The Swedish pharma and life sciences litigation newsletter
IN THIS ISSUE
Peter Kenamets
Partner, Attorney-at-law
Lind.Edlund.Kenamets.
Fredrik Lüning
Partner, Attorney-at-law
Lind.Edlund.Kenamets
PHARMA
Novartis v Zentiva over generic fingolimod product
Novartis is adopting an innovative approach to preliminary injunction (PI) proceedings in Sweden. They pursue proceedings against Zentiva for infringement of EP 2 959 894 (S1P receptor modulators for treating multiple sclerosis) and requests a PI against Zentiva—even though Novartis’s patent is yet to be granted. The original product protected by the patent is Gilenya, a pharmaceutical drug containing the active substance fingolimod for disease modifying treatment of relapse remitting multiple sclerosis.
This is an unusual case. Novartis seeks to obtain an order restraining its generic competitor from entering the market in Sweden before the patent protecting the original product has been granted by the EPO. The Swedish Patent and Market Court, however, dismissed the action in its entirety in a decision in April this year and did not start legal proceedings.
The Patent Court ruled in short that Novartis’s action, no matter how it is worded, is based on an allegation of patent infringement and dismissed the case since the patent in question is not yet granted— even though it is about to be issued in a couple of months’ time, and the wording of the claims have been set by a Technical Board of Appeal.
Under Swedish law, the Patent Court noted, an action for so-called specific performance (e.g., a request for an injunction, or payment of damages—that is, not simply a declaratory action) can only be commenced once the time has come for fulfilment of the claim (e.g., payment or similar). The fact that the patent is not yet granted means that the time for fulfilment has not yet come.
This is also the case for the provisional patent protection, because an action to pursue such a claim also presupposes that a patent has already been granted. Therefore, Novartis has no legal basis for starting its legal action at this point. The Patent Court also felt that there are strong practical reasons to speak against allowing an early action of this type, because it would be very difficult to determine when such an action should be permissible.
The Appeal Court sides with Novartis
Novartis appealed the decision arguing that the Patent Court had misinterpreted when the time for fulfilment shall be due under procedural law (i.e., when the court decides on the merits of the case, rather than when the proceedings are started) and that effective patent protection requires allowing a PI action to be started before the grant of the patent.
The Appeal Court sided with Novartis and reversed the decision of the Patent Court and sent the case back with an order to start legal proceedings. The Appeal Court found that there is some support under Swedish procedural law for starting an action for patent infringement even before the patent has been granted. The Appeal Court firstly ruled that the suit shall be started if it can proceed effectively prior to the granting of the patent, and secondly decided that this is possible given the circumstances of the case.
Notably, the Appeal Court did not address the question of whether a PI can be issued while the patent is not yet granted. That will have to be decided by the Patent Court, unless the patent becomes effective in Sweden before the decision on the PI request is taken.
Opening for a drastic change in proceedings
This decision by the Appeal Court may lead to a drastic change to the framework of PI proceedings in Sweden. If the decision is followed and made into case law, and infringement proceedings may sometimes be commenced prior to the granting of a patent, it will be possible to decrease the time between the granting of the patent and a PI decision. It typically takes 3–4 months from the filing of the infringement action until a decision is taken on the PI request. If this procedural change is implemented, part of that time can be spent in parallel with the formal grant procedure. This is of course a great advantage for the patent owners.
We are naturally also curious to see if a PI can be issued before the patent is granted. If so, it raises the inevitable question of whether an alleged infringer can counter-sue before the patent is granted.
Hopefully we can return to these questions in the next issue of this newsletter.
MEDTECH
Update on Edwards Lifesciences v Meril Life Sciences regarding transcatheter heart valves
In the December issue (2021) we reported on the case between Edwards and Meril where Edwards pursued enforcement proceedings in Sweden against Meril for transcatheter heart valve technology. The matter has now been settled.
The proceedings ended successfully for Edwards, and Meril has admitted to Edwards’ claims and has withdrawn its own invalidity actions. The court therefore issued injunctions prohibiting Meril from marketing, selling etc. its MyVal heart valve and the Navigator delivery system in Sweden. The court also declared that Meril is liable to Edwards for damages and further awarded Edwards compensation for its legal costs for the proceedings.
