Life Sciences & Pharma IP Litigation 2024 Comparisons

A proprietor of a patent has standing to bring a patent infringement action. An equitable owner of a patent may also bring a patent infringement action although he/she must perfect his/her equitable title before final judgment.

Where there are multiple proprietors for a patent, any of them may bring an action without the consent of the other proprietors, but they must be named as defendants in the proceedings unless the court orders otherwise.

An assignee or exclusive licensee of a patent also has standing to bring an action in respect of any infringement of the patent committed after the date of the assignment or licence, or for infringements occurring prior to that date if such right is included in the relevant grant of title. The transaction, instrument or event by which the proprietor or exclusive licensee is conferred rights in a patent should be registered within a period of six months of its date, or if registration within that period is not practicable, as soon as practicable thereafter. The failure to do so does not mean that the assignee or exclusive licensee cannot sue, but it will preclude the assignee or licensee from obtaining damages or an account of profits in respect of a subsequent infringement of the patent occurring after the transaction, instrument or event, but before the same was registered.

Licensees under a licence of right or a licence granted compulsorily may request the proprietor of a patent to bring proceedings to prevent any infringement of the patent, and if the proprietor neglects to do so within two months, the licensee may institute proceedings in his/her own name, making the proprietor a defendant to such proceedings.

Section 82(1) of the Patents Act (PA) provides that the validity of a patent may be put in issue only in the following proceedings:

• a request for examination of the specification of a patent under Section 38A of the PA;
• by way of defence, in proceedings for infringement of the patent under Section 67 or proceedings under Section 76 for infringement of rights conferred by the publication of an application;
• in proceedings under Section 77 (ie, applications for remedies for groundless threats of infringement proceedings);
• in proceedings in which a declaration in relation to the patent is sought under Section 78 (ie, applications for a declaration of non-infringement);
• in proceedings before the court or the Registrar under Section 80 for the revocation of the patent; or
• in proceedings under Section 56 or 58 of the PA (ie, proceedings relating to the use of patented inventions by the government and its authorised parties).

Section 82(2) of the PA further states that no proceedings may be instituted seeking only a declaration as to the validity or invalidity of a patent. A mere declaration means that no further action is taken against the patent apart from the fact that the court has declared that the patent is invalid. This is prohibited by Section 82(2) of the PA. Consequently, if any party wishes to launch a standalone action challenging the validity of the patent, it must be for the revocation of the patent.

Patent infringement in Singapore is territorial in nature. Consequently, only parties who carry out infringing acts within the jurisdiction can be sued for patent infringement.

If the patent covers a product, then as long as the party makes, disposes of, offers to dispose of, uses or imports the product or keeps it whether for disposal or otherwise, he/she can be sued for infringement.

If the patent covers a method of manufacture, then as long as the party uses the process or he/she offers it for use in Singapore when he/she knows, or it is obvious to a reasonable person in the circumstances, that its use without the consent of the proprietor would be an infringement of the patent, he/she can be sued for infringement. Relatedly, any product made from the said infringement process, would also constitute an infringement of the patent.

In Singapore, the typical defendant in life sciences/pharma cases is the generic that applies for marketing approval in Singapore for the sale of the pharmaceutical drug.

Under Regulation 23 of the Health Products (Therapeutic Products) Regulations 2016, when the Health Sciences Authority (HSA) is determining whether to approve a therapeutic product registration application or grant a product licence for a medicinal product, it considers:

• whether a patent under the Patents Act 1994 is in force in respect of the product;
• if the applicant is the patent proprietor, or has obtained the patent proprietor’s consent; and
• if the patent is invalid, or will not be infringed by doing the act for which the licence is sought.

This means that when the generic applies for marketing approval, it is required to notify the patent proprietor that it intends to apply for marketing approval, and give a declaration that the generic product does not infringe the patent. The patent proprietor then has the right to oppose the licence application by commencing a patent infringement action within 45 days from receiving notice of the generic’s licence application and declaration. Once the patent proprietor commences the action, it will inform HSA that it has done so, and HSA will not register the therapeutic product for a period of 30 months. At the expiry of the 30-month moratorium period, if the patent proprietor has not obtained an order and/or declaration of infringement from the court, HSA may proceed to register the therapeutic product without further notice to the patent proprietor.

If a generic makes a false declaration to HSA by omitting to disclose the existence of certain patents that were in force at the time of its application for a therapeutic product, the patent proprietor may seek a declaration from the Court that the generic has made a false declaration, and pursuant to Regulation 24 of the Health Products (Therapeutic Products) Regulations 2016, HSA may cancel the registration (see Millennium Pharmaceuticals, Inc v Zyfas Medical Co (sued as a firm) [2020] SGHC 28).

Any person who makes a false declaration may also be liable on conviction to a fine not exceeding SGD20,000 or to imprisonment for a term not exceeding 12 months or to both.

An application for an interim injunction in patent litigation follows similar principles as those in civil cases.

The applicant must show that there is a serious question to be tried, that damages are not an adequate remedy and that the balance of convenience lies in favour of granting an injunction. The procedure for obtaining an interim injunction is set out in Order 13 of the Rules of Court 2021. In exchange for obtaining an interim injunction, the claimant may be required to undertake to the court to compensate the defendant in the event that his/her claim fails and the interim injunction has caused the defendant loss.

An application for an interim injunction must be made by summons together with a supporting affidavit. The supporting affidavit should set out the nature of the alleged infringing acts, whether these acts are impending and/or continuing, the strength of the patent proprietor’s case on infringement and the strength of the validity of the patent. It should also provide evidence as to why damages are not an adequate remedy, thereby necessitating an interim injunction.

Most applications for interim injunctions are made with notice (ie, inter-partes). If the application is filed with notice, the alleged infringer will be given the opportunity to file a reply affidavit to set out its response. The court will manage the timelines. The alleged infringer is typically given 2–3 weeks to respond with its reply affidavit, and the application will be fixed for a hearing 4–6 weeks from the date that the application for interim injunction is filed. The application will be heard before a judge.

