United Kingdom: Patent Litigation

In the United Kingdom, there are three different legal jurisdictions: England and Wales, Scotland, and Northern Ireland. Patent litigation claims brought in Scotland and Northern Ireland are respectively heard in the Court of Session and the High Court of Justice in Northern Ireland. As the majority of claims are brought in England and Wales, the remainder of this response will address patent litigation in England and Wales only.

Patent litigation claims in England and Wales are brought in either the Patents Court of the High Court of Justice of England and Wales (hereafter the “Patents Court”, the “High Court” or the “Court”) or the Intellectual Property Enterprise Court (“IPEC”).

The IPEC was established to deal with patent and other intellectual property disputes that are less complex and typically of lower value than those heard in the High Court. Its processes are intended to encourage more streamlined and cost-effective litigation, with claims having a limit of £500,000 in value, and recoverable costs typically being capped at £50,000.

For matters that are more complex, longer and/or exceed the IPEC caps on claim value and costs, these will be brought in the Patents Court. The judges and deputy judges of the Patents Court have specialised experience in dealing with patent matters, both in their judicial careers and often from their practice prior to being appointed to the bench. Some Patents Court judges also have technical degrees, which assist them in navigating the technical and legal nuances of complex technical subject matter. Patent cases are assigned a technical difficulty rating from 1 to 5 (from least to most complex), with cases of a difficulty rating of 4 or 5 normally heard by one of a specified subset of judges and deputy judges who have particular expertise and qualifications to hear technically complex patent cases.

Both the IPEC and Patents Court will generally sit in London, but may hear trials outside of London at the application of the parties where it would save time or costs to do.

In selecting a forum, parties should weigh up the streamlined and cost-effective nature of proceedings in the IPEC against the Patents Court’s greater technical specialisation, and its ability to award damages and costs on an uncapped basis.

It should be noted that a claimant’s initial choice of forum is not final, as cases can be transferred between these courts upon application by one of the parties. In the recent case of Kwikbolt Limited v Airbus Operations Limited [2019] EWHC 2450 (IPEC), the court summarised the factors to take into account when considering a transfer, namely: i) the financial position of the parties; and ii) whether it is appropriate to make the transfer. This point ii) will be determined by considering: the value of the claim; complexity of issues; estimated trial length; the importance of the outcome to the general public; and what is in the overall interest of justice. Specialist judges are not a factor to take into account, as these are available in both courts.

Additionally, the Comptroller-General of Patents, Designs and Trade Marks (the “Comptroller”) in the UK Intellectual Property Office (the “UK IPO”) has jurisdiction to hear disputes relating to ownership; compensation (i.e. of employee inventors); entitlement; the grant of compulsory licences; supplementary protection certificates (“SPCs”); and, in some limited circumstances, infringement and validity disputes. The Comptroller may only give an award of damages in respect of the infringing goods and/or a declaration regarding the validity or infringement of the patent. Nevertheless, they have the same power to revoke a patent as the court under the Patents Act 1977 (the “Patents Act”). However, disputes before the Comptroller are relatively infrequent.

Finally, while the UK has ratified the Unified Patent Court (“UPC”) Agreement, this court is yet to be formally established. The UPC, once operational, will be a court common to contracting member states which will have exclusive competence in respect of unitary patents, and also European patents where the patentee or applicant has not opted out under the transitional provisions. Further, under the transitional provisions, actions for infringement or for the revocation of European patents may still be brought before national courts.

Conduct of civil litigation in England and Wales is governed by the Civil Procedure Rules (“CPRs”) and related Practice Directions (“PDs”). The IPEC and the Patents Court have each also issued further helpful guidance to parties litigating in those respective forums, in the form of the Patents Court Guide (latest version April 2019) and IPEC Guide (latest version July 2019). As most significant patent cases are typically heard in the Patents Court, this response provides a general overview of the proceedings in that forum.

Patent litigation proceedings in the Patents Court are commenced when a party files a claim form and particulars of claim. The defendant is then required to file an acknowledgement of service, as well as its defence (and any counterclaim).

Around one to two months following the exchange of the above pleadings, a Case Management Conference (“CMC”) will generally be held, during which the court will make an order for directions setting out in detail the timeline for progressing the matter to trial. A template example of such a directions order is provided as an appendix to the Patents Court Guide. The directions typically include orders in relation to: disclosure, the filing and service of fact and expert evidence, the setting of the trial dates, the exchange of skeleton arguments, and potentially a pre-trial review. The parties are encouraged as far as possible to agree on the order for directions prior to the CMC.

It will generally take around twelve months from the date of filing of a claim for the matter to proceed to trial. However, a patent trial may be expedited by the court in certain circumstances, having regard to factors such as the objective need for urgency, the prejudice faced by the opposing party, and the impact of expedition on the administration of justice. If there is a suitable degree of urgency (and availability in the Court diary), a case may go to trial within around six months.

Additionally, where a High Court dispute involves relatively few issues or little evidence, it may be eligible for the Shorter Trial Scheme, a now-permanent scheme involving simplified and expedited procedures, whereby a trial (of a maximum of four days) must take place within eight months of the CMC, and judgment must generally be delivered within six weeks of the trial.

Where both validity and infringement are raised by the parties to a patent dispute, these claims will typically be heard at the same time (i.e. no bifurcation of the consideration of validity and infringement). Claim construction is considered alongside infringement and/or validity. However, it should be noted that claims are construed independently of the features of the alleged infringing product or process.

A first instance decision will generally be handed down within about three months of trial.

Generally speaking, damages issues will be determined separately from and subsequent to a finding of infringement, and may require a further hearing or potentially an additional trial. However, where the basis of the patentee’s claim for damages is relatively straightforward or is not disputed, damages may be assessed in the course of the infringement decision, or shortly thereafter.

Decisions in patent cases can be appealed. The process for appeal and the tribunal to which the appeal is made will depend on whether the original decision was made in the Patents Court, IPEC or by the Comptroller.

Cases heard before the Comptroller can be appealed to the Patents Court, and permission to appeal is not required.

Decisions from the IPEC and Patents Court can be appealed to the Court of Appeal, provided that permission to appeal is granted. Such permission may be given by the lower court or, where the lower court has refused permission to appeal, the appellant may apply to the Court of Appeal directly for permission. Permission will only be given where the court believes that the appeal has a real prospect of success, or there is some other compelling reason to allow the appeal to go ahead.

Appeals to the Court of Appeal are limited to review of the first instance decision on points of law and will not involve a re-opening of the evidence heard and findings of fact made at first instance. New evidence will not be heard on appeal.
Further appeal from a decision of the Court of Appeal is available, but only for appeals that concern points of law of general public importance. Permission to appeal is required and such permission is granted relatively infrequently, in light of the high threshold of “general public importance”.

Appeals from the IPEC or Patents Court to the Court of Appeal will generally be heard within about 12-18 months of the filing of the appeal, whilst further appeal to the Supreme Court typically takes a further one to two years.

Where the applicant is granted permission to appeal, the orders made to give effect to the first instance judgment are not automatically stayed pending the outcome of the appeal. Nevertheless, the applicant can apply to the court for a stay if one is required.

Subject to the defences/exceptions outlined in the Patents Act, a patent is directly infringed under Section 60(1) Patents Act if, while the patent is in force, a person does any of the following acts in the United Kingdom in relation to the invention, without the consent of the patentee:

(a) where the invention is a product, the person makes, disposes of, offers to dispose of, uses or imports the product or keeps it whether for disposal or otherwise;

(b) where the invention is a process, the person uses the process or offers it for use in the United Kingdom when the person knows, or it is obvious to a reasonable person in the circumstances, that its use there without the consent of the proprietor would be an infringement of the patent; or

(c) where the invention is a process, the person disposes of, offers to dispose of, uses or imports any product obtained directly by means of that process or keeps any such product whether for disposal or otherwise.

To decide whether a patent has been directly infringed, it is necessary for the court to construe the claims of the patent and determine whether the alleged infringing act falls within the scope of the claims of the patent as so construed.

The concept of indirect patent infringement exists under UK law.

Subsection 60(2) Patents Act relevantly provides:

Subject to the following provisions of this section, a person (other than the proprietor of the patent) also infringes a patent for an invention if, while the patent is in force and without the consent of the proprietor, he supplies or offers to supply in the United Kingdom a person other than a licensee or other person entitled to work the invention with any of the means, relating to an essential element of the invention, for putting the invention into effect when he knows, or it is obvious to a reasonable person in the circumstances, that those means are suitable for putting, and are intended to put, the invention into effect in the United Kingdom.

This infringement is ‘indirect’ in the sense that said act of supplying or offering to supply the relevant means relating to an essential element of the invention would not fall within the scope of the claims of patent so as to constitute ‘direct’ infringement, but is nevertheless deemed to ‘indirectly’ infringe the patent.

This subsection is qualified by subsection 60(3), which provides:

Subsection (2) above shall not apply to the supply or offer of a staple commercial product unless the supply or the offer is made for the purpose of inducing the person supplied or, as the case may be, the person to whom the offer is made to do an act which constitutes an infringement of the patent by virtue of subsection (1) above.

A ‘staple commercial product’ is one which is supplied commercially for a variety of uses.

A party may also be liable as a joint tortfeasor for acts of patent infringement committed by another party (the primary tortfeasor), if that party assisted in the commission of the act by the primary tortfeasor, and acted pursuant to a common design. Such cases will generally turn heavily on the particular facts and circumstances of the case, in particular whether (and the extent to which) the first party can be said to have assisted with, procured or encouraged the infringing act.

Section 130(7) Patents Act provides that certain provisions of the Patents Act, including Section 60 which defines infringement, are framed so as to have, as nearly as practicable, the same effects in the United Kingdom as the corresponding provisions of the European Patent Convention (“EPC”), the Community Patent Convention (“CPC”) and the Patent Co-operation Treaty (“PCT”) have in the territories to which those Conventions apply.

