Life Sciences & Pharma IP Litigation 2024 Comparisons

In England and Wales, only the proprietor(s) of the patent or the exclusive licensee can bring an action for infringement. Where multiple proprietors exist, a single co-owner may bring infringement proceedings but the other owner(s) must be joined to the proceedings – either as a co-claimant or, if they do not wish to take part in the action, as a non-participating defendant.

An exclusive licensee can bring infringement proceedings on their own – although the patentee must be joined as a co-claimant or, in a similar manner to co-owners, as a defendant if they do not wish to participate. An exclusive licence can be granted for part of a patent (eg, a particular embodiment of the invention) or some of the rights (eg, manufacturing); however, the exclusive licensee’s right to bring proceedings is limited to the rights that have been licensed. Exclusive licensees should ensure their licence is registered on the patent register in order to avoid consequences that potentially limit their ability to recover costs. Nevertheless, the licensee may still bring infringement proceedings even where the licence has not yet been registered.

Any party can initiate action for the revocation of a patent, and a party challenging the validity of a patent does not need to show standing to bring a claim. A revocation action may be brought either before the courts of England and Wales or before the UK Intellectual Property Office (IPO). Infringement and validity opinions are also both available from the UK IPO but these are non-binding. A patent may be revoked if it is found to be invalid in a UK IPO opinion, however.

In life sciences and pharma cases, claims for infringement are most often brought against companies who manufacture or supply the alleged infringing product to the market. Other entities involved in the import of the product (or the supply or import of a part thereof) may also be sued. Albeit theoretically possible, it is not the practice in England and Wales to sue healthcare practitioners or hospitals for patent infringement; the threat or perceived threat of such actions is viewed harshly by the courts and may give rise to counter-actions for unjustified threats.

If an interim injunction would affect dealings in relation to a pharmaceutical product or medical device purchased by the National Health Service (NHS), the Department of Health must be notified and the court will consider whether the applicant for such an interim injunction should pay any damages the NHS may suffer as a result of the interim injunction sought if it is ultimately found that such injunction ought not to have been granted (ie, if the patent is later found to be invalid). Per the court’s current usual practice, applicants for such interim injunctions will typically be required to provide cross-undertakings in damages in favour of the NHS if the interim injunction is granted.

Additionally, the IPO must be served with proceedings for the revocation of a patent. However, the IPO does not have the option to join in such proceedings.

Preliminary injunctions (PIs) are available in the UK as an interim equitable remedy, which the court grants where there is a serious issue to be tried and the balance of convenience favours the grant of the PI (as detailed later in this section). PIs can be applied for on an ex parte basis if appropriate and can be granted on the day of a hearing if there is sufficient urgency; however, this is rare. It is more common for an application for a PI to be issued inter partes within the context of main proceedings commenced in parallel, and for the application and evidence to be served on the defendant – and exchanges of evidence to take place – before a hearing.

In particular circumstances, where the form of the claims to ultimately be granted is sufficiently clear and certain, PIs can be applied for before the grant of a patent and can be based on an application. (This has only recently been confirmed and, in general, a party will still seek a PI on the basis of a granted patent.)

As English is one of the official languages of the European Patent Office (EPO), translation of a European patent or its claims is not required. (However, if the language of the description of the European patent in suit is French or German, it would be highly advisable to provide an English translation.) Validation is not required before entry to the UK IPO register, either. Patent validity is not assumed in PI proceedings and the alleged infringer has the opportunity to introduce evidence to the contrary in the PI proceedings ‒ although invalidity decisions from other jurisdictions are not normally a significant factor.

The timing and length of PI proceedings depend largely on facts and are based on commercial urgency. The court can also order an expedited trial of the main action to take place within months, in addition to (or instead of) issuing a PI. As a discretionary equitable remedy, courts expect that a party seeking a PI will do so expeditiously – the failure of an applicant to act with sufficient urgency in all of the circumstances is likely to count as a factor against the grant of the PI sought.

An application for an ex parte PI would normally be heard at a hearing lasting one or two days, with the decision from the court reached and handed down at the end of the hearing. A return hearing, at which both parties must be present, will then take place within a couple of weeks.

An application for a PI on notice would generally be heard within a couple of months. Judgment could be extemporaneous or handed down within days to weeks, depending on the complexity and urgency of the matter.

A first-instance PI decision may be maintained pending the result of the appeal of the PI decision or pending the final result of the main proceedings. A hearing and decision on a PI appeal will occur within days of the lower court’s decision if heard on an urgent basis, which will often be the case if there is a risk of an infringing pharmaceutical product entering the market.

When obtaining a PI, the claimant must provide a cross-undertaking to compensate the alleged infringer for damages in the event the injunction is found to have been unjustified (eg, the patent is ultimately found to have been invalid). The undertaking remains in place until a final order is made following the first-instance action and any appeal. The amount of damages is decided in a separate damages inquiry following the main action (if not settled).

Considerations for Granting a PI

The considerations to be taken into account when granting a PI are well established by case law and include the following.

• There must be a serious issue to be tried. (This is low threshold.)
• Damages are not an adequate remedy for the claimant (ie, the claimant will suffer intangible, unquantifiable or irreparable harm if the injunction is not granted).
• The cross-undertaking in damages is an adequate remedy for the defendant if it is later found that the PI was unjustified.
• If damages are not an adequate remedy for either side, the court will consider where the balance of convenience lies in granting the PI ‒ including the merits of preserving the status quo pending determination of the main substantive proceedings.
• PIs are only granted where the matter is urgent. It will be for the applicant to show that there is an urgency in granting the injunction, as demonstrated by reference to both damage to the business without a PI and to the speed with which the claimant has sought the PI. The applicant will likely be required to show why it did not issue proceedings earlier if there was an opportunity to do so.