Where the case is urgent and where notice to the alleged infringer will significantly prejudice the patent proprietor or nullify any benefit of an interim injunction (if granted), the application may be made and heard without notice (ie, ex-parte). Even if the patent proprietor intends to file an ex-parte application for injunction, the Supreme Court Practice Directions 2021 requires the patent proprietor to give notice to the other concerned parties prior to the hearing. The notice may be given by way of email, or, in cases of extreme urgency, orally by telephone. Except in cases of extreme urgency or with the permission of the court, the party must give a minimum of two hours’ notice to the other parties before the hearing. The notice should inform the other parties of the date, time and place fixed for the hearing of the application and the nature of the relief sought. If possible, a copy of the originating process, the summons without notice or the originating application without notice (if no originating process has been issued yet) and supporting affidavit(s) should be given to each of the other parties in draft form as soon as they are ready to be filed in court. At the hearing of the application without notice, in the event that some or all of the other parties are not present or represented, the applicant’s solicitors should inform the court of:

• the attempts that were made to notify the other parties or their solicitors of the making of the application;
• what documents were given to the other parties or their solicitors and when these documents were given; and
• whether the other parties or their solicitors consent to the application being heard without their presence.

Notice need not be given if the giving of the notice to the other parties, or some of them, would or might defeat the purpose of the application without notice. However, in such cases, the reasons for not following the directions should be clearly set out in the affidavit prepared and filed in support of the application without notice.

Even if the interim injunction is not granted, a party may apply for an expedited trial of the action.

Although it is not a requirement, the court may take into account the expediency on which the application for interim injunction is filed. If an application for interim injunction is filed long after the alleged infringing product has been released in the Singapore market, then the court may infer that it is not a situation where damages cannot compensate the loss, because if that were true, the patent proprietor should have taken steps to arrest the problem and stop the release of the product as soon as possible.

In specific relation to therapeutic products to be registered in Singapore, pursuant to the Health Products Act (Cap 122D) and the Health Products (Therapeutic Products) Regulations 2016, a 30-month moratorium on registering the said products is available to patent proprietors who are put on notice that an applicant is seeking to register a therapeutic product which is related to a patent that is currently in force. This moratorium is automatic and will kick in on the date that the application for the moratorium is made. In practice, this is a more viable option than the customary qua timet injunction to prevent an imminent threat of infringement.

Infringement and invalidity are generally heard together due to the need to engage expert witnesses for common issues such as claim construction. It is very rare for the court to agree to bifurcate infringement and validity proceedings. The court will usually agree if there is a very clear case of invalidity. For example, prior to the amendment to the Singapore Patents Act in 2021, there was no grace period of 12 months for prior disclosures to be disregarded, unlike other jurisdictions (eg, USA). Consequently, prior sales within the 12-month grace period might have been excluded in other jurisdictions, but it will be considered as citable prior art in Singapore. In such situations, the court may be of the view that it would be better to bifurcate the infringement and validity proceedings, since the possibility of the patent being invalidated by its own poison prior disclosure is high.

While it is technically possible for another party to file nullity proceedings in court while patent office revocation actions are ongoing, in practice, once IPOS learns that nullity proceedings have been filed in court, IPOS will typically stay proceedings at IPOS pending the court’s determination on the matter.

Proceedings for patent infringement have to be commenced by Originating Claim in the General Division of the High Court. As patent infringement is a statutory tort, the limitation period of six years for an action founded on a tort applies. Where there is ongoing infringement of the patent in question, a fresh cause of action accrues every day. However, the patentee’s right to bring an action is restricted to the part of the wrong which was committed in the past six years.

While not mandatory, a letter of demand is usually sent before proceedings are commenced. This depends on whether the patentee wishes to engage the alleged infringer in negotiations prior to the commencement of proceedings. Under Order 5 of the Rules of Court 2021, the parties have a duty to consider amicable resolution of the dispute before commencement and during the course of any action. A party therefore has to make an offer of amicable resolution before commencing the action unless the party has reasonable grounds not to do so.

That being said, the patentee must be aware that in the event that the court eventually finds that the patentee’s patent has not been infringed, the court has the discretion to award the alleged infringer relief for groundless threats of infringement. Such relief could include a declaration that the threats are unjustifiable, an injunction against the continuance of the threats and/or damages for any loss sustained thereby. Where applicable, it is also prudent to conduct trap purchases before the start of any proceedings. A lawyer may conduct the trap purchases on behalf of its client, or a private investigator may be engaged to do so. A party does not need to wait for the patentee to commence a claim in the General Division of the High Court for patent infringement. If the party wishes to, it may commence a claim in the General Division of the High Court for a declaration of non-infringement of the patent. However, before commencing such an action for a declaration of non-infringement, the party must write to the patentee for a written acknowledgement that it does not infringe the patentee’s patent and furnish the patentee with full particulars in writing of the act in question and the patentee must have refused to provide such an acknowledgement.

A rough timeline is as follows.

• The claimant files and serves on the defendant the Originating Claim, Statement of Claim and Particulars of Infringement. The Particulars of Infringement must state which of the claims in the specification of the patent are alleged to be infringed, and must give at least one instance of each type of infringement alleged. The method of service is personal service, unless the defendant’s lawyers have written to the claimant’s lawyers to state that the defendant’s lawyers are instructed to accept service on behalf of the defendant. If the defendant is out of jurisdiction, the claimant must apply to court for permission to serve the Original Claim out of jurisdiction. Typically, since patent infringement acts are territorial, it is unlikely that the defendant will be out of jurisdiction.

• Within 14 days of the service of the Statement of Claim and Particulars of Infringement, the defendant has to file and serve a Notice of Intention to Contest or Not Contest in the proceedings.
• If the defendant intends to put in issue the validity of the patent (or just asserted patent claims, whichever the case may be), the defendant must give prior notice of his intention to put in issue the validity of the patent within 14 days of the service of the Statement of Claim by filing the Notice of Intention to Put In Issue the Validity of the Patent (“Notice”).
• If the defendant does not challenge the validity of the patent, its defence (and counterclaim if applicable) will be due within 21 days after the Statement of Claim is served on the defendant, whichever is the later date. If the defendant files the Notice, the defendant has to file its defence and counterclaim and Particulars of Objection within 42 days of the service of the Statement of Claim.
• A claimant will no longer have an automatic right of reply to the defence. If the claimant wishes to file a reply, it will have to seek the court’s permission to do so.