Article 69(1) of the European Patent Convention (as amended in 2000) (“EPC 2000”) relevantly states:

The extent of the protection conferred by a European patent or a European patent application shall be determined by the claims. Nevertheless, the description and drawings shall be used to interpret the claims.

Article 1 of the Protocol on the Interpretation of Article 69 EPC 2000 (“the Protocol”) in essence provides that this Article should not be interpreted to mean that the extent of protection conferred by a European patent is defined by the strict, “literal” meaning of the wording used in the claims, description and drawing, nor should it be taken to mean that the claim serves only as a guideline and that the actual protection conferred extends to that contemplated by the patentee. Rather, the extent of protection is to be found in a position between these extremes which combines a fair protection for the patentee with a reasonable degree of legal certainty for third parties.

Article 2 of the Protocol states that for the purpose of determining the extent of protection conferred by a European patent, due account shall be taken of any element which is equivalent to an element specified in the claims.

“Literal” infringement

Pursuant to Article 69 EPC 2000, in the UK the scope of protection of a patent is to be determined purposively by reference to its claims. This involves the identification of what a person skilled in the art as at the priority date would have understood the patentee to be using the language of the claim to mean, interpreted in the context of the specification as a whole. Whether an act infringes a given claim will depend on whether that act falls within the scope of the claim as a matter of normal interpretation.

Infringement by equivalence

Beyond the question of “literal” infringement of the claims, it is necessary to consider the extent to which the scope of protection afforded by a claim extends beyond its “literal” meaning (i.e. according to the normal purposive approach to interpretation, discussed above) and encompasses equivalent products or processes.

Following the UK Supreme Court decision in Actavis v Eli Lilly [2017] UKSC 48, a doctrine of equivalents now applies in the UK. In that decision, the court propounded the following test for infringement by equivalence, whereby an act infringes the claim of a patent even in the absence of “literal” infringement:

i) Notwithstanding that it is not within the literal meaning of the relevant claim(s) of the patent, does the variant achieve substantially the same result in substantially the same way as the invention, ie the inventive concept revealed by the patent?

ii) Would it be obvious to the person skilled in the art, reading the patent at the priority date, but knowing that the variant achieves substantially the same result as the invention, that it does so in substantially the same way as the invention?

iii) Would such a reader of the patent have concluded that the patentee nonetheless intended that strict compliance with the literal meaning of the relevant claim(s) of the patent was an essential requirement of the invention?

In order to establish infringement under the doctrine of equivalents where there is no “literal” infringement, a patentee must establish that the answer to the first two questions is “yes” and that the answer to the third question is “no”.

A defendant faced with a claim of patent infringement has a variety of options open to defend itself against that claim, including:

• Non-infringement – the defendant can argue that it did not carry of the allegedly infringing acts and/or that those acts do not in fact constitute infringement of the patentee’s patent (i.e. as not all of the integers of the relevant claim(s) have been satisfied).  Additionally, the defendant may also seek declarations of non-infringement in relation to alternative products and/or processes which it considers design around the asserted patent(s).
• Invalidity – the defendant can argue that the patentee’s patent is invalid and therefore cannot be infringed. See Question 8 below for further detail on invalidity. As notes above, in the UK issues of infringement and validity will be heard together (i.e. no bifurcation).
• Exhaustion – the placement of goods on the market in any European Economic Area (“EEA”) country with the consent of the patentee generally exhausts the patentee’s ability to enforce their intellectual property in respect of those goods to prevent re-sale elsewhere in the EEA. This doctrine does not apply to goods placed on an EEA market under a compulsory licence.
• Abuse of dominant position – the defendant can argue that the patentee’s conduct in bringing the claim of patent infringement constitutes an abuse of its dominant position in the relevant market, contrary to Article 102 of the Treaty on the Functioning of the European Union.
• Statutory defences – the defendant can argue that, notwithstanding they have performed acts that would otherwise constitute infringement of the relevant patent, one of the statutory defences to patent infringement applies (see below).

Section 60(5) Patents Act sets out the statutory defences to patent infringement:

• Private use for non-commercial purposes.
• Experimental purposes relating to the subject matter of the invention. Such experiments can be commercial, but the defence is strictly construed, e.g. in Monsanto v Stauffer (No.2) [1985] RPC 515, experiments done to obtain an approval required for commercial sales were infringements.
• Extemporaneous preparation in a pharmacy of a prescription given by a registered medical or dental practitioner.
• Use of a product or process by a vessel or aircraft temporarily or accidentally in UK airspace or waters.
• Use by a farmer of the product of his harvest for propagation or the use of an animal (or animal reproductive material), constituting the patented invention, by a farmer for an agricultural purpose following a sale to the farmer by the patentee or with his consent.
• Studies, tests, trials or any other acts necessary for the application of Articles 13(1) to (5) of Directive 2001/82/EC on the Community code relating to veterinary medicinal products  or Articles 10(1) to (4) of Directive 2001/83/EC on the Community code relating to medicinal products for human use (section 60(5)(i)(i), PA 1977).

The experimental use defence has also been widened by sections 60(6D) and (6E) (the so-called Bolar exemption), which protects the generation of bioequivalence data for generic products, allowing them to go through clinical trials and approval processes towards the end of a patent’s lifespan.

Section 64 Patents Act also sets out a prior use exception which provides that if a person in the UK before the priority date of the patent did an act in good faith which would constitute infringement of the patent if it were in force, or makes effective and serious preparations to do such an act, that person has the right to continue to do that act, albeit they cannot grant a licence to others to perform that act. If the prior use was done in the course of business, other employees can be authorised to do the act and, if they sell the part of the business using the right, they may assign it to the purchaser of that part of the business.

• The key grounds of invalidity are:
• The invention is not patentable – Section 1 Patents Act sets out the grounds on which an invention is not patentable:
• it is not novel or is anticipated – the invention disclosed in the patent is anticipated by the “state of the art” at the priority date. The “state of the art” includes anything made available to the public anywhere in the world, including other patent applications with an earlier priority date.
• it lacks an inventive step – the invention is obvious to a person skilled in the art (i.e. the technical field of the invention), having regard to any part of the state of the art or their common general knowledge;
• is not capable of industrial application; or
• is excluded from patentability as such, due to being:
  1. a discovery, scientific theory or mathematical method;
  2. a literary, dramatic, musical or artistic work or any other aesthetic creation;
  3. a scheme, rule or method for performing a mental act, playing a game or doing business;
  4. a program for a computer;
  5. the presentation of information;
  6. contrary to public policy; or
  7. a method of treatment or diagnosis of a human or animal.
• Lack of entitlement – the patent was granted to a person who was not entitled to be granted the patent. This argument may only be brought by a person who has established that they have the right to be granted the patent or a patent for part of the matter covered by the specification.
• Insufficiency – the patent specification does not disclose the invention clearly enough and completely enough for it to be performed by a person skilled in the art. Insufficiency can arise in different guises, for instance “classical” insufficiency, i.e. where the skilled person is unable to perform the invention from the information disclosed in the specification without undue burden; breadth of claim insufficiency; and insufficiency by uncertainty. An allegation of insufficiency can be used as a “squeeze” argument in combination with an argument of obviousness.
• Added matter – the matter disclosed in the specification extends beyond that disclosed in the application as filed or as a result of entitlement proceedings, such that the skilled person would learn something about the invention from the amended specification that they would not learn from the unamended specification.
• Extension of scope – the patent has been extended by an amendment that should not have been allowed.
• In addition to the statutory bases for invalidity, the courts have also found patents invalid for AgrEvo obviousness (where the claimed invention is not inventive because the alleged technical effect is not common to substantially everything covered by a claim); and for lack of plausibility (where the patentee has not disclosed a credible or plausible basis in the specification for supposing that the claimed product or process will have an asserted technical effect). Plausibility as a standard is employed across different elements of patentability, including inventive step (Generics (UK) Ltd v Yeda Research & Development Co Ltd [2013] EWCA Civ 925); novelty (Merck v Ono [2015] EWHC 2973 (Pat)); and industrial applicability (Human Genome Sciences Inc v Eli Lilly and Company [2011] UKSC 51).
• The above grounds for invalidity can overlap in multiple ways, allowing a party to claim invalidity on multiple grounds by way of a “squeeze” argument.

State of the art

As mentioned above, for a patent to be valid it must, inter alia, be novel and involve an inventive step.

Novelty
Section 2 Patents Act provides that an invention shall be taken to be new (i.e. novel) if it does not form part of the “state of the art”.

Section 2(2) Patents Act relevantly provides that the state of the art in the case of an invention shall be taken to comprise all matter (whether a product, a process, information about either, or anything else) which has at any time before the priority date of that invention been made available to the public (whether in the UK or elsewhere) by written or oral description, by use or in any other way.

Section 2(3) Patents Act relevantly provides that the state of the art in the case of an invention to which an application for a patent or a patent relates shall be taken also to comprise matter contained in an application for another patent which was published on or after the priority date of that invention, if that matter was contained in the application for that other patent both as filed and as published, and the priority date of that matter is earlier than that of the invention.
Inventive step

Under Section 3 Patents Act, an invention shall be taken to involve an inventive step if it is not obvious to a person skilled in the art, having regard to any matter which forms part of the state of the art by virtue only of Section 2(2), and not of Section 2(3) Patents Act.
Accordingly, the state of the art differs for the purposes of novelty and inventive step. Such patent applications which form part of the prior art for the purposes of the assessment of novelty (but not inventive step), by virtue of Section 2(3) Patents Act are often referred to as “novelty only prior art”.

Combining documents

Novelty
For the purpose of establishing a lack of novelty, the relevant anticipatory disclosure must be entirely comprised within a single document. If more than one document is cited against a patent, each such document must stand on its own and these documents cannot be combined.
However, if a cited document refers to a disclosure in another document in such a way as to indicate that this disclosure is intended to be included in the disclosure of the cited document, then the two may be read together as though they were a single document.

Inventive step
While it is not possible to combine the disclosure of a given document with other matter to establish a lack of novelty, it is permissible in certain limited circumstances to combine prior art references (whether published documents, instances of prior use or common knowledge) in support of an argument that a claimed invention lacks an inventive step. This is a practice referred to as “mosaicing”.

