Ireland: Patent Litigation

Patents in Ireland are principally governed by the Patents Act 1992, as amended (the “Patents Act”). The Patent Rules 1992, as amended, prescribe the related procedural rules. Actions for infringement of a patent must be brought before the High Court. The Commercial Court is a division of the High Court and patent disputes are generally transferred into that division. Cases admitted to the Commercial Court are subject to a case management system intended to ensure that they are progressed in a manner which is “just, expeditious and likely to minimise the costs of proceedings”. In October 2021, a new Intellectual Property and Technology list was established as a sub-division of the Commercial Court. This new specialised Intellectual Property and Technology List (the “IP & Technology List”) covers all intellectual property related proceedings involving both registered and unregistered intellectual property rights. In the circumstances, disputes in respect of patents, trademarks, passing off, copyright, supplementary protection certificates (“SPCs”), industrial designs, community designs, trade secrets, confidential information and plant variety rights may be dealt with in the new list.

Upon making an application for entry to the Commercial List of the High Court, parties will now be able to specify or request that their proceedings be assigned to the dedicated IP & Technology List.

Actions seeking revocation of an Irish patent must be brought before the High Court or the Controller of Intellectual Property (the “Controller”).

Actions for infringement of a short-term patent (which last for a maximum of 10 years) may be brought in the High Court or Circuit Court (a Court of local and limited jurisdiction).

There is no set time limit within which a case has to reach trial. The time taken will depend on the complexity of the case, the number of witnesses and whether there are pre-trial disputes on issues such as discovery. Cases in the Commercial List generally reach trial within 12 to 18 months from commencing proceedings. Ireland is a common law jurisdiction, and each party must set out its case by means of the exchange of pleadings, witness statements (including experts) and written legal submissions.

Patent proceedings are heard by a single judge without a jury. It is a fundamental principle of the Irish law of evidence that witness testimony is given by word of mouth. However, in patent cases, it is frequently agreed that the written witness statements will be taken as evidence in chief subject to elaboration and to the opponent having a right to cross examine. Written legal submissions are exchanged in advance of trial, and oral legal submissions are generally made at the opening and closing of the trial.

A Plenary Summons is used to commence infringement proceedings and a Petition is used to commence revocation proceedings.

The procedural stages which must be adhered to by the parties are as follows:

• Issue of Plenary Summons (infringement) or Petition (revocation) by the plaintiff;
• Entry of Appearance;
• Delivery of Statement of Claim and Particulars of Infringement (or Particulars of Objection) by the plaintiff (petitioner);
• Delivery of Notice for Particulars by the defendant seeking further details of the material facts being relied upon by the plaintiff;
• Delivery of Defence (to infringement) and Counterclaim (if any) (seeking revocation);
• Delivery of Notice for Particulars by the plaintiff relating to the Defence and Counterclaim (if any);
• Reply (and Defence to Counterclaim) by the plaintiff: this closes the pleadings;
• Discovery;
• Exchange of Witness Statements, expert reports and other pre-trial steps including details of experiments (if required) followed by the exchange of Legal Submissions; and
• Trial.

In the Commercial Court, these procedural stages must be complied with according to directions given by the judge in charge of the Commercial List at various stages, including the initial directions hearing, the case management conference and the pre-trial conference.

Initial directions are made by the Court upon, or soon after, entry of the case into the Commercial List and usually provide a timetable for the exchange of pleadings. A case management conference will be held following the close of pleadings to ensure that, amongst other things, initial directions have been complied with, whether discovery is required, that the issues of fact and law in dispute are defined and/or that all pleadings have been delivered.

Under the revised Order 63A of the Rules of the Superior Courts (revised Rules), the judge in the IP & Technology List may determine that proceedings should be heard on affidavit only, or alternatively on affidavit with oral evidence on specific issues. For the first time, the Court may also direct that a technical primer be prepared.

Pre-trial conferences may be held before a case goes to trial in the Commercial Court so that the Court has a clear picture of the state of the case before trial. At this conference, a judge will also seek to establish practical issues such as a timetable for the trial and whether any special technological arrangements may be required.

The trial commences with opening submissions from the parties, followed by examination and cross-examination of expert and fact witnesses, and closing submissions.

Yes, interim and final decisions may be appealed to the Court of Appeal as of right. Leave to Appeal is not required. The appellant has 28 days (for an ordinary appeal) and 10 days (for the appeal of an interlocutory order) from the date on which the order of the High Court is perfected to lodge any appeal.

If a preliminary injunction is refused and the first instance Court refused for example to grant a stay on the lifting of any ex-parte/temporary injunction that may have been granted, an application could potentially be made to the Court of Appeal for a stay on the lifting of the ex-parte injunction pending appeal. An appeal from a preliminary injunction decision would be heard by the Court of Appeal and this would typically take about 6-12 months unless the Court agreed that the matter was particularly urgent. If the Court agreed that that the appeal was urgent, it could be heard within 2-6 weeks.

An appeal against a first instance decision on a combined infringement/invalidity action usually takes around 6-12 months, depending on whether an expedited appeal is granted or not. The duration of an appeal hearing before the Court of Appeal would typically be 2-4 days, depending on the number of issues involved. If an expedited appeal is granted, an appeal could come on within a matter of months.

