The Swedish pharma and life sciences litigation newsletter
IN THIS ISSUE
- PHARMA – Novartis v Zentiva, Glenmark, Mylan and Teva over fingolimod products
- PHARMA – Neurim v Orifarm over melatonin product
- PHARMA – Bayer v Mylan over sorafenib product
- PHARMA – Biogen v Sandoz and Viatris over dimethyl fumarate products
News from the UPC
Nordic-Baltic regional division
Novartis v Zentiva, Glenmark, Mylan and Teva over fingolimod products
Novartis’ pursuit of preliminary injunctions against generic fingolimod products continues.
We reported in our newsletters in June 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 string of decisions during 2022, the Swedish Patent Court has expressed doubts about the inventive step and refused to issue preliminary injunctions.
The Appeal Court changes its mind and grants leave to appeal
However, Novartis has now managed to completely turn the case around and secure preliminary injunctions against all four defendants. The opportunity for Novartis came in the case against Teva when the Appeal Court decided to grant leave to appeal for Novartis’ request for a preliminary injunction. Notably, and somewhat surprisingly, the Appeal Court had refused leave to appeal in the first three cases against the other defendants.
The Appeal Court then started out by noting that the CJEU has stressed in Phoenix Contact (C-44/21) that European patents are presumed to be valid from grant. The CJEU made it clear that Art 9.1 of the Enforcement Directive prevents national case law by which a request for a preliminary injunction shall be dismissed when the validity of the patent has not been determined at least in first instance opposition or invalidity proceedings. Consequently, the CJEU rejected the so-called battle-tested patent doctrine.
The Appeal Court then went on to conclude that Teva had not managed to present arguments or evidence that overturned the presumption of validity. Teva had, among other things, submitted new prior art that had not been considered by the EPO – but the Court was still not convinced that it added anything of substance compared to the similar prior art already considered by the EPO before grant.
The Appeal Court did not allow a review of the Board of Appeal’s reasoning
The Appeal Court further, and perhaps more interestingly, made a note regarding the lower court’s review of the reasoning of the Board of Appeal at the EPO (i.e., the Board that had decided that the patent should be granted). The lower court had reviewed the Board’s reasoning and the evidence before it and had come to a different conclusion regarding the inventive step.
This, the Appeal Court said, was not consistent with the preliminary injunction procedure and the presumption of validity. In such proceedings, the court shall not conduct a renewed evidentiary examination or legal analysis of the Board’s reasoning and evidence assessment. And it moreover does not matter that there might be room for such questioning of the Board’s analysis in the Court’s own final examination of the validity. The lower court should instead have relied on the Board’s assessment of the inventive step and should have issued a preliminary injunction.
The Appeal Court consequently issued a preliminary injunction against Teva. Novartis then, of course, quickly used this to obtain preliminary injunctions against the rest of the defendants as well. The defendants have appealed the preliminary injunctions. The Appeal Court notably has both granted leave to appeal and issued orders that the injunctions must not be enforced. We will report on the outcome in our next newsletter.
Neurim v Orifarm over melatonin product
We reported in the December 2021 issue of this newsletter that Neurim had issued legal proceedings against Orifarm for infringement of a second medical use patent (EP 3 103 443) protecting its original melatonin product, Circadin, which is indicated for the treatment of certain sleep disorders.
Orifarm has now succeeded in revoking EP 443 in the court of first instance with an argument that is not often seen in Swedish patent litigation.
Orifarm has been marketing and selling the drug Mecastrin in the Swedish market since 2019. In September 2021, Neurim filed a lawsuit against Orifarm, alleging that Orifarm infringed EP 443, which relates to the use of melatonin for the improvement of a certain type of insomnia.
Orifarm responded by requesting revocation of EP 443, inter alia, on the ground of insufficiency of disclosure. It turned out that the case would hinge on Orifarm’s argument that the skilled person would not be able to work the invention across the whole scope of the claim, which is rather unusual in Swedish patent litigation.
The achievement of the therapeutic effect
Claim 3 in the patent is directed towards a specific melatonin formulation for the improvement of the restorative quality of sleep for patients suffering from primary insomnia characterized by non-restorative sleep.
The Court started by noting that, for patent claims directed towards a further medical use of a known substance, the achievement of a therapeutic effect is considered a functional technical feature. This means that the therapeutic effect must be made plausible in the application as filed. If this requirement is not met, the invention is not sufficiently disclosed.
The therapeutic effect was discussed in examples in the patent specification. Patients of varying ages with primary insomnia had been studied. Some patients had received the melatonin formulation, and some had received a placebo.
After the treatment, the patients were asked to compare the quality of sleep with the medicine to their usual sleep. The patients graded their perceived sleep quality between “more restless than usual” and “more restful than usual.” The results generally showed that the patients who received the melatonin formulation indicated an improvement in their sleep quality compared to those who received the placebo. After a detailed review of the case, the Court concluded that the therapeutic effect had been made plausible at a general level. It could be considered as demonstrated in EP 443 that the melatonin formulation is suitable for the medical indication specified in the patent claim, in elderly patients. The melatonin formulation led to an improvement in the recovery value of sleep for the relevant patient group.
No sufficiency across the entire scope of the claim
However, one problem emerged. Some results indicated that patients who were younger than 55 years and who had received the melatonin formulation actually experienced a worsening of sleep compared to the placebo.
