Patent litigation in Ireland: patent infringement and preliminary injunctions

This follows the Supreme Court recalibration of the test for preliminary injunctive relief in 2019 in another pharmaceutical patent case, MSD v Clonmel.

Read more on this topic

• Patent litigation in Ireland: Irish patent system
• Patent litigation in Ireland: pre-action steps and initiating proceedings

Acts of direct infringement

Section 40 and 41 of the Patents Act 1992 (the Irish Patents Act) govern direct and indirect infringement respectively.

Under section 40, a patentee can prevent third parties from carrying out the following acts with respect to its Irish patent:

• making, offering, putting on the market or using a product which is the subject-matter of the patent, or importing or stocking the product for those purposes
• using a process which is the subject-matter of the patent, or, when the third party knows, or it is obvious to a reasonable person in the circumstances, that the use of the process is prohibited without the consent of the proprietor of the patent, offering the process for use in the state
• offering, putting on the market, using or importing, or stocking for those purposes, the product obtained directly by a process which is the subject-matter of the patent.

Infringing acts are classified according to whether the invention is a product, a process, or the product of a process. The onus of proving infringement always rests upon the patentee.

Notably, under the Irish Patents Act, a patent application shall, on and from the date of its publication, provisionally confer upon the applicant such protection with respect to direct and indirect acts of infringement.

Acts of indirect infringement

Section 41(1) provides that a patent holder can prevent third parties from supplying or offering to supply in Ireland a person, other than a party entitled to exploit the patented invention, with means, relating to an essential element of that invention, for putting it into effect in Ireland, when the third party knows, or it is obvious in the circumstances to a reasonable person, that those means are suitable and intended for putting that invention into effect.

Section 41(2) of the Act provides that section 41(1) shall not apply to the supply or offer of a staple commercial product unless the supply or offer is made for the purpose of inducing a direct infringement.

Acts exempt from infringement

Section 42(1) of the Irish Patents Act provides for a number of acts that are exempt from infringement.

This includes private and commercial acts, acts done for experimental purposes, extemporaneous pharmaceutical preparations, acts done on transiently visiting ships and aircraft, clinical or veterinary trials of medicinal products, and acts specified in article 27 of the Convention on International Civil Aviation where those acts concern foreign aircraft.

Acts done in conducting studies, tests, experiments and trials, including clinical trials and field trials, with a view to satisfying the application requirements for marketing authorisation that is required to sell or supply a medicinal product for human use or veterinary medicinal product are also exempt.

Statement of claim, defences and counterclaim

In proceedings for patent infringement the statement of claim must include or accompany particulars which:

• state which of the claims in the specification of the patent are alleged to be infringed; and
• give at least one example of each type of infringement alleged.

Apart from the statutory acts listed above that are exempt from infringement, defendants can also ground a defence on the following bases:

• a patent that is invalid cannot be infringed
• the doctrine of exhaustion provides that a patentee cannot prevent further circulation of goods within the EEA, when the patents rights have been exhausted in the EEA; and
• abuse of dominant position under EU competition rules contained in article 102 of the Treaty on the Functioning of the EU.

It is also a defence to an order for damages or an account of profits if the defendant proves that, at the date of the infringement, they were not aware, and had no reasonable grounds for supposing, that the patent existed.

The required contents and procedure for service of the defence and counterclaim are set out in Order 21 of the Rules of the Superior Courts.

Where separate proceedings have not been issued for invalidity, and where the defence to infringement involves a plea of invalidity, a counterclaim for revocation of the patent should be included with the defence. Grounds of invalidity should be delivered in conjunction with this type of counterclaim.

Where a defendant has delivered a counterclaim, the plaintiff will be given an opportunity to deliver a reply and defence to the counterclaim.

Where a defendant intends or proposes to offer expert evidence on any matter, including on any matter arising only in connection with a counterclaim, at the trial, the defence or the counterclaim should disclose that intention or proposal and state succinctly the field of expertise concerned and the matters on which expert evidence is intended or proposed to be offered.

Disclosure in the form of product or process description

Under the Rules of the Superior Courts, a defendant in patent infringement proceedings may notify another party of its intention to deliver full particulars of the features of the product or process alleged to infringe or breach another party’s rights and any necessary drawings or other illustrations.

Remedies for patent infringement in Ireland

Section 47 of the Irish Patents Act provides for the potential types of relief available for patent infringement in Ireland. Claimants may apply for:

• an injunction
• an order for delivery or destruction
• damages
• an account of the profits for declaratory relief
• a declaration that the patent is valid and has been infringed.

The court must elect between an award of damages or an order for an account of profits, as both may not be awarded by the High Court in respect of the same infringement. Additionally, the Rules of the Superior Courts provides for the rules that govern the granting of interlocutory orders.