Similarly, in an appeal to the Supreme Court, if leave to appeal is granted (usually within a few weeks) and the Supreme Court grants an expedited appeal, the matter could come on for hearing within 4-6 months of the Court granting leave. The duration of an appeal hearing would generally be 2–3 days. The total duration of second instance appeal proceedings would be around 6-9 months (in case of an expedited appeal).

The filing of an appeal does not operate as a stay on the execution of a decision. The grant of a stay pending an appeal is entirely at the discretion of the Court.

Section 40 of the Patents Act sets out the acts which amount to direct infringement. It provides:

“A patent while it is in force shall confer on its proprietor the right to prevent all third parties not having his consent from doing in the State all or any of the things following:

(1) 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;

(2) 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;

(3) 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.”

Yes. Indirect infringement arises where a third party, without the consent of the patent proprietor, supplies or offers to supply a person (other than someone entitled to exploit the invention) in the State with means, relating to an essential element of that invention, for putting the invention into effect in the State, when the third party knows or it is obvious in the circumstances to a reasonable person, that the said means are suitable and intended for putting the invention into effect (section 41, Patents Act).

Where the means supplied are staple commercial products, the patent proprietor must show that the defendant induced the person supplied to infringe the patent.

The leading authority in Ireland on construction of claims remains the decision in Ranbaxy Laboratories v Warner Lambert [2009] 4 IR 584 where Clarke J in the Irish High Court approved at paragraph 31 the then leading case in the UK of Kirin Amgen v Hoechst [2005] RPC 9. The central question of patent construction is;-

“What would a person skilled in the art have understood the patentee to have used the language of the claim to mean.”

The applicable law and principles are comprehensively addressed by Clarke J in his judgment. The starting point is Article 69 (1) of the European Patent Convention (“EPC”) which states that the extent of the protection conferred by a European patent “shall be determined by the claims” and that the “description and drawing shall be used to interpret the claims”.

In the Ranbaxy judgment Clarke J noted that the claims of the patent were to be construed purposively, the inventors purpose being ascertained from the description and the drawings, and at paragraph 30 of his judgment he noted the statement in Catnic v Hill [1982] RPC 183 by Diplock that:-

“a patent specification should be given a purposive construction rather than a purely literal one. The question in each case is: Whether persons with practical knowledge and experience of the kind of work in which the invention was intended to be used, would understand that strict compliance with a particular descriptive work and phrase appearing in the claim was intended by the patentee to be an essential requirement of the intervention so that any variant would fall outside the monopoly claimed, even though it could have no material effect upon the way the invention worked.”

Clarke J approved the statement in the UK case law that:

“……it follows that if the patentee has included what is obviously a deliberate limitation in his claims, it must have a meaning. One cannot disregard obviously intentional elements… the well-known principle that patent claims are given a purposive construction does not mean that an integer can be treated as struck out if it does not appear to make any difference to the invented concept. It may have some other purpose buried in a prior art and even if this is not discernible, the patentee may have had some reason of his own for introducing it.”

Clarke J therefore approved the statement that followed that there was no general “doctrine of equivalents”. However:

“On the other hand purposive construction can lead to the conclusion that a technically trivial or minor difference between an element of a claim and the corresponding element of the alleged infringement nonetheless falls within the meaning of the element when read purposively. This is not because there is a doctrine of equivalents: it is because that is a fair way to read the claim in context.”

Clarke J then set out his own views upon patent construction in the light of these principles and summarised his approach as follows at paragraph 3.32;-

“a Court [will] lean against a construction for which there is no rational basis from the perspective of the patentee. That is not to say that the Court will enter into a detailed analysis of the sort of consideration that might have entered the patentee’s mind. The issue of construction is to be addressed from the perspective of a skilled addressee. That skilled addressee must be taken to know what the purpose of the patent is and the basic principles of patent law which would inform any person as to the general way in which a patent application would be formulated. If, from that perspective, a particular construction would immediately seem to the skilled addressee to be irrational, then there seems to me to be no reason in principle why the Court should not take that fact into significant account in the construction exercise. I propose approaching the question of construction on that basis.“

Whilst the Irish Courts have adopted the purposive construction taken by the UK Courts in Kirin-Amgen v. Hoechst, rather than a purely literal construction, it remains to be seen whether the Irish Courts will reconsider the position in light of the decision in Eli Lilly v Actavis [2017] UKSC 48, where the UK Supreme Court introduced a new two-stage test that introduces an explicit doctrine of equivalents.

Consent, express or implied, is a defence to patent infringement. A defence may also arise in connection with the limitations on the effect of a patent provided for in section 42 of the Patents Act. Essentially, the rights conferred by a patent do not extend to:

1. Acts done privately for non-commercial purposes;
2. Acts done for experimental purposes relating to the subject matter of the relevant patented invention;
3. The extemporaneous preparation for individual cases in a pharmacy of a medicine in accordance with a medical prescription issued by a registered medical practitioner or acts concerning the medicine so prepared;
4. Certain use of the invention on board foreign registered vessels;
5. Certain use of the invention in the construction or operation of certain aircraft or land vehicles; and
6. Acts done in relation to the subject matter of the relevant patented invention which consist of acts done in conducting the necessary studies, tests and trials to demonstrate the efficacy and safety of a product which are conducted with a view to enabling a producer to obtain a marketing authorisation in preparation for the expiry of patent. This is commonly known as the Bolar exemption.

