The Patent Litigation Law Review: Ireland


Historically, there has been comparatively little patent litigation in Ireland, in particular litigation that progressed to full trial. However, in light of significant growth in the pharmaceutical industry, with international pharma companies basing worldwide manufacture in Ireland, in recent years there has been a significant rise in patent litigation, particularly in pharma disputes.

Patent law in Ireland is governed by the Patents Act 1992, as amended (the Irish Patents Act). The Patents Rules 1992, as amended (the Patents Rules), generally read alongside the Irish Patents Act, prescribe various procedural rules. As Ireland has a common law legal system, Irish patent law is not derived solely from the Irish Patents Act, but also from the decisions of the Irish courts; for example, interpreting various provisions of the Irish Patents Act.

The provisions of the Irish Patents Act apply equally to national Irish patents granted by the Irish Patent Office (Irish patent) and to European patents designating Ireland, granted by the European Patent Office (EPO).2

An application for a patent conferring protection in Ireland can be made either to the Intellectual Property Office of Ireland , for an Irish patent, or to the EPO for a European patent designating Ireland. Alternatively, in an application made to the World Intellectual Property Organization, under the Patent Cooperation Treaty, the EPO may be designated and then Ireland may be subsequently designated before the EPO.

Types of patent

Irish patents can be subdivided into two categories: (1) full-term patents (where the term of protection is 20 years from the patent filing date)3 and (2) short-term patents (where the term of protection is 10 years from the patent filing date).4 They are mutually exclusive – they cannot both exist for any one invention.

Short-term patent applications are generally less costly. The distinctive features of short-term patents are set out in Part III of the Irish Patents Act.

i Patentability

Under the Irish Patents Act, an invention shall be patentable if it is susceptible of industrial application, is new and involves an inventive step.5

The Irish Patents Act provides that an invention will be susceptible of industrial application if the invention can be made or used in any kind of industry, including agriculture.6

Further, an invention shall be novel if it does not form part of the state of the art.7 'State of the art' means everything made available to the public, anywhere in the world before the date of filing of the patent application.8

An invention will be considered to involve an inventive step if the invention would not have been obvious to a person skilled in the art, based on the entire state of the art at the date of filing.9

ii Exclusions to patentability

A patent cannot be granted in respect of the following inventions:10

  1. a discovery, scientific theory or mathematical method;
  2. an aesthetic creation;
  3. a scheme, rule or a method for performing a mental act, playing a game, doing business or a program for a computer;
  4. the presentation of information;
  5. inventions where commercial exploitation would be contrary to public order or morality;
  6. a plant or animal variety or a biological process for the production of plants or animals other than microbiological processes and products thereof; or
  7. a method for treatment of the human or animal body by surgery or therapy and a diagnostic method practised on the human or animal body.11

iii Application – securing a patent

An application for an Irish patent must relate to one invention only or to a group of inventions so linked as to form a general inventive concept.

Every application for an Irish patent must be filed with the Intellectual Property Office of Ireland and must contain a request for the grant of a patent, a specification (containing a description of the invention, one or more claims and any drawing referred to in the description or claim) and an abstract.12 The claims must define the matter for which protection is sought. They must be clear and concise and must be supported by the description.13

Ireland is a party to the Paris Convention, and thus the principle of priority applies to Irish patent applications in Ireland. Once a patent application has been filed in Ireland, the applicant is entitled to claim the priority date of that application in respect of all other applications for the same invention made in other states that are signatories to the Paris Convention or are members of the World Trade Organization.

iv Examination

The examination of an Irish patent is carried out by the Controller of Intellectual Property (the Controller).

Once the Controller is satisfied that the invention meets the requirements of the Irish Patents Act, a patent will proceed to grant. Upon payment of the fee by the applicant, the grant becomes formalised. Once formally granted, the Controller publishes a notice of the grant and a brief specification of the patent in the Journal of the Intellectual Property Office of Ireland. The patent takes effect from this date of publication in the Journal of the Intellectual Property Office of Ireland and will continue in existence (subject to the payment of annual renewal fees) for the duration of the patent term.

In relation to Irish-designated European patents, where a European patent is granted in English and designates Ireland, the patent becomes automatically validated.

v Extension of Irish patents

The Irish Patents Act does not allow for the extension of an Irish patent.

