English High Court rejects second injunction bid over melatonin medicine

Justice Mellor was unconvinced by arguments that Teva could have cleared the way.

The English High Court has rejected Neurim Pharmaceuticals' and Flynn Pharma’s application for interim injunctive relief against Teva for a second time.

In a  ruling handed down yesterday, June 29, Mr Justice Mellor refused Neurim’s second application to temporarily block Teva from selling its generic version of a melatonin medicine.

Neurim and Flynn (which markets and sells the melatonin product Circadin in the UK) had applied to prevent Teva from selling its generic product until expiry of the EP3,103,443 patent in seven weeks time.

The ‘443 patent is a divisional patent which claims the use of a prolonged release formulation of melatonin in a 2 mg dose for improving the restorative quality of sleep in a patient aged 55 years or older suffering from primary insomnia characterised by non-restorative sleep.

Mellor had rejected the first application for interim injunctive relief in late April. Since then, the English Court of Appeal had ruled in a melatonin dispute between Neurim/Flynn and Mylan, rejecting Mylan’s appeal. As a result, Mylan was injuncted from selling Melatonin Mylan and was ordered to take certain steps to retrieve infringing product from their customers.

On appeal, according to the court, Neurim and Flynn placed a heavy emphasis on the failure of Teva to clear the way, contending that the balance of the risk of injustice had changed along with the status quo.

“Neurim/Flynn contend that Teva had several opportunities to clear the way but I found these contentions unconvincing,” said Mellor.

He added: “First, Neurim/Flynn suggested that upon grant of the (divisional) patent, Teva could have taken steps in June/July 2021 to revoke it. This is unrealistic because even with an expedited trial, Teva would not have achieved a final cleared way probably until after expiry (assuming an appeal).”

According to Mellor, it was understandable for Teva to wait to see whether Mylan prevailed in its dispute.

“As I indicated in my first judgment at [87], the primary reason why Teva did not realistically have an opportunity to clear the way was because of Neurim/Flynn's own manoeuvring at the European Patent Office in allowing EP443 to be invalidated and then bringing forward the divisional to be granted with only slightly more than a year to expiry,” said Mellor.

On the status quo point, Mellor noted that the relevant status quo is that which existed at the date of deemed service of this second application notice (June 8, 2022). At this point, Teva had been on the market for nearly eight months and there was just over two months until expiry. According to the court, this pointed firmly in favour of no injunction.

“The fact that Neurim/Flynn have faced a highly unusual set of circumstances does not detract from that conclusion, particularly where Neurim/Flynn's own decisions contributed to the creation of those circumstances,” said Mellor.

He added: “Although this is scant consolation at present … I continue to have some sympathy for Neurim/Flynn because they are relatively small entities fighting two powerful generic entities. However, if Neurim/Flynn establish that the patent is valid and infringed by Teva, I have concluded they will receive adequate compensation and consolation then.

Additionally, Mellor ordered Neurim and Flynn to pay £100,000 towards Teva's costs and refused permission to appeal against the first rejection.

For an in-depth look at Mellor’s rejection of the first application for injunctive relief, written by Lydia Birch of EIP, click  here.