Post-expiry relief or ‘springboard’ relief concerns injunctions that are granted for a specified period after the date of expiry of a patent. These types of injunctions act as an alternative to damages for this same period. The purpose of this relief is to cover a legitimate secondary loss or damage that is not caught by usual relief granted in patent cases. Springboard relief has not previously been granted in relation to patent proceedings –however, based on the wide powers to grant relief under statute, it appears that the Irish courts could grant such an injunction, where appropriate.

Modularisation

Patent actions may be split or bifurcated into two separate trials. The first module is typically of liability - infringement and invalidity. The second module is of the quantum of damages. However, the default position is that trials should be unitary. The key consideration is the fair administration of justice and avoidance of the risk of injustice. Whether the proceedings are complex and likely to lead to savings in costs and time is another principle to be considered when assessing a modularisation application.

Calculation of damages

The principle underlining an award of damages or account of profits is that damages are intended to restore the claimant to the position they would have been in, but for the infringement. Where the claimant does not manufacture the invention or licence the patent to third parties, quantum of damages may be assessed by regard to a reasonable royalty rate. In more complex applications, specialist market evidence may be required in order to properly assess damages.

Preliminary injunctions

Interim or interlocutory injunctions are commonly sought by patentees pending the outcome of infringement proceedings. An interim injunction is a short-term relief which is applied for ex-parte - without notice to the other party. These are typically granted in circumstances where there is an imminent threat by an alleged infringer to launch an infringing product. An interlocutory injunction application is made on notice to the other party. The respondent will be given time to submit a replying affidavit in response, and usually written legal submissions are exchanged in advance of the hearing of the application. If ordered, an interlocutory injunction typically remains in effect until the conclusion of the High Court infringement proceedings.

In addition to interim or interlocutory injunctions, patentees may seek Anton Piller (search and seizure) orders and Mareva (asset freezing) injunctions.

MSD v Clonmel test

Before the 2019 Supreme Court decision in MSD v Clonmel, the applicable test in interim and interlocutory injunctive proceedings in Ireland was taken from a 1975 English civil case, American Cyanamid Co. v. Ethicon Ltd., adopted in Ireland as the ‘Campus Oil test’ (in the 1983 case Campus Oil v. The Minister for Industry (No. 2)). This was essentially a three-stage test where the court considered:

• whether there is a serious issue to be tried
• whether damages would be an adequate remedy for the applicant or the defendant; and 
• if damages would not adequately compensate either party, where the balance of convenience lies and whether to preserve the status quo. 

Most applicants fell at the second hurdle, as it was understood that a patentee’s loss was generally capable of being compensated in damages. Under a reformulated test, the Supreme Court in MSD v Clonmel noted that adequacy of damages should not be treated in isolation and must be assessed as part of the balance of convenience. Difficulty in calculating damages, as opposed to impossibility of calculating damages, may be sufficient to tip the balance in favour of the applicant when weighed together with other factors. 

The Supreme Court referred to several factors that might be weighed in assessing the balance of convenience in appropriate cases including: whether the respondent has taken steps to clear the path; the difficulty in calculating damages for either party; the loss of ‘first mover advantage’ by the respondent; the presumptive validity of the patent/SPC; and the strength of any invalidity arguments- including by reference to successive decisions in other jurisdictions in relation to the validity of the patent. The Supreme Court also stressed that the test should be flexible.

Subsequent interpretations of the MSD v Clonmel decision have tended to result in an injunction being granted in favour of the patentee. There has been one exception where an injunction was refused by the High Court in circumstances where the patent in suit was revoked at the High Court, and the patentee sought an injunction pending the outcome of its appeal to the Court of Appeal. This decision was recently overturned by the Court of Appeal.

The law continues to evolve in this area.

The future: fast relief at the UPC?

Ireland is a signatory to the Unified Patent Court Agreement (UPCA), but cannot yet ratify the UPCA without a public referendum to approve it. If Ireland ratifies the UPCA, this will allow Irish litigants access to the Unified Patent Court (UPC) and Unitary Patent (UP). Once Ireland ratifies the UPCA, UPC decisions may have effect in Ireland.

The approach of the UPC to assessing preliminary injunction applications appears to resemble the Irish courts approach in that the UPC courts consider whether the validity of the patent at issue in proceedings before the European Patent Office or a national part of the patent at issue before a national court is a strong indication of sufficiently certain validity.

There are different procedural measures available to parties within the UPC system which do not currently feature in patent litigation in Ireland. For patentees, there is the opportunity to seek orders to preserve evidence and inspect premises under article 60 of the UPCA. Although it is possible to seek an Anton Pillar order in Ireland, recent UPC case law arguably demonstrates that a lower evidential threshold in relation to infringement and risk of destruction of evidence is applied to applications under article 60.

Furthermore, the UPC allows for the filing of ‘protective letters’ which can be a useful strategy for defendants if there is a risk of a patentee applying for a preliminary injunction or other provisional measures ex parte. A protective letter, in essence, is a pre-emptive statement of defence including arguments why a product does not infringe a particular patent. Having such a letter on file allows the UPC to exercise its discretion by taking the protective letter into account when considering whether to grant certain provisional measures.