The Patents Act sets out a number of additional defences which may be available to a defendant, including:

• The rights conferred by a patent do not extend to any acts which, under the obligations imposed by the EU treaties, cannot be prevented by the patent proprietor (section 43, Patents Act).
• Where a patent has lapsed bona fide and a third party commences or makes serious preparations to do an act that would constitute an infringement if the patent had not lapsed, that person has the right to continue such acts even if the patent is subsequently restored (section 37, Patents Act).
• A person who before the date of filing of the patent application or the priority date, does in good faith an act that would constitute infringement of the patent if it were then in force or makes in good faith effective and serious preparations to do such an act has the right to continue to do that act (section 55, Patents Act).

Invalidity may be raised as a defence to infringement proceeding or during stand-alone revocation proceedings. Issues of infringement (if any) and validity are heard in the course of the same proceedings.

A patent may be revoked on the grounds that:

• the subject-matter of the patent is not patentable under the Patents Act;
• the specification of the patent does not disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art;
• the matter disclosed in the specification of the patent extends beyond that disclosed in the application as filed;
• the protection conferred by the patent has been extended by an amendment which should not have been allowed; or
• the registered proprietor of the patent is not entitled to the patent (by reason of the fact that he is, for example, neither the inventor nor his employer). (Section 58, Patents Act)

The test for obviousness under section 13 of the Patents Act is the same as under the EPC, namely, that the invention shall be considered as involving an inventive step if, having regard to the state of the art, it is not obvious to a person skilled in the art. The state of the art comprises everything made available to the public anywhere in the world by means of a written or oral description, by use or by any other means before the priority date.

In Re Glaxo Group Ltd [2009] IEHC 277 Charleton J at paragraph 29 accepted the four stage methodology for approaching the issue in Pozzoli v. B.D.M.O. [2007] F.S.R. 37 at paragraph 23:-

“1 (a) Identify the notional “person skilled in the art”;

(b) Identify the relevant common general knowledge of that person;

2. Identify the inventive concept of the claim in question or if that cannot readily be done, construe it.

3. Identify what, if any, differences exist between the matter cited as forming part of the “state of the art” and the inventive concept of the claim or the claim as construed;

4. Viewed without any knowledge of alleged invention as claimed, do these differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of invention?”

As set forth at paragraph 43 of in Re Glaxo, the common general knowledge is the technical background of the notional man in the art against which the prior art must be considered, and is not limited to what the notional addressee has memorised, but includes all material in the field which he knows to exist and which he would refer to and which he understands is generally regarded as sufficiently reliable.

In Glaxo Charleton J suggested a general preference for the problem/solution approach of the EPO, but it is clear that the EPO approach of permitting reliance only on the closest piece of prior art is not followed in Ireland – a challenger may cite as many pieces of prior art as it pleases.

At paragraph 44, the Court accepted that:-

“to common general knowledge must be added any knowledge that a skilled person would acquire before he embarks on the problem to which the patent purports to provide the solution… in addition to common general knowledge, I must examine what the prior art on the issues in this case teaches the skilled team.”

In respect of “mosaicing” pieces of prior art, Charleton J in Glaxo stated at paragraph 44:- “Since pulling together several pieces of prior art may itself amount to innovation, a mosaic of several pieces of prior art is not inherently likely to be obvious. Where a cross-reference exists in prior art, however, it may be otherwise. Where a piece of information is common to the team in this area, such may be common general knowledge. Where a member of the team has a piece of prior art, properly so considered, it is to be expected for him or her to share it with the team. As the team will have different specialities, I see no reason why they would not add to the discussion as to the prior art, provided the team remains uninventive. The caution against mosaicing is an aspect of the proper approach to obviousness. By unthinkingly applying that caution, the statutory test of obviousness may be lost sight of… the nature of the interaction between the pieces of prior art must be such as to require an inventive step before the test for registration of a patent under the 1992 Act, and under the Convention, can be met… the question is: Is there anything about putting together (a) and (b) or whoever number of pieces of prior art, which is inventive? My view in this case is that the use by the team of the pieces of prior art cited does not attract the caution reminding me that a mosaic is, of its nature, inventive.”

Section 38(2) of the Patents Act provides that the Court or the Controller, as the case may be, may, in the course of invalidity proceedings, allow the patent proprietor to amend the specification of the patent in such a manner as the Court or the Controller thinks fit and subject to such terms as to advertising the proposed amendment and as to costs. Any such amendment is deemed to have had effect from the date of grant of the patent.