Thereafter, the parties will typically proceed to the discovery stage. Once pleadings are filed, the court will hold a case management conference to ask the parties’ views on whether, amongst others, this is a case where AEICs should be exchanged before discovery. Although the court may, in some cases, direct that affidavits of evidence-in-chief (AEICs) be exchanged first before discovery, in practice, this is unlikely to happen for patent infringement matters where the parties have no existing commercial relationship (unlike, for example, contract matters). It is also usually on or around this time during the case management conference, that the court will decide whether the proceedings should be bifurcated or not, either on its own volition or pursuant to an application from a party in the proceedings. It is more common for the court to bifurcate the issue of liability/invalidity and the issue of damages. As explained above, infringement and invalidity are generally heard together due to the need to engage expert witnesses for common issues such as claim construction.

If the court directs that discovery proceeds first, then after discovery (and the disposal of all interlocutory applications and/or interim orders), affidavits of evidence-in-chief (AEICs) will be exchanged. It is usually on or around the stage of the exchange of AEICs that the court will deal with whether the issues of claim construction will be considered separately from or together with infringement and/or validity, and in general how the trial of the matter should be conducted.

It typically takes around 1.5 to 2 years or more from the commencement of the proceedings to obtain a first instance decision.

Further, with effect from 1 April 2022, the Supreme Court of Judicature (Intellectual Property) Rules 2022 introduced a simplified optional track for intellectual property litigation known as the “Simplified Process for Certain Intellectual Property Claims” (“Simplified Process”) to resolve intellectual property disputes in a quicker and more cost-effective manner. The Simplified Process is applicable for certain intellectual property claims (including actions of patent infringement under Section 67 of the PA and declaration of non-infringement of a patent under Section 78 of the PA) where (i) the monetary relief claimed by each party in the action does not or is not likely to exceed SGD500,000, or (ii) where all parties agree to the application of the simplified process. A case may also be suitable having regard to:

• whether a litigant can only afford to participate in the proceedings under the simplified process;
• the complexity of the issues;
• whether the estimated length of the trial is likely to exceed two days; and
• any other relevant matter.

For claims under the Simplified Process, the total costs recoverable is subject to an overall cap of SGD50,000 for the trial, and an overall cap of SGD25,000 for any separate assessment of monetary relief. In line with the spirit of streamlining intellectual property dispute resolution, the court will also give directions on all matters relating to the dispute expeditiously and where practicable, will endeavour to ensure that the trial is completed within two days.

An infringement action can be filed the moment the patent is granted in Singapore. All patent applications filed in Singapore must be filed in English, so there is no requirement for patents to be further translated.

Generally, the patentee bears the burden of proving that its patent has been infringed. However, the burden of proof is reversed in patent infringement proceedings involving a process for obtaining a new product. In such proceedings, the alleged infringer bears the burden of proving that the product is not made by that process if (i) the product is new, or (ii) substantial likelihood exists that the product is made by that process and the patentee has been unable through reasonable efforts to determine the process actually used. There is no automatic requirement for the defendant to provide a process description. If the claimant wishes to compel the defendant to do so, the claimant may apply for the defendant to furnish such details by way of an application to court for discovery or interrogatories. In Towa Corporation v ASM Technology Singapore Pte Ltd and anor [2014] SGHCR 16, the Singapore High Court Registrar held that the Singapore High Court has no jurisdiction to order an inspection of a process in a patent infringement action under Order 29 Rule 2 of the Singapore Rules of Court 2014 (equivalent to Order 13 Rule 2 of the Singapore Rules of Court 2021). This decision has not been overturned by any appellate decision.

Under Order 11 Rule 11 of the Rules of Court 2021, the claimant may seek pre-action discovery and pre-action interrogatories (collectively referred to as “pre-action disclosure”) against a defendant prior to commencement of proceedings against a party to compel it to make disclosures of documents and facts in order to help the claimant ascertain whether he/she has a viable cause of action against a potential defendant. Further, pre-action disclosure may be sought against non-parties to the proceedings in order to identify possible parties to the proceedings.

Pre-action discovery is for the claimant who is unable to plead a case as he/she does not know whether he/she has a viable or good cause of action and requires the discovery to ascertain the gaps in his/her case. Where the claimant has evidence sufficient to commence a claim, he/she is generally not entitled to discovery before action in order to fully plead his/her case. Pre-action discovery is also not designed to allow a party to determine whether it is likely to succeed in its cause of action against a potential defendant. Nor is it designed to allow a claimant, who already has an accrued cause of action, to uncover other causes of action.

An application for pre-action disclosure has to be supported by an affidavit setting out the grounds for the application, the material facts pertaining to the intended action, and whether the person against whom the order was sought was likely to be a party to subsequent proceedings. The applicant also has to prove that the defendant has possession, custody or power of these documents. These documents must also be proved to be relevant to the intended action. In other words, the scope of the pre-action discovery should be substantially similar to the scope of discovery expected during the main action (if launched).

The court must be satisfied that the pre-action disclosure is not frivolous or speculative, and that the claimant is not on a fishing expedition. The costs for the pre-action discovery is borne by the applicant.

Under Singapore law, there is an implied undertaking by a party who receives documents in discovery not to use these documents for a collateral purpose, which includes proceedings in other jurisdictions.

It may be possible to use materials obtained in other jurisdictions. That is dependent on the laws of the particular jurisdiction from which the party obtained these documents. If there is no similar prohibition for use of these documents, then the party can use those documents in Singapore. If there is a similar prohibition, then the party who intends to use these documents obtained in other jurisdictions must satisfy the court in Singapore that permission was by the court of law in that jurisdiction to use these documents in Singapore.

Under Rule 37 of the Supreme Court of Judicature (Intellectual Property) Rules 2022, there are classes of documents that are exempt from discovery. These classes of documents are likely to be similarly exempted from the scope of pre-action discovery. More details relating to the exempt classes of documents are discussed below.

Under Order 13 of the Rules of Court 2021, search and seizure orders (previously known as Anton Piller orders) are available in Singapore. There is no requirement for the main action to be started as part of the application.

In view of the draconian nature of the search order (which is usually made ex-parte in light of the risk that the defendant may destroy or conceal the documents and/or incriminating material), the court will have to balance the claimant’s right to seize and preserve evidence against the violation of the privacy of the defendant who had no rights to defend him-/her-self at the ex-parte hearing.

