found no merit in these arguments. It concluded that the decision by the SMPA did not, either formally or in substance, constitute a modification or revocation of the marketing authorisation.

Glenmark also disputed the validity of the European Commission’s decision underlying the SMPA’s ruling against Glenmark. It claimed the decision was flawed on multiple grounds and further that it did not entail an exclusive right that ought to be protected by the SMPA.

The Administrative Court dismissed these arguments as well. It noted that Glenmark could have brought an action to annul the Commission’s decision but had failed to do so within the prescribed time limits. As a result, Glenmark was no longer entitled to contest the validity of the decision. The court further emphasised that it was required to regard the decision as valid. Consequently, it concluded that the SMPA had acted correctly in prohibiting the sale of Glenmark’s products. A subsequent appeal by Glenmark was dismissed because the appeal court did not grant leave for appeal.

Parallel proceedings are also ongoing in Sweden, where Biogen has initiated infringement lawsuits against Neuraxpharm, Viatris, and Sandoz based on the same patent. The defendants have counterclaimed, seeking a declaration of invalidity for the patent. These proceedings are currently pending before the Swedish Patent and Market Appeal Court.

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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

In our September 2024 issue, we reported on Edwards’s pursuit of proceedings before the UPC Nordic-Baltic Regional Division against Meril and two co-defendants, alleging infringement of its EP 2 628 464, titled “Leaflet Attachment Frame for a Prosthetic Valve”, which protects the Sapien valve delivery system. The defendants have counterclaimed for revocation of the patent.

Edwards has also initiated infringement proceedings against Meril and co-parties based on another patent, EP 3 769 722, titled “Low Profile Delivery System for Transcatheter Heart Valve“. In this case as well, Meril has pursued a counterclaim for revocation of the patent.

We also reported that the proceedings regarding EP 464 had been resumed after a stay, as a Board of Appeal of the EPO had issued a decision in opposition proceedings upholding the patent in an amended form according to an auxiliary request.

The Nordic-Baltic Division has recently held a one-day oral closing hearing in the case relating to EP 722, and the decision is now awaited. We will provide an update once the decision has been issued.

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MEDTECH

Abbott Diabetes Care v Dexcom over continuous glucose monitoring devices

In our January 2024 issue, we reported that Abbott had recently filed a lawsuit before the Nordic-Baltic Division against Dexcom for infringement of EP 3 977 921, titled “Analyte sensor and apparatus for insertion of the sensor”. Dexcom counterclaimed for revocation of the patent.

What has happened since in the proceedings is that the Nordic-Baltic Division held an oral final hearing in Stockholm. Interestingly, the hearing was preceded by a day of expert witness testimony, which is unusual in the UPC’s history so far. Unfortunately, no decision on the merits is to be expected in the case. The parties settled before Christmas.

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