Teva repels PI application in Neurim’s fight against generics

EP 31 03 443 is a divisional of second medical use patent EP 14 41 702, which covers a prolonged-release formulation of melatonin in 2mg dose form. The drug helps improve sleep quality in patents aged 55 years or older. Neurim’s licensee Flynn owns and circulates a melatonin-based insomnia drug, marketed under the brand name Circadin.

Drug in circulation

In October 2021, Teva released its own melatonin-based products for insomnia onto the market. Consequently, Neurim commenced action against Teva, taking the position that Teva did not adequately clear the way before launching its generic drug.

Now the UK High Court has rejected Neurim and Flynn’s preliminary injunction request, which aimed to prevent the generic drug company from ‘disposing, offering for sale, selling or supplying’ a generic version of Circadin. The court has decided that, in granting the PI, the balance of risk of injustice would be on the side of the generic drug manufacturer.

The presiding judge also found that damages would not be an adequate remedy for Teva, either before or after the patent’s expiry. However, the judge noted that the imminent expiry of EP 443 likely prevented Teva from launching invalidity proceedings. Although the European Patent Office only granted EP 433 in June 2021, it expires in August 2022.

Teva on balance

Thus, on the balance of convenience, the presiding judge rejected the claimants’ request for interim injunctive relief. He also cited a lack of certainty over how, or if, a future downward price spiral in the market due to generic entry might impact Neurim. The judge also decided that damages would not adequately compensate Teva, should its products be taken off the market.

But the court also acknowledged that Neurim and Flynn face difficulties in challenging two major generics companies in separate proceedings. The judgment notes that, “Although achieving that state of affairs in this case might have been procedurally challenging, in the future consideration should be given to achieving that.”

Teva and Mylan in defence

This is the third action launched against a generic drugs company by Neurim and Flynn. The previous two actions have concerned generic drug company Mylan, now known as Viatris. In late 2020, the UK High Court found that Mylan infringed Neurim’s valid parent patent, EP 702. However, a few weeks later, the EPO Opposition Division found it invalid for insufficiency.

After Neurim withdrew its appeal against the invalidity verdict, the EPO revoked the patent in such a way that the UK court deemed the patent never to have existed. Then, in March 2022, the High Court found that Mylan also infringed Neurim’s divisional EP 443, which is also the subject of the Teva proceedings.

Initially, the court also refused to grant a stay of the injunction against Mylan, pending the appeal’s outcome.

Court of Appeal keeps busy

Paul Inman

But last week, the Court of Appeal handed down its judgment in the expedited appeal. The court dismissed the appeal against the first-instance decision, which found that Mylan infringes the divisional patent.

The company has also dropped its application for a stay of the injunction, pending the expiry of EP 443.

In another decision in April, the Court of Appeal determined that Flynn remains an exclusive licensee to Neurim. As such, despite having a limited scope of exclusivity, the company may bring patent infringement claims and seek relief against potentially infringing generics.

Pharma flexibility

Since Flynn is a licensee of Neurim, the London offices of Gowling WLG and Pinsent Masons acted side-by-side for the two plaintiffs. Pinsent Masons and Flynn have a long-standing relationship, with Nicole Jadeja the lead partner in this instance.

Nicole Jadeja

Clare Tunstall, who is head of IP and life sciences at Pinsent Masons, brought the client to the firm over ten years ago. At Gowling, Paul Inman led the case for Neurim.

The Anglo-Canadian firm is often seen on the side of originator drug manufacturers.

The London office of Bird & Bird worked on the proceedings for Teva, with a team led by Eleanor Root. The generic drug company is a regular client of the international firm, which also represents Teva in other jurisdictions such as Germany.

For Neurim/Flynn
Three New Square (London): Andrew Waugh
Gowling WLG (London): Paul Inman (partner) (for Neurim)
Pinsent Masons (London): Nicole Jadeja (partner) (for Flynn)

For Teva
8 New Square (London): Charlotte May
Hogarth Chambers (London): Edward Cronan
Bird & Bird (London): Eleanor Root (partner); associate: Josh Price

High Court of England and Wales, London
James Mellor (presiding judge)