It is not possible to extend the duration of a patent; however, a form of ‘extension’ is available in relation to patents for medicinal and plant protection products to which the Supplementary Protection Certificate (“SPC”) regime applies. An SPC does not extend the duration of the patent itself, but only the protection for the specific product which is the subject of the marketing authorisation. The SPC takes effect from the expiry of the basic patent covering the product for a maximum term of five years. An SPC for a medicinal product may also be extended for a further six months if it has undergone the appropriate paediatric testing.

Expert evidence plays a central role within patent litigation in Ireland. The construction of the patent claims is an issue solely for the Court however the Court’s task is to read the claims through the eyes of the skilled person in the art and the expert’s role is to enable the Court to undertake that task. The purpose of an expert in a patent case is to clothe the Court in the mantel of expertise worn by the witness, so the Court may make its own decision.

In Re Glaxo Group, Charleton J characterised the skilled team or addressee as being “an ordinary practitioner in the field of technology who is aware of what was common general knowledge in the art as of the relevant date.”

Accordingly, the expert witness may give evidence as to the state of the art at any particular time, to address technical terms, to address whether the specification allows the invention to be carried into effect, to address what the patent would have taught him or her on any given hypothesis and whether a variation from the precise terms of the patent would have a material effect upon the operation of the patented invention. Certain economies of scale and cost savings obviously arise in addressing both validity and infringement in one set of proceedings before the Irish Court. For example, the expert report(s) would generally deal with both issues and the matters are usually heard and dealt with together in the context of the same hearing.

As mentioned above, in advance of the hearing, the Court may also direct that a technical primer be prepared.

Pre-Action Measures – methods for obtaining evidence and information

There is no procedure for pre-action orders for inspection and samples and/or saisie-type proceedings.

There are two possible options that are available to a patentee in Ireland to obtain information on a potential infringement are set out below:

i. Norwich Pharmacal Order

It is well settled in Ireland that the Courts have jurisdiction to make an Order for Discovery in an action that has been instituted solely for the purpose of establishing the identity of the wrongdoer on the basis that it may be of considerable value towards the attainment of justice. In Megaleasing UK Limited v. Barrett [1993] ILRM 497 Finlay CJ emphasised that this is “a power which for good reason must be sparingly used”. The person seeking the Order must have a genuine intention of commencing proceedings and establish clear proof of a wrongdoing. The importance of confining actions for sole discovery to those where clear proof of wrongdoing exists was confirmed by the Supreme Court in Megaleasing UK Limited. In particular Finlay CJ stated as follows:

“I am, accordingly, driven to the conclusion that the existing authorities upon which the Judgement of the High Court are largely based, which are the authorities of the English Courts, do in fact confine the remedy to cases where very clear proof of a wrongdoing exist, and possibly, as far as applies to an action for discovery alone prior to the institution of any other proceedings, to cases where what is really sought are the names and identity of the wrongdoers, rather than factual information concerning the commission of the wrong”.

The Irish case law including Megaleasing and EMI v Eircom requires clear proof of violation of rights. In the circumstances, an order of this nature may only be sought for the purpose of establishing the identities of the wrongdoers rather than factual information concerning the commission of the wrong.

ii. Anton Piller Order

The Court may also grant Anton Piller Orders (preservation orders where documents and items may be seized by the moving party) where there is a serious risk that articles or documents vital to a party’s case may be imminently destroyed or otherwise disposed of.

Methods available for obtaining evidence and information

Obtaining Discovery in the course of Proceedings

Patent litigation in Ireland usually involves the parties having to give documentary discovery/disclosure. The Court rules require an applicant for discovery to demonstrate that the documents sought are both relevant and necessary for the fair disposal of the case.

Relevance has been held to mean “every document relating to the matters in question in the action, which not only would be evidence upon any issue, but also which, it is reasonable to suppose, contains information which may – not which must – either directly or indirectly enable the party requiring the Affidavit either to advance his own case or to damage the case of his adversary”.

The documents sought must also satisfy the requirement that the discovery sought is necessary for disposing fairly of the cause or matter or for saving costs. An applicant for discovery must show that it is reasonable for the Court to suppose that the documents contain information which may enable the applicant to advance his own case or to damage the case of his adversary. An applicant is not entitled to discovery based on mere speculation or on the basis of what has been traditionally characterised as a fishing expedition.

The Rules of the Superior Courts provide for the discovery of documents which are, or which have been, in a person’s possession or power and, if privilege is claimed, the Court may inspect the documents to decide whether the claim of privilege is correct. The existence of a duty of confidence does not in itself provide a basis for a claim of privilege however a Court may limit the inspection of such documents to legal advisors.

Samples and Orders for Inspection

It is also possible to request samples and/or to request an order for inspection as part of the discovery process. Where the interests of justice require, the inspection may be limited to solicitors, counsel, patent agents and/or independent experts.

Interrogatories can also be useful to obtain admissions in respect of a defendant’s product or process. Leave is not required from the Court to serve interrogatories in the course of proceedings before the Commercial Court.

In appropriate cases, experiments may be ordered upon the application of a party that wishes to establish a fact by experimental proof. In relation to cases in the new IP and Technology List, the revised Rules also address experiments and use of models and inspection of confidential information.