Specific Considerations for Life Sciences and Medical Devices

In pharmaceutical cases where a PI is sought to prevent the launch of a generic or biosimilar version of the patented medicine, the court will consider whether the generic or biosimilar entering the market would irreparably damage the market for the branded product and whether damages can be adequately quantified. Until recently, it was generally considered that the entry of a generic or biosimilar causes an irreversible price spiral in respect of the medicine in question and, as such, that damages cannot be adequately quantified. This was often a decisive factor in the court finding that a PI should be granted to restrain generic or biosimilar entry.

Lately, however, courts have shown an increasing tendency to strongly pressure test applicants’ assertions that failure to grant a PI will result in such an irreversible price spiral. Courts have become cautious in granting a PI restraining generic or biosimilar entry if it is considered only difficult – rather than impossible – to quantify damages. In order to support any claims of an irreversible price spiral, applicants need to adduce detailed evidence that directly addresses and is highly tailored to the particular economics and market circumstances of the product in question, rather than being able to benefit from a working assumption.

When considering whether to grant a PI, the court will also consider whether the generic or biosimilar company sought to “clear the way” (or sought a declaration of non-infringement) before bringing their product to the market – or, conversely, whether the generic or biosimilar company sought to act surreptitiously in their launch activity. Parties that have not sought to clear the way and/or are considered to have acted surreptitiously are likely to be at greater risk of a PI against them. Similar considerations apply to branded products where there is a relevant third-party patent.

As a discretionary equitable remedy, the proportionality of the grant of a PI (or, indeed, final injunction relief) in all circumstances will also be a relevant factor considered by the court ‒ especially in the context of pharmaceutical and medical device litigation, where the granting of injunctive relief may have significant consequences for patients. The courts of England and Wales have shown significant flexibility when exercising their discretion to grant injunctive relief, including a willingness and ability to provide for:

• carve-outs from injunctions for certain patient populations that might otherwise go untreated; and
• a delay to the commencement of injunctions in order to allow patients and their healthcare professionals a period of training and transition between products (in the context of medical devices where re-training with the patentee’s product was required).

Quia Timet Relief for Threatened Infringing Acts

A PI can be obtained on a quia timet basis as part of infringement proceedings where an entity threatens to infringe a patent but before those infringing acts have actually been committed. However, the grant of a marketing authorisation in and of itself is not considered enough to obtain a PI – the claimant must show additional evidence of an intention to launch an infringing product.

Notification of PI Request

For inter partes PI applications, a defendant will be provided with the application for a PI, which includes the claimant’s evidence in support. The defendant will therefore have the opportunity to make representations to the court as part of the hearing on the matter of granting a PI.

The defendant is not normally notified before an ex parte application. The claimant therefore has an obligation to provide full and frank disclosure to the court in its application (including making points that support the defendant’s case) as part of its ex parte application. The defendant has the opportunity to make its representations at the above-mentioned return hearing. The defendant can write to the court and request permission to serve or provide evidence in response to the application; however, protective letters are not part of the law or practice in England and Wales.

Identifying New Court Actions That May Include PIs

Parties can monitor the court’s electronic filing service for new claims that are issued. They will know about the parties to a claim and the type of claim (eg, issued in the Patents Court) but will not be able to view detailed information until a number of weeks later when the defendant has participated in the action by, for example, acknowledging service. They will also not know if the action includes a PI application.

Issues of infringement and validity are dealt with in the same proceedings in England and Wales. The liability trial addressing any issues of infringement and validity takes place before a separate quantum trial, in which the court can decide the amount of damages that applies where infringement has been found (if this amount cannot be agreed through settlement at that stage).

It is possible (and common) to file nullity proceedings in England and Wales based on the UK designation of a European patent while there are parallel EPO opposition proceedings pending in respect of the patent in suit. The proceedings will run concurrently but, upon application by a party/the parties, the court may stay the national proceedings while the EPO proceedings are ongoing.

In theory, the “default” position is that the national proceedings should be stayed pending the final determination of the opposition proceedings in the EPO. However, in practice – owing to the significant length of time it typically takes for opposition proceedings (in particular, the appeal stage) to run their course in the EPO compared with the relative speed of proceedings in England and Wales – that default position is overturned in most cases by the need for commercial certainty on the part of the party that has commenced the national proceedings.

When adjudicating upon an application to stay national proceedings pending parallel opposition proceedings in the EPO, the court will also consider the availability (or lack) of remedies – for example, infringement decisions and non-infringement declarations and Arrow declarations cannot be granted by the EPO, yet can be given by the national court. The court will also consider if the parties have agreed to undertakings for damages if the patent in question would ultimately be revoked in the national proceedings after a stay was lifted.

Starting an Action

Actions relating to patent infringement or revocation may be brought at any time after the grant of a patent. Recovery of damages for acts of infringement date back six years or from the publication of the patent application (whichever period is less).

To start an action, a claimant must prepare a Claim Form, together with Particulars of Claim, and – depending upon whether the claim relates to patent infringement or revocation – either Particulars of Infringement or Grounds of Invalidity. For high-value claims before the Patents Court, the particulars are relatively high-level at this early stage and contain very little detail. This is also the case for the defendant’s response in its defence and any counterclaim, with detailed information following when the timetable to trial is set (particularly at the disclosure/discovery and expert evidence stages).