However, supplementary protection certificates (SPCs) are permissible in two sectors: agrochemicals and pharmaceuticals. SPCs can extend the period of protection to a maximum of 25 years.14 Importantly, the patent term is extended only in respect of the specific product, not the entire scope of the claims.

Procedure in patent enforcement and invalidity actions

i Fora for patent actions

High Court

There are currently no specialised patent courts in Ireland and proceedings are not heard by specialist patent judges. Patent proceedings in respect of infringement and revocation must be heard by the High Court, although infringement proceedings in respect of short-term patents may be brought in the Circuit Court (see below) and may be transferred to a division of the High Court known as the Commercial Court.15 Cases heard by the Commercial Court are subject to efficient case management procedures,16 intended to provide a faster track to trial and to minimise costs.

The Circuit Court

Patent infringement proceedings concerning short-term patents may be heard by the Circuit Court.17 While the Circuit Court is a court of (generally) limited and local jurisdiction, patent proceedings involving short-term patents can be brought irrespective of the value of the claim.

The Controller

While patent revocation proceedings are typically brought before the High Court, applications for revocation may also be made to the Controller.18 Proceedings before the Controller are governed by rules set out in Part VIII of the Patents Act 1992 and in the Patent Rules 1992.

ii Standing to bring patent infringement claims

Actions for infringement of a patent may be brought by the proprietor of a patent in respect of any act that the proprietor is entitled to prevent under Sections 40 to 43 and Section 45 of the Irish Patents Act.19

Where there are two or more joint proprietors of a patent, each joint proprietor has standing to bring infringement proceedings without the concurrence of the others provided that the remaining joint proprietors are named as defendants in the proceedings.20

The holder of an exclusive licence under a patent has the same standing as the proprietor to bring proceedings for acts of infringement committed from the date of the licence.21 Unless the proprietor is a co-plaintiff, it must be joined as a defendant in the proceedings.

iii Standing to bring patent invalidity claims

Any person may apply to the High Court or to the Controller under Section 57 of the Irish Patents Act for revocation of a patent.

iv Limitation periods

The Irish Patents Act does not specify a limitation period within which an infringement action can be issued.

v Commencing patent proceedings

Prior to commencing infringement proceedings, a cease-and-desist letter is typically issued. Such pre-action letters must be carefully drafted to avoid liability under Section 53 of the Irish Patents Act, which provides remedies for a party that receives a groundless threat of infringement proceedings. Similarly, a letter before action is often issued prior to commencing invalidity proceedings.

The initiating pleading for patent infringement proceedings is a plenary summons, which outlines the essential claim made and the remedies sought by the plaintiff.22 In response, the defendant delivers and files an entry of appearance that requires the plaintiff to deliver a statement of claim and confirms which lawyer will represent the defendant.

Patent invalidity proceedings are commenced by way of a petition for revocation, which must be accompanied by Particulars of Objections.23

At this point, an application is generally made by either party to transfer the proceedings into the Commercial Court list.

vi Exchange of further pleadings

In infringement proceedings, the next step is the delivery by the plaintiff of a statement of claim setting out the particulars of the alleged infringement.24 The defendant is then required to deliver a defence.

In invalidity proceedings, no statement of claim is delivered as the petition is accompanied by the particulars of objection. The next step is for the proprietor of the patent to deliver a defence to the petition and particulars of objection. A defendant who, under Section 57 of the Irish Patents Act, counterclaims for revocation shall deliver with his or her counterclaim the Particulars of Objection to the validity of the patent on which he or she relies in support of the counterclaim.25

After the defence (or, if applicable, the reply to defence) is delivered, the pleadings are considered to be closed.

vii Discovery and evidence


General procedural rules regarding discovery are set out in Order 31 of the Rules of the Superior Courts (RSC). Under Irish law, either party to litigation may seek discovery of documents that are or have been in the 'possession, power or procurement' of the other party.

Discovery is generally agreed or ordered by reference to categories of documents, and reasons must be set out as to why each category of documents meets the criteria of relevance and necessity.

In 2016, the Court of Appeal in Boehringer Ingelheim Pharma GmbH & CO KG v. Norton (Waterford) Limited t/a Teva Pharmaceutical Ireland considered and summarised the legal principles applicable to discovery in patent cases.26

Expert evidence

Expert witnesses play a significant role in patent litigation. An expert witness owes a duty to the court to assist on matters within his or her field of expertise.27 This duty overrides any duty he or she has to the party instructing him or her.