New provisions relating to the discovery process for matters in the IP and Technology List

1. Provision of Product or Process Description
   The revised Rules provide that where a party to proceedings in the new IP and Technology List notifies 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, it will not be necessary for the notifying party to make discovery of documents relating to the features of the product or process which is the subject matter of the notification, unless the judge, for special reasons to be set out in the Court’s order, otherwise orders.
2. Alleged Commercial Success                                                                                              Where a patentee intends to rely upon the commercial success of a patent in proceedings concerned with its validity, unless the Court, for special reasons to be set out in the Court’s order, otherwise orders, under the revised Rules it is unnecessary for the patentee to make discovery of categories of documents relating to the issue of commercial success, provided that the patentee has offered to deliver within a reasonable time a schedule containing specific information relating to the commercial success of the product in question.

In relation to process patents, section 46 of the Patents Act provides that a product produced by a person other than the patent proprietor shall be deemed to have been obtained by the process which is the subject matter of the patent where the product is the same and in the absence of evidence to the contrary. The burden of proof shifts onto the defendant.

Admissions may be made by a defendant in its written defence that it is, for example, manufacturing in the State or, particularly in the innovator versus generics scenario, that the product falls within the claims of the patent while contending that the patent is invalid.

Discovery is available and may also help to address the issue. As outlined above, the revised Rules provide that where a party to proceedings in the IP and Technology List notifies 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, it will not be necessary for the notifying party to make discovery of documents relating to the features of the product or process which is the subject matter of the notification, unless the judge, for special reasons to be set out in the Court’s order, otherwise orders. In addition, the rules which govern proceedings in the Commercial Court give the judge wide powers to make orders which assist in the efficient conduct of the litigation:

“the Judge may, at any time and from time to time, of his own motion and having heard the parties, give such directions and make such orders, including the fixing of time limits, for the conduct of proceedings entered in the Commercial List, as appears convenient for the determination of the proceedings in a manner which is just, expeditious and likely to minimise the costs of those proceedings.”

The foregoing includes the fixing of any issues of fact or law to be determined in the proceedings.

Confidentiality clubs may be agreed by the parties or ordered by the Court where the disclosure of certain information might give a competitor an unfair commercial advantage and such arrangements are a common feature of the Irish litigation process. These impose restrictions on the use of discovered documents by stipulating who on the opposing side can have access to the documents being disclosed, how documents may be copied, where they may be viewed and how the information they contain may be disseminated. In some cases, the Court may direct that only the parties’ lawyers, and not the parties themselves, and their experts may inspect the documents. The lawyers and experts will also be required to undertake not to reveal the contents of the documents to their clients or other third parties.

The revised Rules for IP cases also address the inspection of confidential information.

No. However, any person can bring an application to the High Court or the Controller for the revocation of a patent (Section 57, Patents Act).

If there are already Court proceedings pending in Ireland in relation to a patent, it is not open to a party to take revocation proceedings before the Controller without leave of the High Court. However, where validity proceedings are already in existence before the Controller then the Court has discretion to stay infringement proceedings pending the Controller’s decision.

There is no automatic right to have infringement proceedings stayed by virtue of the existence of a challenge to the validity of the patent in a foreign court. It is however open to either party to apply to the Irish Court for a stay of the Irish proceedings in circumstances where a corresponding European Patent is the subject of opposition proceedings before the EPO. The applicant for a stay argues that pressing on with the Irish proceedings runs the risk of conflicting decisions and /or wasted costs. The High Court’s judgment in Condensed Aminodihydrothiazine Derivative & The Patents Act 1992 [2018] IEHC 467 provides guidance on the Court’s discretion to stay proceedings and highlights that to stay an action is the default position in the absence of other factors. In that judgment, the Court granted a partial stay of the proceedings, directing that all pre-trial steps should go ahead but allowing the trial to be delayed pending the determination of EPO proceedings. The Court held that the balance of justice did not justify a full stay of proceedings as there exists a strong public interest to minimise the risk of any delay in supplying a potential new treatment.

Judgments of the UK Courts, in particular, tend to have persuasive effect in Ireland.

In Ranbaxy, Clarke J stated at paragraph 51 that, having regard to the extremely similar legislation in Ireland and the UK, and the states’ common adherence to the EPC, the judgments of the UK Courts in this field have persuasive effect, as may judgments of other common law courts. In particular, he stated:

“…it is important to note that, while the broad scope of patent law has many similarities from one common law country to the next, there are, undoubtedly, some differences in the established approach in the respective jurisdictions. In particular, the underlying statutory basis does differ. Ireland and the United Kingdom have, of course, the European Patent Convention in common, and, as was pointed out by counsel for the plaintiff’s, the Patents Act 1992, is in very similar terms to the equivalent United Kingdom legislation and is clearly closely modelled on the United Kingdom Patents Act 1977. This is hardly surprising, as both the United Kingdom and Ireland are signatories to and have ratified the European Patent Convention. It is fair to state that less caution needs, therefore, to be exercised in considering the application of judgments of the courts of the United Kingdom from other common law countries.”

