The Swedish pharma and life sciences litigation newsletter

IN THIS ISSUE

PHARMA

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

We have written about this case before in the June 2022 issue. Novartis is pursuing infringement proceedings against competitors’ fingolimod products based on its patent EP 2 959 894 relating to the dosage of the drug and is facing counterclaims for revocation. The Swedish Patent and Market Court has now issued decisions and dismissed Novartis’ requests for preliminary injunctions.

Earlier this year, we reported that the Swedish Patent and Market Court dismissed Novartis’ action because the patent in suit was not yet granted.

The Appeal Court allowed proceedings to be started before the patent was granted

Novartis appealed the Patent Court’s decision to dismiss and was successful in the sense that the Appeal Court sided with them and agreed that they could start their infringement action before the patent was granted. Therefore, the Patent Court started the case, but in August dismissed the request for a preliminary injunction against Zentiva because the patent had not been formally granted, and there was only an intention to grant it at that time. Since then, the decision to grant the patent was published in October, and the patent was immediately validated in Sweden. The Patent Court was then in a position to decide on the preliminary injunction request. Novartis also started parallel infringement proceedings against Glenmark, Teva and Mylan.

Unsuccessful requests for preliminary injunctions

Zentiva had first argued that the patent should be revoked because of added matter, insufficiency of disclosure and lack of novelty. The Patent Court, however, dismissed these arguments and went on to review the question of inventive step.

Here, the Patent Court focused on prior art (D47) similar to prior art already considered by a Board of Appeal at the EPO (European Patent Office) in the prosecution of the patent. D47 described results from a clinical phase II study in which patients with RRMS (relapsing-remitting MS) were treated with daily oral doses of 1.25 mg and 5 mg FTY720 (the hydrochloride salt of fingolimod). It was also mentioned that a dose of 0.5 mg will be tested in a coming phase III study and that even lower doses than 0.5 mg had been considered in consultation with the FDA (US Food and Drug Administration).

The Patent Court concluded that the feature distinguishing the invention from D47 was the dosage. Based on this, the court formulated the problem for the skilled person starting from D47 as providing a further way to treat RRMS effectively.

Similarly to the Board of Appeal, the Patent Court took the view that the information about the clinical studies would have given the skilled person a reasonable expectation that a daily oral dose of 0.5 mg fingolimod would solve the problem unless the prior art would teach away from such a dosage scheme.

The Patent Court noted that the Board of Appeal had found that the prior art indicated that a dose of 0.5 mg would be insufficient to give the required lymphocyte reduction. According to the Board, this meant that the prior art effectively taught away from the invention. The Court, however, did not share this view.

Instead, based on an overall assessment of the cited prior art, the Patent Court believed that it does not appear as if the prior art would have led the skilled person away from using the suggested lower dose of 0.5 mg fingolimod. They, therefore, dismissed Novartis’ preliminary injunction request.

Novartis appealed the decision but was not given leave to appeal. The parallel cases against Glenmark, Teva and Mylan are following the same route, and Novartis’ requests for preliminary injunctions have been unsuccessful (with a minor exception in the case against Teva).

PHARMA

Teva v Bristol-Myers Squibb over the validity of EP 1 427 415 (apixaban) and related SPC

Bristol-Myers Squibb (BMS) sells a drug named ELIQUIS, used to treat thromboembolic disorders, preventing blood clots from blocking blood vessels. The drug contains apixaban; an inhibitor of an enzyme called factor Xa (fXa), which is a part of the blood coagulation process. One of the patents protecting ELIQUIS and apixaban is EP 1 427 415 (the patent) entitled “Lactam containing compounds and derivatives thereof as factor Xa inhibitors”. This is a case where Teva, which wanted to launch its own generic version of the original drug, sought revocation of the patent.

Teva raised grounds of added matter, insufficiency of disclosure, novelty, and inventive step.

A crucial priority claim

Starting with novelty, Teva relied on the international patent application WO 03/049681 (WO 681) as prior art. This application, however, had a priority date only after the patent’s priority date and, hence, would only be citable if the patent’s priority was not valid (and then as novelty-only prior art).

The facts underlying the patent’s priority were somewhat complicated. The application for the patent was a regional phase entry from WO 03/026652 (WO 652), filed by BMS, and claiming priority from US 60/324,165 (US 165). This US application was filed in the name of the two inventors, who were, at the time, employees of a different company than BMS. Hence, when BMS filed WO 652 and claimed priority from the priority application US 165, BMS needed to qualify as the “successor in title” of the inventors to US 165 under Art 87 EPC. Otherwise, BMS would have had no right to claim priority, and the priority would be invalid.