Notification to the Defendant

The claimant normally has four months to serve the action on a UK defendant or six months for a defendant outside the jurisdiction. Permission from the court is required (with limited exceptions) to serve documents outside the jurisdiction.

Actions are often served as soon as possible after issue, in order to start the “litigation clock” for providing a defence and moving towards agreeing the timetable to trial. Typically, the claimant’s solicitors serve the action by sending the above-mentioned documents by courier or post to the defendant’s registered address. Where the patentee is the defendant, service can also be effected by sending these documents to the patent agent’s address recorded with the UK IPO.

Timing of Patent Cases

Once a claim has been served, a UK defendant has 28 or 42 days to provide its defence against invalidity or infringement actions respectively – as long as a pro forma “acknowledgement of service” document is filed at court within 14 days (otherwise, the defence is due within 14 days). Any counterclaim is usually expected when the defendant provides its defence. Opportunities to file replies (including, in the claimant’s case, a defence to any counterclaim) are then available for approximately the next 1.5 months – at which point, the “pleadings stage” is closed.

A case management court hearing takes place after pleadings are closed (if the parties cannot agree the trial timetable between themselves). The court will hear the parties and decide the trial date and timetable to trial, including deadlines for important steps (eg, disclosure, expert evidence and any necessary fact evidence). No preliminary opinions are issued by the court; however, there may be interim hearings on specific issues of the case, such as:

• listing the trial at an early stage (recent trends favour standalone applications to list the trial rather than waiting for the case management hearing, owing to congestion in the Patents Court trial diary);
• the extent and timing of disclosure; and
• applications for a stay of proceedings.

As previously mentioned above in 1.4 Structure of Main Proceedings on Infringement/Validity, issues of validity and infringement are considered at the same trial in the UK.

The Patents Court aims to bring cases on for trial within 12 months of the claim being issued. However, this has not been possible in recent years, owing to the busy workload of the court. Cases are therefore taking closer to 18 months to come to trial. Expedition is possible ‒ thereby allowing the timeline to be almost halved or even further shortened – if the court considers this to be appropriate based on:

• the evidence in an expedition application;
• the nature of the case; and
• the availability of an earlier trial date.

A “shorter trial scheme” ‒ allowing trials within 12 months ‒ is also currently available in the Patents Court; however, this scheme is only appropriate for less complex actions. In all cases, judgment is normally reserved at the end of trial and subsequently handed down within two to three months. However, the authors have observed delays ‒ with some judgments taking significantly longer to hand down (particularly in the case of longer trials and/or where the issues in dispute are complex).

England and Wales also offer a court for simpler, low-value patent claims (and other IP rights) called the Intellectual Property and Enterprise Court (IPEC). Unlike in the Patents Court, damages are limited to GBP500,000 and legal costs recovery is limited to GBP60,000. A trial in the IPEC lasts for a maximum of two days, and expert and evidence is limited. The IPEC aims to bring cases on for trial between nine to 12 months after issue. A first-instance decision should be handed down within three months of the trial but may take longer.

A main action for patent infringement can be filed at any time once a UK national patent has been granted and, in certain circumstances, before it is granted ‒ for example, where the examination procedure in the EPO has concluded with a decision that a patent should be granted but the formal grant is yet to take place. As is the case with PIs (see 1.3 Preliminary Injunction Proceedings), translation of a European patent or its claims is not required ‒ nor is validation prior to entry to the UK IPO register.

For process patents producing a new product, the burden of proof may be reversed in certain circumstances that require the maker of an infringing product to show that the product was not produced in the process claimed in the patent.

Pre-action disclosure is not available as of right. Orders for pre-action disclosure can be sought if the would-be claimant can demonstrate that this may settle the dispute without the need for proceedings (as opposed to fishing for information to make out its claim). Pre-action disclosure has been ordered in some cases ‒ including disclosure of samples of a pharmaceutical product, which would enable the potential claimant to determine if the product did in fact infringe. The court can also order a third party to disclose documents to an applicant before proceedings have started in order to enable the applicant to commence proceedings against the appropriate party.

Disclosure in the main proceedings in patent cases is most common in relation to the issue of infringement rather than validity. Disclosure by an alleged infringer on the issue of infringement is commonly provided by way of a Product and Process Description (PPD) ‒ a self-contained document, provided in lieu of the relevant underlying documents, which sets out sufficient information for the court to determine whether or not the patent has been infringed.

Disclosure in the main proceedings follows the provision of an “Initial Disclosure List”, which is provided by the parties when they provide their initial pleadings and sets out the documents upon which they rely. Significantly, there is no requirement to disclose documents that adversely affect a party’s case as part of the Initial Disclosure List.

Unless ordered otherwise (upon application to the court and supported with good reasons), use of documents obtained in disclosure ‒ pre-action or at another point – is restricted to the English proceedings and cannot be used in other jurisdictions.

Search and seizure orders are available as a form of interim mandatory injunction and applications are made ex parte. As a result, the applicant for a search and seizure order is under an obligation to give full and frank disclosure upon the application (including points adverse to the applicant) and must give an undertaking for any appropriate damages if it is later found that the search and seizure order should not have been granted. Most applications for search and seizure orders are made before the issue of a claim but they can be made at any stage of proceedings, including when enforcing a judgment.

Unless the court orders otherwise, the defendant in an action is only able to apply for an interim remedy such as a search and seizure order after it has filed an acknowledgement of service or served a defence. Search and seizure orders should be applied for as soon as possible and any delay in applying may result in the application being denied. Search and seizure orders may also be granted against non-parties to a claim (eg, third parties).

