English court gives Mylan green-light to sell generic insomnia drug
In a victory for Mylan, the English High Court has rejected Israel-based pharmaceutical company Neurim’s attempt to delay a generic version of its insomnia medication.
Justice Marcus Smith yesterday, June 3, refused to grant an interim injunction to Neurim, to stop Mylan’s alleged use of the patent-at-issue, EP(UK) 1,441,702 B1, which covers Neurim’s Circadin, a medication that contains melatonin and is used to treat insomnia.
While the patent was granted by the European Patent Office (EPO) in 2017, it was subsequently held to be invalid and was revoked by the EPO’s Opposition Division after opposition by Mylan and others.
This decision has been appealed against but, according to Smith, it’s unlikely that a final decision on the appeal will be made before 2022 at the earliest. “It is perfectly possible that there will be no decision until the patent has expired which, as I have said, will be on August 12, 2022,” said the justice.
In December 2019, Mylan obtained a marketing authorisation for its generic version in the UK, which "piggy backs" on Neurim's own marketing authorisation for Circadin.
Following American Cyanamid Co v Ethicon, the court weighed Neurim’s need for an injunction against Mylan’s need to be protected against injury resulting from having been prevented from exercising its own legal rights.
American Cyanamid outlines four stages to determine where "the balance of convenience" lies.
First, Neurim had to show that there is a “serious issue to be tried”—Smith said that “it is difficult to see how it could be said that there was no serious issue to be tried as to the validity of the patent”.
The court rejected Mylan’s argument, which relied on the EPO’s revocation of the patent and a refusal by the Patent and Market Court of Stockholm to grant an interim injunction in favour of the patent, that there wasn’t a serious issue.
“In some cases, the decisions of courts of foreign jurisdictions are entitled to great weight. This is not one of those cases. I have no idea what evidence was adduced before the Swedish (and other) courts; more to the point, I have no idea what test for the granting of interim relief these courts applied,” said Smith.
Second, the court looked at whether damages are an adequate remedy for Neurim, proceeding on the basis that Neurim would succeed at trial and obtain a permanent injunction against Mylan.
In concluding that damages were adequate, Smith added: “I also bear in mind that these consequential losses were always going to arise in the relatively near future, on the expiry of the patent in August 2022. All that my failure to grant an interim injunction does is to cause these consequences to vest early and (assuming the patent is indeed infringed) for the limited period.”
He added that the “rest of the generic herd is not going to be far behind”, and failing to grant an interim injunction against Mylan will open the door to other competitors.
However, according to the justice, while the entry of competitors would cause additional complications to Neurim’s damages claim in the proceedings, these additional complications are not sufficient to show that damages are not an adequate remedy.
While Neurim’s application for an interim injunction failed at the second stage of the American Cyanamid process, the justice went on to look at the remaining two stages.
Under stage three, the court considered whether Mylan's loss, in being deprived of the opportunity of competing in the market, is capable of being adequately compensated for in damages.
“My conclusion is that it would be materially harder to assess Mylan's loss than that of Neurim,” said the justice. “I do not say that it could not be done, but the uncertainties inherent in the process would be formidable, and considerably more difficult in my judgment than would be the case with the losses sustained by Neurim and Flynn were the interim injunction not to be granted.”
Finally, the court looked at stage four, where, if there is no remedy for either side, a balancing exercise must be undertaken.
Rather than coming to a conclusion on this stage, the justice offered up his views on submissions by the parties, refusing to put weight on Neurim’s argument that it is facing a “David against Goliath” battle.
An expedited trial in the proceedings is due to take place in a five-day window “floating” from October 26, 2020.
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