However, in order to establish that an invention is obvious in light of disclosures from two or more prior art references, it must have been likely that the notional skilled person lacking in inventive capacity would have considered the teachings from those prior art references together. Put another way, it is not permissible to just link one piece of prior art with another, unless doing so itself would be uninventive. The combination of prior art references is more likely to be permissible in circumstances where one document cross-refers to another.

It should be noted that, in practice, it is uncommon for such mosaicing to be permissible in the UK. Instances where this has been allow remain the exception rather than the rule.

A patentee can seek to amend a patent that is in the midst of patent litigation either nationally (through UK courts) or centrally (through the European Patent Office “EPO”).

UK

In proceedings before the court or the Comptroller in which the validity of a patent may be put in issue, an application to amend a patent must be made pursuant to the specialised procedure under Section 75 Patents Act. This provision empowers the court or the Comptroller to allow the patentee to amend the specification of that patent in such a manner, and subject to such terms as to advertising the proposed amendment and as to costs, expenses or otherwise, as the court or Comptroller thinks fit.
A person may give notice to the court or the Comptroller of his or her opposition to a patentee’s proposed amendment, in which case the court or the Comptroller shall notify the patentee and consider the opposition in deciding whether the amendment or any amendment should be allowed.

Section 76 Patents Act importantly specifies that an amendment of the specification of a patent is not allowable if it would result in the specification disclosing additional matter, or the extension of the protection conferred by the patent.

Once an amendment is allowed, it is deemed to have retrospective effect from the date of grant. Where there is a finding of patent infringement in respect of a patent which is subsequently amended (e.g. in the EPO), the patentee can no longer rely on that earlier finding of infringement to claim damages, because there has not been a finding of infringement of the patent in its amended form.

An application to amend a patent can either take place on a conditional basis, whereby the patentee maintains the patent or relevant patent claim to be valid in its unamended form, or an unconditional amendment, whereby the patentee accepts that the unamended patent or patent claim is invalid.

A national amendment of a patent specification has typically not been allowed in past cases following an unsuccessful defence to a challenge to the validity of the patent.

EPO

Pursuant to Article 105a of the EPC, the proprietor of a European patent may in certain circumstances file a request with the EPO to limit it by amendment of its claims. The effect of such a central limitation is that all national designations of the patent will be amended ab initio, including any such UK designation.

The EPC sets out certain requirements for amendments. These are contained in Article 123(2) EPC (no added matter) and Article 123(3) EPC (no claim broadening in any amendment after grant). Any amended claim must also satisfy the requirements of Article 84 (conciseness, clarity and support).

Where patent litigation proceedings are underway in the UK and a patentee subsequently files for a central amendment, the UK court may stay the UK proceedings while the central amendment application is considered, though it will not necessarily do so. The circumstances where a UK court may grant a stay are considered in further detail at Question 16 below.

The time taken to obtain a marketing authorisation (“MA”) for a medicinal product in the EU can often be lengthy due to the volume of clinical and safety data that must be submitted and verified. In some cases, this regulatory delay may serve to significantly reduce the period during which the patentee can derive a commercial benefit from its patent rights covering the relevant medicinal product. SPCs (as defined above) can serve to compensate for this regulatory delay by providing an additional period of patent protection of up to five years in respect of certain medicinal products.
>Under Article 7 of Regulation (EC) No 469/2009 (the “SPC Regulation”), a patentee must apply for an SPC within six months of the grant of the MA or the grant of the patent, if later. Under Article 3, a product must meet the following requirements in order to qualify for an SPC:

• The product is protected by a basic patent in force;
• A valid MA has been granted;
• The product has not already been the subject of an SPC; and
• The MA that has been granted is the first to place the product on the market as a medicinal product.

Whilst SPCs are provided for by EU regulation, they are not granted centrally. Instead, the patentee must apply to the relevant intellectual property office of each Member State. In the UK, this is the UK IPO, i.e. before the Comptroller.
The SPC Regulation provides that the duration of an SPC is the amount of time between the patent filing and the grant of the first marketing authorisation for the product, less five years. However this is subject to a maximum extension under an SPC of five years. Under the Paediatric Regulation, SPCs may also be extended by a further six months where products have undergone trials for use in paediatric medicine, provided that the application for extension is filed no later than two years before expiry of the SPC. The SPC period is often the most valuable period of protection for a product: for instance Eli Lilly’s antidepressant Prozac achieved 80% of its sales under IP protection during the SPC period.
The right of the UK IPO to grant SPCs is provided for in Section 128B and Schedule 4A of the Patents Act.

A UK-granted SPC may be challenged in the Patents Court on the basis that it is invalid under Article 15 of the SPC Regulation. The grounds of revocation are:

• That the certificate was granted contrary to Article 3;
• The basic patent has lapsed before the term of the certificate expires;
• The basic patent was amended so that it no longer protects the product; and
• After the basic patent has expired, it would have been invalid.

Many proceedings relating to SPCs therefore involve the same patent invalidity arguments outlined above relating to the underlying basic patent. There is also a large body of case law (both in the Patents Court and the Court of Justice of the European Union (“CJEU”)) considering whether certain SPCs were properly granted pursuant to Article 3.
There have been a number of noteworthy recent decisions on the interpretation of Article 3 under the SPC Regulation, such as in Teva UK Ltd v Gilead Sciences Inc (C-121/17), in which the CJEU devised a two-part test for the interpretation of Article 3(a).
A number of other important questions as to the interpretation of the SPC Regulation have recently been referred to the CJEU, for which decisions are expected in the near term:

• Joint referrals in Sandoz v Searle (UK) (C-114/18) and Royalty Pharma (DE) (C-650/17), which seek clarification on the level of specificity required when an active ingredient is covered only by a class-based claim in the basic patent.
• Novartis (SE) (C-354/19), which asks whether Article 3(c) prevents the grant of a second SPC for a second medical use based on the same active ingredient, where that new use is specifically protected by a separate basic patent.
• Santen (FR) (C-673/18), which seeks further clarity on the precise scope of the well-known decision in Neurim (C-130/11) on the availability of SPCs for second medical uses.

Technical matters in UK patent litigation proceedings are typically considered by way of judicial consideration of the evidence of competing yet independent experts engaged by the parties. Under CPR 35.5, experts typically file written expert reports in advance of trial (either sequentially or simultaneously). If at trial a party wishes to rely upon the written evidence filed by its experts, it must allow for its experts to be cross-examined by the other parties to the dispute. This is common where they have given evidence on technical matters which are in dispute. Under CPR 35.6, a party may put written questions about an expert’s report to an expert instructed by another party, or a single joint expert (as discussed below).
Under CPR 35.3, it is the duty of experts to help the court on matters within their expertise, and this duty overrides any obligation to the party providing instructions (and/or payment) to them.

Under CPR 35.12, the court may, at any stage, direct a discussion between experts for the purpose of identification and discussion of the expert issues in the proceedings, and where possible, reaching an agreed opinion on those issues. Further, the court may direct that following a discussion between the experts they must prepare a joint statement for the court setting out those issues on which agree and disagree, along with a summary of their reasons for any disagreement. However in practice, this is rarely ordered.

Under CPR 35.7 where two or more parties wish to submit expert evidence on a particular issue, the court may direct that the evidence on that issue be given by a single joint expert rather than competing experts. If the parties cannot agree on a single joint expert, the court may select the expert from a list prepared or identified by the parties, or direct that the expert be selected in any other manner. In practice, the appointment of a single joint expert in patent litigation proceedings is not common.

Pursuant to section 70 of the Senior Courts Act 1981 the court may in certain circumstances appoint an assessor or a scientific adviser to assist the court in dealing with a matter in which the assessor has skill and experience. Under CPR 35.15, such an assessor will take such part in the proceedings as the court may direct, and in particular, the court may direct an assessor to prepare a report for the court on any matter at issue in the proceedings, and attend the whole or any part of the trial to advise the court on any such matter. Assessors are not commonly relied upon in patent litigation proceedings.

There is also scope for the use of a neutral scientific adviser in technically complex cases (separately from that provided for under the Senior Courts Act 1981), whereby said adviser stages a ‘teach-in’ to assist the court in understanding the relevant technology, without sitting in court for the whole trial. In this regard, see Electromagnetic Geoservices ASA v Petroleum Geo-Services & Ors [2016] EWHC 881 (Pat).

In patent litigation proceedings involving complex subject matter, it is common for the parties to prepare before trial a joint technical primer setting out the agreed basic undisputed technology relevant to the case. The Patents Court Guide at paragraph 13.6 encourages the production of a technical primer in advance of the expert reports so as to avoid substantially the same material being described by each expert. It is also common for a defendant to an allegation of infringement to provide a Product and Process Description (“PPD”) of the alleged infringing product or process in lieu of providing disclosure.

Disclosure

In UK litigation, a party may request evidence from another party to a dispute through the process known as “disclosure”.

The level of disclosure varies slightly between the different IP courts. In the IPEC, parties set out their cases fully in their statements of case, accompanied by initial disclosure of documents that support their case. Further disclosure is only permitted by court order for specific identified issues under CPR 31, considering the cost-benefit of the order. “Standard disclosure” (i.e. disclosure of all the documents on which a party relies, that adversely affect its or another party’s case, or support another party’s case) is very rarely ordered (or indeed in any patents cases).

Disclosure in the Patents Court is very limited. In Positec v Husqvarna [2016] EWHC 1061 (Pat), Birss J made it clear that the court will only order disclosure for validity purposes on an issue-by-issue basis, and will carefully examine the need for such disclosure. Similarly, the courts will deny a request for disclosure if such disclosure will be costly and of little importance to the case (Premaitha v Illumina [2016] EWHC 1516 (Pat)). It should also be noted that disclosure for validity purposes is limited to a four-year window, covering two years on either side of the priority date of the patent.

