In the context of pharmaceutical patent cases involving branded originator patents and generic competitors, it's often (but not always) accepted that infringing market entry will cause unquantifiable damage by irreversible price depression, and therefore the only appropriate remedy is a preliminary injunction.

A clear statement by the offeror that the product will not enter the market until after patent expiry will, nonetheless, normally be sufficient to defeat a preliminary injunction against a party making an offer before expiry. 

Without such reassurance, however, activity suggesting that pre-expiry infringing acts are probable may be the subject of a quia timet preliminary injunction (that is, an injunction in advance, to prevent the infringement happening). 

In such cases, the court has to ask whether:

"…viewed in all the relevant circumstances, there was a sufficiently strong probability that an injunction would be required to prevent the harm to the claimant to justify bringing the proceedings. ..."

A mere possibility is not enough. 

It is not necessary, however, for a marketing authorisation to have been granted for quia timet relief to be awarded. So says Mr Justice Birss in Teva UK Ltd v Chiesi Farmaceutici SpA [2020] EWHC 1311 (Pat). In this case, Teva had started revocation proceedings against three patents relating to a combination of beclomethasone and formoterol in an inhaler. They had not yet obtained a marketing authorisation, but took care to make no statement either way about their intentions to launch before patent expiry.

Instead, they had offered 14 days notice of any launch. Chiesi counterclaimed for infringement of all three patents on a quia timet basis, on the footing that the claimant threatened and intended to infringe. Teva applied to have the counterclaim struck out on the basis that there was no threat or intention to infringe.

Birss J did not think there was any legal principle that a quia timet action cannot even be advanced without a marketing authorisation being pleaded, and found that Teva’s refusal to confirm its launch plans created a strong inference of the intention to launch before expiry, or that it sought to reserve the possibility of doing so: 

"If the claimant had wished to say that it did not intend to launch unless it succeeded in revoking the patent, then it had a clear opportunity to do so in the exchange of correspondence. It did not.">

As an application to strike out, the question for the court was not whether the pleaded material proved threatened and/or intended infringement, but only whether there is a real prospect of success of establishing that at trial. In this case there was such a prospect and the strike out application failed.

Forum: English Patents Court

Date: 2 June 2020