The court assesses the teachings and scope of a patent through the eyes of 'the person skilled in the art'. In considering and determining these matters, the court must 'don the mantle' of the skilled person 'to arrive as closely as it can to the mental attitude of a well-instructed representative of the class to whom the specification is addressed, and no more'.28

It is the expert witnesses who assist the court in adopting the mindset of the skilled person. The skilled person has imputed to him or her the 'common general knowledge', which is, essentially, the standard technical background of the art in question. The expert witness must prepare an expert report or witness statement that is exchanged between the parties and ultimately submitted to the court. The expert generally provides oral testimony and can be cross-examined as to their evidence in chief.

Additionally, a person (an assessor) who is 'specially qualified in the opinion of the court' can be appointed by the court to assist on technical issues.29 Their function is to assist the judge in understanding the evidence before the court.


In appropriate cases, experiments may be ordered upon the application of a party that wishes to establish a fact by experimental proof.

Pre-action disclosure – methods for obtaining evidence and information

Proceedings may be taken directly against a party to obtain discovery of documents identifying alleged infringers by way of a Norwich Pharmacal order.

Although not strictly limited to pre-action relief, a claimant alleging patent infringement may apply for an order requiring the disclosure by relevant persons (including a person found in possession of infringing goods, or found using infringing services, on a commercial scale) of information regarding the origin and distribution networks of allegedly infringing goods and services.30

The High Court and Commercial 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.

viii Presenting and proving materials in court

Generally, materials may be presented and relied upon at a hearing on the merits only when proven (or verified). However, typically the parties serve a notice to admit documents, which is essentially a request that the other party consents to the documents being admitted into evidence without the need for proof. Documents are generally admitted via affidavits (sworn statements) or witness statements. The Commercial Court generally directs that written witness statements be exchanged in the lead up to the trial. These form the basis of the evidence given orally at trial and upon which the witness is cross-examined.

ix Amendment of patents in the course of proceedings

The Irish Patents Act permits the High Court (and thus the Commercial Court) or the Controller, in the course of invalidity proceedings, to allow the patent proprietor to amend a patent's specification and claims.31

Such amendments cannot extend the subject matter of the patent,32 and are deemed to have effect from the date of grant of the patent.33 In re Norton Healthcare Ltd,34 the court exercised its discretion to grant the patentee leave to limit the claims of their patent in the event that the existing claims were found invalid.

x Challenge to the validity of the patent

Pursuant to Section 61 of the Irish Patents Act, a defendant may challenge the validity of a patent in infringement proceedings. This challenge is frequently in the form of a defence or a counterclaim to an action for infringement, or both.

Section 58 of the Irish Patents Act specifies five grounds on which an application for revocation can be grounded:

  1. the subject-matter of the patent is not patentable under this Act;
  2. 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;
  3. the matter disclosed in the specification of the patent extends beyond that disclosed in the application as filed, or, if the patent was granted on an application which by virtue of Section 24 or 81 is deemed to have been filed on the date of filing of an earlier application, it extends beyond that disclosed in the earlier application as filed;
  4. the protection conferred by the patent has been extended by an amendment of the application or the specification of the patent; or
  5. the proprietor of the patent is not entitled thereto under Section 16(1).

If a defendant challenges a patent's validity as a defence in infringement proceedings, the two matters will run in tandem.

xi Timing to first-instance decision for patent proceedings

One would generally expect a patent dispute (either infringement or patent invalidity proceedings) to take approximately 12 to 18 months from the issuing of proceedings to the hearing of the trial, depending on the complexity of the case, the extent of discovery and where the court vacations fall. Shorter expedited timelines to trial can, however, be granted in appropriate cases and an expedited trial could begin within six months.

xii Costs of patent proceedings

Patent litigation costs awards are discretionary, but the usual rule is that costs 'follow the event', and are awarded to the successful party. However, orders are generally only for what are termed 'party and party costs'. Party and party costs will cover only the main items in litigation and will not cover the entire costs. In general, somewhere between one-half and two-thirds of the total legal costs incurred are recoverable. Where the parties cannot agree on quantum, the assessment of costs can be listed before the Taxing Master, who will settle the figure to be paid.

xiii Preliminary injunctions

In an appropriate case, a preliminary injunction can be obtained by a plaintiff quickly. An interim injunction can be obtained almost immediately (within a day or so). This is applied for ex parte and lasts until an inter partes application can be heard. At the inter partes hearing, the plaintiff can apply for an interlocutory injunction that lasts until the trial. An interim injunction is only appropriate where there is extreme urgency on the part of the plaintiff and the court can be satisfied that there is good reason to grant such relief.