LIFE SCIENCES
Decision reached in Illumina v MGI gene sequencing case
After two years of proceedings, the Swedish Patent and Market Court issued a judgment in February this year in a litigation between Illumina and MGI relating to DNA sequencing technology. This is the Swedish part of an international legal dispute that has been brought to the courts in several countries.
lllumina started proceedings against MGI over patents EP 3 002 289 (modified nucleotides for polynucleotide sequencing) and EP 1 828 412 (improved method of nucleotide detection). They claimed that MGI’s DNA sequencing systems are an infringement of their patents. MGI has supplied sequencing platforms and reagent kits to two academic institutions, Karolinska Institutet and Uppsala Universitet, in Sweden. MGI in turn filed countersuits for invalidity on grounds of added matter, sufficiency of disclosure, novelty, and inventive step against both patents. During the proceedings, the court also issued preliminary injunctions against MGI based on EP 289.
The court’s decision is an extensive 155 pages document and deals with many points of law and science. We will look at some of them below.
The court reaches conclusion on claims of invalidity
As summarized in the court’s decision, EP 289 concerns a modified nucleotide triphosphate molecule, a kit containing the molecule, and a method for determining the sequence of a single-stranded polynucleotide.
The purpose of the invention is to provide a nucleotide with a reversible blocking group which is suitable for use in DNA sequencing and synthesis. The blocking group can be removed under mild conditions such that there is no unwanted effect (like denaturation) on the DNA. The claims specify the blocking group to be a ‘3’-azidomethyl group’.
In the proceedings, Illuminate defended the patent as granted, but also filed no less than 41 amended claim sets as auxiliary requests.
The interpretation of the claim term 3’-azidomethyl group played a key role in the court’s assessment of the validity. The parties argued extensively on the interpretation of this term and submitted diverging expert evidence.
The point in dispute was whether the azidomethyl group binds (i) directly to the carbon atom in the 3’-position on the nucleotide’s sugar group or (ii) via an oxygen atom. MGI argued for the former and Illumina argued for the latter.
The court found that there was an ambiguity in the claim and turned to look at the specification. They found that it confirms that the binding takes place via an oxygen atom (that is, 3´-O-CH2N3 rather than 3´-CH2N3).
Based on this finding, the court proceeded to dismiss MGI’s arguments regarding added matter and sufficiency of disclosure.
The court then went on to try the question of novelty. MGI argued lack of novelty over prior art references
Lin and Oksman. The court emphasized that the novelty assessment is strict and quickly dismissed the attack.
Next was the question of an inventive step. MGI ran two types of arguments. Firstly, it argued that the invention lacks a technical effect and therefore is obvious. Secondly, it argued that the invention lacks an inventive step in view of certain prior art references.
As to the first argument, MGI claimed that sequencing by synthesis (SBS) requires a detectable marker tied to the nucleotide and that the product claims do not specify such a marker. Therefore, the desired technical effect (to use the molecule in SBS) is not achievable, at least not across the full scope of the claims. MGI referred here to T 939/92 Agrevo. The court, however, was not persuaded by the argument. It concluded that the evidence in the case showed that unmarked nucleotides can also be used in SBS methods. The court also generally took the view that the facts of the present case distinguished it from the facts in Agrevo.
In its second inventive step argument, MGI brought forward several prior art references (Meztker, Zavgorodny (1991), Oksman, Tsien and Ju) as well as the general knowledge of the skilled person. The court, however, dismissed this argument as well and found that the invention indeed involved an inventive step.
The court therefore concluded that EP 289 should be upheld with the claims as granted.
Next was EP 412. This patent relates to the use of ascorbic acid or a salt thereof as a component in a fluorescent imaging buffer. The ascorbic acid is used at the detection step in SBS and mitigates photodamage to DNA by reducing damage to the nucleic acid. This improves the efficiency of the sequencing process.
Illumina did not defend EP 412 as granted, but eventually relied on four amended claim sets.