Nevertheless, in a bid to streamline disclosure across the Business and Property Courts, the Patents Court is currently involved in a Disclosure Pilot, which is running until the end of 2020, the guidelines for which are contained in PD 51U. Parties may follow one of disclosure Models A to E, depending on the level of disclosure required for the case. At one extreme, Model A only requires disclosure of any known adverse documents; and at the other, Model E requires “wide search-based disclosure”, and is ordered only in exceptional circumstances.

Disclosure is usually further limited as the parties will usually dispose of disclosure on infringement in favour of providing a PPD. This is still permitted under the Disclosure Pilot and is likely to continue to be used in many cases.

Disclosure of documents may also be ordered under CPR 31.16 before proceedings are commenced where such documents are desirable in order to dispose fairly of anticipated proceedings; assist resolution for the dispute without proceedings; or to save costs. For instance, in The Big Bus Company Ltd v Ticketogo Limited [2015] EWHC 1094 (Pat), pre-action disclosure of Ticketogo’s licences with third parties was ordered on a “legal eyes only” basis so that Big Bus could decide whether it was worth settling or fighting the patent infringement proceedings threatened. Such a request will only be considered where both the applicant and the respondent are likely to be parties to subsequent proceedings, and any order made will specify the documents to be disclosed, and may specify a time and place for disclosure and inspection of those documents.

Seizure

The UK does not have a saisie-contrefaçon procedure, but in extreme circumstances, a party claiming infringement may be awarded a search order upon application to the court, allowing their representatives to enter the defendant’s premises and search for, remove and detain any documents information or material pertinent to the case. In the English courts, search orders are considered a draconian measure, and will only be awarded (under their power derived from section 7(1) of the Civil Procedure Act 1997) for the purpose of preserving evidence in the most extreme cases. The patentee must be able to show both that it has a strong case of patent infringement, and that there are good reasons for believing that the defendant is liable to destroy evidence. Search orders are more commonly awarded in counterfeiting cases where there is a claim of trademark infringement or breach of registered design rights, than in patent infringement disputes.

Reversal of burden

Where the nature or features of the process by which a product is manufactured is confidential, and it is not possible to determine or ascertain the process by which the product was manufactured by observing the characteristics of that product, the owner of a process patent may face difficulties in determining whether its patent has been infringed in the production of that product.

Accordingly, and in conformity with Article 34 of TRIPS, Section 100 Patents Act provides for the reversal of the burden of proof in circumstances where the patented process is one for obtaining a new product:

(1) If the invention for which a patent is granted is a process for obtaining a new product, the same product produced by a person other than the proprietor of the patent or a licensee of his shall, unless the contrary is proved, be taken in any proceedings to have been obtained by that process.

(2) In considering whether a party has discharged the burden imposed upon him by this section, the court shall not require him to disclose any manufacturing or commercial secrets if it appears to the court that it would be unreasonable to do so.

Where the burden of proof is reversed, it will then be necessary for the other party to establish that its product was not made by the patented process.

Other procedures

Additionally or alternatively, relevant process information may potentially be obtained from a PPD or from the disclosure process (including pre-action disclosure).

The general rule under CPR 31.22(1) is that a party to whom a document has been disclosed may use the document only for the purpose of the proceedings in which it has been disclosed unless:

• that document has been read to or by the court, or referred to, at a hearing that has been held in public;

• the court gives permission; or

• the party who disclosed the document and the person to whom the document belongs agree.

However, the court may make an order restricting or prohibiting the use of a document that has been disclosed, even where the document has been read to or by the court, or referred to, at a hearing that has been held in public (i.e. an order under CPR 31.22(2)). Any party or any person to whom the document belongs may seek such an order.

In addition to CPR 31.22(2) orders, there are a number of additional measures that the parties can use (as appropriate to the proceedings) to protect confidential information:

• Confidentiality clubs – commonly used, confidentiality clubs are formed by way of written agreement between the parties to the litigation setting out who can have access to confidential documents disclosed in the proceedings, and under what terms. The provisions of the confidentiality club agreement typically contain requirements and restrictions relating to access, storage, labelling, copying, reproduction and destruction of the relevant confidential information, alongside requirements as to court orders that must be sought in respect of the confidential information (such as under CPR 31.22(2) and CPR 5.4C(4)). Where confidentiality is a major concern, for example in relation to very sensitive technical information, access to confidential information may be restricted to the opponent’s legal team.

• Pro tem confidentiality order – another mechanism for protecting the confidentiality of information disclosed among parties to the litigation is the use of a pro tem confidentiality order – an order agreed in many cases by the parties and sealed by the court. 

• Sealing the court file – the general rule is that third parties that are not parties to the litigation may obtain copies of the statements of case filed at court under CPR 5.4C, but not the accompanying attachments or documents served with it. Third parties can nevertheless apply to the court for permission to obtain these additional documents and any other document filed by a party or communication between the court and a party or another person. However, any party or person identified in a statement of case may apply to the court for an order that non-parties may not obtain a copy of a statement of case, that only certain persons (or classes of persons) may obtain a copy thereof, or that persons or classes of persons may only obtain a copy of a statement of case if it is edited in accordance with the directions of the court. Whilst parties to court proceedings sometimes attach a confidential schedule to a statement of case, it is often considered safer to apply to the court to restrict access as described above.

• Hearings in private (‘in camera’) – whilst the general rule is that hearings should be held in public, CPR 39.2 allows part or all of a hearing to be held in private for reasons of confidentiality if and to the extent that the court considers that it must be held in private in order to secure the proper administration of justice and that publicity would damage the confidential information.

• Injunctions – a party may apply for an injunction preventing the use of confidential information at any time, provided there is no other remedy that could adequately compensate for the harm that would be suffered but for the injunction. Further detail on the requirements for obtaining an injunction is set out below

UK

In the UK, although it is possible to seek revocation of a European or nationally granted patent in the UK IPO and the national courts (the Patents Court and the IPEC) there is no national system of post‑grant opposition proceedings.

EPO

Under Article 99 EPC, any person may give notice to the EPO of opposition to a patent within nine months of the publication of the mention of the grant of a European patent in the European Patent Bulletin. Under subsection (2), that opposition shall apply to the European patent in all the Contracting States in which that patent has effect.

Article 100 EPC specifies that the only grounds upon which an opposition may be filed are: that the subject-matter of the patent is not patentable under articles 52 to 57, that the European 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, or that the the subject-matter of the European patent extends beyond the content of the application as filed, or if the patent was granted on a divisional application or on a new application filed under Article 61, beyond the content of the earlier application as filed.

Under Article 101 EPC, if the opposition is admissible, then the Opposition Division of the EPO will examine whether at least one ground under Article 100 prejudices the maintenance of the European patent, and if so, will revoke the patent, and otherwise, will reject the opposition. Under Article 101(3) EPC, the Opposition Division may decide to maintain the patent in amended form. Under Article 21 EPC, appeals from decisions of the Opposition Divisions may be heard by the Boards of Appeal.

Interaction of EPO Oppositions with UK patent litigation

Under Article 68 EPC, where a European patent has been revoked or limited in opposition, limitation or revocation proceedings, the patent shall be deemed not to have had effect from the outset, (to the extent that it has been so revoked or limited). Accordingly, if a European patent is revoked or amended in the course of post‑grant opposition proceedings, that European patent will be revoked and/or amended in any designated state, including for the purpose of any UK litigation proceedings. Given the potential for EPO post-grant opposition proceedings to impact national proceedings by revoking or limiting the claims of the patent-in-suit, a party to national proceedings may apply for a stay of those national proceedings pending the outcome of EPO proceedings. The decision to grant a stay will depend on a number of factors, including: the expected date of disposition of the EPO proceedings as against the UK proceedings, the prejudice faced by either of the parties to the national proceedings as a result of the grant of a stay, and the potential for wasted costs and time. Whether a UK court grants a stay will depend on all of the circumstances, and it should not be assumed that a UK court will necessarily grant a stay as a matter of course.

As noted above, Section 130(7) Patents Act states that certain provisions of the Patents Act shall have, as nearly as practicable, the same effects in the UK as the corresponding provisions of the EPC, PCT and the Community Patent Convention (“CPC”).

In relation to the decisions of the EPO, it is also well-established under UK case law that, although not bound to do so, UK Courts “should normally follow the settled jurisprudence of the EPO (especially decisions of its Enlarged Board of Appeal) on the interpretation of the European Patent Convention in the interests of uniformity, especially when the question is one of principle” (Actavis v ICOS [2019] UKSC 15). Accordingly, UK courts will typically have regard to relevant EPO decisions.

Given the nature of the EPC system, local designations of the same European patent are litigated in domestic courts across Europe. The Patents Court has therefore recognised that “the judgments of courts of countries which are members of the EPC do play a role in influencing the decisions of courts of other EPC states considering the local designations of the same European patent”: Pfizer v Roche [2019] EWHC 1520 (Pat).

Given that, at the time of writing, the UK is a Member State of the European Union, the UK courts are currently obliged to refer a question of EU law to the CJEU if there are issues of EU law that are unclear and the referral is necessary for the court to give judgment. The CJEU is “supreme” in matters of EU law, and therefore its case law must be interpreted and applied in the judgments of the English courts when dealing with points of EU law. Due to the limited scope of EU law in relation to patent rights, there are only certain areas in which the jurisprudence of the CJEU is of relevance. Two such areas are (i) the interpretation of the SPC Regulation, in relation to which the Patents Court and has made a number of referrals to the CJEU in recent years, largely due to the lack of clarity in the drafting of its provisions; and (ii) issues of competition law where they interact with issues of patent law, e.g. in cases such as the determination of fair, reasonable and non-discriminatory (“FRAND”) licensing terms (see below).

When the UK leaves the EU on “exit day”, the body of EU law existing at that time will become UK law. This means that, whilst UK courts will no longer be able to make referrals to the CJEU on points of interpretation of that body of law, pre-exit CJEU case law will continue to bind the lower courts, and future CJEU case law is likely to be persuasive when the UK courts come to interpret the same issues.