• There must be an extremely strong prima facie case of a civil cause of action. A scrutiny of the merits of the plaintiff’s case is an essential preliminary to the grant of a search order.
• The damage, potential or actual, to the plaintiff to be avoided by the grant of an order must be very serious. If an order is sought in order to forestall the destruction of evidence, the evidence in question must be of major, if not critical, importance.
• There must be clear evidence that the defendant has in his/her possession incriminating documents or items.
• There must be a real possibility that the defendant may destroy such material before an application inter partes can be made.

The requirements for a search order therefore goes beyond what is required for pre-action discovery. It is a pre-requisite to a search order that the materials that the claimant intends to seize is relevant and necessary to the action.

It may be possible to use materials obtained in other jurisdictions. See 1.7 Pre-action Discovery/Disclosure.

A patentee may rely on Section 67(1)(e) of the PA to seek a declaration that the patent in suit is valid and has been infringed by the defendant. Conversely, a defendant or any person may rely on Section 78(1) of the PA to seek a declaration that an act or proposed act would not constitute an infringement of a patent if the following conditions are met:

• the proprietor of the patent has not made any assertion to the contrary;
• the person has applied in writing to the proprietor for a written acknowledgment to the effect of the declaration claimed and has furnished him with full written particulars of the relevant act; and
• the proprietor of the patent has refused or failed to give any such acknowledgment.

However, Section 82(2) of the PA further states that no proceedings may be instituted seeking only a declaration as to the validity or invalidity of a patent. A mere declaration means that no further action is taken against the patent apart from the fact that the court has declared that the patent is invalid. This is prohibited by Section 82(2) of the PA. Consequently, if any party wishes to launch a standalone action challenging the validity of the patent, it must be for the revocation of the patent.

To date, the Singapore Court has not dealt with “Arrow” declarations. It remains to be seen whether this will be recognised in Singapore.

The general principle under the doctrine of equivalents is that a device which is functionally equivalent to the patented invention will be held to infringe it, notwithstanding that certain essential features of the patented invention are absent from the device. This doctrine has not been accepted in Singapore on the basis that a wholly functional approach to claim construction objectionably disregards the clear and unambiguous words stated in the patent claims when such words must be given their natural and ordinary meaning.

The obligation for a generic to “clear the way” ahead of a new product launch is statutorily imposed in Singapore pursuant to Regulation 23 of the Health Products (Therapeutic Products) Regulations 2016.

It is very common for parties and consequently the court to rely on expert evidence for patent infringement and validity issues. This is because patent infringement and validity issues often require technical evidence which lawyers and judges require assistance with. In fact, most patent proceedings in Singapore rely heavily on expert-led evidence.

Experts may be called to give opinion evidence on technical matters and scientific information relating to the patent. Parties usually engage their own respective experts. While it is not common for parties to agree on a single joint expert for patent matters, pursuant to the new Rules of Court 2021, parties to all civil proceedings (including actions under the PA) commenced on or after 1 April 2022 must agree on a single expert as far as possible. No expert evidence may be used in court unless it is approved by the court. Expert evidence is admissible in relation to matters that ordinary persons are unlikely to have sufficient knowledge to give meaningful evidence.

Specifically, an expert may give evidence on:

• the prior art at any given time;
• the meaning of any technical terms used in the prior art and an explanation as to facts of a scientific kind;
• whether, on a given hypothesis as to the meaning of what is described in the patent specification, the specification can be carried out by a skilled worker;
• at any given time, what a given piece of apparatus or any given sentence on any given hypothesis would have taught or suggested to him/her;
• whether a particular operation relating to the art would be carried out; and
• what is common general knowledge to a person skilled in the art.

It is increasingly common for the Singapore courts to appoint a court expert (referred to as a Court Assessor) to assist the court in matters where the subject matter is highly technical.

It is the duty of an expert to assist the court on the matters within his/her expertise, and this duty overrides any obligation owed to the person instructing or paying him/her.

Unless the court otherwise directs, expert evidence is given in a form of a written report. This report must contain relevant details, including:

• the expert’s qualifications showing that he or she has the requisite specialised knowledge on the issues referred to him or her;
• the expert’s statement that he or she understands his or her duty is to assist the court in the matters within his or her expertise and on the issues referred to him or her and that such duty to the court overrides any obligation to the person from whom he or she receives instructions or by whom he or she is paid;
• the issues referred to the expert and the common set of agreed or assumed facts that he or she relied on; and
• a list of the materials that the expert relied on and including only extracts of the materials which are necessary to understand the report.

A party may with the court’s approval, request in writing that an expert clarify his or her report in any aspect. This report will be sworn by the expert in his/her AEIC, and either party may cross-examine the other party’s expert on the contents of his/her report. The court may also order that some or all of the expert witnesses give their evidence concurrently by testifying as a panel (ie, hot-tubbing).

A party which desires to establish any fact by experimental proof (the “Requesting Party”) shall serve a notice of experiments on the other party, stating the facts which it desires to establish and full particulars of the experiments proposed to establish those facts. Within 21 days of such service, the other party is to serve upon the Requesting Party a notice stating whether or not he/she admits each fact.

Where any such fact is not admitted, the Requesting Party may seek an order for the experiments to be conducted. At this stage, the court will manage the conduct of experiments and timelines to ensure that there is judicious use of time and costs.

There is no closed list of types of documents that the parties are required to provide in discovery. As long as the category of documents is proved to be material to the issues in the proceedings, and that discovery is necessary, parties must disclose them and the court can order discovery of these documents.

In exercising its power to order discovery, the Rules of Court state that the court must bear in mind that a claimant is to sue and proceed on the strength of the claimant’s case and not on the weakness of the defendant’s case.

Types of documents that will have to be disclosed therefore include the following.

• 1. Proof that the alleged infringing samples were obtained from the defendant, ie, provenance and chain of custody of the alleged infringing samples.
• 2. Evidence of infringement, eg, technical analysis, expert reports, and lab reports.
• 3. If the patent is a process patent, the defendant will be required to disclose its method of manufacture. For this, the defendant can apply for a confidentiality order limiting the disclosure of its method of manufacture to named individuals.