One of the first points the court tried regarded added matter. The court notably found that there was support for the attacked claim amendments inter alia in documents referenced in the specification of the application as filed. MGI had objected that the inclusion of a reference to a cleavable linker (via which a fluorescent label is linked to the base of the nucleotide) in claim 1 amounted to added matter. The specification of the application as filed referred to two other international patent applications. It was stated in the specification that the linkages disclosed in those two international applications could be used in the invention. In the court’s view, this was sufficient basis for the amendment.
The court further held that the claim amendments conferred novelty to the claim over prior art reference US 6,355,420.
The remaining point for the court to assess was inventive step. MGI argued lack of an inventive step based on several prior art references (Braslavsky, Buechler, WO 00/70073 A1, Dittrich, Ying, Rothwell and van Dijk) as well as the general knowledge of the skilled person.
The court, however, found that the invention was a problem invention in the sense of T 764/12. The inventors had identified a problem which had previously not been observed: the nucleic acid template
needs protection against damage caused by light from the repeated and intense illumination used for reading the incorporated fluorophores. This conferred an inventive step to the invention over Braslavsky. The court also dismissed the other prior art references, concluding that Buechler concerns a different technical area and focuses on the effect of long-term storage on biological reagents.
This in summary meant that the court upheld EP 412 (as amended, including a cleavable linker). We note that this contrasts with an earlier decision from the UK, where EP 412 (as granted) was held invalid for obviousness reasons.
Infringement claims determined
As to EP 289, the court noted firstly that MGI did not contest that the reagent kits delivered to Karolinska Institutet and Uppsala Universitet contained a modified nucleotide where one azidomethyl group binds to the 3´-position in the sugar group via an oxygen atom in a certain way. Considering the court’s interpretation of the claim term 3´-azidomethyl group (see above), the modified molecule fulfils all elements of claim 1. Therefore, the kits infringe on EP 289.
Secondly, Illumina contended that the sequencing platforms that MGI had delivered made MGI liable for indirect infringement of a method claim in the patent. To prove its case, Illumina submitted a PPD (Product and Process Description) document from proceedings in the UK. The court was convinced that the document described the same technology as the one relevant in the Swedish proceedings. Again, the turning point was the interpretation of 3´-azidomethyl group. MGI argued that the platforms are not suitable and intended for a method in which the binding takes place directly. But, with the court’s interpretation that the binding takes places via an oxygen atom, that argument became moot.
The next point for the court to decide was whether the reagent kits are a direct infringement of EP 412.
Illumina had investigated kits which the court considered to be representative of the kits that MGI had delivered to Karolinska Institutet and Uppsala Universitet. One point of dispute was whether the kits contained ascorbic acid (or a salt thereof). According to MGI, they did not, even though the buffer contains ascorbate ions. These are different molecules and the ions in the buffer are not a salt, MGI argued. The court, however, interpreted the term ascorbic acid as referring to either ascorbic acid or ascorbate ions, depending on the pH of the solution. The conclusion was that the reagents kits (which are StandardMPS) were an infringement on the patent.
As a last point to note here, the court reviewed the question of joint liability for infringement. Three MGI companies—all subsidiaries of another MGI company—were charged as infringers. They were alleged to have acted as one unit, to be jointly liable. There was also the issue of whether the defendant companies could be held liable for contributing to or aiding each other’s infringing acts. The defendant companies were all a part of the same group, which offers the accused sequencing technology. This alone, however, was not decisive for the question of joint liability. The court reviewed the defendant companies’ supplies of sequencing platforms and reagents kits in detail and partly awarded joint liability. The evidence showed that all infringement acts had a clear factual connection, because the defendant companies had cooperated to supply the products. The court held that one of the defendant companies, which had the agreement with Karolinska Institutet, had contributed to and aided the acts of the other two defendant companies. The acts of these two other defendant companies meant that the contractual obligations toward Karolinska Institutet were met. Accordingly, the court put a significant weight on what company formally had the contractual obligation to supply infringing products when it distributed the responsibility.
MGI has appealed the case and we will continue to report in the next issue.