While there is no obligation under UK law to consider foreign jurisprudence (subject to the abovementioned requirement to follow CJEU case law in certain instances), UK courts may look to foreign jurisprudence if it involves closely related fact, or when considering a new or novel point of law. One such example arose in Unwired Planet v Huawei, the first instance in which the UK courts considered whether it had jurisdiction to grant a global FRAND licence, where the courts considered relevant jurisprudence including from the United States. However, given that the UK is generally considered to have one of the most developed bodies of patent law in the world, it is rarely necessary for the UK courts to look elsewhere for jurisprudence on patent matters.

UK courts have jurisdiction to hear patent actions concerning the validity and infringement of UK patents, and UK-designated European patents. Additionally, while they may have jurisdiction to hear actions concerning the infringement of foreign patents, they will not have jurisdiction in matters concerning the validity of foreign patents, with jurisdiction in such cases being reserved for the state of registration.

Validity

Article 24(4) of Regulation (EU) 1215/2012 (the “Brussels Regulation Recast”) provides that in proceedings concerned with the registration or validity of patents, irrespective of whether the issue is raised by way of an action or as a defence, the courts of the Member State in which the registration has been applied for, has taken place or is under the terms of an instrument of the EU or an international convention deemed to have taken place shall have exclusive jurisdiction, regardless of the domicile of the parties.

Article 24(4) further states that without prejudice to the jurisdiction of the European Patent Office under the EPC, the courts of each Member State shall have exclusive jurisdiction in proceedings concerned with the registration or validity of any European patent granted for that Member State.

Article 27 of the Brussels Regulation Recast provides that where a court of a Member State is seised of a claim which is principally concerned with a matter over which the courts of another Member State have exclusive jurisdiction by virtue of Article 24, it shall declare of its own motion that it has no jurisdiction.

Accordingly, UK courts have exclusive jurisdiction in proceedings concerned with the validity of UK patents or UK designations of European patents. Conversely, where a UK proceeding is concerned with the validity of a foreign patent, including that of another Member State, then the UK court is to declare that it has no jurisdiction. Whether a particular action can be said to be concerned with the validity of a patent will often be a matter of characterisation in light of the circumstances, having regard to substance rather than form.

Notwithstanding this general rule, the CJEU held in Solvay S.A. v Honeywell Fluorine Products Europe BV and Ors (Case C-616/10) that this rule shall not prevent a court from awarding provisional relief on the basis of a foreign patent, such as a provisional cross-border prohibition against infringement, even if the defendants in the main proceedings argue by way of defence that the patent invoked is invalid.

Infringement

The Brussels Regulation Recast sets out a regime for determining whether a party can be sued in the courts of a given EU Member State, including in relation to the tort of patent infringement. Articles 4 and 5 provide in essence that subject to the Brussels Regulation Recast, persons in a Member State shall, whatever their nationality, be sued in the courts of that Member State. Per Article 6, if the defendant is not domiciled in a Member State, the jurisdiction of the courts of each Member State shall, subject to the Brussels Regulation Recast, be determined by the law of that Member State. Pursuant to Article 7, in matters relating to tort, a person domiciled in a Member State may be sued in another Member State in the courts for the place where the harmful event occurred or may occur. Under Article 8, where a person domiciled in a Member State is one of a number of defendants, he may also be sued in the courts for the place where any one of them is domiciled, provided the claims are so closely connected that it is expedient to hear and determine them together to avoid the risk of irreconcilable judgments resulting from separate proceedings. Article 9 of the Brussels Regulation Recast sets out the procedure for determining which court has jurisdiction in circumstances where proceedings involving the same cause of action and between the same parties are brought in the courts of different Member States.

In contrast to validity, UK courts may have jurisdiction in proceedings concerning the infringement of a patent registered in a foreign jurisdiction.

As an example of UK courts determining infringement of foreign patents, the UK Supreme Court in Actavis v Eli Lilly [2017] UKSC 48 recently opined on the infringement of not only the UK designation of a European patent, but also its corresponding designations in France, Italy and Spain. Further, in Chugai Pharmaceutical Co. Ltd v UCB Pharma SA & Ors [2018] EWHC 2264 (Pat), the court granted the claimant a declaration that its product would not infringe a valid claim of a particular US patent, such that no royalties were payable pursuant to a patent licence for the relevant period.

This is not to say, however, that a foreign court may not also have jurisdiction to decide the same question, or that even if the UK court does have such jurisdiction, it will necessarily be appropriate for the UK court to exercise it. In such circumstances, it will be a matter for the relevant courts, applying principles of private international law, to determine which court has jurisdiction to consider the question of infringement of a foreign patent, and whether that jurisdiction should be exercised.

Moreover, where a claim is brought in the UK for infringement of a non-UK designation of a European patent, and invalidity/nullity proceedings are then brought in the court of the relevant Member State, then Article 24(4) may be engaged in which case the UK court will not have jurisdiction to determine the infringement claim, as was the case in Anan Kasei v Molycorp [2016] EWHC 1722 (Pat).

Anti-suit injunctions

It is open to a party to seek an “anti-suit injunction” from the UK court, whereby the court restrains a party over whom it has personal jurisdiction from instituting or continuing proceedings in a foreign court if it is necessary in the interests of justice to do so. Whether an anti-suit injunction is granted will depend on all of the circumstances, though some relevant factors include: whether the proceedings before the foreign court are or would be vexatious or oppressive, whether the UK is clearly the natural forum for the dispute, and whether justice requires that the claimant in the foreign court should be restrained from proceeding there. In this regard, it should be noted that UK courts will tend to grant anti-suit injunctions cautiously since by definition they involve interference with the processes or potential processes of a foreign court, and further, while the prosecution of parallel proceedings in different jurisdictions may depending on the circumstances be undesirable, doing so is not necessarily vexatious or oppressive.

Parties to litigation in the UK are encouraged to comply with the PD on Pre-Action Conduct and Protocols, as the court, when making case management directions and orders as to costs and interest on sums due, will take into account the failure by either party to engage in pre-action conduct. Whilst there are no mandatory provisions specific to patent cases, the PD states generally that litigation should be a last resort and that parties should consider whether negotiation or some other form of ADR might enable them to settle their dispute without commencing proceedings.
Parties are expected to exchange sufficient information to understand the other’s position and to attempt to settle the issues between them without recourse to litigation. They are therefore encouraged to consider ADR at the outset, however they are also encouraged to consider ADR and settlement generally throughout the litigation timetable.

The Practice Direction on Pre-Action Conduct and Protocols explicitly refers to mediation, arbitration, early neutral evaluation and Ombudsmen schemes as ADR options available for resolution of disputes. Further forms of ADR are set out in the ADR guidebook known as the Jackson ADR Handbook. In practice, while parties regularly settle patent disputes prior to trial as a result of negotiation, at present ADR mechanisms such as mediation and arbitration are not commonly used in patent cases. This may change, however, in respect of certain types of patent suit, such as in the increasing number of standard essential patent (“SEP”) cases that are now being litigated. For example, there now exist several specialised FRAND ADR centres (such as at WIPO), where parties are encouraged to mediate and/or arbitrate their FRAND disputes in a central forum.

There are no patent-specific pre-action procedural steps that must be satisfied before a patent action can be commenced in the UK. Under CPR 7, proceedings commence when the court issues (i.e. seals and dates) a claim form at the request of the claimant. A claim form is a brief document, setting out key information about the claim and the relief sought. Once issued by the court it must be served within four months (or six months where it is to be served outside the jurisdiction). More detailed information about the claim is set out in the particulars of claim, which must be contained in, or served together with, the claim form, or served on the defendant within 14 days of service of the claim form (but no later than the latest time for serving the claim form). Given that the claimant has four months from the date of issue of the claim form to serve the claim form and particulars of claim on the defendant(s) (or six months for defendants located out of the jurisdiction), and given that the particulars of claim can be provided separately to the issued claim form, the claimant has a significant amount of time to finalise its particulars of claim even after the claim form is issued.

Although not technically a procedural step, the CJEU outlined in Huawei Technologies Co. Ltd v ZTE Corp., ZTE Deutschland GmbH (Case C-170/13), a number of steps that a SEP holder must comply with in SEP/FRAND actions in order to prevent a claim for an injunction being regarded as an abuse of a dominant position. In summary, these steps involve alerting the alleged infringer of the SEP and how it is alleged to have infringed it, and presenting a written offer for a licence on FRAND terms, specifying the amount of the royalty payable.
Patent infringement is considered a ‘tort’ under English law and therefore the limitation period is six years from the date on which the infringing act took place. Each infringing act (e.g. each sale of an infringing product) is considered separately for this purpose, so where a claim is brought more than six years after the first infringing act, this will not bar the claimant from all recovery – they will still be able to recover damages for any infringing acts that occurred within the limitation period.

In the UK, the parties with standing to bring patent infringement proceedings are patentees and exclusive licensees.

Owner

Section 61 Patents Act provides that, subject to certain conditions, a patentee may bring civil proceedings in a court in respect of any act alleged to infringe a patent.

Section 66 Patents Act concerns the standing of a co-owner of a patent to bring proceedings for infringement. Subsection (2) provides that one of two or more joint proprietors of a patent may, without the concurrence of the others, bring proceedings in respect of an act alleged to infringe the patent, but shall not do so unless the others are made parties to the proceedings. However, any of the others made a defendant shall not be liable for any costs or expenses unless they enter an appearance and take part in the proceedings.
Exclusive licensee

Section 67 Patents Act provides that the holder of an exclusive licence under a patent shall have the same right as the patentee to bring proceedings in respect of any infringement of the patent committed after the date of commencement of the licence.

Section 67(3) requires that in any proceedings taken by an exclusive licensee by virtue of the section, the patentee shall be made a party to the proceedings, but if made a defendant, shall not be liable for any costs or expenses unless he enters an appearance and takes part in the proceedings.

Under Section 130 Patents Act, an “exclusive licence” is defined as a licence from the patentee or applicant for a patent conferring on the licensee, or on them and persons authorised by them, to the exclusion of all other persons (including the patentee or applicant), any right in respect of the invention to which the patent or application relates. Under this definition, it is not necessary for a licence to confer all rights under a patent for that licence to be “exclusive”, but rather that any rights conferred must be conferred exclusively. Accordingly, not all patent licensees will necessarily be “exclusive licensees” under the Patents Act.