The material obtained during the search and seizure may only be used for the purpose of the claim unless the court orders otherwise. As a general rule, the court is unlikely to allow this material to be used in other jurisdictions unless it is in aid of applications for contempt of court or protective measures.

Unlike the saisie-contrefaçon procedure available in France and certain other jurisdictions, search and seizure applications are not a regular feature of patent litigation in England and Wales. These orders are generally regarded as highly invasive and, as such, very good reasons – supported by strong evidence – must be provided by the applicant in order to meet the high bar for securing a search and seizure order. Such an order may be justified where, for example, there is a real risk of the defendant destroying infringing products or evidence in a bid to frustrate attempts to bring proceedings against them.

Declaratory relief is available in the courts of England and Wales and is commonly sought in patent actions. A subsisting cause of action need not be established, although some real dispute must exist between the parties. The English courts have shown an increasing willingness to consider using their discretion to award declaratory relief if this may be useful (in particular, in recent telecommunications litigation).

A declaration of non-infringement may be granted by the Patents Court and IPEC in main proceedings or upon application to the Comptroller. (For an explanation of the differences between the Patents Court and IPEC, see 1.5 Timing for Main Proceedings on Infringement/Validity.)

Arrow declarations (ie, declarations that a claimant’s process or product was obvious or not novel) can be sought in order to guard against future infringement proceedings for patents granted at a later date. Arrow declarations are available in England and Wales and can be granted where “they will serve a useful purpose”. Although the court has a broad discretion to grant them, it will assess the justice to the claimant and defendant and the proposed utility of the declaration. Arrow declarations have not been ordered in many cases in England; however, when they have been ordered, they have all been in relation to pharmaceutical products. Arrow declarations are not available for the sole purpose of aiding the claimant in foreign proceedings – for example, they will not be ordered if no infringement is threatened in the UK.

The English Doctrine of Equivalents (DoE) is a relatively recent development (ie, since 2017). The normal interpretation applied by the English courts is “purposive construction” – ie, considering the words of the claim as understood by a skilled person in context of the patent. Claimants can now plead infringement by an immaterial variant and the court will consider the following legal test.

• Despite the fact 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)?
• Would it be obvious to a person skilled in the art, who reads the patent at the priority date but knows that the variant achieves substantially the same result as the invention, that the variant does so in substantially the same way as the invention?
• 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 as an immaterial variant, a patentee would have to establish that the answer to the first two questions was “yes” and that the answer to the third question was “no”.

The DoE was established in a 2017 case where only infringement was at issue (Actavis v Eli Lilly). Following that case, it has since become a relatively common point argued by claimants. This led to ambiguities as to whether the DoE might extend the scope of patent protection to prior art processes or products. However, discussions in recent UK cases suggest that a defence against this possibility – referencing the Formstein defence arising from the German authority ‒ may be available in the future. No binding decision has been made on this issue as yet.

Although there is no strict legal requirement to “clear the way” ahead of the launch of a new product, it is a relevant consideration in PI proceedings. Failure of a generic or biosimilar company to clear the way ahead of market entry may be a factor in favour of the grant of a PI.

Expert evidence is a key feature of patent litigation proceedings in the UK. Each party will retain an expert (or multiple experts where the court considers this necessary). The experts’ overriding duty is to the court in facilitating its understanding of their area of expertise so that the court can decide the issues in dispute. Unlike in some jurisdictions, it is critically important that experts maintain and be seen to maintain their impartiality and do not argue the case of the party who engaged them. Parties should be especially mindful of how they instruct experts in order to ensure the expert is not compromised.

Experts normally prepare a written report during proceedings followed by a reply report responding to the report from the opposing party’s expert. Further reply reports may also be issued if considered necessary by the court. The expert will be expected to attend trial for oral cross-examination by the other side’s counsel in main proceedings. Cross-examination is unusual in PI proceedings or appeals.

Each party to the proceedings will generally have its own expert, unless specific circumstances apply – for example, all of the claimants in multiparty proceedings will generally be expected to share experts as much as possible in order to preserve court time and costs. In patent cases, it is common to have two or three experts on each side, with each expert forming a part of the hypothetical skilled team to whom the patent in suit is addressed.

Instructions to experts are highly regulated and may become disclosable upon application by the other party. Parties must be careful to instruct experts in a particular way – ie, discussing the state of the art and concepts relevant to the common general knowledge of the skilled person first and subsequently providing prior art for discussion before moving on to providing and discussing the patent. This is necessary to avoid criticism that the expert’s views were tainted by hindsight because they saw the patent at an early stage of their analysis.

There is an increasing expectation from the court that, in cases with more than one expert on each side, the experts should have the opportunity to discuss their views with the other experts on the same side as they would have in the hypothetical skilled team. The giving of concurrent evidence and a joint meeting of the experts can be ordered by the court, although this has not gained popularity in the Patents Court. It is rare for the court to appoint an expert – although it is possible. Scientific advisers may be appointed by the court; however, this is also rare.

Experimental evidence may be used, with the permission of the court, to prove or disprove facts that are relevant to the determination of issues of infringement or validity. The court will often allow experiments in pharmaceutical cases and the use of experiments is usually an issue decided at a case management conference. For experimental results to be admissible, the following steps must be observed.