The following classes of documents are exempted from discovery:

• (a) documents relating to the infringement of a patent by a product or process, if before serving a list of documents, the party against whom the allegation of infringement is made has served on the other parties full particulars of the product or process alleged to infringe, including if necessary drawings or other illustrations;
• (b) documents relating to any ground on which the validity of a patent is put into issue, except documents which came into existence within the period beginning two years before the claimed priority date and ending two years after that date; and
• (c) documents relating to the issue of commercial success (collectively referred to as the “exempt classes”).

Notwithstanding this, however, any party may apply for further and better production or specific production of any document in an exempt class.

Where the issue of commercial success arises in any proceedings relating to an action for infringement of a patent or a declaration of non-infringement of a patent or any proceedings where the validity of a patent is in issue, and where the commercial success relates to an article or product, the proprietor of the patent must serve a schedule containing the following details:

• (i) an identification of the article or product (for example by product code number) which the proprietor asserts has been made in accordance with the claims of the patent;
• (ii) a summary by convenient periods of sales of any such article or product;
• (iii) a summary for the equivalent periods of sales (if any) of any equivalent prior article or product marketed before the article or product mentioned in (i) above; and
• (iv) a summary by convenient periods of any expenditure on advertising and promotion which supported the marketing of the articles or products mentioned in (i) and (iii) above.

Where the commercial success relates to the use of a process, the proprietor of the patent must serve a schedule containing the following details:

• (1) an identification of the process which the proprietor asserts has been used in accordance with the claims of the patent;
• (2) a summary by convenient periods of the revenues received from the use of such process;
• (3) a summary for the equivalent periods of the revenues (if any) received from the use of any equivalent prior art process; and
• (4) a summary by convenient periods of any expenditure which supported the use of the process mentioned in (1) and (3) above.

It is not common for the court to grant discovery of inventor lab notebooks. Usually, the inventor’s subjective intentions and understanding of the patent and the motivations behind his/her invention are irrelevant. Validity issues and claim construction are always viewed from the lens of a person skilled in the art.

The two key defences to patent infringement are (i) the invalidity of the patent, which is a complete defence; and (ii) non-infringement.

While rarely relied on, a defendant may also rely on exceptions created by Section 66(2) of the PA for acts which would otherwise constitute infringement by virtue of being prohibited by Section 66(1) of the PA.

The main categories of exceptions in Section 66(2) of the PA are:

• acts which are done privately and for non-commercial purposes;
• acts which are done for experimental purposes relating to the subject-matter of the invention;
• uses of a patented product or process by aircraft and ships which had temporarily or accidentally entered into Singapore’s airspace or territorial waters (as the case may be) or by exempted aircraft or ships; and
• the parallel importation into Singapore, with consent of the foreign patentee or his/her licensee, of any patented product or any product obtained by means of a patented process or to which a patented process has been applied. Further, under Section 71(1) of the PA, a person who in Singapore before the priority date of the invention does in good faith an act which would constitute an infringement of the patent if it were in force, or makes in good faith effective and serious preparations to do such an act has the right to continue to do that act notwithstanding the grant of the patent.

In the event that post-grant opposition proceedings have commenced at the IPOS Registry prior to the revocation action in the patent infringement proceedings in the General Division of the High Court, the parties can consider whether any of the proceedings ought to be stayed, and if so, which one. While there are no provisions in the Rules of Court that provide for an automatic stay of proceedings, it is likely that parties will opt for the IPOS Registry proceedings to be stayed given that any appeal from the IPOS Registry would eventually be heard in the General Division of the High Court.

It is, however, unlikely for the Singapore Court to agree to any stay on the basis of foreign proceedings since the patent will be different, and the acts are also different (based on territory).

The Singapore Court may take into account the decisions of the Court in other jurisdictions, but the Singapore Court is never bound. Further, the weight that the Court accords to the Court decisions in these other jurisdictions depends on whether the patent language in these other jurisdictions are substantially similar to the patent granted in Singapore and whether the basis of the Court’s finding is based on laws that are substantially similar in Singapore. For example, a finding of infringement for a US-equivalent of the patent on the basis of the doctrine of equivalents will not be relevant at all for the issue of infringement of the Singapore patent.

A patent that is the subject of a patent litigation may be amended in the midst of patent litigation. The patentee may only apply to do so if the validity of the patent has been put in issue before the court or the Registrar. This would usually be in a case where there is a counterclaim filed by the defendant in a patent infringement action to invalidate and revoke the patent.

Regardless of whether the amendment is sought before the court or the Registrar, a patentee intending to do so must give notice of his/her intention to the Registrar and a copy of an advertisement containing relevant details of the patent sought to be amended must be published in the patent journal by the patent Registry. Such details include the full particulars of the amendment sought, whether the amendment is by way of deletion or rewriting of claims and the patentee’s address for service within Singapore. Any person may oppose the amendment and that person must give written notice of his/her intention to oppose to the patentee within 28 days after the publication of the advertisement. This notice is to be accompanied by a statement of opposition, which is to contain full particulars of all grounds of opposition to the patentee’s application to amend. After the expiration of 42 days from the appearance of the advertisement, the patentee must make his/her application to amend by way of summons in the proceedings pending before the court. A copy of the summons and a copy of the specification with amendments marked up in coloured ink must be served on the Registrar, the parties to the proceedings and any person who has given notice of his/her intention to oppose the amendment.

All applications for post-grant amendments will be assessed according to the following criteria:

• whether the patentee had disclosed all relevant information with regard to the proposed amendments;
• whether the amendments comply with the statutory requirements;
• whether the amendments introduce additional matter;
• whether the amendments extend the scope of protection of the patent (ie, the amended patent is broader than the patent in its current form);
• whether there had been undue and inexplicable delay on the patentee’s part in taking out the amendment application;
• whether the patentee had sought to obtain an unfair advantage from the patent by delaying the amendments which it knew were needed; and
• whether the patentee’s conduct discourages the amendment of the patent.

Following a successful application to amend the patent specifications, the patentee (ie, the claimant) may be in a better position to resist any claims from the defendant that the patent in the suit is invalid on the ground of anticipation by the prior art. This is generally why a patentee seeks to amend its patent. However, the adverse implication to an application to amend a patent specification is that it indicates to the adverse party and to the court that the unamended patent as granted may not be valid. In cases where the amendment is sought in proceedings before the court, the court has the discretion to direct whether the hearing of the patent amendment application should be at the trial of the patent infringement suit or separately before the trial of the patent infringement suit. While the patent amendment application is considered an interlocutory application where cross-examination of deponents is typically not allowed, given the complexity and the finding of facts involved in a patent amendment application, expert witnesses are usually cross-examined at the hearing of a patent amendment application that is separate from the trial of the suit.