European patents with UK designations can be invalidated in the UK by the court or the Comptroller, or centrally by the EPO. Only a UK court or the Comptroller can invalidate a UK patent granted nationally by the UK IPO.

EPO

Under Article 99 EPC, for the nine months following the grant of a European patent, any person can file an opposition in the EPO to the grant of that patent. Any person can file an EPO opposition and, as a matter of practice, the identity of the opponent can remain anonymous if the opposition is filed in the name of a “straw man”, such as the European patent attorney firm that represents it, as is often the case.

UK

An application to revoke a granted UK patent can be made before the UK courts or the Comptroller. While it is common for a defendant to an infringement proceeding to bring a counter-claim for invalidity, a revocation action can in fact be brought assertively, and in the absence of an actual or threatened controversy.

Any person may bring an invalidity action in respect of a patent in the UK under any of the grounds specified under Section 72(1) Patents Act, save in respect of patent entitlement, pursuant to Section 72(1)(b).

Under Section 72(2)(a), an application to revoke a patent on the ground that it was granted to a person who was not entitled to be granted that patent may only be made by a person found by the court or the Comptroller to be entitled to be granted that patent or to be granted a patent for part of the matter comprised in the specification of the patent sought to be revoked. Under Section 72(2)(b), such an application may not be made if that action was commenced or that reference was made after the second anniversary of the date of the grant of the patent sought to be revoked, unless it is shown that any person registered as a proprietor of the patent knew at the time of the grant or of the transfer of the patent to him that he was not entitled to the patent.

Section 74 Patents Act specifies the types of proceedings in which the validity of a patent may be put in issue (by way of defence, proceedings for infringement under Section 61 or Section 69; proceedings in respect of an actionable threat under Section 70A; proceedings in which a declaration is sought under Section 71; proceedings for the revocation of the patent under Section 72; and proceedings involving Crown use under Section 58). Accordingly, while (with the exception of the entitlement issue) any person may bring an action for invalidity pursuant to Section 72, not every person can necessarily be a party to every such type of proceeding.

Interim injunctions are available to patentees on application to the court. This is an equitable remedy granted in the exercise of its discretion on a case by case basis. The court considers the grant of an interim injunction to be quite an onerous measure, such that they are less frequently awarded outside of the life sciences context, where for example, the launch of a generic or biosimilar product may lead to irreparable market loss and price erosion. The highly fact-specific nature of the enquiry for the grant of an interim injunction in the UK is illustrated by the contrasting outcomes in interim injunction applications sought in respect of “skinny label” and “full label” generic pregabalin products. In Warner-Lambert Company LLC v Actavis Group Ptc EHF & Ors [2015] EWHC 72 (Pat), Arnold J refused to grant an interim injunction in respect of a ‘skinny label’ generic product (whose marketing authorization excluded the relevant patented indication), but later granted interim injunctions in Warner-Lambert Company LLC v Sandoz GmbH & Ors [2015] EWHC 3153 (Pat) in respect of full label generic products (whose marketing authorization included the relevant patented indication).

As the price for obtaining an interim injunction, the court may require that the applicant give an undertaking in damages, whereby it agrees to pay damages to the respondent for losses caused by the grant of the injunction if it later eventuates that the injunction was wrongly granted. Injunction applications are usually heard on an inter partes basis (i.e. on notice to the alleged infringer), and can be heard within a couple of weeks of the application being made, or if necessary, even in a matter of hours or days if there is a launch at risk where patent rights exist (as in the case of Teva’s launch of an atorvastatin product before the expiry of Warner-Lambert’s paediatric extension).

In order for an interim injunction to be granted, under Section 37 Senior Courts Act 1981, the court must be satisfied that it is “just and convenient”. This is generally established by following the test developed in American Cyanamid Co (No 1) v Ethicon Ltd [1975] UKHL 1. Firstly, there must be a serious question to be tried on the merits. All that needs to be shown is that the patentee’s cause of action has substance (i.e. some prospect of success). At this stage, the court will not attempt to resolve disputed questions of expert testimony by conducting a mini-trial.

If this first step is satisfied, the court will go on to consider the “balance of convenience”. Some key considerations relevant to whether the balance of convenience favours of the grant of an interim injunction are:

• Would damages be a sufficient remedy for the patentee if they were to succeed at trial?
• Will the patentee’s cross-undertaking in damages adequately protect the respondent if the court grants interim injunctive relief which, at trial, proves to have been wrongly granted?
• Where the above factors are evenly balanced between the parties, the court will consider the balance of convenience more generally by looking at “special factors” specific to the dispute. If the court is still unsure as to whether the test has been made out, it will grant the injunction to ensure maintenance of the status quo.

Any delay in applying for an interim injunction will reduce the likelihood of obtaining one. The longer the applicant has managed without an injunction, the less likely the court is to be convinced of the need for one.

Ex parte injunctions (i.e. without notice to the alleged infringer) are available in very exceptional cases, such as where the matter is so urgent that there may not be time to notify the defendant, or where there is a real concern that the defendant may seek to dispose of evidence (see generally CMI-Centres for Medical Innovation, Dr Christoph von Keudell [1998] EWHC Patents 308). Ex parte applications can be heard quickly, usually within a few days of making the application, but the applicant will need to address the need for urgency in its application. The patentee will usually be required to make certain undertakings to the court, for instance that it will commence proceedings by issuing and serving a claim form.

As an ex parte hearing is one-sided, an applicant is under an obligation of full and frank disclosure and must therefore disclose all matters that are material to the court (including legal principles that are not in its favour), and the court has discretion to impose sanction if the applicant does not comply with this duty. If an ex parte injunction is granted, the court will usually make provision for a return date hearing, at which the respondent may contest the injunction.

Section 61 of the Patents Act specifies the remedies that may be sought in the UK in respect of patent infringement.

Further, the EU Directive on the enforcement of intellectual property rights (2004/48/EC) (the “IP Enforcement Directive”) sets out the enforcement measures, procedures and remedies that Member States must make available in the case of infringement of intellectual property rights. Article 3 of the IP Enforcement Directive specifies that these shall be fair and equitable and shall not be unnecessarily complicated or costly, or entail unreasonable time-limits or unwarranted delays, and shall also be effective, proportionate and dissuasive and shall be applied in such a manner as to avoid the creation of barriers to legitimate trade and to provide for safeguards against their abuse.

Monetary

Available final monetary remedies are damages in respect of the infringement, or an account of the profits derived by the infringer from the infringement pursuant to Section 61(1) Patents Act.

Damages are primarily intended (see further below) to compensate the patentee for loss that it suffered as a consequence of the infringement, whereas an account of profits requires the infringer to give up any gain deriving from the infringement.

While damages are typically compensatory in respect of the patentee’s loss, in circumstances where the patentee may not have suffered a loss or the infringer has not derived any gain from the relevant infringing act, the court may award damages under the “user principle”, by reference to the value of the use of the right made by the infringer. This is calculated having regard to the amount that the patentee acting as a willing licensor would reasonably have charged a willing licensee in the position of the infringer at the relevant time for a licence under a hypothetical negotiation (i.e. a reasonable royalty). Such damages are available even where the patentee cannot show that it has suffered a loss as a result of the infringement, nor that the infringer has profited from the infringement.

Section 61(2) Patents Act provides that the court shall not, in respect of the same infringement, award the patentee both damages and an account of profits. Accordingly, it will be necessary for the patentee to elect between these two types of remedies in respect of each infringing act. The election that the patentee makes will depend on the potential sum available under each option, as well as evidentiary considerations in relation to making a claim under each option. However, patentees most commonly seek damages over an account of profits (see further below).

Non-monetary

The non-monetary remedies specified under Section 61(1) Patents Act include: an injunction restraining the defendant from an apprehended act of infringement (on a preliminary/interim or final basis), an order to deliver up or destroy any patented product in relation to which the patent is infringed or any article in which that product is inextricably comprised, and a declaration that the patent is valid and has been infringed.

While final injunctions are commonly sought by patentees and are generally granted by UK courts upon a finding of patent infringement, the grant of an injunction remains a discretionary remedy. Damages are typically sought alongside a final injunction so as to compensate the patentee for loss or damage already suffered. As noted above, the IP Enforcement Directive provides that enforcement measures, procedures and remedies must among other things be ‘proportionate’, which courts will take into account when determining relief, including in relation to injunctions.

As noted at Question 23 above, preliminary injunctions, which are also discretionary remedies, are intended to preserve the status quo pending final determination of the patentee’s claim. As the price for obtaining preliminary injunction, the patentee will typically need to provide a cross-undertaking in damages to the court in favour of the alleged infringer.

The court may also grant other remedies in the exercise of its broader judicial discretion. As discussed below at Question 27, the court has jurisdiction to grant declaratory relief known as an Arrow declaration, whereby it declares that the applicant’s product or process was not novel or lacked an inventive step as at a given date (usually the relevant priority or filing date), such that the product or process could not infringe a patent claim without that claim being necessarily invalid. This allows a party to “clear the way” prior to launching its product.

Damages in lieu of an injunction

Additionally, the court can in certain circumstances award damages in lieu of an injunction. As provided under Section 50 Senior Courts Act 1981:

Where the Court of Appeal or the High Court has jurisdiction to entertain an application for an injunction or specific performance, it may award damages in addition to, or in substitution for, an injunction or specific performance.

The historical origins origins of this type of damages can be traced back to Section 2 of the Chancery Amendment Act 1858 (Lord Cairns’ Act), and are accordingly commonly known as ‘Lord Cairns’ Act damages’. Factors relevant to the court’s decision to grant such a remedy include whether the injury to the plaintiff’s legal rights: is small, is one which is capable of being estimated in money, and can be adequately compensated by a small money payment. Further, the court must consider whether the case is one in which it would be oppressive to the defendant to grant an injunction.

