JANUARY 2024

The Swedish pharma and life sciences litigation newsletter

IN THIS ISSUE

PHARMA

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

Biogen continues to achieve success in enforcing its patent against dimethyl fumarate products from Sandoz, Viatris, and Neuraxpharm, also successfully defending against the validity challenge.

We reported on this case earlier in our newsletter in June 2023. At that time, we wrote that Biogen had successfully obtained preliminary injunctions against all three alleged infringers, thereby halting generic competition against the original product TECFIDERA in Sweden. The injunctions were based on Biogen’s patent EP 2 653 873 B1, which concerns the dosage of the product. As is customary, the generics had challenged the validity of the patent.

Now we can provide an update. The Swedish Patent and Market Court (PMC) settled the validity issue a few weeks ago, ruling in favour of Biogen.

PMC’s decision included, among other things, interesting references to the Enlarged Board of Appeal’s ruling in the “plausibility” case G2/21. Sandoz, Viatris, and Neuraxpharm (below “the Claimants”) had submitted that Biogen’s patent should be invalidated due to added matter, lack of novelty, and lack of inventive step.

The added matter point, in essence, revolved around the argument that Biogen had impermissibly amended claim 1 by making selections from multiple separate lists in the application as filed, namely concerning the specific daily dose (480 mg/day), the substance (dimethyl fumarate, DMF), and the medical condition (multiple sclerosis, MS). However, PMC did not agree with this. According to PMC, claim 1 was based solely on a selection from a single list (concerning the daily dose).

The Claimants also submitted that the patent should be invalidated due to lack of novelty in light of certain prior art (WO 2006/037342 A2, below WO 342) disclosing oral pharmaceutical compositions with DMF and monomethyl fumarate (MMF). However, the argument does not seem to have gained traction with PMC, which briefly stated that to arrive at the invention according to claim 1 from the disclosure of WO 342, selections from multiple lists would be required. Not only would the medical condition (MS) be the result of a selection from two lists, but also the daily dose would be a selection from a list with dosage intervals. Thus, the patent fulfilled the novelty requirement, according to PMC.

Finally, PMC examined the question of inventive step in quite some detail.

The Claimants argued, among other things, that the patent lacked an inventive step over a Phase II study where DMF was administered to patients in doses both lower (120 mg/day and 360 mg/day) and higher (720 mg/day) than the dose according to claim 1 (480 mg/day), and it was compared with a placebo.

A crucial issue was whether PMC should consider certain post-published evidence from Biogen, in the form of reports on two studies where DMF was administered to patients in daily doses corresponding to that of claim 1. PMC evaluated this matter based on the standards set by the Enlarged Board of Appeal in G2/21.

PMC noted that the Enlarged Board had determined that a patent applicant may rely on a technical effect for inventive step if the skilled person would derive said effect as being encompassed by the technical teaching and embodied by the same originally disclosed invention.

PMC also noted that the Enlarged Board had emphasised that inventive step is different from sufficiency of disclosure in this regard, that the assessment of inventive step and sufficiency of disclosure are different and should be treated separately, and that the room for relying on post-published evidence is a lot narrower in the assessment of sufficiency of disclosure than in the assessment of inventive step.

According to PMC, it follows from the case law developed by the Boards of Appeal that the technical effect used for the assessment of inventive step must either be explicitly stated in the application as filed or at least be derivable from the application.

Turning to Biogen’s patent, PMC found that the skilled person would be able to deduce from the application as filed that DMF is effective in treating MS, and that this applies also for the claimed dose, even though the description did not include experiments using the claimed dose. The application namely disclosed certain daily oral doses of DMF and MMF as suitable, and this included the claimed dose. And, moreover, the description disclosed mouse experiments in which doses lower than the claimed dose (when converted to human doses) were used. Therefore, PMC decided to consider the post-published evidence in its assessment of the inventive step.

PMC then found that the post-published evidence demonstrated the efficacy of the claimed daily dose in treating MS and that it represented an improvement compared to the higher dose disclosed in the prior art. This, in turn, led PMC to formulate a relatively ambitious objective technical problem (the provision of an improved oral treatment of MS with DMF) for the skilled person.

Moving on to the closest prior art (the Phase II study), PMC concluded that the skilled person would have interpreted the results as indicating that only the high dose of 720 mg/day had any effect. The skilled person would not have concluded that the results for the lower doses were statistically significant. Consequently, the information in the study did not disclose any dose range or established dose-response trend.

Finally, PMC disagreed with the Claimants that the information in the Phase II study would have prompted the skilled person to conduct routine dose-response studies and that such studies would have demonstrated the suitability of the dose of 480 mg/day. The situation was too complicated and sensitive for that, with for example significant uncertainty surrounding the effect of lower doses. According to PMC, the skilled person would therefore not have had a reasonable expectation of success with such an approach, and there was no try-and-see situation. For that reason, PMC concluded that the invention involved an inventive step.

Since PMC upheld the patent, it also issued injunctions against the sales of the generic products in Sweden. There seem to have been no real disputed issues beyond the validity question.

The cases have been appealed to the Patent and Market Court of Appeal. We will continue to report.

PHARMA

Novartis v Zentiva, Glenmark, Mylan and Teva over fingolimod products

The Swedish Patent and Market Court of Appeal (PMCA) continues to deliver surprises in the case concerning Novartis’ pursuit of preliminary injunctions against generic fingolimod products.