The concept of conditional amendments has not been tested in Singapore.

All patent matters will be heard by judges sitting in the General Division of the High Court of Singapore. Judges chosen to hear patent matters will typically be selected from the list of Intellectual Property Judges.

As mentioned in 1.2 Defendants/Other Parties to an Action, generics are required to obtain marketing approval from HSA before they are allowed to launch the product in Singapore. Regulation 23 of the Health Products (Therapeutic Products) Regulations 2016 provides the patent proprietor a statutory right to commence an action for patent infringement once the patent proprietor is notified of the generic’s application for marketing approval.

In relation to second medical use patents (also known as Swiss-type claims), the patent proprietor must be able to prove that the generics intend to market that product for that second medical use.

An issue closely-intertwined with the infringement of patents with Swiss-type claims is whether the exclusion of the patent-protected indications from the product labels of potentially-infringing medical products would preclude a claim of patent infringement. The practice of excluding patented indications is often referred to as “skinny-labelling” or “carving out”. This is a developing area of the law, both in Singapore and in the UK. On the one hand, there have been some obiter comments in English case law that the problem of infringement posed by “skinny labels” is more theoretical than real, since product manufacturers often have to provide details of the approved indications on its product information leaflets. On the other hand, there have also been decisions in the UK and the Netherlands which suggest that manufacturers of “skinny-labelled” products may infringe a second medical use claim if there is a subjective intention on the part of the manufacturer that the pharmaceutical composition will be used for treating the patented indication. It should be noted that unlike in the UK Patents Act, there is no provision for indirect infringement in the Singapore PA. As there have been no reported local cases on this issue, it remains to be seen how the Singapore courts will decide on this issue.

Regulation 26 of the Health Products (Therapeutic Products) Regulations 2016 provide for protection of confidential information relating to innovative therapeutic product applications. Confidential information received in support of the registration of an innovative therapeutic product is protected for a period of five years from the date of receipt, during which HSA which will not use the information to determine whether to grant any other registration applications. Confidential information here includes trade secrets and information that has commercial value which will be diminished by disclosure.

Regulation 29 of the Health Products Regulations 2016 provide exclusivity of safety and efficacy data. A five-year period of exclusivity is granted for a therapeutic product for which safety and efficacy data has been generated in support of its registration. During the exclusivity period, a subsequent similar therapeutic product will not be able to rely on such data generated for the earlier therapeutic product to obtain registration.

The research exemption more commonly known as the “Bolar” provision protects generics who may need to conduct research and/or trials to prove that their generic version of the product is the bioequivalent of the patented drug or, who may, in the course of obtaining marketing approval for the release of a drug in Singapore, inadvertently infringe a patent.

All pharmaceutical products have to be approved by the Health Sciences Authority in Singapore before they can be marketed and/or sold in Singapore. These approval processes can take very long, and a generic may apply for marketing approval near the expiry date of a patent, with the intention of launching immediately once the patent expires.

The Bolar provision is therefore a legal exemption from infringement if the generic can prove that the acts which otherwise would have been infringing, were done for meeting the marketing approval requirements for the pharmaceutical product.

There is no equivalent of the Orange Book in Singapore.

Singapore has a patent linkage scheme, which is set out in Regulation 23 of the Health Products (Therapeutic Products) Regulation 2016. HSA oversees the administration of these regulations.

In specific relation to therapeutic products to be registered in Singapore, pursuant to the Health Products Act (Cap 122D) and the Health Products (Therapeutic Products) Regulations 2016, a 30-month moratorium on registering the said products is available to patent proprietors who are put on notice that an applicant is seeking to register a therapeutic product which is related to a patent that is currently in force. This moratorium is automatic and will kick in on the date that the application for the moratorium is made. In practice, this is a more viable option than the customary qua timet injunction to prevent an imminent threat of infringement.

There is no public list of applications for marketing approval. Patent proprietors therefore rely solely on the generic’s notice identifying the relevant patents relating to the generic product. Patent proprietors can file a court declaration if the generic is found to have falsely declared in its notice by excluding patents that are relevant to the drug for which the generic has applied for marketing approval.

There has been no known suit against HSA for the refusal to list or grant marketing approval. Since HSA is a statutory body imbued with the authority to grant marketing approvals, any administrative suits will be a judicial review of HSA’s decision.

There are no differences at present in this jurisdiction. See 2.1 Infringing Acts.

There are no differences at present in this jurisdiction. See 2.2 Regulatory Data and Market Exclusivity.

There are no differences at present in this jurisdiction. See 2.3 Acceptable Pre-launch Preparations.

There are no differences at present in this jurisdiction. See 2.4 Publicly Available Drug and Patent Information.

There are no differences at present in this jurisdiction. See 2.5 Reimbursement and Pricing/Linkage Markets.

Under Section 36A of the PA, the proprietor of a patent which subject includes any substance which is an active ingredient of any pharmaceutical product may apply to extend the term of the patent not exceeding five years if there was an unreasonable curtailment of the opportunity to exploit the patent caused by the process of obtaining marketing approval for a pharmaceutical product, being the first pharmaceutical product to obtain marketing approval which uses the substance as an active ingredient; and the term of the patent has not previously been extended on this ground.

There are no extended protection provided for paediatric indications over and above the allowable five-year extension.

See 1.3 Preliminary Injunction Proceedings.

It is not common to apply for an interim injunction for patent cases involving pharmaceutical patents or health products in view of the patent-linkage scheme, which gives the patent proprietor a statutory right to, in effect, a qua-timet injunction of 30 months the moment the patent proprietor files a patent infringement suit against the generic.

In exchange for obtaining an interim injunction, the claimant may be required to undertake to the court to compensate the defendant in the event that his/her claim fails and the interim injunction has caused the defendant loss.

Interim injunctions are enforceable from the date the order is made. A breach of the order will entitle the claimant to commence enforcement proceedings and contempt of court proceedings, which may include a custodial sentence for the directors of the defendant company against whom the interim injunction was ordered.