In most cases, the first and most common type of injunction sought is a preliminary interlocutory injunction. An application for a preliminary injunction can only be made as part of full plenary proceedings. Overall, the plaintiff must demonstrate that the matter is extremely urgent and that it cannot wait for a full trial to receive a final injunction. To obtain a preliminary interlocutory injunction, a plaintiff must show that: (1) it has raised a fair question to be decided at the trial of the action; and (2) the balance of convenience (including that damages would not be an adequate remedy for it) favours the granting of the injunction.35

An application for such an injunction is generally heard within four to six weeks.

The Irish courts had been historically slow to grant preliminary injunctions because of the general difficulty in patent matters in showing that damages would not be an adequate remedy for the applicant.

In April 2018, the High Court refused to grant a preliminary injunction in an SPC infringement case as it found that damages would be an adequate remedy for the SPC holder. The refusal of the preliminary injunction was upheld by the Court of Appeal36 in a two to one majority decision on the basis that damages would be an adequate remedy for the SPC holder. This was the first time the Court of Appeal considered the issue in Ireland. However, in July 2019, the Supreme Court unanimously held that a preliminary injunction should have been granted by the High Court37 setting out a reformulated test and holding that 'the preferable approach is to consider the adequacy of damages as part of the balance of convenience' assessment rather than a hurdle prior to that assessment. They held that the adequacy of damages will continue to be 'the most important component' of the balancing exercise but that other factors may also be considered by the court. It is now acknowledged that a difficulty in calculation and assessment of damages may make it more likely that any damages awarded will not be a precise and perfect remedy, and that difficulty in assessing damages may factor in favour of awarding a preliminary injunction. The test for interlocutory injunctions is therefore recognised as being more flexible.

xiv Condition and security requirements for interim relief to be granted

The plaintiff must give an undertaking in damages in the event that he or she should fail at trial. This is an undertaking that, if the injunction is granted but is subsequently found to have been wrongly given, the plaintiff will compensate the defendant for any losses incurred as a result of the injunction.

Substantive law

i Infringement

Under the Irish Patents Act, the following acts, if done without the proprietor's consent within the territory of Ireland, amount to direct patent infringement:

  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 that 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; and
  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.38

Further, it is an indirect infringement of a patent for a third party, without the consent of the proprietor of the patent, to supply or offer to supply in the territory of the state 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, 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 that invention into effect.39

ii Construction

The Irish Patents Act provides that:

[T]he extent of the protection conferred by a patent or a patent application shall be determined by the claims; nevertheless, the description and drawings shall be used to interpret the claims.40

Although in Ireland there is no general doctrine of equivalents, the Irish Patents Act does provide that, when interpreting the section above:

[T]he Court shall have regard to the directions contained in the Protocol on the Interpretation of Article 69 of the European Patent Convention and set out in the Second Schedule to this Act.41

The Irish courts (both the High Court42 and the Supreme Court43) have approved the approach taken by the UK courts in Kirin-Amgen Inc v. Hoechst,44 namely, a purposive construction rather than a purely literal one, giving the language of the claim the meaning that would have been understood by the notional addressee – the person skilled in the art.

The Irish courts have not yet had occasion to consider the equivalents section of the EPC Protocol or the reasoning of the UK Supreme Court in Eli Lilly v. Actavis45.

iii Defences – statutory exceptions to infringement

Under the Irish Patents Act, the rights conferred by a patent do not extend to:46

  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 or acts concerning that medicine;
  4. use of the invention on board certain vessels or aircrafts that temporarily or accidentally enter the territory of the State;
  5. acts specified in Article 27 of the Convention of International Civil Aviation; and
  6. acts falling under the Bolar exemption.47

iv Other defences

In addition, a defendant may claim that the patentee has exhausted its rights. In short, the principle of exhaustion of rights provides that a patent cannot be used to prevent a third party from importing goods that have been put on the market in another Member State by the patentee or with his or her consent.