• A party wishing to rely upon experimental data must first serve on the other parties a Notice of Experiments, which is a formal document setting out the facts it intends to prove by way of experiments and disclosing how the experiments are to be conducted.
• The other party may request the opportunity to inspect a repetition of some or all of the experimental data in the notice and must then respond to the notice stating whether or not each fact is admitted.
• The party wishing to rely on the experiment will then apply to the court for permission to rely on the experiments, which will normally be granted. If the experiments are repeated in the presence of the other party, it is the results of those experiments that will be relied upon at the trial.

The experts will also give evidence concerning the design and results of the experiments and may be cross-examined. The other party can also apply to conduct its own experiments.

Parties considering experiments must be careful in producing any data or documents, as these may become disclosable to the other side.

Under a series of procedural reforms, and further to developing practices in the Patents Court (and in the courts of England and Wales more generally), the approach to disclosure in England and Wales has moved steadily away from a US-style broad, inclusive approach to disclosure/discovery and towards a narrower model that encourages parties to make specific and limited disclosure requests (if any). The courts’ approach is guided by the overriding considerations of relevance, reasonableness and proportionality. The current disclosure regime also places the onus on the parties to proactively disclose relevant documents – in particular, there is a continuing duty on the parties to disclose any “known adverse documents”.

In patent proceedings, as noted in 1.7 Pre-action Discovery/Disclosure, disclosure is most common in relation to the issue of infringement rather than validity and is typically done by way of service of a PPD. Disclosure in relation to issues of validity (including inventive step as well as lack of sufficiency) is now difficult to obtain in light of the courts’ scepticism concerning the relevance of such disclosure to validity issues in most cases. However, if a patentee decides to rely on ‒ and therefore proactively discloses – a selection of its own documents as evidence in support of some factual contention, disclosure of other documents (eg, assignment or licensing agreements, laboratory notebooks and employment contracts, where relevant) potentially related to that issue may be warranted in response.

Pre-action disclosure and provision of “initial disclosure” upon service of pleadings is also discussed in 1.7 Pre-action Discovery/Disclosure.

The primary defences to infringement actions are invalidity and non-infringement of the patent – or a combination of the two in the form of the “Gillette defence” squeeze, where a defendant says that their product or process existed in the prior art.

Additionally, there is a variety of further defences to infringement available, including:

• consent;
• compulsory licence;
• private use;
• prior use (which has a jurisdictional restriction so that the use must be in the UK);
• mere repair;
• experimental use (a form of which is the Bolar exemption – see 2.3 Acceptable Pre-launch Preparations);
• exhaustion; and
• extemporaneous preparation of a prescribed medicine in a pharmacy.

Infringement and validity proceedings can be stayed pending the outcome of the EPO opposition proceedings (see 1.4 Structure of Main Proceedings on Infringement/Validity). It is less common pending proceedings in other jurisdictions.

The court may note the outcome of parallel proceedings, particularly in the EPO, but is not bound to follow the results of such proceedings in other jurisdictions.

Patents can be amended post-grant upon application to the UK IPO, which may grant the amendment with any conditions it sees fit. Amendment is not permitted as of right while there are pending validity proceedings before the court or the IPO but may be granted following an application to the court and advertisement by the IPO. There is an opportunity for opposition to the proposed amendments. If part of court proceedings, the opposition would generally be heard during the trial. Conditional amendments (ie, in the event that the claims as granted would otherwise be found invalid) are permitted in England and Wales.

Claim amendments may also be made for European patents either:

• through the central limitation procedure at the EPO; or
• in the course of opposition proceedings (eg, by way of auxiliary requests ultimately upheld in the course of such proceedings).

It is common for patents to be amended by one or more of these mechanisms in the course of patent litigation, particularly given that there will frequently be parallel EPO opposition proceedings in respect of the patent in suit.

Specialist judges decide cases in the Patents Court and in the IPEC (which deals with less complex patent cases, among other work). Patent cases in the Patents Court are assigned a technical complexity rating in the early stages of the case. The more complex cases (ie, those that receive a technical complexity rating of four or five out of five) are assigned to one of a list of judges – each of whom has particular expertise and experience in patent cases – that are approved to hear such cases. In the IPEC, cases are not assigned a technical rating; however, if they are complex and require extensive expert evidence, they may be transferred to the Patents Court.

Other than choosing whether to issue an action in the Patents Court or the IPEC, no forum shopping is available within England and Wales.

The right to bring an action for infringement in respect of small molecule pharmaceutical products is the same as for other pharmaceutical products.

An application for ‒ or the grant of – a marketing authorisation (MA) or an application for reimbursement are not considered infringing acts in themselves but can be seen as an indication that the applicant has serious plans to enter the market and therefore infringe the rights of the patent holder. The submission of a response to a request for tender or an offer to supply a product covered by a patent that is made before the patent expires is not seen as an infringing act if the actual supply is to occur after expiry.

In the UK, applications for marketing authorisations (MAAs) and reimbursement are not readily available on the public record – nor are submissions of responses to a request for tenders. However, the grant of an MA is in the public record once granted. The holder of an MA for a reference product is not notified of new generics or biosimilar MAAs and will only find out that an MA has been granted once it is public information.

The grant of an MA is often the trigger for engagement with the alleged infringer by the patentee/exclusive licensee. A new market entrant who does not wish to risk being enjoined should be willing to state that it will not enter the market until after the patent expires.

Second Medical-Use Patent Considerations

In the UK, medicines are generally prescribed based on their international non-proprietary name rather than the brand name. In addition, courts will primarily consider the external presentation of the medicine – ie, the indications for which the generic medicine is approved and which appear in the packaging and inserts for the product – when considering infringement of a second medical-use patent. Accordingly, apart from in exceptional cases where there is strong evidence to suggest an actual intention by the generic manufacturer to sell its product for the patented indication, it is now difficult to establish infringement of a second medical-use patent if a generic product has carved a patented indication out of its label (ie, it has a “skinny label”).