An appeal does not operate as an automatic stay of the interim injunction. The defendant must file an application for a stay pending appeal, and in so doing, the defendant must convince the court that if a stay is not granted, it will nullify the appeal. It is in practice difficult to convince the court of this since an interim injunction is usually a prohibitory injunction rather than a mandatory injunction, unless these is a time limitation of the defendant to do the act which is covered by the interim injunction and the expiry of the said time limitation will cause irreparable prejudice to the defendant should the defendant not act.

Generally, final injunctions are prayed for in the claimant’s Statement of Claim. While the court retains discretion as to whether a final injunction should be granted, if the court eventually finds that the patent in the suit has been infringed, the court will generally grant the final injunction. The standard form of final injunction is one which restrains the defendant “from making, disposing of, offering to dispose of, using, importing and/or keeping whether for disposal or otherwise products which infringe the patent in issue, and/or using or offering for use in Singapore processes which infringe the patent in issue”.

Final injunctions are enforceable from the date the order is made. A breach of the order will entitle the claimant to commence enforcement proceedings and contempt of court proceedings, which may include a custodial sentence for the directors of the defendant company against whom the final injunction was ordered.

Unlike an interim injunction, there is no requirement for the patent proprietor to give an undertaking as to damages or to pay a bond before it can enforce the final injunction.

An appeal does not operate as an automatic stay of the final injunction. The defendant must file an application for a stay pending appeal, and in so doing, the defendant must convince the court that if a stay is not granted, it will nullify the appeal. For example, if the injunction covers the whole of the defendant’s business, and the defendant will no longer be able to finance the appeal if the injunction is in place, the defendant may be able to convince the court that stay should be granted.

Injunctions are an equitable remedy. Consequently, the court will have the discretion to decide whether it should award injunctive relief.

In practice, once the court finds that there is infringement, the court will readily order a final injunction unless the defendant has given evidence that it has already ceased with the alleged infringing activities even before the order was made, such that an injunction is of no use.

A successful claimant is entitled to damages as compensation for the loss that it suffered due to the infringement. Typically, patent infringement claims are bifurcated, and damages are assessed at a separate inquiry held subsequent to the infringement trial.

In a great deal of cases where the patent proprietor does not have a competing product of its own, the proper measure of damages is a reasonable royalty in respect of each infringement committed. If the patentee habitually grants licences at a particular royalty, quantum is easy to estimate. Even if he/she does not, an estimate can be made.

Claims to larger damages can be made, on the ground that the patentee has lost profits, or, for example, has had to reduce his/her prices. The patent proprietor has to elect whether it intends to claim damages, or loss of profits. It cannot claim both. The onus is on the claimant to prove that his/her lost profit has resulted from the infringing acts and that if those acts had not taken place, he/she would have made the profits. If he/she cannot, the reasonable royalty basis will apply. Claims are often made for other damages (for example, loss of sales of related products not covered by the patent, or loss of orders of spare parts or loss of service contracts).

Damages/loss of profits will be calculated from the date of when the infringing activities occur and when the patent is valid and in force, subject to the limitation period of six years. There will be interest fixed at 5.33% per annum. This interest is determined and fixed by the court for all post-judgment interest.

A successful party will be able to recover about 30% to 40% of its legal costs from the losing party and 100% of court filing fees and reasonable disbursements from the other side. These costs are generally awarded on a standard basis (ie, the winning party will be able to recover costs that were reasonably incurred and are reasonable in amount, and any doubts that the court may have as to whether the costs were reasonably incurred or were reasonable in amount shall be resolved in favour of the paying party). Costs are awarded at the discretion of the court, and in exercising its discretion, the court must have regard to all relevant circumstances, including:

• efforts made by a party at amicable resolution;
• the complexity of the case and the difficulty or novelty of the questions involved;
• the skill, specialised knowledge and responsibility required of, and the time and labour expended by, the solicitor;
• the urgency and importance of the action to the parties;
• the number of solicitors involved in the case for each party;
• the conduct of the parties;
• the principle of proportionality; and
• the stage at which the proceedings were concluded. Additionally, the court may disallow or reduce a successful party’s costs or order that party to pay costs if:
1. that party has failed to establish any claim or issue which that party has raised in any proceedings, thereby unnecessarily increasing the amount of time taken, the costs or the complexity of the proceedings;
2. that party has done or omitted to do anything unreasonably;
3. that party has not discharged that party’s duty to consider amicable resolution of the dispute or to make an offer of amicable resolution; or
4. that party has failed to comply with any order of court, any relevant pre action protocol or any practice direction.

In appropriate cases, the court also has the discretion to order costs to be assessed on an indemnity basis (ie, the winning party will be able to recover all costs except those that have been unreasonably incurred or are unreasonable in amount, and any doubts which the court may have as to whether the costs were reasonably incurred or were reasonable in amount shall be resolved in favour of the receiving party). A defendant may apply for a security for costs (SFC) order, which requires the claimant to put up a certain amount of money as security/guarantee for the defendant’s legal costs in the event the claimant loses his/her case. For the avoidance of doubt, the legal costs referred to here are Party-and-Party Costs (“P&P Costs”). Usually, a losing party must pay the winning party’s P&P Costs. P&P Costs are not the legal fees a party pays to his/her lawyer, which are called Solicitor-and-Client Costs (“S&C Costs”). P&P Costs are not meant to compensate the winning party for his/her S&C Costs and are generally far lower than S&C Costs. However, P&P Costs still go some way towards the winning party recouping its expenses. SFC applications are usually granted when the court is persuaded that the defendant will have difficulty obtaining P&P Costs from the claimant if the claimant’s claim fails. The grounds on which an SFC application can be sought is set out in Order 9 Rule 12 of the Rules of Court 2021:

• where the claimant is ordinarily resident out of the jurisdiction;
• where the claimant is a nominal claimant who is suing for the benefit of some other person and that there is reason to believe that he/she will be unable to pay the costs of the defendant if ordered to do so; or
• where the claimant has not stated or has incorrectly stated the claimant’s address in the originating claim or originating application, or the claimant changed the claimant’s address during the course of the proceedings so as to evade the consequences of the litigation.