In those circumstances, it seems to me, that while it would not be appropriate to ignore the jurisprudence of other common law countries, it is the decisions of the United Kingdom courts that require most attention. The broad approach to the construction of patents is, of course, at least similar. Unless there is a material statutory difference or an established variation in the applicable jurisprudence, it does seem that the non-United Kingdom common law authorities are also persuasive in this context. However, for the reasons I have set out, caution should be applied and it should not be assumed that all relevant factors are necessarily the same.”

However, differences in evidence before the Irish Court may lead to that Court deciding that it ought to depart from a foreign judgment on the same patent. Thus, in Re Glaxo Group, Charleton J in the High Court, whilst ultimately reaching the same conclusion as the English Court that the invention was obvious, noted that before the Irish Court;-

“substantially different facts were argued and new witnesses called [with the result that it would have been impossible, notwithstanding my respect for Pumfrey J [in the English High Court] and for the courts in the neighbouring kingdom, to proceed towards a conclusion on the correctness of the decision in the previous litigation without examining this evidence in detail and with an open mind. Since a finding on that issue could change the other aspects of evidence which may have been common between this case and that tried in the United Kingdom, a complete re-evaluation of all of the evidence was required in the present case.”

The normal rules under the Brussels Regime will apply or, where Brussels does not apply, the rules of private international law will apply. The Irish Court has exclusive jurisdiction in proceedings concerned with the validity of any Irish patent.

Arbitration

The Arbitration Act 2010 gives effect to the UNCITRAL Model law on International Commercial Arbitration and where the parties agree to arbitration any awards made are enforceable and binding on the parties in accordance with this model law.

ADR

The parties can agree to resolve patent disputes through ADR. In addition, the Court may of its own motion, or on application by any party to a dispute, adjourn proceedings in order to give the parties time to resolve the dispute by ADR. Mediation is a process that is used voluntarily by the parties to a dispute. The Mediation Act 2017 imposes an obligation on parties to consider mediation and to confirm to the Court that they have considered mediation as an alternative to litigation, prior to the issuing of proceedings. When commencing proceedings, the solicitor is obliged to confirm by statutory declaration that he/she has complied with this requirement.

Whilst there is no requirement under the Patents Act to send a cease-and-desist letter to an alleged infringer before issuing patent infringement proceedings, it is usual to do so. Failure to send a cease-and-desist letter may be looked upon unfavourably by the Court when it comes to dealing with the question of costs.

A claim for patent infringement is time-barred six years from the date of the infringing act.

Actions for patent infringement may be brought by either the patent proprietor or the exclusive licensee in its own right. In particular, section 51 of the Patents Act provides that the exclusive licensee “shall have the like right as the proprietor of the patent to take proceedings in respect of any infringement”.

When the exclusive licensee brings the action, the proprietor, unless joined as a co-plaintiff, must be named as a defendant in the proceedings. Similarly, where any co-proprietor does not concur in the bringing of infringement proceedings by another co-proprietor, the non-concurring co-proprietor must be joined as a defendant. The purpose of joining such parties as defendants in this way is to give them notice of the action: however, they will not be liable for any costs unless they enter an appearance and take part in the proceedings.

Any person has standing to bring an invalidity action against a patent.

Yes, preliminary injunctions are available from the Irish Court in patent litigation proceedings. Whether a preliminary injunction will be granted by the Irish Court tends to be highly fact sensitive. Preliminary injunctions are granted if the party seeking the injunction establishes:

1. There is a serious issue to be tried;
2. The “balance of convenience” favours an injunction.

The applicant for a preliminary injunction will need to adduce affidavit evidence which shows that there is a “fair or serious issue to be tried”, which means no more than the case not being frivolous or vexatious. It is not necessary for the applicant to establish a prima facie case: that is, that on the balance of probabilities it is more likely than not that the plaintiff will succeed at the trial of the action. In Ireland, the granting of preliminary and permanent injunctions is subject to equitable principles and therefore the Court always has discretion whether to order an injunction.

The test used in Ireland reflects the American Cyanamid approach. In Merck Sharp & Dohme Corp v Clonmel Healthcare Ltd [2019] IESC 65 (“the MSD decision”) in which Whitney Moore acted for MSD, the Supreme Court delivered an extremely important and far-reaching decision concerning the appropriate test for the grant of a preliminary injunction which reasserts the flexible nature of the remedy and clarifies that adequacy of damages (or irreparable harm) should be assessed as forming part of the wider balance of convenience. Irish Courts must now consider the whole balance of justice and not just irreparable harm when deciding whether to grant relief.