Parallel Imports

The viability of parallel importation of patent-protected medicines into England and Wales depends on the approach to the exhaustion of IP rights that the UK chooses to adopt following Brexit. This issue currently remains under consultation and is subject to clarification and potential change in the near future.

As things stand, the position between the UK and the European Economic Area (EEA) is asymmetric. The UK continues to adopt a regional exhaustion approach that extends to the EEA, while the EEA no longer includes the UK in its regional exhaustion regime. This means that IP rights subsisting in goods placed on the UK market will not be exhausted in the EEA, whereas rights in goods placed on the market in the EEA will be considered exhausted in the UK market. It remains to be seen how the UK government decides to change the law and what the ultimate outcome for IP rights-holders in the UK will be.

Regulatory data exclusivity provides eight years of exclusive rights to the MA holder for the data submitted in their MAA for branded reference products. This means that, during this period, a generic or biosimilar cannot file an MAA that relies on the data submitted in relation to the branded reference product.

Market exclusivity provides an additional two years of protection following the expiry of regulatory data exclusivity. The generic or biosimilar cannot be placed on the market during this period; however, an MAA can be filed relying on the data submitted in relation to the branded reference product. An additional year of market exclusivity protection can be obtained if, during the first eight years after the grant of an MA for the branded reference product, the MA holder obtains authorisation for a new therapeutic indication that is deemed to provide a significant clinical benefit. Overall, there is a maximum of 11 years’ exclusivity (the “8+2+1” year formula).

Challenges to data and market exclusivity are uncommon in the UK. The method for challenging decisions of the Medicines & Healthcare Regulatory Authority (MHRA) in relation to data and market exclusivity is by judicial review proceedings in the administrative division of the High Court.

Paediatric Extensions

Upon the completion of paediatric studies in compliance with the relevant paediatric investigation plan for a medicine, and their inclusion in the summary of product characteristics (SmPC), an MA holder may receive the benefit of a “paediatric extension” to one of the protections for that medicine. This can take the form of either:

• a six-month extension to a Supplementary Protection Certificate (SPC) in relation to that medicine; or
• an additional two years of orphan market exclusivity (in the case of orphan medicines).

Importantly, the MA holder cannot seek to obtain both paediatric extension rewards. If it wishes to opt for the SPC extension, it must take steps to remove the orphan designation from the product.

Orphan Medicines

In order to encourage the development of orphan medicines, the relevant indication will benefit from 10 years of market exclusivity from when it receives marketing authorisation. Orphan market exclusivity prevents products with the same therapeutic indication as a similar medicinal product from being granted an MA within the period of protection. Orphan exclusivity therefore grants protection that is broader than normal market exclusivity.

Generics companies can rely on the “Bolar exemption” in order to conduct the necessary activities to obtain the required regulatory approvals prior to patent expiry. Recent amendments to the UK Patents Act have clarified that activity conducted for the purpose of medicinal product assessment is expressly covered as a particular species of the general experimental use exemption from patent infringement. This exemption therefore covers not only activity by generics and biosimilar companies for the purposes of seeking regulatory approval but also applies to the preparation and running of clinical trials for innovative drugs that would otherwise infringe a patent.

The UK does not have the Orange Book or any other patent linkage regime. However, the British National Formulary (BNF) publication does provide information on medicines and branded and generic products available from the NHS.

See 2.1 Infringing Acts for a discussion of MAs.

Pricing and reimbursement, along with the grant of MAs, are not linked to patent status in the UK. See 2.4 Publicly Available Drug and Patent Information for discussion regarding public availability/notification in relation to MAs and pricing and reimbursement.

In England, the National Institute for Health and Care Excellence (NICE) assesses the cost of new medicines against their effectiveness and the price set by the manufacturer. NICE is likely to enter into discussions with the manufacturer and then make a recommendation that, in practice, will determine whether or not access to the medicine will be subsidised by the government and made available through the NHS. Judicial review proceedings can be brought against NICE if a manufacturer considers that an illegal decision has been reached with regard to pricing or, for example, the recommendation that a drug should be used off-label instead of the originator product. NICE health technology guidelines are specific to a medicine for the treatment of a condition (or multiple conditions), as listed in the guidance.

Administrative suits by way of judicial review proceedings can be filed against NICE or other public bodies for the decisions made regarding:

• whether treatment is to be funded;
• the terms of its availability; or
• how NHS Clinical Commissioning Groups issue guidance to prescribers on which medicines to prescribe (including off-label use of generic drugs).

These challenges are rare.

There are no differences in terms of infringing acts if the litigation concerns biologics or biosimilar patents rather than generics (see 2.1 Infringing Acts).

The MHRA’s guidance on the licensing of biosimilar products (issued in 2021) confirmed that the MHRA does not intend to require comparative clinical trials for new biosimilar products unless there is a scientific rationale for doing so. This will enable biosimilars to potentially enter the market much earlier than they would have otherwise.

There are no differences in terms of acceptable pre-launch preparations if the litigation concerns biologics or biosimilar patents rather than generics (see 2.3 Acceptable Pre-launch Preparations).

There are no differences in terms of publicly available drug and patent information if the litigation concerns biologics or biosimilar patents rather than generics (see 2.4 Publicly Available Drug and Patent Information).