Along with the grounds above, the court will still have regard to all the circumstances of the case and order the SFC if the court thinks it just to do so. The process of obtaining SFC is started by the defendant writing to the claimant requesting for security to be provided. If the claimant refuses, the defendant will have to make a formal application to court by way of summons supported by affidavit. This affidavit will contain the defendant’s reasons for wanting security to be provided and the amount of security sought. If the court grants an application for SFC, the claimant may provide security by way of depositing the sum of monies into an account held by the Singapore Court, or by way of a bank guarantee, or by way of a solicitor’s undertaking.

For claims under the Simplified Process, the total costs recoverable is subject to an overall cap of SGD50,000 for the trial, and an overall cap of SGD25,000 for any separate assessment of monetary relief. In line with the spirit of streamlining intellectual property dispute resolution, the court will also give directions on all matters relating to the dispute expeditiously and where practicable, will endeavour to ensure that the trial is completed within two days.

See 5.5 Legal Costs.

A health product is counterfeit if it is presented in such a manner as to resemble or pass off as a registered health product when in fact it is not, or it is presented with any false information as to its manufacturer or origin (Section 2(2)(b), Health Products Act).

The principal regulatory agency tackling the problem of counterfeiting in the pharmaceutical sector in Singapore is the HSA.

All health products (which includes Western medicines – also known as therapeutic products) must be granted a licence by the HSA before they are allowed to be marketed and sold in Singapore. This better enables the HSA to detect counterfeit, adulterated and/or illegal health products at the first instance.

The manufacture, import or supply of a counterfeit health product in Singapore is an offence under the Health Products Act and is punishable by a fine not exceeding SGD100,000 and/or imprisonment for up to three years.

In this regard, the HSA has wide powers of enforcement, including the power to search premises that are suspected to be used for or in connection with the manufacture, import or supply of counterfeit health products. The HSA can also seize any health products that are suspected to be counterfeit.

In addition, the HSA continually monitors the safety, integrity and quality of health products, acting on its own independent surveillance reports as well as in response to reports or complaints from the public. The HSA also maintains a publicly accessible list of illegal health products in Singapore that have been detected and tested.

Copyright disputes in the life sciences and pharma sector are not common.

Trade secrets disputes in the life sciences and pharma sector are not common, save for situations where a patent infringement suit has commenced and the defendant has to disclose its manufacturing process to the patent proprietor to prove non-infringement. The generic’s manufacturing process may be a trade secret. In such situations, the generic will typically apply to establish a confidentiality club to limit the disclosure of its manufacturing process to only named individual members of the confidentiality club.

A party intending to appeal against a preliminary injunction decision has to file the Notice of Appeal one month from the date of the judgment or order. If the matter involves patents, then appellate court hearing the appeal will be the Court of Appeal.

The appeal will be heard by way of a rehearing. The matter will not be heard de novo. There is no further right of appeal after the Court of Appeal.

If the preliminary injunction is overturned on appeal, the preliminary injunction is lifted immediately from the date of the order.

For the substantive suit, the parties have a right of appeal to the Court of Appeal. Appeals to the Court of Appeal are by way of a rehearing. The parties are entitled to appeal on all issues, including findings of facts. When filing the appeal, the party must therefore indicate whether it is appealing against the whole or part of the judgment or order.

If the matter is bifurcated into validity tranche and infringement tranche, the parties will have a right to appeal the trial judge’s decision in each of these tranches. Procedurally, the matter will not move to the second tranche (assuming the patent is found to be valid) until the issues in the first tranche have been completely disposed of, including the exhaustion of any appeals.

In general, the Court of Appeal will be slow to upset an exercise of discretion by the trial judge. In relation to finding of facts, an appellate court is also generally slow to overturn a trial judge’s findings because the trial judge is in a better position to assess the veracity and credibility of the witnesses, unless they can be shown to be plainly wrong or against the weight of the evidence. Similarly, in relation to patent matters, an appellate court will be cautious in differing from the trial judge’s evaluation of what was obvious.

On the other hand, there is a distinction between the perception of facts and evaluation of facts, the latter of which an appellate court is in as good a position as the trial court to make an evaluation from primary facts.

If a final injunction is overturned, or if the patent is revoked, the final injunction will be lifted immediately from the date of the order. For completeness, the Court of Appeal will usually include in its orders that all orders by the trial judge (including the order for the final injunction) are set aside, if the appellant is successful on appeal.

Singapore has specialised Intellectual Property Judges who will be docketed to hear patent matters.

The substantive act that governs patents in Singapore would be the Patents Act.

There are two sets of court rules that govern IP matters.

The first set of rules will be the Rules of Court 2021, which applies to all court proceedings regardless of subject matter.

The second set of rules will be the Supreme Court of Judicature (Intellectual Property) Rules 2022, which applies in addition to the Rules of Court 2021, for matters involving IP.

No information has been provided in this jurisdiction.

Under the Order 5 of the Rules of Court 2021, the parties are obliged to consider ADR options before commencing a claim.

Intellectual property (IP) disputes are capable of being resolved by arbitration as between parties to that dispute under Singapore law, although this is not a common dispute resolution option for patent matters as it requires both parties to agree to refer the matter to arbitration.

Mediation is another possible, and more common, alternative dispute resolution (ADR) option. The parties can request to refer the dispute to mediation at any time before the case has been decided. In general, the court and/or IPOS will ask parties to consider ADR options such as mediation to resolve the dispute. This is especially when Order 5 of the Rules of Court 2021 requires the parties to attempt an amicable resolution to the dispute.

There are various mediation service providers in Singapore. Apart from the Singapore Mediation Centre and the Singapore International Mediation Centre that handles general mediation disputes, the World Intellectual Property Organization Arbitration and Mediation Centre (“WIPO Centre”) is a global mediation provider that specialises in IP disputes.

If parties attempt mediation, the court and/or IPOS will, at the request of the parties, generally allow a stay of proceedings pending the outcome of the mediation. A failure or refusal to genuinely consider ADR options may lead to an adverse costs order being made against the refusing party.

The Competition and Consumer Commission of Singapore has released guidelines on the licensing of SEPs on FRAND terms. Where an owner of an SEP has a dominant position in the market, its refusal to license its SEP on FRAND terms to any application for a licence may give rise to competition concerns under Section 47 of the Act. However, there is no known decision in Singapore regarding SEPs yet.

Further, the life sciences industry has not had to deal with SEPs yet.