The decision clarifies that the adequacy of damages, although often the most important factor, is part of the overall balance of convenience and is not an antecedent, stand-alone test which must be satisfied prior to a consideration of the balance of convenience. The Court recognised that there may be other factors which are relevant, and which may tip the balance. The Supreme Court outlined eight steps which might be followed in applications for preliminary injunctions:

1. The Court should consider whether, if the plaintiff succeeded at the trial, a permanent injunction might be granted.
2. Is there a fair question to be tried? This may also involve a consideration of whether the case will probably go to trial.
3. The Court should consider how best the matter should be arranged pending the trial, which involves a consideration of the balance of convenience and the balance of justice.
4. The most important element in that balance is, in most cases, the question of adequacy of damages.
5. In commercial cases where breach of contract is claimed, Courts should be robustly sceptical of a claim that damages are not an adequate remedy.
6. Difficulty in assessing damages may be a factor which can be taken account of and lead to the grant of an interlocutory injunction.
7. A number of other factors may come into play and may properly be considered and weighed in the balance in considering how matters are to be held most fairly pending a trial and recognising the possibility that there may be no trial. These may include: the presumptive validity of intellectual property rights, the preference for preference for preserving the status quo, the outline of similar litigation in other jurisdictions; and whether the alleged infringer could have “cleared the way” by way of invalidity proceedings.
8. Any application should be approached with a recognition of the essential flexibility of the remedy and the fundamental objective in seeking to minimise injustice.

The Court (at para 61) placed considerable emphasis upon the rights holder having a right that was presumptively valid, the existence of which represented the status quo prior to the defendant’s product launch. Further, at paragraph 62 it was stated that:

“..in cases where the balance of convenience may be finely balanced, it may be appropriate to have regard, even on a preliminary basis, to the strength of the rivals arguments as they may appear to the court. Certainly, if it was apparent that Clonmel’s case for invalidity was strong and/or if there had been successful determinations in Clonmel’s favour of a similar challenge in other jurisdictions, then that might weigh the grant of an injunction. In intellectual property matters where the same issues adjudicated on in other comparable jurisdictions, it may be recognised in the decision in American Cyanamid that if the question of adequacy of damages is evenly balanced, it may not be inappropriate to consider the relative strengths and merits of each party’s case as it may appear at the interlocutory stage. Courts are correctly reluctant to express views on cases which are to come to trial. However, it would be absurd if this rule of abstention were to result in a court conducting an agonised and necessarily imperfect assessment of a number of variable factors in a field with which it has little familiarity and where the evidence is indirect, written, and untested, all the while averting its attention from the area (perhaps of pure law) in which it can justifiably claim expertise.”

The reliefs that may be granted at the conclusion of a plenary hearing are set out in section 47(1) of the Patents Act, and comprise:

“an injunction restraining the defendant from any apprehended act of such infringement;

an order requiring the defendant to deliver up or destroy any product covered by the patent in relation to which the patent is alleged to have been infringed or any article in which the product is inextricably comprised;

damages or an account of profits in respect of the alleged infringement;

a declaration that the patent is valid and has been infringed by the defendant”.

In Ireland, a final or permanent injunction is a discretionary remedy which is normally granted by the Court at the final determination of the case (section 47(1), Patents Act). It must be demonstrated to the Court that there is some activity to be injuncted on an ongoing basis. Where infringement and a threatened continuation of such infringement to a material extent, has been established, then the proprietor will have a prima facie entitlement to a permanent injunction. However, as a general principle of Irish law, the Irish Courts may refuse to grant a final injunction if it is considered that an award of damages alone is a more appropriate remedy. This would be assessed on a case-by-case basis in accordance with the Court’s underlying discretion to grant an injunction.

Damages or an Account of Profits – the plaintiff may elect for either damages or an account of the defendant’s profits (section 47(1), Patents Act). As a general rule, damages are awarded only to compensate the loss suffered as a result of the infringement. In assessing the appropriate “quantum” to be awarded, a Court will therefore seek to place the plaintiff in the same financial position as he would have been in had the infringement not taken place. Loss of profits will, naturally, be central to this determination. The Court may also look to the amount which would have been payable by the defendant as a reasonable royalty for the infringing use. Damages are not generally awarded on a punitive basis in infringement actions.

Orders for Delivery up or Destruction – This remedy can only be ordered in respect of patented articles, or of any article in which they are inextricably comprised. The articles must be within the power or possession of the defendant. Infringing goods which have been delivered and sold to third parties will not be within the power or possession of the defendants.

Damages, as a general rule, are awarded only to compensate the loss suffered as a result of the infringement. The Court, in assessing the appropriate ‘quantum’ to be awarded, will seek to place the defendant in the same financial position he would have occupied had the infringement not taken place. Loss of profits will be central to this determination. Courts may also look to the amount which would have been payable by the defendant as a reasonable royalty for the infringing use. Damages are not generally awarded on a punitive basis in infringement actions.

An account of profits is based on the principle of restitution (or unjust enrichment). The focus is therefore on the gain made by the infringing party.

A successful plaintiff in Irish patent proceedings may seek either damages or an account of profits, but not both.

Final injunctions are routinely granted if the plaintiff is successful at the trial of the action where there is an act to be restrained on an on-going basis and damages alone are not an adequate remedy. However, as a general principle of Irish law, the Irish Courts may refuse to grant a final injunction if it is considered that an award of damages alone would be an adequate remedy.

Any person may apply to the Court for a declaration that he has not acted in a manner which infringes a patent, provided that he has first written to the proprietor (or licensee) requesting written acknowledgment that he is not infringing and has been refused such acknowledgment.

In respect of entitlement questions, any person may apply to the Court for a declaration that he is entitled, by operation of law or otherwise, to any Irish patent or patent application. The Court may also make declarations in respect of groundless threats of patent infringement.