There are no differences in terms of reimbursement and pricing/linkage markets if the litigation concerns biologics or biosimilar patents rather than generics (see 2.5 Reimbursement and Pricing/Linking Markets).

SPCs are available in the UK to provide protection for patented medicines beyond the term of the relevant basic patent. Regulation EC No 469/2009 sets out the regime for human and veterinary medicinal products. The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 imported the SPC regulation into UK law after Brexit.

The product that is the subject of the SPC must be protected by a basic patent that is in force. An MA must also be in place for the product and it must be the first MA to place the product on the market. The product must also not already have been the subject of an SPC.

An SPC extends the protection of the patent for up to five years for a particular indication and, if a paediatric extension is available, an additional six months’ protection can be obtained (see 2.2 Regulatory Data and Market Exclusivity). An SPC must be applied for within six months of the date of the MA for the relevant medicinal product or, where the SPC is granted based on the patent, within six months of the date of grant of the basic patent. An application for a paediatric extension to an SPC must be lodged no later than two years before the SPC expires.

An applicant for an SPC must hold the basic patent forming the basis of the application; however, the applicant need not be the holder of the MA. As such, so-called third-party SPCs are allowed. Given that the patentee and the MA holder can be separate unlinked entities, situations may arise where an SPC is applied for by a patent holder without the consent of the MA holder and, therefore, the patentee is prevented from obtaining an SPC. This has led to situations in which the MA holder has tried to have the SPC revoked or ultimately had to obtain a licence in order to be able to market its product.

SPCs are no longer available for a different application (ie, second medical use) of a product for which an earlier MA has already been granted. Only the first use of an ingredient or combination authorised by an MA can be granted an SPC.

At present, the case law in England and Wales concerning SPCs continues to be mostly derived from referrals to the CJEU prior to Brexit. There are numerous issues that have not been fully settled or on which the law on SPCs in England and Wales may diverge from the EU following Brexit.

SPC manufacturing waivers ‒ largely imported from EU regulations into UK law via the Intellectual Property (Amendment etc) (EU Exit) Regulations 2020) – are available in the UK, as in the EU. They allow for the medicinal product covered by an SPC to be manufactured by third parties while the SPC is in force for the purpose of:

• exporting from the UK and EU; or
• stockpiling for the final six months prior to SPC expiry in order to enable “day-1 market entry” following SPC expiry.

Paediatric extensions of six months are available for SPCs where studies have been conducted in accordance with a paediatric investigation plan. See also 2.2 Regulatory Data and Market Exclusivity.

Cross-undertakings for damages are required from the applicant for a PI and are covered at 1.3 Preliminary Injunction Proceedings. The NHS is likely to be party to any cross-undertaking for damages in life sciences patent cases.

PIs are enforced by a court order that is served by the court or the party obtaining the injunction against the potential infringer. If a person subject to an injunction does not comply with the court order, proceedings for contempt of court and other enforcement actions can be applied for from the court. However, it is rare that such actions need be taken in patent litigation cases.

A PI application will normally be filed in the context of a parallel main action. If a PI is sought and ordered before a main action is issued, the injunction is normally granted with the condition that a main infringement claim will be brought against the entity being enjoined.

It is sometimes (albeit rarely) possible to obtain a stay of a PI that has been obtained, pending appeal to the Supreme Court. There is no option to pay a bond in order to lift a PI.

Injunctions are enforced by way of the order of the court and are effective upon service on the defendant. A party (or a company’s directors, as applicable) subject to an injunction that breaches the order may be subject to fines, imprisonment, or committal of assets. Further applications can be made to the court to enforce an injunction.

Stay of a final injunction can be obtained, pending appeal or pending a decision on an application for leave to appeal. Examples of this include cases concerning critical life sciences products where, in the public interest, the parties agree to stay the final injunction pending appeal in order to prevent a supply chain/patient access from being interrupted. Prospects for obtaining a stay of a final injunction are otherwise limited. There is no option to pay a bond to lift a final injunction pending appeal.

An injunction is the default remedy for patent infringement. However, the court will consider whether it is proportionate in the circumstances to award an injunction and, in particular, whether damages would be an adequate remedy. As discussed in 1.3 Preliminary Injunction Proceedings, the English courts have shown a willingness to tailor the terms of an injunction by way of carve-outs and delaying the commencement of a final inunction.

Damages for infringement are available from the publication of the application underlying the infringed patent or from the first date of infringement (if later). The patent proprietor can elect to receive the alternative award of an account of profits; however, monetary relief in the form of damages is chosen in the overwhelming majority of cases. Interest is payable on the final award.

Quantum is decided in a separate hearing following the conclusion of the main action on liability. The date for payment of damages is provided in the final order following judgment and is generally within a few weeks. Interim awards are not available. Damages inquiries are evidence-heavy and time-consuming and therefore often settled before reaching the quantum trial. Damages can be assessed by a range of different assessment methodologies, including lost profits and reasonable royalty approaches. Where the court exercises its discretion not to order final injunctive relief, it may instead decide to order damages in lieu of the injunction.

Where a cross-undertaking as to damages has been given – ie, in return for a PI – by a patentee who is ultimately unsuccessful at trial, the beneficiaries of the cross-undertaking (which, in pharmaceutical cases, will often include the NHS) will be parties to the damages inquiry as well.

Legal costs (or a proportion thereof) are recoverable and follow the general principle that the losing party pays the winner’s costs. However, the court has wide discretion in relation to costs orders.