The Patent Court started by reviewing whether the inventors had transferred their rights to the priority application, including the priority right, to their employer (BMS Pharma, a wholly owned subsidiary of BMS). The court found that this was the case. The right to claim priority had been transferred to BMS Pharma.

The Patent Court then went on to assess whether BMS had acquired the rights to the priority application from BMS Pharma before BMS filed WO 652. This point was to be determined according to Delaware state court law. BMS did not rely on any formal assignment from BMS Pharma to BMS. It instead made the case that, according to the group’s internal policies, BMS was in control of the relevant intellectual property rights, including the priority application, to make it the factual (“beneficial” as opposed to “legal”) owner of the priority application. The court sided with BMS and found that it had proven it was the beneficial owner of the priority application at the relevant time. The court also concluded that this meant that BMS had become BMS Pharma’s successor in title in the meaning of Art 87 EPC when it filed WO 652.

It followed that the patent’s priority was valid, that WO 681 was not citable prior art, and that the patent had novelty.

Next was the question of the inventive step.

Inventive step turned on “plausibility”

It was common ground between the parties that WO 00/39131 (WO 131) was the closest prior art. The Patent Court considered that the claimed compound apixaban distinguished from the compounds described explicitly in the closest prior art in at least two positions. Apixaban has a lactam group as the B group and a different heterobicycle. The heterobicycle is the same for one of the prior art compounds, but apixaban has a carboxamide group in the position where the prior art compound has trifluoromethyl.

Next was the question of the technical effect and, in particular, whether an effect had been made plausible in the application for the patent. Teva argued that it had not. According to Teva, the application did not make it plausible that apixaban had any effect as an fXa inhibitor or at least not that it had any improved effect as compared to the fXa inhibitors disclosed in the closest prior art.

The Patent Court noted that the patent application contains a general description of certain tests but lacks an account for specific biological data. But then the court went on to underline that there is no absolute requirement that experimental data should be disclosed in a patent application. It can, in some cases, be sufficient with a mechanistic explanation or the skilled person’s common general knowledge.

The Patent Court concluded that the skilled person who studied the patent application would find it likely, given their common general knowledge, that apixaban was an fXa inhibitor. And, in the absence of something indicating the contrary, would not have found reasons for doubt. The lack of specific biological data would not have been enough to prompt the skilled person to question the function of apixaban. The evidence of the case had further not revealed anything else that would have given the skilled person reason to doubt the compound’s function as an fXa inhibitor. The answer was, therefore, “yes”; the effect had been made plausible.

After that, the Patent Court dismissed Teva’s argument that the invention lacked an inventive step in view of the closest prior art (WO 131) and the skilled person’s common general knowledge. Starting from the structurally most similar compounds in the closest prior art, the skilled person must make several separate and independent choices to get to apixaban. The skilled person would, therefore, not have reached the invention just given their common general knowledge.

The Patent Court also reviewed another inventive step attack and the alleged insufficiency of disclosure but dismissed these arguments rather swiftly.

Teva has appealed the decision, and we will continue to report in upcoming issues of this newsletter.

PHARMA

Biogen v Neuraxpharm over dimethyl fumarate product

Biogen is pursuing enforcement proceedings against Neuraxpharm for a dimethyl fumarate product for treating multiple sclerosis and has secured a preliminary injunction in Sweden. The action is based on EP 2 653 873 B1 relating to the dosage of the drug. Biogen’s original drug is TECFIDERA. Neuraxpharm is counterclaiming for the revocation of the patent.

Unusual ex parte injunction

Biogen started infringement proceedings this summer and convinced the Patent Court to issue a preliminary injunction against Neuraxpharm on an ex parte basis, which is unusual in Swedish patent proceedings. Neuraxpharm appealed, however, and managed to get the preliminary injunction lifted. The Appeal Court emphasised that there must be an urgency and a severe risk of irreparable harm for an ex parte injunction to be issued. The court was not convinced that this was true in the present matter.

Since then Neuraxpharm has filed a revocation action against the patent and is raising arguments of added matter, insufficiency of disclosure, novelty, and inventive step.

The Patent Court has now revisited the preliminary injunction issue, and the validity assessment at this stage evolved around the presumption of the patent’s validity which applies in preliminary injunction proceedings.

Presumption of validity not overturned

Neuraxpharm argued that the validity presumption should be set aside in the present matter because the EPO had overlooked considering certain third-party observations against the patent. Neuraxpharm also argued that the EPO had failed to consider WO 06/037342 and that this document was novelty-destroying. Lastly, it argued that the EPO had not considered whether certain prior art combinations meant that there was no inventive step.

This, however, did not convince the Patent Court, which reviewed the EPO’s communications and ruled that it could not see any mistake as alleged by Neuraxpharm. The court also considered that the prior art combinations advanced by Neuraxpharm did not appear to be closer to the invention than the prior art already considered by the EPO. The court, therefore, upheld the presumption of validity.