Declaratory relief is sought by way of plenary proceedings which would involve the steps outlined at question no. 2 above.

The costs incurred will vary greatly and will depend on such factors as the length and complexity of the proceedings, the length of the trial and the amount of pre-trial applications involved. The award of costs is always a matter for the discretion of the trial judge; however, costs generally follow the event. The general rule is that costs are awarded against the losing party.

Yes, to an extent. The general principle is that costs are awarded to the successful party on a “party and party” basis, which would normally cover approximately two thirds of the successful party’s total legal costs. If there is no agreement on the amount of costs to be paid, this is decided by the Office of the Legal Costs Adjudicator of the High Court who will assess and determine the appropriate amount of costs to be paid by the unsuccessful party.

Many of the major global pharmaceutical/biotech and medical device companies have set up manufacturing operations in Ireland. A consequence of this is that Ireland has become an important jurisdiction for patent litigation in Europe with a significant increase in patent litigation, particularly relating to pharmaceuticals/biotech and medical devices.

An appeal to the Irish Supreme Court (in the main action on liability) was heard in December 2021 in the case of Merck Sharp & Dohme Limited v Clonmel Healthcare Ltd 2022 [IESC] 11 (hereafter “MSD” and “CHL” respectively), in which MSD sought a reference to the CJEU on the core issue in the appeal namely, the appropriate interpretation and application of Articles 3(a) and 3(c) of Regulation (EC) 469/2009 concerning the supplementary protection certificate for medicinal products (the “SPC Regulation”). The application was opposed by CHL who contended that a reference was unnecessary because the law was already clear.

In these proceedings MSD sought an injunction and damages for infringement of an SPC in respect of an anti-cholesterol product, marketed as “Inegy”, a combination product combining ezetimibe with simvastatin. CHL, which produced a generic version of Inegy, counterclaimed contending that the SPC was invalid having regard to the provisions of Art 3 of the SPC Regulations as interpreted in the decisions of the CJEU.

In a unanimous decision delivered by the Supreme Court on 21 February 2022, the Supreme Court agreed with MSD that the law was not acte clair and in particular, that a referral to the CJEU was necessary. Questions were referred to the CJEU under Article 3(a) and 3(c) of the SPC Regulation on 22 March 2022. This is the first referral to the CJEU by the Irish Court in a Patent or SPC matter. The referral to the CJEU is very important for SPC holders as it will hopefully clarify the tests to be applied to determine the validity of combination SPCs granted under the SPC Regulation.

The Court has referred the following four questions to the CJEU for ruling:

“1. (a) For the purpose of the grant of a supplementary protection certificate, and for the validity of that SPC in law, under Article 3(a) of Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products [2009] OJ L152/1, does it suffice that the product for which the SPC is granted is expressly identified in the patent claims, and covered by it; or is it necessary for the grant of an SPC that the patent holder, who has been granted a marketing authorisation, also demonstrate novelty or inventiveness or that the product falls within a narrower concept described as the invention covered by the patent?

1. (b) If the latter, the invention covered by the patent, what must be established by the patent holder and marketing authorisation holder to obtain a valid SPC?

2. Where, as in this case, the patent is for a particular drug, ezetimibe, and the claims in the patent teach that the application in human medicine may be for the use of that drug alone or in combination with another drug, here, simvastatin, a drug in the public domain, can an SPC be granted under Article 3(a) of the Regulation only for a product comprising ezetimibe, a monotherapy, or can an SPC also be granted for any or all of the combination products identified in the claims in the patent?

3. Where a monotherapy, drug A, in this case ezetimibe, is granted an SPC, or any combination therapy is first granted an SPC for drugs A and B as a combination therapy, which are part of the claims in the patent, though only drug A is itself novel and thus patented, with other drugs being already known or in the public domain; is the grant of an SPC limited to the first marketing of either that monotherapy of drug A or that first combination therapy granted an SPC, A+B, so that, following that first grant, there cannot be a second or third grant of an SPC for the monotherapy or any combination therapy apart from that first combination granted an SPC?

4. If the claims of a patent cover both a single novel molecule and a combination of that molecule with an existing and known drug, perhaps in the public domain, or several such claims for a combination, does Article 3(c) of the Regulation limit the grant of an SPC;

(a) only to the single molecule if marketed as a product;

(b) the first marketing of a product covered by the patent whether this is the monotherapy of the drug covered by the basic patent in force or the first combination therapy, or

(c) either (a) or (b) at the election of the patentee irrespective of the date of market authorisation?

And if any of the above, why?”

The CJEU decision is expected in the second half of 2023.

N/A

It is currently anticipated that the Unified Patent Court (“UPC”) will be up and running from 1 April 2023.

Ireland has committed to ratify the UPC Agreement and to establish a local division of the UPC, but ratification of the UPC Agreement requires a referendum to amend the Irish Constitution. It is currently anticipated that this referendum will be held sometime in late 2023. In the Summer of 2022, the Irish Government reaffirmed its commitment to establish a local division of the UPC and to hold the required referendum.