Further, a defendant may claim that it has a right to continue use that had begun before the filing or priority date, provided such acts are done in good faith.48

Finally, a defendant may plead that neither damages nor an account of profits should be awarded, on the basis that he or she can prove that at the date of the infringement he or she was not aware, and had no reasonable grounds for supposing, that the infringed patent existed.49

Final remedies for infringement

If a patent is found to be infringed, or where a litigant's claim is otherwise successful, a range of remedies may be available. These include the following.

i Monetary remedies

Pursuant to Section 47 of the Irish Patents Act, damages or an account of profits (but not both) can be awarded for the infringement of an Irish patent. It is ultimately at the discretion of the court to decide which is appropriate.

Damages are compensatory in nature and are predominantly calculated by way of assessing loss of profits. Alternatively, damages can be calculated based on the sum of money the infringing party would have had to pay as royalties.

An account of profits is a calculation of the profit made by an infringing party as a result of its infringing activities. An account of profits is intended to prevent unjust enrichment and to restore the patent holder to the position it would have been in had the infringement not occurred.

The court will not award either remedy against an 'innocent infringer', where an infringing party was not aware and had no reasonable grounds to know that the patent existed.50

ii Non-monetary remedies


Permanent injunctions51 can be sought to restrain an infringing party from 'any apprehended act of such infringement'. Injunctions can be prohibitory or mandatory – as was seen in Smithkline Beecham plc v. Genthon BV52 – and are routinely granted at the conclusion of infringement proceedings.

The court ultimately has discretion to refuse a final injunction, and may in some instances impose a licence in lieu of a permanent injunction.

Delivery up or destruction

Pursuant to Section 47(1)(b) of the Irish Patents Act, the court can order the delivery up or destruction of infringing goods.


Where a patent holder is successful in his or her infringement proceedings, the infringing party is declared to have infringed the patent. Furthermore, an order for the publication of the judgment can be made by the court at the request of the patent holder.53

Other types of patent proceeding

i Declarations of non-infringement

Any person may apply to the High Court for a declaration that its acts, or proposed acts, do not infringe a patent (a declaration of non-infringement: DNI).54 The validity of the patent cannot be challenged in proceedings for a DNI, and the making or refusal of a DNI does not imply that the patent is valid.55

ii Compulsory licences

At any time after the expiry of the period of three years beginning on the date of the publication of notice of grant of a patent, any person may apply to the Controller for a licence under the patent, or for an entry in the register to the effect that licences under the patent are to be available as of right.56

iii Disputes regarding entitlement to ownership of a patent

Under the Irish Patents Act, any person can request that the High Court determine entitlement to ownership of a granted patent.57


Decisions of the Controller can be appealed to the High Court.58 There is an automatic right of appeal of every decision of the High Court (including the Commercial Court) to the Court of Appeal. This is not limited to a decision on the merits and includes interlocutory decisions such as preliminary injunction orders. An appeal does not operate as an automatic stay. The court has discretion to decide whether or not to grant a stay.

To appeal against a High Court order, the appellant must lodge a notice of appeal within 10 days (for an expedited appeal)59 or within 28 days (for an ordinary appeal) of the date when the High Court order is perfected.

In certain limited circumstances, there is a possibility of a further appeal to the Supreme Court, where (1) the decision involves a matter of general public importance; or (2) it is necessary in the interests of justice that there be an appeal to the Supreme Court.

Additionally, direct appeals (from the High Court) to the Supreme Court will be allowed where (1) the decision involves a matter of general public importance; or (2) it is necessary in the interests of justice that there be an appeal to the Supreme Court; and (3) exceptional circumstances warrant a direct appeal.

The year in review

The year 2019 has been busy for patent litigation in the Irish courts.

The Supreme Court, in a landmark decision,60 adjudicated on a preliminary injunction application in respect of alleged infringement of an SPC. In granting leave to appeal, the Supreme Court found that the divergence in the application of the test between England and Ireland gave rise to an issue of law of general public importance.