Orifarm’s argument was that, since the patent claims cover patients of all ages and the patients who were younger than 55 years experienced a significant worsening of restorative sleep compared to the placebo, it had not been shown that the invention works across the entire scope of the claim.
Neurim countered by arguing that the results for the younger patients (below 55) could be explained by the fact that those patients suffered from other types of insomnia than the claimed type. The results were analysed in the patent description, which stated that primary insomnia characterized by non-restorative sleep is more common in older people, while younger people typically may have trouble falling asleep and suffer from sleep deprivation. It further stated that the results indicate the effectiveness of melatonin against primary insomnia characterized by non-restorative sleep, but the medication can have a negative impact on other types of insomnia (e.g., lack of sleep and difficulty falling asleep). Neurim submitted that the younger patients experienced negative results because they did not suffer from primary insomnia characterized by non-restorative sleep.
Neurim further argued that this explanation was confirmed by an analysis in a post-published report. The report contained a statistical covariance analysis of the results for the younger patients and, according to Neurim, showed that the younger patients reported improvements in the subjective quality of sleep if they suffered from non-restorative sleep.
According to the Court’s assessment, the results reported in the patent specification for the younger patients would have led the skilled person to seriously doubt the effect of the melatonin formulation in those patients.
Post-published evidence considered
The Court proceeded to consider the post-published evidence. It ruled that the evidence should be considered, and not disregarded, because it provided an explanation of a hypothesis already included in the patent specification. However, this did not help Neurim. The Court found that the evidence did not demonstrate that the younger patients simply suffered from other types of insomnia. The serious doubts of the skilled person about the effect of the invention for patients under the age of 55 were therefore not overcome.
Consequently, the Court revoked Neurim’s patent due to insufficient disclosure.
Neurim has appealed the decision, and we will continue to update you as this case develops in the Appeal Court.
Bayer v Mylan over sorafenib product
With only a few days remaining of the patent term, Bayer obtained a preliminary injunction based on EP 2 305 255 against Mylan’s sales of Sorafenib Mylan 200 mg film-coated tablets. Bayer’s original product is Nexavar, used to treat certain types of liver, kidney, and thyroid cancer in adults.
Mylan did not deny infringement as such but countersued for the revocation of the patent on grounds of added matter and inventive step. The Court emphasized, as it often does, that there is a presumption of validity in preliminary injunction proceedings under Swedish law, that the assessment at this stage is preliminary, and that the Court will only conduct a brief assessment to determine whether there are reasons to assume an infringement.
The Court summarily dismissed the added matter argument by noting that this issue had already been addressed by the EPO. Regarding inventive step, Mylan cited prior art that had not been assessed by the EPO and a new expert witness report. The Court compared Mylan’s prior art with other prior art that had been assessed by the EPO and noted that both references contained largely the same information. Both referred to clinical phase I studies concerning sorafenib and reported similar data. The Court, therefore, considered that the presumption of validity had not been overturned. This was moreover not changed by the new expert evidence or foreign decisions going in different directions.
The preliminary injunction decision has thereafter ceased to be in force when the patent term expired. The processing of the case continues.
Biogen v Sandoz and Viatris over dimethyl fumarate products
Biogen continues its successful patent enforcement against dimethyl fumarate products from Sandoz and Viatris.
We have previously reported on Biogen’s enforcement proceedings against Neuraxpharm for a dimethyl fumarate product used in treating multiple sclerosis. The action is based on EP 2 653 873 B1, which pertains to the dosage of the drug. Biogen’s original drug is Tecfidera.
Biogen has now obtained further preliminary injunctions against the sales of dimethyl fumarate products by Sandoz and Viatris. These injunctions are based on the same patent, EP 873, as in the case against Neuraxpharm. EP 873 is a divisional patent of EP 2 137 537 B1, and the parent patent EP 537 has been revoked in EPO opposition proceedings.
Sandoz and Viatris attempted to challenge the presumption of validity by arguing that there were substantial errors and flaws in the prosecution of EP 873 at the EPO. They particularly emphasized that the only difference between revoked claim 1 of EP 537 and claim 1 of EP 873 was the substitution of “consisting of” language with “comprising” language. They also pointed out that the Examining Division of the EPO did not provide a record of how it arrived at a different conclusion from that of the Opposition Division for EP 537.
However, the Court was not convinced by their arguments. There is no obligation for the Examining Division to account for its reasoning in the manner suggested by Sandoz and Viatris. The Examining Division is not bound by assessments made in relation to other applications, even if the subject matter of those other applications is similar. Additionally, claim 1 of EP 873 is indeed different from revoked claim 1 of EP 537. The Court obviously did not find it relevant that EP 873 (comprising) is broader than EP 537 (consisting of) and not the other way around.
Furthermore, Sandoz and Viatris argued that there was some prior art that the EPO had not considered. However, the Court dismissed this argument by comparing the new prior art with the prior art that had already been considered and concluding that it was not demonstrated that the differences would lead to a different analysis.
Sandoz and Viatris appealed the decisions but were unable to have the preliminary injunctions lifted.
News from the UPC
Nordic-Baltic regional division
Edwards Lifesciences v Meril Life Sciences, SMIS and Sormedica over transcatheter heart valves
The Nordic-Baltic Regional Division of the UPC, with its seat in Stockholm, has received its first life sciences case. Edwards Lifesciences has issued infringement proceedings against two Meril Life Sciences companies and two co-defendants named SMIS and Sormedica. The case is based on EP 2 628 464, which protects the Sapien valve delivery system. We will closely monitor the case’s progress.