The Patent Court further considered that Neuraxpharm’s product was administered according to the claimed dosage regime and issued a preliminary injunction against the product. Neuraxpharm appealed the decision, but the Appeal Court refused to lift the injunction.

PHARMA

Update on Krka v Merck Sharp & Dohme over the validity of SPC for sitagliptin and metformin product

We have written about this case before in our December 2021 issue. Krka is pursuing revocation proceedings against Merck Sharp & Dohme (MSD). The revocation regards a Swedish SPC related to MSD’s diabetes medicines Januvia, Janumet, Velmetia, Ristfor and Efficib. The Patent Court has now issued its decision.

To present some background, MSD is the holder of EP 1 412 357 B1 (the patent) and the invention concerns compounds inhibiting the dipeptidyl peptidase-IV enzyme (DP-IV-inhibitors, DPP-IV-inhibitors or DPP-4-inhibitors). DP-IV-inhibitors are used mainly for the treatment of type 2 diabetes. One DP-IV-inhibitor is sitagliptin, and this compound was the first active ingredient among the DP-IV-inhibitors to receive a marketing authorisation (MA). MSD has been granted a Swedish SPC for the combination product sitagliptin and metformin hydrochloride, based on the patent and an MA for the drug Janumet (which is also marketed under the names Velmetia and Efficib). MSD has also been granted an SPC for the mono-product sitagliptin monohydrate phosphate, based on the same patent and an MA for the drug Januvia. The present case concerns the validity of the SPC for the combination product.

Krka argued that the requirements of Art 3 of the SPC regulation were not fulfilled and, hence, that the SPC had been incorrectly granted and should be revoked. The requisites set out in points (a)-(d) of this provision are notoriously difficult to apply and have led to a long series of case law, not least from the Court of Justice of the European Union (CJEU). The Patent Court assessed each of points (a), (c) and (d) carefully.

Art 3(a): is the product protected by the basic patent?

It was common ground between the parties that the basic patent protected sitagliptin, but Krka submitted that the combination product (sitagliptin and metformin) was not protected. According to Krka, the combination could not be considered protected by the patent unless the combination represented an independent innovation or was protected separately from sitagliptin in the patent.

Following a detailed review of the relevant case law from the CJEU, the Patent Court was not convinced by Krka’s argument. According to the court, it was sufficient that the combination was specified in the patent claims (which it was in certain dependent claims), and the combination was moreover specified in the patent description. Therefore, the court concluded that Art 3(a) was also fulfilled for the combination.

Art 3(c): has the product already been granted an SPC?

Krka argued that Art 3(c) is not fulfilled because MSD had already been granted an SPC for the mono-product. MSD can, therefore, not obtain an additional SPC for the active ingredient in combination with another ingredient, which is not protected as such in the basic patent. Krka also stressed that MSD filed the SPC application for the mono-product before the application for the combination product. As a result, it does not matter that the combination product had an earlier grant date than the mono-product.

The Patent Court, however, took a different view and stressed that what matters is whether the product has already been granted an SPC. This was not the case here. The SPC for the combination product was granted before the SPC for the mono-product. Hence, the SPC for the combination product was the first SPC to encompass sitagliptin. When the SPC for the combination product was granted, there was no earlier SPC preventing other manufacturers from providing sitagliptin alone or in combination with other ingredients. Moreover, when MSD filed the application for the combination product, there was no earlier SPC granted based on the patent. This means that Art 3(c) is fulfilled.

Art 3(d): is there an earlier MA for the product?

Krka submitted that Art 3(d) is not fulfilled because the MA for Janumet should not be considered the first MA for the product protected by the basic patent in the sense of the SPC regulation. Instead, the first MA is the one for Januvia. MSD was first granted the MA for Januvia and was only subsequently granted the MA for Janumet.

However, the Patent Court took a different view. The combination product meets the criteria for being a “product” pursuant to Art 1(b) of the SPC regulation. It follows neither from the wording of Art 3(d) nor from the CJEU’s case law that the product in Art 3(d) is something other than the product according to Art 1(b). Since the MA for Januvia does not encompass metformin hydrochloride, it does not concern the combination product and does not constitute the first MA for the relevant product. It follows that the MA on which the SPC is based – that is, the MA for Janumet – was the first MA in the meaning of Art 3(d).

SPC upheld

In summary, the Patent Court’s analysis concluded that the SPC for the combination of sitagliptin and metformin had been granted correctly in accordance with Art 3 of the SPC regulation and Krka’s action was dismissed.

Krka has appealed the case, and we will continue to update you in coming issues of this newsletter

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

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

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