Most common remedies

The most common remedies sought for patent infringement are: an injunction in respect of future infringement, declaratory relief (e.g. declaration that the patent is valid and infringed), delivery up or destruction of infringing products, as well as damages or an account of profits. Monetary compensation will typically be granted as a matter of course upon a finding of patent infringement. While injunctive relief will typically be granted upon a finding of patent infringement, it remains an equitable remedy to be granted in the exercise of the court’s discretion. Accordingly, there may be limited circumstances where an injunction is refused, having regard to matters including public policy (such as where health or safety may be negatively impacted by the grant of an injunction – see Question 26 below).

Under Sections 61(1)(c) and (d) Patents Act, the court may award damages in respect of patent infringement, or order an account of the profits derived by the infringer from the infringement. However, under Section 61(2) Patents Act, the court shall not, in respect of the same infringement, award both damages and an account of the profits. Section 62 Patents Act sets out certain restrictions on the recovery of damages for infringement, including in relation to (i) a defendant who proves that at the date of the infringement they were not aware, and in light of all of the circumstances had no reasonable grounds for supposing, that the patent existed (with marking goods as ‘patent’ or ‘patented’ without providing the patent number generally being considered insufficient to establish such grounds); and (ii) the infringement of an amended patent before the decision to allow the amendment, subject to Section 62(3) of the Patents Act.

Damages are awarded on a compensatory basis given that patent infringement is a tort, with the aim of putting the patentee in the position they would have been in had the relevant patent not been infringed. Such an award is subject to standard remedial principles such as causation and reasonable foreseeability. These may include damages for lost profits in respect of infringing sales that the patentee would otherwise have made, damages for lost profits where the sale of the infringing product caused price competition, or a reasonable royalty in respect of infringing uses of the patent, even where these do not correspond with a loss to the patentee. A reasonable royalty is calculated by reference to the rate which would have been arrived at in a hypothetical negotiation at arm’s length between a willing licensor and a willing licensee in the positions of the respective parties.

An account of profits requires the infringer to give up any gains derived from the infringement so that they are not unjustly enriched. Where an account of profits is ordered, it will be necessary for the court to assess the gain made by the infringer as against the deduction of relevant costs and overheads. This gives defendants an incentive to inflate their costs and overheads so as to minimise the sum payable under the account of profits. Further, it will be necessary for the court to assess the portion of the profit that was derived from the infringement, which may not be straightforward in circumstances where only part of a product or a process infringes. Given the potential challenges and complexities in assessing an account of profits, a successful patentee will typically only elect for an account of profits if the amount it would receive is substantially higher than the compensatory damages to which it would be entitled.
As noted at Question 1 above, cases heard in the IPEC have a £500,000 limit on the damages or account of profits payable by infringers.

Whereas the Copyright, Designs and Patents Act 1988 (UK) allows for the award of additional damages in respect of copyright infringement, there is no specific allowance for exemplary damages under the Patents Act in respect of patent infringement. However it should be noted that under Article 13 of the IP Enforcement Directive, judicial authorities when setting damages can take into account not only negative economic consequences of infringement, but also elements other than economic factors, such as the moral prejudice caused to the rightholder by the infringer. This has been implemented domestically by regulation 3 of the Intellectual Property (Enforcement) Regulations 2006. Accordingly, there may be flexibility under Article 13 to award additional damages beyond actual economic loss in the case of patent infringement on such a basis.

It should also be noted that there exists a general principle under English law that additional damages, where available, may be awarded where damages on an ordinary compensatory basis can be seen not to be sufficient to do justice, such as when the defendant’s conduct had been calculated by him to make a profit for himself which might well exceed the compensation payable to the plaintiff: Kuddus v Chief Constable of Leicestershire Constabulary [2001] UKHL 29.

In the UK, while final injunctions are ordinarily granted in respect of apprehended acts of infringement following a finding of patent infringement, the grant of an injunction remains an equitable remedy that is granted in the exercise of the court’s discretion, and is not granted as of right to a successful party.

It is noted under Article 3(2) of the IP Enforcement Directive that the measures, procedures and remedies provided by Member States shall be among other things, ‘proportionate’.

Accordingly, there may be circumstances where a UK court refuses to grant a final injunction, instead granting a monetary remedy in lieu of an injunction (i.e. Lord Cairns’ Act damages), or perhaps granting an injunction in a narrower form than it otherwise would, carving out permitted acts of infringement subject to the payment of damages. In Edwards Lifesciences LLC v Boston Scientific Scimed Inc [2018] EWHC 1256 (Pat), consequent upon a finding of patent infringement, the court carved out from the scope of a final injunction (which it also stayed) use of an infringing medical device in a particular patient population for whom that device was the only medically suitable device, and instead granted a royalty in respect of any such device sales.

The decision to grant damages in lieu of an injunction will be made in light of all of the circumstances and each case will very much turn on its facts, but some relevant factors include whether the size of the injury to the plaintiff’s legal rights is small, whether it is capable of being estimated monetarily, whether it is one which can be adequately compensated by a small monetary payment, and further, whether it would be oppressive to the defendant to grant an injunction.

Considerations which may favour the refusal of an injunction include: the public interest, whether any persons are likely to suffer any negative health impacts (such as in the case of an infringing medical device or medicinal product where there is no direct substitute), the potential impact of an injunction on consumers, the remaining length of the term of the patent, the contribution of the infringed invention to the overall product (such as in the case of a multi-component product like a mobile phone or connected car), or the proportion of a supply of a given product that will be put to an infringing use.

It has been observed, however, that where the right sought to be enforced by the injunction is a patent, the court must be very cautious before making an order which is tantamount to a compulsory licence in circumstances where no compulsory licence would be available. Accordingly, where no other countervailing right is in play, the burden on the party seeking to show that the injunction would be disproportionate is a heavy one.

Conversely, there may be circumstances, particularly in a FRAND context where the typical remedy is a licence on terms set by the court rather than an injunction, where the court may nonetheless decide to grant an injunction. For instance, in TQ Delta LLC v Zyxel Communications Ltd & Anor [2019] EWHC 745 (Pat), the court decided to grant injunctive relief in view of the defendants’ “hold-out” behaviour. Whilst this case is fact-specific it provides a good example of the fact that an injunction is a discretionary remedy and that numerous different factors can be taken into account by the court when deciding whether to grant an injunction.

Where a final injunction is not ordered, the basis upon which damages awarded in lieu are calculated will vary in light of all of the circumstances.

Under Section 61(e) Patents Act, a patentee may bring civil proceedings in respect of an act alleged to infringe the patent and in those proceedings make a claim for a declaration that the patent is valid and has been infringed.

Under Section 70C(1) Patents Act, proceedings in respect of an actionable threat may be brought against the person who made the threat for a declaration that the threat is unjustified.

Under Section 71 Patents Act, a person can apply to the court or the Comptroller for a declaration that an act does not, or a proposed act would not, constitute an infringement of a patent (“DNI”) in proceedings between the person doing or proposing to do the act and the patentee, subject to certain requirements.

A further form of declaratory relief that may be sought is an Arrow declaration, which is in effect a declaration that a party has a “Gillette” defence as at a particular date. This then prevents a patentee from enforcing later patents against the subject of the declaration. By way of explanation, a Gillette defence (deriving from the speech by Lord Moulton in Gillette Safety Razor Co v Anglo-American Trading Co Ltd (1913) 30 RPC 465) arises where a defendant contends that a process, product or use was not novel or was obvious at a particular date (usually the relevant filing or priority date), and cannot accordingly fall within the scope of a valid claim of a later patent. For example, a party may apply for an Arrow declaration, if it seeks to launch a product and obtain commercial certainty before launch that the product (or a relevant process or use within the product) will not infringe a valid patent, because any patent later asserted against would accordingly be invalid for a lack of novelty or inventive step.

The UK court’s jurisdiction to grant an Arrow declaration was confirmed by the Court of Appeal in Fujifilm Kyowa Kirin Biologics Co., Ltd. v AbbVie Biotechnology Limited and another [2017] EWCA Civ 1. In considering whether to grant an Arrow declaration in the exercise of its discretion, the court will take into account justice to the parties, whether the declaration would serve a useful purpose, and whether there are any other special reasons why the court should or should not grant the declaration. Arrow declarations are increasingly sought in patent litigation proceedings and the recent cases have focused on whether such declarations will serve a “useful purpose”. For example, in Glaxo Group Ltd & Ors v Vectura Ltd [2018] EWHC 3414 (Pat), the court granted the claimant an Arrow declaration, focusing in its reasons on the useful purpose that doing so would serve in the circumstances. Conversely in Pfizer Ltd v F. Hoffmann-La Roche AG & Anor [2019] EWHC 1520 (Pat), the court declined to grant Arrow declarations on the basis that doing so would not serve a useful purpose in the circumstances.

Fees are payable to the court for hearing the dispute. The claimant must pay an issue fee to the court in order to commence proceedings. This may be up to £10,000 for cases where the claimant seeks to recover in excess of £200,000, or £10,528 where a claim is for both damages and a declaratory non-monetary claim. Such fees are also payable by any counterclaimant, as if they were the subject of separate proceedings.

Trial fees of £1,090 are also payable on the multi-track (i.e. for cases worth over £25,000) and £545 on the fast track. Any party making any application during proceedings must also pay a fee of up to £255 per application.

As stated above, decisions of the Comptroller can be appealed to the High Court. This application must be accompanied by an application fee of £240. When appealing a Patents Court or IPEC decision to the Court of Appeal, a fee of £1,199 is payable for all appeals, including where permission to appeal has been granted or is not required (i.e. for IPEC appeals). Where Patents Court appeals require permission to appeal, an additional £528 is payable.

If a Court of Appeal decision is further appealed to the Supreme Court, further fees are payable, including for: an application for permission to appeal (£1,000); filing notice of an intention to proceed with an appeal (£800); filing notice of an appeal (£1,600); and filing a statement of relevant facts and issues and appendix of essential documents (£4,820).