We reported in our newsletters in June 2023 and December 2022 about Novartis’ patent infringement actions under EP 2 959 894 against competitors’ fingolimod products for the treatment of multiple sclerosis. In a series of decisions during 2022, the Swedish Patent and Market Court (PMC) expressed doubts about the inventive step and refused to issue preliminary injunctions. However, as reported in June 2023, Novartis managed to completely turn the cases around and secure preliminary injunctions against all four defendants.

These intriguing cases have now evolved even further. The defendants Zentiva, Glenmark, and Mylan appealed the preliminary injunctions, and PMCA decided to lift the injunctions against these three defendants. This is noteworthy and somewhat surprising since PMCA had previously issued a preliminary injunction against Teva in a decision in April 2023, based on essentially the same set of facts (as far as we are aware).

In its April decision, PMCA reasoned that PMC should not have reassessed and disallowed the decision by the Board of Appeal at the EPO (which concluded that there was an inventive step). Such a reassessment is incompatible with the summary nature of the preliminary injunction procedure, PMCA emphasised. However, PMCA now appears to have changed its mind about the approach to be taken. PMCA indeed reviewed the Board’s decision – and came to the opposite conclusion to that of the Board.

Contrary to the Board’s opinion, PMCA did not believe that there was anything in the prior art that would have steered the skilled person away from considering the claimed dosage regimen. The skilled person would not have refrained from testing the dosage regimen unless such a restraint is essentially dictated by the common general knowledge and it represents a general view among experts in the field. The skilled person would generally not refrain from testing just because something is taught against the solution in a single available document, such as an article or research report. In addition, PMCA found that there was new evidence that contradicts the premises of the Board’s decision. Therefore, PMCA considered that there is likely no inventive step.

This means that three out of the four generics companies ultimately succeeded in avoiding Novartis’ requests for preliminary injunctions. It remains to be seen how the cases will unfold when they are finally heard. Notably, PMC has scheduled a main hearing in the case between Novartis and Glenmark for the end of January 2024. The remaining cases have been stayed pending the outcome of the EPO oppositions against the patent.

MEDTECH

Edwards Lifesciences v Meril Life Sciences over transcatheter heart valves

In previous issues of our newsletter, we highlighted Edwards’ efforts to pursue patent enforcement proceedings in Sweden against Meril concerning transcatheter heart valve technology. Another case initiated by Edwards before the Swedish Patent and Market Court (PMC) in August last year concluded when the Board of Appeal at the European Patent Office (EPO) revoked the patent in question.

This time, Edwards based its action on EP 3 583 920, titled “Perivular Sealing for Transcatheter Heart Valve”. Edwards asserted that Meril’s product, the Myval Octacor transcatheter heart valve, infringed the patent. Edwards sought, among other things, a preliminary injunction against the product’s sales. In response, Meril counter-sued, challenging the validity of the patent.

However, the case ultimately hinged on a decision by a Board of Appeal at the EPO. Edwards’ patent faced opposition at the EPO, and while the Opposition Division upheld the patent, it did so only in amended form. This decision was appealed, leading the Board to revoke the patent on grounds of added matter in a decision in December last year. Consequently, Edwards withdrew its action before PMC.

PHARMA

STADA Arzneimittel v Takeda Pharmaceuticals over lisdexamfetamine dimesylate product

STADA initiates legal proceedings before the Swedish Patent and Market Court to challenge Takeda’s Swedish Supplementary Protection Certificate (SPC) safeguarding the Elvanse product used for ADHD treatment.

STADA filed the lawsuit in October last year, seeking revocation of Takeda’s Swedish SPC, which relies on EP 1 644 019, titled “Abuse Resistant Amphetamine Compounds”, and which protects the original product Elvanse designed for ADHD treatment.

The grounds for the invalidity claim are that the SPC in question was granted in violation of Art 3(d) of the SPC Regulation. STADA presents the following arguments briefly: The SPC concerns lisdexamfetamine, which consists of the active substance dexamfetamine and the amino acid L-lysine. L-lysine does not exhibit any independent pharmacological, metabolic, or immunological effects. The sole active ingredient is dexamfetamine. The SPC was granted referencing a marketing authorisation (MA) for Elvanse in the United Kingdom as the first MA. However, earlier MAs for dexamfetamine had already been granted (to parties other than Takeda). Consequently, the MA for Elvanse in the UK was not the first MA under Art 3(d).

We will monitor the progression of this lawsuit and provide continued updates.

News from the UPC
Nordic-Baltic Regional Division

MEDTECH

Edwards Lifesciences v Meril Life Sciences, SMIS, and Sormedica over transcatheter heart valves

The case reported in the previous issue of our newsletter appears to still be pending at the Nordic-Baltic Regional Division. Edwards is pursuing proceedings 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 are asserting a counter-claim for invalidity of the patent.

MEDTECH

Edwards Lifesciences v Meril Life Sciences, SMIS, Sormedica, and Interlux over transcatheter heart valves

In addition to the transcatheter heart valve case mentioned above, Edwards has initiated proceedings before the Nordic-Baltic Regional Division against Meril and three co-defendants for infringement of EP 3 769 722, titled “Low Profile Delivery System, for Transcatheter Heart Valve”.

MEDTECH

Abbott Diabetes Care v Dexcom over continuous glucose monitoring devices

Another case to report is that Abbott Diabetes Care has recently filed a lawsuit before the Nordic-Baltic Regional Division against Dexcom for infringement of EP 3 977 921, titled “Analyte sensor and apparatus for insertion of the sensor”.

We will continue to monitor these cases and provide updates.

Peter Kenamets
Partner, Attorney-at-law
Lind.Edlund.Kenamets.

Fredrik Lüning
Partner, Attorney-at-law
Lind.Edlund.Kenamets.

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