If the successful party in the Patents Court wins on all the issues raised in the litigation, it may recover its proportionate and reasonable costs (which equates to around 60%‒70% of their costs). If the losing party has conducted itself unreasonably in the litigation such that the court decides to make an order for costs on an “indemnity basis” as opposed to the “standard basis”, then the winner will be entitled to its reasonable costs without reference to the proportionality of those costs ‒ thereby resulting in a higher costs award in the region of 70%‒80% of the winner’s costs. This amount is likely to be reduced if the winner is considered to have lost on any particular discrete issues in the case. Additionally, the court will take into account offers the parties have made to settle the proceedings.

The court may make a summary assessment of costs (where costs are assessed by the judge who heard the case) or order a detailed assessment to be performed by a costs officer. Given the complexity and expense of the detailed costs assessment process, parties in patent litigation will typically reach an agreement on costs rather than resorting to that procedure.

Costs are recoverable from when the action is filed and include court fees. The court may choose to make an award on costs of an interim application at the time of hearing that application. It is also common for courts to require an interim payment of costs following first-instance judgment, pending assessment of costs or agreement between the parties on costs. Recovery of legal costs is capped at GBP60,000 in the IPEC.

When making an assessment of the recoverability of costs, the court will keep in mind the overall conduct of the parties during the whole course of the litigation. A party that is seen to conduct itself improperly during litigation may be subject to an adverse costs award, including the higher indemnity costs recovery threshold where the party’s conduct is considered to be outside the norm. Additionally, costs are not recoverable if they are unreasonably incurred or unreasonable in amount (unless indemnity costs have been awarded). Owing to the nature of patent litigation cases, there is generally no requirement to engage in pre-action correspondence and the parties are not penalised on costs for failing to do so.

In addition, for equitable forms of relief (eg, injunctive relief) and relief that is generally at the discretion of the court (eg, declaratory relief), improper conduct on the part of the party seeking relief is likely to be taken into account in the court’s assessment of whether it is appropriate in the circumstances for the court to exercise its discretion to grant the relief sought. In general, it is said that a party seeking equitable relief must come to the court “with clean hands” and that a party “who seeks equity must do equity”.

Trade mark disputes in the pharma sector are uncommon in England and Wales but are most commonly seen in relation to products where there may be confusion for the end customer or misuse of a company’s goodwill. They are more commonly seen in relation to consumer healthcare products rather than pharmaceuticals or medical devices.

Copyright issues are rare in the life sciences sector in England and Wales.

To date, trade secrets disputes have been uncommon in the life sciences and pharma sectors in England and Wales – despite the number of prominent life sciences trade secrets cases in other jurisdictions (eg, the USA). However, the increasing prevalence of collaborations between partner companies in life sciences and the increased mobility of the professional workforce between companies may see an increase in trade secrets disputes in England and Wales in the future.

An appeal against a first-instance main decision must be applied for within 21 days of the date the decision is handed down in the IPEC or the Patents Court (or within any deadline set by the court).

Appeals against decisions in patent litigation are not available as of right – permission to appeal against a decision must be sought from the High Court. Permission may be granted by the judge who made the decision (typically at the “form of order” hearing that follows judgment) or directly from the appellate court if permission is initially denied by the first-instance judge.

Appeals can be made to the UK Supreme Court within 28 days of the appellate court’s judgment. The grounds of appeal are that the lower court was either wrong in reaching its decision or that the decision was unjust because of a serious procedural or other irregularity in the proceedings.

When considering whether to grant permission to appeal, the court will consider whether the appeal has a real chance of success and if there is some other compelling reason for the appeal to be heard (eg, significant questions of law to be decided). For the UK Supreme Court to take an appeal against a decision of the appellate court requires the appeal to raise an arguable point of law that is of general public importance.

Generally, an appeal will be limited to a review of the lower court’s decision on legal issues, rather than issues of fact ‒ unless, in the circumstances, it would be in the interest of justice to hold a re-hearing of the case. Even on a review, the court still has discretion to receive fresh evidence.

Where a PI has been granted, an appeal must be lodged within 21 days. If the appeal is granted, it is usually expected to be heard with some urgency.

Where a preliminary or final injunction decision is overturned on appeal, the injunction is automatically lifted. If the EPO or UK IPO were to revoke a patent where a PI had been granted, an application must then be made to the court for the PI to be lifted. An urgent application to lift the PI would likely be heard within days or on the papers.

Appeals from the IPEC (other than those from the IPEC Small Claims Track, which are heard in the IPEC) and the Patents Court are to the Court of Appeal and then the UK Supreme Court upon further appeal. Although there are judges in the Court of Appeal that were previously judges in the Patents Court, there is no guarantee that they will sit on the case.

The Patents Court and the IPEC have special procedural requirements, which derive from parts of the English court rules (the Civil Procedural Rules) that make specific provisions for IP proceedings. Additional guidance is given in court guides, especially in the Patents Court Guide.

Applications for customs actions are available in the UK, particularly in relation to counterfeit products. Once an application for a customs action has been issued, the customs authorities will automatically seize suspected goods identified at the border.

The court encourages the parties to explore ADR – especially mediation – but it is left to the parties. Arbitration is also an option for life sciences disputes. However, in large-scale patent cases, litigation before the court through to a final judgment is the most common option.

In the past few years, the UK’s Competition and Markets Authority (CMA) has taken an increased interest in the pharmaceutical industry and the cost that the NHS pays for medicines. The CMA has pursued several “pay-for-delay” cases and imposed significant fines. The CMA has also pursued cases where it suspects abuse of dominant market position.