Applying a reformulated test, the Supreme Court ultimately found that a preliminary injunction restraining the infringement of an SPC should have been granted by the High Court and by the Court of Appeal in 2018. Their decision, handed down in July 2019, qualifies the approach taken in many previous cases that damages would be an adequate remedy for the plaintiff and confirms the flexible nature of the remedy. Although adequacy of damages will continue to be 'the most important component' of the balancing exercise, the court found that 'the preferable approach is to consider the adequacy of damages as part of the balance of convenience' assessment rather than as a separate and antecedent hurdle prior to that assessment.

Availability of damages will not be decisive: other factors may be considered and weighed in the balance by a court, which may include presumptive validity of intellectual property rights, a preference for preserving the status quo ante, and whether the alleged infringer could have 'cleared the way' by way of invalidity proceedings.

Finally, the Supreme Court found that in preliminary injunction applications, a court could consider whether the merits of the claim were likely to succeed where the strengths in the parties' cases were apparent. For example, the court observed that determinations of invalidity of the disputed intellectual property right in other comparable jurisdictions might weigh against granting an injunction.

The Irish Commercial Court61 heard an application for a stay and departed from the existing precedent in Merck & Co Inc v. GD Searle & Co (Merck)62 by refusing to suspend national patent revocation proceedings while parallel opposition proceedings were ongoing in the EPO. Although the decision was handed down in late 2018, it is worth mentioning here. The applicant seeking the suspension of the Irish proceedings relied on Merck, arguing the potential waste of resources that would result from simultaneous proceedings before two separate bodies. However, the court refused to stay the entire proceedings, and in a departure from previous Irish case law, directed that all pre-trial steps in the proceedings should go ahead, including the exchange of pleadings and any discovery but allowed the trial to be delayed until after the result of the opposition proceedings before the EPO.

In October 2019,63 the Irish High Court revoked64 Gilead's SPC for Truvada, an anti-retroviral combination drug, which was also the subject of noteworthy decisions of the Court of Justice of the European Union and the English Court of Appeal65 regarding the interpretation of Article 3(a) of the SPC Regulation. In a subsequent judgment66, Mr Justice McDonald also revoked MSD's SPC in respect of a cholesterol reducing drug comprising a combination of two active ingredients, namely ezetimibe and simvastatin, on the basis of Article 3(a) of the SPC Regulation. The Irish Court of Appeal is due to hear the Gilead appeals and the MSD appeal in late 2020. There is also a cross-appeal by the defendant in the MSD case in respect of the High Court's finding that Article 3(c) of the SPC Regulation was satisfied. These appeals are of particular interest, as to date the Irish Court of Appeal has not issued a decision on the interpretation of Article 3 of the SPC Regulation and the criteria for obtaining an SPC for a combination of active ingredients.67


The recent Supreme Court decision referred to above, which has clarified the test for preliminary injunctions, will have particular resonance for patent and SPC holders. Prior to this judgment, it had traditionally been difficult for rights holders to overcome the adequacy of damages threshold and the judgment may now encourage more rights holders to assert their rights by way of preliminary injunction in the Irish courts. This is an important development and means that a more flexible enforcement tool is now available. It remains to be seen in what circumstances and to what extent the lower courts will apply it.

Another interesting development is Regulation (EU) No. 2019/933, which amends Regulation (EC) No. 469/2009 and introduces an exception to the protection conferred by an SPC, allowing EU-based manufacturers of generics or biosimilars to obtain a waiver to manufacture SPC-protected products or medicinal products containing those products in the EU, provided such manufacture is for export to non-EU countries where patent or SPC protection for those products have expired or never existed. It also permits the stockpiling of generics and biosimilars during the final six months of SPC protection to enable a 'day 1' launch for those products. The SPC waiver entered into force across all member states on 1 July 2019. However, importantly the Regulations provide for a three-year transition period until 2 July 2022.

The developments relating to the Unified Patent Court are being keenly watched from Ireland and the government has indicated its intention to establish a local division.



1 Laura Scott and Charleen O'Keeffe are partners at William Fry.

2 Section 119 of the Irish Patents Act.

3 Section 36(1) of the Irish Patents Act.

4 Section 63(1) of the Irish Patents Act.

5 Section 9(1) of the Irish Patents Act.

6 Section 14 of the Irish Patents Act.

7 Section 11(1) of the Irish Patents Act.

8 Section 11(2) of the Irish Patents Act.

9 Section 13 of the Irish Patents Act.

10 Sections 9 and 10 of the Irish Patents Act.

11 Section 10(2) of the Irish Patents Act, states that the exception under (g) shall not apply to products, in particular substances or compositions, for use in any such method.