However, the majority of the cost of the dispute incurred by parties will be incurred by way of legal fees. These will vary significantly depending on the complexity of the dispute; the time taken to resolve the dispute; whether the first instance judgment is appealed; and the law firm and barristers engaged.

In accordance with the IP Enforcement Directive, the general rule is that unsuccessful party is responsible for paying the successful party’s legal costs relating to the dispute. As noted below, in practice a successful party will typically be able to recover the majority but not all of its legal costs.

However, the court has discretion to make such costs award as it sees fit under CPR 44. This may therefore mean that in the circumstances, due to poor conduct by the successful party, the costs awarded may be limited, or indeed no costs may be awarded at all in the most serious cases (though this is rare). The conduct taken into account by courts for this purpose includes the parties’ pre-action conduct, whether the PD on Pre-Action Conduct was followed, and the manner in which they conducted their cases.

In making an order as to costs, the court must consider the overriding objective that cases be dealt with ‘justly and at proportionate cost’. When considering whether costs incurred are proportionate, the court will consider: the amount in dispute; the value of any non-monetary relief sought; the complexity of the case; any additional costs relating to poor conduct on behalf of the unsuccessful party; and any other relevant factors in the circumstances. The general rule is that costs will be assessed on the standard basis, which allows for the recovery of proportionate costs. This may mean that some costs are not recoverable and others are reduced. Parties should expect that if costs are calculated on the standard basis, the successful party will recover 60-75% of its costs.

In assessing the proportion of its costs that a successful party may be able to recover, the court will typically consider the number of the issues on which that party succeeded, as well as the time spent at trial on the issues raised by each of the parties. One device that the unsuccessful party can use to limit the amount of recoverable overspend is to request detailed assessment of costs and the production of costs schedules. By setting out what time was spent on, the court may take the view that a lower percentage of costs should be recoverable. The successful party may resist this form of assessment though it will generally be granted if agreement on costs cannot be reached between the parties, particularly in high-value disputes.

Costs can be assessed on the indemnity basis if ordered by the court. A party has to ask for indemnity costs when the court makes a costs order. The key difference in this measure of assessment is that there is a presumption of proportionality in favour of the successful party. Whilst the successful party will recover a higher percentage of their costs than assessment on the standard basis, they are still unlikely to recover 100% of their costs (though will be much higher than, say, 70% recovery). If a patent is upheld as valid by the court, and another party subsequently challenges it, a ‘certificate of contested validity’ can be obtained by the patentee meaning that if the patent is upheld a second time, the challenger must pay the patentee’s costs on an indemnity basis.

In the IPEC, the court will follow the guidelines outlined above, bearing in mind that costs are subject to a cap of £50,000. Similarly, in multi-track cases worth up to £10 million, parties are required to file and exchange costs budgets estimating the costs they will incur at each stage of the litigation process, unless the court otherwise orders. A costs budget, once approved by the court, will in effect act as a cap on the costs recoverable by that party. So if parties incur more fees than they have budgeted for they may not be able to recover the costs above the cap (on the standard basis of assessment) unless they have had a revised budget approved or agreed by the court, they can justify the costs as an unexpected interim application reasonably not included in the budget (PD 7.9) or they can show good reason for going over the cap on a detailed assessment. There are serious consequences for failing to file a costs budget when they are required in a case: if that party is successful in the litigation, they will be unable to recover their costs from the other side.

Telecoms – the decision of Birss J in Unwired Planet v Huawei, in which the Court granted an injunction against Huawei unless it agreed to take a global licence for Unwired Planet’s standard essential patent portfolio, has precipitated an increase in litigation in the telecommunications sector in particular by SEP holders seeking the determined of global licence rates within a single forum (e.g., Conversant Wireless Licensing SARL v Huawei Technologies Co. Ltd & Ors [2018] EWHC 808 (Pat); Koninklijke Philips NV v Asustek Computer Incorporation & Ors [2018] EWHC 1224 (Pat); TQ Delta, LLC v ZYXEL Communications Ltd & Anor [2019] EWHC 562 (Pat)).

Biologics – the UK continues to see a strong flow of complex biologics cases in the courts. Biologic products now comprise the majority of the top selling medicines globally and recent times have seen an increase in originator-biosimilar litigation (e.g. Pfizer Ltd v F. Hoffmann-La Roche AG & Anor [2019] EWHC 1520 (Pat) (in relation to bevacizumab)) as well as originator-originator litigation (e.g. Takeda UK Ltd v F Hoffmann-La Roche AG [2019] EWHC 1911 (Pat) (in relation to vedolizumab); Eli Lilly And Company & Ors v Genentech, Inc [2019] EWHC 387 (Pat) (in relation to ixekizumab)) and even biosimilar-biosimilar litigation (Samsung Bioepis & Biogen v Fresenius Kabi (in relation to biosimilar adalimumab formulations)).

Arrow Declarations – seeking Arrow declarations in the UK (discussed in Question 27 above) may become an increasingly popular tactic for implementers looking to obtain FTO and increased commercial certainty in technology areas with crowded patent landscapes and sophisticated claim amendment and divisional filing strategies (e.g. biologics).

• One of the most contentious patent litigation issues in the UK currently is to be decided by the UK Supreme Court in late 2019 / early 2020 in the Huawei v Unwired Planet / Huawei, ZTE v Conversant appeals, and relates to whether the UK courts can and/or should make a determination of FRAND licensing terms in SEP cases on a global basis, including in circumstances where the vast majority of the implementer’s sales are in another jurisdiction. As things currently stand, an implementer found to infringe a single UK standard essential patent can be required by a UK court to take a licence for the relevant portfolio of patents across multiple jurisdictions, at risk of being enjoined from selling its products in the UK market. This is a highly contentious issue that has emerged as a result of the interplay between the globalised licensing practices for complex technological products with the territorial nature of the international patent system, whereby patents are granted and enforced on a territory-by-territory basis.
• A contentious and unresolved patent litigation issue in the UK, following on from the recognition of a doctrine of equivalents by the UK Supreme Court in Actavis v Eli Lilly [2017] UKSC 48, is whether there exists a Formstein defence to a finding of infringement by equivalents. Under such a defence, where an accused product or process is found to fall within the scope of a claim under the Actavis doctrine of equivalents, but that equivalent would have lacked novelty or an inventive step over the prior art as at the priority date, then it will be deemed to fall outside the scope of the claim, so as to provide a defence to infringement. This is a contentious matter, because it involves a conflict between the UK Supreme Court’s recent extension of the scope of patent protection by way of equivalents, and the longstanding feature of UK patent law that a patent cannot enable the patentee to stop a trader from doing what they had been lawfully entitled to do before the patent was filed. The alternative may mean that the patentee could obtain protection via the doctrine of equivalents for something that they could not have obtained protection for directly.

Delay – whilst the route to trial is fairly swift, taking about one year from filing the claim (and with provision in place for expedited trial timelines of six to nine months where necessary), parties can wait a long time to have their appeals heard. On average it takes 12 to 18 months from receiving the first instance judgment to receiving a judgment from the Court of Appeal, and another 12 to 18 months to be heard at the Supreme Court. Given that appellate courts are typically concerned with reviewing issues of law, parties do not typically require this amount of time to prepare their appeal cases, and are therefore left at the mercy of the court timetable as to when their disputes are finally determined.

Service out of jurisdiction – the current rules in CPR Part 6 are antiquated and do not reflect the way global businesses are run these days, with email being the primary means of borderless communication. Service out of jurisdiction can be a long and protracted process taking several months before the substantive stages of the proceedings can properly begin. There are however indications that the Patents Court is changing its approach in this respect. In a recent service out of jurisdiction application by Edwards Lifesciences Corporation, Arnold J ordered service by email on German company Meril GmbH and Indian company Meril Life Sciences Pvt. Ltd.

Accessibility of case information – there is no comprehensive, central and publicly accessible service to provide essential information (e.g. hearing dates, parties, legal representatives) and access to key documents (e.g. pleadings, orders, skeletons) in relation to on-going cases. Whilst the Patents Court maintains a Patents Court Diary, this is updated relatively infrequently and cannot be relied upon to provide accurate information. The implementation of an easily navigable public database that is updated in real-time would be a boon to the public interest in transparency of and access to justice, as well as to third parties with an interest in on-going cases.

Disclosure Pilot – the new Disclosure Pilot being trialled in the Patents Court, discussed further at Question 13 above, has introduced a level of uncertainty into the disclosure regime for patents cases. Given that disclosure has always been significantly more limited for patents cases than general litigation, some of the new procedural rules, for instance the disclosure Models A – E are not easily applicable to patents cases, particularly given that disclosure is often dispensed with in favour of a PPD. Parties are finding that a significant amount of time and cost is going into navigating these new rules that are not well-suited to patent litigation.

• Setting clear guidelines for the enforcement of SEPs in the context of global supply chains for complex products, in view of the proliferation of Internet-of-Things (“IoT”) enabled device and the advent of 5G wireless technology.
• The need to clarify the scope of patentable subject matter, in view of rapid developments in the life science and technology sectors which continue to test the boundaries of what is and what should be patentable.
• The need to develop targeted, appropriately crafted and proportionate remedies for patent infringement. This raises the question of the circumstances under which injunctive relief might be refused, including in relation to life-saving medical treatments, or multi-component technological products which may read on thousands of patents, only some of which may be infringed.
• Ensuring that the UK patent system remains functional and fit-for-purpose both during and following its anticipated exit from the European Union.
• The long-discussed establishment of a UPC to allow for the enforcement of Unitary Patents in up to 26 EU Member States, which will help to simplify, harmonise and lower the cost for enforcing patents across much of Europe. Current challenges for the project include a German Constitutional Court challenge to ratification of the project, as well as the role that the UK will play in the project in view of its impending exit from the EU.
• Maintaining political support and momentum for the adoption and harmonisation of patent laws across developing countries and rising powers, in particular China.
• Ensuring harmonisation and minimising divergence between EU Member States on the interpretation and application of EU law, and obtaining clear decisions from the CJEU that can readily be applied by courts in Member States.