12 Section 18 of the Irish Patents Act.

13 Section 20 of the Irish Patents Act.

14 Pursuant to Regulation 469/2009/EEC & SI No. 307/2008.

15 Rule 1(d) of Order 63A of the Rules of the Superior Courts (as amended).

16 Rule 5 of Order 63A of the Rules of the Superior Courts (as amended).

17 Section 66(5) of the Patents Act 1992.

18 Section 57(1) of the Patents Act 1992.

19 Section 47(1) of the Patents Act 1992.

20 Section 48 of the Patents Act 1992.

21 Section 51 of the Patents Act 1992.

22 Order 94 RSC, Rule 3.

23 Order 94 RSC, Rule 23.

24 Order 94 RSC, Rule 4.

25 Order 94 RSC Rule 7.

26 [2016] IECA 67.

27 Order 39 Rule 57.

28 Charlton J in In re Glaxo Group Ltd [2009] IEHC 277 quoting from Fletcher Moulton LJ in British Ore Syndicate Limited v. Minerals Separation Ltd [1909] 26 RPC 124 at 128.

29 Section 95(1) of the Irish Patents Act.

30 Article 3 of the European Communities (Enforcement of Intellectual Property Rights) Regulations 2006.

31 Section 38 of the Irish Patents Act.

32 Section 38(3) of the Irish Patents Act.

33 Section 38(4) of the Irish Patents Act.

34 [2006] 3 IR 321.

35 The Supreme Court in Campus Oil v. Minister for Energy (No. 2) [1983] IESC 2, which accepted the test laid out in American Cyanamid v. Ethicon [1975] UKHL 1.

36 Merck Sharp & Dohme Corp v. Clonmel Healthcare Limited [2018] IECA 177.

37 Merck Sharp & Dohme Corp v. Clonmel Healthcare Limited [2019] IESC 65.

38 Section 40 of the Patent Act.

39 Section 41(1) of the Patents Act, which is subject to the caveats in Section 41(2).

40 Section 45(1).

41 Section 45(3).

42 Ranbaxy Laboratories Limited & ors v. Warner Lambert Company [2007 IEHC 256] and Medinol Limited v. Abbott Ireland & ors [2011 IEHC 128].

43 Ranbaxy Laboratories Ltd & ors v. Warner Lambert Company [2006] 1 IR 193.

44 [2005] 1 All ER 667. Also see Catnic Components Ltd v. Hill & Smith Ltd [1982] RPC 183.

45 [2017] UKSC 48.

46 Section 42 of the Irish Patents Act.

47 Acts falling under the Bolar exemption exception are particularised at Section 42(g) and 42(h) of the Irish Patents Act.

48 Section 55(1) of the Irish Patents Act.

49 Section 49(1) of the Irish Patents Act.

50 ibid.

51 Section 47(1)(a) of the Irish Patents Act.

52 IEHC [2003] 623.

53 Paragraph 5 of the European Communities (Enforcement of Intellectual Property Rights) Regulations 2006 (SI 360/2006).

54 Section 54(1) of the Irish Patents Act.

55 Section 54(2) of the Irish Patents Act.

56 Section 70 of the Irish Patents Act.

57 Section 81(1) of the Irish Patents Act.

58 Section 96 of the Irish Patents Act 1992.

59 Expedited appeals are described in Order 86(A), Rule 7.

60 Merck Sharp & Dohme Corp v. Clonmel Healthcare Limited [2019] IESC 65.

61 Condensed Aminodihydrothiazine Derivative v. Patents Acts 2017/1 Pap.

62 [2002] 3 IR 614.

63 [2019] IEHC 683 (in the Irish High Court Gilead's SPC infringement cases as against Mylan and Teva and their respective counterclaims for invalidity were heard together).

64 Gilead successfully obtained a stay of the order revoking the SPC pending the Court of Appeal decision.

65 (C-121/17) and [2019] EWCA Civ 2272, respectively.

66 [2019] IEHC 814

67 (C-121/17) and [2019] EWCA Civ 2272, respectively.

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